India’s Private Health Care Delivery: Critique and Remedies [1st ed. 2021] 9789811597770, 9789811597787

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Sanjeev Kelkar

India’s Private Health Care Delivery Critique and Remedies

India’s Private Health Care Delivery

Sanjeev Kelkar

India’s Private Health Care Delivery Critique and Remedies

Sanjeev Kelkar Pune, Maharashtra, India

ISBN 978-981-15-9777-0    ISBN 978-981-15-9778-7 (eBook) https://doi.org/10.1007/978-981-15-9778-7 © The Editor(s) (if applicable) and The Author(s), under exclusive licence to Springer Nature Singapore Pte Ltd. 2021 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Palgrave Macmillan imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-­01/04 Gateway East, Singapore 189721, Singapore

It is unfortunate that today’s health system benefits every stakeholder except the patient. Author The tragedy and the limitation of today’s health care system is that it needs a live patient to practice its trade. Health care would be equally happy if it could do it through dead patients. Author

Dedicated to (Late) Professor V S Ajgaonkar, my first teacher during my postgraduate years Professor R D Bapat, the humanist surgeon from Mumbai

Preface

The most relevant and basic questions regarding private health care sector are: What were the ideas the private health care delivery had to start with? How did more ideas appear and how has private medical care in India evolved? What is its place in the total context of health and people? How has it changed the larger social, economic and political situation and India’s health care delivery over the last 50 years? How many reasonable and relevant solutions has it offered to satisfactorily solve health issues ? That is to say, have these ideas and workings resulted in a health care delivery system by making it accessible, affordable, high quality and endowed with equity and justice? How many challenges has it addressed efficiently or how many new challenges has it created for good or for ill? And finally, what is the balance between benefits and injury caused to health care? These questions have an added dimension today in mid-May 2020 of the Covid-19 pandemic and the destruction it has caused worldwide, including in India. The final manuscript of this volume went into the pre-­ publishing process in the second week of February 2020. The Covid-19 lockdown started on March 25, 2020. I considered it essential to have a brief overview of the Covid-19 situation and assess the role, contribution and relevance of private health care in India vis a vis Covid-19. Sectors such as pharmaceuticals have considered this an unprecedented, once-in-­ a-lifetime opportunity to make money (see below). For me it was a lifetime opportunity to test the many elements, observations, shortcomings and other injurious effects of the private sector, as well as its contribution to the fight against Covid-19. It is also a lifetime opportunity for me to ix

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weigh the measures suggested by me with respect to the private sector regarding its current suitability and effectiveness. In my 49 years in medicine I have never found the health system of any country prior to 2020 in such great difficulties.

Covid-19 as a Disease as Such Covid-19 has given rise to many controversies and accusations on the global scale which we will discuss before turning to India. Is it a biologically present virus which for various reasons has spread across the world at an alarming speed causing diabolical destruction or is it a virus created in a laboratory by China with a view to destroy the global economy and to gain economic and hegemonic supremacy over the world as a whole and Western economies in particular? At the World Health Assembly in May 2020, 123 nations asked for an investigation into China and its role in the WHO; the accusations of China destroying early evidence of Corona has lent this scenario a sinister dimension. Why did it spread along the 40° latitude so rapidly with devastating results in Europe, particularly in Western nations such as Italy, Spain, France, Germany and the US, where an enormous number succumbed very quickly? None of these nations were particularly keen on lockdown initially, even vacillating over it, and they have paid the price. Why did it then spread to South America with Brazil becoming the new epicenter, and then other nations such as Australia and countries in Africa later than this, breaking the 40° N latitudinal boundaries? What were the reasons for the initial deaths being confined to older people, or the high numbers of African Americans and then scale-down to the younger population later? What are the pathological mechanisms which have caused these deaths? Why is it taking so long to flatten the curve of infections and deaths after such a long period of months? How long is it going to stay with us, or is it a permanent feature of our environs? One answer has been given for this question by Dr Shailendra Mundhada, a pathologist whose Dhruv Lab is the only private lab in Nagpur India, with permission from the National Board of Laboratory Accreditation to test samples. He says that it will enter into a differential diagnosis like SARS 2 or H1N1 in severe respiratory infections in a short while. Like other viruses its infectivity will go down, Dr Madhavi Deshmukh of Dhruv Labs stated (Mundhada and Deshmukh 2020). Dr Randeep Guleria, Director of the All India Institute of Medical Sciences, also stated on DD News on May 18, 2020 that the

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recovery rate will be nearly 90%, which in some ways supports these possibilities (Guleria Randeep, Dr Director AIIMS, May 18, 2020, DD News). For selecting the private labs to test Covid-19, the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation is the criterion the government has laid down for private labs to test Corona samples, while the government labs within public health care have been allowed to carry out testing without this quality check. This is somewhat odd since the test is delicate, needs careful handling from collection to the report stage. A chain of ten individuals is needed to conduct tests in a day (Mundhada and Deshmukh 2020). Thus the possibility of false negative tests may surface more particularly in government labs and the numbers reported so far could be higher, although these are already quite high. One fact has stood out with respect to the high-quality private sector setups—these have not come forward to test samples, probably because they did not want patients to come to them who could be positive. This is not an entirely valid reason since such a setup could easily have been made available at a distance from the entry gate of their hospital blocks to collect the swabs. Some other questions are: What is the inherent capability of the virus to mutate? Will such mutations make it more or less virulent? In the latter case will one vaccine do the job or will multiple vaccines will be needed? The two previously mentioned doctors from Dhruv Laboratories say that this possibility so far does not appear to be high. Or will it simply disappear by the time the vaccines come in? It will not, but the danger will diminish. The experts have acknowledged that the world has no experience of this virus to devise any strategies to combat it, except testing, isolation, contact tracing and treating seriously ill patients as best as possible, social distancing and mask wearing. Will there be a second wave or reinfections, especially when the influenza illness occurs? This question has been categorically answered in the negative by Dr RR Gangakhedkar, in a highly informative debate on DD News on May 18, 2020 (Gangakhedkar 2020). Three days without symptoms and a negative report is enough for discharge. He also pointed out that the two negative tests initially advised, after new data is screened are superfluous and earlier discharges will reduce the nosocomial, that is hospital-­acquired, infections, about which the medical profession is deeply concerned even on a day-to-day basis. There are scores of claims of vaccines or other therapeutic measures which are likely to be available within 12 to 18 months. There are also

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questions about how the successful therapies or vaccines could be ramped up for production. These questions will be dealt with here as there is a wide involvement of the public and private sector across the world and there is experience of successful developments with the recent Ebola virus and the effectivity of earlier viruses such as polio and smallpox.

The World Situation Why is the mortality rate among African Americans as high as 58% of those infected? Is it because of the limited access to economic opportunities or structural racism, or the socioeconomic disparity or some other cause? African Americans and Latinos are the poorest ethnic groups in the US. Fifty percent of these groups do not have/cannot afford private medical insurance and cannot pay their medical bills; they try to self-medicate and by the time they reach hospital it is generally too late (Gupta Dipankar 2020). In contrast, 70% of white Americans (and other higher-income groups) have private insurance. Italy is said to have a first-class health care system. So why did it suffer so badly? Why did the Russian health system crumble, giving rise to a high number of infections and deaths? Then there is a question mark about the dramatic and complete recovery of China, spurts of infected cases still arising, and what this means in terms of data on numbers and deaths reported by China. The extraordinarily high numbers from Europe and America did give India a massive scare, leading to lockdowns and stoppages of railways and airlines, both domestic and international. Without doubt these were extremely tough decisions and it is no longer questionable whether these were justifiable over the months of the Corona pandemic.

The Issue of Vaccines and their Complexities In the past, the process of developing a vaccine in order to make it available worldwide used to take 10 to 15 years. Today, with data sharing, a strong push and unprecedented global collaboration at high levels, the Corona vaccine should be in the hands of all nations in approximately 18 to 24 months. These three collaborations among 1. those engaged with discovery of a vaccine, and 2.  manufacturing, to  3.  all others connected with the logistical exercises listed below hopes to achieve this feat. In addition, there are many financial arrangements at the global level

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which could lead to even an experimental vaccine for the end users across the world. The 300,000 Ebola doses were made available when it was at the investigational and experimental stage. As of now there are more than 100 Covid-19 vaccines under development (Berkley Dr Seth 2020). After the discovery of a vaccine, the challenges the world will have to face will include: 1. Need for a global system to oversee the vaccine allocation; 2. Deciding who has the capacity to manufacture vaccine/s on a large/ required scale; 3. Managing the balance between first supplying the population of the nation where it is developed and then the other nations with equal or greater need; 4. Need for global access agreements, preferably even before a vaccine is available; 5. The two directions for such availability are, first, if there are threatening outbreaks which will involve continents; and second, priority use in non-threatening conditions, the category of which is formed by health workers followed by high-risk groups such as the elderly and those with co-morbidities, and lastly the general population; 6. The vaccine alliance on the global scale will have to strive for equitable distribution while also looking at the financial transactions on a massive scale, vis a vis the affordability and danger level of individual nations; 7. Pre-committed incentives to vaccine manufacturers for pneumococcal vaccine had spectacularly saved 700,000 children on introduction; let us hope that Covid vaccines do the same for us. 8. Building and preserving large storage capacities for vaccines for continuing or recurring use (Berkley Dr Seth 2020).

Diagnostics and the Public—Private Partnership The speed with which ICMR has widened the scope of testing should be appreciated. While RT-PCR remains the standard, ICMR has widened the range of options for testing for Covid-19, by including the much less expensive and simpler to perform test ELISA, developed by ICMR in collaboration with the National Institute of Virology, Pune. It has been in use

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in detecting TB, HIV, Ebola and Zika. It detects IgG antibodies against a particular infection and is approved for testing. It will indicate a later stage of Corona infection. ELISA for Covid-19 is approved only for surveys—in high-risk areas and segments such as containment zones, immuno-compromised individuals and frontline health workers, to scale up or down the public health activity depending on the level of infections detected in a community and, for prevention and control of the disease. In May, ICMR approved in quick succession two of the seven companies manufacturing these kits in India designed by Transasia Bio-Medicals Ltd., Mumbai and Euroimmun US, Inc. ICMR has evaluated 97 kits of various manufacturers for RT-PCR and approved 40 so far, which is commendable (Barnagarwala Tabassum July 14, 2020). As of May end, the ICMR had capped the cost of an RT-PCR test at Rs 4500 for private laboratories. That cap has now been removed and has been reduced to around INR 2500 at the maximum, and the states are to fix the costs. Initially, purchase of a separate machine was necessary, and more cost effective than purchasing a system with extremely high cost for testing multiple viruses. The earlier higher cost was also the result of the high costs of even simple ingredients such as alcohol due to transport and manufacturing logistics, (which have now decreased). The cost of  and involvement of 10 different human beings with some protective gear will remain the same. Rapid antibody test was accepted by ICMR for population surveys only, widening testing capacity. It also detects antibodies in the blood, within 20–30 minutes, and is much cheaper, costing Rs 600 less than ELISA and RT-PCR per test. It may, however, report false positives, and hence positives are retested by RT-PCR for confirmation or otherwise and negatives are left as is. ELISA is more accurate than a rapid test and this is why rapid tests have not been approved for diagnostic confirmation. If this were done the chain of a false positive, contact tracing, isolation and admission would be an exercise in futility, as well as being costly and arduous. ICMR has evaluated 46 rapid testing kits, and approved 14 so far. Eleven of these manufacturers are based in India. This is fast work. TrueNat works on the same principle as RT-PCR, but with a smaller kit, with small and portable machines, mostly running on batteries, and provides results within 60 minutes. It involves taking nasal or oral swabs. Across India there are over 800 machines to test for TB; and hence the government will not have to invest further in machines. It is also

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commonly used for HIV testing. Recently, the ICMR-approved TrueNat for screening and confirmation for Covid-19, further widening the net for more testing. If a sample tests positive, a second confirmatory assay called RdRp gene has to be performed; if it is negative it is treated as negative. In addition to this quick action, ICMR has also provided an algorithm for how, where and when to use these tests (Barnagarwala Tabassum July 14, 2020). This is a commendable achievement by the private sector in pandemic times. In addition to expanding the test base, a prompt and creditable action by the government of India procured RNA extraction test kits, crucial for the diagnosis of Covid-19, to the tune of 700,000 tests even before the available test kits had been used up. This was even more creditable since the Chinese test kits proved to be inferior and unusable, and were thus indefinitely suspended by the Indian Council of Medical Research (ICMR). The supply was secured when India wanted to exponentially increase the daily testing as it was preparing for relaxation of lockdown norms. The targeted number was 100,000 tests per day but only 75,000 tests could be performed by the public sector mechanisms. This number has been constantly scaled up—from a few hundred to 58,686 tests on April 30, 2020 (Barnagarwala Tabassum July 14, 2020). No private sector hospital is reported to have asked for the kits, with the lone exception of Peerless in Kolkata with a small 11-bed ICU for Covid-19 patients (Raghavan Prabha, April 30, 2020). The NABL accreditation in the private sector is widely available as a selling proposition but there is no willingness to make an effort in this direction. This would have made up for one of their deficiencies of unpreparedness to deal with Corona cases. The availability of Real Time Polymerase Chain Reaction (RTPCR) tests has increased from one lab to 292 government labs and 97 private ones, but the private hospitals do not seem interested in testing their patients, as shown below. The government once erred earlier, by asking the private labs to conduct the tests free of charge, which the private sector justifiably refused. Here was one place where a boost to diagnosis and all the steps that follow could have been given by allowing them this reasonable charge for all those who could afford it. This expectation, however, was later withdrawn. If the kits were provided free of charge there could have been a reduced tariff but this has not been the case thus far.

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The Private Sector in Pandemics, in India and Generally Pandemics are a government business, not of private sector was conveniently acceptable to the private sector in India becuase it was closed down by the government except for emergency care. In a Covid-19-like pandemic and this collective fight, the corporate health care system, based on the individual’s capacity to pay, doesn’t come to the rescue. If it did, the most privatized health care delivery system, that of the US, would have fared much better than it has in respect to its more than 80,000 deaths and more than a million infections, and counting. Italy’s Lombardy region was considered to be the most devastated province in Europe by Covid-19. From 1997, Lombardy and its Bergamo district enthusiastically started to convert its public health system into a private one. This link could be significant. Lombardy, with 16% of Italy’s population, ended up with 66% of deaths from Covid-19 in the country overall. Does privatizing health care help in times of pandemics? Most likely it does not. The problem of the considerable number of poorer people in any society remains and is accentuated in pandemics (Gupta Dipankar 2020). Americans generally do not support state health care. However, their experience with Covid-19 may result in a second look at public health care and its balance with private care. The ranks of Independents and Republicans seem to consider the public health care component more relevant than the private one. On average hospital revenues are down by 50%, and losses of giants like the Mayo Clinic have gone into the billions. Routine and more lucrative surgeries are at rock bottom. There is a decrease in the number of those receiving emergency treatment for stroke or heart attack. PPE costs have been a strain on budgets. The fiscal package of the US of $175 billion will cover only about 35% of the revenue lost by the private health care sector in the first quarter of 2020 (Thompson Dennis, May 6, 2020). This fiscal allocation may be too little or too late for those hospitals located in rural areas which are already in trouble. With Corona cases flaring these may be pushed to bankruptcy (Gupta Dipankar 2020). It is clear that in pandemics involving communicable diseases, privatization and the private sector do not work. The fear of the private sector to willingly come forward to treat Corona involves the subsequent contamination of their personnel and of their own setups once the pandemic is over, and the fear of associated stigma after the pandemic is over, as will be

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shown below. In addition, poor people, who are likely to be hit harder by pandemics, as shown above, are abandoned by the private sector. The weak public health care component, as a result of emphasis on privatization or a poor public health system tilting the balance in favor of privatization, does not come to the rescue of the most needy and those who are unable to afford the costs either. These numbers are generally considerable in any society, and cannot be handled by the private sector. Other reasons outlined in this volume such as each unit’s independence, vested interests, and a mindset of competition and not collaboration for a united fight have turned out to be relevant in this pandemic. There are many other reasons which have now surfaced which give little credit to the private sector, and these are discussed below mainly in the context of India’s fight against Covid-19.

Lessons to India As has been pointed out and emphasized repeatedly in this and the volume India’s Public Health Care Delivery: Policies for Universal Health Care, soon to be published (Kelkar Sanjeev 2020), there is no alternative but to build a strong public health care delivery system even if a private sector exists. This is the only way to deter the private sector from tendencies toward criminal profiteering. The pandemic has outlined this need clearly. It has been argued in several places here that a strong and well-functioning public sector performance should be a yardstick for the private sector to perform better than the public sector in order to survive and grow. Many other interrelated aspects between the two sectors have also been discussed in both of these volumes, with an understanding that there is a need for both in the mixed economic system of India (Kelkar Sanjeev 2020). In Britain, the government-run National Health Service (NHS) was preferred by nearly 90% of people in a 2015 survey (Gupta Dipankar 2020). The NHS has its deficiencies—it is considered by many as monolithic, monopolistic and unimprovable. Many influential British Conservatives have never supported the NHS and want to infuse private money into it in innovative ways. NHS funds have been curtailed. The same NHS, however, saved the life of the British Prime Minister Boris Johnson. Some rethinking may be in order.

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The Biopharmaceutical Sector The international alliance GAVI believes that Indian manufacturers have an important role to play in developing Covid-19 vaccine supply, as they do in the supply of high-quality vaccines globally. In this volume I have described why India is called the global cradle of drugs in the chapter on the pharmaceutical industry (of India.) Their record is also quite as good in vaccines. The expanded immunization program includes many new vaccines, and objections have been raised from the beginning by many about the validity of such measures, also labeling it as a money-making business without scientific rationale. For the time being we can leave this controversy behind and agree that a high level of vaccine production for many countries of the world including India will be considered a signal achievement for the pharmaceutical sector in general as and when it happens. There is another signal achievement of the Indian pharmaceutical sector of providing whatever drugs that were asked for by 123 countries, per the Prime Minister’s speeches during the Covid-19 pandemic. It matters little here whether drugs help in fighting Covid-19. India in April partially lifted a ban on the export of hydroxychloroquine and paracetamol following requests from US President Trump and the UK respectively. This is probably also an indicator that the production systems of these countries cannot swiftly ramp up the output in epidemic situations. Since this is a volume devoted to policy matters I will not go into the medical aspects of areas such as the effectivity, relevance or appropriateness of drugs. However, the games that are played when it comes to uncertain times and unproven/likely to be effective drugs will be outlined below. In all probability, the quality testing was suspended by USFDA when these bulk drugs were sent for immediate use. HCQS imports from uninspected plants in India and Pakistan according to the American vaccine expert were also allowed. It went to the extent of saying that “the Trump administration ignored the concerns of doctors about quality over the import of hydroxychloroquine thereby flooding the US with the unproven and potentially dangerous anti-malarial drug to treat corona virus patients.” It is a moot point whether the complaint was about Pakistan and the mention of India’s name was to soften the effects. Dr Rick Bright said he was ousted for questioning the potential of hydroxychloroquine sulphate (HCQS), an anti-malaria drug touted by President Donald Trump as a “game changer” for treating COVID-19 patients (Jha Lalit K, May 6, 2020).

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These kinds of statements, including serious life-threatening side effects for such a safe drug like HCQS and dangers of its administration, indicates certain other economic interests, internecine pharmaceutical wars for individual drugs from each one and so on. The only problem with these statements is that they diminish the small rays of hope for the population waiting for relief from this disease. Another laudable step taken by the government of India was to approve a 130 billion rupees ($1.7 billion) investment to make more bulk drugs and medical devices. This also aims to boost local manufacturing of drug intermediates and active pharmaceutical ingredients to cut dependence on imports from China, something the National Drug Policy 2017 has been aiming toward (https://economictimes.indiatimes.com/news/economy/foreign-­t rade/india-­l ooks-­t o-­l ure-­m ore-­t han-­1 000-­a merican-­ companies-­o ut-­o f-­c hina/articleshow/75595400.cms?utm_source= contentofinterest&utm_medium=text&utm_campaign=cppst. May 7, 2020). This is discussed as a necessity under pharmaceuticals; the government has cashed in on the anti-China sentiment to reduce China’s 60% share in the pharmaceutical sector without much ado.

Reaction of Private Sector Health Care: The Indian Scenario 1. The orders to restart the OPDs and routine practice after the initial prohibition, and another order saying not to do this now, led to confusing and contradictory signals from the same government, leaving the doctors in a quandary. They were later given just a few days to equip themselves with standard operating protocols to screen, transfer, admit and discharge patients. The timeline is a significant element. April 30 was the 38th day of the lockdown and the response of the private sector till then was to stay away from Covid. That attitude necessitated such orders. The private sector is now being directly pressured in Maharashtra because the government is finding it far beyond its ability to cope with the massive numbers of Corona cases which they had boasted about in handling. 2. As has been pointed out, money and profiteering are a reflex habit within the private sector. The bills are running in 0.4 to 1.6 million rupees  for a stay of 10 to 15  days. The  day-to-day routine tests were charged at 3 to 4 times more during Covid. Even the cost of

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the personal protective equipment (PPE) billed to the patients has skyrocketed (Nagarajan Rema, May 2, 2020). Do the PPEs really cost so much? In a reputed tertiary institute in Nagpur this is being provided for INR 1100. There may be more sophisticated varieties but there will be adequately quality-tested, lower-cost options also. If Indian women can produce PPEs and masks to the tune of 200,000 per day for weeks after the lockdown PPE cannot be a high-cost, complicated product. When a hospital is fueled by a desire to make up for the money being lost during this period, PPE comes in handy in increasing their bills. 3. The Brihanmumbai Municipal Corporation (BMC) issued a show cause notice dated June 6, 2020, to Lilavati Hospital for exorbitantly overcharging patients admitted under the government quota of 80% of its beds which were taken over by the administration. Following the notice, the hospital refunded the money. 4. It took three weeks of long negotiations to fix the maximum permissible charges on a per-day basis and notify these on May 22, 2020 for a Covid-19 patient. Charges fixed for isolation ward were Rs. 4000, intensive care unit (ICU) Rs.7500 and ventilator charges Rs 9000 per day. These charges were to include drugs, doctor consultation fees, nursing, food and bed charges. They will, however, exclude a Covid-19 test, personal protective equipment, MRI, CT scan and expensive drugs like tocilizumab. 5. Earlier, a Covid-19 patient would usually be charged Rs 40,000–50,000 for a ventilator per day in a private hospital. Hospitals have been instructed to take no more than Rs 70,000 as advance deposit for quota patients. Earlier it was reported to be 150,000 to 200,000. PPE kits were to be charged with a 10% markup (Barnagarwala Tabassum July 14, 2020). 6. The state of Gujarat also took over 50% beds from private hospitals with specified charges using other schemes or insurance scheme rates, but it also specified how much the hospitals should charge for beds under these  early. In stark contrast, Maharashtra has allowed 20% of hospital beds to be charged at their own discretion (Sandeep Acharya, May 17, 2020). 7. In the first two months of Corona, most of the five star hospitals, instead of cooperating, looted the patients or refused treatment, defying the Epidemic Disease Act of 1897. When the Chief Minister spoke to these hospitals the officer of the Mahatma Phule

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Jeevandayee Scheme, an earlier equivalent of Ayushman Bharat, Sudhakar Shinde, read out a long list of exorbitant charges made by these hospitals, which left most present speechless. 8. There is no reason why the rate fixation and/or participating in the fight against Corona took so long in Mumbai, unless it was over cost and tarrif. A number of rate charts were available under the Mahatma Phule Scheme, (see above), the General Insurance Public Sector Association (GIPSA) rates, and the Ayushman Bharat (Barnagarwala Tabassum Mumbai, May 14, 2020). 9. If this does not indicate unwillingness to accept or participate what else does it mean?

General Non-Cooperation of the Private Players in Dealing with Corona-Infected Individuals As soon as the lockdown was announced on March 23, 2020, all hospitals and medical establishments of different sizes and levels were asked to stop all routine activities of care and to attend to only emergency patients. In the initial scare caused by Italy it would be considered sensible to avoid person-to-person contact, the most significant cause of Corona transmission on an unprecedented scale when it came to India and its massively populated cities. The other intention implicit here was emptying the hospitals as much as possible to make space for the expected rising numbers of the infected in India. This naturally included the public health hospitals and medical colleges as well. 1. Most private practitioners, small nursing homes and establishments, without realizing the second intention, simply shuttered down. This was carried too far. There was a spate of refusing patients mostly in private hospitals, which led to a warning from New Delhi and Maharashtra to “Turn away no patient, Covid or non Covid without examination and treatment… to remain functional and ensure that anyone needing any essential critical services, … warning the hospitals of cancellation of registration of erring hospitals without further notice.” Three such orders were issued by the Delhi government up until April 30, 2020. The Epidemic Diseases Act of 1897 was also cited in support by the

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Maharashtra government both to the nursing homes and private doctors. Larger establishments also restricted their activities. 2. On June 13, however, the Delhi government issued an order to take over nursing homes with 10 to 49 bed capacity for Covid-19 beds. Having done nothing much for the first 47 days after the lockdown to increase the capacity of beds for rising cases, the Delhi government then withdrew their order issued just a day prior. The withdrawal was due to the red flags and apprehensions raised by the hospital owners. The various reasons put forward by the hospital owners included mixing of Covid-19 patients with existing non-Covid-19 patients; existing infrastructure needing upgradation; lack of trained staff, medical equipment and ICUs to cater to Covid-19 virus patients; most such centers being located in residential neighborhoods, increasing the spread of infection; and the fact that many of the doctors are above 60 years of age, and live within the hospital premises. As per the Delhi Nursing Homes Registration (Amendment) Rules, 2011, they are required to provide essential assistance at the time of a natural calamity. Private practitioners wooed the Delhi government to allow an escape from this duty. 3. Some owners expressed an inability to run their institution as a Covid-19 facility or the nursing home because they do not have a physician and further said that the government should take over their hospitals. The order for reseving beds came when most smallscale hospitals and nursing homes were beginning to see OPD patients after temporary suspension during the lockdown, fearing a sharp fall in revenue and a struggle to pay rent—an instance of inept handling by the Delhi government. 4. Reasons put forward were the limited facilities in Old Delhi where nursing homes attend to emergencies and the worry that these emergency patients would not be served. Other reasons for their refusal were worries about contracting the virus, a significant proportion of the staff having left, these small nursing homes being located inside residential areas and mostly run by husband-wife doctor couples living on the premises, local residents demanding that the hospital should not be converted into a Covid-19 facility, and inability to turn away their existing non-Covid-19 patients coming to them for many years (Patel Shivam, June 14, 2020). 5. These reasons are not convincing in regard to willingness to participate in the fight against the Covid-19 challenge and rather

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reveal an avoidance of responsibility consistent with the behavior of the private sector illustrated in a dozen places in this and the volume India’s ­Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev 2020). 6. These concerns could have been raised 47 days earlier as well and there would have been time to sort them out. Even then, if a oneday-­old order to help the government is equally dramatically withdrawn, the stick and withdrawal game can mean other transactions, pleasing to the AAP government. 7. The question whether the nursing homes keep the minimum standards, referred to in this volume in the chapter on the Clinical Establishment Act, has been exposed, and will at best remain moot or the reality may not be palatable. This aspect is also dealt with in detail in this volume in the chapter on the Clinical Establishment Act and reservations in medical education. The other anomalies found were the refusal of the private sector to examine or delay treatment and admissions and unduly holding back ambulances. One logical step would have been to make some elementary arrangements to see the patients in isolation or develop/follow the standard operating procedure, but there was no desire to do so. (Raghavan Prabha, April 30, 2020). The SOPs were not very complicated and were ready early on in the pandemic. 8. Those private sector personnel who were willing to reopen found that they did not have any support from their paramedical staff. 9. In Kolkata, private hospitals felt they were ill-equipped to handle suspected Covid-19 patients. If one does not want to do something any lame excuse can be asserted. When patients with Covidlike symptoms arrived, they were simply redirected to dedicated Covid-19 hospitals. 10. The smaller private facilities closed due to lack of PPE, reduced manpower or inability to financially sustain themselves (Raghavan Prabha, April 30, 2020), or all these factors together. The last of these predicaments was because of a significant drop in the routine walk-in patients as well as extra expenses for PPEs and other sanitary measures. 11. Loss of revenue was a big issue raised. I have shown in this volume the predatory profiteering methods of these big hospitals in great detail. What is beyond my comprehension is where this money that was earned before Covid-19 has gone. The revenue decline

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12.

13.

14.

15.

after Covid-19 is understandable, but the whining about it is not. Are we to understand that these biggies have no reserves whatsoever to sustain their staff for a mere three months of Covid-19, or that these entities ­function by not saving anything for tomorrow? The simple conclusion is that the response and responsibilities in a situation like this do not surface spontaneously. Others have taken some measures to cope with the situation. Max Health Care opted for a pay cut of 25% for non-frontline workers and senior doctors not involved with Covid-19. In corporate business it is the top few who consume most of the earnings equal to those of hundreds of lower staff, and they would be the most unwilling to make a sacrifice. The plea is that the health care industry, like others, does not have the option of reducing operations or laying off staff, while bearing increasing costs and simultaneously increasing capacity. Each and every argument is incorrect. The operations have been reduced by order; if this had not been done the corporates would have done it to avoid confronting Covid-19. Staff can be laid off as most routinely opt for contractual labor. If one does not want to do this, a negotiable settlement to lower wage distribution is an option. The trust deficit in these hospitals between the management and the staff may not achieve this. In Covid time no one was asking them to increase capacity, in fact lower the existing one hence the question of needing more money does not arise. As a practicing doctor with long experience of corporate hospitals I question whether today these hospital expenses are unbearable. The reader is referred to the chapter on corporate hospitals in this volume. The work has not stopped because they are expected to function for all emergencies, which will give them considerable revenues. In such situations there are ways to reduce expenditures on new items such as PPEs by rotating staff and reducing the numbers attending. These hospitals will do all of this but complain about expenses, which means only two things—they do not want to practice during a pandemic and they want to hide the fact that their profit margins have shrunk, a matter with which they are not at all comfortable. Several hospitals, especially in Tier 1, 2 and Tier 3 cities, are afraid of acquiring the tag “mahamari aspatal (pandemic hospital)” affecting business for many months to come even after the pan-

 PREFACE 

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demic subsides. Bihar has more than 250 for-profit and not-forprofit private hospitals, empaneled under the Ayushman Bharat- Pradhan Mantri Jan Arogya Yojana, and these simply closed down, fearing their inability to contain the infection if it spread in their hospitals (Raghavan Prabha, April 30, 2020). 16. In Madhya Pradesh the manageable caseload has given it the liberty to keep private resources on standby for treating Covid-19 patients in government facilities. Only selective private health care facilities in Madhya Pradesh have been involved by the state as dedicated centers, avoiding chaos, and the risk of spreading infection. 17. In Uttar Pradesh, private hospitals can treat patients, but Covid-19 facilities are provided in private medical colleges with a total bed capacity of 10,000. So far this is the only mention of the private medical colleges and their contribution in the struggle against pandemics. These colleges, as pointed out in this volume, as such do not serve any good cause and should be shut down (discussed in the chapter of capitation fee colleges). 18. Lodges, colleges and schools around the small private hospitals are being used as isolation facilities for Covid-positive symptomatic/ asymptomatic patients and  vacating the hospital beds for more seriously ill patients. For the private sector it is the fear of being sealed and apprehensive staff that leads them to play it safe (Nagarajan Rema, May 2 2020). 19. In Telangana, private facilities were earlier restricted by directing these to send Covid-19-positive patients to government facilities. Due to the fear of staff being infected by asymptomatic Covid-19 patients, leading to large numbers being quarantined, the private sector said that it could not afford it at this time. If not this time then at which time would the private sector do anything for the society? 20. The unwillingness to test patients preoperatively or on admission led to asking for more clarity about testing. The meaning is clear. In most aspects of testing and other matters enough clarity has existed from the beginning. 21. There are exceptions—Deenanath Mangeshkar Hospital, Pune, has a block converted into a Covid facility. Fortis Healthcare has set up isolation wards and earmarked 350 isolation beds across its 28 hospitals (Raghavan Prabha, April 30, 2020). Hospitals such

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as Apollo can afford PPEs and other measures in treating critical, non-Covid-19 patients by reasonable addition of the protective equipment costs. In Ahmedabad, Sterling Hospital and HCG Hospital started treating Covid-19 patients in the last week of April. Gujarat never discouraged private hospitals from treating Covid-19 if the patients could afford it. Narayana Multispeciality Hospital, however, was still in the process of drafting its treatment protocol as on April 30, 2020 (Nagarajan Rema, May 2, 2020).

Matters Related to Treatment One complaint that recurs in the private discourse is the lack or ambiguity of treatment protocols. This is another matter I do not understand. The private sector, used to prescribing exorbitantly costly drugs and antibiotics ad libitum with slender evidence and adding many similar drugs, should not stumble over a treatment protocol for a virus with approximately 3.5% mortality where no corrective or causal treatment is available, and in addition have half a dozen drugs with a vast collective experience of safety over decades, the use of which is almost without danger. Why not use them, while providing oxygen and supportive treatment with hydration and nutrition? The bottom line about the private sctor is that they are afraid, and do not want to jeopardize their safety and wash hands off any responsibility. They want to hide that fear from others. If it is not doctors who will then treat these patients? On top of this, complaints have surfaced about the private sector not only refusing treatment for patients with influenza-like symptoms but not referring patients to government facilities. What can one do about this? Despite warnings and advisories by states, many private hospitals are still unwilling to risk whatever little business they are getting from non-Covid-19 patients (Raghavan Prabha, April 30, 2020).

Treatment Guidelines, Pharmaceuticals and Profit Consideration Initially it was widely acknowledged that there is no known cure for Covid-19. Hence the development of a vaccine took all the momentum. It was likely that the pharmaceutical sector would try to encash this

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opportunity. Hydroxychloroquine was first deemed useful and then later ineffective. Remdesivir was first labeled as ineffective or having no data to support its use. Within weeks it came in for off-label indications for Corona and the game of importing it in India started with the Drug Controller roaring that illegal imports from Bangladesh from companies not approved would not be allowed. Now as many as six Indian companies want to import it. Much later, dexamethasone was claimed to be successful in saving patients after the extensive trial RECOVERY.  This is a drug that is commonly used in inflammatory lung conditions but is cheap and easily available. The drug tocilizumab then entered the race. This and remdesivir are of interest as these are high-cost drugs, which become more costly when import/manufacturing restrictions make the availability for use in desperate situations even more costly. The players, either the firms or the governments, become interested when an action or deal involves high costs for obvious reasons. Convalescent plasma therapy in moderate cases of Covid-19 also appeared. In sum, the commercial interests of a lifetime opportunity have risen and several steps in approving a drug such as remdesivir became an obstacle in the possible profit game (PTI, New Delhi, June 14, 2020 18:45 IST). From the third week of June 2020 it is increasingly apparent that the numbers of infected will increase drastically as tests increase and as the lockdown is eased, but the numbers needing actual treatment, either supportive or intensive, will be much lower than those needing simple isolation. Despite all these factors, the mortality rate is likely to decrease below 3%. In December 2020 it has already reduced to 1.4% There will be an increase in cases, probably substantial enough to strain all preparations so far. Ultimately, the private sector will come a cropper, not even as a silent bystander, for having done nothing to solve the pandemic. This in its turn will bolster the need for stronger public health care delivery. In the story of the pandemic there are many pluses in general non-health areas and measures and some negatives for the Indian government and its public health care delivery, its people and its structure-function relationship. This will be discussed in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Now I will turn to the volume as it was submitted prior to Covid pandemic. Independent India has followed the model of mixed economies. In the initial decades the government sector was dominant in health care. The private sector started growing by the late 1960s and in the late 1980s it grew by leaps and bound. The public sector became increasingly

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disappointing and deteriorated over decades. In the 1980s and 1990s the private sector brought in massive benefits to the country, such as state-ofthe-art care, among many others. All these changes began to take place before globalization and before its effects established widespread roots. Globalization and a drive for privatization and liberalization created the rapidly growing neo-middle and rich classes and many other new divides with them—poor against rich, employable against non-employable. The five criteria on which to judge health care—affordability, accessibility, quality, equity and justice—did not remain the main focus in private health sector. The consequences of this massive transition have not been reflected in the health literature. It merely resulted paradoxically in an anti-capitalist campaign in the unipolar world. The government sector before and after globalization had no adequate answer to meet these criteria either, and deteriorated further. This volume will consider and fill the gap at various places and discussions on and in the major domains in India’s private health care delivery. More money for good return on investment, irrespective of how it is earned, has become the central feature of the private health sector. The deep-rooted vested interests, power to dominate care and high stakes involved have affected the fiber of health care, as well as the fundamentals of health care which outbalance the gains they have brought in. Modern medicine with its breathtaking advances also became extremely costly. Private medical colleges were allowed to proliferate in an unbridled manner, which led to super-saturation and malpractices. The Indian health scenario is vast and multifaceted. The information available about different aspects of the private sector is scattered and sketchy, localized and for a limited stakeholder area; hence the total picture of this sector in health in the Indian context does not emerge. That is why the questions raised at the beginning have remained unanswered. Furthermore, the analysis has also remained sketchy, hardly ever covering the total context of the health situation. Aiming the discussions simultaneously at all the stakeholders, patients and families, and policy and administrative machinery, is similarly rare. To make it intelligible, leading to a comprehensive understanding, this  review is adequately wide and deep and the information is provided in much greater detail. The emphasis is more on finding equitable solutions, presented in great detail in the most practical manner with a road map on how to implement them. It also shows how most of the agencies involved can be made complementary to solve the health needs of the country.

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No construct in any area can be designated as a pure curse or boon or strength or weakness. It is the balance between the magnitude of the ill effects and good effects on the system of health which should determine their place in the overall scheme of things here. The final test of all endeavors is achieving justice for all people. More important today is to explore if there are resources within the Indian health care delivery system which can be utilized and/or fostered, notwithstanding what globalization and other factors might have changed. Are these resources in optimal condition? If not, are these remediable to be put to some use? Will it be able to change the balance in favor of the common man? If so, what would be the methods, mechanisms and policy changes needed? The affirmative answers to these questions can be found in this and the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Each one of these stakeholders has to start thinking about his field anew, in the light of the propositions and analysis offered here. Only then will better arguments and solutions emerge, improving the work and its environment, benefiting patients and society. If a system deters the growth of its people, or if the people for their individual growth damage the system, both are doomed. There is a lot to consider here as one goes through the details and decides how to make matters better. Above all, the practice of clinical medicine has received a great deal of attention, which it is hoped will stimulate the thinking of doctors. Not having a clear picture will lead only to faulty, unreasonable or vengeful actions, losing what positives for care we have acquired. This project will help us see where we are going, showing us how to resolve all the inequities and injustice in the system without causing any unjustifiable hurt to any of the agencies or people involved. Read with the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one, it will lead to a far better understanding of health care as a whole and the direction it should take. So far, to the best of my knowledge, no such inputs have been given while discussing health care, at least in India. Pune, India May 20, 2020

Sanjeev Kelkar

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References Gupta Dipankar, Falling Sick Together: Covid-19 pandemic has immensely boosted the case for Universal Healthcare. The Times of India  – Mumbai e-Edition, 4/30/2020. Berkley Dr Seth, CEO of Gavi – The Vaccine Alliance, interviewed over email by Kavitha Iyer. Thompson Dennis, May 6, 2020, COVID-19 Leaves U.S. Hospitals in Financial Crisis. HealthDay Reporter, Wednesday, (HealthDay News). Kelkar Sanjeev, India’s Public Health Care Delivery: Policies for Universal Health Care, Palgrave Macmillan, 2020. Jha Lalit K, May 6 2020, in The Indian Express, Thursday, May 7, 2020 Delhi Edition. https://economictimes.indiatimes.com/news/economy/foreign-­ trade/india-­l ooks-­t o-­l ure-­m ore-­t han-­1 000-­a merican-­c ompanies-­o ut-­o f-­ china/ar ticleshow/75595400.cms?utm_source=contentofinterest& utm_medium=text&utm_campaign=cppst. May 7 2020. Nagarajan Rema https://economictimes.indiatimes.com/industry/healthcare/ biotech/healthcare/huge-­mark-­ups-­even-­on-­ppe-­send-­private-­hospitals-­bills-­ soaring/articleshow/75568578.cms?utm_source=contentofinterest&utm_ medium=text&utm_campaign=cppst. May 2 2020. Prabha Raghavan, For Private Hospitals, Covid Synonymous With Loss in 3 parts, The Indian Express, April 30, 2020, with inputs from Sohini Ghosh in Ahmedabad, Ravik Bhattacharya, Santanu Chowdhury and Atri Mitra in Kolkata, Santosh Singh in Patna, Avaneesh Mishra in Lucknow, Milind Ghatwai in Bhopal, Abantika Ghosh and Aashish Aryan in New Delhi. Barnagarwala Tabassum Hospital show caused over ‘exorbitant’ charges. The New Indian Express, Mumbai, June 12, 2020. Sandeep Acharya, May 17, 2020. https://www.loksatta.com/maharashtra-­news/ government-­to-­take-­over-­80-­per-­cent-­beds-­in-­all-­private-­hospitals-­in-­the-­ state-­scj-­81-­2164093/. Mundhada Shailendra, Deshmukh Madhavi, 2020, Dhruv Lab, Nagpur. Guleria Randeep Dr, Director AIIMS, May 18, 2020, on DD News. Gangakhedkar RR Dr ECD, Indian Council of Medical Research, May 18, 2020, on DD News. PTI, New Delhi, June 14, 2020 18:45 IST.

Acknowledgments

Conventionally, this section acknowledges those who helped shape a book. In this case it is not just that but a mention of a lifelong gratitude to all those who shaped me and my thinking to make me able to handle this enterprise. I have worked with numerous individuals and many institutions of all hues, creeds and colors as well as thinking in the health field. Each one of them has contributed to my growth in this as well as other fields in which I have worked in my life. My stint with the private health care sector began when I graduated from medical college in 1980, and not finding it resonating with my nature. After years of working in tribal areas and in public service institutes I went to Novo Nordisk, the multinational giant. Lars Rabian Sorensen, Witte Rijberg, Sanjeev Shishoo, Sanath Ramakrishna and others helped me decipher the core pharmaceutical thinking of the private world. Two of the outstanding people with whom I navigated the public and private health sectors in this maturation process are Professors Sam G P Moses from Chennai and Anil Kapur from Bangalore. My contact and work with the World Diabetes Foundation, Copenhagen, Denmark, added to my understanding of the private—public interface and ways of working with it in needy areas. It also brought me in contact with the affluent world and the high and mighty attitudes of the US, Western Europe, Australia and Southeast Asia to give me a global perspective of the health situation. I had a close association with the Indian pharmaceutical world in those years. Lessons from corporate culture, thinking, ways of xxxi

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management, its economy, its practices and interaction with professionals were highly beneficial. People like me in their 60s are in a way fortunate, having experienced our early adulthood during the Nehru-dominated economic model. India remained largely poor and underdeveloped. In our later, somewhat more mature, adulthood, we have seen the entire process of globalization, privatization and liberalization unfolding over the last two decades. Traveling throughout Western Europe, the US, China and Japan, most of Southeast Asia and Australia in these very years while living in India has contributed quite a bit to my thinking. I had an in-depth experience of the corporate hospital world again between 2011 and 2015. Had I not undergone this intensive experience it would have been impossible for me to write this volume. I must thank Dr Sabahat and Richa Azim, Dr Om Tantia and Dr Ghanshyam Goyal for this. Professor Bhagyalaxmi Katakwar and Professor Nirmala Borade Savarkar must be mentioned for their contributions to this volume. Dr Kayathri Perisamy, Colombo, was of great help in contacting Sri Lankan health policy makers. I also acknowedge gratefully the contributions of my two friends B V Srinivas and Vaidya jayant Deopujari.  The discussions helped bolster my thesis. I am thankful to my friend Dr Jayeeta Bhattacharya for bringing me in contact with Palgrave Macmillan and its perceptive editor Ms Sandeep Kaur who went through the manuscript carefully and made many valuable suggestions. Lastly it is my surgeon wife Sanjeevanee who brought to me insights into medicine that I could never have imagined. She stood against all odds in our somewhat hazardous life in tribal rural areas, reared our children and participated in all our adventures daringly. I am eternally grateful to her. In working with people of high intelligence and ability I have learnt to guard myself from taking dogmatic positions with an air of finality or from enforcing any idea as superior, instead dealing with it as an evolution of understanding over that time. Looking at others I tried to keep myself free from becoming bound up in any one ideology or ism. This allowed me to accept the good works, remedies, opinions and contributions of these ideas, without agreeing with many other things such people might be doing. Hostility toward other ideas or ideologies is another form of becoming bound up that prevents synthesis of commonalities and valid comparisons of different actions and viewpoints. In addition to this, my widespread and continuing interest in the humanities gave me a much wider view than I might have had otherwise. With a sense of fulfillment of a lifetime I place this work in the hands of the reader.

Contents

1 Introduction  1 2 Corporate Hospitals  9 3 Capitation Fee Medical Colleges 51 4 Perspectives on Pharmaceutical Industry 93 5 Pharmaceutical Industry and Clinical Medicine137 6 Regulations and the Regulators in Health Care177 7 Clinical Establishment Act and Reservations in Medical Education221 8 The Western Model in Disease and Health Care Delivery245 9 Health Insurance, National Health Protection Scheme, Public—Private Partnership275

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Contents

10 Integration of Medical Systems: A Theoretical Perspective and Practical Blueprint333 Index371

Abbreviations

ACCME AEH AFRC AHPI AICTE AIIMS AMRIT ANM APIs ASEAN ASHA AWACS AYUSH

Accreditation Council for Continuing Medical Education Aravind Eye Hospital Admission and Fee Regulatory Committee Association of Healthcare Providers India All India Council of Technical Education All India Institute of Medical Sciences Affordable Medicines and Reliable Implants for Treatment Auxiliary Nurse Midwife Active Pharmaceutical Ingredients Association of Southeast Asian Nations Accredited Social Health Activist Advanced Working, Action and Correction System Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy BAMS Bachelor of Ayurvedic Medicine and Surgery BHMS Bachelor of Homeopathic Medicine and Surgery BHU Banaras Hindu University BMSICL Bihar Medical Services and Infrastructure Corporation Ltd. BMWM Act 1998 Bio-Medical Waste (Management and Handling) Rules BNHRA Bombay Nursing Home Registration (Amendment 2005) Act BPL Below Poverty Line BPPI Bureau of Pharma Public Sector Undertakings of India BSBY Bhamashah Swasthya Bima Yojana CAGR Compound Annual Growth Rate CBHI Community Based Health Insurance CBI Central Bureau of Investigation xxxv

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ABBREVIATIONS

CCAR CCIM CCRAS CCSRAI CDRL CDS CDSCO CEA CEO CGHS CHC CHE CHWs CII CIS CMIE CMJNMH CPA CROs CT DBT DCGI DoP DOTE DPCO DTAB EBM EDQM EHR EMRB ESIC ESIS EU FDCs FDI FMCG FMGE FOGSI FRLHT GBM GLP GMP

Central Council of Ayurvedic Research Central Council for Indian Medicine Central Council for Research in Ayurvedic Sciences Central Council for Scientific Research in Ayurved Institute Central Drug Research Laboratory Chromeleon™ Chromatography Data Software Central Drugs Standard Control Organization Clinical Establishment Act Chief Executive Officer Central Government Health Scheme Community Health Centre Catastrophic Health Expenditure Community Health Workers Confederation of Indian Industry, Commonwealth of Independent States Centre for Monitoring Indian Economy College of Medicine and Jawaharlal Nehru Memorial Hospital Consumer Protection Act Clinical Research Organizations Computerized Tomography Direct Bank Transfer/Department of Biotechnology Drugs Controller General of India Department of Pharmaceuticals Directorate of Technical Education Drug Price Control Order Drugs Technical Advisory Board Evidence Based Medicine European Directorate for Quality Management Electronic Health Record Ethics and Medical Registration Board Employees’ State Insurance Corporation Employees’ State Insurance Scheme European Union Fixed Dose Combinations Foreign Direct Investment alt Foreign Direct Influence Fast-Moving Consumer Goods Foreign Medical Graduate Examination Federation of Obstetric and Gynaecological Societies of India Foundation for Revitalisation of Local Health Traditions Guidelines Based Medicine Good Laboratory Practices Good Manufacturing Practices

 ABBREVIATIONS 

GNMs GPL GST HCEs HDU HMO HWCs IANS IAS IBEF ICMR ICSSR IDSP IEC IGNOU IIHMR ILO IMA IMC Act IMF INR IP IPHA IPHS IT J&J JSA KSMs LCPS LIM LIMS LMPs M&As MAC MANI MARB MBM MCI MCQs MNC MOHFW MRI

Graduate Nurse Midwife Globalization, Privatization and Liberalization Goods and Services Tax Health Care Establishments High Dependency Unit Health Management Organization Health and Wellness Centers Indo-Asian News Service Indian Administrative Service India Brand Equity Foundation Indian Council for Medical Research Indian Council of Social Science Research Integrated Disease Surveillance Project Information Education and Communication Indira Gandhi National Open University Indian Institute of Health Management Research International Labor Organization Indian Medical Association Indian Medical Council Act International Monetary Fund Indian National Rupee Intellectual Property Indian Public Health Association Indian Public Health Standards Information Technology Johnson & Johnson Jan Swasthya Abhiyan Key Starting Materials Licentiate of the College of Physicians and Surgeons Licentiate in Indian Medicine Watson Laboratory Information Management System Licentiate Medical Practitioners Mergers and Acquisitions Medical Advisory Council Madhav Nidan (an important Ayurvedic treatise) Medical Assessment and Registration Board Marketing Based Medical Practice Medical Council of India Multiple Choice Questions Multinational Corporation/Company Ministry of Health and Family Welfare (GoI) Magnetic Resonance Imaging

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ABBREVIATIONS

MRP MSF MTP Act MTP MUHS NAAC NBE NCEs NCHRH NDA NDDS NEET NGOs NHPS NHS NITI Ayog NLE NLEM NMC NNEF NNT NPPA NRHM NRIs NSSO NTI NUHM PATH PBL PCPNDT PGIMER PGMEB PHC PII PMBJP PMJAY PPP PTI QbD RCH RCTs RMP

Maximum Retail Price Médecins Sans Frontières Medical Termination of Pregnancy Act (amended) Medical Termination of Pregnancy Maharashtra University of Health Sciences National Assessment and Accreditation Committee National Board of Examination New Chemical Entities National Commission for Human Resources for Health National Democratic Alliance Novel Drug Delivery System National Entrance and Eligibility Test Non-Governmental Organizations National Health Protection Scheme National Health Service of England, National Institution for Transforming India National Licentiate Examination National List of Essential Medicines National Medical Commission Novo Nordisk Education Foundation Numbers Needed to Treat National Pharmaceuticals Producers Association National Rural Health Mission Non-Resident Indians National Sample Survey Organization National Tuberculosis Institute National Urban Health Mission Promoting Action Toward Health Problem Based Learning Pre-Conception and Pre-Natal Diagnostic Techniques Postgraduate Institute of Medical Education and Research Postgraduate Medical Education Board Primary Health Centre Personally Identifiable Information Pradhan Mantri Bhartiya Janaushadhi Pariyojana Prime Minister’s Jan Aushadhi Yojana Public—Private Partnership Press Trust of India Quality by Design Reproductive and Child Health Randomized Control Trials Registered Medical Practitioners

 ABBREVIATIONS 

RNTCP Revised National Tuberculosis Control Programme RSBY Rashtriya Swasthya Bima Yojana RSSDI Research Society for Studies in Diabetes in India RTI Respiratory Tract Infection SC STs Scheduled Castes and Scheduled Tribes SC Sub-Center SECC Socio-Economic Caste Census SHGs Self-Help Groups SLE Systemic Lupus Erythematosus SOP Standard Operating Procedure STI Sexually Transmitted Infection TPA Third Party Administrators TRIPS Trade-Related Aspects of Intellectual Property Rights UGC University Grants Commission UGMEB Undergraduate Medical Education Board UKMCR UK Medical Research Council UKPDS United Kingdom Prospective Diabetes Study UN United Nations UPA United Progressive Alliance USFDA United States Food and Drug Administration USG Ultrasonography USIBC US India Business Council WHO World Health Organization WTO World Trade Organization XDR Extensively drug-resistant (tuberculosis)

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List of Boxes

Box 4.1  Box 5.1  Box 5.2  Box 5.3 

Perspectives on Pharmaceutical Industry Pharmaceutical Industry and Clinical Medicine Pharmaceutical Industry and Clinical Medicine Pharmaceutical Industry and Clinical Medicine

125 163 163 164

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CHAPTER 1

Introduction

This volume is about how the private sector caters to India’s health needs. It starts with the most visible emblem of private health care—corporate hospitals. These have contributed a great deal to the quality and multifaceted growth of medicine in India. However, for reasons of shortsightedness at its roots, it has deteriorated in myriad ways and no longer serves the center of care, the patient. The mechanisms, operations and ill effects it has caused for health care delivery outbalance its positives. Unjustifiable cost escalations, relentless pursuit of money involving exploitation, super-saturation in urban locations, and malpractice for monetary gain have affected the fundamentals of clinical management, which cannot be excused. Along with this, the ethics of the practice are violated, as well as the doctor—patient relationship, followed by a sense of hopelessness and anger among citizens. To rectify the situation there should be a powerful buildup of public health care delivery to answer most questions in a sizable community within short distances. The other remedies needed are discussed in the chapters of this volume. The second factor which has significantly affected the ‘health’ of health care is the unbridled development of the private or capitation fee medical colleges. The sordid history, false reasoning about its necessity to exist, the immorality of the enterprise and the machinations working therein are unpleasant. This has converted the meritocracy in education to a money market. No one likes the system, not many really know about what happens in these colleges, many connive to gain access to them for the likely © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_1

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S. KELKAR

benefits that can be purchased in case of need, and some build elaborate facades of shortages of doctors to justify their existence, hiding the ulterior money-making motive. Legal systems defend the tremendous and deep-­ rooted vested interests and work to keep them intact, resisting any interventions by using the powers invested in them. The sanctity of human life and legal ethics are also violated. In the absence of any justification for the existence of these colleges, a systematic plan for phased elimination is necessary, outlined here in detail. The world of pharmaceuticals is perceived in different ways by different people: thinkers and activists, the government machinery and those who are working in this industry. Having worked on both sides of the industry, the details of the operations of various interested parties detailed here should give a balanced and real picture. The massively moneyed pharmaceutical industry faces a difficult challenge here—to introspect. The first of the two chapters devoted to the pharmaceutical industry paints a picture of the achievements of the Indian drug manufacturing industry, now the global center of drug manufacturing The important issue of the quality of the drugs manufactured, the way it is done in the present system in India and what should be done to rectify this is not well understood. Additionally there is a serious deficit in the capacity for drug testing for quality before allowing drugs on the market. The technical, legal, economic, administrative and ethical issues associated with drug approvals, safety and optimization in clinical trials and how these affect the health of the population is another area where understanding is limited. Many other issues plaguing the drug industry and the economic hardships the patients suffer under it are now being addressed by the Draft National Pharmaceutical Policy, 2017. Analysis of this policy will give a clearer picture of the efforts being undertaken to make the situation better. Among the many issues connected with this policy are imports and the need for price fixation. National Essential List of Medicines is a necessity to achieve it, to make drugs available to the vast non affording population sector at lower prices, rational formulations and weeding out irrationality in manufacture of drugs together acting as a deterrent to profiteering will shed light on this all important aspect of drugs. These measures also have a long-term effect on the economics of the industry. However, in the end it is not a losing game. Modifications to the patent laws have now produced a level playing field. Its relevance on the backdrop of activist demands for it is explained

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3

here. In the globalized world other challenges are thrown up, such as mergers and acquisitions on transnational scale. Some of its basics are discussed with a sense that in the big money game these may be ignored. To manage these enormous operations newer technologies are needed and have been developed, and these are presented here. The pharmaceutical industry and clinical practice are discussed to further the understanding of clinicians, the final purveyors of the policies and the source of expectations for the betterment of patients. The professionals’ understanding and reorientation of their practices will go a long way to improving the industry and the patient care. Factors such as relevance of a national list of essential medicines, criteria for drug selection before prescribing, prescribing rationally manufactured drugs and the concept of rational therapeutics are needed to build healthy relationships between the industry and doctors. There is a need to improve the understanding of generic drugs and generic prescriptions among doctors and the patients as well. An in-depth discussion about this and the efforts being undertaken by the government will help to ensure better drugs and better practice at much lower costs. Fixed Dose Combination, FDC drugs, mostly are irrational for all the defenses. The industry defended it with professional support. But it is a travesty of the fundamentals of pharmacology, of the issues of bioavailability in modern medicine on one side and poor outcomes for patients on the other. Hardly any thought has been given to these factors by clinicians and thus a thorough critique of FDCs should be an eye opener for all. The ability to judge the quality of the evidence produced by the clinical trials, the quality of the trials themselves, the relevance and purpose of trials and properly translating this understanding into practice have to an extent been an Achilles’ heel for clinicians. The details here will give a much better understanding of these matters, rarely discussed in professional forums. Regulations and regulators have played an unenviable role and caused deterioration in the health sector. The Medical Council of India (MCI) stands accused of many of the ills therein. Despite this, however, every effort is being taken to save MCI from being dissolved. These efforts can be matched with determination to save private medical colleges. This war has become the epitome of the tendencies of Indian medical professionals to oppose anything and everything which may either render them accountable or interfere with their politics or their earnings, be it the MCI, the Clinical Establishment Act, fixed dose combinations being

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eliminated or, as will be seen, the efforts to mainstream the AYUSH system of medicine. The last of these issues is extensively dealt with in Appendix B in the volume India’s Public Health Care: Policies for Universal Health Care published with this one. Naturally, the National Medical Commission bill, drafted by Dr Arvind Panagaria, the first and now ex vice chair of NITI Ayog, to overcome most problems existing in the field of regulation and health care quality, is being attacked by the profession. From 2017–2018 until June 2019 this bill was effectively blocked by the lobbies as well as in Parliament. In addition, the sharp contrast in the composition of MCI and NMC has become another bone of contention for the same reasons as MCI dissolution. This is unfortunate. The sincere hope is that it gets passed under the new government of 2019 has now been fulfilled. However, and luckily, the National Eligibility-Cum-Entrance Test, NEET, and the National Licentiate Examination (NLE) for all medical colleges as a prerequisite for registration and postgraduate entry were implemented in spite of all the virulent opposition they received from many different quarters. This was made possible because the Supreme Court reversed its earlier decisions. Implementation of both has produced many far-reaching welcome effects to an extent not expected or explicitly anticipated in the bill. A reasoned reply has been given to all opposition in this volume. Attempts to implement the Clinical Establishment Act have received the same opposition by professionals for the same reasons they have for opposing the dissolution of the MCI. Opposition over details within the Act may be different but the motivation is the same. Caste-based reservations in medical education is a chronically sensitive issue. In the last few years many other politically flavored issues and demands have been added and complicated the issue. The commentary on this is likely to spark debates once again, but there is no way we can escape its amicable and reason-based resolution for the good of the reserved castes, people in general and health care. The mainstream model of curative health care is Western. The invasive and pervasive nature of this model affecting clinical thinking is not sufficiently noted, at least in India, which tends to follow it with implicit faith. It is necessary to at least discuss whether such captivation and submission helps the quality of health care in India. This system is backed strongly by transnational bodies whose words are treated like gospel. There are fault lines not within the model as a science but in the way it is implemented.

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Rationality and sound clinical reasoning should direct its use. The benefit of its technology, its ways of furthering knowledge and its implementation in practice should be reaped by intelligent perception and reasoning. The main weapons of this system are the clinical trials, the hegemony of evidence, the protocol and guidelines with which it bombards the average conscientious physician, and its technological dominance. Information technology finally takes the process through in clinical medicine and administration of health care as a whole. It is high time somebody sits up and attempts to analyze what is going on and gauge the rationality of it overall. There are present difficulties and future challenges of IT in the Indian health sector. Health insurance in the Western model of medicine has its positives and negatives, and it is time these are understood correctly. The recent scheme of Ayushman Bharat (Indians Living Long Life) in the budget speech of the Finance Minister on February 1, 2018 is being propagated and understood as Universal Free Health Care. But in fact it is a scheme funded by the government. Insurance schemes operating in the health care sector in India over many years are discussed in some detail. Insurance does not seem to have eased the situation as much as expected and the insurance sector in India is small. It is yet to witness its consequences in full measure and it needs to be handled intelligently, trying to avoid these consequences by setting certain limits to its rampant growth. Public—private partnership has been a desirable element in India’s health care delivery for over five decades now. Its ideational development and the way it has been dealt with both by the government and the private sector is discussed here in detail, showing the reasons why this idea has remained ineffective so far. The chapter discusses the mechanisms through which it should become mature and beneficial to become an effective contributor to the health of the people. There are some fundamental rules which are being overlooked, causing more agony for people. The chapter on health institutes and voluntary health work describes certain models the private sector may find useful to think about and develop. These could vary for complex disorders of varying nature and frequencies and address them specifically. In addition, it discusses in detail the essential nature, and the conditions to be built in them to come to the level of an Institute which more discerning leaders of health care may find useful to think about and orient their work.

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We have all but forgotten the voluntarism in many fields of social life, including health. A new breed called NGOs, or non-governmental organizations, has arisen. Prima facie this is a misnomer as upon closer inspection there are many undesirable elements, most of which are unapparent. This calls for a discussion on this sphere of health activities. The terms reductionism and holism are bandied around without having a precise idea of what exactly these are and their dichotomous relationship. Some understanding of their relative relevance to the wider conceptual horizon is necessary. Reductionism and holism are directly related to the notion of integration of the Indian and the Western systems of medicine and health. The term integration is also similarly not well understood in all its dimensions, which makes the discussion on this futuristic and long-range aspect of medicine somewhat haphazard, and it tends to fragment into relatively strong positions among the believers of these systems. An in-depth dissection is necessary. For this to happen, a clear understanding of the bases of these two systems needs elucidation. Effort is required to dissect their different layers, ideas and a more rational understanding of them. The subsequent steps of how to proceed in this direction are outlined in this volume and will be of interest. These will open up work areas for the institutions connected with both systems. The present position of Ayurvedic education, curriculum and different supports of intellectual nature like textbooks, encyclopedias, understanding of the fundamental texts of Ayurveda called Samhitas mentioned here also will serve as an indicator to the agencies for the road ahead. As difficult as this may be considered, the integration is a message that should be delivered. That there is a definite place for AYUSH graduates in the mainstream health care system cannot be ignored or blindly opposed, as is being done. There are many controversies in this regard which are covered in detail in the other volume published with this one on India’s Public Health Care Delivery: Policies for Universal Care. Increasingly varied, fragmented among new fields, with newer powerful technologies and greater complexities, health care delivery has ironically become more and more unsatisfactory for any stakeholder, mainly the patient, displaced today as the least important factor. Can it be simplified to her satisfaction? In addition, medicine is embedded in the large and complex matrix of social reality as a whole. Can the practice of medicine also be oriented in this perspective? Some answers may be found in the pages of this and the other volume on public health.

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Last of all, irrespective of the field, the government is central to all of this. It plans, sanctions, restricts or frees the system, provides legal backing, and is finally responsible for the outcomes. Every word of this volume is ultimately for the governments to think about in terms of what has been happening and what needs to be done. It is the work of a lifetime. I hope it receives a thoughtful and unbiased reading.

CHAPTER 2

Corporate Hospitals

Private Sector before the Advent of Five Star Hospitals At the time of independence, India had 13,000 professionals in single, private outpatient clinic practice, composed of MBBS, Licentiate of College of Physicians and Surgeons and Registered Medical Practitioners. The latter two survived until the early 1980s (Duggal and Leena 2005). As early as 1955 a well-qualified surgeon opened the first nursing home of Bangalore. Nursing homes opened and owned by a single specialist started appearing in Mumbai by 1968. Polyclinics with a number of specialists from different branches was the next development in all the capital, metropolitan, and A Class cities. It was convenient for the specialists to offer their services by admitting their patients and availing services of other specialists if needed. This helped the nursing homes to get established. Such nursing homes were certainly a requirement of urban people. They addressed many needs—proximity of care to the residence and home support available for the patient, which relieved strain on the nursing home. Affordable rates, known and trusted professionals, a fair place to be treated, multiple specialties, negotiability of expenses in good faith and familiarity were the additional reasons for preference for nursing homes. To a considerable extent this prevented the fragmentation of care that was to follow. But the nursing homes were still a small money business. © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_2

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Barring some of those in larger cities which were quite well organized, the nursing homes in bigger cities as well as smaller towns remained infrastructurally and technologically poor, due to lack of finances, poor paying capacity and fewer patients. The requirement of the more sophisticated equipment was not cost effective due to smaller numbers of serious complications that were easily  referable to a medical college, a regular and legitimate referral channel which even the multi-specialty nursing homes chose. In metropolises the additional referral point was the large private/ public hospitals. And admittedly such references from rapidly increasing individual nursing homes would be few. Advancing diagnostics in the late 1970s and early 1980s came to the large private hospitals and the medical colleges in capital cities such as Mumbai and Delhi. By the late 1990s as a direct effect of globalization, privatization and liberalization, India’s economy had started to grow. The so-called Great Newly Rich Middle Class of India had started to emerge, and was soon to become a solid 150-million population. The rapid, sweeping and all-pervasive rise of the corporate health sector, in which the moneyed business class saw huge profits, started emerging in greater numbers compared to the few which started in the mid-1980s. These hospitals brought technology and fueled the rapid rise of super-specialty practices, and soon brought the Indian health care curative capabilities somewhere near a world-class level. All this came at a cost, and unless there was a market ready to utilize this, these shrewd businessmen would not invest their money. It is also thus contended by many that the success of paid care in cities with added technology also prompted and stimulated the idea of the super-specialty or corporate hospitals as the next logical step where profits could be voluminous. A word about the difference in the five star hospitals against the corporate hospitals will do justice to the latter. Five star hospital culture from the beginning was geared toward making the guest more comfortable, pampered and entertained, and these hospitals charged exorbitant amounts to their rich clientele who did not have serious disorders. Almost all the types of outfits of inpatient care facilities have done this at different levels. There was prestige associated with being admitted and treated at five star hospitals by reputable doctors. In the 1970s and the early 1980s, some of the famous hospitals in Mumbai struck pay dirt when Arabs who expected pampering and did not have serious disorders came to India for enjoyment via health. Germany has this clientele even today. This was the last stage of the deterioration of the five star hospitals.

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Advent and Justification of the Super-specialty Corporate Hospitals India’s first corporate hospital, Apollo Hospital, opened in Chennai, in the mid-1980s, followed by one more in Hyderabad by the same name in 1988. Others such as Breach Candy, Jaslok and Bombay Hospitals existed much earlier but had not been called corporate hospitals. All of them started with the idea of all care under one roof with all the sophisticated technological facilities then available that could be brought to India. It took some years for this defining characteristic of such private hospitals to emerge. The high cost, specialty care, the large number of facilities, the sparkle and the sophistication were some of the features. A change in the way the medical profession started to look at the patient had set in when the University of Mumbai and the other three metropolitan cities started what is wrongly called the ‘super-specialty postdoctoral degrees.’ Every anatomical or functionally integrated organ system became a specialty in itself. Until then the basic post-MBBS, MD or MS was able to competently handle the whole body, attending to most illnesses. The fragmentation of the human body started, and it was not long after that people in general started deriding this approach. It was only later that patients were avidly submitted to super-specialists.1 The superb professional expertise combined with technology made available for patient care is a signal service these hospitals have created for the Indian population, for which we should be grateful and indebted. The extra knowledge required for the proper use of the technology leading to the super-specialty practice was logical and justifiable. Corporate hospitals had the greatest use and ability to recruit their services. India gradually developed the numbers with this talent and intelligence to answer to these specialties and serve them. This upgradation allowed Indians to practice sophisticated medicine at almost world-class level and address more problematic health care issues. This is an invaluable service and contribution of the corporate hospitals. 1  Today each super-specialist in India thinks that he should manage only his specialty and that each problem should be tackled by the respective specialty. However, this does not result in integrated care, and the care begins to fragment. This has led to poor quality of care in the corporate world. The argument of sharing the responsibility of complicated cases, thereby leading to better care, is absolute nonsense. It merely serves to inflate the bills, adding to the corporates funds and each one’s share. Paradoxically, the patients are happy to know that so many specialists are seeing them.

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Further Evolution of the Corporate Hospitals Nothing probably could have been as incongruous regarding our total picture of health and nation as the corporate hospitals, as well as five star hotels. One finds it difficult to imagine that our country had this kind of resources flourishing with money and credentials in the 1980s. One may actually feel happy that an outlet was provided to such money to come in the main stream economy again. But one should not assume that everything is fine with either of these types of hospitals. They face the enormous problem of sustaining their infrastructure as well as the quality of services that are on offer every day. Ultimately, these hospitals do seem to manage this quite well, and this is particularly the case with the corporate hospitals. One should be grateful to them for this sustained quality. The next sea change that occurred was what used to be called in the late 1980s the ‘Glamour Attraction Dependency Cycle.’ Glamour of what is available and strong attraction to it, enough to create a desire for the facility. In a populous country like India there are always enough people who can avail the sophistication, pay the costs and boast about their experience. This also started driving the lower classes to these hospitals. This is not in any way a derogation of the hospitals themselves. These currents established the corporate hospitals, which were then starting to be called five star hospitals, like the hotels, especially by pro-poor health care activists. But this comparison is not accurate: there is a huge difference between the two. The basic contention was that this was not a model for India, just as the five star hotels were not. But these theorists were only partially correct. Corporate Hospitals and the Masses One more consideration was and remains about  how to harness these super-styled care hospitals as well as their quality of care in the service of each and every citizen of India in a rational manner, through a dialogue with a win-win intention. This may be a sophisticated, technological, disease-­oriented Western model which the corporate hospitals practice. It is, however, necessary to understand that there is a crucial need for it for the general population as well. The issue is whether it should only be available to people in cities who can afford it, without any concern for poverty or affordability. In addition, there is no element of public health activities in these super-structures.

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The successive governments should have channeled the work their public system could not handle but a corporate could, under reasonable third-­ party payment agreements, but they failed to do so for a long period. Policies such as keeping a percentage of the beds free for the poor were created but never followed. Even after the advent of many insurance schemes and the National Rural (and Urban) Mission (NRHM and NUHM) this relationship did not evolve further (NRHM document 2012). Provincial Insurance schemes or Rashtriya Suraksha Bima Yojana (RSBY), that is, the National Health Insurance Scheme, started in 2011, did not make as useful an impact as expected. The reasons for this are described in detail in Chap.  9 on Health Insurance, National Health Protection Scheme, Public—Private Partnership. Referral of poor patients to higher centers like the corporates, approved by the various governments to avail life-saving care, is not pursued by government doctors with any regularity, alacrity or willingness in smaller cities even today. Government doctors aim to enter into an arrangement on their own with the management of the corporates and earn some commission for referring cases. Since 2014 the central government has been seriously attempting a tie­up between more sophisticated private hospitals to treat poor people  by giving predetermined fee for the service. The latest plan in this regard is the Ayushman Bharat National Health Protection Scheme, popularly called ModiCare along the lines of Obamacare, though these two are completely different. These attempts will face difficulties in financial terms of engagement, the most contentious issue. The effects have not yet reached a stage of demonstrably better health care for the vast majority of disadvantaged people, especially in the corporate private health sector. This issue is complex and has many layers of consideration which need a much more detailed account of what is happening. This is discussed in great depth and detail in Chap. 9 on health insurance and public—private partnership in this volume. In this chapter our concern is to give a detailed account of the anatomy and functional aspects of corporate hospitals and the various ways they have changed health care, both positively and negatively. At the same time there is a contrast. People, whether rich or poor and despite the non-affordability and costs, are resorting to corporate care. They go to there for every minor disease. To prevent such wastage of resources in the form of misutilization or unnecessary utilization we need a capable second-level care facility across the country accessible to everyone in the public health care delivery system. This will give the corporate hospitals breathing space and time to attend to their

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necessary work. Methods will have to be established to draw upon their strengths and work through third-party payment, bound referral channels and contract services to make sense of these useful systems. This and many other aspects of the above issues have been discussed in several places in this as well as the volume on India’s Public Health Care Delivery: Policies for Universal Health Care, published with this one, in great detail. Super-specialty Professional Manpower and Corporate Hospitals The advent of what are erroneously called super-specialties in India started in 1980.2 The corporates came only a few years later. Cardiology was the first super-specialty, beginning in Mumbai. Over about 12 years, the majority of the super-specialties were established at All India Institute of Medical Sciences, New Delhi, the Post Graduate Institute of Medical Education & Research in Chandigarh and several other high-class public hospitals. However, this underlined the fact that whatever the discipline anywhere in the country, at any point in time, only a miniscule population was able to approach and could afford these services. The super-specialists logically demanded higher inputs from the corporate setups. Coronary artery bypass surgery, cardiac surgery for congenital defects and valve damage, dialysis and later kidney transplants led the process, with cutting-edge  technology. Doctors are  now conducting bone marrow, cardiac and liver transplants. Simultaneously, the phenomenal and extremely useful diagnostic equipment had already arrived on the scene by the mid- to late 1980s, and technologically invasive cardiology was the next effective cutting edge. Suddenly the whole milieu awakened to a large number of complex conditions that could now be tackled more effectively in India. This resulted in the public demanding all kinds of costly care with which medicine was able to save human lives at a high cost per case. Since then on this ratio of high cost to benefit at individual level has not changed and has dominated the medical scene.

2  The term sub-specialty is used in the USA and UK instead of super-specialty. A person is a Professor of Medicine, with a sub-specialty in cardiology. This is a strong reminder to all practicing physicians that they are an MBBS first, a basic specialist such as surgeon next and then a sub-specialty holder. While doing a specialty job one should also be able to deal with the basic aspects of the cases and provide integrated care. Adding another sub-specialist creates confusion, overlaps and contrary orders. Most of this can be managed by the specialist on the basis of their basic specialty.

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Contribution of Corporate Hospitals to the Development of Market Economy The private sector has also created, probably without a conscious design, a taste for a ‘market economy’ with its positive elements and beneficial aspects. From 1992 onwards we have been recognizing the principle of the market and therefore ‘free adventurous economy’ in our national life. We have opened India for competition, privatization and globalization. Imbibing this major step has flooded our lives with better utilities. Life has also become more thrilling and qualitatively improved. The private sector has ridden the tide and made people aware that if they want something they can obtain it for a price and they should not be asking for it ‘gratis,’ a situation even the people understand. Some More Redeeming Facts There is absolutely no doubt or denying that the advancement of highly sophisticated medicine at par with global standards in many places in India is due to the corporate hospitals. This is a culmination of all the efforts over many years by high-achieving individuals. Today the private sector as a rule looks to a more positive role and more daring interventionist practice of its trade. By choice and by force of high-complexity medical conditions, practitioners have not continued with the narrow outlook of a single-person project, but actively think of making it a multi-person project, starting not alone but with an institute in mind. On this point they have again shot forward, leaving behind medical colleges and a large number of government institutes. These are perfectly legitimate attempts to attract their share of medical tourism where they can use their superior talents and treat people from around the world. It brings large amounts of money to them but also to the country. There are many benchmark corporate hospitals of clinical excellence in India in the world class treatment domain. These corporate hospitals incessantly deal with serious disorders of health. To do this the most advanced technologies, high-level medical knowledge and serious hard work is needed. Facing life-threatening disease every minute is a taxing endeavor in terms of the human effort these hospitals have to put in. The corporates have done this for decades; five star cultures cannot sustain this.

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The Flip Side of the Contributions of Corporate Hospitals There have been many drivers intrinsic to the process of deterioration undergone by the corporates. Not all of these drivers can be excused or forgiven based on the argument that they are a part of the free market economy in which the corporate hospitals are operating. There are many questions that arise with super-specialty practices, sophisticated and high-­ cost diagnostic gadgetry, and the brand of therapeutics and one-­upmanship practiced by these hospitals. The corporates have a relatively small number of patients to cater to at high cost. Of these, the critically ill patients in emergency medicine, with diseases such as cancer, curable degenerative and congenital diseases and the major metabolic syndromes, are the staple diet of the corporate hospitals. At higher and higher levels of complexity the number of patients that need to be treated becomes smaller. The hospitals may thus not be able to draw the required numbers of patients to economically sustain their highly sophisticated complex services. Therefore, the patients who can pay high costs for treatments for the abovementioned disorders would be even fewer. The corporates therefore try to expand these numbers by making simple medical cases into complex problems, as will be shown later. Simple commonsense medicine which is much more widespread has no need of all these features. Corporate Hospitals and the General Medical Scenario The detailed classification of prevalent diseases by Professor BM Hegde adapted here will make this point amply clear. Emergency medicine Degenerative diseases Congenital diseases Diseases like cancer etc. Psychological illnesses Miscellaneous Patient-thinks-he-has-a-disease syndrome Doctor-thinks-patient-has-a-disease syndrome Minor illness syndromes Hegde BM (2009)

05% 10% 05% 15% 05% 05% 10% 0% 35%

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One may not fully agree with the exact percentages attributed to each category, and variations are acceptable. Psychological illnesses are much more prevalent and can be included in the Patient-thinks-he-has-a-disease syndrome, giving a much larger percentage. To add to this, one may refer to Professor Sam GP Moses, a leader in modern medicine, who says, “Common diseases are commoner than one thinks and rare diseases are rarer than one does.” Most routine problems thus do not need anything more than a sound clinical approach, which is fast becoming extinct. One somewhat unfortunate aspect of the newly evolved complex medicine is that it has also invaded the patient’s psyche. People have come to believe that there cannot be anything simple or logical in medicine providing low-cost solutions of great relevance in the large majority of cases. How to convert this psyche of the people in terms of common, simple and logical medicine which they should have more faith in? This is a challenge. The answer is the demystification of the disease processes and subsequent empowerment of the patient. These are certainly not common practices in the corporate setting or in the private sector at lower levels, creating awe regarding the corporate hospitals. This pattern should be broken. Collateral Damage Caused by the Corporate Hospitals The fierce competition among the corporates for survival and growth was created by none other than their promoters. Too many promoters overestimated the numbers of high-complexity diseases in different population segments. Each new corporate entrant thought that he could also make or spin money through the high-cost establishments to become richer. This was the first trigger for corruption to start, which we will discuss in more detail in this chapter. The numbers of super-specialists and super-specialties grew steadily and were employed by the ever-increasing numbers of corporates, the second process leading to their super-saturation within the cities. This has led to all kinds of malpractice since it became almost impossible to make money ethically, sustain the establishment and reinvest in more technology. Higher and newer technology being a must became an obsession under the dominant logic of one-upmanship, the third factor leading to corruption of services. No one initially realized that the higher or newer the technology, the more difficult it is to sell and exploit. The base percentage of people needing it does not change as per the availability of

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gadgetry. Realization that the supply at that level of illness exceeded demand, this logic being suicidal, came later. To avoid this, more practices, that were not exactly honest, had to be discovered. Health care was relegated to the background. Overprescribing, over-investigating by using costly gadgets and over-intervention, none of them necessary, are just  a few examples of the many malpractices.3 Such malpractices have become widely known even among the common people. The second decade of the new millennium saw the corporate hospitals spilling over into districts, and sometimes even tehsils, due to super-­ saturation in metropolises, the capitals and the A and B cities. The logic practiced was: one particular such hospital at such a level of population seems to have succeeded and hence there is scope for a second one as well. The earlier establishment would have service lacunae which could be exploited by better service. Specialties not possessed by the first one can be supplied by the second. Good quality staff can be pinched from the first or from other sources. The logic then extended to all kinds of unethical practices and ill-gotten money generation. The shortsighted approach made it sadly visible that the corporates did not look at areas where no such facility existed and was badly needed. Profiteering by the corporate sector was assumed widely for a long time. The actual figures now presented are horrifying. In the ill-famed Adya death case of 2018, Fortis Memorial Hospital, Gurgaon, had charged an up to 1700% margin on medical consumables, over 900% on some non-­ scheduled drugs, ranging from 18% to 343% on 36 out of 39 drugs, many scheduled (under price control), in the treatment of a minor girl (Rema 2017).

3  One may legitimately question whether the medical profession can be accused in so sweeping a manner. The unfortunate fact is that it is the truth in an extraordinarily large number of cases. It is happening commonly in cities with 2 million people and to cities of less than 200,000. This disproportionate proliferation is found across India at district and wealthier sub-district level. This is medical lassie faire, and is symptomatic of another process which has taken root in the population’s psyche, fueled by the large-scale publicity or spread of the incorrect perception of the capabilities of modern medicine to save and make life better. Such successes do occur in a large number of cases but there are substantial failures as well. Medicine saves but not all those who are saved get a better life.

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The Ill Effects of the Corporate Saturation The burgeoning presence of the high-cost corporate hospitals and a sea of people suffering from poverty and deprivation with complex disorders that need treatment at higher centers at huge cost are irreconcilable opposites. Here is an exploitative, soulless inhuman configuration of corporates. It has no challenge except when people decide to die rather than go to a corporate setup and fall into a debt trap, ruining their and their family members’ lives. A functionally competent structure and referral system within the public health system or voluntary institutes is the only answer. However, this has not been achieved even remotely, and corporates have strongly underlined this defect. This measure alone would eliminate the need of the corporate hospitals for a large number of problems in a poor population, in the villages and in semi-urban or urban locations. A balance has to be struck. How to do this is the subject of the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev 2020). A Horrendous Way to Establish Referral Channels This was attempted recently, and this case shows how it should not be done. The Karnataka Private Medical Establishments (Amendment) Bill 2017 wanted to ensure humane and timely treatment of patients and to crack down on malpractice by levying severe punishments. But it exempted government hospitals from the ambit of legislation. Given the dire straits of government services all over the country, this differential application of numerous severe punitive measures was in bad taste (Seethalakshmi S and Sunita Rao R 2017). The bill mainly focuses on the fixation of charges on services and investigation. Private doctors are certainly not happy about this either. The protests, however, are mainly for exclusion of government doctors from punishments. Karnataka had not even adopted the Clinical Establishment Act (CEA) as of December 28, 2018 (PTI December 28, 2018). CEA has a much wider base, making many other measures more easily operable, which will benefit people. CEA  must first come into force. Its absence effectively gives the regulatory framework arbitrary and unjust powers since there is no basis for imposing any penalties. This is not the way to regulate the corporate/private sector. It may be exploitative but it is the only guarantee

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that people will be saved. This justifies all the protests and closure of services observed by the private sector of karnataka over this bill. Applying CEA in a non-confrontational manner is the first step. Only then will the era of healthy collaboration between the two sectors including the corporate hospitals emerge. At the same time, there is no robust, result-oriented and competent public health system which can do a great job at much lower cost. Therefore there cannot be any meaningful exchange as equal partners who may achieve the desired results. The aim of this and the volume mentioned earlier is to suggest ways in which we can strengthen public health care, and take important measures toward achieving this.  xtinction of Smaller Private Sector E One more offshoot of the proliferation of corporate hospitals is the threat of extinction or difficulties in surviving faced by individual doctors and their small establishments (Gadre 2015). This extinction can happen in variety of ways. The patient is manipulated into believing that such small and ‘ill-equipped’ establishments will not provide effective services and will still charge heavily. The corporates’ successful creation of such a state of mind is marketing at its purest. The dependence of the smaller establishments on large centers, be it medical colleges or corporate hospitals, can send negative signals to the people who still go to these. There is also the perception that if one has to pay then it is better to pay at the ‘better’ center. This removes the obstacle of lower prices of the smaller establishments to the benefit of corporates. This may, and does, lead to the corporate gobbling up the smaller establishments or even larger facilities existing under different arrangements and spread their clout. These machinations have resulted in chains of the same hospital, like McDonald’s, on their own or by different types of collaborations and forms of franchises. Medical colleges and public health services were free for decades. Now the system charges on a scale that is small in comparison to the corporate setup. This situation is worsening day by day due to government policies (ibid., Gadre, 2015), and this is forcing people to the private, that is, the ‘profiteering,’ sector. The governments, instead of making a wholehearted effort to improve the public health system, seem to prefer the private route to push the population there. This will be discussed further in Chap. 9 Health Insurance, National Health Protection Scheme, Public— Private Partnership. 

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Paradigm Shift in the Outlook of Medical Practice: Going Back a Little Two landmark observations changed the picture of medical care considerably around the turn of the millennium. The first was the number one cause of death in India. It was now due to non-communicable or metabolic diseases, and this number exceeded that from communicable diseases by a good margin. The second landmark observation was that the number of people with diabetes and glucose-related disorders had reached epidemic proportions in the metropolitan cities of India, and this number was rising (Ramachandran A, et al., NUDS 2001). Diabetes turned out to be the mother of all disorders. The number of  metabolic complications increased affecting all organs, as compared to those without diabetes. The latter group was much easier to manage. The clinical profile of diabetes was complicated by lifestyle issues. More than one specialty had to be involved in managing such patients, and the large number of general as well as specialist doctors had to take care of these patients. Private care had facilities for treating these maladies. As the numbers and the complications increased it fell to the corporate hospitals to take care of these people in more complicated cases of diabetes. This turned out to be a bonanza for the corporates. Today, any disease segment has at least 50% of people with diabetes with at least one or two additional complications. The disease profile among the population now stratified itself into simpler to treat and often self-limiting diseases, and next only a serious disease state that could not be managed at lower levels. Recently the face of medicine has further changed, and today less complex illnesses are growing rarer. The potential has increased for any disease, ordinary enough otherwise, to become highly complicated. It is to this that the private sector again is able to give a more powerful answer and solution which the governmental, voluntary or large general hospitals cannot. We have to accept this whether we like it or not. Finally, the routine practice of a single specialty has shifted to a multisystem operation. In terms of the private sector, this meant that more institutions with much higher levels of competence and facilities would be required to deal with the rapidly rising numbers. Large capital outlays were required to deal with these serious illnesses, which could not have come from small nursing home owners but required financing from large players with deep pockets. A large majority of these facilities thus developed in the private sector.

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Many Induced Shifts The increased diagnostic powers and finer imaging of the gadgetry routinely increased detection of many inconsequential abnormalities, and subsequently the face and orientation of medicine changed. It did not remain confined to legitimate cure of the suffering the patient had come for. It now shifted to treating whatever was treatable even in the absence of any suffering whatsoever or long-term consequences. Shockingly, it included an idea proffered to the patient that there are many unnecessary organs which may become diseased, and that it is better to remove them through legitimate surgical procedures. This is patently wrong. The organs often indicated were appendix, uterus and gall bladder. The unspoken reason given was: if I do not do it someone else will, so why not me? The hidden danger of losing that money was manifest in that there were too many of them who wanted a share of a small disease pool. The super-specialists also went to smaller cities where the basic specialists had saturated the environment and corporates had started making inroads. The super-specialists wanted to reach there first, find the patients, and practice their craft there also if possible, to make as much money as they could. They had to negotiate with their high status and their egos in order to go to smaller cities. This was a substantial contribution of the private sector to the growth of advanced curative medicine at a somewhat deeper and more widespread level. Simultaneous Deterioration of Public Health System After 1980, the medical colleges and the government general hospitals began to languish. They were simply unable to match competition with the evolving and ever-expanding private sector over the years to come. With this came accusations from activists that the government had facilitated the development of these corporate hospitals through numerous undue concessions. Such munificence from the government would not come without the corporate hospitals reciprocating the deed first. I personally do not believe the governments to be so far-sighted that they deliberately developed these hospitals. Assuming that governments did this, was it on account of the defeat they accepted: that it is not possible to improve the medical colleges or the public health care delivery at all? That they surrendered to their deterioration so completely that they stopped thinking seriously about any

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improvements? Or was it that the rapid development of the private sector directly resulted in the deterioration of the public sector, medical colleges in particular? Is this the reason why the governments have been offering lackadaisical and incremental improvements within public health care which are of no use? These questions will be answered at different places in this and the volume India’s Public Health Care Delivery: Policies for Universal Health Care’ (Kelkar Sanjeev 2020).

The Costs of the Corporate Hospitals and Other Issues The erosion of the corporate ethos started and continued steadily with more competition. High and unjustifiable costs for the sake of profits alone are the biggest negatives of this system. One need not be a Marxist Messiah for the poor who glorifies poverty. Simultaneously one should not refuse to recognize the unipolar nature of the world after the defeat of Communist polity. In the unipolar world there are different means of creating wealth and this is a much better world to live in. As a corollary, making even an enormous pile of money is not a sin if it is achieved by methods not at the cost of justice or demeaning to human dignity in any way, as has been done by the corporate hospitals. The costs come under serious objections and scrutiny when the common medical problems are made out to be much graver and the patient is subjected to every kind of unnecessary exercise. Fear is the key. The entire system is geared to frightening the patient into signing for various types of procedures. Then more is done to inflate the bills. The rapid rise of powerful facilities was backed by large investments and the corporates were converted into companies with shareholders. The money power had to use numerous ways to get its money back. Marketing, cartelization, escalating costs and every other conceivable device were at their command, which they used and continue to use even today. There was also a rise in high-cost insurance offered by many agencies and private banks, which made it easier to avail these new facilities. To cover rising costs or make undue money the corporates with insurance companies have indulged in creating false records and gobble the insurance money in connivance with the patients  also (ibid., Gadre 2015).Wherever insurance is involved, it escalates the costs continuously (Ashtekar 2015). Under the loose logic that the patient is not paying anyway, carrying out unnecessary procedures which

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made the costs rise was justified. This does not take into account that patients may fall sick again in today’s complex disease patterns, and it would be wise not to spend this insurance quantum on the first illness and preserve it for a second illness. Not preserving insurance money will push the patient into the same debt trap if he falls ill again. These considerations should emerge from any doctor with compassion.4 Unjustified Interventions Corporate management undertook many practices and procedures as a part of the treatment not necessarily indicated by clinical reasoning and hence not necessary. Undertaking these practices carried additional risks, some of which are described in the section on communication between doctors and patients in corporates. Such acts of commission generally suffer from a generally tenuous logic. In fact no malpractice has been left out, including cut-practice, which is shameful in the medical profession. In a large number of cases the ‘benefit’ patients receive is to be treated additionally for something they did not or would not suffer from. What Has then Changed? How Has It Led to Increasing Costs? The initial unique selling proposition was for a highly competent cutting-­ edge treatment, even for the most complex and serious disorders, all under one roof. The caveat was that it would cost you top dollar. Earlier the relation between the cost and the seriousness was more direct and probably more honest. But the methods within corporates to achieve this have changed drastically in the last 10 to 15 years. This is the third paradigm shift in medicine in less than 25 years. It is extremely difficult to arrange the factors which have changed the working of corporates in a cause and  There is a built-in fundamental conflict in the medical insurance concept. The insurance company has certain fixed notions about how each and every disease should be treated. Clinicians treat the group of disorders and not necessarily each disease in isolation from the others. Unexpected situations do lead to measures which may or may not be in the design of the insurance package. No doctor can ever remember what provisions are there in each disease situation. And indeed he should not, as this will hamper the quality of his work. At the time of claim submission it is the insurance company which calls the shots or objects to too many things done and releases only a part of the bill, the rest being paid by the patient. The doctors do not like their on-the-spot judgments challenged by non-practicing doctors or non-medical insurance personnel. On the whole it is a mess and does not lead to positive outcomes. 4

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effect manner. It is not possible to describe them in terms of most causal and less causal or in chronological order. These are not discrete and well-­ defined single items. Each of these factors mentioned above entered the world of medicine. They intermingled and transformed themselves into a power. This power affected other factors and/or was affected in turn by these very factors. However, one aspect is common to all the factors: each continued to grow in magnitude and force or proliferated in number and accelerated the entire conglomerate toward a system that is no longer serving the interests of patients by raising costs significantly. Super-saturation of Facilities and Its Ill Effects One of the major factors in escalating costs is the higher and newer technologies described earlier, available within a few kilometers of each other in urban locations in the last 20 years. This superfluity could have been avoided by joint action of several corporates in a big city sharing the burden and the money earned equitably under much less pressure, without committing the moral crimes mentioned below. But this was not the case. Even by the standards of rich corporates, upgradation to cutting-edge technology is a costly matter. It requires credit for which they have to knock on the door of the financial institutions. The loans have to be paid back and the only way to do so is to force people to use these technologies. Did this help the process of healing? In most cases the answer is no. No one bothered about the effects of money lost in such usage of gadgetry on the marginalized patients, directly leading to indebtedness, loss of property and being pushed below the poverty line. Medical hardware is also a weapon of mass destruction in the sense that every minute someone is being destroyed by losing huge amounts of money mainly to satisfy the appetite of these giants and commissions changing hands. This has remained criminally unjust since lower versions at much lower costs can do almost as good a job. The high-level care was thus defined primarily in terms of ‘facilities’ available and not the doctor’s credentials. The only logical conclusion was that the services would continue to become costlier. Secondarily, or simultaneously, the highly skilled manpower, which did not hesitate to flout their skills and demand much more money from the management, led to further cost escalations, as shown below.

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Managing Fewer Numbers, High Repayments and Profits To achieve the numbers, the individual super-specialists were initially targeted on cross-references by the corporate management. If the cross-­ references were found ‘inadequate,’ the initial requests of the management to increase them turned to demands, pressures and then coercion. Fixing targets and quotas for the cross-references is a routine reality of today. By monitoring the cross-references the management ensures that more and more patients are also sent to the higher, highest and even the ordinary machines for testing so that they are used maximally. This coercive force has been one of the tensions between clinicians and management. Coercion of specialists by management and coercion of patients by doctors results in a series of crimes which after a while become an automatic and shameless habit. The next thing that drives these unnecessary interventions is the varying percentage that the specialist receives for every investigation, drug prescribed, procedure advised, referral to other specialists and surgery performed, that is, each and every act which requires the patient to pay. This is forced on the doctors, who prefer a fixed payment for their services, as well as the specialists, whose primary demand is a percentage for each and every such act. The first category of doctors, in an attempt to remain honest with their patients, keep hoping to create money equal to their services in a fair manner for their fixed remunerations. The second category, which demands payment against the services they use, exceeds the former in number today. For these doctors it is difficult to overcome this greed, and soon such practices turn into an involuntary habit. The money created by both categories and the attached percentage is calculated by the management, if it is mentioned in the contract. This process is far from honest in corporate culture. It tries to omit or shuffle such percentages in the management account or in the marketing teams. These dishonest calculations are used to show the doctors that they are not earning enough. Such calculations are deployed when the management decides to remove a doctor, especially the first category of fixed pay. The most prevalent reason for such dismissals is generally the integrity and the upright nature of the doctor compounded by the open conflict such doctors often have with the ugly management techniques. The doctor has to keep an eagle eye on the accountant to see that everything has been credited to him. Honest doctors do not like it nor do they have time for

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all this. The numbers of such doctors are, however, declining. Such a doctor is threatened with the discontinuation of his position. One way to make these coercive demands work is the appointment of additional specialists in the same area irrespective of the need of the population or the facility, or the number of patients attending the hospitals. This creates the threat of being ousted from the position if the demands of the management are not met by the specialists in the same field. Since there is crowding of specialists each one goes for multiple attachments, repeating the situation of having limited time for each patient, this time due to their own doing. Here the excuse that serves is their time is up here and begins somewhere else. This in turn creates a rush for the patients and their attendants to catch up with the consultants. The number of patients to be seen and the time available, directly affect communication between the doctor and the patients. The idea to give patients enough time and justify the role they have to play in the sickness of the patient is no longer in the reference frame of these doctors. No doctor will want to limit the number of patients since they are his percentage in the scheme. I will discuss below the ways that have been found to cope with patients, and we will look into the myriad forms of these kinds of situations as we go along. This is an emblematic malady of the entire business today. As if this were not enough to keep the machines running every minute, the practice of paying cuts or commissions to the referring doctor began. To accommodate this, higher tariffs were fixed and an oligarchy of sorts of different establishments brought these prices to the same narrow range in a geographical locale. Nowhere in this entire process had the patient and his needs and abilities to pay featured. We must be aware that this is happening at the highest level of health care. It is easy to imagine the kind of mess we will meet below this level.

Bedrock of Doctor—Patient Relationship: The Quality of Communication This is the supremely important element in health care. Over the last 40 years there has been a steady decline in this area, leading to the erosion of trust between patient and doctor. This leaves the patient in a situation where he is unclear about what exactly is wrong with his health. Communication is a broader name for the entire doctor—patient

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relationship. However, in the light of the way doctors deal with patients this term is inaccurate. In good clinical practice a review of records of at least the recent past, prognostication of the illness in future, the ways and means to prevent or delay complications, explanations of the steps being taken and what those steps are expected to reveal, previous drug intake, constitute a detailed review of the therapeutic program and its crucial elements. Scrutinization of each  of these elements has taken a severe hit today in the so-called corporate hospitals. The nature of communication in this process has changed enormously. Instead of being endowed with empathy, working toward the demystification of the disease and providing empowerment of the patient to deal with his disorder and his life, clinicians do an exact opposite. There is no dialogue. The communication is from the doctor to the patient, assuming that the patient is an empty vessel and the doctor is the full vessel of knowledge which he imparts to the patient. The dialogue is thus not patient-centered; his needs are not center stage. The communication is paternalistic and demeans the intelligence of the patient. It is condescending and can diminish the patient’s self-esteem. It uses jargon which the patient does not understand. And it is judgmental, which is the worst of all these attributes. The doctor does not speak to the patient. He speaks at him. This is not the way to create trust. It affects the treatment results and satisfaction as well. The entire communication process is reduced to an investigative format. Doctors have also wholeheartedly accepted the inevitability of subjecting patients to technology over clinical assessment. This replaces everything else in the process of diagnosis, treatment and management, and this is why the consideration for the adequacy of time the doctor gives has reduced drastically. In a large majority of such investigations nothing is found which can explain the malady. The investigative route can often be dishonest because its rationality cannot be justified. The exact physical deficits are not defined due to the absence of a logical approach. All that the doctor says is that the problem the patient has presented with is not his area and then he refers it to someone else who repeats the process. The doctor’s communication involves a cryptic and more often than not dismissive explanation of the reports if the investigations do not reveal any significant cause for the illness. The investigative route prolongs the suffering and difficulties of patients. The process leads to application of further unwarranted examinations, and satisfies everyone except the patient, whose malady remains in no man’s land and unsolved. The money

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spent by the patient to meet the doctors to find out which among the many can help him increases and the time spent is prolonged. It is equally a myth that by conducting sophisticated investigations the quality of diagnosis improves and/or becomes more precise. It does not. The clinical diagnosis has disappeared. The investigations are therefore not rationally ordered. This is why so often nothing relevant to the illness is seen and data that is unrelated, irrelevant to the presenting problem and unimportant will be thrown up due to the power of modern imaging techniques in particular. These become the new points of fear in patients, which takes away attention from the real issues or the disability for which the patient has come to see the doctor. This sets in motion another process of finding newer diagnosticians who can make sense of these incidental findings of no significance and the communication is now directed toward the patient’s newly created anxieties. The cost escalations become palpably apparent. The costly but truly relevant, fundamental and logical investigations that bear directly on the disorder in question are pushed aside, prolonging the suffering of the patient. The investigative route leads to further manipulation by over-­ interpreting the information revealed, making it frightening for the patient, and leading him directly to more costly, risky, unnecessary and even hazardous intervention.5 The common but unjustifiable refrain of the doctors about dozens of small or insignificant abnormalities thus found is: let us deal with it just because something is there which may become a problem later on. This leads to an unbalanced situation where real issues are entirely different. This is the worst kind of practice for old school physicians like me. These are exactly the areas where the doctor has to come out and say, “The clinical relevance of these findings from the highly sophisticated 5  It is not just the doctor ordering the investigation but the demand of the sick population as well. There is a far greater possibility today that a specialist using his clinical abilities and investigating selectively and sparsely will ultimately be discredited in the eyes of his patients. This medicalization of the society is another sad reality created by doctors. Today, to put it simply, disease is not a part of life but rather life is a peripheral issue revolving around disease. This inordinate reversal is to a substantial extent due to the fear and anxieties doctors have instilled in the minds of people. This induced fear is a way to make them undergo measures they may not need. The process as a part of imparting knowledge and strengthening them— the empowerment and demystification effort—has all gone wrong: the doctors have got it wrong. Good clinical reasoning cannot be matched by all the technology one can enslave for humanity. This is one among many major challenges we have to overcome before we can think of improving health care.

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techniques is to be decided by me. I will decide whether the accidental findings need to be dealt with or not, when and if at all.” It is here the doctor needs to say “there is no need to do anything about these findings in today’s situation. We will look after the problem for which you have come here”. The doctors no longer take these responsibilities to assure patients that if anything is to develop out of these accidental findings we will deal with this ‘together.’ The clinical wisdom goes against the concern over more money. Even if a rare doctor so assures the insignificance of such findings,  patients no longer believe doctors’ advice regarding the unimportance of accidental findings. Patients think that there must be something grossly wrong in what the machines have shown which the doctor does not understand or does not want to communicate. The reason is simple. Patients do not frequently encounter clinicians who explain the total picture, further limiting the number of those clinicians they feel they can trust. One comment with respect to honesty is telling in this respect: “Healthcare in India begs honesty and ethical standards on the part of healthcare providers, helping informed decision making without compromising on health for profit. Patients also should (take) responsibility for their  health, Profit is an automatic outcome of honest services” (Jain, Mukesh 2014). Corporate hospitals have also created widespread psychological clout and awe among the population. Consultation below the corporate level and outside it at every level degenerates into a tentative interaction not believed in by the patients. Correspondingly, from the doctor there is no full effort to advice, because he is aware that after all he may do and do well, this patient will go to a corporate hospital. When the patient actually does go to the corporate hospitals they will extract their pound of flesh to prove their superiority. The corporate hospitals have thus made a further contribution to the deteriorating doctor—patient communications. No one believes in anything or anybody today. The process of loss of trust did not begin with people or with the advent of the Consumer Protection Acts or with technology but rather with doctors. Today even if a patient meets a new doctor he puts forward his investigations as if treating the report is going to solve his problems. The patient does not understand how to talk about his suffering in terms of symptoms even when told to do so. That is because doctors who go by the history first are no longer a reality.

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The Logic of Care Today The first logic is to tell the patient, “let us rule out our slightest doubts, to make the intervention safe and safer.” The patients may not or cannot follow this advice for several reasons. First, they may not/do not have enough money. Patients are often not convinced of the necessity. In that case the super-specialist will tell the patient clearly that there could be an additional risk which will not be his responsibility. He has conveyed everything to the patient and his relatives in the best interest of his patient. The second part of the logic then is to convince the patient that now even if something goes wrong the Consumer Court cannot blame and charge the super-specialist. This ‘self-protection’ drive has also got strengthened further by the litigious mentality of the patients’ relatives and the physical violence which is on the increase. In a survey of 435 emergency department doctors, 97% said they order medically unnecessary imaging scans to mitigate risk of malpractice lawsuits. The survey reports that fear of lawsuits fuels almost $210 billion worth of unnecessary procedures each year and potential medical harm, such as false positive test results. (Kanzaria et al. 2015). Dr Hemal Kanzaria, lead author of the study, encourages doctors to educate and involve patients in the decision making (Kanzaria, Hemal 2015). I would add that patients should also be involved and encouraged to take calculated risks by not indulging in unnecessary costly interventions. A couple of other aspects of the litigious mentality will be dealt with below. The painful issue at the bottom of all this is the erosion of trust between the parties. Since the corporate hospital generally deals with critical or high-risk cases they more frequently face the consumer courts and legal action. As collateral, the image of the doctor is at stake, with the hospital and aggressive media interfering to point out what often does not exist. What is being plainly overlooked is that the patient becomes terrified and does anything and everything asked of him. Then if something goes wrong, the already strained and stressed relatives will seek revenge. In all these machinations the patient and his welfare are ignored. An additional logic employed is to find a facetious explanation for doing something which is not needed, to hide the shame a doctor may feel in asking for it. Let it be stated bluntly and clearly that most of such extraneous logics are absolute bunkum. If clinical logic and reasoning is well used and communicated to the patient a sound diagnosis is easily

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established without resorting to unnecessary use of labs and gadgetry. This calls for honesty, trust, courage, competence and a sense of justice the doctors increasingly do not seem to have. Illogical Explanations In simple terms, the likelihood of a complication occurring during an intervention in a patient’s situation can be told to the patient as 1%, 15% or more than 50%, on the basis of experience and research. The next point for discussion with the patient is whether such complications are manageable duing the intervention or not, what is the life-threatening potential of such complications and how worried the doctor or the patient should be if they were to occur. This kind of dialogue should be an example of the routine communication happening day in and day out. However, it is not. Even the low possibilities and little danger of a complication under deliberate miscommunication are made to appear serious but the relevant details about the frequency and manageability are not conveyed to the patient thereby terrifying him. There is no justice in this behavior; in fact it is perjury if we do not speak about these aspects. It is tantamount to making 1% appear as 100%. Here the honesty in dealing with the patient and increasing his trust in the specialty and the hospital curtails  unnecessary use of costly  gadgetry or unnecessary references. These happenstances is not to the liking of the management and pressures to use them mounts.  Logic of Evidence-Based Medicine and Protocols The other ‘moral’ support brought in to defend this circus is the so-called standard treatment protocols and/or the so-called Evidence Based Medicine, EBM. There are other types of EBM and guidelines which are held in great esteem by the professionals, as listed below6 (Fitzgerald Isaac D 1999; Gail Edwin 2015). This has actually led to highly dubious treatment practices. It has also resulted in the unholy alliance of diagnostics  Eminence Based Medicine is related to senior colleagues who believe experience trumps evidence. Vehemence Based Medicine is the substitution of volume and stridency of evidence. Eloquence or Elegance Based Medicine is oratorical and verbal. Providence Based Medicine is where the decision is best left in the hands of the Almighty. Diffidence Based Medicine is doing nothing from a sense of despair. Nervousness Based Medicine out of fear of litigation goes into overdrive to avoid it. Lastly, Confidence Based Medicine emerges from sheer bravado. Edwin Gail, editor of Diabetologia, has added two more guidelines as evidence: Market Based Guidelines and Pharmaceutical Based Guidelines. These will be discussed in detail further on and in Chap. 8 The Western Model in Disease and Health Care Delivery.  6

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and therapeutics sans first critically and clinically reasoned problem solving without using these aids. Even if costly interventions are necessary, enough evidence has to exist to justify the investigation as well as the intervention, be it physical or through drug therapy. This matter must be communicated to the concerned parties in detail, in a language they understand. This can be explained even to the illiterate. This process is often hampered by the absence of the patient’s relatives. If a new development has occurred and the intervention is urgently required, the action is delayed when the patient’s situation cannot afford this to happen, simply because no one from the patient’s side is available to give consent. Today doctors do not have patients’ assurance that if they proceed and intervene for reasons of non-connectivity or non-availability this will be taken in good faith. This is sad in every aspect.

Costs Again Cost of services to patients and costing of the services as a basic exercise are two different concepts. The methods of costing are arbitrary to say the least. Itemized costing is basic. Extra costs for quality can be understood and are acceptable up to a point. Then comes the departmental costing which has aspects beyond the itemized costing due to continuity of time of people in particular. There are costs for other utilities running for 24 hours irrespective of the work quantum. These are the secondary costs such as for refrigerators and incubators. I have deep suspicions that the costing process in the corporate sector is faulty. I understand the intricacies of costing services well enough to know that the aim is to raise the final cost as much as possible to a tolerable limit even when the actual cost plus decent profit could be a much lower figure. These corporate outfits do not believe in health care as a turnover industry, which by definition should be a low-profit high-number turnaround of patients, consumables and efficient work. No one is ready to lower the prices even when the number of available patients is shrinking. The typical shortsightedness of these sellers and marketing people is to extract as much as possible once you are in contact with a patient. For the sake of records there are standard tariff lists. But the doctors are not part of the tariff and price fixation; they cannot change the grade of an operation or a

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procedure, but a 25-year-old marketing person or a higher-level non-doctor manager who negotiates the price can do so. Notice the paradox. This right no longer resides with the doctors since they may for various valid reasons lessen the grade of illness, thereby reducing the bill that comes to the hospital. The controllers of the process simultaneously think that the doctors have no understanding of costs. The suspicion or the belief is that by lowering the grade of treatment the doctor will pocket a part of the relief given by him to the patient. The high level of systematized control carries the underlying assumption that everyone is a cheat except the management, when in fact it is the management which is the biggest cheat. And it is behind an iron curtain from which nothing can be known except the poor-quality inputs that finally surface. When it comes to admitting people it is always an exploratory and negotiable tariff which is dealt with by people trained in extraction. These people are in management and are not doctors qualified to discuss tariff versus illness. It has nothing much to do with the diagnosis written up by the doctor. The negotiator manager does not understand what the diagnosis or any operation or illness means in terms of complexity or simplicity, and hence they cannot and do not understand costs. This practice actually turns away more patients than it admits due to doctors being excluded from the process. It is sad that a judgment of the utility of a person is made in deciding how much one can extract from a patient. Yet the corporate management in all its wisdom does not think so or manages to get what they want from the fewer who get admitted. It is a dirty game. Corporates are unruly; they do not really care about anything at all. They should be the easiest to catch for malpractice, due to the very nature of their structure, functional styles and being ‘on paper’ all the time. But this does not happen. Once the regulatory clearances, governmental transactions and inspections are completed by a corporate hospital by using all means available to get them, the corporates simply do not bother about what they are doing. The entire legal framework is manipulated from beginning to end. Strangely enough, so far the MCI has had no authority of any kind over private practitioners. The National Medical Commission draft bill aimed at replacing MCI also does not have such jurisdiction over these hospitals. In fact no one does. The reasons as to why the simple item of introducing the Clinical Establishment Act (CEA) has met with such fierce resistance

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should be apparent from the discussion so far. Corporates have another advantage. The Babus, the bureaucracy, in government have a soft corner for them. All the Babus know that in case of life-threatening emergencies or serious disorders they have to look to these hospitals. They are clear about the government system’s sheer inability to do anything for them in such situations. Many things are therefore connived and ignored. It is not a secret that the corporate management will make every attempt to inflate the bills, not just for the insurance patients but also for people paying OOP, that is, Out of Pocket. It is common knowledge now that admissions to ICUs and attempting to keep the patient in the ICU for as long as possible are common tactics to inflate bills. The hospital’s share and the doctors’ share increases in this arrangement. What is sad is that there is never any declaration from any consultant to the ICU in charge as to who can he shifted to other wards or semi-ICUs if the need for the ICU is over. If there is an emergency and an ICU bed is needed, shifting one’s patient is resisted by the doctors. Obtaining a fixed number of beds allocated to one’s specialty and then making sure that these beds are never empty, the length of stay prolonges  and discharge not given optimally. These are common but disgusting practices among super-specialists. It is not surprising how easily doctors succumb to these practices. The fear is that the large chunk of money that the institute gives them will not thus be earned and consequences can follow. Often it is an open deal. The process is immoral, but practiced blatantly. Several years ago I was offered this in the plainest terms. I quit the job. There do exist islands of honesty and competence and of patient consideration in the health system, but this is not the dominant pattern. The long list of unwanted drugs is the final straw for the patient in corporate hospitals, and is one of the best weapons with which to extract money. In a corporate setup the management expects that the doctor will write up as many new and costly drugs as possible, for as long as possible. Twenty years ago even patients thought that the doctor who prescribes more, newer and costlier drugs is the better doctor. Today no one thinks this except doctors and corporates. It is assumed that newer and costlier is better. Anything supported by the slenderest evidence that could do something for an injured organ must be added. This will be discussed further in the chapter on the pharmaceutical industry and clinical medicine.

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The Drug Culture in Corporates The thinking about the operational aspects of drug and consumable sales, storage, inventory, turnover and price fixations in modern hospital management training is completely wrong. The reality is that the six corporates I threw this challenge at, all of them scrupulously and studiously avoided it. This speaks volumes about the entire operational aspect. In the private sector the management is struggling with procurement of the doctors’ recommendations based on combination drugs and brands. The single drugs or drugs in combination have many different concentrations. Brands recommended by doctors are potentially wasteful, as are the irrational combinations. Long lists of such drugs ordered regularly add to the expiries in the inventory. Most private hospitals do not dare to challenge doctors about this and stock all such drugs. Still, there will be dissatisfaction about non-availability of many drugs and many others not moving, and this could lead to disputes. Cost-cutting generally leads to stocking of generic drugs or drugs with dubious qualities. Ordering a single drug from different companies leads to price variation, adds complexity to bill correctly every item and also to wastage. All these maneuvers ultimately land the hospital with many drugs that are used variably and much less in large quantities, or drugs that are in fact useless. This also often leads to non-availability of the most frequently needed drugs many times over. No one counts the quantum of money such a patient would have given. Such losses are numerous. The irremediable loss no one is even aware of is that more and more patients start believing that these hospitals cannot be relied upon for a constant and quality supply of the drugs they require over a long period. Such patients no longer visit the pharmacy of the hospital and no one keeps count of them. Optimization of resources is the first logical method to be adopted for garnering ethical and decent profit. But this is not as easily done even with competence or honesty. The simple reason is that there is enormous temporal unexpected variability of profiles of illness in the community, defying all the assumptions of the corporates in optimizing resources. The proportion of expected illnesses may be variable compared to the capacity of the assets made available, either in excess or shortage. This upsets the inventory calculations. Or the financial support for adequate resources could be unequal to the load. Thus, keeping a strict control over the costs by optimizing resources/inventories/consumables becomes extremely difficult.

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There is also a darker side to this. Since management does not take issue with doctors on this point they obtain more items to ‘negotiate’ with the vendors and, as will be shown, this is always a welcome point for the managers. The corporates need multiple types of costly medical and related expertise. This raises the cost but there is no guarantee that the various items of inventory for such occasions will be optimally utilized even after all the coercion, as mentioned earlier. The astonishing fact is that the doctors are not part of this inventory management. The complex facility thus turns into a top-heavy structure since all these matters are handled by only the management with a new breed of hospital managers.

The New Breed of Hospital Managers, their Manpower vs the Doctors The management consisting of this new breed of hospital managers insists that newer methods are needed to optimally control all functional aspects of the hospital, including the above variables of procurement and inventory. It was and is believed that appointing people trained or specialized in hospital management will handle/solve the problem better than the doctors who are not capable of this operation. During the initial years of the corporate hospitals there was no presence Hospital Managers.  Much of the expertise that was required was drawn from the medical and paramedical personnel within. In other words, the specialist and super-specialist doctors integral to the management had a lot of say. During this time, without doubt these hospitals grew rapidly and were identified by a few doctors in whose integrity, expertise and competence the population believed. From the single-room clinic of an average doctor to the most complicated care facility, the acceptance of a few specific doctors by the patients remains the key factor to the successes of the hospitals. The corporates, however, do not believe in this at all today, and this has led to most of the undesirable changes described below. Evolution of Hospitals into Credible Facilities For a hospital to shed the identification with their doctors and become an entity on its own merit takes many years. People then recognize this as the reassuring reality and go there in emergencies or for more complex

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situations without having a particular doctor in mind. In the case of many hospitals which are closer to communities, especially in smaller cities and towns, the doctors continue to be the face of the hospitals even after 20 years. There are in fact only a few examples of such institutions which are on their own, without this identification with the doctors working there. Corporates do not seem to believe in the value of their doctors and what the clientele thinks of them. To them the doctors are merely replaceable units. This seems unbelievable but it is true. On the naïve and innocent side, the promoters may have falsely assumed that they have become an institute in their own right, without their doctors who are replaceable. Today the doctors thus stand displaced, dismissed, enslaved and humiliated in the corporate setup. In addition, the management pays them a lot of money, which makes them sheepish. There is dehumanization from top to bottom in the managerial hierarchies in corporate hospitals. It is a soulless configuration sans patient welfare. This is because the management is concerned only about money, both for the hospital and for themselves. It will always have some way of justifying its nefarious practices. It is not interested in providing quality if it starts to cost money. It wants and expects the doctor to work with as minimal resources as possible and not make a sound about it. It does not act upon the requirement of the doctors to procure the resources, and if it does so at all it will rarely be on time. The entire management is intransigent in this regard. On the other hand, they are ready to pounce upon doctors for the most insignificant aberrations, such as time, without realizing that doctors have put in a lot of extra odd hours and need time of their own and know when to visit their patients. This kind of treatment usually comes at the hands of medical superintendents or other members of the managerial cadre, who have not seen even one case in a clinical setting. It would also be wise to see if this change commonly found in such hospitals has been brought in by some specific mechanism. If so, then numerous explanations can be extended to prove the contention that the corporates have turned into a curse and are no longer worth admiring. The New Management Methods In this system a qualification for such persons involved in the management of this complex machine is paramount. Just as there are super-specialists, there are super-managers. These hospital management courses are

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extensive, intricate, and employ and require a great deal of computer skills. From the smallest to the largest of the hospital activities there is nothing that these courses do not teach about how to handle them. This learning results in a formal degree and later employment. The emoluments depend upon which institute has provided formal training and the hospital that employs them. So far so good. This is a reflection of the formalism we find in society today, which relies on qualification. There is less concern about quality; it is preceded by qualification and this is an absolute necessity. Quality is for a later date if at all. These courses have given the hospital managers information but not the capacity to first arrange it as knowledge and reflect upon it in order to convert it into prudent patient management. Their practice of administration looks at procedures and protocols in a highly fragmentary manner, which actually harms the patient care. At this point the reader should be aware of the later Chap. 8 The Western Model in Disease and Health Care Delivery. There I present a detailed discussion on algorithms, protocols and technology in health care handled by the managers and their affiliates. This type of thinking assumes that every thought or action can be reduced to a single cell on an Excel sheet and that different circumstances are micronizable, the situations are finite, and the nature of what needs to be handled—all questions, all remedies—is the same and repetitive. It assumes that this way of working is the only approach to efficient management which will give the desired result, make the hospital run smoothly, cut costs, not create any patient inconveniences and also catch thieves and those who are lazy. Further, it assumes that, through further and further micronization of every such activity, it can create a machine of extraordinary capability. This idea is simultaneously bolstered by the protocolization of the hospital activities and functions and how they should be performed. The new breed of managers thinks that a particular work must be done in only one manner which has now been protocolized. Take the simple process of bringing the somewhat sicker patients to the notice of the doctor in any Out Patient Department, out of turn. This does not happen because the protocol has no variations within the same process, no exceptions, no scope for using common sense. This is pervasive. The strict expectation is that the work is to be carried out mechanically, essentially the automation of human beings. All this is attempted through the agency of the new breed called Masters of Hospital Administration (MHA).

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It may be argued that such a system is welcome in Indian work culture, which strictly forbids giving 100% to the work at hand. The protagonists of these models have precisely this or such reasons to insist on such models. Make a system which people have to follow without any questions so that there are no system errors. However, the reality is that the purpose for which it is designed is not served, when the technology is trying to convert  the humans in  robots  or mechanical and unintelligent automated individuals. The promoters of the corporate hospitals and management institutes together have begun to think that if such manpower is created the large corporate hospitals will function better and more satisfactorily in terms of the patient’s experience. This is either circular logic or the proverbial self-­ fulfilling prophesy. The corporates stopped thinking of doctors as the most essential input in developing the working method of the hospital and managing hospitals, large or small. Very few doctors with a postgraduate degree will opt for such courses. They have such a massive quantum of unconscious knowledge as to how to build the whole of the hospital activity around the single focus of patient care that they do not need such struts. The non-allopathy doctors with many other non-medicos are found in the hospital management cadre. This is the vicarious form, a partial compensation for being in clinical medicine, intensely desired but unfulfilled, leaving them with a sense of inferiority. These Masters of Hospital Administration first have snatched the administration from the highly qualified doctors with the connivance of the promoters. They have never practiced for even a day in a clinic or hospital. Even then they think they need/should not be asking the clinicians for anything whatsoever, since they know the superior techniques of administration which the doctors do not. One need not be more explicit than this about the non-doctor MHA managers and their understanding of the hospital’s workings and management. Then there are Marketing ‘Greats’ among the MHAs who boast of their ‘contacts’ or ‘market knowledge’ as their greatest ‘strengths or skills.’ In reality it is massive market ignorance. In reality, these strengths and skills are nothing but the avenues to offer large commissions, gifts or discounts and to bring quick business which does not last. When things do not work or reach a saturation point when their inability to bring results starts getting questioned, they simply jump to another hospital. They have

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long years of experience in doing this and this is how they become ‘seasoned and senior professionals’. In most such hospitals the roles and responsibilities are not even clearly defined. Hence, irrespective of the designations, everybody seems to be doing the same thing. The marketing is not supported by the service quality, which leaves no scope for doing real work, creating value or growing professionally. What differs is the level of availability of resources in different corporate setups. At present these managers are having their way since there is a severe shortage of just the right people the doctors, who have been ousted. A new concept of friends referring friends, ‘networking,’ has also started.

How Do the Corporate Hospitals Operate? What Goes on Inside Them? “It is to be stressed that Hospital Administrators (have) failed to recognize two important divisions of their work—Human Relations and Business Techniques” (David Michel n.d.). One more comment is also equally illustrative of the situation. We are now mature enough to realize that it’s not possible to fit patients, patient care, or human relations into convenient administrative slots… and that a lot in healthcare is based on personal handholding and emotional support…the human component—the ability to provide care compassionately and with empathy, is becoming increasingly important. This is why we need to temper our enthusiasm, rather than expect technology to provide (administrative) solutions to what is essentially a human problem of caring for others. (Malpani, Aniruddha 2014)

Can Practicing Consultant Doctors be Good Managers? There is absolutely no doubt about the fact that practicing consultant doctors can be good managers. The MHAs described above are nowhere in the race. Doctors are focused about their work and know how to get it done. The impression deliberately fostered and continued for over three decades is that doctors are unable to understand business, accounting, money, marketing or any other business area, in other words management of anything other than their patients. This belief is found to be even more prevalent among the marketers and managers in the pharmaceutical

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industry. But this is not correct. Doctors’ contribution is in doing the work in the way it should be done for patient satisfaction. The new system described above runs counter to the methods of doctors handling patients. In a hospital the practicing consultant doctors should be assisted by the young cadre of various departments, doing the physical work and the nitty gritty. However, this has been systematically reversed. The handle of control of the staff behavior is now in the hands of the managers. Hence, the doctors and nurses delivering the actual care have no one they can command to do the required job since everyone else is responsible to a non-clinician who is also the paymaster. In corporate setups the doctors are no longer paymasters. This is why the entire system constantly runs counter to the way the doctor wants the patient to be treated and the way he is made to treat them. This is the truth and the heart of all the unsatisfactory, unpleasant, rude and insulting experiences people have today with corporate health care. Among the MHAs, what was once a desire to remain associated with the hospitals as doctors has now degenerated into total control and power over all. And this is where the unfortunate nature of the corporates has emerged in manifold ways, which will be dealt with below. The Second Most Important Fallout—Procurement The middle managerial levels assume the management of tangibles such as appliances, consumables and drugs. Their constant availability, covering routine and emergency care, is the most important consideration, and the cycle of replacing them to maintain constant availability is the second most important. The balance between understanding the urgency and necessity of keeping available each and every input is the third aspect. The quality, cost and procurement time in case of an occasional shortage is the fourth. Then there is the need for quality, ethical standards and safety. Minimizing the number of items in each category, parity of costs among them and optimal shelf life are more complex than might be assumed. The attempt is to order and manage supplies by random minimalistic or hapazard ways far too frequently. This creates inefficiency in the system of procurement, supply and quality of care. The managerial cadre handling this function today in corporate or private hospital setups, including voluntary agency hospitals, is completely ill equipped for these functions. In today’s procurement methods the Toyota way of managing the inventory, the “Just in Time” Method, is practiced. This method is simply inapplicable to a hospital setup, but the

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allegiance to it is so strong that any alternative approaches are deemed unacceptable. Even among doctors there are few who understand how to manage this adequately to fulfilling their needs. These observations are applicable to almost every type of hospital, in smaller places, in chains under a single management and even in big cities. The Shadier Aspects of Procurement Hospitals need thousands of items and there are hundreds of thousands of suppliers available to fulfill this need. There is a price war and employment of all kinds of measures to finally procure an order. Whichever way it is done, the procured drug is never sold at less than Maximum Retail Price (MRP) even when the margins for the hospital on bulk purchase are high. The benefit is not passed to the patients. The suppliers are at the mercy of the management cadre. There is no procuring agency whose soldiers will not exact their pound of flesh before obliging anyone. The most obliging will win. Other than cost escalation, the hospitals land themselves with a dubious low-grade supply of drugs or equipment due to such mechanisms.7 The entire management is involved in making it work. The transactions are done behind an iron curtain: no one knows what goes on. Most importantly, these managers do not want doctors to know about the quality of purchase, or anything else that they are doing, since the doctors are the only ones who can quickly spot what is going on.  Inferior porducts are bought as it suits the deal the way the manager wants it. It has to be accepted by the doctors. The two people who suffer are the doctors who do not obtain quality material and the patient for the same reason. They also have to pay an increased amount to fill the pockets of the procuring manager. Today the patient is cheated both in terms of quality and fraudulently high costs. What can one do if he has asked for a particular kind of rapid glucose assay meter to be used throughout the hospital and is given one which is a third-class product? As a doctor he has to use it and take the responsibility if something goes wrong. The managers are immune and can give any lies to escape the situation. Low drug quality, third-rate manufacturers and counterfeit drugs are serious issues on which these managers will not have any proper background 7  In August 2015, the Government of India sent 43,000 drug samples for quality testing. This was a highly necessary move. It also allocated 900 crore for strengthening the drug testing government laboratories, which is most welcome.

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or understanding. This knowledge comes to a great extent automatically for practicing physicians. The one and only thing managers know is the ‘deal.’ This divide is too deep and affects the quality of care significantly, something which these corporate hospitals do not want the population to understand. These are the reasons for the marginalization of the doctors kept out of the procurement process.

Communication, Complaints and Criminal Suits Doctors are prone to be poor communicators. They are generally not taught how to communicate in their younger formative years. As time passes they can become arrogant and rude. This leads to extreme unwillingness to look into their ways of practicing medicine and to learn from or even listen to others. This also includes acceptance of a mistake from the hospital’s side which may have caused inconvenience to a patient in a small or considerable way. Even in developed countries hospitals are slow to adopt patient apology policies (Rice 2015). And even before accepting a mistake or denying that there was a mistake, the complaint should be heard in an honest and thorough manner. Then one can tell the aggrieved party what the initial situation was, what happened, what has gone wrong if anything and why it happened. “…given the ever-present concern about medical malpractice suits, it’s an inexplicable oversight for hospital managers…(those) patients and their family members are far more likely to pursue legal action when they feel a lack of accountability, disrespect or poor communication from their providers” (Rice, ibid.). If this is the case in Michigan then one can easily imagine what must be going on in the corporate hospitals in India. If it is handled in a more honest manner it certainly helps. What surfaces is the impression that these outfits do not care. The manager or the lawyer will never even accede to this commonsense approach (Boothman, Richard 2012). The litigation mentality has forced the defensive attitude routinely taken by doctors even more  to be safe since the introduction of the Consumer Protection Act in India. There is, however, no guarantee that a complaint will not be lodged even if nothing has gone wrong or they will not be manhandled. The primary cause of this litigation is of course the failure of communication from the doctor about the risk stratification, inadequate care facilities for post-operative care, or inadequate experience and competence under which unnecessary interventions and operations are forced upon the patient. A considerable

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number of these litigations are also due to the patient party’s mistaken understanding of the real situation, explained in full when the patient was brought in. But that alone is not the full story. In bigger cities there are well-laid out nexuses between doctors and lawyers. It is fellow professionals who report on their own colleagues to the lawyers in the nexus, especially so if an unwarranted situation has arisen during care. Such situations do arise in medical practice. The lawyer then gets the party to file a suit against the doctor. In fact this has become a large money-spinning business in some metropolises. In smaller towns like Talukas or smaller, a death can result in the doctor being beaten, or the doctor pays as much as a few lakhs to the party and escapes. Being defensive is the death knell of the trust. The patient’s condition or diagnosis that inevitably led to the death, irrespective of the place or the doctor’s honesty or competence, does not matter to relatives. Informed Decision Making Informed decision making is an important step in determining the treatment route, be it surgery or any other intervention. It is also some guarantee of avoiding or winning a lawsuit. Proper record-keeping is another. Doctors should extend help for the patients to achieve this communication in full and healthy measure. This is fair and just, and hence fundamentally important. The above discussion points to the possibility that this is not a routine experience. The process of informed decision making is often a mechanical and lifeless experience. It is a submission to an already hopeless situation which both parties know. Or it is a process badly carried out. The sad part is that the process is carried out on the basis of distrust between the treating doctors and the institutes against the patient and his relatives.

Evidence and Protocols in Corporate Practice At the specialty level there are two more processes attached to care. One is called Evidence Based Medicine and the other is called Protocol Driven Care. In their essence these ideas are not bad. The Indian health care system has for a long time been individualistic, which is a strong characteristic of the people of India. It therefore has been highly variable, based on the golden words ‘In my experience this is correct, not what the evidence says.’ Therefore there is no ambiguity in my mind about the utility and particularity of Evidence Based Medicine and Protocol Driven

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Care as absolutely necessary in the Indian context. Suffice it to say here that in day-to-day care these sacrosanct processes provide the gateway for investigation and more drug therapy or interventions, drastically escalating the costs with dubious improvement in the quality of care, which often affects recovery rate. This will be dealt with again in much greater detail in Chap. 8 The Western Model in Disease and Health Care Delivery.

The Suicidal Market Trends—Super-Saturation at Lower Levels of Population The super-saturated private care in capital cities and A/B towns survive due to the drainage of patients from the periphery. This is the most singular reason. The spread of such peripheral areas, the number and extent of people affected or who develop complications and come to the larger cities, is uneven. There are large tracts where no care exists. Yet, the providers of the private care do not go to the areas which need them most. The logic is likely that these areas will not pay. The counter-logic is that if another initiative has succeeded in a particular locale there is certainly space for theirs, as argued earlier. This is how each of them is trying to survive only in certain locations, where saturation is more than obvious, leading to super-saturation. And without exception, super-saturation breeds corrupt medical practices which will destroy all the enterprises, more often pull each other down the path to suicide or fratricide. Even when such possibilities are right in front of these enterprises, they will not take stock of the ‘real need of the people’ by undertaking surveys, to apply easier and more relevant alternatives that others are not offering. They will not take cognizance of the fact that studying the market will lead to more viable alternatives that are needed in a particular locale. Identifying such locales will lead to less struggle and better results and abet the chances of a venture turning into a suicide. If they were to look at these aspects they could make more money by limiting the initial extent of the investment. They could offer those services which are desperately needed, even if they are somewhat sophisticated. The capital outlays and costs will thus still be reduced. These are the reasons why each corporate setup struggles and ends up in difficulties. Can we as a nation afford these luxurious high-cost projects? Or should we leave these costly affairs to their fate, allow them to hang themselves by their own rope and not regret having done so? The strict

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and cruel moral code of the market economy demands this. The liberty of the individual to buy gadgetry needs the support of the governments since it is purchased in foreign currency. There should then be consideration of the placement of these sophisticated equipment, along with avoidance of super-saturation and more equitable distribution. Somebody has to look at this. The government does not as long as the permission to buy such costly equipment is preceded by necessary greasing. As seen earlier these may be underutilized. We cannot afford to lock our resources in such wasteful manners. Should we then, as a nation, intervene in this matter to stop this wasteful expense? The clear answer is in favor of curbing, controlling or regulating these trends. The good news is that there are long-term answers to this given elsewhere in the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev 2020). To find convincing answers as to where, when, how, how big, with what and for whom, a corporate hospital should start a project by following and studying many aspects of different locale described below. The information should be compared with their own experience up to that point by the corporates. Their honesty in accepting their failures and difficulties they faced and could not solve fully or partially will take them much further on their path. Instead of this they play the blame game in which only self-deception remains and the true answers are pushed aside. Here are a few answers, as well as my additional comments from the experience in this field. The market research, the process before starting a project, should be carried out with the engagement of the CEO directly and should not be assigned to a third-level manager. But this is exactly what always happens. It is not just ‘Knowing the Market,’ since no one can know it completely. There is a much greater ‘market ignorance’ not taken in to account. Investors looking to make money in India think that it is the country which spends the highest amount on out-of-pocket expenses. Less than 15% of people in India are insured. The sheer size of the free market, the government system in shambles and the great Indian middle class expanding ensure returns. Hence the investors think that one need not go through the rigor of a really detailed market survey before choosing a location. There are a few matters which one cannot afford to miss if a corporate setup is what one has in mind. (1) Availability of those doctors whose expertise is greatly needed (found after a detailed survey) where the initiative is planned, either full time (greatly preferred) or part time from the beginning. (2) The demand for health services is decided by the market size; the elements to be taken into consideration start right from the population size to disease profile to purchasing power and availability of other

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similar services. This includes many other aspects such as crop patterns, irrigation, which changes the economic profile of a large tract completely in favor of such corporate projects, and communication facilities such as railways, roads and nowadays even waterways to determine the real needs and plan accordingly. (3) Pricing of services should be commensurate with what people can pay without much difficulty, lower or at par with those operating earlier in the area. These two factors should finally dictate the tariff of the enterprise. No one takes this trouble. Much higher (and often non-negotiable) prices are often set up on account of the egotism of providing superior service which is not proven on the ground after the project starts. One has to keep aside what he wishes to do, because it may be completely irrelevant to the locale, and pay attention to the local needs to modify plans and wishes. It is not at all uncommon for the promoter to brush aside all this data and do what he originally wanted to do. The first mover advantage in such a well-chosen virgin and needy locale much earlier could lead one to an extraordinarily high degree of achievement, growth and satisfaction. This gives time to develop a stable system, an image, an ecosystem around them, as well as sound financial back-up. The experience gathered will facilitate greatly in replicating the project elsewhere, tweaking this experience to the new environmental study findings. Many hospitals are yet to understand themselves first before understanding these issues and their competitors. Many never reach that stage. Corporates today rarely succeed in getting both the operations and marketing department work together. Marketing will be more effective if it knows what the operation department is able to do for the patients within the hospital and what it cannot do, before they attempt to reach people and make such promises which the operations can fulfill. The CEO has to make sure the people/patients are able to understand the communication and the enterprize is able to keep its promises. Time before beginning marketing should be devoted to making key decisions: from investments to creating a business model or getting doctors on a panel, as well as building a strong treatment system. The last item is absent today, and the other aspects are not well handled. Corporates must think beyond discount and commissions. No one will be or has been able to build a brand through this process. If one thinks, somewhat erroneously that  the future of the hospital has to depend on marketing, then marketing is all about informing, educating, guiding and properly looking after patients when they come for treatment and making

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their lives extremely easy. The patient should feel that he has benefited adequately or well every time he deals with the corporate setup. For that the operating base should be sound, and for this to happen one has to have the right people—those who are skilled, talented, with the right attitude and credentials, to be able to accommodate the industry culture, and, most importantly, those who have a high integrity level.

Conclusion: People are Angry Today there is enormous anger in people who have gone to a corporate hospital even once. They may continue to go there if the bare minimum quality they expect is available or if nothing better is available. They look at the balance between the expenses incurred locally and the cost of going to metros agianst the benefits and quality. If one is favored over another, they will choose accordingly. It is an everyday discussion about the exploitation, dishonesty, horrible costs and so on. From the common man to even an editor of a prestigious daily, today people are not afraid of expressing this anger and frustration and denouncing the private sector. This must be addressed and equitable care should be made available. To this aim is devoted the large part of this treatise.

References Ashtekar, S. Chikitsa Arogya Sevanchi (analysis of the health Services) Manovikas Publications, Pune, 2015. Boothman, R., Chief risk officer, University of Michigan Health System, Perspectives on Safety, interview 01_March_2012_Boothman.mp3, 2012. David, M. University of Chicago, n.d. Duggal, R., & Leena, G. Review of Health Care, CEHAT, Mumbai, 2005. Fitzgerald, I.D. Seven alternatives to evidence based medicine, BMJ, 319, 1618 quoted in a post of Neeta Deshpande, Belgavi, Karnataka dated August 4, 2017, 1999. Gadre, A.  Kaifiyat, Manovikas Publication, Pune, Anusandhan Trust, SATHI, Pune, 2015. Gail, E., former editor, Diabetologia, in a conference in Kolkata, 2015. Hegde, B.M. What doctors do not learn in the medical school, Paras Publication, 1st edition, 2009. Jain, M. Business World on December 9, 2014.

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Kanzaria, H. HealthDay News, accessed on March 27, 2015. Survey appeared in Academic Emergency Medicine. Kanzaria HK, Hoffman JR, Probst MA, Caloyeras JP, Berry SH, Brook RH. Emergency physician perceptions of medically unnecessary advanced diagnostic imaging. Acad Emerg Med 2015; 22: 390–8. Kelkar, S. India’s public health care delivery: Policies for universal care, Palgrave Macmillan, 2020. Malpani, A. March 4, 2014 on the healthsite.com. NRHM document. Framework for implementation, 2005–2012, Ministry of Health and Family Welfare Government of India, Nirman Bhawan, New Delhi, 110001, No. L. 19017/1/2008, 2012. PTI. December 28, 2018 | 16:37 IST. Ramachandran, A., Snehalatha, C., Kapur, A., Vijay, V.  Mohan, V., Das, A.K., Rao, P.V., Yajnik, C.S., Prasanna Kumar, K.M., & Nair Jyotsna, D. for the Diabetes Epidemiology Study Group in India (DESI). High prevalence of diabetes and impaired glucose tolerance in India: National Urban Diabetes Survey. Diabetologia 44, 1094–1101, 2001. Rema, N. | TNN | December 16, 2017, 08:40 IST. Rice, S. in a blog on August 15, 2015. Seethalakshmi, S. & Sunita Rao, R. | TNN | June 14, 2017, 11:54 IST.

CHAPTER 3

Capitation Fee Medical Colleges

Introduction A patient is the most important person in any hospital. He is not an outsider; he is a part of the hospital. The doctor or the hospital is not doing the patient a favor by serving him; the patient is doing the doctor a favor in furthering his career, and is helping the hospital to grow. What has happened now is the patient is no longer the center of health care. He is the human figure necessary to manipulate for ends totally different from his welfare. Money is at the center, and the tragedy is that no one’s conscious seems to be bothered about these matters. The capitation fee colleges have several foci that need to be considered: the number of students that pour into the system, their quality, their relevance to health care delivery as a whole, both private and public, and finally money politics. The Numbers Added to Health Care Numbers of doctors produced undeniably are in excess of the needs in many states which also have too many capitation fee colleges. Private medical colleges of poor quality should be shut down and no more such colleges should be allowed to open. There is a serious job crunch and frustration among doctors, as explained by Dr Sulphi, secretary Kerala IMA (Nagarajan Rema, September 2, 2018). © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_3

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A total of 492 colleges exist today with an intake of more than 61000 admissions for MBBS. There are at least 250 non-governmental colleges registered mostly as trusts or societies and 242 government medical colleges. Only 10 of the private medical colleges for MBBS course are closed in the last 30 years. Only 114 have been given 1 or 2 seats for postgraduate degree or diploma by recognition/permission, by compliance verification or by increasing the seats later (Medical Council of India February 23, 2018). Of the 61000 who pass MBBS, 15% will go abroad and 80% will opt for postgraduation. In addition, the Non-Resident Indian quota students and the Foreign Students will return to their countries of origin (Bapat Ravi 2011). The excess number is also because the doctors do not retire unless they are too elderly or disabled to practice. At least half of those who pass will come from private colleges. Will they be willing to go to rural areas or ever want to join government service after internship or even after clearing/not clearing the postgraduate degree? Why are we allowing them to be added? Is shortage of doctors the reason? These are the issues which will surface again and again in this and other chapters, as well as in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one (Kelkar, 2020). The claim that there is a shortage of doctors is completely demolished in the volume mentioned above. A few unanswered issues are dealt with below. Should the Capitation Fee Colleges Be Taken Over by the Governments? The only instance of a capitation fee college being taken over by the government was in Solapur, Maharashtra, prior to 1972 after large-scale agitations (Limaye, n.d.) It is, however, neither feasible nor acceptable today to cite this and say all the capitation colleges should be taken over by the government. The reason is that there are too many of them and most do not need to exist for any reason whatsoever, as discussed below. Suggestion 1: Nationalization of Private Medical Colleges  Nationalizing the capitation fee colleges is simply unworkable, even if it is under a committee of experts as argued later. Governmentalization will kill the goose laying golden eggs year after year for the powerful politicians. It will be opposed in hundreds of different ways, and the fight will not end for years. The genesis of capitation fee colleges is the brainchild of politicians, who have a tremendous vested interest in the continuation of

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these colleges. To say the least, appointing a committee under a senior politician will not lead to impartial consideration without pressure from all quarters. The next step of course is the process of bundling out the capitation fee colleges, as discussed in this chapter. Will this ever be done by the present MCI or the next body of the National Medical Commission (NMC) if it comes into existence? The answer in March 2018 turned out to be negative after the draft bill for NMC was tabled in Parliament on January 1 of the same year. Many other interesting developments took place from 2016, jolting the private colleges severely, even when closure was not attempted (for a full discussion on the draft bill for the National Medical Commission the reader is referred to Chap. 6 Regulations and the Regulators in Health Care in this volume). The closure of the capitation fee colleges will be opposed tooth and nail. The politicians think it is their birthright to make vast sums of money, and the promoters will go to any extent to prevent this from surfacing. The MCI is unwilling to rise to the task of improving the quality of the private colleges. The MCI’s machinations that make them massive amounts of money by granting recognition to even poor-quality colleges are now well known since the Ketan Desai saga unfolded in 2010–11. The draft bill for the National Medical Commission has created the mechanisms to regulate the quality of the product in the education paradigm in the colleges which will be discussed in Chap. 6 Regulations and the Regulators in Health Care in this volume. Rightly, the bill has left the issue of deployment of this manpower to the states and the central institutions. In the volume India’s Public Health Care Delivery: Policies for Universal Health Care a workable economical solution is provided, simultaneously negating the dogma that shortages exist (Kelkar Sanjeev, 2020). The major argument is that an acute shortage of human resources is the main barrier to achieving universal health coverage. This idea is being promoted to divert the attention of the government and garner the sympathy of the general population. Even high-level functionaries in the Central government seem to have bought into this argument hook, line and sinker or by a shrewd calculation of what it can bring to them. This is an utterly unacceptable argument since the prevailing concept of shortage is in itself faulty. The exact nature of the number shortages is a deployment problem, and not a need for more numbers. The issue of shortage lies in the quality

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of the manpower produced which is needed at certain population segment levels. The issue extends to the ways in which such manpower should and could be developed, which is equally important. Hence the methods that should be used are discussed at length in the volume and many chapters in it mentioned above, which is dedicated to the reorganization of the public health care system. Sound reasoning and the confluence of experience rather than political expediency can solve this issue. Suggestion 2: Improving MCI Functioning  One issue of importance was originally discussed at the time when the National Medical Commission bill idea had not yet been born or was rudimentary. This issue was about the MCI and how it could be improved. MCI is tightly controlled by the states who have an interest in private colleges.  States would not be interested in improving the education system which may lead to closure of poor standard colleges or stoppages of admissions. In attempts to improve the existing ones the Central government through MCI may deny permission to open new colleges with huge loss of revenue to state politicians. Therefore the states will somehow find a sneaky shortcut using all kinds of measures to circumvent improvements in education standards. As regards the quality of education and permissions to open more state private colleges raised above, the draft bill for NMC has now sorted out the process. It is at once time bound and without any of the loopholes that existed in the MCI act discussed in Chap. 6 Regulations and the Regulators in Health Care. Suggestion 3: To open more government medical colleges Up until the end of the United Progressive Alliance (UPA) II in 2014 opening new government medical colleges was a burden neither the state nor the center was willing to lift. UPA II had left India bankrupt. However, since 2014 the center has been helping states such as Uttar Pradesh and Rajasthan to open many colleges, 5 and 11 respectively so far in these two states. In the past the states were not willing to take on the economic or logistical burden to improve the quality of the existing medical colleges. Today, however, after demonetization and the Goods and Services Tax (GST) a large amount of money has come into the main system. The Central government has allocated funds to improve the infrastructural qualities of the medical colleges across the country. This suggestion, first made in 2013, has therefore become much more valid. The only caution that may be sounded is to ascertain that these state medical colleges are not opened by third parties, that is, private players. I will also mention here, however, that opening half a dozen new AIIMS-like institutes does not seem like a good idea. Suggestion 4: Cancelation of the affiliation of donation medical colleges

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There are so many colleges, both government and private, that function as deemed universities under the same legal status. This is a large hurdle. Being deemed universities they will laugh at the removal of affiliation. The terms of reference as to what constitutes an offense for derecognizing the deemed university / college, how this will be proved and who has the sanctioning power to derecognize the college will take some time before formalization. The pertinent criteria exist with the MCI but will have to be made relevant and brought up to date to become effective under the National Medical Commission (NMC). A new hurdle to this process has appeared in the  National Education Policy 2020, discussed in India’s Public Health Care Delivery (Kelkar Sanjeev 2020).  The cancelation of affiliation should not become a piecemeal job. Such capitation colleges will challenge this process at every stage. These entities are powerful, have traction in the judiciary and among politicians, as will be shown below. Only time will tell when this cleaning process will begin, whether and how effectively it is completed and whether and how much it will change. There is hope. In addition, those colleges which do not have deemed status will fight legally  for long over years, during which the inflow of students in these colleges  will continue with the  inflow of money, effectively making this a highly ineffective way of correcting the situation. It is now an open question as to how long these horrific businesses are going to be tolerated. The question is: Do the governments have enough power or even a little courage to close them down? The deemed universities do not usually appear on the radar of the state governments. The procedure and the law do not seem to empower the government to control the tariff of ‘deemed universities’ either. Suggestion 5: Encourage the big business houses to run the colleges The most important issues here are: Why should they do it at all? Where is the core competency in the big businesses to run these colleges? Will the big businesses ever want to do this? What would be the settlement price to take them over? Can they afford this price? How long would they be able to continue and how can it be ascertained that they will run these better? Or is it possible that they could make a decent amount of money while being reasonable about recovering their costs? Is there any government or any other body entitled to make a request/suggestion like this? This smacks of the characteristic suspicion of the left that the businesses have made unethical money and would do well to spend it on such a venture.

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Anatomy and Functioning of the Capitation Fee Colleges: An Overview Most colleges start in a hurry, without adequate infrastructure, qualified staff or sufficient funds. The state governments in connivance with MCI make adjustments to get these approved. Faculty is temporarily and intermittently borrowed or transferred from government and even private non-­ teaching institutes and private practitioners during inspections. The education quality deteriorates. Politicians from the states are only interested in selling the seats. The fundamental problem is that we have allowed the market to determine where the health care services are going, under the patronage of states which permitted the sale of seats in medical colleges. We have also allowed the market to open new medical colleges according to the demand for a professional degree and not according to the health needs of the society. The end result is that we have an oversupply of doctors in areas with high purchasing power and also a situation where a small state like Kerala has 27 medical colleges whereas the whole of Sri Lanka, with similar health indicators to Kerala, has only 5 medical colleges (Dr Chandanie Wanigatunge, Information given in a discussion in Colombo on December 2, 2018). Where Supply Exceeds Demand An oversupply of doctoral services in the area of health no longer caters or cares for the nation’s sick people and their health care needs. The first effect of this excess number of doctors is the generation of supplier-­ induced demand. These service providers have only or mainly monetary considerations. What will be the response of a doctor who has invested a millions in his education in the private medical colleges and is now struggling to pay back his education loans? He will attempt to provide more and more unwarranted care to meet his return on investment, and the targets of health care will be ignored. J P Naik in his volume Health for All, by 2000 written in 1981 predicted a future. Because of their unique position in an unequal power relationship with their patients, doctors would be subjecting them to over-treatment, over-prescribing and unwanted surgeries and other interventions to recover the costs they have paid to obtain their degrees. The prophecy has come true and has become one of the greatest public health challenges for many years now.

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While blaming the doctors, one should also blame society for its failure which permitted this menace by keeping quiet and allowed it to become a monster. The society chose to believe, conveniently, that the religious outfits, cash rich castes and many other agencies will open medical colleges which  will solve the issue of  shortage of doctors and answer  the  health needs of people. However a Capitation fee college was never a service to the community. These bodies made a killing, and continue to do so. Society and the misguided students are paying a heavy price, in return receiving degrees but no knowledge, no wisdom and no experience about how to alleviate people’s suffering. Ultimately, it was a game of greed for money, and later a prestige point of having one medical college because a rival caste had one. It obviously had nothing to do with national needs or the attendant manpower production. The strike by medical students in 2015 in Tamil Nadu demanding that there is no need for any more colleges in Tamil Nadu focuses attention, once again, on the medical education system in the country, which still does not have a coherent policy on the subject. The blame for this rests on the successive Central governments and the various state governments, that is to say the politicians who deliberately stayed away from making any such policy. The important arguments put forth by proponents of private medical colleges were: 1. There is a need for more doctors, especially in rural areas. This was completely false at the beginning of the inception of these colleges in the 1980s and is much more so in 2020. 2. There is a demand for medical education, and the state has no resources to meet this. Hence private colleges are desirable. However, demand per se is not a justification. For example, tomorrow, given the high levels of drug addiction among Punjabi youth, should the drug supply be made legal? These two arguments are closely linked. In 1981, a study group made the following observation. With regard to medical education it stated, inter alia, “It is obvious that we are going in for an over-production of doctors…this will be a colossal waste of human resources apart from a serious threat to the health of the people” (Naik JP, 1981). In 1981, there were approximately 220,000 allopathic doctors and another 600,000 registered and unregistered medical practitioners. Around one-third of the

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allopathic doctors were in the public sector and the rest in private practice (Naik JP, 1981, ibid). There were 106 medical colleges with an annual output of more than 11,000 doctors. In 2015, there are 492 medical colleges of which only 261 were government-owned. The output of doctors from  all these colleges put together was above 61 thousand per  annum (Medical Council of India, 23 February 2018, ibid). Such a large yearly turnout of doctors has, as expected, super-saturated the urban market. In Uttar Pradesh, the state government announced five more new medical colleges in May 2017. We still do not know if it is the central or the state government setting them up. If it is left to a third party to invest all the money then the purpose of this will be lost as the fees will go up exponentially. The other folly of this move is that it adds to the pool of doctor numbers without eliminating the numbers from capitation fee colleges in any way. Two Immediate Steps Suggested by Health For All The first step was  “There should be no new medical college and no increase in the intake of existing medical colleges and b) there is no need at all to set up new and additional institutions to train additional doctors through short-term courses” (Naik JP, 1981, ibid). The second step is even more significant and far reaching in its implications than the first. The idea of “additional institutions with short term courses to train additional doctors” has been bandied around since 1977 when Dr Pramila Tople, the then Janata Party Minister for Health and Family Welfare in Maharashtra, made a serious attempt in this regard. However, it never really took off. Twenty-five years prior to this, Licentiate Medical Practitioners (LMPs) and all such other degrees were cancelled. Looking back, this seems like a mistake since quacks have proliferated. And 38 years after Dr Tople, similar ideas have continued off and on to date. In 2015 Gulam Nabi Azad mentioned it again. How far this will help the villages, whether any one of them will go there or whether they will saturate the towns is difficult to say, but it looks unlikely. This cadre will be another half-baked one which will not hesitate to call them doctors and add numbers to the system. Such schemes do not make any sense whatsoever. There is also the issue of multiplicity of the agencies. I have dealt with this at length in various places in my other volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020). Such ideas do not solve the problem.

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Short-Term Courses and the Chinese Idea There has been an additional and somewhat romantic view of what China has done in this area and continues to do even now. The root of the idea of short-term courses for doctors lies in the idea of barefoot doctors trained in and going back deep into their traditional Chinese medicine and into their communities where they are to help people. What China does and can do and the way the Chinese mental framework responds or reacts to this is a completely different cup of tea. We would probably be better off if we were to study the Chinese project with all its the history to see what we can take from there while giving up all the illusions that such a thing can be extensively implemented. To the best of my knowledge no such serious study has been attempted. What has been happening in China now is interesting. Public providers have begun to act with private mindsets since the 1980s and 1990s, which has resulted in the blatant rise in unnecessary tests and treatments. If you visit any medical fair in India, dozens of Chinese companies have products which have nothing to do with traditional Chinese methods. The Existing Health Army of India When there is already an ancient tradition of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) from which we receive a huge human input yearly, similar to traditional Chinese medicine, the idea of barefoot doctors is a mere multiplication with sub-standard education leading to superfluity and saturation, indifferent or harmful care, and malpractice. In spite of such numbers there is an unimaginably large number of quacks. This issue is discussed in detail in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. The place of AYUSH is discussed in detail in the same volume (Kelkar Sanjeev, 2020). In addition, there is already a vast army of male and female Community Health Workers (CHWs), Auxiliary Nurse Midwives (ANMs), Accredited Social Health Activists (ASHAs) or Mitanins, Graduate Nurse Midwife (GNMs) in many primary health centers, Lady Health Visitors and male supervisors who have varying degrees of training, and Primary Health Center (PHC) officers. How much more clutter do we want at the periphery (Kelkar, 2020, ibid)?

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In the Sixth and Seventh Five-Year Plan periods, roughly in the 1980s, the Central government policy was to discourage opening of new medical colleges. The policy was reviewed in 1991, and on August 27, 1992, the President promulgated an ordinance to amend the Indian Medical Council Act (1956), which was converted into an Act of Parliament in 1993. The main provision of the Act dispenses with the need to seek prior permission of the Central government to establish an institution imparting education in medical sciences, increasing the intake of students, or introducing a new or higher course of study. Thus, within two years (1991–1993), the Central government, without any public debate in civil society and against the recommendations of its own expert committee, passed an Act of Parliament regarding medical education which opened the flood gates for the medical colleges to start in all the states. The reasons given for the Act are revealing. The Ministry of Health and Family Welfare website states, “…. it was recognised that a large number of posts of doctors were lying vacant in many places, especially rural areas and there was tremendous pressure for gaining admission into medical colleges.” This is spacious reasoning indeed, especially when several reports commissioned by the government itself pointed out that two-­ thirds of doctors are in private practice and increasing the number of doctors would not solve the problem of shortage in rural areas. To quote the Health for All report again: “The medical education system and the health care delivery system have each gone their separate ways. There is little congruence between the role of the physicians and the needs of society, little equilibrium between medical education and health care” (Naik JP, 1981, ibid). There has been no attention paid to such a colossal error. For the last 60  years these two departments have been involved in turf wars. This aspect comes under more detailed discussion in the volume mentioned above. Here it is being mentioned to show from various credible sources that we do not need so many doctors to justify the existence of capitation fee colleges (Kelkar Sanjeev 2020). The World Bank had also warned of an oversupply of doctors in countries such as India. In addition, it pointed out several other ills of doctor oversupply. A high number of specialists tend to increase the frequency of unnecessary and often risky procedures. This drives up health care costs and reduces quality of care. Thus, it is obvious that the decision to permit more medical colleges, especially in the private sector, has nothing to do with the needs of society. It is merely fulfilling the demand of an affluent pressure group. Therefore, it is clear that there is no need for more

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colleges in states already overflowing with these as far as the needs of society are concerned. Padmashri Dr Madhav Deo, long connected with MCI, states that: There is a huge and probably a deliberate misunderstanding created that there is in India a severe shortage of doctors to the tune of 600,000. Therefore there are forceful advocates for establishing some 200 new medical colleges in the next 10 years to meet the projected huge shortage of doctors, which will reduce the medical colleges to pathshalas, that is elementary schools. …States like Maharashtra (and all 4 Southern States) are now producing surplus MBBS doctors. The Government of Maharashtra has, therefore, decided to scrap the service bond to serve rural sector given by all students in government medical colleges. (Deo M, April 2013)

More Arguments in Favor of Private Colleges In a truly democratic polity, such important policies would be widely debated in civil society. However, India remains a pseudo-democracy, like many others. There are debates and reactions are invited, but what is rational is finally discarded and the law is promulgated the way the pressure groups, that is, the people who have made money and want to make more under the sanctity of law, want it to be. The second argument in favor of the capitation fee medical colleges is that many meritorious students cannot gain admission. This is also fallacious. In a course like medicine, where the number of people desirous of being admitted exceeds the capacity, there has to be a cut-off point. If it is 90%, those attaining 89% will feel aggrieved; if it is 85%, those attaining 84% will feel aggrieved. This is a fact that we have to live with. It cannot be solved, because the solution (increasing the number of seats) is against the larger good of the society. The contention of the government that it cannot prevent the establishment of new colleges is not based in fact. The Supreme Court, in the TMA Pai Foundation case, while agreeing that anyone had the right to open a college also stated that this right was subject to reasonable restrictions (Supreme Court, in the TMA Pai Foundation case, Writ Petition (civil) 317 of 1993, Date Of Judgment: October 31, 2002). Moreover, it is always open to the state government to enact a new law to regulate medical education and seek presidential assent.

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Another argument is strange indeed: that neighboring states permit such colleges and hence any state wanting to start a college should be permitted to do so. Should an unhealthy, corrupt or counterproductive practice in a neighboring state be imitated? Finally, it is sad that students in Tamil Nadu in 2015 had to resort to a strike to emphasize the situation, with the poor patients bearing the brunt of the strike, as always. But in a situation where other methods fail, a strike may appear to be the only option left. Now the National Rural Health Mission (NRHM) has made its appearance in a nuanced manner to give credence to the falsehood of India needing more doctors than we manufacture. To increase medical manpower NRHM has taken a convenient route and subtly introduced a few considerations so that more medical colleges can be opened. This logic is presented below. A fresh look also needs to be given on the norms for setting up new medical colleges under the regulations framed under Indian Medical Council Act to see whether any relaxation is necessary for such areas. Apart from creating teaching infrastructure at the district level, such a college would also promote much needed investment and improvement in  care in the district hospitals raising it to tertiary care level which is difficult, takes a long time if at all it is accomplished. In general these arrangements are cumbersome and disadvantageous to the teaching purposes. (Italics ours) (NRHM Document 2005–2012)

I have contested and will continue to contest these claims. Clearly there is no need to repeat the futility of these claims. Such statements long dormant in documents  could be activated  at any unguarded moment  for its declared purpose of making up for shortage of doctors, hiding the undeclared huge monetray benefits intended and protecting the vested interests. Many of these suggestions have been dealt with and negated in the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020).

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The Rise and Rise and Rise of Capitation Fee Colleges Cost of Medical Education Then In November 1975, anyone graduating from the Mumbai Municipal Medical College would have paid a total of Rs 2115 as term fees, at Rs 235 per each of the nine terms. The state bore the expenditure for this education. The stipend for internship was a meagre Rs 225 per month. The full-time house officers were paid Rs 450 per month, and it was possible to ride through the postgraduate years on a few such jobs. If the house officer worked for two additional Sundays, she would be paid an additional Rs 100. However tough it might have been, it gave value for their money and effort, which in turn gave value to their degree. In the money game there is no value for anything except money. The Costs Now The average fee charged by some of the better-known colleges and even less known ones for an MBBS seat is stated to be between Rs. 400,000 and 500,000 per year, that is, Rs. 2500,000 to obtain an MBBS degree. It is all standardized. A private Bachelor of Dental Surgery seat costs around Rs. 600,000. As far as postgraduate seats go, the rate varies between Rs. 50,000 and Rs. 3 crores, depending on the course one picks. There are private colleges where up to Rs. 80 lakh is being charged as capitation fee for an Ear, Nose and Throat (ENT) specialty and anywhere up to Rs. 9 lakhs per annum for the next five years. Clinical courses usually demand the maximum capitation fee, while non-clinical subjects are at the bottom of the pile. The top grosser is radiology, said to cost anything between Rs. 1.5 crores and Rs. 3 crores. The payments are, of course, ‘off the record’ (Kannan Ramya, The Hindu, June 28, 2013). Here are some more examples of the fees and irregularities associated with them. In Thiruvananthapuram the fee regulatory committee for self-­ financing medical colleges  under Christian management  revised the fee structure for them to Rs 4.8 lakh for one year for a general seat and Rs 18 lakh per annum for NRI seats (TNN | November 1, 2017, 15:30 IST). This was done after cases regarding the fee were settled by the Supreme Court. However, the Christian management association has refused to accept this fee structure, threatening to go to Supreme Court

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and claiming that the committee has no authority to fix the fees (probably on the grounds that under (30), (1) of the Constitution of India it is a minority institution). In Bengaluru, the Fee Regulatory Committee headed by Justice DV Shylendra Kumar allowed a maximum of 8% increase over the previous year’s fee. The maximum fee in 2016-17 was Rs 630,000. Many private colleges had sought a hike as high as 30% (TNN | June 9, 2018, 09:26 IST). Justice DV Shylendra Kumar stated that “During inspection...any college charging more than the stipulated fee, the government may levy a fine up to Rs 10 lakh or double the excess amount collected, whichever is higher.” The governments are also shameless about exorbitant fee hikes which they connive at or participate in. The Telangana government effected a fourfold increase in medical education fees without even consulting the Admission and Fee Regulatory Committee (AFRC) (Mutha Sagar Kumar, August 24, 2018). The High Court had to stay the hike. Now that the Central government has placed stringent demands on these colleges in terms of the infrastructure and other facilities to be made available, these colleges have argued that their overheads have gone up. They also claim that they have to woo the faculty. SRM College Chengalpattu, in Tamil Nadu has therefore increased its annual fee from Rs 1 million to 2.1 million per annum or 9.45 million for the full four and a half years. Katihar Medical College in Bihar increased its annual fee from 0.8 to 1.25 million per year. Dr D Y Patil Institute in Navi Mumbai routinely increases its annual fee by 3%. Now it has been hiked by 32%, 1.65 million per annum or 7.62 million for four and a half years. Sangeetha University in Tamil Nadu raised its annual fee from 0.9 to 1.5 million per annum. The fees a government college charges a student for the entire course in Rajasthan is Rs 9000 and 440,000 in Punjab. The fee hikes in private colleges are astronomical. Private medical college spokespersons have the audacity to say that private colleges have been wrongly painted as a profit-making exercise, which has been backed by economic reasoning. It seems that it is very difficult for the medical profession to relinquish its link to money. The demand to make these colleges viable states that the private medical colleges should be allowed fix their fees, adding that fee fixing especially by the government is a futile exercise. The spokepersons add that instead NMC should insist on transparent fee structure. (Network of Health Reporters, The Times of India, September 26, 2016, Nagpur Edition). In fact, the NMC bill has left 60% of the seats to be filled by the management without any stipulation for capping the quantum (see more on this in Chap. 6 Regulations and the Regulators in Health Care in this volume).

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A separate report states that the Fee Committee members of states are helpless in controlling the fees charged and it is for the public to go to the courts with this issue. This is a pathetic and pitiful scenario, and all the more so if the law does not allow this. As the members have stated, this is especially true for the deemed universities where the Supreme Court had allowed them to fix their own fees (Network of Health Reporters, The Times of India, September 26, 2016, Nagpur Edition page 9). There is an additional disadvantage. The state governments have stated that deemed universities are not under state control. Any action against them can only be taken through the Central Ministry of Human Resource Development. This means that another non-state government agency has a right to interfere with a concurrent health issue. If a complaint is received by one of the two there will have to be a coordinated action between the two agencies, which is a difficult proposition.

Capitation Fee Colleges: A Political Device Has Nothing to Do With Medicine or Health This game of private or capitation fee medical colleges was started in Karnataka on a large scale by a diehard Socialist, one among the young Turks of Indian politics around the time of the Emergency, belonging to a cadre of people who were pro-poor and anti-capitalist. As the then Chief Minister of Karnataka, this man developed the game well by announcing that he would provide a medical college for every district and every major caste in Karnataka. The merit for entry was strictly money and a certificate of passing Standard 12. There was a spectacular response and an impressive collection of money which the people were ready to pay off the record. This man was Ramakrishna Hegde. I had sent an article on Hegde’s shameless actions to two English dailies in Karnataka, where I was then working in the rural, tribal areas. It was titled “Too Ridiculous to be Funny, Too Agonizing to be Tolerable!” Neither daily printed it. There was nothing either socialistic or moral about this enterprise of Hegde. It was a plain political devise to amass money to win elections and make more money on an assured year-to-year basis. This is borne out by the rates for various courses quoted above. Without exception, the reason why they have come into existence is to open a grand avenue to make vast sums of money for furtherance of one’s own person without an honest day’s work.

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In the article mentioned above I had written: A medical collage should take birth in the womb of a large and busy hospital flocked by people due to their trust in it for good services, with laid out systems to be able to run on its own smoothly. Then only the real life experience of treating patients in ward and learning will come. Capitation colleges come into existence. But they are not born in the womb of such a large hospital nor do they fulfill the needs of the nation. It takes any such capitation fee college to develop a College-ness or to develop in to a large hospital they need to teach, at least 15 to 20 years. To develop to the mature teaching hospitals it takes several more years of hard work. Most do not reach that status even after a dozen years and languish at the same level. (Kelkar Sanjeev, July 1981, unpublished)

In the discussion to follow exceptions are made for a few well developed institutes such as Manipal far as the infrastructure and quality of care is concerned. But by and large most of these colleges will be examined in this discussion. What Really Is the State of Private Medical Colleges? An Illustration The health of medical education in Maharashtra was exposed in a rigorous audit report (Bapat, Ravi, 2011). It looked at whether the medical colleges have complied with the rules of the Medical Council of India while establishing and running the medical colleges. The salient findings were as follows: 1. Lack of teachers was quasi-universal. In ayurvedic and homeopathy colleges the required number of teachers was less than 50%, within which there were categories of full-time, part-time honorary and contractual teachers, which made the situation worse. 2. There were two or three colleges which showed the names of the same teachers on their teachers register. Some of them were on the register across state borders in other states as well. 3. It is nearly impossible to judge if all the teachers who were on the register ever attended the college. 4. The secretary of the Medical Education Department did not allow the vice chancellor of the State Health University, (Dr. Ravi Bapat) to

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examine government medical colleges under the argument that this university had no right to examine the government medical college. Obviously the secretary did not want the pathetic situation to go public. 5. The argument of the secretary was to let the colleges grow, along the lines of ‘The more the merrier and the weaker will die.’ Unfortunately this did not happen. The plea that it was a question of the lives and futures of young boys and girls did not move him. 6. It is the political people who have entered this business and have acquired a reputation for being great personalities in education. 7. If a report like this disqualifying a large number of medical colleges goes public the government shakes and quivers. If the health university withholds the permission for such a college the entire machinery works to loosen the rules to bail them out. 8. The vice chancellors themselves are appointed by the government and all the money comes from the government, making it impossible for the vice chancellors to oppose the government consistently and long enough to be effective. 9. Attempts have been made to abolish this health university in Maharashtra itself as a troublesome institute. This was done by constituting a committee of those medical politicians who demanded its abolition. The idea was to produce an adverse report so that it could be abolished. 10. What is even more surprising is that the private professionals are also not willing to raise their voices against this system. If this is the state of affairs in a so-called progressive state like Maharashtra, one gets a fair idea of the situation prevailing in states like Uttar Pradesh and Bihar.

The Money Makes All the Mares Go The following is an account of the detailed secret survey done by me and my team of researchers on one of the ‘above average’ capitation fee medical colleges, located in a mega city and around 15  years old. From this account one can make his own deductions as to the situation in the much below average institutes which are far too many in number. The genesis and maintenance of this college year after year was carried out through an entrepreneur who had political connections, as is the case generally. It was brought into existence in its most basic form with project

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planning, land acquisition and application for permission, which is a long process and consumes enormous amounts of money. But once the admission process starts and the money is flowing in, the game really begins. The first important event on this journey is obtaining and maintaining the recognition of the Medical Council of India. The norms, over which the college will be questioned and checked, are well known. In order to meet the norms an on-paper profile of false records must be created for each and every aspect of work, systems and faculty where it is necessary to show that the records are compliant. Such false records are created and put before the inspecting team.1 To give an idea of what is done regarding the faculty, a few examples are as follows: creating faculty roasters and recording their presence at least a few days a week or a month more generally, to see to it that all of these sporadic faculty are present on days of inspection by MCI, and that staff recruitment and presence and their payment records are maintained in an efficient manner. As regards the record of the number of patients admitted, the number of procedures/operations conducted, the records of student attendance during the teaching programs, and every such record that the MCI may look at and check off are meticulously maintained. Every detail is worked out. If something cannot be thus worked out, the inspecting agency is always ready to connive at it or turn a blind eye or simply check it off, as long as the overarching ‘consideration of the continuance of the great enterprise of teaching’ is intact and somehow delivered. MCI occasionally has the temerity to carry out surprising inspections. Even then there will always be a certain level of preparedness present in the institute. Once the approval is obtained there is an unspoken moratorium for a few years when MCI will not bother about these colleges. The amended MCI act specifically stipulates that if no objection is raised by the Medical Council within a year the proposed college can consider itself sanctioned and go ahead. There will be sanction of a certain number of students on the first try. This in turn will depend on how much of an illusion the college was able to create on the day of inspection. 1  An interesting example of faculty recruitment was the ACPM Medical College of Dhule district with a population of 20,50,862 in the 2011 census. The faculty status in 2005, when the population was not more than 14 million, was as follows—Anesthesia 14, Anatomy 9, Preventive and Social Medicine 18, Microbiology 15, OB and Gynecology 19, Ophthalmology 16 and Medicine 45. I do not think any further comments are necessary. As of now Dhule has only one college added to the above.

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The money that the students started bringing in, in the context of this college, initially went toward further development of the infrastructure and then to expanding it. Now, a few years later, the super-structures of modern medicine are being installed and further expansion of the infrastructure of the college has been undertaken. This has been going on since around 2009. All this started happening after a dynamic vice chairperson took over. All the student money went into providing for continuous reduction of the charges levied on patients initially, to a stage where as to date there are no charges. Their patient base is also readily available on demand for admission when needed, on the day of inspection. The story of this college, however, is somewhat different since it made an attempt and came through credibly well by inviting inspection by an accrediting body. On its first visit, the accrediting body told the college authorities to improve on 70 criteria. The college worked hard with the body for 18 months to meet all of these criteria. During the first evaluation conducted after this exercise the accrediting body gave the college an A+. This body was not the MCI. It was NAAC, the National Assessment and Accreditation Council. The rigor and honesty with which the inspection was carried out was in total contrast to MCI.2 There are a few questions here begging answers: . How has such a body remained so purely focused on merit? 1 2. How has it retained its rigor and managed to give honest judgment on one hand but also help the institute under inspection to meet all the criteria on the other? 3. How has it kept itself free from corruption when it is almost impossible to find an institute in India today that is honest, competent and thorough? 4. In an earlier version of the draft bill for the National Medical Commission in 2016 it was mentioned that the director of the National Assessment and Accreditation Council (NAAC) was to be 2  To the credit of the surveyed college, what must be mentioned is the number of teaching instruments it has devised and uses in its examination system. There are structured long questions with a segmented mark pattern to reduce personal biases. These questions to be solved need a logical approach which the students are likely to have absorbed. The space for purely mechanistic and information-based MCQs is reduced with some MCQs based on reasoning and logic. This is a trend which is being observed more generally in the Pre Medical Tests as well, and is welcome within the total context of examinations.

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a part of the Medical Advisory Council. In the bill tabled in Parliament, why was this idea dropped while the Medical Accreditation and Registration Board (MARB) was still allowed to receive help from other reliable accreditation bodies? The reasons behind this intellectual rigor and honesty of the accrediting body were made clear by one of its members in Mumbai. This body draws its faculty and assessors from all over the country. No assessor will meet a fellow assessor he or she has worked with previously, again. Thus any development of a bond or link or an attempt at cartelization or dubious approval is avoided. Most of these people do the job out of a love for academics and desire to raise the standards. Aside from what they get as an honorarium, it is this noncommercial social service attitude that keeps bodies like NAAC clean. No NAAC member will accept any gift whatsoever, even as a courtesy. At the same time, as the member made clear, NAAC is a body for accreditation. It has no powers of punitive or regulatory action. On my questioning the member as to why the body should not be given this power, the member preferred to remain silent. I believe such powers may bring in the unsavory corrupt elements that NAAC has strictly kept at bay. Notwithstanding all this, the point is that such a body is needed which can accredit and/or close useless institutes charging capitation fees. Obviously it cannot be MCI. If an honest NAAC demanding quality  exists then why not give it a larger role in the government as well as in private medical colleges to see that they maintain their standards, rather than MCI? Such a move, however, will lead to multiple agencies and multilateral authorities in the system. These two maladies have been repeatedly referred to in different contexts and critisized  strongly  throughout the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020). Dissolution of MCI has taken too long a time. National Medical Commission has come in its place but has  not  started acting  effectively yet. Inclusion of NAAC in this period could have salvaged some damage. The CEO of the college we studied has an obsession with quality in the college under consideration, and the staff of the investigated college responds well to this. This is also not a general phenomenon. The impetus in actually meeting the quality targets could be sustained due to the dynamic chairperson of this college. It has expanded the patient base, has strengthened the teaching program, and has seen to it that the faculty

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attend conferences and are active in publishing their work. The faculty is given better working conditions and equipment and currently the college is in a rapid expansion mode, and as of now has two such accreditations under its belt. The Ulterior Motive of Quality Improvement Prima facie the entire exercise of two accreditations is ostensibly for quality improvement of this college. The institute is spending a large amount of money as well to improve the quality and quantity of work, which is to its credit. But all this talk and effort and achievement, and all the first-class grading, are driven by the more fundamental, powerful and original aim with which the enterprise began, that is, to make more money. The final modus operandi and the calculations are to increase the number of undergraduate students well beyond 275 or 300, by increasing the patient base and by introducing super-specialty operations. This type of expansion will undoubtedly give a boost to care. The still broader game of increasing the tools and infrastructure that are used by the super-specialties, however, is to increase the number of students the college can admit for postgraduate studies in the first phase. Once more super-specialty facilities and postgraduate seats are added, they will be in a position to ask for permission to admit postgraduates in super-­ specialty degree courses in the hospital. Each and every step will lead to astronomical amounts of money coming in. The real drive for quality is thus to make a claim to the MCI, to grant permission, and to increase the number of students admitted year on year. The college has managed to keep the admission number rising over the last 16 years, and it now stands at well over 150 undergraduate medical students per year. One of the oldest colleges in that state, with much larger infrastructure, well-built traditions, a large patient base but a low satisfaction level of the beneficiaries, still has only 200 students admitted yearly, even after 60  years. The money collected additionally by the increased number will go partly toward further development of infrastructure but the promoter group will keep a substantial amount for themselves. This money will also be useful for the vultures the college may have to satisfy.

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Managing and Balancing the Passing Out Parade The increasing entry number at the undergraduate level must be matched by an equal number of students passing out. If a substantial number of them fail to make the grade then the smoothly built up teaching and the other related machineries are going to be burdened by the detained students. And to obtain money from the parents for a few more years to maintain the students on roll is going to be a headache. The simple expectation of the parents is that the money is given for a stipulated period as per prevailing practices. Seeing that the student graduates is the job of the college. It is a delicate situation which, in the best interest of all concerned, should not arise in the first place. One inevitability that every medical college or any teaching institute, government or capitation must concede to is that not all the students are going to pass. The government will have the distinction and advantage that it has a majority of students with merit. Even then there are generally many different reasons due to which not all pass. In fact upwards of 30 to 40% of students may not pass in the government system. But the government sympathetically carries them on and sooner or later, far too often later, ejects them out of the system. Nobody minds their burden. This cannot be the case with private medical college. The likelihood of far too many students failing here is much greater because merit is not the criterion for most of the admissions—the principle difference between the two systems. Students will fail in both systems for other reasons, such as fundamental dislike or incapacity to learn medicine. This becomes apparent if the student has been forced to go into medicine due to the parental desire to make their ward a doctor to continue to manage their business. The second reason could be the development of habits by hostellers during their first time away from the pressure and watchful eye of their parents and supported by money. Depression, fear of failure and peer pressure are some more possible reasons for students to inevitably fail. However, the central problem remains that the entire machinery and the processes are built on the presumption that what comes in goes out. This is not a small problem; in fact it is enormous. And this has to be overcome by some means. The one mechanism these institutes use to solve this problem substantially but not completely is to obtain the status of a deemed university. This institute had built quality and had created excellent systems and everything else that was needed but they had no control over how many

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could pass since an independent state health university conducted the examination and assessment. It was difficult for a single college to establish control, particularly over assessments to see that the students passed in large numbers. To overcome this they had to obtain the deemed university status for the good work they had done earlier. Thereby the college could construct syllabi, create its own standards, create different headings under which marks could be distributed, set the examination papers and carry out the assessment themselves according to those provisions, as well as issue certificates of qualification. After all, this is what the state universities do. Thus the status of a deemed university has advantages. The college did later acquire the status of deemed university, and this saved it. Attaining this status was not at all a cake walk. The state had a regular medical university against which they were seeking deemed status. Then we went into the examination system of the state university before the deemed university status was obtained. It was not the best. The lapses were in the exactitude, non-ambiguity and clarity of the questions asked. Nearly two dozen Multiple Choice Questions (MCQs) had been assigned completely wrong answers and there was no negative marking. This helps enormously to pass. But, then, the State University system was not built to fail students on reasonable grounds either but to pass as many of them as possible. The state system is such that even if a student begs to fail, the system cannot allow this to happen without compromising the procedure. This college found that after using each and every device to pass students, it was still impossible to pass around 18% of them. This further underlined the necessity of acquiring the status of a deemed university. However, acquiring this status also could not help certain student behaviors that turned out to be detrimental to passing these students. The student factors were apathy toward learning, not fulfilling the expectation of teaching modes such as tutorials where the students have to come prepared by reading a topic, not paying attention to the teacher, an impolite callousness about what the teachers try to tell the students, absenteeism, and studying late at night after recreational activities and then sleeping in class. The other dividends would follow after getting deemed university status. The promoters of many capitation fee colleges had already started many other paid courses related/unrelated to medicine under the same principles of monetary operation. Thus such a large group of colleges can be brought under one banner of deemed university status. This is absurd. Many states in India have established health universities yet new deemed

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universities have appeared. There are currently 44 in the country. This has gone too far. Even the best-quality institutions or institutional complexes obtaining the status of a deemed university are demeaning to the very idea of a university, which has a halo around it in Western societies. Western societies by and large will preserve and support the culture of their universities and the sanctity of the research they do. The West guards their institutions, while we trivialize them and destroy their sanctity.3 The Process of Near Total Passing Out Even after the deemed status is obtained the college has to find ways to pass as many students as possible. The system to achieve it is to break the distribution of marks in as many heads as can be thought of. With the heads comes the percentage of the marks that are given to a student. This mechanism keeps most students in and around the passable limit, which is lower than that of the state university. The overall pattern is such that the student is unlikely to fail unless the situation is truly beyond redemption. Oddly, attendance is not used as a tool to be strict with student behavior. It is not used to stop him from passing even if his sincerity and knowledge are spurious. Here a specified percentage of attendance gives the students some more marks which will help him cross the line. Then there are averaging methods, and persuasion of the external examiner to keep the overall balance. The central point is that throughout this pursuit the strong focus on a good product, a quality doctor, is not only lost but is also replaced by the system working to create more and more money while producing a mediocre product in most instances. We studied a few more institutions, at times even participating in their teaching sessions, tutorials or rounds in the wards, and what was found was largely disappointing. There are two clear divisions among those students who are admitted. One of the groups, about 15% plus or minus 3%, are those who are bright, studious and sincere, and are the rank holders. In one of the institutes, two out of the eight or nine rank holders were Muslim students, which was pleasing. These eight or nine were the 3  Apparently this is no longer the case even in well-developed countries with a ‘university culture.’ Highly substandard universities seem to have proliferated which target the students abroad to enroll by paying vast amounts of money. In my own surroundings I see young men and women who do not attain the required grades in India go abroad by paying the sums to obtain degrees and try to repay the loan by staying and working there.

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wards of families in which medicine runs through generations. But the remaining 80% are disinterested in studies, as shown above. The sole purpose is to be marked present, since there are ten marks for this. These students are not marked absent even if tutorial after tutorial they cannot answer any questions. Fifteen to 20% find it difficult to reach the meager 35% passing limit. An equal percentage is in need of grace marks and such other devices which the deemed university has created by which the parade of passing out in maximum possible numbers is ensured. The Student Types and the Issue of their Merit 1. Those students missing the cutoff and having to resort to capitation fee colleges is the first group. 2. The issue of the merit of those who are way below the cutoff but are admitted to the private medical colleges has often been a sensitive point. 3. These  private college students with much lower percentage of marks  are compared to the SC and ST students who get in to the  government medical colleges  on much lower percentage of marks. The implication of the comparison is to say that  both are incapable of developing in the profession and become  a threat to public life. This is a deliberate and vicious expression of the uppercaste people against the SCST students who reduce the open merit sats. 4. The reality is that all three groups, upper castes from both the government and private colleges and the SCs and STs from the government colleges, have students who cannot cope with the curricular pressure. All of them after passing out may be sub-optimally functioning. The solution is to improve the medical college teaching, and such ugly insinuations should be ruthlessly removed from public debate. 5. The other charge against the doctors coming out of capitation fee colleges is the assumed immorality of the economic extortions they will bring about and its adverse  effect on people. It is unfortunate. Today a large number if not all those who pass through the government system also extort money from people. It does not matter as to which group they belong. Even if this charge is true there are enough and more other reasons to oppose capitation fee colleges.

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Capitation Fee College Issues Not Discussed So Far 1. These colleges bring enormous money power to the health and education sectors, which is funneled off into the coffers of the politicians who have started these colleges. 2. The Communist state of Kerala initially reacted against these colleges for the right ideological reason only to see the money game and agree to start these colleges in the state. The Tamil Nadu motivation is money. The three southern States of Tamil Nadu, Karnataka and Andhra Pradesh have among them the largest number of colleges, and consequently, MBBS seats. 3. The then state of Andhra Pradesh, which was the first to establish a health university in India, is also among these leaders in the game of private or capitation fee medical colleges today. 4. This devise has nothing to do with the health of the people and is completely callous about what it will do for the health of the poor. There has been no consideration of what it will do to the medical system, not even ills and evils it will generate. 5. These colleges are the perpetuators of hereditary Chaturvarnya— the famous fourfold Indian social system. The doctors have worked for years and developed their own nursing homes, small or big institutions, valued at crores of rupees, earned their name in their area. They want the business to continue for many reasons other than an affinity for it. The best way out is to train their own children in medicine even if it comes to enormous amounts of money until at least a postgraduate degree is obtained. The medical profession has become a hereditary phenomenon as was prevalent in the age-old social system of Chaturvarnya, which should be destroyed as it is completely out of date. 6. The fallacy inherent in this hereditary system is that the child may have no inclination for medicine, and hence will never be able to rise to the level of their parents in practice, who came up the hard way. This is a common phenomenon and has serious implications for the mental health of these students over their lifetime. Dynastic medicine, however incompetent it may be, is perpetuated on the populace. Alternatively the child may be interested in becoming a doctor like his parents but simply does not have the capacity and is similarly destroyed in this system.

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7. If the extreme demand of closure of these colleges is fulfilled this may lead in the longer term to higher numbers of doctors not developing their own establishments and instead attaching themselves to other large institutes which will do at least some public good, and safely avoiding sinking into this quagmire. It will also substantially end this hereditary Chaturvarnya.

Some More Issues 1. These are iniquitous economic terms where meritorious students will not have the money which others may have, using a legalized alternate norm of corruption for higher and professional education in the society as an opportunity. This is not justifiable on any count, including the economic class of the parents. Those who miss out on the government colleges and cannot afford this cost are the ones who most often face economic inequity and the stringent experience of an unjust system. It is the moral as well as ethical objection to this system. 2. The claim of correcting the numerical shortfall of doctors by opening more private medical colleges has been shown in brief to be completely false. This will be discussed further in my other volume on public health care delivery. The issue is our failure to garner our own human resources from the public medical education system. And the solution certainly is not increasing these private colleges. 3. Similarly, one should be fully aware that doctors graduating from private or capitation fee medical colleges in large numbers are not going to fill the rural vacancies. Solution to these issues are laid out extensively in the chapters on Reorganization of Health Care Delivery in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one. These solutions will work even after closing these private colleges. 4. These private colleges are the biggest drain on those government college professors who like to teach. Many of them now teach in the private colleges just because they are age barred from serving in government medical colleges. This has led to a crisis in the state-run medical colleges particularly, in terms of good teachers, good clinical practice, and some grounding in relation to what one is to do as

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a doctor. These teachers should be brought back. Against this background the Central government decision to increase the retirement age of medical college faculty is a sensible step which might reduce the flow to private colleges  a little. The government students will have the benefit of learning under those who will be unmatchable in their wisdom, knowledge and skills as they grow older. 5. The private sector is the generator of numerous cases of malpractice, especially in cities and towns, largely in the ‘money for service’ sector. In general, wherever there is super-saturation of doctors at any level of practice, malpractice will arise, first for the sake of survival, second for the repayment of loans or realization of the money spent on capitation fee colleges, and third the greed for money. 6. Capitation fee colleges have the raw power to successfully and systematically knock the merit off, bend the judiciary in their favor and corrupt the system. Examples of these are given in the following chapter in the section on law and the fraud of capitation fee colleges. It is like a bad coin driving a good coin out of circulation. 7. The importance of holding down the price line for patients cannot be overemphasized. The products of the government and more particularly the private colleges will make it impossible to achieve this. The parents and students who spend such huge sums will want to recover their money, which is not easy due to super-saturation. The cases of malpractice being resorted to will not help to hold down the price line as long as the system does not first cut out the roots of super-saturation in private colleges. 8. This extortion in itself and in a nation where poor people continue to suffer is unacceptable. It is only possible to keep the price line of medical services as low as possible if the medical education remains subsidized. This is also discussed in other places in this volume and in India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020). 9. The tremendous insecurity coupled with poverty and the stagnant economy for several hundred years has now given way to the possibility of making much more money. Large sections of the neo-rich have emerged which have money. They want to use money for what they do not have. These people also think that costlier and more sophisticated-­looking merchandise is better to buy. The presence of this class has also resulted in costly education outfits which are fashionable, have sparkling uniforms, look sophisticated, speak English

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and have a deadly culture of pushing the pupils into the ruthless game of competing from an early age, as well as draconian behavioral norms.

The Neo-Rich and Their Outlook on Money As an extension, health education has become costlier, and the class that can afford it is abounding. From childhood to adulthood through old age, health care also has become costlier. With money comes the greed for power, control and vicious authority. To attain these, if justice has to be bought it is again a costly business. Thus, the more money one has, the avidity for money to obtain more money increases. Private colleges are one result as well as an outlet of this money culture. We have ceased to look at our kin as our own. They have become a separate economic entity and a calculable economic burden as their age advances and their health becomes an encroachment on the freedom of the young. Almost anything and everything the rich in the society do, they do it thinking all the time of money. For human relationships this is unhealthy. This is why the trend of dominance of money over mind needs to be reversed. Constant consideration of money is a corrupting influence. Society cannot afford to have money be the dominant force when the driving idea should be to save and make better, poor human lives. A few actions can be undertaken to make the health sector much less costly by eliminating expensive factors such as the private medical colleges, controlling medicine and device costs. The Central government is doing this job well,  as seen in the drastic reduction in the coronary stent costs and including over 500 drugs in the National Essential Medicine List under strict price control. See the following two chapters  in this volume. Controlling costly corporate practices and use of costly gadgetry and other measures is not easy. The state subsidized medical education is the best way of training doctors.  Public health care systems can be made much better and far less costly. In it the government bears the educational expenses and will have a right on their time after pasing. By deploying these doctors in it, the public health care systems can be made much better and far less costly. This is the reason why the centers of manpower production, that is, the medical colleges, should remain low-cost centers, and the doctors coming out should be supported well in the initial years and deployed where needed. To understand the full dimensions of this process see the abovementioned volume. 

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In medicine, human development ensues on account of seeing the suffering of mankind and wanting to eliminate it, or reduce it and make it bearable. A large majority of colleges have a poor patient base, facilities and/or faculty. This is why the private medical colleges are insufficiently effective for this human side of development. In addition there are other factors—‘moneyed atmosphere,’ the rich students with fancy and costly bikes ready to splurge money on lady students followed by general permissiveness in the capitation collages. These are serious questions and problems regarding these production centers. Where the students know that this institution is running on account of the large amounts of money their parents have paid, will they ever develop in their social consciousness, towards the suffering patients and humanity? The same could be repeated in many other areas of life, and health reforms could lead the changes as a model. Better-equipped people can come up with their own ideas in their areas of operation. If we do not do this, an inevitable tremendous recession will occur; imagine a country of 130 crore in the grip of a recession…. Closing Private Medical Colleges Dealing with capitation fee medical colleges, trying  either to improve them or to close them, is a difficult task. Several suggestions are presented in this regard. 1. The situation should be improved as best as we can through the due process of law at the state and central level to deal with the capitation fee colleges. This clearly requires an MCI which is honest in rating these colleges for quality and recognition (which has not happened). This should normally have led to the de-recognition process, temporary stoppage of admissions, hand-holding and guidance given to improve in a narrow timeframe. This has also not happened. 2. The National Medical Commission will be able to do a much better job through the Medical Accreditation and Registration Board (MARB). On the process of de-recognition bill for the National Medical Commission is compared with the hitherto MCI practices. See Chap. 6 Regulations and the Regulators in Health Care in this volume. 3. If a college does not show the ability to meet the required standards after the first chance this should lead to stricter consequences regarding closure forthwith. The most adequate and justifiable time period is two years. There should not be more than two chances given for improvement before closure under new rules and modified laws.

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4. The procedure mentioned above if applied will tell us in just a couple of years how many colleges were truly irremediable and had to be closed down under due process of law. It will at least reduce the most degraded clutter in the system. Those that are found remediable in the short run could be encouraged to shape themselves into a different role but not the undergraduate medical college, expalined later. 5. The reason these steps are mentioned is to be fair, to show that one is respectful toward the instruments of change in a democratic polity and to avoid all kinds of uncharitable words used against the proposals made herein. It should, however, be pointed out bluntly that this process resulting in closures is asking for the moon. The government abolished MCI, brought a new body and new procedures in but the deeply ingrained dishonesty of our nation will again show that things are as well as before with most colleges and the system will continue. None of this can come to fruition unless the babus and the bureaucracy of the MCI and other national bodies are liquidated, bundled out and thrown into a remote corner from where they cannot touch the new system or any changes to the law for the better. The messages from the abovementioned survey of Dr Ravi Bapat and the Ketan Desai episode are adequate to explain my opinion about the babus. It should be a matter of great delight that the NMC bill has specifically mentioned that babus will be removed en bloc as if taking a clue from this, then unpublished, volume. 6. The status of postgraduate training in these capitation fee colleges should also should determined. If it is found unsatisfactory, it should be closed forthwith, the postgraduate students shifted elsewhere and the faculty closed. Whichever stream the newly formed MBBS doctor may come through, the government or the capitation fee college, he is to some degree raw. The real maturation takes place during the postgraduate years. One may be ‘more considerate’ about the quality of undergraduate training in colleges but one cannot be lax in the postgraduate years. 7. If the postgraduate training program of a capitation fee college is in fact effective, it will be beneficial for it to continue. The college framework of conditions for admission will or should have a larger percentage of students entering on open merit. The fee scale will or should be reduced, the degree of which can be mutually decided.

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8. Last and the most important, the graduation will be followed for all who pass out to work in the public health system for a minimum of 2 years. It should be a non-negotiable condition. 9. The precondition to this is the revamping of the public health care structures, without which such a rule will be highly unjust to all. The revamping is discussed in great detail in the chapters on manpower planning and reorganization of public health care in the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020) 10. A few more salient points are made here. There will not be a payand-­get-out type of bond. It will be the same as the conscription in the army in most European countries. This will be a well-paid job which will combine clinical work and teaching the graduates of the private medical colleges as well, in public health using the government system. If this proposition is not acceptable to a private college it should be closed down. But the government certainly takes the manpower for its own planning and utilizes it. 11. This action will have to seek recourse in different laws and/or procedures. One of the foremost would be to cancel the deemed university status of those colleges possessing this rank. Establishing state health universities to affiliate these colleges until they are closed down was an option in the past but today, after NEET, the system has become lean, efficient and honest. It does justice to quality as no other system has done in last 70 years. NEET has taken one of the two functions of the universities, conducting examinations, out of their hands. 12. Any university today is beyond rectification in the short run. It is removed from the arena of medical education through NEET, which is a blessing.

Prohibition of the Capitation Fee Colleges by Law—The Present Options 1. A comprehensive bill is necessary, as directed by the Supreme Court, to curtail large-scale corruption, payment of capitation fees and unfair trade practices in medical admissions. It has asked Parliament to enact legislation for curbing these unfair practices.

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2. Getting such a bill passed will be a lengthy process in terms of both its formation and implementation. The law will probably ‘ineffectively’ control only the money inflow and will not touch the other evils associated with the capitation fee system. 3. It is not that there are no laws. Existing laws, not covered in this volume due to space constraints, are sufficient to curb many practices. Such directives with due respect to the Supreme Court are offhand, and not considered in depth. 4. However hopeful one may be about the efficacy of such a law, sadly it must be emphasized that this will not work, as shown below. The only solution is to completely and comprehensively root out the private colleges. 5. Making more laws and adding to the existing ones is also evidence of the habits of the system, particularly the executive arm in opting for multiplicity of instruments, bodies, laws and procedures, none of which effectively do the job due to their sheer intermingling or entanglement with one another. Health is a concurrent subject because of which these complications multiply (the reader will come across serious critique of the matters mentioned immediately above over and over again in the volume on India’s Public Health Care Delivery: Policies for Universal Health Care). 6. A Law with teeth to prohibit the demand/collection of capitation fees is no doubt needed. It should effectively curb these practices without loopholes like those that exist in the present laws enacted by states such as Karnataka, Tamil Nadu, Andhra Pradesh, Maharashtra, Kerala and Delhi. Many such colleges which indulge in these practices can get away by paying a meager fine. (See below about what the High Courts of these states think of and how they protect these capitation colleges in detail).

The Courageous Path to the Solution to This Issue What follows is a list of what should be done in the light of the discussion above. 1. No permission should be given over an indeterminate time period to open any new capitation fee colleges across the states and union territories, as well as the Central government arena. Until the existing

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clutter is removed, even the central and state governments should not open new colleges on their own. 2. Using the reasonable criteria described earlier and putting in place the process of closure will ensure that sooner or later we will be able to eliminate this curse. With each closure the accompanying evil money market will start to break apart, helpful to an extent in reducing cases of malpractice, both present and future. 3. These two measures will also progressively reduce the additions to the pool of doctors from these colleges. 4. All the ongoing undergraduate capitation fee colleges should cease to exist after five years. This will give the promoters time to think of what else they can do. It will also prevent a loss of the years for students already admitted. 5. All the capitation fee medical colleges and any other colleges with deemed university status should lose their status and should come under the NMC and NEET for admissions. This has happened for NEET but the deemed status continues. 6. The colleges found to be completely unsuitable to function should be ordered to close down their postgraduate facility forthwith and the students should be dispersed elsewhere. 7. If the colleges are found to be extremely low in terms of quality they will have to close down immediately, and the students will be given their money back and asked to compete in all-India single competitive examinations and to reenter a government college. 8. Without doubt there are private medical colleges of far better caliber and excellent in every aspect of the required infrastructure. They should be converted into purely postgraduate institutes along the lines of PGI Chandigarh and should cease to admit undergraduate students from the next year. This will give them and the states time to decide how they can be partially supported and how they can raise resources. 9. The Central Health Ministry with the National Medical Commission should  now become the arbitrator in operation to  look into the numerous issues that might arise in this multifaceted process.

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Ancillary Works 1. This winding up process had to be preceded by a complete overhaul of the Medical Council of India and its state-level affiliations. Instead of that the MCI has been now dissolved and a new law and agency of the National Medical Commission has started the process of taking over. The present structure of the National Medical Commission, discussed in detail in this volume, in the chapter on Regulations and Regulators looks promising in this respect. 2. The existing government medical colleges will have to be revamped. This is discussed in some detail in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. 3. To achieve the proper deployment of manpower, extensive changes in the public health care delivery system will have to be brought about. This is also discussed in my volume on public health care delivery.

The Laws, the Legal Frauds and the Capitation Fee Colleges The aim of this chapter so far has been to show that there is no a priori justification for the entities of capitation fee colleges—social, moral, medical, and for the served as well as the unserved population of this country and the havoc they have created in terms of social destabilization and inequity. Now recourse is taken to the legal provisions, restrictions placed by the law, or the liberties given or grounds left to see whether the capitation fee colleges cannot be closed through the legal route. The following are some examples from the popular press which illustrate the atrocious methods of operation of the capitation fee colleges and the way in which the courts come to their rescue. From there it is a simple guess as to why these judgments are passed. Tamil Nadu Medical Education Mess: High Court Protects the Unlawful Activities An August 6, 2015 judgment of the Madras High Court has summarily dismissed the serious charges filed by the Central Bureau of Investigation (CBI) against a Chennai-based private medical college accused of illegally

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collecting capitation fees, and four private medical colleges for fraudulently presenting impersonators as faculty members during inspection by a Medical Council of India (MCI) team. It has shocked and outraged educationists, lawyers and the general public in Tamil Nadu. (Raghupathi Hemalatha, The Times of India, August 9, 2015) An administrator of Shri Sathya Sai Medical College and Research Institute and Melmaruvathur Adhi Parasakthi Institute of Medical Sciences had earlier been discharged by a trial court. The CBI challenged the discharge. In a speedily delivered judgment, the court dismissed the revision petition. It also quashed charges against another, Sri Lakshmi Narayana Institute of Medical Sciences. All three institutions were accused of forging documents and presenting impersonators not on their faculty payrolls before an MCI inspection team in April 2010 to secure or renew recognition of their colleges. Consequently they were charged under Section 420 (cheating), 463 (forgery) and 120-B (conspiracy) of the Indian Penal Code, 1860. (Raghupathi, 2015, ibid) Delivering the high court’s judgment, Justice Aruna Jagadeesan said that “the MCI Act, 1956 does not prescribe penal consequences for violation of its provisions, and ruled that faculty shortfalls and submission of false declaration forms were not punishable offences under the provisions of IPC or the Prevention of Corruption Act (PCA), 1988” (Raghupathi, 2015, ibid). The Judge further ruled and stressed that Contravention of rules may be an offence against the statute but is not a crime. There is no room or jurisdiction for any external agency like the CBI to investigate the affairs of a medical institution coming within the purview of the Medical Council of India, that the MCI Act was a self-contained law with provisions to punish misconduct by doctors and medical institutions. Therefore it was improper for the CBI to file criminal charges against violators. (Raghupathi, 2015, ibid) The speed and pedantic reasoning with which the high court dismissed charges against the four medical colleges has stunned judicial circles in the state. “By taking away the CBI’s jurisdiction, the high court has given unfettered powers to MCI. Although every regulatory and statutory body has its own rules and regulations, they cannot be outside the purview of the CBI,” said a veteran prosecutor (Raghupathi Hemalatha, The Times of India August 9, 2015).

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The high court verdict is a brazen and blatant or is an arrogant protection offered to the capitation fee colleges in Tamil Nadu and probably more generally to other state colleges. The reasons for such travesty of law could become obvious with a little thought. It also highlights how badly drafted legislation, casual enforcement and cavalier judicial interpretation have allowed scams and scandals in medical education to grow and multiply. Despite the Tamil Nadu Educational Institutions (Prohibition of Collection of Capitation Fee) Act, 1992 and two Supreme court verdicts in the T.M.A Pai Foundation Case (2002) (Supreme Court, in the TMA Pai Foundation case, Writ Petition (civil) 317 of 1993, Date Of Judgment: 31/10/2002) and PA Inamdar vs. State of Maharashtra (2005) (Supreme Court AOR Examination—Leading Cases—P.A. Inamdar v. State of Maharashtra (2004) 8 SCC 139, By Dr. Ashok Dhamija—May 16, 2015) specifically prohibiting the levy of admission or capitation fees by professional education institutions, the 22 private medical college managements in Tamil Nadu routinely extract huge capitation fees under the management quota. To date not a single college or official thereof has been convicted for breaching this law. (Raghupathi Hemalatha, The Times of India, August 9, 2015) “Neither the state government nor the MCI is interested in eradicating the malpractices of government and private medical colleges. Moreover, the MCI itself is a corrupt body and cannot be relied upon to take corrective action,” says Prof. E.  Balaguruswamy, former vice chancellor of Anna University and currently chairman of EBG Foundation, Coimbatore. By allowing administrators of medical colleges indulging in brazen criminal misconduct to get away scot free, the Madras high court seems to have made a messy system messier. (Raghupathi Hemalatha, August 9, 2015)

An University official was caught while asking for capitation fee, but he was let off-hook later. High Court said that the official is not a public servant. Five years after a sting operation by Times Now and The Times of India exposed a well-oiled capitation fee racket in MBBS admissions in the state, the Madras High Court has quashed a charge sheet filed by CBI against Dr A Subramanian, then deputy registrar (academics) of Sri Ramachandra Medical College and Research Institute, in a sensational case. Justice Aruna Jagadeesan said that “Dr A Subramanian could not be considered a public servant and hence provisions of the Prevention of Corruption Act 1988 Section 2(c) could not be invoked against him… there is no room for any external agency to investigate a case of corruption or illegality in medical colleges since the subject falls entirely under the purview of the MCI… it was improper for the Central Bureau of

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Investigation, (CBI) to slap cases against the violators…the CBI had sought to selectively deal with the problem of illegalities in medical colleges by picking on managements and doctors and not proceeding against the MCI or its chairman…” The judgment suggests that the MCI should be left alone to clean up the mess in medical education without any intervention by other agencies. The question how a regulator can be expected to put itself to the cleaning of the system, especially when its chairman himself is under a cloud, remained unanswered. One may note that it is the same judge who delivered the earlier verdict. The speed with which courts acted to ensure that the accused did not face trial baffles me…high courts are usually extremely wary of quashing FIRs and charge sheets, more so if they are probed by CBI. Power to quash as vested with high courts under Section 482 of Cr P C should be used only if it is clear that continuing the criminal proceedings would cause ‘gross injustice’ to people concerned… a former Senior Advocate said. (Subramani A, Times Group, July 2014)

Concurring with him, an ex-prosecutor said “it was too early for the trial court as well as the high court to discuss ‘threadbare’ such legal issues as essence of cheating and criminal conspiracy,” which are the main charges against these institutions. The CBI prosecutor’s cry against courts’ interference in the cases even before the start of the trial, obviously, fell on deaf ears (Subramani A, Times Group, July 16, 2014). This is the state of affairs. Courts to the Rescue of Accused Capitation Fee Colleges: People facing criminal cases cannot be allowed to ‘short-circuit a prosecution’ and achieve ‘sudden death’ of the case by using the high court to get proceedings quashed, said the Supreme Court a decade ago. Exactly the contrary was achieved by four medical colleges from Tamil Nadu and Pondicherry (July and August 2014) when they managed to wriggle out of CBI proceedings against them (obviously through the court). (Subramani A Times Group, August 08 2014)

My own conclusion is that either the law is without teeth or there is a deliberate lack or loss of political will to enforce it. The net result is unbridled money operations under the capitation fee system. After pending for

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a couple of years in Parliament, the Prohibition of Unfair Practices in Technical and Medical Educational Institutions and Universities Bill has slipped into oblivion. But I believe action can still be taken against institutions and officials that demand capitation fees. Even in Tamil Nadu there is a Prohibition of Collection of Capitation Fee Act. The Tamil Nadu Educational Institutions (Prohibition of Collection of Capitation Fee) Act, 1992 Act No.57 of 1992, Prevention of Malpractices in Education Bill states that “every institution should mention the facilities offered and the fees collected. If they fail to do this the officials will have to spend three years in jail and will be fined crores.” “However, across the country convictions under this Act are rare, if at all. The government … is not interested in putting a stop to this…the government should really show that it has the political will to do this” (Anandakrishnan M, Jul 17 2014). Prevention of commercialization of education is integral to the parent Act of AICTE, MCI, UGC and other statutory bodies. “The only way to stop this practice is to put three or four erring principals behind bars. Then, everybody will hesitate to demand capitation fee” (Jain Jayant B, July 17 2014: Quoted in The Times of India, Chennai). Complaints Against the Exorbitant Fee Collection DMDK legislator R Mohanraj, citing the Times of India report on the capitation fee menace in Tamil Nadu colleges, sought an explanation as to why the state could not curb the practice. P Palniappan, the Minister of Higher Education, declared on the floor of the House that there were no complaints that institutions in Tamil Nadu were collecting capitation fees. The parliament records in answer to a question raised earlier clearly shows that 139 complaints of capitation fee collection have been filed against self-financing technical institutions in Tamil Nadu with the AICTE between January 2012 and March 2014 (Jain Adarsh, Times Group 2014). Uttar Pradesh lodged 180 complaints. The UGC recorded five complaints against TN colleges between 2010 and 2013 and the directorate of technical education (DOTE) in Tamil Nadu received 130 complaints between June 2013 and March 2014. (Jain Adarsh, Times Group 2014). What a brazen answer! The defense given by Mr Palaniappan was: “Only if you mention names, of the college that collected the capitation fee or the student who paid it, we can take action against the institutions. Without mentioning names

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you are making it look like the state is making these mistakes….”4 In fact few complaints about capitation fees are followed up (Jain Adarsh, Times Group 2014). A senior official in the fee committee on condition of anonymity said, “Only 130 complaints have been recorded by the committee. Complaints are received all through the year but we sort out most of them over the phone. The institutions are asked to refund the money to the student and are given a verbal warning.” Is any further comment necessary to expose the Government capitation fee colleges’ nexus? (Jain Adarsh, Times Group, 2014)

In conclusion, there are enough laws to curb the capitation fee menace as well as the loopholes. The amounts of money involved are so enormous that even the High Courts can think of flimsy interpretations to let the perpetrators off the hook. The MCI Chairman can go scot free and the MCI sanctions new colleges and increases admission quotas to make up for the colleges banned from admitting students. It is not easy to end this game but it should be attempted since the machinery to demolish it is very much present.

References Nagarajan, Rema, 2018 | Times News Network | September 02, 2018, 08:28 IST Medical Council of India, https://www.mciindia.org/CMS/information-­desk/ for-­students-­to-­study-­in-­india/list-­of-­college-­teaching-­mbbs, accessed on 23rd February 2018 Bapat, RD, Postmortem, Manovikas Publication, Pune, 2011a Limaye, Arun, Chloroform, n.d. Naik, JP, Health for All: An Alternative Strategy 1981 Indian Council for Social Science Research (ICSSR) and the Indian Council for Medical Research (ICMR) Deo, M, Apr 2013, Doctor Population Ratio for India—The Reality. Ind J of Med Res; 137(4):632 -6325 Kannan, Ramya, Charging an arm and a leg for medical seat, The Hindu, June 28 2013, 13:19 IST 4  It is an open secret that all private medical colleges collect capitation fees, and the amount runs into billions of rupees. Every time a public-minded citizen points this out, he/she is asked to give proof, but it is not easy to detect these transactions. To therefore suggest that they do not really exist is akin to saying that because adultery is difficult to prove it does not exist. What then are our investigating agencies for?

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TNN | November 01, 2017, 15:30 IST TNN | June 09, 2018, 09:26 IST Mutha Sagar Kumar TNN | August 24, 2018, 21:03 IST Network of Health Reporters, Times of India 26th September, Nagpur Edition Network of Health Reporters, Times of India 26th September, Nagpur Edition page 9 Bapat, Ravi, ex vice chancellor of the Maharashtra State Health University, Nasik in Postmortem, Manovikas Publication, Pune, 2011b Times of India, August 9, 2015 Hemalatha Raghupathi, Tamil Nadu: Medical education mess, Jul 16 2014: Education World, The Times of India, Chennai [email protected] Subramani, A, Aug 08 2014: The Times of India Chennai, Subramani A, The Times of India, Jul 16, 2014 Anandakrishnan M, chairman of the board of governors of IIT-Kanpur, on capitation fee colleges Jul 17 2014: The Times of India (Chennai) Jain Jayant B, president of Forum for Fairness in Education, Jul 17 2014: Quoted in The Times of India, Chennai Jain Adarsh, Jul 16 2014: The Times of India (Chennai) The Tamil Nadu Educational Institutions (Prohibition of Collection of Capitation Fee) Act, 1992 Act No.57 of 1992 Supreme Court AOR Examination—Leading Cases—P.A.  Inamdar v. State of Maharashtra, (2004) 8 SCC 139, By Dr. Ashok Dhamija—May 16, 2015 [Supreme Court, in the TMA Pai Foundation case, Writ Petition (civil) 317 of 1993, Date Of Judgment: 31/10/2002] NRHM document, 2012 Framework for Implementation, 2005-2012, Ministry of Health and Family Welfare Government of India, Nirman Bhawan, New Delhi-110001 No.L.19017/1/2008-

CHAPTER 4

Perspectives on Pharmaceutical Industry

Human Beings in the Eyes of International Pharmaceutical World There is a reasonable certainty that human beings will start living up to 80 years in a decade or so due to medical advances. It is possible to calculate drug and other health needs even before birth until the eightieth year, on a yearly, five-year or in certain periods decadal calculation. In plainer terms the revenue that a human being can provide from being alive and well can be and has been tabulated in the strictest possible modeling. In still plainer terms this means the existence of human beings matters because it gives a certain amount of money to the health industry. That is the value of human life. This thinking, however, does not end here (Patil 2016). The question being intensively researched/attempted to be answered is: How can a human being be made to survive until 100 years of age instead of 80 as easily and in as good a condition as he can in today’s world. The strongest and the most intense focus is on this research, and will achieve two objectives. First, many newer therapeutic remedies will be available to keep humans functioning at their optimum efficiency of 80 years which will add to their monetary value. Second, an individual will continue to provide additional revenue by continuing to use all that he has been using to reach 80 years for 20 more (Patil, ibid. 2016). This raises one important question. Assuming that the bulk of the population finish their financially active and productive life at the end of © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_4

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60  years and have to live on their accumulated savings with or without further enhancements through lucrative investment, individuals will have 40 more years of their life remaining. Will they have the capacity to buy such medicines month on month or year on year? And if they cannot, will their caretakers be willing to do this with the financial strains that it will cause? At present this question can be answered by stating that only a minority will be able to do this. On a philosophical and physiological level one could say that the lives of individuals have already been prolonged beyond the abilities they are born with to serve any purpose due to increasingly dysfunctional organ systems. The cognitive systems are affected even more. Where would this all lead by increasing life expectancy by another 20 or 30 years? In today’s world, where money matters the most, such thinking need not be regarded as demonic. At its worst, it states the reality of how the world has reduced the value of human life to a figure in the individual currency of nations. At its best this thinking has been clearly articulated in the most honest manner. We have to live with it. In today’s world the universe against the single man has reached its zenith. Throughout the present chapter and those that follow the discussions will focus on how to challenge the mighty forces of this research world or the regulatory agencies and other powers that either collude or connive with them. This prevailing situation is pinned in the back ground to keep the reader constantly aware of it. The other background to be constantly underpinned is the economic scenario of India in the last two decades of the twentieth century and thereafter. India currently has an ever-expanding middle class which may reach 250 million in a few years to come. While there are large tracts of devastation still, the rural economy is no longer the same. Otherwise the concept of fortune at the bottom of the pyramid would not have been exploited by the Indian, Western and multinational companies so ruthlessly and successfully in various health and non-health areas (Pralhad C K, Hart Stuart 2005). From the health point of view people are today ready to pay if the public system does not help them. For the last 15 years insurance coverage has been increasing; the health sector is booming. India has an enviable/unenviable record in the pharmaceutical sector. The first great achievements of the industry will be discussed here. I will then look at the negatives it has thrown up particularly since the turn of the millennium. These negatives have changed the course and the character of clinical medicine just as the investigative mode changed the

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character and the course of medicine in the decades preceding and following the year 2000, as seen in the chapter on corporate hospitals. The drug culture in corporate hospitals was discussed from one perspective, while here I will present a full exposé of it.

The Achievements of the Indian Pharmaceutical Industry In terms of numbers, turnover, quality, the significant improvements in formulation technology, and earning foreign exchange for India, the pharmaceutical sector has impressive attributes. It is particularly noteworthy that it is in the generic market that Indian pharmaceuticals have succeeded greatly in developed as well as developing countries. The Indian pharmaceutical industry is cost efficient because of the low cost of production and the sporadic costs of the Research and Development (R&D) undertaken. Only a handful of pharmaceutical companies do any meaningful research here, and this boosts the efficiency of the Indian pharmaceutical companies. For example, India’s cost of production is approximately 60% lower than that of the US and almost half of that of Europe (these are estimates [Pharmaceuticals Export Promotion Council of India 2016]). Due to lower cost of drugs as well as treatment, India has also emerged as a destination for medical tourism.

Indian Pharmaceutical Sector: The Picture in 2014 The Indian pharmaceutical sector is a massively moneyed and extremely diverse undertaking. India is a leading global pharmaceutical producer, and the industry accounts for about 1.4% of the global pharmaceutical industry in value terms and 10% in volume terms. It is also among the fastest-growing industries today. Revenue from the Indian pharmaceutical industry was expected to grow at a compound annual growth rate (CAGR) of 17.8% during 2008–16 to reach USD36 billion (IBEF, August 2013). This means that each Indian would be spending around 2160 rupees on drugs and related items. For the last 30 years drug activists have been protesting about generic drugs not being made available to the common man. But the growing generics market suggests otherwise. Indian drugs are exported as generics to countries like the US, which sells only generic drugs without any combinations. The small neighboring nation of Sri

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Lanka has so far refrained from using combinations (Wanigatunge, Chandanie, Professor of Medicine, Jayawardhane University, Sri Lanka, personal conversation December 2, 2018). It was expected to grow to USD26.1 billion by 2016 (IBEF, August 2013).The Indian pharmaceutical industry is expected to reach US$ 55 billion by 2020. However, all of this pales in comparison to Pfizer, which reported worldwide sales of US$55 billion in 2017 (ibid. Pharmaceutical Export Promotion Council). India’s generics market has immense potential for growth, and ranks fifth in terms of attracting Foreign Direct Investment (FDI). It attracted 5% of the total FDI into India from April 2000 to March 2013, and the cumulative FDI inflow amount was worth USD10.3 billion from April 2000 to March 2013, grossing USD14.0 billion into the sector over April 2000—February 2012, and making up 8.6% of total FDI into the country in that period (ET Health World 2014). The statistics for the years 2013 and 2014 have changed considerably and are still changing on account of the Central government activism on issues related to drugs and health since June 2014, which is welcome. These statistics are therefore representative of the situation for the decade since globalization. To give a glimpse of the situation in 2016,the Indian pharma market ranks third in volume and thirteenth in value across the globe with a market size of Rs.252,000 crore (IIHMR University, Jaipur, 2016). The Indian Institute of Health Management Research (IIHMR) is a WHO collaborating center for district and primary health care, releasing this data at the end of a national symposium it organized. “It is likely to create over 1.30 lakh jobs in 2016 itself,” IIHMR University President S. D. Gupta said in a statement. The latest available data shows that the annual turnover of the industry in 2015–16 was Rs. 2,04,627.15 crore (Draft Pharmaceutical Policy Government of India, 2017, article 1.1). Of this, exports constituted Rs. 1,10,5,34.220 crore (Centre for Monitoring Indian Economy [CMIE] 2017). Domestic consumption was valued at Rs. 98, 414.4 crore (Pharma trac-2017 from the database of All India Organization of Chemists & Druggists & Advanced Working, Action and Correction System [AWACS]) The Indian pharmaceutical sector is largely fueled by exports and is the third largest foreign exchange earner for India. According to the CMIE data, the industry grew at a compound annual growth rate (CAGR) of approximately 10% over the period 2010–11 to 2014–15. However, the growth rate decreased from 14.36% in 2010–11 to 8.68% in 2014–15 (based on sales data of CMIE Industry Outlook). It employs about 2

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million people across the value chain. This should also alert us to the enormous power of the forces we are dealing with when it comes to making decisions about what is good for the industry (in monetary terms) but this is not good for the welfare of patients (11. ibid. CMIE).

Infrastructure for Drugs Manufacture in India According to the Confederation of Indian Industry (CII), India has around 300 large- and 8000 small- and medium-scale pharma units at present with over 20,000 manufacturers in all, in both the organized and unorganized segments. These could be the manufacturers of active pharmaceutical ingredients in bulk or loan licensers, the latter of which are common. Or they could also be the marketers. The India pharma industry has 77% formulation manufacturers and 23% bulk drug manufacturers with 169 United States Food and Drug Administration (USFDA)approved plants and 153 European Directorate for the Quality of Medicines and Healthcare (EDQM)-approved facilities at present (IANS 2016). The Indian pharmaceutical industry has the largest number of USFDA-approved manufacturing facilities, 262, outside the US.  Two hundred and fifty-three plants are approved by EDQM and 1300 by the World Health Organization (WHO) for Good Manufacturing Practice (GMP)-compliant plants (Draft Pharmaceutical Policy, ibid.). Top exporting destinations are North America (27%), the European Union (18%), Africa (18%), the Middle East (7%), ASEAN (6%), Latin America (6%), and the CIS (6%). India is also called the ‘pharmacy of the world’ and is renowned for high quality drugs at cost-competitive prices. Yet on the ground there is a somewhat bizarre picture, for which multiple factors are responsible. As far as the health is concerned there is a universal medicalization of the society just as there is universal criminalization of politics. Qualitatively, the difference is not significant since the target of both is the harassment of the common man to make money from them. In spite of this information it should be mentioned that there is no complete and fully authentic database on the pharmaceutical sector. Such a database will be created by the Department of Pharmaceuticals along with the Drug Controller General of India (DCGI) on manufacturer-wise, brand-wise and product-wise manufacturers (Draft Pharmaceutical Policy article 5.12 p. 14).

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However, the picture is not completely rosy. In the last few years every week there is at least one report which either says that such and such company has recalled its drugs, more often in large quantities from the US, or some other country due to quality standards infringement. Sometimes the drugs are withdrawn even from Indian markets. None of these companies are shady operators; rather, the USFDA has increased its level of scrutiny in recent years. The challenge has become tougher since the USFDA now has the Office of Pharmaceutical Quality to take a closer look at imports. In attempts to be compliant with the USFDA, costs have gone up for companies who are trying to export to the US. This should be responded to since the US is such an important and large market. This as an opportunity for the Indian pharmaceutical industry to strive for recognition of the quality of its drugs. Indian pharma has always looked at improving quality as an increase in manufacturing cost, not developing it as a core competency and ethical value. Instead of looking at it as the big government regulatory scrutinizing us Indians as an irritant and a cause for cost-escalating factors, the Chief Executive Officers (CEOs) can look at it as an opportunity to meet the standards to enter that high-monetary value market and make the Made in India brand a quality standard. One may be tempted to see the USFDA refusals and then withdrawals as snobbery or deliberate obstructionism. A genuine copy of the USFDA observations for two plants of a powerful and reputed company came into my hands. Based on its contents the above allegations cannot be substantiated. What comes through is some basic negligence in manufacturing. Usage of unqualified and untrained personnel by the industry and their lamentable ways of looking at their work geared to quality appear to be the main causes. It should not come as a surprise that child labor is also employed. One need not go far to see the lack of focus by the regulators at home and the contrasting vigilance of the international customers regarding quality in Indian companies. This chapter discusses the Indian drugs industry in all its aspects including quality. Unlike the USFDA, no such quality checks with so much care are undertaken by the Indian regulators. If there were, such instances would have diminished. The saddest part is that the companies are more worried about their share price falling after such observations than about the quality issues.

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Quality of the Drugs Manufactured in India The WHO, as reported in The Economic Times health reports, estimates that up to 20% of branded drugs sold in developing nations are counterfeit, which can have profound implications for patients. For example, tuberculosis and malaria counterfeit drugs, which largely originate in India and China, are estimated to kill some 700,000 people a year. The report also mentioned that India, the largest producer of generic drugs in the world, is reported to be the source of 35% of all counterfeit drugs sold worldwide (ET Bureau | September 29, 2018). Counterfeiters, similar to legitimate drug manufactures, are keen to benefit from the low manufacturing costs, 50% less on average in India, compared to developed markets. As a result, India’s counterfeit market has reportedly grown at a rate of approximately 25% per annum, and represents a significant proportion of the global counterfeit drug market, thought to be worth between $75 billion and $200 billion a year. Results of surprise checks conducted by the central drug regulator’s office along with their state counterparts show that in Jammu and Kashmir, 17% of the drug samples tested were found to be sub-standard and unacceptable. Himachal Pradesh emerged as the next worst performer with 7% of drugs failing the quality test.

Scenario of Quality Testing for Drugs in India There are not enough nationally accredited laboratories to conduct frequent and regular tests; the record of regular audit of these in itself is not very encouraging. The manufacturing permission for established drugs, already on the market for more than four years, is given by state drug administrators without any bio-availability or bio-equivalence tests of the claimed products. The inspection of the manufacturing premise and processes is often perfunctory or non-existent. Many manufacturing units are not compliant with the WHO’s GMP or the good laboratory practice (GLP). All of these separately and in combination give rise to grave quality concerns in the pharmaceutical industry. Samples were drawn from government hospitals, retailers and wholesalers between April and December 2013 by joint teams of central and state drug control officials, according to a document stating the test results. In this connection it should be noted with satisfaction that the Central government picked some 43,000 samples from the drug market and sent

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them for analysis in the first year after their coming into power in June 2014. It may have been a routine lift, but for all the stringent watch of many drug activists such a routine was never mentioned in the last 30 years. It was also simultaneously announced that the government would be setting up a new drug testing laboratory and had allocated a total amount of Indian national rupee (INR) 1750 crore for a period of three years. “Out of the total amount of INR 1750 crore, INR 900 crore will be spent on strengthening central structures and INR 850 crore will be made available to the state governments after signing a Memorandum of Understanding,” an official statement said. This also seems to be an unprecedented step in the last two decades at least (Press Trust of India, PTI | 13 August 2015). The Indian government’s Draft Pharmaceutical Policy 2017 (hereafter called Policy 17) has addressed this issue creditably by mentioning a number of ideas to change the scenario to prescribing generic medicine on a very large scale, all of which are described here. In article 3.2, Policy 17 says, inter alia, that “drugs that get exported have a stringent quality assurance system, put in place and insisted upon by the importing countries internal requirements; …….even then the rejections and recalls (as mentioned above from abroad and from Indian market even by reputed companies) are frequent.” Concerns have been raised on the quality surveillance of indigenously manufactured drugs for domestic consumption in such a situation. It is a must to bolster internal compliance to keep up with evolving global and domestic regulations concerning the quality of manufactured drugs. This has the potential to drive significant competitive advantage by producing high-quality drugs at lower costs in India, in which case other companies need not be given the right to manufacture for mass needs. The relevance of this will become clearer in the discussions on patent laws later on. Regular inspections, even internal, to check the quality systems and procedures and any deviations the company may make (change in the input materials and testing methods when these companies change over to largescale production) is one such step. This may seem elementary but given the USFDA’s remarks and drug recalls there is a need to mention this. There is one more dire deficiency. The industry allegedly produces 73,471 brands (https://www.medindia.net, December 25, 2014). Policy 17 has mentioned it as more than 60,000. Some reduction may be present since 6000 fixed dose combinations (FDCs) and other irrationally

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combined brands were supposed to go off the market. Assuming that each brand is manufactured twice a year, the number of samples that should be tested for quality before being released in the market will be 146,000 plus. But the actual number of tests needed is much larger. The reason is that the thousands of brands which have two or more active pharmaceutical entities necessitate testing of each ingredient. If such testing finds that one or more of the ingredients is not at the optimal quality and quantity this opens up a new can of worms. Further, in such a condition it will be asking for the moon if we expect these laboratories to test the drugs for an interaction within the combined drugs, whether one or more drugs form compounds that are either difficult to absorb or lose their properties. This issue has been dealt with in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one, and it discusses the Revised National Tuberculosis Control Programme with serious conclusions coming out of it. Thus it is not a rhetorical hypothetical question (Kelkar Sanjeev 2020). The eight central drug testing laboratories will be able to test only about 15,000 plus samples. Until January 2014 the testing capacity of Gujarat, which has a high manufacturing as well as exporting drug base, was approximately 6500 samples a year. There are roughly 35 to 40 certified drug testing laboratories across the various states but their total capacity to test all the drugs marketed in India or exported drugs is simply not matchable to the needs. This stands to reason if one notes that most drugs are not being tested at all before entering the market. The samples may be sent and the report for the quality will also be sent back or collected. Yet the truth of the matter could well be otherwise. The well-tested drugs which enter the market will come only from those companies which have quality testing laboratories of their own. Such drugs would be quantitatively far less. Wealthy city dwellers who may only ever purchase drugs from the best-known companies may find these statements a little unjust. But in India the large majority of the drugs which are sold come from lesser known companies. They are sold by doctors in the North and Northeast who maintain their own store. It is an extremely common practice. These drugs are cheaper. Large numbers of hospitals also sell these medicines to obtain a substantial margin. These drugs are also ordered by such hospitals for many other reasons described in detail in the chapter on corporate hospitals.

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Lower Costs and High Drug Quality These need not be contradictory terms. It is important to bolster internal compliance to keep up with evolving global and domestic regulations concerning the quality of manufactured drugs. This additional expense may still be able to produce low-cost drugs in India that will have significant competitive advantage over the other multinational companies (MNCs). Active Pharmaceutical Ingredients (APIs), Intermediates and Reduction of Cost of Production in Policy 17 in clause 3.1 states that India is highly dependent on imports from just one or two countries for the APIs and the intermediates needed for manufacturing drugs. More than 60% of APIs are thus sourced. In certain APIs the dependence is 80 to 90%. It is an alarming situation, more so in case of intermediates for stages prior to APIs and key starting materials (KSMs.) These are the building blocks for the drugs. It has a direct bearing on the drug security and availability for the nation as a whole (Draft Pharmaceutical Policy, Government of India 2017, 3.1). The Draft Pharmaceutical Policy, Government of India, Policy 17 then continues: As a result, our competitiveness and capability in manufacturing some of these APIs has also dwindled. For various reasons the APIs, intermediates and KSMs and other intermediates manufactured in India are not price competitive against imports. Indian APIs and KSMs are, however, of as good or much better quality. The new pharmaceutical policy therefore needs to address the ways and means to restore and revive the API and KSM (and other intermediates) manufacturing capabilities indigenously. Policy 17 article 5.1 further states that to encourage end-to-end indigenous drug manufacturing including the three above ingredients these should be given preference in government procurements. Such formulations may be taken out of price control for five years and the price control is linked to the cost of the indigenous content of the formulations. The WTO-recognized principle of Rule of Origin may be used to give differential ceiling prices calibrated to the percentage of indigenization. All APIs which can be indigenously manufactured should then be imported at peak customs duty. Additionally, Policy 17 proposes setting up mega bulk drug parks to avail benefits of scale by using common facilities for pollution control, effluent treatment or any such common activity provided by the Central government. The center would encourage the

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states to set up such parks in a public—private partnership mode. This thinking is commendable. Policy 17 should take note of the possibility of many large pharma companies disinvesting in bulk drug manufacturing to reduce costs and outsourcing the intermediate manufacturing to other companies. The Indian regulator has a challenge here to reverse this trend. Measures for Maintaining the Drug Quality Some of the measures that can be taken are as follows: upgrading the capacity of the state governments by equipping the state drug testing laboratories with modern technology and the latest rapid testing equipment, and enforcing serialization, non-cloneable packaging and 2D bar coding. The Drug Controller has also proposed a bar code on all exports, and the serial number in the package can be scanned and verified from a central server to ensure the authenticity of the drug. More on this is discussed below in connection with the US and EU rules and blockchain technology. The small and medium pharmaceutical companies have not backed the move (Das Soma, Apr 13, 2015). The point is that the companies have developed a paranoid attitude toward anything that sounds like control, even if it is for the good of patients. The industries resisted these measures for a while, but have now put in place this mechanism. They have also implemented a bar code for maximum retail price (MRP), across their supply chain, so that the drug is not sold above MRP and extortions at the point of delivery to the patients can be reined in. This bar code verification can easily be extended to verify the authenticity of the drug. Implementation of this idea is viewed as a difficulty in terms of response to the patient and the negative brand value it will create in the market. Here it might be appropriate to recall what the Gujarat government did for industrial safety. Instead of the inspectors giving the safety certificate it asked the industry to self-certify themselves. The pharmaceutical industry may also be allowed to declare their products as safe. Then, if their drugs are found to be sub-standard, serious offenses may be registered against them. In Europe the quality control personnel of the pharmaceutical companies are endorsed by the government, and if the drug is found lacking in quality in the market, the company employee will be personally liable and the government will take action against the individual. Policy 17 has mentioned this as an interim step. Until such time that the Central Drug

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Regulator develops the capacity for annual inspections for drug quality and Good Manufacturing Practice, such a step is welcome. Except in bio-­ pharmaceuticals where our stage of development is suboptimal, such self-­ certification also could be permitted for other drugs for the time being. Lastly, the Central government wishes to invest in more ‘new drug manufacturer inspectors,’ the intention of which needs to be examined. India’s performance record under the black history of the Inspector Raj is quite poor and these measures may not see much success. What will happen if a batch is found to be sub-standard by these inspectors? The size of the batch in value terms, the urgency of delivery and such other matters will be given more importance in settling the issue. In today’s world manufacturing also takes advantage of scale. Then such a batch of sub-standard drugs could mean large values involved not only of the manufacturing process but also of distribution. And the callback of the same would involve complex logistics and logistical expenses which could be avoided by other means. Policy 17 article 5.3 states that the government shall ensure that all manufacturing units adopt the World Health Organization’s Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Toward this, as the first step, all national/central as well as state government-­level procurement, conducted through the National Health Mission, would be mandatory from such WHO-certified GMP- and GLP-­ compliant manufacturing units. This one step will greatly enhance the value of the Jan Aushadhi Yojana, the Scheme for Drugs for the People. In the case of small-scale industries this will be mandated phase-wise and they would be given incentives to upgrade. This thinking at least strongly indicates that the decision makers are utilizing a commonsense dictate: ‘Start with what you have.’ Attempts at coordinating and utilizing existing resources, which are a notable feature of the Central government installed in June 2014, will also be discussed in the discussions below.

National List of Essential Medicines Both the WHO and the Indian government published the National List of Essential Medicines (NLEM) in 2015  in the Report of the Core-­ Committee for Revision of NLEM, November 2015. The latest tally of drugs selected for the NLEM is 815. The government has cut the prices

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of 234 essential drugs by up to 5%, 134 formulations were reduced in the range of 5–10%, 98 more products by 10–15% and 93 other formulations saw prices drop by 20–25%, 65 products ranging between 25 and 30%, 46 products between 30 and 35%, 24 products in the range of 35–40% and 59 products over 40%. Such differentials speak of the non-random and well-considered price cuts with a view to curtailing excessive profiteering (PTI | March 14, 2018). Undoubtedly, the drugs included in NLEM are the most representative of the class for which they have been included, but are also the most cost-­ effective example of the class. It should be noted that drugs/devices together could cost upwards of 30 to 40% of the cost of treatment. The Indian government has published a detailed report addressing the mechanism and reasoning adopted by the committee in deciding how they have modified the earlier lists. Each practicing doctor may peruse this or such lists yearly and check with himself how many non-essential drugs he is using and at what cost (see Policy 17). Profiteering from the Drugs/Devices This arises mainly from a single factor: by taking a drug out of price control; the consequences are notable in areas of interest to those who decontrol the prices without much ground on which to defend this. There was a period when the UPA government was ruling when only 74 out of approximately 2000 drugs approved by WHO as necessary for treatment were under price control. Surprisingly, no one considered the medical transplants or implants for price control in all these years, although complaints about the possibility of jacked up prices were frequent. The 2014 Modi government did remarkably well in this area. To give an idea of the profiteering on devices, the following details are given with respect to cardiac stents which may be eye-opening. From manufacturers to distributors to hospitals to the patient, the final sales price of a stent ranges from 270% to 1000% over and above the purchase price, as per data released by the National Pharmaceutical Pricing Authority (Nagarajan Rema, January 17, 2017, 09:10 IST). In the chain from manufacture to use on patients hospital margins are about 650%. A plethora of information is available on this issue but here this is sufficient. Profiteering had already turned into an addictive greed prior to slashing prices of devices. To make up for the loss of revenue the hospitals are changing the tariff labels and have allocated high costs to these labels,

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thereby keeping the bill amounts the same as before the prices of devices were slashed. Price capping has not thus reduced the hospital cost. Professionals are using it as an indicator of the futility of the capping. This is a facetious logic of the industry, disguising their unhappiness over the loss of (unjustifiable) revenues. The Facetious Logic Used Against Price Capping The logic is that R&D in stent technology is discouraged by this price cap. This is laughable. It would be interesting to know which entities are conducting this R&D in India. Anything between 75% and 90% of the requirements is met with imports from the US, Europe and Japan. The computer hard disc capacity has allegedly been doubling every two years. Do stents, after all the R&D, show such sophistication every two years? Why not come out openly and say that their greed is not being satisfied? Nobody is forcing the companies to carry out costly research. A couple of stent-importing companies stopped imports. However, no shortage was reported, and no one died. In fact the unnecessary angioplasties seemed to decline considerably. Who will take the risk of unnecessary angioplasties when the profit is low? (Shahapurkar 2017). These findings show that a large number of stenting procedures were unnecessary. We can very well solve the problems of Indian patients with what we may get even after capping from abroad. The one non-negotiable argument against such reasoning about shortage is the large market of India, the lure of which and the money that can be earned here will go against all this ranting about price caps. Allegedly, the price cap-induced protection will only encourage indigenous device manufacturers to be more complacent. This routine denigration of what is Indian will not go far. Device and stent development has featured the involvement of people such as Dr Soma Raju and Dr A P J Abdul Kalam. Does anyone think that this duo would not care about poor quality? Why has the pig valve devise from Sri Chitra Institute not become a routinely used instrument? The trade-off between price and quality does not always demand high prices. The reality was that of disproportionate profit making with the patient at gunpoint on the angiography table, the company man being on the phone nearby to supply a stent, in contact with the hospital machinery. This shameful exploitation has led to price capping.

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Similarly, the charge that unavailability of the latest medical devices and surgical instruments will kill the prospects of India’s medical tourism industry does not hold water. There are numerous other factors to facilitate the reduction of the money in medical tourism unrelated to the allegation above which have not been discussed due to space constraints. Newer developments by default do not mean superiority over older ones (the reader is also referred to the discussions on evidence with respect to trials and the chapter on Western models in this volume). Another argument is that in a market economy competition rather than price control should be relied upon to bring down as well as keep the price factors low, without losing the quality, and further argue that markets are rational and self-corrective. The objectors are still in the era of neoclassical economists, two centuries ago. We refer these supporters to David Orrell’s work Economyths for a better perspective. Such steps as price fixation have to be brought about because of the distortions in the markets and oligopoly. This is worse than a monopoly since the exploitation is carried out through cartelization and collective consent to robbery in the face of available competition. Against this, a monopoly raises prices unjustifiably for profits simply because there is no one to compete. The other objection is that price control will promote a disguised form of protectionism. Let there be no doubt that it is protectionism for the patients. When large-scale price regulations of drugs and then devices came into effect the apprehension was about whether the government would succumb under pressure, and whether it would reduce or reverse the process. Fortunately this has not happened…yet. Similarly, the Jan Aushadhi Yojana has made effective inroads in many places and is likely to stay the course and increase the reach. None of these ideas are palatable to the industry, notwithstanding the Pralhad principle of fortune at the bottom of the pyramid which these companies ignore.

Price Control Regulated Prices At the government level price regulation and deregulation are the two principal mechanisms to control costs. All our previous governments were tardy in price fixation, deregulated more and more drugs, or did do nothing. This new government has been a reformist activist in this area. The Central government in late 2017 pulled up the National Pharmaceuticals

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Producers Association (NPPA) and ordered it to revise prices of 799 drugs in two months. Earlier it had taken three years to fix prices for 535 drugs in the NLEM, in 2011. Policy 17 under section 5.18 (p. 15) states that the NLEM will remain the basis of the medicines to be brought under price regulation. Over time the devices have been added to the NLEM. To ensure the accessibility and affordability of drugs, ease of doing business and more coordinated synergies, all the regulators/commissions, pertaining to pharmaceutical industries/sectors, doctors, pharmacists, other experts, civil society representatives, industry representatives and government representatives will be brought under one department within NPPA for pricing. The body will be responsible for recommending the price to be fixed. NPPA will also be responsible for maintaining a database of information required for fixation of price ceilings. For all these functions, the authority shall announce and publish its compendium of standard processes and procedures for dealing with every aspect of its work (Policy 17, p. 17). Now with the advent of the Goods and Services Tax (GST) the tax matters have changed further from July 1, 2017. With a couple of provisos the local taxes over and above MRP have been abolished. Medicine is or should be a turnover-based industry. The lower the profit margin, the more consistent continued sales year after year remain. The principle of wealth from the bottom of the pyramid established that a population predominantly consisting of huge numbers has poorer people at the bottom. If they buy because of affordable prices this will offset the losses of lower margins (C K Pralhad 2005, ibid.). Around 2007 the pharmaceutical companies started combing the rural markets to sell their products. These people can even afford the brand prices if they are reduced, and can buy the products regularly and be healthy.1 Today there are far too many chronic disorders that need multi- or poly-therapy on a year-on-year basis. Poorer people are also the victims of such chronic disorders in substantial numbers. The poorer sections thus purchase high-cost drugs as and when they have money. This justifies price regulation even more.

1  There is direct experience that cosmetics purchase could take precedence over correcting malnutrition and healthy diet. Cheaper drugs may divert some money to purchase drugs for health. Dr Sanjeevanee Kelkar and Mrs J S Pendharkar conducted an empowering program, Myths and Realities, from 2000 to 2006, for school-going adolescents, covering 30,000 students in semi-urban/urban Maharashtra, where this observation was made.

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Keeping the brand prices high for immediate profit is a pointer to the inherent inability of the marketers to see over a long-term expanse of time where the purchase cycle constantly repeats itself. They are imprisoned by the notion and demand of an inviolable level of net profits after taxes and expenses every year. For them the pay packet should escalate. That is all they can think of and they never understand what Pralhad was saying. People in the highest brackets do not or cannot think that the solution to any problem could be simple or far simpler than they assume. Other Ways of Reducing Prices From 1996 with globalization and open markets, some consideration had to be given to the rules and demands of the World Trade Organization (WTO). Without going into detail it can be stated that the imported active pharmacological ingredients (APIs) and intermediates became more cost effective due to the enforced reduction on import tariffs. The indigenous API and intermediates were not priced in a competitive way and their trade declined. Policy 17 article 5.1 proposed to boost the indigenous APIs and intermediates. To encourage end-to-end indigenous drug manufacturing from indigenous APIs the latter were to be given preference for procurement by the government. Such formulations would also be taken out of price control for five years and the price control would depend upon the indigenous content of the formulations (see above). Additionally, under the World Trade Organization (WTO) there was an accepted principle of rule of origin, under which differential ceiling prices could be offered depending upon the percentage of indigenization. To achieve import substitution, custom duties can be raised greatly so that indigenous production of APIs becomes affordable. Setting up big bulk drug production centers for the benefit of scale production would lower production costs. The state governments would be encouraged to set up such production centers in a public—private partnership mode with minimum interface/single-window clearance. By using common facilities for pollution control, the cost of effluent treatment or any such common activity would be met by the Central government.

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Why Should Drug Prices Be Regulated/Controlled in India? Policy 17 clearly states that every country in the world with one or two major exceptions has a price regulation mechanism for drugs. For social safety, it is necessary that drugs are available at reasonable prices to the common populace. This is even more the case for India because 65% of the medical costs are on drugs which are out-of-pocket expenses. Therefore drug pricing will be made more oriented to benefiting the poor while at the same time retaining its industry friendliness. Medicine is a unique commodity—the consumer is under distress, he does not have a choice about buying medicines and cannot be particular about the prices of drugs, which are non-negotiable. It is a purchase made under duress. Professionals must understand how to protect especially non-affording patients from high prices. For this there should be drugs which have been justifiably priced: cheaper but equally good alternatives. It is also necessary that irrespective of the price situation the professionals stick to prescribing drugs which are absolutely necessary and affordable, which unfortunately they do not. The process of drug price control runs as follows: 1. The prescriber doesn’t pay and the buyer doesn’t or cannot decide. This is all the more reason why the buyer should be assisted, by the professional as well as the government, through price control. 2. Unlike in developed countries, in India expenditure on medicines constitutes about 70% of outpatient illness treatment costs. In the West, this is only 15%. In India 90% of the medicine cost is out-of-­ pocket expenditure by patients, (NSS 55th consumer expenditure survey 2011–12). 3. Even the so-called free market countries of the EU and UK have some form of price control and volume control. 4. In developed countries, medicines are bought for the patients from the pharmaceutical companies by state agencies or hospitals under the insurance scheme. In India, the insurance-covered population percentage is extremely low. Hence most of the population is at the mercy of market prices. 5. The doctors are unconcerned about the total costs of medicines in poorer sections even if they are not insured. If they are insured then the doctors take it as a free ride to prescribe recklessly. This is discussed in detail in the chapter on insurance.

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6. Hospitals and institutes buy drugs on rate contract and obtain them for a price well below the MRP. But they do not pass even a fraction of this difference to the patients by lowering prices below it. Hence, the lower the MRP the better. With the fullest confidence based on year-on-year experience of selling bulk drugs, I can say that even if 25% profit is taken on the total cost of the purchase the actual cost will be much below the MRP. 7. Widespread inadequate power to purchase in India also demands price control of this essential commodity. I would rather call it non-­affordability than poverty. This is because of the unjustifiably high costs of some drugs. This can be illustrated by the large amounts of statistics available. The reader is referred to “Impoverishing the Poor: Pharmaceuticals and Drug Pricing in India” by LOCOST/JSS Vadodara. The document is old (2004) but the situation had changed only marginally by 2014. Now it is changing substantially. 8. The Indian drug industry has a track record of massive profiteering. An alternative view is that they were smart to take advantage of weak market systems, not just small-time competitors of small companies, but absence of comparator price mechanism checks like purchase under state or insurance. 9. In weak market competition 50 big corporations have a turnover of INR 18,000 crore, that is, approximately half of the total production from 6 to 8000 manufacturing units. They possess adequate persuasive power to set the prices of their much better quality drugs. The rest of the smaller drug manufacturers have difficulty maintaining the quality, which I have dealt with extensively later, recommending their closure. I am aware that this could lead to some form of oligopoly or cartelization—which already exists—considered more dangerous than monopoly. The only way to rein in these powers is to be stringent on quality and to be strict on price control. NLEM is one of the most powerful ways, as is now implemented by NPPA. 10. The market share is cornered by the leading three or four products in each segment of therapy, while hundreds of other brands in that segment will struggle. The free market economy does not have an answer for this. Only if more companies produce as effective brands and fight for increasing the sales not only by lowering prices but also through quality and relationship building without

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commercial incentives can the brand monopoly be broken and become more distributed. 11. The reader will notice that the concern over quality arises every time an issue is discussed. This is because one of the fundamentals I wish to argue is in favor of quality. The order of day is quality, without which India does not stand a chance in the world. It is no longer just quantity that matters. I have explained more about this in my other volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one. 2. The number of drugs under price control in India decreased from 1 347 in 1979 to 76 in 1995. The margin allowed on even ‘essential drugs’ under price control increased from 40% to 100%. The Pharmaceutical Policy of 2002 aimed at reducing the “rigors of price control” to about 30 to 34 drugs, a policy which has been pursued by the government over successive years. This trend is now being reversed by the new Central government established in June 2014. The NPPA is controlling the prices of 900 plus drugs and will do more. The pace is much better on the center’s orders for rapid completion of these matters mentioned (Nautiyal 2016). Pharmaceutical products’ price controls in other countries under different agencies are as follows: the UK: Pharmaceutical Price Regulation Scheme (PPRS); Canada: Patented Medicines Prices Review Board; France: Transparency Commission and Economic Committee on Medicines; Egypt: all drugs under price control; Italy: restricted wholesale margins; and Germany: reference pricing system. Some system of price monitoring and price regulation prevails in Japan, the Netherlands, China, Indonesia and Colombia. In some of these countries drug pricing is linked to national health system reimbursements and/or insurance schemes (Phadke Anant, Dr, September 13, 2008). Easily Applicable Cost Containment Mechanisms One basic mechanism that has been followed for a long time is to add a 100% margin to the production costs. There was an attempt to overturn this starting in 2013. What was proposed then was to replace this 100% margin over cost of production by taking a simple mean of prices of all brands with 1% of market share. This is highly objectionable, however, as the prices thus fixed

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will not be much lower than the high-priced brands. This will mean that for the brands already priced highly, their profit margins may not come down significantly. But on the other hand the lower brand prices will go higher. In either case the patient will not benefit. Now it is proposed that the simple average of all brands and generics should be the basis for price fixation. It is difficult to see any acceptable rationale behind this either. The first alternative appears more reasonable since it is far too easy to vary the single margin of 100%. The quantum of this margin can be made negotiable so that the well-developed sector is not given a deathly blow. Single-drug generic production, discussed at length in the next chapter, could lower the prices considerably. The number of purchasers and the frequency of purchase will go up due to lowered prices and a considerable quantum of the lost money can be gained back in the years to come. This happened in 2018, barely two years after nearly 400 FDCs and irrational combinations were banned, which came to about 6000 brands and price caps introduced for all NLEM drugs. If this had been undertaken earlier we would have at least provided millions of people with a more sustained drug supply without hurting their economic situation. The following simple measures would have been all that were necessary. 1. Scrap all irrational combinations. The Central government record in this area is quite spectacular but such drugs continue to remain available in the market even now since doctors continue to prescribe them. 2. Increase the number of medicines based on their utility and merit under the essential medicine list and a negotiable price fixation until the lowest minimum is reached. This has been done steadily since 2014. 3. Any drug manufactured under the NLEM will also be subjected to the accepted and prevalent price control mechanism even if there is a change of dose. Policy 17 has expressly advocated this. 4. All congeners available within the class will be under the price control mechanism. 5. The costs will not change according to the customer price index but will be dependent on the manufacture cost changes. Of course the relation between the two would be close. As a principle it is sound. 6. Respect and apply patent laws judiciously, which is being done (see below).

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Examples of Drug Price Control The National Pharmaceutical Pricing Authority (NPPA) on February 27, 2019 brought 42 non-scheduled anti-cancer drugs under price control, capping trade margin at 30%. Now the maximum retail price of 390, that is 91%, of the 426 non-scheduled cancer medicines has been reduced by up to 87%, which would result in annual savings of around Rs 800 crore for the 2.2 million patients (PTI | March 09, 2019, 06:34 IST).The manufacturers of these 42 drugs have been directed not to reduce production volumes of brands under regulation. The latest controversy concerns also bringing non-scheduled drugs under price control by changing the price setting method mentioned above. The pharmaceutical companies say that this method will be detrimental to the industry’s growth and kill competition. The Indian Pharmaceutical Alliance (IPA), a group of leading domestic drug companies, argued that the amendments are being discussed without carrying out an impact assessment of the current price control and policy (Rajagopal Divya | Economic Times Bureau | October 17, 2017). Non-scheduled drugs are those that are outside the price-control regime. Patented drugs will not fall under this formula. Given the wide variations in the prices of identical drugs by different companies this calls for some rationalization. Dr Arvind Panagariya, ex-vice chair of NITI Ayog, has cautioned that the NLEM drugs are being priced “too low,” and has said these need not be under automatic regulations of prices. Capping them low should not make it unprofitable to manufacture them, thereby depriving the population from their availability, a sane piece of advice (Shrinate, Supriya May 10, 2017, interview with Dr Panagariya). The second fallout of this amendment relates to the drugs in combination before 2013. Companies that launched combination or single-dose drugs that might not be part of the essential list before 2013 continue to remain outside price control. However, under the new proposal, if a company is launching a new drug that might be a combination of a scheduled and a non-scheduled drug, the regulator will still fix the ceiling price of the drug. Such a combination is not likely to be rational. If it is, this step should not produce much stress.

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The After Effects of Price Control The pharmaceutical industry has raised serious concerns that the growth of India’s generic pharma industry has slowed down from 12% to 3.8% due to price cuts, a ban on fixed-dose combination drugs and the implementation of the Goods and Services Tax (GST) on July 1, 2017. The insistence on doctors writing generic prescriptions and not brand names to disrupt the nexus between drug companies and doctors is, according to the industry, the additional reason for this drastic fall. Policy 17 article 5.7, however, states that the issue of unreasonable trade margins and bonus offers by various Stockiest, Distributors and Retailers has been adversely affecting both the industry as well as consumer interest. After detailed stakeholder consultations, the level of trade margins will be prescribed to create a level playing field for the Industry and to bring down the prices. Institutions receiving supplies directly from manufacturers/distributors or retailers will also be covered under the trade margin reforms.

Issues Related to Drug Manufacture For any manufactured drug with its excipients, the quality of the process of manufacturing is finally judged on the bio-availability of the intact drug within the body. Bio-availability depends upon many factors, such as tablet compression, the staying power of the drug itself, dissolution time, particle size it attains after dissolution, and non-interference from other chemicals present in the formulation which may hinder it. Bio-availability has to be carefully worked out on samples before the drug is approved or if there is a change of formulation process or excipients. The issue becomes slightly more complicated if more than one drug is present in the proposed formulation which has come for approval. It has to be ascertained that these two or more drugs do not react with and destroy each other. Or that they do not interfere with the absorption and bio-availability of either one. These matters are determined by other factors as well, such as dissolution time. Now, the market has been flooded with thousands of such drugs by hundreds of different companies. The drug approval process in case of all such particularly fixed dose combination drugs (FDCS) is discussed in a long critique of FDCs in the next chapter.

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Enhancing the Manufacturing Capacity of Drugs in India There are many suggestions in this regard given below. India has a huge core competence in manufacturing. As shown above, passing the USFDA requirements continues to be difficult. The shortcoming pointed out in this regard is the lack of investment in systems and processes and bringing in quality human resources or developing these internally. The human capital needs training to inculcate a culture of quality and make quality as an ethos deeply engrained. It should also not only hold people at the manufacturing sites accountable, but also endow them with the spirit of ownership. Industry leaders should consider such investments in quality a basic essential and not an afterthought. This will give great results (Ian Wilcox, August 7, 2015). Similar investment in the proper machinery for manufacturing, its maintenance and precautionary measures and stringency during production processes is considered necessary for India to improve its drug production standards. Strong IT systems obviously play a major role. Taking assistance from European pharma regulators or the FDA with a willingness to spend more and improve the process will be helpful. From manufacturing chemicals to the next step of making biosimilars, these will all help India ride the next wave in the coming 10 years. Investing in biosimilars will soon become necessary since many of the blockbuster drugs will be coming off patent and will become generic in the next few years. For this to happen, quality should be the buzzword. Policy 17 acknowledges the present competence as low and allows loan licensing with some caveats, but the message as to where to reach is clear. Recent Trends for Manufacturing Quality Quality by Design (QbD) assures translation of laboratory product performance to the life situations in which it finally operates. The approach to development defines the objectives of the manufacturing process and emphasizes understanding product and process control. It is based on science and takes caution against risk factors in achieving quality and the management thereof. Mainly QbD offers substantial improvement in manufacturing quality. This is expected to lead to safe and effective drug supply to the consumer. The USFDA finds that QbD achieves these objectives and increases efficiency. More important, though, is the assistance it gives for more efficient and effective control of changeless batch failure,

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leading to better return on investment/cost savings. QbD improves yield and lowers costs, also due to fewer investigations, reduced testing and less recall. QbD facilitates changes in the manufacturing process within the approved design without further resubmission to the FDA and regulatory review. It enjoys greater confidence of the regulator, less intense regulatory oversight and fewer post-approval submissions. It is a large gain. From a manufacturing technology point of view, technology transfer to a unit of manufacturing is more efficient with QbD. It reduces the time to market from 12 to 6 years. Continuous improvement over the total product life cycle is possible. For the consumer, there is greater drug consistency (Umesh n.d.).

Newer Technologies and Pharmaceutical Industry: Blockchain NITI Aayog is working on applying blockchain technology to the drug industry with Apollo Hospitals and information technology major Oracle in supply chain management. It aims at detecting spurious drugs and for complete traceability of drugs. Blockchain technology is considered important among emerging technologies for ease of doing business and for a free market. Many processes change under this new technology (PTI | August 4, 2018, 06:04 IST), and this is briefly described below. How Does Blockchain Work? The Technical Explanation “Blockchain brings everyone to the highest degree of accountability, helps to guarantee the validity of a transaction by recording in a main register and a connected distributed system of registers. Secure validation mechanism connects these.” (Ian Kahn, March 14, 2018). Information held on a blockchain cannot be corrupted by altering any unit of information on it. To do so requires an enormous amount of computing power to override the entire network. In theory, this is possible but in practice it’s unlikely to happen. Paradoxically, it is said that the best opportunities related to blockchain are in the countries where such technologies are not prevalent (Don & Alex Tapscott 2016).The reasons probably lie in its incorruptibility of data.

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This is more of a track and trace requirement and the technology industry is not considering this as a full blockchain initiative. Additionally if the source data itself is tampered, this technology would not be of assistance even when it can help the integrity of the information. QbD could play an anchor role in good data capture for blockchain directly to make this foolproof. Real World Uses of Blockchain in Pharma and Health Care  erifying the Authenticity of Returned Drugs V From the pharmaceutical manufacturers back through the entire supply chain in the market the journey of returned drugs for many reasons is long, variable and complex. Two to three percent of drugs are returned, valued at $7–10 billion per year. These perfectly good drugs can be resold under certain conditions. The pharmaceutical companies have a legal obligation to verify the authenticity of the returned drugs before reselling/ disposing of them. Idea of bar coding the drugs for domestic drug supply was not enforced till June 2019 at least. Bar coding is an extremely complicated issue. The Drug Supply Chain Security Act (DSCSA) Public Law, 113–54—NOV. 27, 2013, USFDA has not seen much change till end 2020.  The European Union has a central database for manufactured drugs. The companies and distributors connect to this to verify drug authenticity. In the US there is no centralized database regulator, making it logistically prohibitive to reconcile the numbers. A far better and recommended approach is to have pharmaceutical manufacturers record the serial numbers of their packages on a blockchain, which serves as a decentralized and distributed ledger. Wholesalers and customers can then verify the authenticity of a drug package by connecting to the blockchain.  revention of Counterfeit Drugs and Medical Devices P Drug companies have a difficult time keeping track of their products, thereby allowing counterfeiters to introduce fake drugs into the system. Eight percent of the medical devices in circulation today are counterfeit. By using blockchain as the drug/device moves through the supply chain, the transactions can be recorded, making it possible for all parties to track drugs and making it harder for counterfeit drugs to be introduced into the supply chain, and distributed to unsuspecting consumers.

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 ompliance in Pharma Supply Chain C As drugs move through the supply chain, logistics companies need to adhere to drug guidelines for storage, handling, transport, and maintaining temperature range, humidity and air quality within specified limits which have to be tracked. Otherwise these have a direct impact on the quality and efficacy of the drug. At present this is done by using the Internet of things and its devices for all such factors throughout the supply chain life cycle. Blockchain technology provides a better way to add compliance and governance. If such conditions are not met, the information is transferable to the relevant parties in the chain. Additionally, smart contracts automatically invoke within the blockchain, the invoice amount due to the logistics company. Deductions in it can be made based on its level of non-compliance of storage conditions. Transparency and traceability of consent in clinical trials using blockchain and improving the quality and reliability of clinical trial data will be discussed in the next chapter.  atents and Intellectual Property (IP) P Intellectual property IP is arguably the most significant core aspect of any new drug. The most critical part of a patent is its composition of matter. To obtain a patent, proof of creator, time when it was created, what was included then and proof of non-alteration since then must be provided. Blockchain assists in proving the IP assets, proof of origin and ownership, without any disclosure of data. Thus, confidentiality, security, trust and legally accepted record can be achieved all at once (Sinkar Tushar | April 11, 2018; B. Clark and B. McKenzie, February 2018). Licensing and Royalty The pharmaceuticals industry has never been under  such tremendous pressure to deliver new drugs, especially in the antibiotics line. The life cycle of patents is on the decline. The research pipelines do not have much to offer. The market is unstable and mergers and acquisitions frequent. The only effective and efficient solution is highly confidential collaboration among different stakeholders, with complementary strengths and mutually beneficial contracts. Trust in the collaborating parties is a must in the process of splitting royalties and in ownership of IP. When regulators approve the drug, the stipulated royalties can be triggered by using

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blockchain smart contracts, data integrity which can protect from being defrauded (B. Ramsundar: March 11 2018). Research Literature, Referencing and Authenticity With the ever-increasing research papers available, the trustworthiness and authenticity of literature is often placed under scrutiny in the scientific community. Blockchain can aid in establishing the authenticity and trustworthiness of the literature. Other Recent Advances Chromeleon™ Chromatography Data Software (CDS) has also helped in maintaining Data Integrity. Watson Laboratory Information Management System (LIMS) automation solutions decrease costs while optimizing the efficiency of pharmaceutical companies and contract research organizations (CROs) over a broad range of studies. These technologies are expected to help in development, manufacturing and drug analysis. These are competitive tools and adhere to the norms of GLP and GMP. There are several Cloud Solutions which the companies use by collaborating with research institutes and start-ups to develop new drug delivery systems such as disintegration time of capsulation and targeted therapies such as monoclonal antibodies. Like the computer throughput drug design, robots are now used to test the pharmaceutical value of existing molecules. Automation is also being used for handling of hazardous compounds, detecting underfill and overfill of samples, and metal and foreign dense contaminants in the manufacturing unit. All this improves quality and protects brand image (Chopra Amit, April 27, 2017).

Drug Quality and Loan Licensing System The likelihood of the quality being negatively affected arises from the process of loan licensing for manufacture of drugs. Genesis Even the bigger companies which have manufacturing capacity for their bulk product give it to a third-party manufacturer who does a brilliant job of producing an exact replica of the drug originally produced by the big

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company. The big companies can certify these drugs through their own quality control laboratories. This practice reduces the total labor force that the big company needs to otherwise retain. Thus there are fewer issues to deal with and less trouble with the union mentality and probably some coercive obstruction. It reduces the possibility of manufacturing being delayed and/or stopped due to labor trouble since there is already a way open. Aside from this, such a practice reduces their pure manufacturing costs since the third party will do it at less cost. Dubious loan licensing companies which do not sell drugs in the market, manufacture drugs for other marketing companies (see below). These manufacturers will use every concession regarding the exact quantity of a drug that must be present in each tablet or capsule. Generally the concession wavers around 5%. Invariably the product manufacturer will add as small a quantity as possible or a far lower quantity below the recommendation or no quantity of the drug at all. In the first two situations the saved drug continues to be recycled for the same or some other unit order, again saving on drugs and involving no fresh purchase. The larger the original order, the greater the dishonest drug saving. If the manufacturer gets paid by some other company to make the same formulation anew, the same saved drug will be used to manufacture it without having to purchase it anew fully or partly. Many top bosses or people highly placed in a large pharmaceutical company retire. Often they cannot stay away from the pharmaceutical milieu for long. They form and register their own companies. Such companies do not have manufacturing capacity and consequently have no reason to maintain a quality testing laboratory. With the company, they register a few medicines which are already current in the market. Some show the wisdom of producing specialized brands. They catch hold of a source which will supply the drug to a loan licensing manufacturing facility contracted by their company. The manufacturer will either give a quality assurance certificate or obtain one from the government or private quality testing laboratories. The value of the certificate can be understood. This leads to the entrance of more and more brands of ‘me-too’ drugs, with their attendant quality issues. Many of these newly registered companies are purely and strictly local. The marketing and sales people who form such companies manufacture a number of brands of the common fast-moving consumer goods the (FMCG) type. They will then request their doctor friends and leading practitioners in a specific area with whom they had excellent relations when

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they were themselves employees of a pharmaceutical company, to write these brands. One such extremely clever example which our research team discovered some years ago was a company in a rapidly developing city in Maharashtra. Here the one who floated the company made all his prescribing doctors the shareholders of the company, thereby creating a genuine interest in writing these brands whether they were necessary or not. The Process of Manufacturing My research team has seen such facilities where the drug mixing is callous, done by visually measuring the drugs or excipient to be mixed, notwithstanding the filth and dirt of such manufacturing capacities. Even potatoes or onions are probably measured with more care. Not that every one of them will manufacture drugs in the such objectionable ways. But then with thousands of manufacturers producing thousands of brands and the poor quality control testing mechanism we have seen above, how many could answer to this description is beyond the capacity of the team to find out. It is this indeterminate number and the unknown facilities that are alarming. Repacking of expired drugs and selling them once again is also a common practice of the low-cost manufacturers. This is generally the source of drugs that are inferior in quality or are fake, or both. A fake drug is that which looks exactly the same as a well-­ known product of a reputed company but will not have the correct content or no content at all. Many of these third-party manufacturers without doubt can produce drugs that look exactly the same. Duplicates are those manufactured without the companies’ duly placed orders. Such formulations may or may not have the drug of the desired quality from reliable source manufacturers. Such drugs take advantage of the brand leader drug’s popularity and sell it through the chemists. I had my first exposure to this trend in 1982, when people offered such identical-looking fake drugs at low cost with advice to sell them at MRP plus taxes. They were from Bengaluru. The margins must have been good and there must have been many takers since they came to the hilly tribal area, 4000 feet above the mean sea level and 250 kilometers away from Bengaluru, to sell them. It was then and is now also the famous market which continues unchecked and well protected. There is one major disadvantage these drugs create in such conditions. No one else outside that limited territory will ever have heard of these

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names. If these patients go to another doctor, away from this territory, these drugs will not be found in any of the drug reference books or on the internet. This creates a situation where the treating practitioner will not know the chemical entity, whether he needs to change it, or even what he is changing, thus not knowing if he is withdrawing a drug suddenly when it should actually be weaned or whether the drugs the patient was taking have caused some of the ill effects. No one will know if there is a single chemical entity or whether it is a combination of two or more. Treating such patients becomes a big gamble, a stone thrown in the dark. Or it will result in one more blunderbuss therapy as it used to be called in the 1980s, where you give all possible drugs pertaining to one or more likely diagnoses and the system likely to be affected, hoping that if not this then some other drug in it will work. Abolishing this system is therefore a necessity for patient safety. What Does the Government Have to Say About Drug Manufacture in Policy 17? The article numbers quoted below come from Policy 17. 3.9 The practice of ‘loan licensing’ and ‘contract licensing’ also undermines the veracity of drug manufacturing and pricing practice. 5.8 Loan licensing was decided to be discontinued in a phased manner in the drug policy of 1986 (until now nothing was done to implement the suggestion). However, in the present context, when India is saturated with formulation manufacturing, ‘loan licensing’ is not of overwhelming benefit. Instead, it raises many quality maintenance and assurance issues. Therefore, in Plan A, except in biopharmaceuticals and pharmaceutical formulations of other drugs, ‘loan licensing’ will not be allowed. Plan B includes (i) phasing it out over three years, (ii) loan licensing to be allowed only for WHO GMP-approved facilities and (iii) loan licensing to be allowed up to only 10% of the total production of the company. 5.9 Similarly, another variant of loan licensing, that is, the practice of P2P (product-to-product) manufacturing will be phased out. Here, one manufacturer manufactures one pharmacopeial drug under multiple brand names and gives them to the various manufacturers to market them at a price chosen by them. This phase-out will be achieved by following a principle of one manufacturer, one salt, one brand name and one price.

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Anterograde and Retrograde Rectification As always, when we think of the cures to get rid of undesirable situations like this loan license system, there will first be an anterograde cure and then a retrograde cure. There should be some automatic but comprehensive fallouts of the draft pharmaceutical policy 2017. If anyone wants to register a pharmaceutical company he/she should have a manufacturing capacity of their own since only 10% of the drug output can be manufactured by loan licensing hereafter and that too by WHO-accredited plants for Good Manufacturing Practice. The companies without this facility will have to just fold up and quality control questions will not arise unless they start their own manufacture. This will stop new companies from coming up. Thus once and for all there will be a deterrent to the introduction of more brands and there will hopefully be no further increase in low-quality and fake drugs. The loan licensing system from where even the big companies procure their drugs manufactured should also now conform to the above norms, a highly desirable situation. This will automatically clean up a lot of the detritus in the pharmaceutical sector. Systematic, criteria-based search of all the manufacturing facilities using a random sampling method should be undertaken at the state and the union territory level without excessively straining the machinery available. There is no need to make an effort to write the criteria once again. Suffice it to say that the old criteria are looked into and suitable modifications made. A few honest teams are needed which can be constituted in a variety of ways. For example, each team must have either one quality testing chemist or a person well versed in manufacturing or a pharmacologist and a couple of officers from the state department. A few random inspections without notice are enough if the assessment is truthfully made and punishment is honestly decided and swiftly executed. If there is a cutoff limit of the grade the manufacturers should achieve but do not during inspection, such a facility might as well be closed down. In the effort to create a database of all companies Policy 17 talks about, these elements should be included in the information gathered. The last of the measures is establishing quality testing laboratories. This is one area where the PPP model could work well. The paucity is severe and the wide quantitative discrepancies that are possible are shown elsewhere in this volume. But what is good for the millions of poor does seem to be highly detestable to some in the pharmacy trade.

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Box 4.1  Perspectives on Pharmaceutical Industry

“If you fall ill, go to the doctor and pay his fees so that he should survive. Go for the testing if he orders one because that person must survive. Then go to the chemist once doctor has seen the reports and prescribed some medicine and buy it because the chemist must survive. After going home throw all the medicines away because you should survive.” (Anonymous) Voltaire said that doctors treat the disease about which they know little and the patient about whom they know nothing. Today we have come to the horrifying conclusion that patients remain alive not because of but in spite of doctors.

Understanding the Patent Law and why this is a Sensitive Issue The key considerations in developing a fair patent law include the following: 1. Striking a balance between ensuring affordability of and access to life-­ saving treatments while protecting the market of the future of innovative new medicines locally and globally. This means abstaining from indiscriminate de-patentization of each and every drug in the name of people’s health. 2. Consideration needed for the R&D expenditure in developing a new drug while changing the patent law: The R&D involved in developing a new and more effective drug from laboratory benches to market requires investment to the tune of 500 to 700 million USD, in 2005 prices, and at least ten years of work. It is necessary that when such effort results in a good drug after many failures, the effort and expenses should be rewarded monetarily for a finite time at least. The drug discovery process nowadays involves basic research and computer-­assisted designing of molecules that can work over a pathway found by basic research. If the drug proves safe after preclinical development, animal toxicity experiments, and phase 1 to 4 trials it goes through the rest of the development process. Of the 5000 compounds

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thus looked at, 5 enter trials and 1 gets/may get approved. But that one drug may still fail. Drugs well established in the market may also fail, as was the case of the sensational failure of Troglitazone. The USFDA issues black box warnings, mandatory indications and instructions, which are all a part of product packaging. Contraindications previously unidentified may emerge. In that case the process is either reversed or an alternate drug candidate is sought, to reduce or eliminate risk. At times the project is abandoned. Drugs are constantly debated and derided, and USFDA reviews and senate hearings occur. The monitoring systems are strong. Any new drug with a high cost is easily threatened by reverse engineering, which Indians are extremely good at. Disputes arise when the company with their drug under patent is seen as making an exorbitant profit due to monopoly, leading to a ‘conceivable’ discomfort of suffering people. In this perspective it is better to look at the situation of patents in India. Higher prices and market protection through patent laws are fully justifiable demands.

The Backdrop for the Patent Laws For many decades now health thinkers have directed their tirades against the pharmaceutical industry. It was a great fight between unequals which the activists could never have won without the help of the government. They also directed their fight against the patent laws under which drugs were sold  years before the Globalization set in, in India. The unipolar world came into existence and the Indian economy incrementally integrated into the global economy. There were thus areas which could not be completely disregarded. The patent issue was one of them, which represented certain basics of the economic functioning of the new unipolar capitalist world in this regard. The theorists rightly attacked the patent laws which needed to be changed. Additionally, however, taking recourse from a court and reaching a decision would take decades in this country. In such a situation anyone claiming the right to intellectual property could/would be challenged and the matter could keep hanging. This had to change a great deal as the country talked about patent enforcement. For most of these theorists/activists patents represented the Western, economically exploitative hegemony, designed to deprive the world’s poor from accessing more effective drugs. This was lopsided opposition lacking

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recognition of R&D efforts and expense. Even then, the Indian government did a good job by amending and actually applying patent laws in India in January 2005. It retained the rights to revoke patents in certain grave situations of epidemic proportions where the new drug would be particularly effective, leaving the principle of intellectual property rights untouched. The drug authorities also thus invited the ire of these health activists. A furious debate ensued. Interpreting the Law Related To Drug Patents: Process Patents The drug market situation is a little different in India than in the US or other developed nations. In the US, when a new drug is launched only the company that holds the FDA patent is allowed under law to sell the drug, thus giving it a market monopoly. In India there was a patent law of 1970 which was modified in some crucial ways in 2005. The Patents Act 1970 allowed process patents for drugs, foods and products of chemical reactions. Anyone could replicate any drug in India without legal repercussions by using even the slightest modification in the manufacturing process. Indians proved themselves to be the masters of reverse engineering, and by tracing the drug backwards through all the steps of synthesis produced many such drugs. No product patents were allowed for inventions related to such substances (The Patents Act 1970, erstwhile Section 5 of, Controller of Patents Office January 14, 2015). Up until then the law had meant that patents could be continued for a long period. The Evergreening of Process Patents The devise used for such a patented drug to remain under the patent involved such drugs being manufactured by only slightly modifying the process or by causing a slightly different kinetic property or other molecular modifications. This was possible because the process and not the product was patented. This is the evergreening of the patent. The other way to continue the greening game was to develop a new process to produce the same drug and that process was again patented. Reverse engineering was a disincentive for foreign countries bringing newer drugs to India or setting up R&D laboratories for further drug development, though setting up R&D even then in India was cheaper by 40% compared to Western Europe or the US. Since the 2005 Patents Act modification this situation has changed considerably.

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In an attempt to eliminate these tricks of evergreening the patented drug, Section 3 (d) now runs thus: the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. (Italics mine)

This effectively negated the process of patent viability. The text added to section 3(d) suggests that in the case of a medicine that claims to cure a disease, the test of efficacy can only be the condition of “enhancement of the known efficacy.” Further, the explanation requires the derivative of such a drug to “differ significantly in properties with regards to efficacy.” What is therefore evident is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to therapeutic efficacy. While dealing with the explanation as provided in Section 3(d), each of the different forms mentioned in the explanation has some properties inherent to that form, for example the solubility of a salt or hygroscopic potential. Unless these forms differ significantly in property with regard to ‘therapeutic efficacy’ they are expressly excluded from patentability. Section 3(e): Claims related to compositions obtained by mere admixture resulting in aggregation of the properties of the individual components are not patentable under section 3(e) of Act. However, in a composition if the functional interaction between the features achieves a combined technical effect which is greater than the sum of the technical effects of the individual features, it indicates that such a composition is more than a mere aggregation of the features.

This type of situation rarely occurs in therapeutic medicine. The issue should be taken further in this direction. The combinations do not as a rule enhance the therapeutic ability or efficacy, and in fact may cause a loss

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of it compared to when the combined drugs are to be used separately (refer to the note on the combination of oral antidiabetic drugs in the next chapter). Such non-enhancing effects of drugs or their congeners do not have a place in medicine and under patents. Chapter 5 of the Law of Patents relating to inventions, where only the methods or processes of manufacture but not the product are patentable, has also been thus omitted by the Government (Patents [Amendment] Act, 2005) and product patents were introduced in response to the inevitable Trade-Related Aspects of Intellectual Property Rights (TRIPS) which allowed a transition period of ten years to bring in product patents and remove process patents. These changes are decidedly beneficial. A Special Consideration: Mass Disease Outbreak and Patented Highly Effective Drugs Yet there was one aspect of a patented drug that needed consideration. What if such a drug was found to be of far greater efficacy for a large or very large number of patients, a number which could be said to have reached epidemic proportions? In such a situation the question remained as to how or whether such a patented drug could be allowed or made to be available at a much more reasonable price. On this the Indian government has taken the position that it can revoke the patent right and allow the drug to be manufactured by others to meet the high demand for this large number of patients, if it finds such a decision leads to extraordinarily large public good. This was particularly relevant since, in India, 70% of expenditure on health care is out-of-pocket, which has led the government and its judiciary to take steps to promote the use of generic products and prevent prices of life-saving drugs being set by market forces and or the Patent Privileges (http://ipindiaservices.gov.in/rqstatus/Cause_list. ASPX, updated January 14, 2015). This issue came to head when Bedaquiline, an effective drug, was prescribed for patients suffering from extensively drug-resistant (XDR) TB. This is the first therapeutic advance in 40 years in the treatment of TB approved by the US Food and Drug Administration. The question was, given the high and rising prevalence of XDR TB in India, whether it should be manufactured by others and given to patients on a large scale. In March 2018, Mumbai-based Macleods Pharmaceuticals and US drug giant Johnson & Johnson (J&J) were in talks for a voluntary license deal for Bedaquiline, which would allow Macleods to manufacture a generic

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version of the drug, which would improve access to this new TB drug. Presently J&J has offered this drug free of cost to the Health Ministry’s Revised National Tuberculosis Control Programme (RNTCP) under a conditional access program (Rajagopal Divya | ET Bureau | March 13, 2018, 10:53 IST). Bedaquiline sold under the brand name Sirturo by Janseen (a subsidiary of J&J) costs approximately $900 for a six-month treatment, via import. The experience that is widely accepted is that “… donations of medical products and health technology are difficult for both treatment providers and ministries of health to manage effectively and in a sustainable manner that ensures long-term access to treatment for patients” (Medicines Sans Frontiers (MSF), Lydia Ramsey, October 16, 2016). According to MSF, patients can either go through the government program or import the drug. A drug under patent if found to be of such importance for a public health issue and that if a country having poor or no manufacturing base and has no way to meet the demand in the wake of the public health crisis, what can be done for these under developed countries? This is an important consideration. This is the case if large-scale outbreaks, especially from HIV/AIDS, tuberculosis, malaria and other epidemics  in under developed countries develop. The ministerial conference of WTO adopted the Doha Declaration on the TRIPS Agreement and Public Health (2001). It provided a mechanism for compulsory licensing to supply medicines to countries with insufficient or no manufacturing capacity (Guidelines for the Examination of Patent Applications in the Field of Pharmaceuticals Capacities 2001). The declaration also explicitly stressed that the TRIPs Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all. Consequently, a provision (Section 92A) was introduced in the Patents (Amendment) Act 2005 for Compulsory Licensing for the purpose of export of pharmaceutical products to any country with insufficient or no manufacturing capacity. This has caused a number of issues for multinational companies, leading some to question the commercial viability in India: 1. In April 2013, Novartis lost a six-year legal battle after the Supreme Court ruled that small changes to its leukemia drug Gleevec would not obtain a new patent.

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2. Recently India upheld a compulsory license of Bayer’s cancer drug Nexavar, effectively allowing generics firms to copy the patented drug. 3. The patent for Pfizer’s cancer drug Sutent was revoked. 4. Roche’s patent on Pegasys, an anti-hepatitis C drug, was denied. These challenges, among others, caused the growth of the pharmaceutical industry to slow over the year 2014 (from 16.6% to 9.8%), a trend that both domestic and multinational companies are looking to reverse. For this to be achieved companies will need to work closely with the Indian government, regulators and other key stakeholders to establish compliant business practices that are commercially viable. Signs of strong recovery have appeared from 2017 till 2019. 

R&D, Pharmaceutical Industry and Draft Pharmaceutical Policy 2017: Some truly Important Considerations To help the above situation to resolve satisfactorily the developed world alone cannot continue to foot the bill for innovation. It is becoming increasingly apparent that R&D engines in India need all the help they can get in terms of facility location in the country, where costs of running the laboratories are much lower than elsewhere. Setting up R&D where the drug industry has developed to a high level of sophistication to understand R&D and support those with well-trained manpower at low cost would be practical and useful. India is the ideal prescription for this. The government has to take it upon itself to see that more and more R&D facilities are located here rather than elsewhere. If India can adopt these solutions it has the potential to grow to a level that is comparable (in value terms) to most developed markets by 2020, something the pharmaceutical companies of today surely will be looking at. R&D in India has grown from 5.3% of sales in 2012 to 8.4% in 2018. Clinical trials have gone up but the quantum change is not as significant. The neglect of R&D is on account of disproportionate focus on generic formulations. Whatever R&D exists is also limited to new processes for the same product, that is to say Novel Drug Delivery System (NDDS). For a long time there have been no new molecule discoveries by indigenous manufacturers. In addition, there are pressures of pricing and the intensely competitive US market, drug quality issues and returns over sub-standard drugs, and the need for new molecules, and all of these combined should

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lead the companies to focus more on their R&D. The first to have paid serious attention to this is Lupin, which has overhauled their R&D (Mukherjee Rupali, March 11, 2019].

Mergers and Acquisitions: Cross Border in Particular in Pharmaceutical Industry Without doubt the Indian pharmaceutical companies have grown big, almost giant, so much so that they are ready to take the global stage. This observation is driven by the Lupin Limited of India buying US-based Gavis for $880 million, the largest cross-border acquisition so far and Lupin’s fifth foreign acquisition in just 18 months. A few words of advice to Indian pharmaceuticals going into the acquisition and merger business are worth noting (Wilcox Ian, August 7, 2015 Ibid.). The Indian companies are promoter driven, which is unique. The need and the process of getting globalized will require changes to make the company management more professional than the promoter alone directly managing it. Indian companies should identify their core competencies and the ethical values they may wish to perpetuate. The globalization process may then be easier (Wilcox Ian, August 7, 2015 Ibid.). In cross-border acquisitions, Indian companies should look closely at the quality of the talent they want to acquire. There also has to be a cultural congruence. Due diligence is needed to place greater store in people and their training. This necessarily goes beyond the financial considerations alone. People and their training, assimilation and cultural fit are the intangibles which are extremely important (Wilcox Ian, August 7, 2015 Ibid.). A completely different risk may emerge in acquiring a company which has different expertise vis a vis the core competence of the company which is buying the other. These people with their expertise are important for the company acquiring the other. After the acquisition care should be taken to recognize their competencies and retain them in a happy state of mind since they are needed. They have to be brought into the acquisitioning company culture and atmosphere. Physical distance and inadvertent or careless distancing from these people is a real challenge. It should not be allowed to surface in any case. Bridging the cultural divide is just as important. The greater the distance, the higher the risks, and it must be bridged. Promoters must know their deficiencies or requirements which need a fillip. It is not always a financial gamble; it is more cultural (Wilcox Ian, August 7, 2015 Ibid.).

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It is being predicted that mergers and acquisitions will lead to volatility in industry which will then simmer down to only a few big players remaining in the field. More consolidations will take place in the next five years. One question is whether and how the merging companies look at their R&D prospects.  Will R&D  improve or deteriorate or nothing will be done about it? One factor for survival and growth under M&A is the efficiency of the pipeline for newer products before and after the merger. Indian pharmaceutical companies do not have an enviable record in R&D. If mergers do not provide an answer to this, there is a distinct possibility of becoming irrelevant with only the established products remaining viable (Business News, May 28, 2015). An important operational issue is the merger of two different IT systems. This is a difficult and time-consuming process and can produce blind spots, making full visibility difficult. The IT system of even a single company more often than not works from various databases and information. This will compound the problems of a merger between two pharmaceutical companies.

Foreign Direct Investment and the Indian Pharmaceutical Industry An investment in the Brownfield project is one in an already established company. Greenfield on the other hand is an unexplored area. The Draft Pharmaceutical Policy 2017 admits that liberalization of foreign direct investment (FDI) has undermined the competitiveness of the Indian pharma industry. In article 3.6 it states that it is “happening through …..acquisition of Indian companies, by foreign companies” (Policy 17, ibid.). Countries that are traditionally not strong in manufacturing formulations have started to acquire formulation manufacturing plants/companies through automatic and government approval routes. This admission also raises questions on the move of the Union Cabinet in June 2016 to raise the cap on Brownfield FDI under the automatic route in the pharma sector to 74%. The draft policy proposes that the “investee firm should continue production of NLEM drugs, spend on R&D, and should be ready for transfer of technology, before getting approval in brown field FDI.” But this provision, it is contended, will have only minimal impact on the incoming FDI since it applies only when the FDI in Brownfield is above 74%. One hundred percent acquisition is considered more amenable to technology transfer. At present there is no mechanism or system to monitor the post-acquisition activities of the

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company. A system would be developed to monitor the adherence to these conditions. This is a far-reaching decision which does not need any further comment. Policy 17 also notes that since liberalization there is only one FDI investment in one Greenfield project. The remainder have all come in Brownfield projects. As they are unexplored areas, the Greenfield projects may be perceived as risky and may be avoided but established competence in Brownfield projects is taken advantage of (PTI August 18, 2013, 09.11PM IST).

Pollution Control, Environmental Protection and Pharmaceutical Industry From the foregoing discussions it may appear that the pharmaceutical industry is being saddled with too much work, taking on too many responsibilities, increasing their expenses and is still subject to price control on their final product, cutting away too many practices and so on. Pollution control adds to this workload. It should, however, also be an integral part of the pharma industry. Setting up a plant requires a public opinion hearing. In mass production a minute quantity of an impurity will result in a massive amount of effluents, which the company has no option but to drain/landfill. These demands will not necessarily lead to large or overall losses or kill the industry. These are rational measures to successfully implement these demands where vindictive anti-capitalist rants to destroy free enterprise are not needed. It is a common experience that the right (rational) course will be taken after all other paths have been exhausted. The pharmaceutical industry will not be an exception to this rule. Take, for example, pollution control itself. The cost of treating effluent should be built into the cost of the drug production. Doing nothing about it is not the solution. Unwillingness of the chemical industrial plants to undertake pollution control has been the greatest difficulty in the Clean Ganga project. No one is ready to undertake effluent treatment to keep profits as high as possible. Contrarily, the price fixation mechanism discussed above calls for a 100% markup on the cost of production. Costs of pollution control can be easily built into cost while negotiating the price, even under regulations. Then the return on investment will be realized under the present price control mechanism. Effluent-regulating agencies and drug authorities need to work together to provide solutions and compliance regulations to ensure the environment is protected.

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In conclusion, from the poorest to the richest, quality matters today and technology almost always brings prices down, still making large profits. Overall, a large amount of public good can be achieved with rational measures. The new government at the center also seems to have the political will to act upon these measures in the health field in general.

References PatilVaibhav, SAP Worldwide Consultant for Pharmaceuticals, personal communication 2016. Pralhad C K, Hart Stuart, The Fortune at the Bottom of the Pyramid: Eradicating Poverty Through Profits ,Grin Publishing, 2005. Pharmaceuticals Exports Promotion Council of India, Aranca Research, 2016, Business Monitor International (BMI). IBEF, India Brand Equity Foundation, August 2013. Wanigatunge, Chandanie, Professor of Medicine, Jayawardhane University, Sri Lanka, personal conversation 2nd December, 2018. ET Health World, 2014; www.researchpublish.com. Indian Institute of Health Management and Research, a WHO Collaborating Center (IIHMR) University Jaipur, 2016. Gupta Prof S D, President, Indian Institute of Health Management and Research, a WHO Collaborating Center (IIHMR) University Jaipur, 2016. Draft Pharmaceutical Policy Government of India, 2017. CMIE, Centre for Monitoring Indian Economy – Economic Outlook, 2017 circa. Pharma trac - 2017 circa the database of All India Organization of Chemists & Druggists & Advanced Working, Action and Correction System (AWACS). IANS, Indo-Asian News Service | 2016, quoting IIHMR University, Jaipur. Economic Times Bureau | September 29, 2018, 06:42 IST. Press Trust of India, PTI | 13 August 2015, 3:30 AM IST, Cabinet Committee on Economic Affairs (CCEA) on strengthening drug regulatory system. http://www.medindia.net, accessed on 25th December 2014. Das Soma, Seth Dilasha, ET Bureau| Updated: Apr 13, 2015, 06.04 AM IST. Mandaviya Mansukh A, Minister of State for Chemicals and Fertilizers, as quoted by PTI | March 14, 2018, 15:47 IST. Nagarajan Rema | Times News Network | January 17, 2017, 09:10 IST. Shahapurkar Dr. Surgeon, Kolhapur, Drastic reduction in Angioplasties after price fixation of cardiac stents, personal Conversation 2017. Phadke Anant Dr. Co-coordinator, SATHI- CEHAT, taken from a symposium conducted in CIIMS Hospital, Nagpur on 13th September 2008. National Sample Survey Organization, 55th consumer expenditure survey 2011–12. Nautiyal Shardul, Mumbai, Monday, April 11, 2016, 08:00Hrs [IST]2016.

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Press Trust of India, PTI | March 09, 2019, 06:34 IST. Divya Rajagopal | ET Bureau | October 17, 2017, 04:42 IST. Supriya Shrinate, ET Now  |  May 10, 2017, In talk with Dr Arvind Pangaria, 17:33 IST. Ian Wilcox, VP and Global MD, Life Sciences at Hay Group, as quoted by Dearton Thomas Hector, ET Bureau|, Here’s why Indian pharma firms need regulatory experts on their boards, Last Updated: Aug 07, 2015, 05.19 AM IST. Umesh, n.d. Technology Transfer Officer Actavis, Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications, n.d. https://lear naboutgmp.com/general-­v alidation/phar maceutical-­ quality-­b y-­d esign-­q bd-­a n-­i ntroduction-­p rocess-­d evelopment-­a nd-­ applications/. Press Trust of India, PTI, | August 04, 2018, 06:04 IST. Ian Kahn, Key note address delivered in WHDusa.com/net, on 13th September 2017. Don & Alex Tapscott, Blockchain Revolution 2016, PenguinRandomHouse.com. B.  Clark and B.  McKenzie, “Blockchain and IP law: a match made in crypto heaven?” February 2018. [Online]. http://www.wipo.int/wipo_magazine/en/2018/01/article_0005.html accessed 10 03 2018. B.  Ramsundar, “Why Blockchain Could (One Day) Topple Google,” [Online]. Available: http://rbharath.github.io/why-­blockchain-­could-­one-­day-­topple-­ google/ as quoted by Tushar Sinkar, March 11 2018. Amit Chopra in ETHealthWorld | Updated: April 27, 2017, 13:47 IST. Patents Act 1970 (accessed at Controller of Patents Office 14th January 2015. The Patents Act 1970 erstwhile Section 5 of, Patents (Amendment) Act, GoI, 2005. Rajagopal Divya | ET Bureau | March 13, 2018, 10:53 IST. Medicines Sans Frontiers (MSF) Lydia Ramsey: October 16, 2016, 23:15 IST https://www.businessinsider.in/Why-­Doctors-­Without-­Borders-­is-­turning-­ down-­a-­million-­free-­pneumonia-­vaccines-­from-­fizer/articleshow/54801117. cms?utm_source=contentofinterest&utm_medium=text&utm_ campaign=cppst. Guidelines for the Examination of Patent Applications in the Field of Pharmaceuticals Capacities. 2001. Mukherjee Rupali | Times News Network, TNN, | March 11, 2019, 15:25 IST. Business News, 28 May 2015. PTI Aug 18, 2013, 09.11PM IST. Kelkar Sanjeev, India’s Public Health Care Delivery: Policies for Universal health Care, Palgrave Macmillan, 2020.

CHAPTER 5

Pharmaceutical Industry and Clinical Medicine

Medicalization of Society With innumerable drugs available for hundreds of symptoms and disorders, the notion that there is a pill for every ill has been successfully instilled in people’s psyches. And the medical professionals try to ensure that patients will continue to take the drugs without really thinking much about it. This is because no patient today wants his/her unbridled life to decelerate in any way during illness or otherwise. It is assumed to be the responsibility of the medical profession and the drugs and modern equipment to bail the people out of every hazardous situation they may land in. Iatrogenic disorders are high in number. The profession needs to apply its collective mind to see that optimization in treating the patient becomes the norm, not over-drugging. The belief that every ill can be sorted out by a pill has resulted in losing the qualities of endurance and steadfastness to face up to life. We have lost the ability to stoically accept the delayed fulfillment or gratification of our desires in general and during periods of ill health in particular. We have opted for a ‘now and more and more’ attitude, and the medicalization of society is one of the many prominent forms of this. Doctors also have become an impatient breed which quickly grows bored with the daily activities of writing prescriptions of long-available and well-tested drugs. Hence the patients are made to believe that new equals better. Through fanciful prescriptions doctors achieve immediate gratification and avoid © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_5

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boredom. Despite there being no significant difference in the action, spectrum, warnings, precautions and side effects between the old and the newer drugs, the cost difference could be from 3.5 times upwards.

How Badly Are Medicines Handled on the Ground? There are three factors in this operation: the medicines, the doctors’ actions and the pharmacists, with the patient caught between the two scissor blades. There are allegedly nearly 74,000 brands coming out of a mere 400 single drugs approved for use. Draft Pharmaceutical Policy 2017 has mentioned 60,000 as the most recent figure. On the ground also 74,000 brands are handled because all of them are prescribed by the doctors in various settings and different areas, states and so on. None of them are prescribed by their generic names. A large majority of these brands today are combinations of every conceivable variety, for a particular abnormality complex. The generic name of the drug or drugs is printed on the strips in such miniscule type as to make it difficult to read. It is challenging to find a drug with a single ingredient. The majority of combinations are of two drugs. There are many triple-­ drug combinations with the same or even greater difficulty in reading the names. Then there is the argument ‘How can you write a generically named drug when you want to prescribe a combination? Combinations reduce the number of tablets a patient has to swallow. That makes for better compliance.’ This, however, is not exactly correct aside from the fact that it creates other innumerable difficulties, described later. Whether it is a single-ingredient drug or a combination, each has numerous brands, and the difficulties arising out of such diversity are described below. The persons who handle the drugs at the sale counter add to the difficulties due to a number of factors, also described below. These three factors are so intricately connected that it is better to consider them in terms of a real-time transaction at the sale counter. The stand-alone pharmacies, the familiar medical stores, are in the name of a ‘qualified’ so-called B pharmacy or D pharmacy graduate. The owner is often absent or sitting idly. Numerous pharmacy colleges churn them out, and the training these colleges offer is poor. In the 73 years since independence, the majority have followed the route of private medical colleges: higher fees, admission and passing out. The large majority of their salespeople do not have any qualifications. They are gradually trained to use the software and dispense the

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prescription as it is. The difficulties start when the prescribed brand is not available. Their ability to find an equivalent brand composition is limited. When it is a combination brand the inability is even more glaring. Some are clever enough to substitute a costlier brand for which they obtain better margins, pleading non-availability. Some have the audacity to change the drug itself to a different one. This may be met with resistance from the patients and they go back to the  doctor  wanting to know whether this substitute is the same drug and whether they should accept it. If substitution is allowed by the doctor the patients still come back to verify the drug. This interferes with the doctor’s work. Consensus doctors may at times warn and be weary of substitution of costly drugs for equally good lower-cost drugs. On the other hand, the chemist calls the doctor to ask about the ingredients in the brand prescribed because he has not come across that name. In smaller places the knowledge of the chemists and their half-trained assistants is extremely limited in terms of the number of similar brands they can identify. Even lower is their understanding of the pharmacopeial names of the drugs. For the brand is the drug not its contents. And even lower is the number of brands they can relate to the particular use of that drug. Needless to say, their knowledge of the generic names is so poor that their ability to relate the generic to the brand name is also extremely low. Their knowledge of formulation technology and the changes it causes in the drug action is also poor. Hence their understanding of doctors’ prescriptions is miniscule. The overwhelmingly dominant practice of prescribing brand names makes things even more difficult. The medicine handlers simply keep telling the patients that this particular medicine is not available and push the patient on a long search for the same brand. The sick people or their relatives thus keep going from pillar to post, or wait for days and weeks until the brand is available or somebody comes out with a viable alternate choice. This is not just the experience of smaller places, where it may be understandable if not pardonable. The experience of treating patients in a metropolitan IT hub is the same. This is the plight of the patient and a sheer waste of their time. The patient on the next visit may come back without either the prescription or the alternate drug dispensed earlier, or both. Then it becomes extremely difficult to know if the alternate brand given is acceptable or correct. It is impossible even for the doctors to know all such brand names. Another reason is the strictly local brands described in the previous

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chapter which cannot be searched for. Nowadays patients go online and look for the combination but do not have the courage to go ahead and purchase the drug. Such is the paucity of drugs even when there is abundant drug supply in the market. In established corporate hospitals the identification of the prescribed brand may be better but costlier drugs are likely to be prescribed. Many of the problems mentioned above still remain. The Doctors Adding to the Conundrum Affordability is a substantial issue when the drug list prescribed is inordinately long. Today, almost without exception, these lists are too long. The doctors have no qualms about writing numerous drugs and not clarifying why there are so many prescribed. They will not admit that any one medicine can be omitted or is not a priority. The doctor does not even think that some medicines are superfluous, unproven, irrational and/or not required, with excess synergy or antagonism or cross-reactions. He is not bothered about the strain he is putting on the patients’ meager means. The poorer patients will often find it difficult to choose medicines most relevant to their illness and buy the irrelevant/cheaper ones, depending upon the money available. Or it is entirely possible that with available money supply, the unnecessary or less important drugs, often at high cost, will be purchased and the more relevant ones will not. Tonics without any rational justification are most likely to be purchased. In the last dozen years low-cost, long-trusted drugs have been much less likely to be available because there is no good profit margin attached to them. This is why they are not produced regularly or adequately. No one cares for the plight of the poor. My years of experience in the villages of West Bengal and in the state of Tripura testify to these realities. People practicing in cities may  not realize that such things happen routinely. The dominant tendency is to prescribe high-cost drugs in place of affordable long-standing, well-trusted drugs. The assumption is that the newer the drug, the better it is. In reality both drugs will have the same properties, without proven superiority of effect or low side effect profile of one over another, but the cost factor could be ten times greater. The medical representative has the ability to promote drugs with a plethora of schemes to push newer drugs with the doctors, the chemists and the patients. There are other fringe/substantial benefits attached to high-cost

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prescriptions. To top it all off, two brands of the same composition are prescribed at different times to make room for these benefits.

Drug Situation: Changing Times Technology and competition have come to help. Online stores have opened in metros where patients can place orders through a website, upload a prescription and get the medicines delivered to their home at a discount at the maximum retail price (MRP) of the product. Information technology and start-ups are bridging the distributors, chemists and patients and providing services of delivery of medicines at discounted rates. The software is also sending reminders to chemists and patients to buy their next month’s supply of chronic disease medicines and helping patients with reminders to take medicines through alerting systems for compliance. These are a posteriori facilitations but the ‘prescription’ has not changed. The Draft Pharmaceutical Policy, Government of India, 2017 (Policy 17 hereafter) states in article 5.14, “Skilling Program for Pharmacists will be designed to meet the modern day requirements of drug dispensing. Skill set of the Chemists and Drug Stores will be improved keeping in mind the emerging requirements and challenges of proper and efficient dispensing of drugs.” This is another a posteriori where the ‘prescription’ does not change. Most notably, there is no talk of improving the standards of the pharmacy colleges, a basic shortfall in addressing the issues. The mention of the skill set indicates some other machinery like National Skill Development in health care but not the colleges. This is the classical government thinking. To solve a problem create new machinery. My volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one supports and supplements the skill development program with more streamlined ideas for much greater effectiveness. The government may pay some attention to this but much more so to eliminating, stopping or banning those numerous, mostly far below the minimum standards pharmacy colleges. Contrarily, and to its credit, the Central government since 2014 has taken many steps to reduce the clutter of numerous drugs and has begun the movement of generic prescriptions.

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NLEM and Its Clinical Relevance The development and implementation of the NLEM is one of the many singular achievements of the 2014 government. To site a few examples of this stripped down list of nearly 800 drugs, there is no mention of tramadol or angiotensin receptor blockers, which are a huge and costly market today. The essential medicines go with low cost; there are few combinations and they are generic. Prescribing such drugs is part of rational therapeutics. This is where the entire machinations of the pharmaceutical industry loses its edge. The industry wants the doctors to prescribe drugs that are outside the NLEM. These drugs have passed the due process of research and verification and have been legally approved. These medicines are almost without exception much costlier and are promoted as an improvement over the base drugs included in NLEM in terms of therapeutic efficacy and better side effect profile. An example is enalapril against the Angiotensin Receptor Blockers. Thus there is a war between the older first-in-class drugs and the newer ones. These are characterized by varying dosage strengths and combinations, and multiple and far costlier congeners. Most of these are off-patent drugs and therefore there is no a priori reason why they should be given high prices and higher profit margins. The prices need and should be decided by the price fixing mechanisms discussed in the preceding chapter. Drugs in the essential list do not lead to such profits. This results in low or no production of these drugs by pharmaceuticals, resulting in serious uncertainties about the availability in the markets. Perforce one has to write an alternative which is new, and hence costlier. Including a drug in the essential list could be the first step for the government to reduce the costs and make it more affordable for the masses. It is also a laudable step to bring the medical devices under the price capping mechanism discussed earlier. No one had thought of this before. Criteria for Drug Selection Before Prescribing: Doctors to Take Note 1. Will prescribing one drug versus another result in a better response to the condition, or only a marginal one or an exaggerated one causing discomfort? If the latter two are the results, why add it?

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2. Can the patient/society (when it comes to some other agency paying for the treatment) afford it? If not, is there an alternative available that is cheaper and equally effective? 3. It is necessary to restore poor people’s health and preserve their financial ability to adhere to the treatment. Keeping them solvent financially for a likely recurrence of the illness of their dependents is an important humanist consideration. Doctors should remember that 40% of families that undergo catastrophic illness are pushed below the poverty line. 4. What is the risk or a likely added discomfort in prescribing yet another drug? Do the benefits outweigh the risks? Answering this question requires considerable experience. 5. Are we prescribing drugs without a thorough bedside examination and history taking and have we really reached the full diagnosis? Is the new drug relevant to the health/disease need and is it a priority? 6. One of the most dangerous outcomes and the proof of the academic failure to upgrade therapeutic knowledge  is the antibiotic resistance that India is facing. There is a fear that we will soon reach a dead end when newer molecules stop emerging. Organisms of all kinds would become resistant to many or most of the antibiotics which we and the world now have. Those people with and without qualifications in medicine, people without any organized support to treat seriously ill patients, as well as qualified people practicing medicine have rampantly and thoughtlessly used every costly and highly effective antibiotic and have brought this situation about. 7. A much larger number of drugs have been included in the list which cannot be sold without prescription which the chemists are following. This is a welcome trend. Prescribing Rationally Manufactured Drugs It is a good idea to define or elaborate the idea of rational formulations and then rational therapeutics. One may argue that this is built into health care and hence that it is not necessary to discuss this. Yet, there is a considerable irrationality in medical practice and this is reflected in the drug industry and vice versa. The most fundamental ingredients of rational formulations are:

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1. Manufacture of a single uncombined drug, in doses appropriately defined by the various pharmacopeia, with standard excipients, additives and formulation technology; 2. Combining only those drugs in a single tablet which have a solid and irrefutable rational basis and trial proofs resulting in greater efficacy than if each drug were used singly; 3. Not to combine those drugs which have different pharmacokinetics and pharmacodynamics, or are antagonistic to each other; 4. This would also mean that they will be sold under their generic name; 5. The drugs in the NLEM have these characteristics. Most of these are single-ingredient drugs. Rational therapeutics may be given a working description or definition in the administration or prescription of drugs described above. This would also mean prescribing drugs only if needed, and for the correct frequency and duration, thus almost ways weeding out combinations. Thus it will also exclude unnecessary drugs which may consist of tonics where no deficiency or therapeutic need has been established for any of the ingredients, or placebo effect injections, saline and so on. Issuing of drugs has much wider implications. Rational therapeutics should be the basis of all these aspects.

Need to Build Healthy Relationships Between the Industry and the Doctors These are the tripartite interests and relationships. The paramount interests are those of patients who should get justice from the treatment. The interest of the pharmaceutical companies is to sell the maximum amounts of high-cost drugs through the prescription route, which brings larger profits. The third interest is that of the doctors in pleasing pharmaceutical companies which give them gratuities in return. However, one must understand that there are other means to maximize the profit for doctors and companies. Prescribing too many long-term and costly medicines is just one way. This, however, may not serve the purpose for long or might only serve it partially, as shown above. In practice, today the patient’s interests have been dispensed with and the other two interests have come to the fore. Admittedly, the aim of every stakeholder is patient welfare. In pursuing better methods, newer drugs, research and efforts to educate, while being

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simultaneously assaulted with cost control and banning of combinations in the interest of patient welfare, will the pharmaceutical industry survive? The answer is a simple ‘yes.’ The industry as well as the doctors will survive well. As a collateral gain the patients will also do better. Under the several measures for cost control described earlier companies complain that their profits are ‘endangered’ or the R&D is affected. The actual profits are spent by the industry in large proportion that undoubtedly goes to providing gratuities to the doctors and raising the salaries of all the employees. Barring a few who spend on research, how much has been spent on research to cry foul that it will be affected? (See the discussion on stents in the preceding chapter.) If the profits are spent on activities like research or education the final profit margin will still be decent. The entire trail of this logic is faulty. Therefore the parties must understand that if they build a more ethical relationship none of them or their interests are going to be harmed. This will be discussed again in detail. Improving manufacturing plants, technology and research of different varieties not just new molecules will go a long way. In the preceding chapter the deficiencies leading to deterioration of quality and huge consequent losses is described in detail. The Indian drug pharmaceutical companies are a major players in the world. For the companies to retain and improve this position these expenditure avenues are useful with far greater profits to follow. These are not idealistic musings, but rather plain pragmatism. One may call it egalitarian pragmatism. The Mutuality of the Warring Factions The parties, the doctors and the companies have together sullied their earlier reciprocal, cooperative, joint relationship, harming patient care. The pharmaceutical companies cannot do without doctors; nor can doctors do without pharmaceutical companies. There is an unfortunate deterioration of this mutual respectful dependence, to detrimental levels. For the sake of patients and health it has to improve. No one side can dominate the other. What is to be blamed? Not profit motive but profiteering. The limits of earning profits with regulated prices have to be set without killing the profit motive. Decent profit is needed to maintain high quality drugs. Freeing markets through decontrolling the prices as seen in the preceding chapter will not work. The lack of availability and reluctance in prescribing generic drugs also adds to profiteering. In spite of the market’s limits of

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affordability, costly medicines are brought in leading to unjust financial demands for patients. Profit motive is fundamental to and the driving force of human endeavor, creativity, self-valuation, power and ultimate satisfaction. Healthy profit motive is the value fixed proudly to his effort by the manufacturer, trading it for equal value that the buyer appreciates and is willing to pay. It is the healthiest trade practice. What Happened to Economies Without Profit Motive? The Russian collapse is not really or necessarily the defeat of communist ideals of empathy for the masses. It is the collapse of an unworkable arrangement based on the non-profit principle. The Chinese Cultural Revolution in 1966 that caused a great deal of misery and death to millions failed due to no personal ownership, attachment or surplus in the new economic arrangement. Will Islamic economics of non-interest banking work on the vast national or transnational level? Why is Sharia being reinterpreted to accommodate the new economies and economies?

Great Contributions of the Pharmaceutical Industry One of the great contributions which is either not realized or derided is doctoral education in business as usual. Pharmaceutical companies have been and substantially even today are the only source of information for the doctor in the interior. This is such a powerful element that harnessing it to deliver proper information and precautions, and to stop improper or inappropriate usage and its future dangers such as antibiotic resistance, should form the content when it comes to detailing in the interior. In the interior it is not the sales pitch and the target that are the goal; this will automatically be achieved. More and more non-governmental agencies are and will be working at higher levels of care in the hinterland in times. They will and do need support from the industry for lower-cost, high-­ quality, rational and generic drugs. This tie-up is urgently needed. Such efforts, however, require a measure often conceived as impossible or self-destructive by the pharmaceutical companies. Each and every company that goes to the interior must have this common understanding mentioned above, and they should be willing to collaborate with each other, and at least sit together to determine if there are common goals. There have been opportunities in my life when such collaborative opportunities

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were created and offered by me to the pharmaceutical industry, but no company, even after comprehending its merit, agreed to rise to the occasion and challenge. However, if doctors rely on the pharmaceutical companies to educate them, there is a bias toward the products they make and the doctor may not really know the truth or at best will be confused. There is a flip side to the education of the patient through the internet. Even this information could be biased toward the company/hospital presenting it. The purpose of providing information to the doctor is to enable him to empower the patient and not to create fear. Instead of empowering, doctors induce fear in the minds of the patients routinely, making them dependent on them. From there on all the other mechanisms that have created the tensions take over. Pharmaceutical Industry and Knowledge Processes Pharma’s contribution to the knowledge process needs to be rescued from the level to which it has fallen. In its early days in the 1990s, its approach was directed toward neutral academics and the betterment of doctors with a clear separation between commerce and continuing education. The industry has not been able to retain this long-term vision nor has it been able to digest the idea that education is one of the best marketing tools if conducted in the right manner. This has happened in spite of clear evidence available in practice. In the section on continuing medical education in the chapter Medical Education in the volume India’s Public health Care Delivery: Policies for Universal Care there are plenty of practical suggestions for the pharmaceutical companies to contemplate and implement. Without doubt it will deliver further loyalty from the profession and give the industry legitimate profits. The educational activities have now deteriorated to a point where doctors are twisting pharma’s arm for self-­ aggrandizement, money, numerous useless conferences and ‘collaborating with Western agencies.’ The Pharmaceutical companies have retaliated by dictating the terms. Is There an Overall Regulatory Failure Regarding the Pharmaceutical Industry? The race is on between the governments which make laws to maintain checks and balances and intelligent people try to bypass bend or differently interpret  the laws leading to lawsuits. It happens everywhere.

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Regulatory authorities keep controlling and keep coming back, even in India. The pace agreeably is slow since there are human failures, greed and corporate scandals difficult to detect or control. The system needs to be strong in today’s unipolar world. A few failures of the regulatory mechanisms are that there is no recourse available to the patient either with the pharmaceutical company or with the doctor when in difficulty. The mechanism available for redressal of adverse drug reaction, to address medical negligence have been laborious in the first and perverted in the case of second. In the economic game the company, hospital and the doctor play, the patient is on the receiving end in spite of paying for both of them. No one seems to stand by him.

Multinational Corporations Multinational Corporations (MNCs) need to be looked at from a different perspective. MNCs are an offshoot of Western culture, embedded in its matrix, and are an integral part of its homocentric culture. It has grown with it. The positives of MNCs are inherent in Western culture: the insatiable curiosity about external life, veneration of the body, experimentalism leading to research that becomes better by the decade in methodology, developing path-breaking drugs, investigative and curative technologies, all geared to the protection of the individual. Western culture is engaged in an inexorable, persistent, untiring effort in pursuit of the secrets of the universe. It has decoded the Secret of Life and is now on the verge of manipulating the highly complex regulation of life itself. There is a stark absence of all this in India. Now MNCs’ technologies follow the true path of science, piecing knowledge together, discarding errors with equanimity, bringing in newer products on trial. They do not hold on to obsolescence. Many MNCs like Novo Nordisk today are environmentally conscious about their production processes. They want to be the best in the business, economically viable, proud of their profits and wish to discharge their corporate social responsibility. In building relationships to take patient care to a higher level some of the negatives of MNCs will have to be weeded out. The aggressive, money powered promotion of drugs, manipulation of research and the research bodies, associations, federations or universities must stop. Promotion of

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the products has to be factual and specifically ethical. The research should be outsourced to independent researchers. At times the MNCs do consciously stay away from site monitoring, and data collection, and leave even analysis to Clinical Research Organizations, declare the conflict of interests so that analysis can be impartial and leave the conclusions to the researcher’s domain. There is much to emulate. Having discussed the players in the arena of pharmaceuticals and doctors it is important to discuss the drugs which are at the center of care and of this chapter. The pages below will discuss a broad array of issues.

What Are the Generic Drugs? Availability and Other Issues Generic drugs have the same chemical composition as branded drugs but are sold under their chemical and not their brand names. To make a further differentiation, any drug which has been manufactured even under a brand name which is not under patent is also a generic drug. In India there were no patent laws (discussed in the preceding chapter) that were proper and relevant to today’s situation until 2005, which meant that anyone could replicate any drug in India without legal ramifications. This led to the trend of branded generic drugs, which make up 99.5% of the country’s generic drug share. However, this is now likely to change (see below). The tragedy unfolded in two ways. The pharmaceutical companies built their brands and gained immense faith from doctors as well as patients in purchasing the brand name drugs rather than buying generically or chemically named drugs. The latter did not even exist and were not widely available, and this is why the top 10 companies have a market share of 37% in India and the top 5 have a 22% share, since they have leader brands. The second tragedy that unfolded was due to combinations of generic drugs under a brand name. The brand names very often read like shorthand and indicate which two or multiple drugs are combined. It is highly inconvenient to write a generic name where two or more drugs are combined; if three or more are combined it is impossible to reduce them to a generic name, thus inevitably making any prescription to consist of brand names only. Thousands of brands with two or more drugs have been added to the market, making generic prescriptions even more difficult (see below). A large majority of these drugs in reality were irrational in combination and composition, and are now banned.

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Building a brand so that the prescriptions are written only consisting of brand names is a costly exercise on which millions are spent. This necessitates a higher price of branded medicine, opening up a chapter of negotiation with the drug controller authorities in India to either give higher prices or to bring the drug out of the price control regime, as we have seen in the previous chapter. More will be discussed here. The Popular Perception of Generic Drugs Any company producing standard-quality formulations should be able to produce the same quality generic drug and give it a generic name. Such a drug could be 30% lower in cost. But the popular perception of the entire medical fraternity—doctors, chemists, pharmaceutical representatives and patients—is that the generic drugs do not have the same quality as branded drugs, are of poorer quality and are less effective. But there are others who say that they are as good as branded ones. Doctors also aren’t aware of the availability of generics due to lack of advertising and marketing and far lower numbers as well as shops selling them compared to brand names. People who can afford branded drugs don’t buy the generics, believing them to be of inferior quality since they are cheaper. Most doctors, except in government hospitals, don’t prescribe generic drugs. In the private sector the prescription of generics is exceedingly rare. Brand names predominated for other reasons as well. Doctors expect chemists to hand over exactly the brand they have prescribed. This is further linked to a commercial equation of keeping exact track of the value of the brand sold based on prescriptions from different doctors. From this the various incentives for doctors can be calculated. Private doctors would never prescribe generic drugs because there are no kickbacks or incentives from pharmaceutical companies. The Medical Council of India (MCI) has tried to stop these incentives but has only partially succeeded in doing so. The Department of Pharmaceuticals has not been able to do anything about generic prescriptions and availability of generics for decades. These actions were initiated by the Central government starting in 2014, as briefly discussed in the previous chapter and will be discussed here in greater detail. India has one the highest out-of-pocket health care expenditures in the world, between 70 and 90%. Despite providing cheaper health  services (compared to rates for countries such as the US and UK) it is still inaccessible to many due to poor purchasing power. The importance of generic drugs is that they are one of the major gateways to reducing prices and

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making health care more affordable for the large non-affording population. The only way to promote generic drugs is to reduce their price with fairness since brand-building exercises are not necessary, and they will still remain much more affordable for millions of people. Large numbers of people will be able to buy them and this will lead to more than necessary, if not exorbitant profits for the pharmaceutical industry. In health care what can make better sense than increasing the ability to purchase drugs by lowering the costs, thus helping numerous people having lower purchasing power to become healthier and still reaping a fortune? Today there are far too many chronic disorders that need extremely effective multi- or poly-therapy on a month-on-month, year-on-year basis. The medical market takes advantage of the rapidly changing and improving economics and hence the betterment of the social situation. It makes them available to a class which does not mind paying considerably more even if it pinches a little. This allows the company to easily achieve and set inviolable profit margins. But the sections of people who cannot easily afford these drugs are still much larger. Cheaper but high-quality generics are not available, and this is why generic prescriptions are not written. Poor people often purchase high-cost drugs as and when they have money. Such patients buy drugs either intermittently or will skip buying drugs for variable periods depending upon money available. Neither practice will result in better control of chronic disorders. Generic Drugs and Lowering of Prices One fallout of selling generic and all single-ingredient drugs sold only under pharmacopeial names will bring forth market forces making branded drug prices competitive. Medicines sold under brand names also have wide variation in terms of the prices of different brands of the same drug. In a price-competitive market, these prices should narrow down toward generic drug costs. All generic drugs should be and are allowed to print the name of the company. The drug activists have accepted this. It must also be ensured in some way that chemists do not dispense costlier generic drugs of certain companies only. One way is for the doctor to write the company/companies name/s after the generic prescribed. This is somewhat tedious. It also means the wide brand price variation should not be allowed in the generics market. This pointed observation has already been partially addressed by the government. The PMJAY, the Prime Minister’s Jan Aushadhi Yojana (scheme of medicines for people) is now widely available with more than

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500 drugs from the NLEM initially, and it is expanding further. These stores were opened primarily in the medical college premises which are visited by the poor. The people today do ask for cheaper brands at the chemist shops if they find a drug rather costly (see below). as they are aware of the Jan Aushadhi stores. This will serve as a partial deterrent to large-scale price fixations for drugs outside the NLEM. Efforts on the part of pharmaceutical companies to sell high-priced drugs will now become difficult. The government has also included over 800 generic single drugs including cancer drugs and devices in NLEM in its second expansion. This has led to reduction in costs at astounding levels. Over 330 FDCs, said to include 6000 brands, have been banned. The government has held onto these changes without succumbing to pressure for over three years now and remains aggressive. These are the clear signals for the pharmaceutical companies to think about in tilting their marketing sails with these new winds blowing. Draft Pharmaceutical Policy 2017, however, has recognized a place for FDCs where a certain rationale exists and allows their manufacture under brand names. There is a high probability that manufactures will try to maintain their FDC brands. This issue has been substantially addressed by the government by eliminating large numbers of irrational FDCs. The issue is not of manufacturers turning to FDCs. Most of what they manufacture will be drugs that have already been banned and are hence illegal. It is the continuance of these banned FDCs in the market which does not seem to have been reduced in any effective way. This needs to be tackled. Patented drugs have been excluded from the requirement of sale under pharmacopeial names. There is nothing much that can be done about it as the legal right under the patent laws lies with these companies, except under extreme circumstances. A Practical Step by the Government of India The purchasing for this Jan Aushadhi scheme will be from both public and private drug manufacturing companies certified by WHO as compliant with Good Manufacturing Practice (Draft Pharmaceutical Policy, Government of India, 2017). The Bureau of Pharma Public Sector Undertakings of India (BPPI) has already floated the tender seeking applications for supply of medicines for the program. It will launch its own Jan Aushadhi stores that will sell these low-cost generic medicines. Experienced and established companies have been making these generic brands for

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export a major revenue earning item for decades now. But these have not been made available in India for poor Indians. The situation should change now. The BPPI will be the nodal agency under the Department of Pharmaceuticals (DoP) for implementing this project. This proposal has been vetted by the Medical Council of India (MCI) and Indian Medical Association (IMA.) Initially, the aim was to set up 3000 generic drug stores around the country since there are so few shops selling generics. The Jan Aushadhi stores were initially run on the premises of public hospitals (state and central) either by the hospital’s administration or a non-­governmental organization. Initially, there was no provision for any private company or individual to open a generic drug store but now the BPPI is looking to involve the private sector and individuals and allow them to open these stores. A Jan Aushadhi website notification is to be issued when such a decision is taken. The scheme expects the doctors initially from the government sector to write prescriptions under the Jan Aushadhi branded generic names. The scheme of Jan Aushadhi needs to be strengthened and should be used to break down the doctor—big pharmaceutical company nexus. This will facilitate the common man being able to buy quality medicines at cheap prices from chemists and druggists from whom the patient should specifically ask for the Jan Aushadhi brand. This introduction will initially cover New Delhi through 800 selected chemists and essential medicines that will include antibiotics, painkillers and vitamins. Besides these, medicines used for treatment of cardiovascular, respiratory and gastroenterological diseases, as well as diabetes, will also be covered. This is a good start in the right direction. It is imperative that simultaneous efforts are made to introduce this on a national scale and bring all the states under the scheme. The introduction could be sequential in all the metros and a strict timeframe set so as to focus on and bring about the availability of Jan Aushadhi availability. The rest of the country will be covered over time. The Ministry of Health in each state must also be given the task of launching the scheme. All druggists and chemists must also display details of the availability of Jan Aushadhi brand drugs. If there is a senior citizens discount applicable, this should also be shown clearly. However, the shift to prescribing generic medicine does not seem to be easy. The following story is frightening. West Bengal pharmacy owners, after a heated exchange, assaulted a group of junior doctors at College of Medicine & Jawaharlal Nehru Memorial Hospital (CMJNMH), a government hospital in Kalyani, on July 4, 2016. The doctors were prescribing

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generic medicines instead of branded names as per the directive. One of the attackers took out a gun and held it to a doctor’s head. Before leaving, they threatened the doctors with dire consequences (Poddar Ashis, July 6, 2016). This illustrates the deep and disturbing vested interest in the undue profits of selling brand drugs only. All government-run hospital shops sell generic medicines at 60–70% cheaper than the maximum retail price. Recently, in a written reply to a query in the Lok Sabha, Minister of State for Chemical and Fertilizers Mansukh L Mandaviya stated that the government is selling generic medicines at prices cheaper by up to 96% compared to their branded generic equivalents, through its Prime Minister’s Bharatiya Janaushadhi Pariyojana (PMBJP) Kendras (centers). The minister also gave a price comparison list. A 1000  mg vial injection of gemcitabine, used for treating bladder cancer, has an average market price of Rs.6412 and the PMBJP price is Rs.631, a saving of 90% for patients (Srinivasan Arun, January 5, 2018). The Status of Jan Aushadhi in January 2018 The government has in principle given clearance to set up 36,000 stores across the country under the Jan Aushadhi project and several memoranda of understanding have been signed in this regard with state governments and non-governmental organizations to promote the scheme. The applications are also from individual entrepreneurs who are keen on opening outlets in various parts of the country. Individual applicants other than doctors and registered medical practitioners should have a B.  Pharm or D.  Pharm degree to obtain approval to start a Jan Aushadhi outlet. All billings should be done using software provided by the BPPI. No medicine can be sold in the store without using the software provided by the agency. From the initial 504 items for procurement the number has increased to 652 medicines, 154 surgical items, and consumables covering therapeutic categories such as anti-infective, anti-diabetic, cardiovascular, anti-­ cancer and gastro-intestinal medicines. Three thousand and thirty-one PMBJP Kendras were operational across the country by January 2018. Uttar Pradesh had the highest number with 472 Jan Aushadhi stores, followed by Kerala with 316 centers. In Delhi, there were 41 stores of which only four were in the public sector. The reach will continue to expand substantially (Srinivasan Arun, January 5, 2018).

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PMBJP in December 2018 In December 2018, the list increased to 800 medicines covering 23 major therapeutic groups. The maximum retail price (MRP) of a medicine sold through the Prime Minister’s Bhartiya Janaushadhi Pariyojana (PMBJP) outlets is fixed in such a way that it is at least 50% below the average MRP of the corresponding top three brands of that medicine. In some cases, the price is fixed at 90% below the MRP of corresponding branded medicines. Unbranded generic medicines worth Rs.417 crore from inception of the scheme util the end of December 2018 have been sold through 4677 outlets under the scheme functional in 35 states/UTs of the country, Mandaviya stated in reply to a question in the Rajya Sabha (Srinivasan Arun, ibid., January 5, 2018). WHO India Head Henk Bekedam has stated that the move, Jan Aushadhi Yojana if successfully implemented, India’s generics project can bring down medicine costs not just in India but globally. Make in India is important as India will be able to produce a greater quantity of good quality generic medicines, which will bring down the cost of medicines globally and more people in India and globally will be able to afford quality medicines. (Henk Bekedam as quoted by IANS | May 24, 2017, 14:37 IST)

Bekedam also stated that India is already the world’s pharmacy, exporting quality generic medicines and vaccines. Foreign pharmaceutical companies, which are major suppliers of branded medicines, will be affected.

Critique of FDCs The biggest obstacle, second only to price and trade, under generics today is the innumerable combinations of drugs, a large majority of which are irrational. If there are two drugs effective for a single disorder which have two different levels of doses for each, this will result in a minimum of four combinations. The pharmaceutical companies want to squeeze out the individual single drug. Combinations can be sold at higher process, notwithstanding the extremely poor rationale behind many combinations. It is for doctors to make it a movement to ruthlessly weed out every such combination not backed by pure and uncompromising rationality. This is an effort carried out by a minority of doctors over decades and has until now been defeated hands down by the combination business.

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The initial ban on 344 combinations was expected to be followed by more combinations. That has happened in spite of the legal wrangles, which we will examine below. There are additional issues involving the difficulties arising due to excessive numbers of brands and combination brands enumerated below. None need arise if we prescribe single generic drugs. 1. It is impossible for any doctor to remember all the brands along with their ingredients with their dose variations. Hence if for any reason some other doctor is to treat such a patient, comprehending the treatment being received will be close to impossible. 2. This will also lead to missing out on some aspects of the earlier treatment. There may be no instruction about other medicines from an additional, usually a specialist, doctor who has prescribed medicines on a long-term basis. These medicines may inadvertently continue or be deleted by the next doctor or similar drugs can be prescribed again, which will lead to overdose. 3. At present, doctors do not spare much time for the patients. Sorting out these drug issues in the drug history is never a priority for them. Repeated interactions of this nature will result in evergrowing unintelligible prescriptions and investigations, leading to confusion, an unclear medical situation and distorted syndromic presentations a patient is mainly suffering from. This does not lead to either cure or any further understanding of the patient about drug-to-drug interactions, let alone achieving a healthy status through treatment. 4. Brands written by super-specialty consultants add to the woes of the patient. Each one will write his own prescription. No one will bother about whether anything similar has been prescribed by another specialist. Diabetes and the mandatory treatments that have evolved with it, overlapping the fields of cardiology, neurology and endocrinology, is a classic example. 5. Many of these brands are local market brands. They are not available anywhere else in the country. This factor arises out of the innumerable pharmaceutical companies operating in small geographic areas of India. Their prescriber base is often fixed and committed to writing what these companies manufacture. The trouble starts when the patient goes out of the territory and seeks medical help.

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6. If there is drug intolerance it will be difficult to sort out which of the combination drugs is responsible. 7. If there is more than one combination used, identification of the troublesome drug will become even more difficult. 8. In such a case the combination will be withdrawn and one drug after another will have to be prescribed to see which one is causing the troublesome side effect. Until this is determined, the  second drug with or without the troublesome effects will have to be reintroduced in some other form of combination or singly. 9. When many combinations are used the withdrawal of one of them will/may affect the schedule of others and the whole prescription will have to be restructured. 10. Hence removing such combinations or one or two ingredients will be cumbersome since this affects many other drugs also. 11. The drug quantum delivered at one time is large, which is likely to lead to intolerance and subsequent discontinuation of not just one tablet but up to three or four drugs. This can be disastrous. 12. By the time this happens the basic syndrome for which the patient has sought medical help will have changed so much that one would not know what is being treated and what other different conditions have arisen. Many such conditions/symptoms will then be iatrogenic, that is, arising out of treatment. 13. It takes a lot of time to rationalize this state, and few doctors bother to do so or are incapable of doing so willingly. 14. If one of the ingredients of the combination needs a change of dose or formulation or timing, and not because of side effects, being in a combination will hamper this single quick change by spliting the two drugs and prescribing them separately changing the dose of one. In case one of the two drugs is producing side effects it will result in the same cycle of changes described here. 15. This is not desirable but happens all the time. It is also true that one who thinks of these considerations will probably not prescribe such combinations. 16. The large-scale alteration of the prescriptions every now and then, burdens the patient with the additional task of memorizing a new drug routine and deleting earlier drugs. She has to build the drug schedules into her own system and daily life. 17. This is particularly dangerous since stressed patients are not known to be good listeners, are often bogged down by the burden of their disorders, or are too sick to comprehend these changes. Patients’ interest, disinterest, intelligence levels and language dif-

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18. 19.

20. 21.

22.

23.

ficulties will add to the confusion, making the entire process overly complex, and will result in suboptimal therapeutics for a long time. This will invariably result in drugs being taken not as instructed but as the patient remembers, which is almost always unreliable. Doctors should think about these situations to verify their own experiences in handling patients who they have been seeing for years. Doctors must also remember that by using combinations they are violating the principles of pharmacokinetics and pharmacodynamics of the drugs. Respectively, these two terms mean the travel of the drug through the body and the effects of the drug on the body. If attention is not paid to these aspects trouble-free control of syndromes will always be suboptimal. What will happen to the discarded drug/s the patient has purchased at higher cost? These continue to pile up in the patient’s home and money is wasted. Why should two drugs be administered when one drug in its sub-­ maximal dose may be sufficient? If synergism is already proved between the two drugs combined, has the prescriber tried these two drugs independently and sequentially or together to reach the sub-­maximal doses of each (as is the dictum in diabetes treatment at least) before combining the two together? The answer to these questions is a resounding ‘no.’ No one does that. No one thinks about these matters since no one has the time. The final test comes at this point. Does the combination achieve the ideal, inadequate or excessive control, putting the patient in lot of difficulties with the latter two? These are not theoretical matters. In reality millions are suffering on this count as these lines are typed. If one desires to achieve all these goals, generic single-drug prescriptions are the only way.

Non-Infectious Disease Preponderance, Polytherapies and Drug Combinations Today in India non-infectious or metabolic diseases cause far more deaths than communicable diseases were hitherto. We also have the massive

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burden of diabetes. There is abundant evidence like that from the United Kingdom Prospective Diabetes Study trial that many diabetes-related complications such as elevated blood pressure, hyperlipidemia, widely prevalent neuropathy and nephropathy, eye disorders, diabetic foot problems and cardiovascular diseases could be present at the time of diagnosis of diabetes (Paromita King, et al, UKPDS 1999). These are killer complications singly or in combination. Eighty percent of people with diabetes die due to cardiovascular involvement. All these factors need pharmaceutical intervention among many other measures to control these complications for secondary and tertiary prevention. Secondary prevention is stopping the complications inherent in a disease like diabetes. Tertiary prevention is reducing the speed of deterioration from these complications if these do develop to avoid severe morbidity and mortality consequences. There is abundant evidence for achieving these goals which will lessen both. A number of different classes of drugs need to be given to people with diabetes with risk factors. This results in polytherapies with a large number of drugs. Under the spacious plea that a large number of single tablets are the significant factor for non-compliance, the pharmaceutical companies vigorously promoted combinations. The companies drastically changed their formulation pattern, leading to the combination of as many drugs as possible in as many permutations and combinations across these classes in single tablets. The golden rule that any combination of drugs is irrational unless proven otherwise was conveniently forgotten. This is indubitable, but for a quick summary as to why combinations are irrational the following may be noted. The all-important factors mentioned just above and the 23-point list of shortcomings of the combination drugs and unwelcome results that follow were completely ignored. Irrationality of Combination Drugs Combining drugs from two different classes for a particular disorder violates the fundamental principle of each drug having its own pharmacodynamics, pharmacokinetics and timings. This is why individual drugs have to be applied individually to take advantage of these aspects. This relates mostly to the time of day and the related conditions. When drugs are combined this most valuable advantage is taken away. It does not achieve the indices or the criteria of good control either. It is here where the main objection to the combination of drugs lies.

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There are many complicating factors and issues we have less knowledge about when it comes to bio-availability for a desired length of time. This is the final test of a well-formulated drug. The evidence for bio-availability will be briefly discussed below. The bio-availability of both drugs combined in one is also extensively discussed in India’s Public Health Care Delivery: Policies for Universal Health Care in the section on the Revised National Tuberculosis Control Programme, with some shocking observations (Kelkar Sanjeev, 2020). Some Examples with Respect to Pharmacodynamics and Kinetics The sulphonylureas are combined with metformin, in all conceivable combinations of dosages of the individual drugs, with different dissolution times. In many such combinations, the formulation techniques change the duration of action. The manipulation, it is claimed, will give better results and make them more appropriate as combinations. The controls resulting from these combinations are dismal, in hundreds of cases. Split the two and use them separately according to their pharmacokinetic and pharmacodynamic properties, changing the timings according to meal quanta, and the same drugs act wonderfully. I am privy to this, having spent my career in diabetes. In case of a combination of or more than a couple of drugs from different classes of antihypertensives, patients reel under the related lower(ed) blood pressure. They somehow tolerate this but the clinicians do not seem to take notice. Joint National Commission (JNC) criterion of blood pressure to be lowered to 135/85 mm of mercury in all patients, as evidence based, prevailed for the last 20 years. JNC however had also stated that such a lowering should not be accompanied by side effects. Twenty years later the same JNC says that there is no particular need to lower the systolic pressure in the elderly below 150 mm of mercury. This is something which physicians of my generation and earlier generations have known for over four decades. How far are we going to go blindly? And does the JNC state that even if there are side effects of lowering blood pressure to the earlier levels it must be maintained at such low levels? No. Thousands of combinations have caused an extraordinarily large number of people to consume two or more drugs where one drug could have worked adequately, exposing them to a stronger synergistic effect than is

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desirable, which affects the day-to-day quality of life. There is universal exposure to the second drug even before the requirement of an additional agent is established. These combinations make it difficult to tailor the treatment to specific individual factors by using drugs individually. This type of prescription practice of many combination drugs produces lethargy among the doctors to split the ingredients and use them more rationally at certain times. This necessitates a change of the entire prescription. At other times the combinations will continue. When these matters are not consciously recognized by doctors, so much effort to keep patients at least trouble free if not fully controlled is not expected to be undertaken diligently and vigorously. This discussion should show clearly that in practice combinations do not serve the original purpose of reducing the number of physically separate drugs. They are continued under the pharmaceutical company’s pressure or lures to prescribe a higher number of drugs, which in numerus cases are uncalled for. There are several such drugs marketed under the so-called evidence base of the active ingredients, helping to mend some of the distortions in small ways. It is doubtful whether there is a quantum difference regarding any drug used extraneously or additionally in a syndromic disorder with multi-organ involvement. The evidence is scarce. Measuring the appropriateness of such additions is extremely cumbersome and is a time-consuming process requiring certain technological sophistication. In addition to this tablet reduction goal the formulation technology has made some inroads by way of attempting to change many short-acting molecules into a slow-release variety. Except for a few drugs countable on the fingers of one hand, there is no evidence to show that the changed property of the molecule in any way makes it better. In approving such modifications to be marketed widely, no evidence appears to have been freshly sought or developed to show that such a change is desirable or needed and whether these changes actually happen or not. The overwhelming experience is that they do not work to keep or bring the parameters under optimal control. The motive behind bringing about all these changes in therapeutics is not just the pristine one preached by the pharmaceutical companies of better treatment modalities. Each of these entities means a different brand name. Changing the pharmacokinetics also has the same motive; it can be

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sold at much higher prices, the brand can be built as a better brand and the costs escalated to earn a higher profit. This proliferation of the numerous brands essentially negates any possibility of prescriptions under the generic name. The last and the most surprising practice is to prescribe a drug twice in a day but use two different brands for the same compound and the patient never being told about this. Aside from other mundane effects described below, the possibility of somewhat different pharmacokinetics of the two brands may seriously affect a continued well-controlled state of the condition being treated. The non-availability or the not-so-easy availability of one or both of the brands will make the patient go to several shops to get it. The chemist may not know and hence cannot say or would prefer not to say that the patient can take the morning or evening brand both times if one of them is not available. This will be done under the pretext that he cannot change the prescription. Very righteous indeed. This practice satisfies two companies adequately enough to offer such doctors other incentives like travel abroad in the name of conferences. One important aspect of these frequently prescribed combination therapies is the tacit agreement that all the risk factors are universal and require treatment all the time. Gender, family history, age, phenotypical differences, habits, social status and level, outlook toward the disease, affordability of the treatment and being monitored frequently (at high cost), the results of the subsequent monitoring, and purchasing power are not considered. The limit of control of the parameters even in older age is considered to be the same as in the young, which is detrimental. This should be relaxed a little. These factors and monitoring should in fact be the greatest modifiers to lead to minimization of the number of drugs prescribed. All patients are not identical. The doctor should put in effort in determining what must be treated and for how long and how intensively. These are unanswered questions because today the clinicians do not ask them. Theirs has become a reflexive, knee-jerk practice method. This sad picture has emerged out of the depressing reality that an averagely trained or even specially trained doctor has never developed the ability to critically evaluate the so-called evidence produced by research. During their training they have never been systematically taught how to evaluate evidence and determine its place in the overall context of the disease.

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Box 5.1  Pharmaceutical Industry and Clinical Medicine

The Cochrane database is the ultimate judge of the therapeutic options. I explored the evidence and opinion of the Cochrane database, for a few combination drugs. I did not find any trial in which two drugs were used simultaneously in either arm or in which two drugs were used as a combination. In fact the largest of the trials, such as UKPDS, which has produced path-breaking evidence for therapeutics, have never used combinations. As a result we are forced to accept that there is no hard evidence to support the idea of drug combinations. One simple matter will explode the lack of evidence status: How many such combinations have been promoted to us doctors by all the companies in the last 20 years which have received justification from the Cochrane database? I am sure that the medical departments of pharmaceutical companies are wise enough to know the importance of this database.

Box 5.2  Pharmaceutical Industry and Clinical Medicine

There are around 1500 scientifically proven drugs mentioned in standard medical textbooks, out of which there are around 400 essential drugs, out of which only about 40 to 60 are rational fixed dose combinations (e.g. iron-folic acid, estrogen-progesterone contraceptive pill, and the penicillin cephalosporin group of drugs with clavulanic acid or tazobactam to make them effective against resistant bacteria). Development of congeners in a class is made easy by the high-­ throughput technology and these are produced in high numbers. But these are not far more effective drugs and are not necessarily better niche products, as they are made out to be during promotion. By almost a rule of thumb a blockbuster drug is a five-year phenomenon. And this is where the whole business of modified drugs has become a condemnable issue.

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Chronic conditions treated with ill-combined drugs gradually become worse and then go beyond redemption. Antibiotics resistance is one of the effects of irrational therapeutics. To obtain a recent view of what has been reported on antibiotic combinations, the following will be of help. The report, by researchers at Queen Mary University of London and Newcastle University, states that millions of antibiotic pills in the Indian market have not been regulated in India, the UK or the US (Canton Naomi, February 5, 2018). It found that out of “118 different formulations of Fixed Dose Combination (FDC) antibiotics being sold in India between 2007 and 2012, 64% were not approved by the Central Drugs Standard Control Organization (CDSCO.)…. and were associated with antibiotic resistance [which is] high in India.…” (Canton, ibid.). Only 4% of the FDCs with two or more drugs in a single pill were approved in the US or UK. The FDC antibiotics are sold under more than 3300 brand names made by nearly 500 pharmaceutical manufacturers, of which 12 are multinationals. This research was published in the British Journal of Clinical Pharmacology. It is hoped that this battle to weed out irrational combinations will be won with the Central government banning 344 combinations involving a prima facie loss of Rs. 3000 crore for the drug industry. The Health Ministry is now examining 1700 more products to decide if they are safe and efficacious. If the outcome is in favor of banning these drugs, it will shake the foundations of the industry upset over the ban of just 344 drugs (Prabha, 2016). “Cleansing the system is important. We cannot have the tag of a country that manufactures irrational drugs,” the Health Ministry official on condition of anonymity told the health reporter Prabha Raghavan of the Economic Times. Box 5.3  Pharmaceutical Industry and Clinical Medicine

The majority of the drugs available are irrational fixed drug combinations. The alternate or flip side is the professional training that is sorely lacking for specific use of specific content. For this to develop, a sound process of clinical reasoning needs to be in place. Otherwise using multiple drugs will lead to blunderbuss therapy. This means that the prescriber has not made or has not taken pains to make a precise diagnosis and has put together many differently acting drugs thinking that any one or two will act and produce a cure—even if temporary. Temporary cure means the patient will revisit. That is a delight to the doctors.

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The Ongoing Fight Against Fixed Dose Combinations (FDC) and the Legality Over It Drug activists have been demanding this for over three decades. The long-­ held view was that these irrational combinations have dangerous side effects, are not accepted elsewhere in the world and many of these combinations do not have any advantage over the individual drugs. Finally, the first government to act upon them was the one installed in 2014. The opinion of the Kokate Committee which recommended the ban was accepted. Three hundred and forty-four FDCs of 6000 medicine brands were banned (ET Bureau | December 1, 2016, 13:37 IST). In November 2016, the Delhi High Court quashed the government ban, stating that the government action was taken in a “haphazard manner” (Ghosh  Abantika | December 2, 2016). Pharma companies also argued that the center did not follow the procedure in the Drugs and Cosmetics Act. Additional comments of the Court questioned the competence or jurisdiction of the technical committee vis a vis the provisions in the Act. The rather surprising Court observation was: What is the urgency to do so when these combinations have existed for decades? This last question does not do much service to the Court. It is sad that the Courts are deciding on what is patently out of their competence and hence not acceptable. Undeterred, the Health Ministry banned 80 more fixed dose combination drugs on the recommendation of the Drugs Technical Advisory Board (DTAB), which came into force on January 11, 2019 (PTI | January 18, 2019, 07:57 IST). Antibiotics, painkillers, anti-fungals, hypertension and anxiety-related drugs came under the ban. It specifically prohibited the manufacture, sale and distribution of these drugs. The total number of banned FDCs now stood at 405. Along with these, another 325 drugs were banned in September 2018. A legal challenge was mounted by the affected pharma firms. In September 2018, the Supreme Court allowed the sale of 3 out of 325 drugs. The Legal Wrangles With so much money and ‘health of people’ involved, a stay order given by more than one High Court was anticipated. The Madras High Court issued one such stay (Times News Network, TNN | March 23, 2016). The Courts questioned the validity of the ban on the basis of whether the states had approved the combination or whether it was approved by the center.

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The Courts argued that the ban was illegal if the Central government had not approved the drugs it was banning, and if the states had approved the same drugs the center has no locus standi to ban them. With due respect to the Courts this is a strange logic. Coming from a particular court does it look more routine? The stay order was issued swiftly less than 24 hours after the petition was filed. This shows how alert the courts are to health issues while hundreds of thousands of cases are pending for years in the same courts. All these stays or remarks or decisions of various courts are either based on technicalities or are ignorant of what the medical profession understands about these as harmful. Some pharmaceutical companies have received temporary relief from the Courts. Several others are planning to challenge the legality of the government decision and selective interpretation of the clauses that empower the Health Ministry to prohibit marketing drugs in the public interest. The Health Ministry officials have stood firm on the legal grounds of the action taken. The Central government has so far held the fort and will have to be ready for a pitched battle. Some Biological Issues with FDCs Any manufactured drug is finally judged on its bio-availability. Bio-­ availability depends upon many factors, such as tablet compression, the staying power of the drug itself, dissolution time, particle size it attains after dissolution, non-interference from excipients and hygroscopic potential. It should be thoroughly tested on samples before being approved or if there is a change of formulation process or excipients. The documentation has to be careful and is voluminous and submitted to the Drugs Controller General of India (DCGI.) It should demonstrate that the conditions have been met. The approval issue becomes much more complicated if more than one drug is present in the proposed formulation. Now the market has been flooded with thousands of such drugs by hundreds of different companies. Would all of these have carried out the studies in detail to get the permission? Bio-availability studies are carried out at a cursory level in India. How do we ascertain that the multiple ingredients have not reacted among themselves and formed a new compound? If so, then is the result consistent with all the drugs with the same combinations? If not then why is this interaction present in some but not all brands? Or has the drug after the

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interaction become inadequate in quantity alone, or has it changed, or have all others in the combination also changed? How many of these hundreds of companies have the wherewithal and money power to take all the trouble and expense to get their first license? To answer these questions sophisticated analytical laboratories are required, which at present India does not have. Until then the quality and efficacy will remain an unsolved issue.1 While exporting drugs to regulated markets like the US or Western Europe, bioequivalence is to be proved in the existing as well as in the new drug entity. That is the guarantee of drugs being available in the human system adequately. The combination drugs are treated as a new drug entity, and advanced clinical study data need to be produced and reviewed by regulators, to see the effects of the combination drug and its interactions in humans. For this to happen there should be adequate quality control standards and review methods available in the company. Since the cost of the clinical trials is enormous this will make the combination drug economically unviable. This is why there is leniency among drug regulators in this area in India. The inspectors from the importing countries usually make a surprise visit and check the procedures, contrasting with the not so scrupulous Indian regulators. The companies selling drugs in regulated markets produce high-quality drugs even though the price of the drugs being exported falls drastically every year. The same drugs in the Indian market may not have the same standard.

The Approval of Drugs The processes of making a drug ready for approval if properly conducted would be accompanied by truckloads of papers which deal with the other aspects such as clinical trials, toxicity studies and animal studies discussed in the next chapter. How far have these papers satisfied the testing of these issues? It is difficult to imagine that each company in the last 20 years specifically registering a combination drug in its product mix has prepared 1  This is a serious issue. Evidence is present in the case of rifampicin—isoniazid combination used for tuberculosis as the first-line drugs. Interaction between these two has led to deficient bio-availability. In turn this could have led to unsatisfactory cure on one hand and development of XDR (extensively drug resistant) tuberculosis on the rise on the other. A detailed discussion on this can be found in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one.

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authentic reports, or that somebody in the DCGI has had time to find the submission genuine. It is also likely that the figures could be extrapolated by a multiplier factor at the study level to show the desired result. The companies will seek approval on the basis of an identical compound and identical methodology of formulation as submitted in the past. And the approval will be based on this assumption—if this methodology works, the same one here should also work. If this drug license has approved the drug recently or many years ago, if there are no patent issues, this drug should also get approval. This is how ‘me-too’ drugs and combinations proliferate in hundreds and not dozens. Most of these drugs are out of patent, and hence the approval has to have a basis in the past evidence or pure clinical reasoning in the submission. Once one such drug is approved and all the detailed reports are submitted, the floodgates are open to approve a thousand similar ones based on the demand or proposition of the basis of earlier approvals. The provisions available should first be looked at in approving claims. Answers to all these questions can be found in those provisions (the Drugs and Cosmetics Rules, 1945, as corrected up to November 30, 2004). The argument of the companies will be somewhat like this. FDCs including individual active ingredients have been widely used for years. There is a necessity to use these drugs concomitantly. The claim is also about the convenience since polytherapies in many cases are necessary. The ingredients are unlikely to have significant interaction and a stable acceptable dosage is offered based on past experience. The requirements of approval are as follows: “Additional animal or human data are generally required for the FDCs, for marketing permission if the FDC has an acceptable rationale, or if the active ingredients have already been approved/marketed individually when combined for the first time. In case of obtaining permission with a proposed change of the ratio of active ingredients or to make a new therapeutic claim or a new drug for which permission is being sought, these drugs are expected to undergo a clinical trial in India. However, these requirements can be relaxed if adequate data on safety is given from already available data.” The last proviso answers how the numerous ‘me-too’ drugs have entered the market. Clinical Trials and Evidence-Based Medicine vis a vis Approvals My experience of working with clinicians dealing with chronic or acute care in recent years is that they rely on guidelines issued by various

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international bodies. The tendency is to consider these sacrosanct. The inference can therefore be drawn that perusal and evaluation of high-grade evidence is on the decline or is rare. There are associated issues about use of guidelines which affect practices in some unexpected ways. The latter is discussed thoroughly in the next chapter. Here I feel it necessary to briefly discuss evidence itself to emphasize that finer and final practicing methods must evolve from the high-grade evidence and not guidelines. The best and the most rigorous form of randomized trial is a double-­ blind, active comparator crossover one with a washout period in between. IA evidence is counted as the best—the meta-analysis of a number of similar randomized clinical trials. These are strict and clear-cut in their conclusions and help to make clear-cut decisions. IB is the evidence of a randomized well trial as above. From then on, depending upon the rigor of the trial being single blind, open label, observational studies and so on, the rigor of the evidence progressively declines. The expert opinion, that is, the guidelines, come as the last and lowest-weighted evidence. Within the trial spectrum the purposes for which these are conducted can be differential and graded, especially regarding newer drugs. Safety of the Trial The expert committee must be fully satisfied with the documentation on the safety of a new drug. It is only then that the drug can be given permission for marketing. If the new drug is thought to be superior, this has to be demonstrated in various ways. Non-Inferiority Trial for Drugs By definition this is an active comparator trial. It rules out placebo trials completely. In any case, today when numerous drugs in different classes are available to treat various disorders. This effectively brings the value of placebo trials to almost zero. Non-inferiority is about the effects of the new drug or the side effect profile being the same as the older established drugs. Whether such a drug should be added to the armamentarium of a country where the older drugs are well established is a policy decision. Such an admitted drug should preferably undergo larger trials in the new population. There will always be a possibility that some aspect superior to the existing drugs of equal efficacy may get discovered in the new drug.

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Establishing Superiority of a New Drug The superiority is not just in terms of efficacy. It can also be about a much smaller problem or a much less frequent profile of side effects in case of particularly bothersome reactions. Even a difference of 5 to 15% could be considered more advantageous. Applying the results of a trial to a different population to one’s own on whom the trial was conducted requires some caveats to be added. Ethnic differences and other differing conditions could throw up different conclusions for better or worse, which makes decisions on allowing newer drugs for a different ethnic population more appropriate, easier and more solidly justifiable or they could be rejected. Without these steps the net effect would generally be to expose the population to a new, much costlier, drug without any added advantage. Not all new drugs are blockbusters. In the absence of these steps the conclusion can be drawn that permitting such drugs will help in the recovery of research expenses, may acquire a monopoly or may achieve some other objectives at the cost of the untested population. A new drug in India has a tendency to become permanent even when serious side effects are discovered, and even if the drug gets banned. Hence, maximum care should be taken at the introduction level. In approving these drugs there should be mention of the time for which it is approved, of conducting a valid trial within a stipulated period, and of when to seek further approval. In India if these caveats are not applied the motive could come under a cloud of suspicion. India in fact is an ideal fit to conduct trials given its diverse pool of patients with varied treatment needs in fair to adequate numbers and access to a large, scientifically skilled workforce. For these reasons investigators have been coming to India for over two decades, leading to growth in this area. Clinical Trial Quality There are various ways to judge the quality of a trial. For that the clinicians must become familiar with the ways of reading research, discussed in the next chapter. It is ideal for a professional caring for a large number of patients to get involved with trial work for their growth. A brief description of trial quality is given below. It is a matter of who designs, who executes and who interprets the data.

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The trialists must understand that what has been prescribed to be done in the trial is not discretionary but demands blind adherence to the procedure. The designs are finalized with great care and discussions are acceptable until that stage but not after. Some companies remain involved in the sponsored trial, and these may have well-trained people responsible for executing it, helpful in handholding, especially for new trialists; quality control of the conduction of the trial by visiting the sites; checking the records; monitoring data entry; deciding on gaps as permissible to be filled or to disqualify a patient, and so on. This still leaves a small entry point for bias, the killer of any credibility in trials. Today the trend is to design the trials at the transnational or headquarters level, transferring the execution to reliable contract research organizations, (CROs)  and its  interpretation to independent  agencies.  This separation is considered desirable to avoid any manipulation and/or prevent bias from entering the trials at all costs, and to improve the trial quality considerably. Indian professionals were slow to understand the core of this type of research, for which rigid standards were being laid down and the process and the procedure were being improved over years. The clinical trials prior to 2007 were largely a matter of the investigator and the content research organization employed by the company. This could lead to non-rigid execution of the trial, bias and falsification, affecting the validity of the data and conclusions. In 2007 the registration of any trial was made compulsory. Now the trials have to be approved by the recognized permanent ethics committees. Ad hoc committees cannot be founded for a particular study. There were procedural changes to reduce the chances of manipulating the patients into signing onto something with potential risks of varying magnitude or even regarding the understanding of how he is expected to perform during the trial. More attention was paid to the compensation of the patients, including their risk coverage. This, however, has led the pharmaceutical companies to shift the trials to South American and African countries where the regulations are not strict. This was tantamount to patients being used as guinea pigs, with no concern shown about the possible adverse effects and meagre patient compensation. It is retrogressive and has raised various concerns.

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Clinical Trials and Compensation This is something the professionals also must know about. Since 2005, in over 17,000 drug trials an estimated 5000 patients died across the country (Mustafa Attar Mirror Online | January 21, 2019). Hundreds of patients were diagnosed with cancer, paralysis, asthma and skin-related diseases, among others (Amulya Nidhi, The Indian Express, Jun 2, 2018). In 2013 the provision for compensation was uniform for any injury to the trial subject irrespective of its causality. The government made these changes to the Drugs and Cosmetics Act, 1940. However, to date, only 508 affected people have received compensation. The blanket compensation was one of the factors keeping sponsors away. Now the compensation is made commensurate with the severity of the injury (Thatte Suneela, June 2, 2018). It is now compassionate and quick, staged to decide that the death was due to trial, the interim 60% compensation not to be returned and was over and above the medical expenses incurred during the treatment. The objections raised to this also included the following: 1. Many sponsors may consider these clauses unacceptable, which, put bluntly, suggests that they really do not care what happens to the patients and are not interested in spending more money and making the trial costly. 2. International ethics committees do not make such decisions. 3. Their lack of expertise in such issues would be an unfair burden on those sponsoring the trials. 4. If it is not reconsidered it will drive away the drug firms. 5. India will lose big money. 6. Most ethics committees in India are not appropriately trained in this area (Thacker Teena, July 10 2018). This illustrates how difficult it is to balance fairness, science, costs incurred and research. It also shows how the money consideration drives the otherwise multimillion dollar trial business. There could be methods for determination of the compensation quantum in trials where the potential for death is high but the expectation of success could be low, as an answer to the objections raised above. 7. “That such clauses will also hamper WHO’s work with India to conduct clinical trials on a particular condition … as a public health

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priority. (In that case) WHO may be unwilling to act as sponsor. The other partners may be similarly discouraged” (Thacker, ibid.). Many conclusions from these veiled warnings need not be elaborated further.

Fast-Track Designation The drug development enterprise may come up with promising drugs fulfilling several needs. There must be some mechanism to bring these drugs up for consideration as soon as possible. The fast track approvals of USFDA provide a standardized way through four avenues, detailed below. To enter this path the drug developers, by presenting non-clinical/clinical data, demonstrate the drug’s potential. Fast-track Designation: To qualify, an unmet clinical need should be satisfied by the drug, or provide a marked benefit for patients intolerant to the current available therapy, or deliver a significant improvement over it or produce a similar benefit with less toxicity. For full advantage, drug developers should submit requests before their pre-New Drug Application (NDA) meetings with the FDA with such data. Breakthrough Designation: To qualify, the preliminary clinical evidence on the drug must indicate substantial improvement over the available therapies. The FDA then gives the developer access to intensive guidance on how to best expedite the development. Accelerated Approval: To qualify, the drug should show a meaningful advantage over available therapies and deceleration to an irreversible stage of the disease, before entering this pathway. Priority Review: This applies to drugs that offer a significant improvement in safety or effectiveness, guaranteeing a review in six months for the marketing application, which may take 10 months. Fast-Track Approvals and the CDSCO The Central Drugs Standard Control Organisation (CDSCO) was characterized by Dr Harshvardhan, the India’s Health Minister in 2014, as a snake pit of corruption (Pulla Priyanka, 2014). The way it functioned from 2008 to 2013 more than justifies this remark. The functioning of the CDSCO is also in total contrast to the way the USFDA works on fast

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track. Some examples are shown below to make the clinicians aware of the risks of using such drugs approved by the regulator. Despite strong warnings by the Parliamentary Standing Committee (PSC) on Health and Family Welfare, the CDSCO continued to approve new drugs without holding any clinical trials on Indian patients to test their safety and efficacy. The parliamentary panel had exposed the approval of 38 new drugs without trials on Indians between January 2008 and October 2010. In spite of this, two years after that the CDSCO approved 26 more new drugs without local trials. The committee pointed out that these drugs did not even fall in the category of medicines for emergencies. As many as 35 new drug molecules were approved in 2013 alone. As many as 56 new molecules have been approved without clinical trials in India, and as many as 17 drugs have been approved for additional strength or additional routes of administration, for which there is no conceivable rationale. As many as 22 have been accepted for a new indication. While 8 new drug molecules of biologicals and non-biologicals were approved in 2013, 2 were allowed for sale in 2015 (Economic Times, January 5, 2015). This is a disturbing level of corruption. The CDSCO is also guilty of creating a maze of multilevel committees to deal with different types of drugs that need to come under trial (Ramesh Shankar, October 30, 2014). This is how a slew of drug approvals came about. Ethical matters are important, and allowing a drug to come in without testing by exposing the population to unexpected disastrous effects is amoral. The pharmaceutical company’s behavior, criticized especially by the health activist medical community, may appear exaggerated. In the game of sanctioning mentioned above the companies are also a guilty party. The safety and other issues are worked upon with extreme caution in the developed world, while most developing countries struggle with effective implementation of the good clinical practices. The officials of the health ministry have given explanations that are utterly unconvincing and in total contrast to the findings of the PSC. The change to insist on clinical trials as a result came after the government changed in 2014 with a proviso to relax this condition if (adequate numbers of) Indian patients are already included in trials abroad. Approval of a drug by USFDA will not be the basis for introducing a new drug unless it has been tested on Indians. The decision was taken by the technical committee in the public interest (Dey Sushmi, October 11, 2017).

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Clinical Trials and Data Security Data in any systematic enterprise is confidential and sacrosanct. In clinical trials massive data transfers occur to and from the CROs, central laboratories and so on. Trustworthiness of data being shared among stakeholders becomes a crucial question. Such data has been stolen in the past. As a result drug regulators around the world have started questioning the authenticity of data being produced for regulatory approvals. Blockchain technology in Clinical Trial Area is a useful tool to protect the confidentiality as well as the veracity of data at each stage and step the data is collected. Every process of data collection can be subjected to its tampering. Blockchain in clinical trials can provide transparency and traceability of consent by a mechanism which cannot be falsified. Smart contracts arising from within the Blockchain can help to keep the process flawless. It thus helps in improving the quality and reliability of Clinical Trials data. The complete planning and execution can be carried by blockchain by leaving limited specific access to any data handler which then cannot be tampered (M. Benchoufi and P. Ravaud, Trials, 2017). Unpublished Clinical Trials Half of the registered trials and the data collected therein do not seem to come to the knowledge of the concerned people. Negative results which do not add to claims on drug merits or results which show inferiority of one over the other may be the reason for this. A negative result is also a piece of truth. To overcome this, some of the world’s largest funders of medical research, the Indian Council of Medical Research (ICMR), the UK’s Medical Research Council, PATH and the Bill & Melinda Gates Foundation, have decided to make public the results of all clinical trials (Dey Sushmi, May 25, 2017).This is necessary for clinical care practices and to decide about allocating resources for future research (Dey Sushmi, May 25, 2017). Unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices. This can lead to the use of suboptimal or even harmful products. There should not be any further excuses for not reporting on clinical trials. In conclusion, this chapter acquaints the professional with the nature of activities of the pharmaceutical companies and the governments, for them to guard against these, facilitating their work and knowledge level. The aim of the chapter is to describe and defend the many steps taken by the

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government where the pharmaceutical industry and clinical medicine coalesce. There still are many other issues which clinicians should know about, and these will be discussed in the chapters to follow.

References Pulla Priyanka, BMJ 2014; 349, https://doi.org/10.1136/bmj.g4762 (Published 22 July 2014) BMJ 2014; 349:g4762 LOCOST/JSS Vadodara, Impoverishing the Poor: Pharmaceuticals and Drug Pricing in India 2004 Draft Pharmaceutical Policy, Government of India, 2017 Ashis Poddar | TNN | Updated: Jul 6, 2016, 10:34 IST Arun Srinivasan, New Delhi Friday, January 5, 2018, 08:00 Hrs IST Henk Bekedam as quoted by IANS | May 24, 2017, 14:37 IST Paromita King, Ian Peacock, and Richard Donnelly. The UK Prospective Diabetes Study (UKPDS): clinical and therapeutic implications for type 2 diabetes Br J Clin Pharmacol. 1999 Nov; 48(5): 643–648. PMCID: PMC2014359, PMID: 10594464 Canton Naomi | TNN | February 05, 2018, 08:03 IST Raghavan Prabha | ET Bureau | Mar 16, 2016, 06.17 AM IST Economic Times Bureau | December 01, 2016, 13:37 IST Ghosh Abantika | December 2, 2016 The Indian Express accessed 6:35:46 am Times News Network TNN | 23 March 2016 The Drugs and Cosmetics Rules, 1945 as corrected up to the 30th November, 2004 Mustafa Attar Mirror Online | January 21, 2019, 12:08 IST, first published in Maharashtra Times on 20 January, 2019 Amulya Nidhi, The Indian Express, Jun 2, 2018 Thatte Suneela, The Hindu, Jun 2, 2018 Thacker, Teena, Tue, Jul 10 2018. 10:40 PM IST Economic Times, 5th Jan 2015 Ramesh Shankar, Mumbai, October 30, 2014, 08:00 Hrs IST Dey Sushmi | TNN | October 11, 2017, 09:39 IST Dey Sushmi | TNN | May 25, 2017, 10:46 IST Benchoufi, M., Ravaud, P. Blockchain technology for improving clinical research quality. Trials 18, 335 (2017). doi:https://doi.org/10.1186/s13063-­ 017-­2035-­z

CHAPTER 6

Regulations and the Regulators in Health Care

Medical Council of India and National Medical Commission This chapter establishes the context of the discredited Medical Council of India (MCI) and National Medical Commission (NMC) which  has now  replaced it. MCI, the most important central body responsible for quality education for years, has been failing miserably. Among the vast numbers of professionals, relatively  few have any idea about this. Some glaring evidence is given about its status today to inform the doctors. The tragedy  in recent times  was that the powerful professional bodies  were hell-bent on its preservation. As a consequence, they were opposing the NMC which replaces it, based on all kinds of unsustainable objections. The NMC is discussed in greater detail and forcefully supported against the MCI background, in the context of these objections. Loss of Credibility of MCI: The Ketan Desai Saga Until the sensational arrest in 2009 of the president of the MCI, Ketan Desai, who was in possession of a mindboggling haul of INR 1.8 billion and 2 tons of gold, medicos did not have the faintest idea of the level of corruption to which MCI had stooped. The source of so much wealth must have been various processes where favorable MCI decisions under suboptimal conditions were crucial. © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_6

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This was featured by the media for only a couple of days or even less. It was substituted by the arrest of Amit Shah, the then home minister of Gujarat, by the CBI, alleging that Shah was responsible for the killing of Sohrabuddin Anwarhussain Sheikh, a known terrorist, in a false encounter. It was consistently played out for weeks. Here the contrast was that of a person who had amassed money by using his powers by abetting the possibility of lowering standards of education, directly reflecting on the level of care for millions against one possibly premeditated murder of a known terrorist. The world bodies played no small part in the shamelessness, evinced by electing Ketan Desai as their next president. Desai was finally freed on unknown grounds and he has been a free man for many years now, participating in a public rally with the new central Health Minister J P Nadda in late December 2014. This could not have happened without political patronage (Dr Bal Arun).This is why the CBI could not make a strong case, or rather did not make one. MCI has remained so powerful that even 10 years after the Ketan Desai saga and six years of the Modi government since 2014 its liquidation has not been possible. Despite Ketan Desai’s removal, the babus of the MCI have not only remained there but are still working for the powers that be. MCI is thus a national shame. Several more aspects of the dismal case of MCI are discussed below. Ethical Medical Matters and MCI MCI, with no reputation for ethical medical matters, was given the maintenance of ethical practice  — adhering to the best interests of patients. The original MCI Code of Ethics states that doctors should not receive cash or gifts from pharmaceutical companies or any health care representative. Subsequently, the convicted doctors were discharged after issuance of a warning if they apologized. In 2015 a proposal was passed by MCI after amendments to define clear punishment for doctors accepting kickbacks as gifts and so on (the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002).This is what the amendment proposed: Bribes or gifts and worth in INR 1000 to 5000—Warning to the doctor; 5000 to 10,000—Suspension from state medical council for 3 months;

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10,000 to 50,000—Suspension from state medical council for 6 months; Over 50,000—Suspension from state medical council for 1 year. The implementation of this most elementary (and useless) corrective measure has not occurred so far because a gazette notification for the same has been in abeyance since then, the delay being attributed to administrative issues. MCI as an Elected Body That is where the trouble starts. There is a difference between a nominated and an elected body. The professional expertise and integrity needed to deliberate over quality of education in all its related and basic matters is possible only through nomination and not through the election process. India has seen in successive parliamentary elections the evil intent with unsavory effects results if the election route is taken. In the UK, regulators are selected by the Public Service Commission (PSC) based on merit and suitability. The UK Medical Council also has patient groups, student representatives and civil society activists as members. In the absence of such openness and transparency there can only be abuse of power. Instead of changing this scenario the Congress government at the center appointed a board of directors many times over. The only intent in reconstituting the Board three times was to continue holding elections later. In between, a National Commission of Human Resources for Health Bill (NCHRH) was proposed but it retained the election process, thereby nullifying the nomination of experts with integrity. The NMC bill could not be passed in 2018, due to the disgraceful behavior of regional parties, for weeks on end in the Upper House, necessitating an ordinance to appoint one more Board in 2019. It is a shame for the medical profession that it is opposing tooth and nail the dissolution of MCI and its replacement with NMC. The practice of having a Board of Directors has continued for a long time. In the process the quality of education has not improved across most colleges.1 People’s health apparently 1  Forget improvement. The introduction of the National Eligibility Cum Entrance Test has amply shown the extremely poor quality of the entrants of private colleges, discussed later. Achieving parity with global standards of education is impossible with such arrangements. The mess has to be cleaned up.

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does not matter. The principle flaw in the election process of MCI is that those who are to be regulated get elected as the regulator. However, despite this contradiction  the professionals feel that  MCI must be preserved.2 Regulating the Prime Regulator: The Tragedy and the Reality The only alternative was to replace the MCI with a new body. This was called the National Medical Commission 2017, for which a bill was tabled in Parliament. Comparing these two will be helpful in describing the failures of MCI, the nature of the corrective measures taken through the NMC and the reasons for the medical community to oppose MCI’s dissolution and NMC taking over. The government which was able to demonetize the 500 and 1000 rupee notes in a swift and sudden announcement took nearly 40 months to prepare to dismantle the MCI through a new bill of the National Medical Commission. The primary purpose of MCI was to maintain a medical register for India for all the qualified doctors by an “approved institution” recognized by a university (the Indian Medical Council Act, 1956 (102 of 1956), December 30, 1956 (as amended by the Indian Medical Council (Amendment) Acts, 1964, 1993 & 2001). Made wiser by hindsight, we now find that the medical colleges, both government and private, the universities, the state health universities deemed universities, the National Board of Examination (NBE) and MCI have all collectively failed India for decades. Universities were dependent on the University Grants Commission. There was no single or coordinating body to deal with these matters in a broader view. The need to look at the kind of changes in the curriculum has been here for decades.  That  had not been adequately addressed. The All India Technical Education Council (AITEC) was unclear about the field of medicine being under its auspices or under MCI only. These are but a few examples that NMC had to take cognizance of and evolve a far simpler and effective system, which it did. From the word go, the NMC (draft) Bill has proposed to achieve a much needed linearity and removal of multilateral authorities, and to improve ease of coordination of all matters related to medicine. 2  From 2000 to 2010 the elected body of MCI was shunted out  twice, once by the Supreme Court and then by the government. Such a humiliation.

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National Medical Commission The aim of the National Medical Commission (draft) bill is stated as follows: (Only the articles relevant to discussion are included). 10. (1) The Commission shall perform the following functions, namely (a) Lay down policies for maintaining a high quality and high standards in medical education and make necessary regulations in this behalf. (b) Lay down policies for regulating medical institutions, medical researches and medical professionals and make necessary regulations in this behalf. (c) Assess the requirements in health care, including human resources for health and health care infrastructure and develop a road map for meeting such requirements; (National Medical Commission Draft Bill as presented to the Parliament on January 1, 2018). About (a) and (b) no comments are necessary. (c) is a meaningful and relevant declaration. The extremely disappointing and disturbing way in which the health care requirements have been handled hitherto is extensively dealt with in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one, which the reader may refer to. The NMC draft bill aims at correcting this but contains few ideas. What is of importance is that the NMC has recognized this deficiency (Kelkar Sanjeev, 2020). NMC should take on board or at least consider the detailed road map on how in particular human resource management could be remedied/ achieved, and how this could lead to scrapping and cutting out a lot of deadwood in the schemes, including the flagship National Rural Health Mission (NRHM) (see the volume mentioned above). Then there would be hope for a thorough dialogue on how this should/could be done. The structure of NMC, the Medical Advisory Council (MAC) and the boards with common members are discussed below. This will facilitate an important meeting point for those to be trained and those to be deployed, essentially in public health care under the NMC. This will hopefully reduce the dichotomy of the Director of Medical Education and Director of Health Services in states, their refusal to work together for efficient manpower development and deployment discussed in India’s Public Health Care Delivery: Policies for Universal Health Care.

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Such a dialogue will also have to take into consideration the Modi government’s inclinations to attain more and more services from the private sector, under the name of public—private partnership (PPP), adding to it the most ambitious National Health Protection Scheme declared in the 2018 Union budget, universal health care, which will be collectively discussed in the chapter on health insurance and PPP in this volume. (d) Ensure coordination among the autonomous boards. The commonality and overlap of members of the four boards intelligently woven into the Act to ensure that this happens will be discussed in greater detail below. (e) Take such measures as may be necessary to ensure compliance by the State Medical Councils with the guidelines framed and regulations made under this Act for their effective functioning under this Act. This is not a routine addition in a set manner. This area needs strong and effective action. The apathy, disconnect and disinterest of the central body, MCI, and the machinations of the State Medical Councils are well known. It is hoped that there will be improvement in this area. (f) Lay down policies and codes to ensure observance of professional ethics in the medical profession and to promote ethical conduct during the provision of care by medical practitioners. This is going to be a challenge even for NMC. The MCI either did not have the will or the implementing machinery, or both, to control this. MCI had suggested that practicing professionals should complain and bring such misconduct to the notice of MCI but nothing much seems to have resulted from these complaints. The biggest challenge is breaking the nexus between the pharmaceutical industry and the Doctors. It must, however, be admitted that this kind of funding has taken indirect routes which still provide the doctors similar help. (i) Frame guidelines for determination of fees … of seats, not exceeding 40%, in the private medical institutions and deemed universities which are governed by the provisions of this Act.

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These are the seats for government quota. From the earlier 25% this has been raised to 40%. Whatever the compulsion of the NMC and the Health Ministry, this is an inadequate measure. MCI did not have this mandate. There is a bizarre mechanism of committees to fix the fees at state levels and for plenty of malpractice as shown in the chapter on capitation fee medical colleges in this volume. NMC is currently not leaning toward abolishing the private medical colleges altogether. The charge by the bodies opposing NMC, raised elsewhere in this regard, is that the education for the remaining 60% will become dearer since the private colleges will raise this fee quantum to cover their expenses and maintain their profit margin. As a result, the poorer as well as richer students will both suffer. The fee system for private colleges has never been pro-poor. Hence, regardless of whether 60, 100 or 80% of the seats for the college have fixed fees, this is an absurd and invalid argument. ‘Those who can pay will pay more’ is also not a sound argument since there will always be a limit to how much can be extracted from these students. In addition, it is going to be increasingly difficult to deal in cash alone since this group of people will come under the lens of some financial controlling agency or another. RERA, the Real Estate Regulatory Authority Bill passed by both the houses on March 25, 2016, has shown this clearly. A demand for transparency over fee collection for the 60% of seats is or would be a legitimate demand instead of complaining about the 40% quota the government has proposed to reserve for merit students alone. The National Eligibility Cum Entrance Test (NEET) becoming compulsory for the All India admission list has also resulted in a marked reduction of the flow of students in the private colleges. If this continues, the war over the number of management seats for poor or rich students will become hypothetical. One will have to watch for a couple of years more to see how it continues or reverses and the effect it has on the capitation fee colleges. The most praiseworthy decision was to abolish all state medical entrance examinations, and the right to hold such examinations for the private or capitation fee colleges as well as the deemed universities, and bringing about NEET at undergraduate level and the National Licentiate Examination (NLE) at the postgraduate entry level. The NMC (draft) Bill has done well to constitute the two boards for undergraduate and postgraduate examinations with common members under one umbrella organization.

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Extensive changes have followed after the NEET, now held four times over as this volume goes to print. The after-effects are described in detail in the volume India’s Private Health Care Delivery: Policies for Universal Health Care in the chapter on shortage of doctors and government medical colleges. NMC has taken upon itself a lot more than it can chew and has laid out what looks like an adequate structure for efficiently achieving it. One more good decision is that the Act extends to the whole of India and inevitably all the States Medical Councils will be governed by it.

More About the National Eligibility Cum Entrance Test and NMC The history of NEET is gory. In 2012 a Supreme Court judge, one day before he retired from the position, reversed an earlier order and made NEET non-compulsory. This meant that dozens of examinations across the country would continue. The existing system where private medical colleges could admit students without merit would have a free run. Hundreds of other ways to make money would continue. The single all India NEET was rendered meaningless. The system continued effectively until the end of 2016. The Supreme Court reversed the reversed order and made NEET a single examination. The states, the private colleges and the deemed universities had strongly resisted a single NEET and all of them continued to do so even after 2016. The reasons for this dishonorable protest are described below. Opposition to NEET The courts, state governments and the professional bodies have played a significant role in fiercely opposing NEET in the graduate, postgraduate and super-specialty entrance processes. At the root of opposition was saving the medical seats for their own state students, to preserve the full numbers entering private medical colleges so that the money game continued. The quality issues NEET wanted to establish as the criteria for admission have defeated all these endeavors. A few examples will make this clear. The paucity of students who can afford but may not get enough marks to get into a private college badly hit such colleges after the introduction

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of NEET. The NEET merit list is what even the deemed universities had to  go by in the admission process. More than 5000 MBBS/BDS seats were left vacant across several deemed universities after three rounds of centralized counselling (Narayan Pushpa | TNN | August 30, 2017). What surfaces in every such instance is the fact that for years, sub-standard students were getting into the private colleges. NEET was substantially resisted by Banaras Hindu University and Aligarh Muslim University, by reserving 50% of their seats for students graduating from their own universities, apparently ignoring the NEET-­ based list to some extent. The remaining 50% were to be reserved only for Uttar Pradesh students who qualified in the merit list. The Supreme Court ruled that the latter 50% should come from the All India merit list (TNN | June 6, 2017, 08:20 IST). The NEET Aftermath Those who score above the cut off percentage get into the much cheaper government medical colleges. There will be students among these who cannot get into the government colleges, falling short by a few marks, but who cannot go to the private colleges for financial reasons. This was partially made up by the 25% reservation of seats for the government to fill for them in capitation colleges. This limit has been now raised to 40% To overcome this drastic reduction in numbers the cutoff points were lowered. After this 11,114 students who scored 270 or less out of 720 marks got admission into medical colleges, mostly in private colleges in 2017. The remaining 60% seats were for wealthy students with much lower merit in NEET which may pose difficulties in learning medicine. The National Eligibility Cum Entrance Test (NEET) for MBBS admissions for 2018 announced even lower cutoffs than 2017. This translated to 17% marks, 122 out of 720 in NEET, all one needs to get an admission to a medical college, mostly a private one. In an average college the passing percentages of the three MBBS examinations are 40 or 35. It will be interesting to see what the quality of those entering medical colleges is going to be (Rema | TNN | June 5, 2018). As a result, over 7 lakh students from the 13 lakh plus who appeared for the exam have qualified to join medical colleges which have a total of 61,000 seats. There are no cutoffs for individual subjects within NEET.  Many students who were admitted to medical colleges had zero or negative marks in physics and chemistry, both integral to a good understanding of medicine.

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Eighty percent of NRI medical seats were vacant even after mop-up counselling all over India. These students also had to appear for NEET.  This means that the number of students eligible under this category have fallen short and are below the grossly lowered cutoffs shown above. Money is not necessarily a problem here. Of those passing, 20% offered to join and still did not (Narayan Pushpa TNN August 22, 2018). For decades Non-­Resident Indians (NRIs) and foreign students have been getting admitted to Indian colleges and going back. One can now infer the quality of these students and the disservice India has done them and their countries of residence. Postgraduate and Superspecialty Entry and NEET Till the idea of National Licentiate Examination came around, NEET was a practice for Post Graduate seats. An addition was the NEET-SS (superspeciality). The Tamil Nadu government added 30% of the NEET marks to those of in-service doctors to enable them to get into the PG courses, blatantly violating the sanctity of NEET scores in which no such provision is made. The Madras High Court directed the state government to rework the merit list. Of the 1066 postgraduate degree and diploma seats in 13 government medical colleges, only 67 seats went to non-service candidates even after the 30% additions without which 80% of the seats would have gone to candidates not in service. There were many other irregularities in this business but the quality issue of candidates eligible for postgraduate courses was thrown out of the window (TNN June 18, 2017, 08:15 IST). In Trichy in June 2018, a national seminar conducted by the Tamil Nadu Medical Students’ Association demanded the rollback of the Union government’s proposal making an exit test mandatory for medical students as an entrance test for the postgraduate courses in future (TNN June 11, 2018, 12:29 IST). This is the National Licentiate Examination, NLE. Further arguments given in its favor are absurd enough. Quality is the only casualty in all this. The Andhra Pradesh High Court stayed NEET-SS (superspeciality). Counselling for filling super-specialty medicine seats by using a Presidential Order issued under Article 371D which allows both these states to fill all the seats available under their health universities and medical colleges with local candidates of Andhra Pradesh and Telangana only. It also presented an interim finding that the central authorities cannot impose common national-level counselling on Telangana and Andhra Pradesh states, claiming that 371D supersedes all new rulings, also quoting a Supreme Court ruling (Mutha Sagar Kumar TNN August 18, 2017).

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For admissions to super-specialty courses on an all-India basis, the National Eligibility cum Entrance Test (NEET)-Super-specialty was conducted by the National Board of Examinations, for the first time. Nearly one in three sought-after super-specialty medical seats were not filled by September 17 (Rao Yogita | TNN | September 19, 2017). Super-specialty seats in Tamil Nadu seemed to be going largely to students outside Tamil Nadu under the NEET selection. After NEET-SS of the 192 super-specialty seats in 2016 only 19 from the state got the seats. In all the preceding years all seats were occupied by doctors from the state. At once it was apparent that the doctors who passed the postgraduate examination and appeared for NEET SS did  not seem to have enough wherewithal to secure merit. A few super-specialists want the Tamil Nadu government to seek permanent, not a temporary  exemption from NEET. The General Secretary of the Super Specialist Association, Dr G R Ravindranath, said that only 470 students from Tamil Nadu managed to score above 400 marks out of the total 720 in NEET this year (4000 students from Kerala, around 11,900 from Uttar Pradesh and around 9000 students from Delhi secured more than 400 marks). The disappointment is that no one is going into the details of why this has happened. Instead, provincialism is evoked to say that Tamil Nadu will be deprived of super-­ specialists. This is pathetic and detestable parochialism.

More About the NMC Draft Bill The NMC (draft) bill clause 14 gives exemption from NEET to those institutions which are governed by a separate Act of Parliament, such as the All India Institute of Medical Science (AIIMS), which will have their own entrance examination aside from NEET.  These are the Boston Brahmins of Medicine, as well as representatives of the dictum of democracy that some are more equal than others. Sympathetically speaking, at this stage, the committee forming  National Medical Commission must have found the removal of the special status too complicated a process and not wise to deal with lest the Bill gets delayed. Whether these institutes should also be brought into the common pool is a moot question. Examples quoted elsewhere in this and the volume India’s Public Health Care Delivery: Policies for Universal Health Care show that these institutes are neither above reproach nor less controversial at times and are susceptible to corruption and manipulation. However, this is not an important

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issue at this point, except that more of them are being created under the same act, adding to the tally. (2) The Commission shall conduct the NEET in English and in such other languages. There are many implications to this provision, and are discussed in detail in India’s Public Health Care Delivery: Policies for Universal Health Care published with this one in the chapter on medical education. (3) NMC divided the counseling on central and state and levels; the former would counsel eligible students for All-India seats… the State Government shall conduct the common counselling for the seats at the State level…. The differential counselling specified will help the states in counselling the students, especially those who may later appear for NEET in a provincial language. (j) To frame requisite policies for the governance of Medical Education. Suffice it to say that a long-felt dire need is likely to be addressed. What could be done and how it could be done has been extensively discussed in the chapter on medical education and manpower deployment in India’s Public Health Care Delivery: Policies for Universal Health Care. It is hoped that NMC will take cognizance of this in good faith. National Licentiate Examination (NLE) for Foreign Graduates NMC Draft Bill 15 (1) in essence states that a person who is a citizen of India obtaining a medical qualification in any country outside India shall not be entitled to be enrolled in the National Register unless he qualifies in the National Licentiate Examination (NLE). The agency which gives the citizen a degree in medicine abroad will be recognized only after the person passes the NLE. This is another sensible step taken by the NMC. Earlier, MCI or the National Board of Examinations (NBE) on its behalf was conducting this examination under the Foreign Medical Graduate Examination (FMGE) twice a year. Now care has been taken that the NLE, which will also be a single postgraduate entrance examination, will also be applicable to foreign graduates. This reduces the clutter and multilateral authorities. The average number of students who traveled to other countries to learn medicine, from 2012 to 2014, was 11,210 over three years. The average of

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students passing out from FMGE in five terms from March 2013 to June 2015 was 16% (Jha Durgesh Nandan | TNN | October 1, 2018). The data above indicates three things. First, majority of these students going abroad are not trained / equipped adequately or prepared intellectually at least by Indian standards. Second, the desire to be an allopath is strong, thereby shunning the traditional systems in India, going abroad and getting an MBBS degree. And third, the standard of all the colleges abroad  may not be matching Indian demands of passing out NLE.  All three indications are correct. This passion for modern medicine originates from the lure of large amounts of money the ill-equipped students think they can make in their native places.3 NEET will make the statistics worse, as has already happened in India, which will be shown below with respect to NLE.

National Licentiate Examination (NLE) for Indian University Graduates NMC bill in essence states that passing NLE for granting the license to practice and enrolment into the Medical Register(s), of India is a must for all institutions imparting medical education. The website given below lists the various objections raised. Objection 1: It closes the gates for Indian medical graduates while it opens them for foreign doctors and foreign-educated medical graduates (Docplexus2018). This objection is baseless since these students, instead of FMGE that has been current for so many years, they  will take NLE.  What is more important is that they pass FMGE or the Licentiate Examination in the future as well. The objection that it facilitates entry of these graduates and blocks domestic students is completely unfounded. The pathetic passing percentage under FMGE adds a meager 12% to the 61,000 passing out from within India. Objection 2: It is the fate of students who go through five-year study at an accredited medical college, pass an approved examination process  in 3  China is the most popular destination, followed by Russia, Ukraine, Nepal, Kazakhstan, Bangladesh, Kyrgyzstan, Armenia and the Philippines. The cost of education in Ukraine is Rs 2 million, including hostel fees. In India, it is 5 million. Those who fail live in impoverished conditions and join coaching classes to pass FMGE. Their image is not enhanced by the fact that graduates from abroad perform poorly in FMGE.  They are paid lower salaries than domestic graduates, and are deployed on emergency, night shifts or as assistants to senior doctors. To earn respect, they have to obtain a postgraduate degree. It is a constant struggle.

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that college consisting of viva and practicals, are declared fit to practice, but may fail to qualify on just an MCQ paper examination conducted by the NMC as the post-MBBS exit examination (Ibid © Docplexus2018). It is incorrect to assume that the NLE will consist of MCQs when no details on how it will be conducted are mentioned yet. This change will take three years before it is implemented after the bill becomes an act. Given the shape of things to come there will be scope for discussion. The NMC bill had been stalled in the Upper House in India among many other important bills. Thus there will be further delay and there is no basis for objecting to it.  The individual college examinations by then will be removed and only NLE will remain.  Objection 3: It is the compulsion of all those graduating from anywhere in India to obtain a license to practice, even if they do not want to do a postgraduate course. The real, fundamental objection is not the foreign Indian graduates but the NLE itself. The students graduate from all sorts of colleges, deemed, health or regular universities. By making the National Licentiate Examination compulsory the NMC bill admits the extremely poor standards of a large number of graduates graduating from institutes with poor teaching, nepotism, and corruption in passing students at individual college/university level, from the capitation fee colleges and government medical colleges. This is discussed in India’s Public Health Care Delivery: Policies for Universal Health Care. This is a preventive measure not to let loose sub-standard, poorly trained doctors on the populace. Dr Arvind Panagariya, Chair of the NMC draft bill preparation and ex-­ vice chairman of NITI Ayog, states that Some have opposed the exit examination arguing that it constitutes hardship for students. Frankly, the objective of the examination being to identify unqualified candidates in a profession that deals with human life, such opposition is unconscionable. In the US, doctors must renew their licenses every two or three years, and one of the requirements of the renewal is the evidence of [attending] continuing medical education.4 (Arvind Panagariya, ET Contributors|February 6, 2018)

India demands and needs quality today and not quantity, and compulsory NLE is a step to ensure it. It also cuts through a lot of corruption which many would like to continue with.  Please refer to the chapter on medical education in India’s Public Health Care Delivery: Policies for Universal Health Care that deals extensively with the improvement of continuing medical education. 4

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This is also a candid and hence welcome admission of the inability to improve all conditions in the majority of medical colleges in the near future. NMC must be congratulated for this. It is a serious situation and must be improved. NMC has come out with a simple, uncluttered solution to this in NLE.5 Today nearly 80% of all graduates want to opt for a postgraduate course (Bapat, 2011). For them the NLE serves as the single postgraduate entrance exam instead of going through ten separate tests. Hence there should be no objection to NLE. This is a unique and pleasing example of simplifying matters in a non-duplicating, non-redundant way, rarely found in the solutions offered by government. The remaining 20% who do not choose postgraduation are the issue, which must still be judged on the basis of the quality of the doctor. NMC bill (15.3): The National Licentiate Examination shall become operational on such date, within three years from the date of commencement of this (NMC) Act… The consideration given for the timeline is commendable. It looks at the logistical conveniences of all concerned, allows NEET to settle down and gives the NMC time to think about the pattern of the NLE.  Objection 4: This single-day Multiple Choice Questions (MCQ) or objective exam for three hours under NLE cannot be a substitute for hands-on training in the fields of surgery, pediatrics and other medical specialties wherein the students are trained for five and a half long years, including one year of internship (©Docplexus, 2018 ibid). This is a self-defeating argument. The existing MCQ pattern for postgraduate entrance is also an extremely dubious passing mechanism for testing the five and a half years of hands-on training for the branches of study mentioned above. The profession did not have any objection to students appearing for numerous such examinations for years. There is no need therefore for concern over an NLE i) even if it continues the same pattern of MCQ examination, ii) when it has not announced the pattern yet, iii) and going by the practice of the erstwhile and the reelected Modi government for open dialogue for which, iv) NMC has ample time to evolve to the satisfaction of all a pattern which will suitably judge the five-­and-­ahalf year training. 5  Improvement in the externalities of medical colleges and medical education by replacing over years the British Didactic Model with Problem Based Learning is discussed in detail in the volume India’s Public Health Care Delivery: Policies for Universal Health Care.

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Objection 5: Shouldn’t the institution in which the student has studied for four to five years be the best authority to assess and provide a degree to a candidate for him or her to start practicing? Is it a good idea that only the government distributes licenses to candidates after they take this examination? The training institutes are in bad shape and cannot do this job to a satisfactory level and cannot be improved in the short run, as has been abundantly shown so far. If the suggestion of the objectors is to be instituted, then all forms of entrance should be scrapped and left to the state to judge the merit on 12th standard with domicile as the criterion. The entrance examinations were brought in since this procedure was considered defective for all the above reasons. One should know and learn from the past. The hidden vested interest is that students can be passed at the MBBS level from these places and through the postgraduate entrance examinations. Under NEET and NLE this is not easy. Such arguments have a single object—the quality is not to be bothered about but the manipulability to pass and the money cycle should continue. All developed countries and even some developing ones follow strict medical licentiate requirements and it is not the government which distributes these licenses but rather the government-authorized medical board. In this case it is the NMC. Dr Panagariya, Chair of the NMC bill, states in no uncertain terms that since we have over decades moved towards a more heterogeneous model of medical education/colleges (government/private/trust run/religious/for profit) we need to become more vigilant on their outcomes. NMC will become what the bar council is to the legal education in this aspect. (Panagariya Arvind Ibid)

Whether it is the dissolution of the MCI, creating an NMC or introducing a Clinical Establishment Act (discussed in Chap. 7 in this volume), the way the Indian Medical Association (IMA) in particular and the professionals in general react has many hidden motives. The perception is that their liberties to behave and practice the way they want, unfettered and driven by only one consideration, is coming under the scanner. They have a false sense of their being the demigods which may be undermined, which also lurks beneath this opposition. This arrogance is still voluble and often vitriolic when the profession has already lost the moral ground for any of the demands and objections.

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One of the most important aspects of achieving high education standards is the way examinations are conducted. The quality of these myriad agencies conducting these is dubious today. The single test achieves uniformity of standard and quality, and thus the process is far simpler and more just. It also effectively removes the products of institutes responsible for poor standards from the process of passing students. The quality of the product today is / should be the single criterion of all new thinking. In the past, the regulatory role of MCI should have been more comprehensive and effective on these matters. The performance of MCI on this count is briefly reviewed below.

MCI Act 1956: 3. Constitution & Composition of the Council Only the articles of the Indian Medical Council Act relevant to the situation today have been taken into consideration. Indian Medical Council Act: 17. Inspection of Examinations, sending visitors at examinations to observe and report but not to interfere with the conduct of examinations… This seems more like a business between the external examiner and the internal caretakers. The exchange can take various forms in persuading the examiner to be in line with the general trend of the marks given under the dozen heads discussed earlier, in Chap. 3 on capitation fee colleges in this volume. The MCI does not seem to be interested in the examination process. As a result, one need not even comment on the quality of the output of medical colleges. The modern medical professional are vociferously opposed to the dissolution of MCI for many indefensible reasons. One of the reasons is the numerous positions and additional committee memberships and so on they could occupy to play their games. Having a look at the composition of MCI against the NMC composition discussed below will be instructive. Without it the beauty and simplicity as well as effectiveness of the NMC bill will not be appreciated. A list of members entering MCI is given below.

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1. One member from each state to be nominated by the Central government in consultation with the state government concerned, that is, 29 members. 2. One member from each of the 44 universities to be elected from among the members of the senate of the university, that is, 44 members. 3. One member from each state in which a State Medical Register is maintained, to be elected from among themselves by persons enrolled on such register, that is, 29 more members. 4. Seven members to be elected from among themselves by persons enrolled on any of the State Medical Registers who possess the required medical qualifications. Around 225 doctors are added from these procedures. 5. Eight members to be nominated by the Central government. This is a random choice. Thus the total number of people constituting MCI is roughly 300+ members. 6. The President and Vice-President of the Council shall be elected by the members of the Council from among themselves.

Composition of the NMC Under the NMC Draft Bill 2017 4. (1) The Commission shall consist of the following persons to be appointed by the Central Government: (a) a Chairperson; (b) twelve ex officio Members; (c) eleven part-time Members; and (d) an ex officio Member Secretary, totaling 25 against the 300+ members of MCI. If ever there was an example of a lean and therefore potentially efficient body for working and delivering health care it is this. The reader is referred to the chapter on Government Planning and National Rural Health Mission to see the multilateral, multiauthority bodies it has created in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one. (2) The Chairperson shall be a person of outstanding ability, with proven administrative capacity and integrity, possessing a postgraduate degree in any discipline of medical sciences from any university and having experience of not less than 20 years in the field of medical sciences, out of which at least ten years shall be as a leader in the area of health care delivery, growth and development of modern medicine or medical education.

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The demand by some that the NMC chairperson should be a medical doctor is hereby fulfilled. (3) The following persons shall be the ex officio Members of the Commission, namely: ( a) (b) (c) (d) (e) (f) (g) (h) (i) ( j) (k) (l)

The President of the Undergraduate Medical Education Board; The President of the Postgraduate Medical Education Board; The President of the Medical Assessment and Rating Board; The President of the Ethics and Medical Registration Board; The Director General of Health Services, New Delhi; The Director General, Indian Council of Medical Research; The Director, All India Institute of Medical Sciences, Delhi, or his nominee; The Director, Postgraduate Institute of Medical Education and Research, Chandigarh, or his nominee; The Director, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, or his nominee; The Director, Tata Memorial Hospital, Mumbai, or his nominee; The Director, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, or his nominee; and One person to represent the Ministry of the Central Government dealing with Health and Family Welfare, not below the rank of Additional Secretary to the Government of India, to be nominated by that Ministry (Ibid, NMC draft bill).

The accusation that the NMC is neither national nor regional is completely demolished by this arrangement. Notwithstanding the probable clout and interests these ex officio members may have, there is no doubt that they are highly competent people who needed to be nominated since none on their own would ever have made or wanted to make their way to MCI.  In addition, these are full-time medical professionals outside the lure of private practice as long as they are there. (4) The following persons shall be appointed as part-time Members of the Commission, namely: (a) Three Members to be appointed from among persons of ability, integrity and standing, who have special knowledge and professional ­experience in areas including management, law, medical ethics, health research, consumer or patient rights, advocacy, science and technology, and economics;

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(b) Three Members to be appointed on a rotational basis from among the nominees of the states and union territories on the Medical Advisory Council for a term of two years in such manner as may be prescribed; (c) Five Members to be elected by the registered medical practitioners from among themselves from such regional constituencies, and in such manner, as may be prescribed … This brings the total representation from the states to eight (see below for further discussion). Under pressure from powerful organizations, NMC has yielded to the demand of retaining electoral process for five members. It is a meaningless victory for the medical politicians. Instead of governing the medical field for its betterment, medical professionals of all types had converted MCI into a boxing arena of electoral politics. The degeneration of the MCI was then inevitable. Losing this fillip, the political clout the doctors are used to, is the root cause of all the uproar that was expected. However, this deserves to be ignored. Instead of a single large MCI body, four new boards have been created with many officials common to all the boards. This reduces the numbers, and the knowledge of what is happening in each is automatically shared. This is a fair guarantee that matters will not go haywire and that the likelihood of inappropriate events will be greatly reduced. In the IMC act clear cut divisions as found in the NMC was not the case but several functioning units with different members handled different  matters. The  functional pattern proposed by the National Medical Commission Bill may not pass without controversy. Not just in health but wherever the Modi government has attempted transparency, accountability, going on record, becoming a tax payer, disclosing income and so on, this has met with strong resistance from interest groups. For the same reason this may also be contested. This is a step that indicates that the Central government means business. In this and the volume India’s Public Health Care Delivery: Policies for Universal Health Care it is mentioned that health has to be rooted in its wider social matrix with many other considerations—social, economic and geographical situations and so on.  The experts from varied fields brought in NMC could go forward in this endeavour. MCI is run by powerful doctors who can get the politicians on their side. The understanding both may have of the total health scenario and many other connected domains is inadequate. These required insights are

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supplemented by the way NMC will be peopled, leading to a comprehensive or holistic vision and therefore to solutions, which  cannot emerge if vested interests dominate as in MCI. This is a complete transformation of MCI. The people brought together will constitute a fine think tank and hopefully give the medical profession the support it needs. Such a wider and nominated representation is laudable. The Central government (or the three-member NITI Ayog committee) has emphasized that NMC should retain its recommendatory nature in the same manner as MCI. It means the final decisions of importance will be taken by the Central Government. Part-Time Engagement of Experts The NMC (draft) bill (7) in essence provides for temporary/part-time engagement of experts and professionals of integrity and outstanding ability, special knowledge and experience in medical education, public health, management, health economics, quality assurance, patient advocacy, health research, science and technology, administration, finance, accounts and law to assist the Commission. Many of these members will be helpful in viewing health care delivery much more comprehensively than doctors alone. The wisdom of this is apparent too. MCI was an unwieldy, dysfunctional and slow-moving dinosaur, and hence already evolutionarily unfit. The higher the numbers, the greater the commonality of vested interests and groupings, and lobbying culminating in disputes. Whither education? Whither standards? Now all this will hopefully disappear. NMC draft bill Clause 58 (3) categorically states the following: “On the dissolution of the Medical Council of India, all the employees and appointed persons as the Chairman and every other person appointed as the Member and any officer and other employee holding office as such immediately before such dissolution shall vacate their respective offices of the Medical Council of India. [They] shall be entitled to claim compensation not exceeding three months’ pay and allowances for the premature termination of their office or of any contract of service. Those on deputation stand reverted to his parent cadre.” From 1982 to date only 35 officers from MCI have retired. The babus are more like bandicoots in the way they cling to their positions. An even more important issue than the dissolution of MCI was the removal of the erstwhile babus sitting in the MCI bureaucracy. Had this not been achieved, the entire NMC exercise would have been completely futile.

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Autonomous Boards: NMC Draft Bill 2017, 16.1 “The Central Government shall constitute the following four Autonomous Boards, within the NMC which will under the overall supervision of the Commission, perform specific functions assigned to such Boards.” ( a) (b) (c) (d)

The Undergraduate Medical Education Board (UGMEB) The Postgraduate Medical Education Board (PGMEB) The Medical Assessment and Rating Board (MARB) and The Ethics and Medical Registration Board (EMRB)

A remark on comparison of NMC and MCI should first be made. The clarity, details and imagination of the machinery by NMC is not found in MCI. This arrangement is in stark contrast to MCI. All relevant aspects and agencies have been brought under a single umbrella organization, the merits of which are obvious for coordination and simplicity of structure. NMC (draft) bill (2) “Each Board shall consist of a President and two Members. They will be persons of outstanding ability, proven administrative capacity and integrity, possessing a postgraduate degree in any discipline of medical sciences from any University…in the area of medical education, public health, community medicine or health research or…of management, quality assurance, law or science and technology…or who has demonstrated public record of work on medical ethics. They will hold the office for 4 years and shall not be eligible for any extension or reappointment.” Such a constitution will no doubt provide a holistic appraisal of the situation and the functions the members have to carry out. The stringency of the qualifications may raise doubts if they have been included to target specific persons for these posts. However, the numbers are few, which is laudable. Career medical politicians and medical bureaucrats like to populate such boards for obvious gains in as large a number as possible, which has been cut away mercilessly. This is the cause for all to chafe and protest against the NMC bill. The Central government will not hesitate to cut to size powerful bodies. The Undergraduate Medical Education Board in NMC Draft Bill Without going into legalistic detail on the wording of the bill and by coalescing the sections it can be said that the mandate for the Undergraduate

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Medical Education Board is comprehensive at the undergraduate level. The basic continuing functions and responsibilities are as follows: To determine minimum requirements (of the) standards of medical education, (for)  conducting courses, oversee all aspects relating thereto (and) for the purpose of “…flexibility to (be) allow(ed to) design changes in academics, undergraduate courses, determine standards and norms for infrastructure, faculty and quality of education having regard to the needs of the country and the global norms, and examinations for undergraduates in medical institutions.”

 bout Standards Infrastructure and Academic Activities A Sadly, there are very few such institutes in the country with good standards and academic activities. In the form of the Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh, we have excellent examples to emulate for laying down the standards and functioning to improve academia. It is good to see the Director of PGIMER included in the NMC. UGMEB Functions To develop competency-based dynamic curriculum for primary medicine, community medicine and family medicine to ensure health care in such areas. Community medicine is part of the undergraduate curriculum, and making it interesting is the real challenge for NMC. There has been nothing like effective and interesting training for primary care in the medical curriculum so far and it is indisputable that it would be a good addition. However, in my view the model proposed in the volume India’s Public Health Care Delivery: Policies for Universal Health Care actually dismantles much of the conventional structure and function within primary care. It is proposed in that model that the MBBS will no longer man the primary health center but will be placed in a highercomplexity medical scenario in a community health center. Even for the AYUSH doctors in the scheme proposed, particular training needs in the primary area will be minimal. Hence to me this provision of community medicine appears redundant. The suggestion is that it may be put on the back burner until we arrive at a more detailed understanding of what to do for rural health care, the central focus of the abovementioned volume. There is a dire need for family care physicians. But the MBBS graduates will have to be trained and guided by the same logic of the placements of MBBS and the interns in community health centers (CHCs) as described

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in the abovementioned volume. The MBBS cadre also may find it satisfactory to start a family physician career after three years in community health centers when they leave the public health care services. Super-specialists and specialists are admirable and respectable. Yet, for the majority of the population mainly the basic specialists are available. A finer and higher form has to be practiced by the basic specialists who are closer to the families and patients. The large recurrent and daily experience in thousands of places calls for it. After the patient has visited half a dozen super-specialists he finally comes back for advice to the nearby specialists who he knows and trusts. These specialists are in a better position to understand the advances and nuances of modern super-specialty treatment and can generally decide on the right measure for the patient. If they have undergone the compulsory three-year posting in CHCs as detailed in India’s Public Health Care Delivery: Policies for Universal Health Care, their ability to judge such situations will be much greater, unless they fall prey to foul practices. The emphasis on developing new courses by individual institutions may seem like a good idea but in all such cases the devil will lie in the details of facilities, faculty and commitment. A new course is generally considered to be a revenue stream by the private colleges, while neither the government colleges may show the will or interest to develop them nor the universities. This will have to be considered before taking this idea further in the future. The National Medical Commission (NMC) bill has shown the flexibility to allow design changes in academics, which is creditable. Various states are grappling with difficult challenges. For example, Bihar and Jharkhand are contending with Kala Azar in epidemic proportions, Tripura with malaria, Uttar Pradesh with Japanese encephalitis, and a few Southern states with a resurgence of leprosy. The curricular emphasis will have to vary in such states, although the main body of the medical education will remain unaffected.  o Facilitate and Implement Research T Research has never been an idea to which undergraduates were exposed. Its full potential can be reached with Problem Based Learning (PBL), as argued for in India’s Public Health Care Delivery: Policies for Universal Health Care. Concerted work for a decade can bring PBL into existence. The pitiable state of ‘research’ in the postgraduate years is described in the volume mentioned above. With the changes suggested therein for faculty restructuring in medical colleges with an alert NMC, matters could improve a great deal.

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 o Develop a Competency-Based Dynamic Curriculum T “It includes assessment…such that medical graduates have appropriate knowledge, skills, attitude, values and ethics for providing health care, as per the societal needs.” While the inclusion of attitude, values and ethics in the curriculum is a welcome addition, we will have to wait and see how these will be implemented. The earlier similar changes in the curriculum made by the MCI have clearly and completely disrupted the goals. This is also discussed in India’s Public Health Care Delivery: Policies for Universal Health Care. We will have to wait and see whether the UGMEB corrects it, removes it or makes a sensible and acceptable modification to it.  o Facilitate Development and Training of Faculty T Members teaching undergraduate courses will gain particular benefit. This again is a long-neglected need. The new introduction to attend Continuing Medical Education activities (CMEs) is not the only or real answer for updating the knowledge, as shown in the chapter on medical education in India’s Public Health Care Delivery: Policies for Universal Health Care. The upgradation is needed in the teaching techniques and the technology of education for the faculty. The answer to this is Problem Based Learning (PBL). It should be dealt with under NMC by a separately constituted bench within the Undergraduate Board. The International Undergraduate Student and Faculty Exchange Programs This modern idea always appeals to the planners. The prerequisite is the soundness of the fundamental teacher training program, which today is absent. Selecting those likely to benefit most by attending a foreign university and detailed map of what they have to do is important. Nepotism should have no place. Foreign students should be properly placed based on their interest of work to get maximum benfits under proactive teachers. There is no particular hurry to go after such ideas for implementation since many works of extremely high value have to be finished first.

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NMC and the Institutional Amendments (i): specify norms for compulsory annual disclosures, electronically or otherwise, by medical institutions, in respect of their functions that has a bearing on the interest of all stakeholders including students, faculty, the Commission and the Central Government…. This section indicates that such annual or otherwise disclosures were not mandatory. If so this is a welcome step. The loathing that the Indian psyche has toward remaining accountable and the NMC’s ability to deal with non-compliance with a strong hand is the crucial factor here. The monetary penalties under the Rating and Assessment Board in this area are welcome and are discussed below. Since mid-2014, electronic monitoring, rating and display of information of all types of agencies in the public domain has become the norm. Hitherto the integrity of functionaries was lacking. The potentially important role of the National Academic Accreditation Council (NAAC) is mentioned in this respect in the chapter on capitation fee medical colleges in this volume. The NAAC director was among the invited members of NMC, now removed. The scope for working freely should be there for such agencies.6 The norms for infrastructure have been put in place  since long, and how these are treated in certifying the colleges is detailed earlier in Chap. 3 on capitation fee colleges in this volume. Arguably, there is always scope for improvement, which the NMC bodies will hopefully focus on. The equally important issue is the functional aspects described earlier. The issue, however, does not end here. Attaining results will depend upon the proactive working of the UGMEB, forcing colleges to make an effort to improve and UGMEB remains corruption free in these matters. These will remain major concerns. It is hoped that there will be a separate mechanism for accreditation with a lean structure. Dr Panagariya has echoed the sentiment of quality thus: The Bill proposes to place quality in medical education at the centre of the regulatory process. Under the MCI, regulation has focused solely on enforcing strict infrastructure and personnel norms. It has resulted in widespread allegations of corruption and steady deterioration of education quality. The proposed Bill replaces this regulation by a system of accreditation and exit 6  After this writing, as on March 2, 2019, the NAAC director, through a choice by one of the members, has been deleted for unknown reasons.

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examination. Accreditation will serve as a signal of quality of education and research in respective institutions. (Ibid, Arvind Panagariya)

The exit examination NLE will itself achieve a great deal in terms of quality. The NEET has already contributed to weeding out students unfit to learn medicine, delivering a blow to the private colleges. However, the one single issue the UGMEB should be prepared to look into is closure of colleges, both government and private in particular, that are operating far below the norms. This could be an unequal battle. The stiff financial penalties which NMC proposes will be the first step. A roadmap in this regard is presented in this volume.

The Postgraduate Medical Education Board (PGMEB) This has the same structure and functions as those of the undergraduate board and includes super-specialty courses as well. The same comments applicable to the undergraduate board are applicable here, with some added information and comments. The National Board of Examinations (NBE) and PGMEB The NBE shall be merged with the PGMEB. NBE has been degenerating in many aspects. The unfortunate situation involves the way in which the Diplomate of National Board (DNB) training institutes are selected, the poorly organized teaching by the DNB faculty from within such institutions, their lack of interest in adding value to the candidate’s experience and understanding of his subject, and the unsatisfactory way in which the faculty allocates work and gets it done. All these factors have greatly undermined the quality of the DNB postgraduates. However, NLE may now be able to admit better candidates for postgraduate courses under a single authority. The NMC bill was still being prepared when the merger of NBE within NMC was proposed circa 2017–18. At that time there was a hasty expansion in NBE allegedly under the notion of NBE playing a larger role in narrowing the gap between the undergraduate, postgraduate and super-­ specialty courses. The expansion of number of seats was set at 36,000 more postgraduate and undergraduate seats, as stated by a health ministry

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notification dated June 17, and published in the Central Government Gazette on June 20. For this 14 new members were appointed to the National Board of Examination who had a tainted background. The Health Ministry defended these appointments by saying that “10 were de jure ex-officio members of NBE including the IMA President when the IMA itself is under the cloud. The idea was that the postgraduate courses should not suffer until NMC became an act. NBE also waged a turf war against the merger, saying that “MCI and not NBE was to be restructured. The three-member expert committee appointed by the prime minister (in April 2016) to examine the overhauling of medical education has not yet submitted its report, hence NBE can act on its own.” Eventually the NMC bill laid down that the separate body of the National Board of Examination will be dissolved and the entire function, course and liabilities will come under the PGMEB. This is not about ease of functioning alone. It is another example of eliminating multilateralism and multiple authorities, criticized particularly and extensively in India’s Public Health Care Delivery: Policies for Universal Health Care. In addition, the parity the merger will bring between the NMC-­ sanctioned postgraduate degrees and the degrees previously bestowed by NBE is an important step. This makes the existing DNB degree holders eligible for medical college faculty positions, thereby helping to get more of these empty posts filled, as emphasized by Dr Arvind Panagariya. (Panagariya Arvind Ibid)

NMC Draft Bill 26. (1) The Medical Assessment and Rating Board (MARB) MARB shall perform the following functions: (a) Determine the procedure for assessing and rating the medical institutions for their compliance with the standards laid down by the Undergraduate Medical Education Board or the Postgraduate Medical Education Board, as the case may be, in accordance with the regulations made under this Act. This is a good example of avoiding the chronic habit of rediscovering zero or the proverbial wheel and of multiple agencies doing the same things, as is extremely common in governmental ways of thinking. (b) Grant permission for establishment of a new medical institution in accordance with the provisions of section 28…

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This and the related sections have come under wild and angry criticism. It is discussed below and is compared with the situation for opening new colleges under MCI. Sections (c and d): “MARB is to carry out inspections of medical institutions for assessing and rating such Institutions…. that the MARB may, …hire and authorize any other third party … for carrying out inspections….” The suggestion of employing a body like NAAC in the chapter on capitation fee colleges was made long before this one came along. This inclusion would have greatly facilitated the quality approach, removed the frequency of inspections and the Inspector Raj, close/diminish one major avenue for corruption and disallowed sub-standard colleges to continue (Panagariya Arvind, Ibid]. (e) “Make available on its website or in public domain the assessment and ratings of medical institutions at regular intervals….” Accountability has become the norm since 2014 and is welcome. With digitization being pushed by the government and compulsory web display of hundreds of agencies, the screws have been tightened on falsification. This will also make the entrant aware of the quality of the college that has been allocated to him and make him examine whether he should choose it. Monetary Penalties (for Capitation Fee Colleges) (f) “Take such measure, including imposition of monetary penalty, against a medical institution for failure to maintain the minimum essential standards specified by the Under-Graduate Medical Education Board or the Post-Graduate Medical Education Board; … the medical institution which has been imposed a first-time monetary penalty fails to take any corrective action, the Medical Assessment and Rating Board may impose a secondtime monetary penalty for continued failure which shall be higher than the first-time penalty and on continued failure, impose a third-time monetary penalty which shall be higher than the second-time penalty…. “Provided further that the third monetary penalty imposed…. shall not be less than one-half, and not more than ten-times, the total amount charged, by whatever name called, by such institution for one full batch of students of undergraduate course or postgraduate course.”

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It is sweet music to the ears that such a strong action has been sanctified under MARB. The NMC has started functioning now but is still in early stages and is not in full command yet as on December 2020. (f) Provided also that even after the imposition of third-time penalty, if the failure continues, the Medical Assessment and Rating Board shall forward its report to the Commission recommending to withdraw the recognition granted to the medical qualification awarded by that medical institution. This is somewhat of an anti-climax. It would be instructive to see how this game was played under the MCI. 10B.  Non-Recognition of Medical Qualifications in Certain Cases (Under the IMC Act 1956) of giving degrees to the students, or doing the same for a higher course or a postgraduate course would come in, only in cases of medical colleges not approved by the central government. Health being a concurrent subject, the medical colleges in the states are the only such colleges the MCI has the power to de-recognize. The tool of de-recognition without any severe monetary penalties paves the way for an ongoing play, first to threaten them with de-recognition, then wait for things to happen, then de-recognize and recognize them again when ‘some more acts’ are performed by the de-recognized institutes. This meant that a medical college could still be opened at the state level, as has been happening since 1980, without the permission of the center (see below). This is in sharp contrast with the way the NMC draft Bill wishes to deal with this matter. This clause under MCI seems also to imply that states through their state universities could still provide a certificate to students and enter them in the medical register of the state, even if a college was not recognized by the MCI. Moreover, during the existence of a previously approved college if the said college is de-recognized all the MCI will do is not recognize these degrees. No further punitive powers are vested in the MCI to logically follow the reasons for non-recognition. The NMC bill proposes to provide those tools before the process of de-recognition is even considered, which is a commendable action (see above). Non-recognition is a tool that is well deployed with or without any merit to back it up. How about the follow-up of the stages between recognition and non-recognition? Who would do this and for what ‘consideration’? Would MCI have the wherewithal for this meticulous work when

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it comes to the approximately 500 medical colleges in various states? These questions are absurd but are raised to show the ridiculousness of the situation. It is a stick which will be retracted if the carrot shown is sufficiently juicy. Do we need to go further in the mud to spill dirtier mud? The NMC bill, if paraphrased on this issue, shows that non-recognition as a tool is as powerless and without any immediate or long-range effect on the situation as was MCI. That is a sad situation. MARB constituted by the Commission shall make a representation to that effect to the Central government. Period. This shifts the focus of the drama of de-recognition and re-recognition again to the Central government. The real option which remains unspecified in the NMC bill, even after de-recognition, is its willingness and ability to recommend closure of these irremediable colleges even after such heavy penalties to the Central government. Throughout the NMC bill the recommendatory nature of MCI has not been changed and perhaps wisely so, except for the monetary penalties mentioned above. It is a moot point as to why even closure of thoroughly useless government medical colleges cannot come under this ambit. This question needs to be answered at this stage even after the bill is passed and has become an act. 

27. (1) The Ethics and Medical Registration Board (EMRB) Under the provisions of the NMC draft bill 2017 and under the guidance of the Commission, the EMRB will: (a) maintain a National Register of all licensed medical practitioners The details related to this can be found in the discussion on the National Licentiate Examination. Many more aspects of this process are described in the Appendix on Controversies over the AYUSH system of medicine in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. (b) Regulate professional conduct and promote medical ethics by itself or by and through the State Medical Council where it has been conferred this power

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Since no details of what constitutes misconduct or offence are given we take it that whatever exists today and was under MCI and General Law is assumed here. The exact ways in which it will be tracked and acted upon are not clear. (c) Develop mechanisms to have continuous interaction with State Medical Councils to effectively achieve these aims The vociferous but incorrect objections about the states not being properly represented is dealt a blow under Medical Advisory Council in this chapter, exposing the hollowness of it. This is an additional area in which the states will be in contact with the NMC. However, it is not going to be liked by professionals. (d) Exercise appellate jurisdiction with respect to the actions taken by a State Medical Council which specifies how the states should respond to EMRB and under section 30 lays down a clear path for an aggrieved medical practitioner to approach EMRB, NMC or the Central Government… (against) any action taken by a State Medical Council Can anything more be done in fairness to all? Dr Panagariya has further clarified that the entry of the newer medical colleges will be more relaxed, although I have a fundamental difference of opinion that India is truly short of doctors and hence newer (private) colleges should be allowed.

NMC Draft Bill 2017 Section 28: Opening New Medical Colleges (1) No person shall establish a new medical college without obtaining prior permission of the Medical Assessment and Rating Board. The first and the most major impact of this short statement is that the states have lost their right to open such medical colleges. Ideally this will stop/reduce the anterograde increase in the number of such private colleges. This clearly applies to any person or trust or any other non-­governmental bodies wanting to open a medical college. More than 250 private colleges come under the name of a trust or society at the time of this writing.

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The most disturbing aspect, however, is the government’s intention that a medical college should be present in each district.7 The genesis of it is traceable to a past WHO opinion that there should be a medical college (number of admissions unspecified) for every 5 million people. The false logic and the naïve (often subtly serving business interests) arguments of doctor’s shortages and need for more medical colleges has been adequately exposed in the earlier chapters of this volume. Hence it is important to see what the NMC draft bill has to say about opening newer medical colleges. (2) For … (which) a person may submit a scheme to the Medical Assessment and Rating Board … in such manner, as may be specified by regulations. (3) The Medical Assessment and Rating Board shall, having due regard to the criteria specified in section 29, consider (such) scheme… and either approve or disapprove (it) within a period of six months…Provided that before disapproving such scheme, an opportunity to rectify the defects, if any, shall be given to the person concerned. (4) Where a scheme is disapproved …or where no decision is taken within six months of submitting a scheme the person concerned may prefer an appeal to the (National Medical) Commission for approval …within fifteen days of such disapproval… (5) The Commission shall decide the appeal received….within a period of forty-five days …either the Commission approves the scheme to establish a new medical college or disapproves it…. or fails to give its decision within the specified period, the person concerned may prefer a second appeal to the Central Government within thirty days of communication of such disapproval or …lapse of specified period. There is a vociferous objection currently circulating that the NMC bill removes all the regulations required to start a medical college, that under this bill, no permission is needed to start a medical college. Also, any private medical college can increase its undergraduate / postgraduate seats on its own and this will lead to a compromise of medical education. The procedure to open a new medical college has clearly outlined a path for appeal against the decision if it is adverse. These stipulations need to be compared with the procedure for opening newer medical colleges under the MCI. 7  This has been repeated by the late Arun Jaitley, former Finance Minister, in his blog on the declaration of the National Health Protection Scheme (see the chapter on health insurance and public—private partnership).

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MCI Act 10A: Permission for Establishment of New Medical College, New Course of Study Only the sections having to do with opening a new medical college are discussed below. The only article that sets the NMC bill apart from the MCI is that quoted below. MCI Act Clause 10A: 2. 5: Where, within a period of one year from the date of submission of the scheme to the Central Government under sub-­ section (1), no order, passed by the Central Government, has been communicated to the person or college submitting the scheme, such scheme shall be deemed to have been approved by the Central Government in the form in which it had been submitted, and accordingly, the permission of the Central Government required under sub-section (1) shall also be deemed to have been granted. Provided further that nothing in this sub section shall prevent any person or medical college whose scheme has not been approved by the Central Government to submit a fresh scheme and the provisions of this section shall apply to such scheme, as if such scheme has been submitted for the first time under sub-section (1). What could signal more blatantly and freely the permission to open new colleges than the above provision? Apply, wait for one year, see to it that no order is passed, and open a medical college. In complete contrast, the NMC draft bill lays down a clear pathway for approval, shown above. Even then the professional bodies are shouting themselves hoarse that NMC allows colleges to open without permission. The clarity on this has been twisted. MCI is preferred over NMC so that such a rigorous route is not followed, and hence the strident opposition to the NMC bill. It is the money game under MCI that the people with vested interests wish to perpetuate. Unless the MARB shows too much alacrity to sanction such colleges and ignores the norms, which is unlikely due to its structure, opening a new college is a difficult proposition hereafter. Here the NMC decision to not sanction a college will raise numerous questions challenging the credibility of the government under vicious propaganda. One can only hope that the government will remain steadfast in its decision. The NMC draft bill clearly lays down what is it looking for if permission is to be given.

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Objection: The NMC bill has explicitly stated that the colleges can increase their postgraduate seats on their own without the permission of NMC. Dr Arvind Panagariya has further defended the freedom to increase the number of seats to 250 in the existing colleges as long as they maintain acceptable quality standards of education. The accreditation, and not regulation and excessive focus on the infrastructure or faculty alone, will be the driving force.8 (27.4) The MARB or the Commission or the Government, while passing the order under sub-section (3), either approving or disapproving the scheme, shall have due regard to the following factors: ( a) Adequacy of financial resources; (b) Whether adequate academic faculty, necessary facilities to ensure proper functioning of medical college has been provided or would be provided within the time-limit specified in the scheme; The state of availability of faculty has been clearly shown in Chap. 3 on capitation fee medical colleges, which is dismal. (c) Whether adequate hospital facilities have been provided or would be provided within the time-limit specified in the scheme. In the same chapter mentioned above the birth of a medical college in a large functioning hospital as most natural is detailed. The experience is that this occurs in the reverse direction. Such colleges seek all kinds of hospitals, including government hospitals. NRHM put this in a nuanced way, as seen in the chapter on primary care and NRHM in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one. Opening a medical college is a serious business with hundreds of considerations. It cannot be established in such a careless fashion as this. Such carelessness is what caused the deterioration of this all-important single factor for medical education. 8  At the time of writing the NMC bill, the full force of NEET was yet to be seen. The drastic reduction of candidates who are eligible but cannot afford the private colleges declined so much that even with large increases in the number of seats to a college on its own (the point of objection) without the NMC interfering, the objection becomes meaningless now.

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Subject to the previous approval of the Central government, the criteria may be relaxed for the medical colleges which are set up in such areas as may be specified by regulations. This stipulation, however, needs to be completely removed. After so much good decision making it is difficult to see the reason for this provision. In an earlier draft of the NMC bill in 2016 clause (c) read “Provided that the above criteria may be relaxed for those Medical Colleges which are set up in an un-served area.” The more elaborate version of draft bill 2017 merely disguises the purpose clearly stated earlier. Today there are few areas which can be considered unserved, as in Arunachal Pradesh, for example. This is due to the paucity of population. Opening a medical college there is difficult to run and serve. In addition, there are numerous colleges which have been purposely situated in quasi-urban rural areas, which under this criterion are sanctioned and many more will open. The real issue is the patients. Everything and everybody including the faculty can be brought there if the promoter spends large amounts of money (which he is not really willing to), but not patients, and they are the foundation of learning. The situation is that today there are no unserved areas and only badly served areas all over the country. Unbridled Permission to Increase Postgraduate Numbers also by NMC: Many Objections Objection from the professionals: There is a widely circulating allegation that the medical colleges have been permitted to increase the number of seats on their own in the postgraduate courses and can also start new courses on their own without taking permission from the NMC. If the draft NMC bill as presented in Parliament is the correct document of reference then the above allegation is a completely false and fabricated one to make headlines. It may be further stated that the press (Ibid Nagaraj Rema, 2016) has quoted an official of the department stating that the number of postgraduate seats to be increased in the medical colleges has been specified as three students under every professor and two under each assistant professor. To fill these seats there need not be any approval process. Such blatant lies from the profession are not in good taste. Dr Arvind Panagariya, the architect of the NMC bill, has further commented on the controversies which may be worth considering. “Vested interests have deliberately created some of this fog. These measures will

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greatly alleviate the current faculty shortage. Competition for entering students between NBE and NMC-blessed postgraduate programs will also bring pressure to improve quality standards in postgraduate education on the two entities” (Panagariya Arvind, Ibid). The NMC draft bill 2017 does not make any mention of the permission to start new courses and increasing the number of students. This could also have been twisted to be implicit permission for such courses to start and numbers to increase. It is advisable for NMC to specifically and separately include directives on starting new courses as in the case of opening colleges.

The Medical Advisory Council—MAC NMC Draft Bill 2017, article 11: The Medical Advisory Council (MAC) has been well conceived and organized to be the body to constantly receive feedback from all the parties involved. It will communicate the same to the four autonomous boards of NMC. This has helped reduce the numbers in the executive and decision making arms of the NMC. The composition is such that some expertise on the action would be available there and facilitate quick action or redressal. By making the NMC chairman and the MAC chairman the same person and all members of NMC ex officio members this has in fact reduced many obstacles to communication. 12. The MAC shall be the primary platform through which the States and Union territories may put forth their views and concerns before the Commission and help in shaping the overall agenda, policy and action relating to medical education and training. The Council shall advise the Commission on measures to determine and maintain and to coordinate maintenance of the minimum standards in all matters relating to medical education, training and research on measures to enhance equitable access to medical education. What about the objections raised by professional medical bodies and doctors that the states have no role to play? The Composition of MAC “One Vice-Chancellor of a State Health University to be nominated by that State Government, one from each Union territory, to be nominated by the Ministry of Home Affairs in the Government of India; the

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Chairman, University Grants Commission, the Director, National Assessment and Accreditation Council, four Members to be nominated by the Central Government from amongst Directors in the Indian Institutes of Technology, Indian Institutes of Management and the Indian Institute of Science:” The total number is just about 13. Can one expect a better combination for the ideas to be heard by the Council? With it the government has achieved one collateral gain. Such unification will help them to work together, which is no mean achievement. These are premier institutes of India. Biomedical investigation and improving diagnostic equipment are being experimented with outside the medical field, as at the Indian Institute of Technology (IIT). The molecular biology research will also more often than not be done at the Indian Institute of Science (IISc). The proposals made about the reorganization of public health care in India’s Public Health Care Delivery: Policies for Universal Health Care have a large component of human power management as well as economic and fiscal angles. Someone from the Indian Institute of Management (IIM) would be in a better position to consider such issues. This would be a good body for cross-fertilization of ideas. This kind of thinking is certainly a characteristic of the Modi government where time and again we have seen that the bureaucratic silos are being broken and inter-ministerial coordination has been made the norm.

The Objections and Objectors to NMC Many objections discussed below have been listed on blogs and in interviews on www.docplexus.in in 2018 mentioned above as well. It allegedly has a viewership of 200,000 doctors of modern medicine including specialists. Only a few objections not answered so far will be discussed. A. The proposed NMC is devoid of federal character. Admittedly, only a few states at a time will be sitting as regular members for 4 years. Others also will get a seat by rotation.9

9  According to mythological legend, Ravana was defeated and killed since he had ten heads which quarreled and confused him. Imagine what could happen if 36 more heads from states and union territories populate the MAC.

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The prominent function of the Medical Advisory Council of the NMC bill is for continuous contact with states. The charge of its being non-­ federal thus does not stand. B.  NMC is non-representative of medical professionals as more than 50% of members will be non-medicos and hence a poor substitute for MCI. It is also not correct. Several members are medical doctors. If the objectors mean privately practicing doctors by the term medicos, they may not qualify. C. Most of the constituent members are drawn from within the ranks of government and quasi-governmental organizations. The privately practicing professionals are upset about not getting electoral representation. The objectors are congratulated for the candid but equally embarrassing admission that the private politician professionals want the MCI to remain as their handmaiden as it has been for decades to play their games and politics. D. NMC, unlike MCI, has been made into a quasi-governmental body, and hence no longer an autonomous one. This is not completely true. However, the objectors would do well to understand that it is a cautionary reaction to what was a predominantly privately dominated body. It was not autonomous in its true sense and function. It has been damaged by them so much that it is beyond redemption in its present form. There will be some professionals from outside the clamoring segment of the doctors with high levels of integrity and experience. These professionals will never find their way in NMC  if electioneering was the route. MCI anyway did not have a place for them. Hence they are being nominated. Admittedly such individuals are far fewer today. The objectors do not have any moral ground here either. Still more basic to the objection is the intolerance of the private professionals about any process which can hurt or control their vested interests, except what previously prevailed which served them, the MCI. The present government should not get  dictated to by such bodies. The Government is giving NMC and the Advisory Council the character of a strictly regulatory government body. Yet, restraint has been admirably shown in that it has few punitive powers. E. The NMC bill will pave the way for widespread corruption. This is a baseless allegation. There is nothing to suggest that the corruption facilitated by NMC will happen. After Ketan Desai it would be decent for the medical profession not to talk about corruption.

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F. As far as the penalty to be imposed on erring colleges is concerned, this will open new doors of corruption, and the wrongdoings that occurred will go unpunished. This is a genuine fear. India always fails in administering because of lack of people with integrity who are incorruptible and could also be vulnerable to danger. MCI made corruption a regular business. With fewer than 25 individuals with a high level of integrity sharing many jobs, it is much less likely that such corruptions will go undetected. At the same time it will not do any harm for a newly constituted body to be given a chance. G: The medical universities are not represented in NMC. This is not true. The state representatives are expected to be of the rank of vice chancellors of health universities and no less. Under NEET and NLE, however, one of the two principal functions of all universities, the examination process has been taken away, making the university representatives irrelevant. H: The ultimate authority of giving/rejecting affiliation/recognition to medical degrees or to new colleges rests with the Central government. Is this not too much centralization and overkill? Since 1980 all that we have seen is an unprecedented number of medical colleges that have come into existence unbridled. Whether one considers NMC as centralization or overkill, this step is an absolute minimum. It is hoped that it will check the uncontrolled proliferation of unnecessary colleges. Even during the period of MCI, this authority was with the Central government. With the malleable MCI under an even more malleable Central government, matters could easily swing in favor of the medical colleges as a whole. Now under the NMC this will not be the case, and hence all the protests. I: Within a week of the NMC bill, objection was raised that the draft National Medical Commission Bill was full of anomalies. These are listed below and rebutted. Anomaly 1: With the representation of the practicing doctors taken away, it remains to be seen how the ethics of these doctors providing care to 80% of the population can be managed. There could not be a more blatant statement admitting that representation from the practicing private doctors could save their tribe from action under unethical practices routinely undertaken, if caught or accused.

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Anomaly 2: The Indian Medical Association (IMA), the collective consciousness of more than three lakh doctors was not consulted when the Union Cabinet took this decision to replace the MCI with the NMC. It is for IMA, state medical councils and such other bodies to consider whether they have any locus standi in any way in this matter. Anomaly 3: The bill is not IMA-friendly, and nor is it state medical council-friendly, as it takes away their autonomy to function. It is a strange remark that the bills should be friendly to those very stakeholders who have created this need for scrapping MCI and establishing NMC. If it was stated that it is an unjust bill one would have carefully considered this remark. Anomaly 4: The NMC is not a ‘commission’ as any commission requires the provision for a developmental grant in the five-year plan. The Planning Commission and the five-year plans are history now. The channels of funding are now totally different. Anomaly 5: Full powers are given only to three full-time nominated members on the board appointed on salary by the government. One answer is—there is nothing wrong in it. Almost all the members are employed either in the governments or in other prestigious institutes who do not need any salaries as such. An honorarium for their time and expenses would be all that matters. It is such a trivial issue. Anomaly 6: The commission has only appellant powers. So did the MCI. The punitive action rested with the Central government, as is the case here as well, except for the severe monetary penalties that the NMC can levy on defaulting colleges. Anomaly 7: The penalty for violating norms will vary from half to 10 times, for example, from 5 crore to 100 crore. (The amounts mentioned here are not precise but these refer to the specified and specific quanta mentioned above.) Also, the Central government has total control over waiving of penalties, giving permissions, and allowing doctors to practice without fulfilling all norms. There was no penalty in the MCI Raj. Now it is present and is directly under NMC to levy, strictly specifying the ways in which it will be levied. The Central government has always held the power to reverse such decisions and allow malpractices. Courts are there to support aggrieved parties, as has been seen so far in this volume. The track record and the intentions of the government since 2014 are clear and are effectively hurting many corrupt people, organizations and so on; now it is health. Anomaly 8: The so-called autonomous boards are not really autonomous as all boards are under direct control of the government and the

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Commission. And the Commission has regulatory as well as directional powers. The secretary of the Commission can be a non-doctor appointed by the government. What is more important: the autonomy or the controls that have gone to the government to rein in the ugly situation, or that the private lobby has no say now? The profession does not want any hurdles which is the reason for all the hue and cry. As an autonomous body it should have both regulatory and directional powers. However, the secretary is more likely to come from the Health Ministry, as he is the convener secretary. The possibility of a non-doctor heading the commission is real. It is often not a bad idea to appoint someone who has no knowledge of an area. Such a person may have fantastical ideas which may not strike a chord with a doctor but stimulate new ways of thinking. Anyone who can make it to NITI Ayog will not be an ordinary person. The key architect of the brilliant draft of NMC, Dr Arvind Panagariya, is a professor of economics. Anomaly 9: Not only this, the NMC will even have directional power over state governments. I hope the standing committee on health will rectify these anomalies by either amending the present NMC act or bring in a better act. In that case let us replace NMC once again with the MCI Act.

Reasons Behind Change in the Composition of MCI With most members of the MCI being elected, the NITI Aayog Committee (2016) noted the conflict of interest where the regulated elect the regulators, preventing the entry of skilled professionals for the job. The Committee recommended that a framework be set up under which regulators are appointed through an independent selection process instead. This is the issue which, when attempts were made to solve it, gave rise to loud protests. NMC (draft) Bill Section 10: Search and Selection Committee to nominate various members of NMC (will be) consisting of i. Cabinet Secretary, ii. CEO, NITI Ayog,

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iii. One person having outstanding qualifications and experience …in the field of Medicinal Sciences/Public Health, iv. One person having outstanding qualifications and experience … in the management, or law, or economics or science and technology to be nominated by corresponding ministry Government of India and v. Secretary to the Government of India, in charge of the Ministry of Health and Family Welfare, as the Convener to be nominated by Ministry of Health and Family Welfare, Govt. of India. At least now there will be transparency and excellent people will find a way to wipe out the mess to create a sound system. This committee merely underlines the point that the Central government is keener on getting the right people on board. In conclusion, the bodies opposing the dissolution of MCI and its replacement by NMC, ringing in NEET and NLE and so on, seen in various places in these two volumes, have no moral locus standi, IMA in particular  because of a phantasmagorical  decision it  took,  IMA decided to give  Dr Ketan Desai  an award given to a person  for his/her consistent contribution to the cause of medical education and health profession, the Medical Statesman, the Highest Order Award of IMA. Do we need to say anything more? (Shrivastav Snehalata | TNN | December 31, 2016, 09:57).

References Dr Arun Bal, ex member of MCI Ethics Committee in personal conversation after the fraud was exposed. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The Indian Medical Council Act, 1956, (102 of 1956), 30th December, 1956, (As amended by the Indian Medical Council (Amendment) Acts, 1964, 1993 & 2001. NMC Draft bill, 2017 as presented to the parliament. Narayan Pushpa | Times News Network, TNN | August 30, 2017a, 16:56 IST. Times News Network, TNN | June 06, 2017b, 08:20 IST. Nagarajan Rema | Times News Network, TNN | June 05, 2018a, 09:18 IST.

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Narayan Pushpa | Times News Network, TNN | August 22, 2018b, 11:33 IST. Times News Network, TNN | June 18, 2017c, 08:15 IST. Mutha Sagar Kumar | Times News Network, TNN | August 18, 2017d, 10:01 IST. Rao Yogita | Times News Network, TNN | September 19, 2017e, 07:21 IST. Times News Network, TNN | June 11, 2018c, 12:29 IST. Jha Durgesh Nandan | Times News Network, TNN | October 01, 2018d, 06:13 IST. © Docplexus2018 https://www.docplexus.in/#/app/posts/68cefd68-­f389-­ 4696-­9 2e6-­5 f0ac4486494?utm_campaign=Push-­N otification&utm_ content=CTA&utm_medium=Email&utm_source=Docplexus&utm_ term=Push-­Browser1-­4March18. Panagariya Arvind ET Contributors | Feb 06, 2018, 07.25 AM. Shrivastav Snehalata | Times News Network, TNN | December 31, 2016, 09:57.

CHAPTER 7

Clinical Establishment Act and Reservations in Medical Education

Introduction There are other areas of medical activity which are not covered by the MCI where stricter regulations or implementation of the same is necessary. The Clinical Establishment Act (CEA) has come under the demand for regulation as a solution for this vast sector. These are the clinical services such as nursing homes or small hospitals that are outside public health care. The other areas are the private medical laboratories owned by qualified laboratory technologists, qualified pathologists, or the franchises that belong to the renowned laboratories; the blood banks run by individual doctors in the private sector; imaging centers for sonography; x-ray facilities; computerized tomography (CT) or magnetic resonance imaging (MRI). All of these require permission from the state. Then there are the private auxiliary nursing midwife (ANM) training centers and the independently run private nursing schools with some tenuous connections with hospital, agencies. Many other private agencies train the laboratory or x-ray technicians, especially in larger cities and in South India. These are numerous, and the rest of the private sector and the corporate hospital services come under them. These areas are as important as the treatment facilities for quality health care. Quality has been emphasized repeatedly in these pages. To make it clear, these facilities do not come under the purview of the MCI. Nor will these facilities come under the National Medical Commission, which has become a law and has © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7_7

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started its operations bundling MCI out. Whether they should is a necessary consideration. All of these activities come under the state health ministry. Similarly, if something goes wrong with these facilities, it is the state machinery which first deals with them for further action. If the offense is breaking the rules which result in cognizable or criminal offence the state will conduct the procedure through the Courts. An indeterminate number of such establishments are poor in quality, and are regulated in a lax, perfunctory manner. These establishments also send kickbacks to doctors.

Demands for Regulation of the Medical Profession Most of these services lie in the private sector. The demand for regulation has arisen mostly in health activist quarters. Most activists implicitly believe that the private sector is largely exploitative and a symbol of capitalism, and that improvement there is an absolute necessity. Their major focal area is the nursing homes and hospitals, since the work for all other agencies mentioned above arises from these. As a result, these are also the root of corruption and exploitation. Thus the agitation has focused mainly on them. The proposed regulation in general is of two types: one is a legal route and the other is a financial one. The objection to the private sector goes much deeper; that it should exist at all in health care. People at large and poor people in particular are the ones who are exploited. There should be no place for it; public care is all that must exist. No system that levies a fee for health services is acceptable and all health care should be free. In the unipolar world since 1989 and decades after globalization these premises have not changed. This will become clearer in this volume in Chap. 9 Health Insurance, National Health Protection Scheme, Public—Private Partnership. Another issue with regard to the dissatisfaction about the private sector is its apathy for primary care activity, which incidentally is the fondest idea of the activists. This is discussed in great detail in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one (Kelkar Sanjeev, 2020). However, since private enterprise in health cannot be eliminated, the least that could be done is to strongly regulate this. The factors supplementary to this demand are legitimate. The most significant of these are poor infrastructural conditions, non-standard treatment methods used in an exploitative manner and unqualified staff to care

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for the patients. The effort to develop the content and implement the CEA is to rectify these factors, and rightly so (Clinical Establishment (Registration and Regulation) Act, The Gazette of India, August 19, 2010, no. 31). Inter alia, the Act also addresses the issue of basic dishonesty which prevails in practices. Why has the demand for regulations arisen at all? Why are they needed, in the private sector? The answer lies in the way doctors in the private sector practice the trade. Doctors alone have brought upon them the necessity of CEA. Can regulations solve these issues? If not, are more regulations the solution? What is disturbing is the belief that regulation is capable of solving them. Regulations are sorely needed but they are not the only/single solution. Today’s buzzwords denote other ideas which could also be helpful. For example, less government and more governance, accreditation and facilitation rather than regulation is an idea that runs counter to regulation. The point is that some regulations are seriously required even when these newer ideas are circulating today, for the entire private and corporate sector. CEA is one of the many that are needed. Background and History of CEA CEA has been on the anvil for rolling out for a long time now. It had all the mandates. Yet the Central and state governments have not succeeded in harnessing its full implementation across the country. In spite of repeated appeals, as on December 28, 2018, only 11 states, Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, Uttar Pradesh, Bihar, Jharkhand, Rajasthan, Uttarakhand, Assam and Haryana, had adopted it. Health is a state subject. Unless states adopt it under article 252 of the Constitution of India the provisions do not become applicable. The Act was passed by the Central government in 2010; hence all union territories (UTs) except Delhi have adopted CEA (PTI | December 28, 2018, 16:37 IST). It is no surprise that the New Delhi government notorious for its hostility and non cooperation with the central Government for over 7 years and many other states for reasons unknown has not followed suit. The Act is aimed at registration and regulation of all clinical organizations with a view to prescribing the minimum standards of facilities and services provided by them in the country, and to streamlining health care services in India. The Act is applicable to both therapeutic and diagnostic clinical services in the public and private sector. Under the Act, standard treatment guidelines are specified for 227 diseases, including dengue,

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chikungunya and malaria. The hospitals are supposed to abide by minimum standards in terms of infrastructure, services, staff, and equipment and lighting arrangements. Health facilities are to display the charges for each procedure and facility to keep the patient informed in advance. Aside from state government tardiness or disinterest it could not take the IMAs with it to support it and to get it adopted. The central Clinical Establishment Act was passed in 2010. Under pressure from IMA the Act is not progressing any further than this; for example, the IMA is demanding the elimination of the provision of standardization of rates in the private health care sector. This in fact is one of the core ideas behind CEA. It only exposes how the private health sector exists only to obtain as much money as can be made and is not subjecting itself to regulations. The patient is no longer at the center. Controversies like that about the private insurance companies and private hospitals having been locked in a tussle over rates for procedures in private hospitals in Pune have now become routine.1 Sadly, a revised document of the flagship program of the National Rural Health Mission in 2012 did not come up with any ideas to regulate the sector that provides 80% of curative health care services. Legal regulation of methods of private practice has been somewhat disturbing in the hands of the state machinery. Even when the CEA was not passed in full, other laws were in place. In India there is a law against pre-­ natal determination of the sex of a child. Has the government been able to effectively check the female feticides being carried out in spite of the Pre-­ Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act? It is doubtful. Its implementation has gone astray. Under these stringent rules, permission to start a sonography clinic takes months. Once it is given, there is no judicious check on anything, mainly for four reasons: first, the sheer numbers using ultrasonography (USG) machines, which are difficult to monitor; and second, the parents committing female feticide will never make complaints about it to the state governments to act. The third reason is that even if the state wants to, it cannot act on its own against thousands of ultrasonologists. The fourth reason is the way the state machinery behaves. For any provision that requires a nod from the state governments, it is the babus who give it. They will not do this without asking for hefty bribes. Inspectors visiting sonologists harass the innocent practitioner under threats of sex determination practices, and unless the sonologist 1  In the chapter on insurance it will be shown how the rate war was the cause of intermittent breakdown of services.

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bribes them they cannot work. Those who refuse to bribe the Inspectors on moral grounds, are mercilessly harassed. Many instances in which these professionals have stopped their practices have been recorded across India (Gadre 2015). Similar is the case among those who carry out medical termination of pregnancy who somehow manage the records to avoid suspicion and checks. The most disturbing action by the babus is to make life miserable for those upright people who are known not to carry out such medical terminations. The regulation thus turns into devilish machinery in the hands of bureaucracy in controlling the private sector practices (Gadre, ibid.). Certain observations on the way the CEAs are drafted are pertinent here. The Central government CEA and of some other states have not gone into detail in the areas that require maximum stringency. This creates a structure that talks of all the peripherals but not the core (the National Rural Health Mission (NRHM) document is a typical example of this). The center states the rules which should be appropriately formed by the state governments. The state governments make acts but do not specify what they want. The Government, the Indian Medical Association (IMA) and the CEA Ironically, the body that should have been at the center of the consultation process in forming the details of the CEA, the Indian Medical Association, seems to be unhappy about the Act as a whole. IMA issued a press release on November 28, 2012, opposing the proposed adoption of the Clinical Establishment Act (CEA-2010, latest version is 2014 as draft bill) by the state of Maharashtra. Some articles pertinent to the objections raised by the IMA about the draft CEA of Maharashtra are discussed below. 5. The State Council shall (a) Classify the clinical establishments into different categories; (b) Develop the templates for developing minimum standards of clinical establishments by appointing subcommittees… (for these categories); (c, d, e) Determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments to be mandatorily provided by clinical establishments and make it available in public domain as prescribed. (f) Compile and publish a State Register of Clinical Establishments within two years from the date of the commencement of this Act;

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These works have not been accomplished so far. There is no a priori reason why any stakeholders should resent these aspects. However, on the ground it raises more disturbing questions than CEA can answer. There are many provisions in the Act which could cause discomfort to the practicing doctors or the nursing home owners. Such sections have been picked up and abridged and comments are attached as to why there is so much opposition to the Clinical Establishment Act from many quarters and whether it is justifiable or not. This is an example from Maharashtra which has at least produced an act, but the case may be similar to this in most of the country where the CEA is attempted. 10(A): The clinical establishment should be under the management of qualified and registered practitioner for the particular system and category, for provisional and / or permanent registration of a single or multiple care categories. It is a well-known fact that there are clinical establishments which are owned by non-clinical people or businesspersons, non-registered and non-­ qualified people who have no qualms about or consideration for what they do to obtain money. Such people appoint superior doctors and dominate them. They will be discomfited by this section. (B) For provisional and/or permanent registration of a single or multiple care category the establishment should maintain (iii) The minimum standards of space, facilities and services as may be prescribed. There is apprehension on the part of nursing home owners that the minimum standards prescribed will be impractical, and will be based on some fanciful foreign criteria which will not be applicable or affordable, and will be extravagant or irrelevant to the situation. This applies to both space and facilities. On the other hand, the authorities will find it rather difficult to fix upon standards for different population levels and the grade of the towns. If it does not suit people, this exercise will lead to endless quarrels and litigation. (iv) The minimum qualification and requirement of personnel as may be prescribed; Preamble: This issue is the most complicated. Neither CEA nor the practitioners will be able to find solutions for it even with full cooperation among one another. The causes for the situations created by the entire system described below lie outside the CEA.

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This can cover the specialists and MBBS doctors. A nursing home may hire doctors who may have adequate legally valid qualifications. But this does not cancel out the possibility of their work being inferior or unsatisfactory or downright dubious. Fulfilling the demand for qualification does not address this fully. There is no denying that this situation exists. The more complex issue is whether it will also cover the Bachelor of Ayurvedic Medicine and Surgery (BAMS) and Bachelor of Homeopathic Medicine and Surgery (BHMS) doctors who may be working as duty doctors. They will find themselves in the peculiar situation where they are following allopathy for which they have been legally disallowed even now in many states like Kerala. These doctors may/may not have enough experience in allopathic medicine; they may not have received/undergone any necessary or satisfactory training.2 In January 2020  as the volume goes to print, the idea of the bridge course for AYUSH doctors is suspended (see Appendix B in the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020). This makes the justification to employ them even more unusual. The nursing homes have such a paucity of MBBS duty doctors that they have no other recourse but to employ AYUSH doctors. Combining all the factors mentioned above, there is no hope that the authorities will be able to decide about which doctor could and could not be considered qualified to work in a clinical establishment. As a result, the Act will not present a well-delineated role for the AYUSH doctors. The third category of people employed is paramedics, be they laboratory personnel, x-ray technicians or nurses. It is a sad fact that the majority of these clinical establishments may have just one person or no one with a trustable qualification in each paramedical area. Other staff with no qualifications will be working with the qualified paramedic. They will be trained on the job but the seriousness of the effort of training and the resulting quality will be uncertain. Within the strict definition of CEA these people cannot be allowed to practice. 2  To provide adequate experience so that they could practice appropriately at different levels of health care there is only one avenue: placing them in the community health centers (CHCs) after passing for three years, bridge course or no bridge course. The latter is discussed in Appendix B in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Placement in CHCs, the rationale behind this and how to make CHCs functional are described in five chapters on reorganization of public health care in the abovementioned volume.

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Whether it is a hospital or a nursing home, finding qualified people is extremely difficult. Those with good qualifications will go to corporate hospitals, and the smaller establishments cannot match the corporate pay packet. Contrarily, the owner deliberately may not make any effort to employ nurses at a decent pay. Quality costs, and owners are not willing to pay for it. All other services can be utilized from outside from quality-assured centers. Even then the hospital/nursing home owner still cannot solve the crucial problem of nurses. Qualified nurses have to be physically present to take care of patients. If every such expectation is specified in detail in the CEA, in the rules, followed by penalties, all the deficiencies of a private establishment will come under the scanner. The means of survival for doctors with small establishments will be threatened. This is what the small nursing home owners or others with larger establishments think. If it is not closed it will be bought and disposed of by bigger players. That is a logical end. A deliberate disregard on the part of those responsible for patient safety in terms of care cannot be ruled out since making money is the motive. There could also be a deliberate disregard on their part to provide at least safe medical service. The patient is likely to be cheated. In such a complicated scenario what should the authorities do to the nursing home? Close the service or the nursing home? Warn it to bring in some qualified people? Or suspend the services and use the same at other places nearby with qualified paramedics? In today’s world anyone who wants to do business has to maintain quality since there is currently demand as well as a need for this, at affordable price. If this means reduction in the profit margin, so be it. One cannot have one and not the other. The more complex the demands from the Act, the more susceptible the owner is to the babus who will make his life miserable. These elementary articles of CEA have raised numerous other issues. If this is not feasible, then what other avenues are open to an average doctor in order to survive? And an even more fundamental question is: Why were or are the doctors driven to open such services of poorer quality? A partial answer can be given for the causes of these complexities and their solution. As argued in this volume, an excess number of doctors is being produced, and there is an unwillingness of doctors to move away from the cities, the reason behind this being the recovery of high costs paid by them to get a degree or a postgraduate qualification, all leading to

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super-saturation and malpractices to survive that have several effects. Availability of and capability to employ the right personnel is a major one. CEA will thus help only to an extent. At worst it may lead to closure of hundreds of establishments, and at best these establishments will continue under bribery to the babus. The cause of the opposition to CEA by the IMA is due to hundreds of their members who are likely to be threatened into penury. The issue should be solved by applying corrections at the fundamental level. This is the purpose of this volume and India’s Public Health Care Delivery: Policies for Universal Health Care. (v) Provisions for maintenance of records, display and reporting as may be prescribed; The first of these, the maintenance of records, is one factor that the medical profession in India does not want to keep, or keeps it in the most bizarre conditions where money is involved so that no one can determine what is going on. This is reflected in the examination and the prescription paper which the patient finally receives. Every unbecoming practice will be used to prevent anyone from guessing the true income and to make as much money as possible by keeping no records and collecting unreceipted cash to avoid taxes. It is not unusual to find hundreds of thousands of rupees under the beds of even sophisticated specialist doctors. The required displays are of many types. Displays would be notorious in these establishments, if they were ever put up. If these are found then there will be inflated and exaggerated information on them. The names and the specializations may be present but the persons may never visit. There will be no transactions to support their valid connections. Or there will be sketchy displays which do not conform to the norms. Either way, such a section is uncomfortable for most current establishments. The display of tariff is even more contentious about and even the big hospitals are highly evasive in this regard as we have seen in the chapter on corporate hospitals in this volume. Formatted record keeping for better reporting is anathema to the Indian mind. Quite a few do not like to put pen to paper or facilitate computer use. This is why there is opposition to electronic health records. Honest recording, honest displays and conformity to law are simple elementary decent values which have come to us in recent times from the West. There is no justification in not following them because it has come from West. It is just the ways Indians do their transactions in vague or non transparent ways that should change. (vii) Display of notice regarding availability of facilities and services and rates for the same,

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When corporate hospitals do not display rate charts will these small establishments do so? Facilities and services are promoted while the patients, hundreds of times a week, will be told that this or that service is not available today or the facility is not working. These are indecencies which need to be halted and a more honest atmosphere needs to prevail in the clinical establishments. It is a tall order. There are matters such as fire safety equipment, desire for cleanliness and for infection control, convenience facilities that need some sort of mention in the CEA in greater detail. But the establishments are not going to like it. It costs. Standard treatment guidelines are also mentioned in the legislation. Two hundred and twenty-seven diseases have been chosen to be treated according to the guidelines. Writing such guidelines, converting them into electronic form, confining the doctor to use them with algorithms, and readymade treatment options are undertaken passionately by many, struck by the idea that technology will erase poor-quality medical care. I believe, however old fashioned I may seem, that the sequence has gone wrong. The doctor should work without these readymade databases which may be used when a satisfactory conclusion is not forthcoming from the illness to check its course. Technology in health care is a larger issue than may be assumed. This is discussed extensively in Chap. 8 The Western Model in Disease and Health Care Deliver in this volume.

The Other Provisions in CEA under Different Articles 13. (5) The conditions laid down by the act for provisional registration, for temporary registration, acknowledgement of the receipt of the application, conditions for grating provisional registrations, conditions of deemed provisional registration (14) validity of every provisional registration, renewability for next one year. (16) non extendable renewal period of … registration of such establishment, (22) depending upon the date of various establishments 5 year validity of the certificate of permanent registration, (28) the time given to applications for renewal of permanent registrations, similarly reapplication criteria, after deficiency corrections.

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(29) cancellation of registrations under the offenses prescribed, (30) (b), if there is imminent danger to the safety of patients by the clinical establishment … or the person is convicted, provisions of appeal and the constitution of the appellate authorities are covered in  several Sections in the CEA (for them.) Even if viewed with skepticism these are as fair as can be. The apprehension is about dealing with babus and wastage of time. No government can assure the people that they will not have to face all this. In 2020, all these processes should be online reducing this human interface. The section which IMA seems to be opposing most vociferously is 37 about the Offences, in connection with the various applications mentioned above. The penalties are mild, and financial and adequate time periods are provided to rectify mistakes. Does the IMA want a shady presence for their members away from the law? (39, 1) penalties for willful disobedience or obstruction to the authorities These penalties are even milder than previous ones. Willful misdirection by providing false information is another contention the IMA seems to have a problem with as far as the fine of Rs 1 lakh is concerned. In short, any kind of record and accountability through this is anathema to IMA. Article 54 of CEA demands that the rights of the patients should be displayed, the contents of which are also provided. This is to prevent disrespect for patient’s rights. Such measures empower patients, something the profession is unwilling to do. However, even if these are displayed it may still not change the attitudes. IMA’s press release on November 28, 2012, states that “Provisions in the said Clinical Establishment Act will increase the establishment cost … directly reflecting into the increased cost of treatment … the provisions in the Act are such that small hospitals giving treatment by charging very low fees will have to be closed down. The Act insists upon the maintenance of Electronic Health Record, which the IMA feels will escalate the costs” (IMA press release November 28, 2012). There was a rebuttal to this press release by Dr Anant Phadke, essentially exposing the unreasonable opposition, the suggestions of which are mentioned below in the flow of discussion (Phadke Dr. Anant, December 9, 2012 10:36 PM via email ‘Clinical Establishments Act, 2010’: IMA’s Opposition to ‘Clinical Establishments Act, 2010’: Taking a look at the facts).

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Installing a few computers and simple software should make little difference to the final cost. It is very unlikely that expenditure on hardware will lead to closure of small hospitals, as argued by the IMA. There are several software programs for accounting, taking inventory, ordering, purchasing, billing and all such administrative and finance matters, which are now well established in society. IMA and such establishments have no justification for not adopting these, unless it is driven by the desire to show as few earnings as possible. The situation regarding patients’ electronic health records (EHR) is not so simple. How extensive, how intensive, with what features to capture which data are not simple questions to answer. It should be needs-­ based and guided by the size of the operation of the establishment—and will have to be simpler for smaller establishments, and intensive for larger ones. Instead of specifying or creating EHR, it should be left to the owners of the establishment. The numbers and the conditions under which patients are seen in India is markedly different and far more taxing than in Europe or the US, putting considerable limitations on doctors. Thus the opposition to electronic health records does not boil down to expenses but to the completely alien logistics discussed in Chap. 8 The Western Model in Disease and Health Care Delivery in this volume. An electronic billing system under a negotiated and accepted tariff in all third-party payment systems is a precondition which the establishments accept. Hence, instead of a blanket opposition to the Act, adopting such a setting can also serve their general accounting needs and EHR as well. There is no Retrospective Implementation of the Act, as argued by the IMA in Maharashtra. Existing Clinical Establishments will be given two years to implement the quality parameters that would be formed under this act. The formulation of the quality parameters as per the Act itself will take some time to be prepared. An IMA representative has been given membership in these committees. IMA at the national level is already involved in the process of setting up of clinical standards. (Phadke, ibid.) Fines in the Act seem to be confined only to non-registration within one year of the Act coming into force, to the tune of Rs 50,000 if the registration is not done within a year, and 1 lakh if it is not done in two years. Moreover, the decision of the Registering Authority is appealable before the State Council, specified within the Act. Thereafter the jurisdiction of the Courts can also be invoked. There is no clause of imprisonment

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in this regard which the Bombay Nursing Homes Registration Act has, which the IMA incidentally praises. Stabilization of the patient’s health in an emergency as a sacrosanct duty was decreed by a judgment of the Supreme Court of India as long ago as 1989. It was passed in a ruling by the Supreme Court which makes it obligatory for hospitals and medical practitioners to provide emergency medical care (Katara Paramanand v. Union of India (AIR 1989 SC 2039)). The Central government has declared that it will bear the cost of treatments for such emergency patients for the first 24 hours. IMA believes that by making it compulsory within the law, the patient— doctor relationship will be spoiled, and this will do more damage to the health of the nation than the Consumer Protection Act (CPA) has done since its inclusion of doctors. Every doctor will have to add a casualty department to his present clinical establishment if stabilization is included in the Clinical Establishment Act (Clinical Establishment (Registration and Regulation) Act, The Gazette of India, August 19, 2010, no. 31; Clinical Establishment Act (CEA-2010, latest version is 2014 as draft bill)). However, this is not true. The CEA 2010/2014 merely re-emphasizes the SC judgment. Further, the Act under article 12 (2) mentions clearly that the clinical establishment shall undertake to provide ‘within the staff and facilities available’ such medical examination and treatment as may be required to stabilize the emergency medical condition of any individual. This does not require setting up of a casualty department in every clinical establishment. The Toothless Act Since there is no autonomous designated regulatory structure or staff to implement this Act, it is more likely to mostly remain on paper. Moreover, there are problems with this Act and its implementation. Hence a great deal of civil society initiative will be required to prevent Inspector Raj, to ensure that the standards that will be set will not be such that they will only suit the big corporate hospitals, but will protect the human rights of the patients and the legitimate interests of small hospitals as well as general practitioners. It is necessary for IMA lobbies to obtain an improved version of the Central Act legislated by taking into account the valid suggestions of various stakeholders including doctors, while developing the state-level rules and standards. The current 60-year-old Bombay Nursing Home

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Registration (Amendment 2005) Act (BNHRA) is mostly on paper, is grossly inadequate and is obsolete. It will be repealed once CEA is passed. In the interests of all stakeholders, it has to be replaced by a much better Act, for example the Maharashtra Government’s act. Further to this, the clinical establishment and doctors have to comply with all the other laws and regulations, such as the Indian Medical Council IMC Act 1956, Bio-Medical Waste Management and Handling (BMWM) Act 1998, Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994, Medical Termination of pregnancy (MTP) Act 2002 and CEA 2011. Certain state laws mandate that Health Care Establishments (HCEs) be registered. Instead of bickering over these matters the IMA can take up many other works related to quackery, as well as the issues of the illegality of employing AYUSH doctors (see Appendix B in the volume India’s Public Health Care Delivery: Policies for Universal Health Care for a full discussion (Kelkar, ibid.). Implementation of Clinical Establishment Act Jan Arogya Abhiyan (People’s Health Movement), Maharashtra State, in their letter to the then Health Minister of the state, have made a few suggestions to make the clinical establishment act to become more precise and effective (Dr. Anant Phadke, et al., January 24, 2015). 1. The Authority over the implementation of the CEA 2010 at every level is in the hands of the government health services. Since the number of doctors in private sector is around six times than those in the government set up, (and is very large in absolute terms) and the government health services already overburdened cannot really handle this. 2. The CEA covers Public Health Services also. But the Executive Officers of the Public Health Services, to be regulated are ex-officio in charge of the regulatory function also. This involves conflict of interest. Executive and regulatory authority will have to be different. This argument echoes the reasons for dissolving MCI. There is a need to create separate posts of Public Officials who would be in charge of regulation of private and public health services.3 3  This is the classic government thinking, the trap activists are falling into. The reader is referred in particular to the chapter on government planning and NRHM in the volume

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3. Registration in CEA is based on self-declaration by clinical establishments through online submission of a registration form for temporary registration and the clinical establishment has to furnish evidence of having complied with the prescribed minimum standards. Some designated staff would be needed to verify the claim (in different sized sampling) made by the clinical establishment. 4. Secondly, to assess whether the Clinical Establishment is complying with Standard Treatment Guidelines would require a system in place like prescription audits and indoor treatment audits on a sample basis by technical experts. All this involves tremendous work, given the sheer volume of number of private clinical establishments.4 5. Separation of the regulatory, executive and redressal mechanisms is desirable to give justice to the work at hand. Hence the Act itself needs modification to provide separate, autonomous regulatory structure, additional staff at different levels, mechanism for implementation and related dedicated budget. Without this, there is a risk that the Act would remain by and large on paper. 6. Increased representation for civil society groups in the State Council: Out of 20 the civic society has 3 representatives. It is a skewed representation. The government and the health care providers who are to be regulated an overwhelming 13. It would then become difficult to push, within State Council, issues of public concern which touch upon vested commercial interests. The selec-

India’s Public Health Care Delivery: Policies for Universal Health Care published with this one. It is shown there in great detail how numerous multilateral authorities are created by the government not so much to solve the problem but for it to continue in this maze. The suggestion above does exactly that. One does not know what the intention is. 4  This is a clear example of how issues become or are made complicated, discussed in the text bove as well. First the guidelines are created for standard treatment by hundreds, a huge machinery for verifying whether these are being followed or not will come in existence. It will be inherently faulty and leave a lot of leeway to decide in favor or against the same. This will clearly lead to further encroachment on the time of clinicians away from treating their patients properly. Then there will be conflict and the processes are unlikely to see a proper end. Penalties, if added, not yet mentioned, is a contentious issue. Doctors will resent this and argue on a case-by-case basis, again not seeing the end. All of this is highly wasteful. Instead of getting in to this endless maze it may be worth its while for all to develop better methods to teach and indicate that the guidelines are an aid after the clinical work gets in to difficulty and leave it at that.

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tion of the civic society members should have a transparent methodology to avoid such conflicts of interest, nepotism and favoritism.5 7. There should be a provision of prescribing ‘Range of Rates’ for clinical establishments for different kinds of treatments, for different categories of clinical establishments because there is a wide variation up to ten times between the lowest and the highest charges for the same services in a particular locality. This will avoid/prevent excessive charging and thus exploitation of patients. (Phadke, ibid.) 8. Reimbursement of charges for emergency first aid given to poor patients at standardized rates by the government should be reimbursed for which the Act will need provisions. Otherwise there is likelihood that such poor patients would be given some very perfunctory treatment if the hospital is uncertain about the expenses as recoverable from the government. In sum, these provisions also do not simplify the lengthy processes but are at least rooted in provisioning justice. There is no substitute for a service motive, compassion and sublimated self-interest.

Regulation of the Private Sector Regulation is an unpopular word. Even while defending the CEA, the fears about regulations must be addressed. Any regulation means, without exception, a powerful, sophisticated, discriminatory, merciless and extortionist handle provided to the governments, represented by the babus. For the corrupt they are not a threat but a welcome easy way out. The ways to torture the honest man are mentioned above (Gadre, ibid. 2015). Hence regulation should have a benevolent face. The related idea of a grievance redressal system is utterly worthless since it delays justice and overwhelmingly protects the babus. The agony is over the time consumed in proving one’s honesty against the corrupt machinery which labels you otherwise. Regulations will catch only those obeying the law. The crime continues. 5  The argument in itself is sound but it does not solve the problematic issue of creating body after body. These two volumes on public and private health care have insisted that all governing systems should be simple, with as little stratification as possible and decentralized, which alone make them workable. The recommendations in 4 and 5 above go in the opposite direction in all these aspects. This will not work.

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Regulations for Corporate Hospitals: A Few Suggestions The terms ‘facilitation,’ ‘streamlining’ and ‘making the private health sector people-friendly’ do not strongly convey the need and are too civil to describe the monster of the entire medical field. Therefore, all the fears about regulations have to be balanced by facilitation and such other ideas actually practised in an effective manner. Ideas about the regulation of the private sector may be considered in this light. Seemingly, the job looks impossible. In a liberal democracy like India we cannot stop an individual from doing business as he may see fit. We cannot nationalize this sector. The most important measure to undertake is to mend the public health system. To this subject is devoted the volume India’s Public Health Care Delivery: Policies for Universal Health Care, published with this one. The private sector arose due to an erosion of faith in the deteriorating government system. All measures described therein must be applied, and to do this, no new laws are needed. If there are any laws which prevent or prohibit these actions they should be repealed. Controlling Private Sector and Costs: A Few Simple Measures High-cost gadgetry should be physically located in a clinical facility and not outside as  standalone, at least hereafter. If these are outside the treating centers referrals  for its use creates an avenue for getting cuts  making it ­costlier to the patients. If these are within a treating facility cuts are not needed making it cheaper for patients of the facility or referred from outside as well. Additionally these technologies are frequently used for critical patients. It will cut the hazards of taking patients outside and bringing them back in such conditions. If these outside facilities under some arrangement can be relocated in the hospitals retrospectively it will help in many ways. There should be a mechanism to make the public aware that the tariff cards should be shared and displayed even before the treatment is accepted by the patient. This will reduce much of the extortion. This should have long been the practice but it was never insisted upon. All other measures discussed in the chapter on the pharmaceutical industry and clinical medicine in this volume should be undertaken. To the credit of the Central government, an intensive exercise for accrediting the hospitals and laboratories has been undertaken. Pune in Maharashtra has topped the nation in this regard with 471 certifications in 2018, which the doctors have found enabling. This should be extended far and wide. All the sub-standard laboratories should be closed down immediately. Capitation fee colleges should be weeded out as discussed.

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The consultants and super-specialists should concentrate on a maximum of two treatment facilities. Alternate Creation of Excellent Hospitals The government should rebuild or take over and hand over defunct hospitals to group practicing doctors under strict tariff contracts. See Chap. 9 Health Insurance, National Health Protection Scheme, Public—Private Partnership for a detailed discussion in this volume. The voluntary sector working in the interest of the nation should be directly facilitated for more work, especially in the hinterland.

Regulation of the Reservation of Seats in Medical Colleges A consensus has to be built on this issue. The reservation quotas for the SC/ST students, the depressed and the economically or otherwise backward class have risen from 27 to 33 to 56 to 75% of seats over the last few decades for undergraduate admissions. The percentage varies from state to state. Tamil Nadu is leading the tally. However, over the last 15 years it has become a shameless trend for people of privileged castes to demand to be declared backward castes and given all the benefits of reservation. The original idea of reservation in independent India was for the ‘Original (downtrodden) Castes and Tribes’ of the Hindu society. That they should continue to have this facility for their entry in medical colleges is not contestable. The request by both the Christian and Muslim community to give them the same kind of reservations for such people in their ranks cannot be addressed since this would require substantial constitutional amendments. Pursuing this would create completely unnecessary complications in place of which many other initiatives could be undertaken to make everyone’s life better. Further, if the Christian and Muslim groups want reservation for those earlier belonging to these backward castes when they were Hindus, both religious authorities must admit that there is inequality in their religious ranks as well. But neither of these religions will do this even though such stratification exists and sentiments are strong. One cannot play the double game of converting people and still demanding what has been reserved for the emancipation of the Hindu downtrodden without admitting to the notions of high and low.

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The Census of 2011 clearly revealed that the so-called Dalit Christians have retained their Hindu names to be able to demand reservation by this deception (Pachpore Virag, 2015). Like Dalits in the past, Muslims habitually demand something or the other from the governments and reservations also. If the demands are not fulfilled, a cry of discrimination or persecution goes up. I am a strong proponent of reservations for Dalits, and this should continue until they feel that they no longer need this assistance. The primary issue still  is the objection that such reservation facilities take away the desire to achieve prosperity and wellbeing with one’s own effort. The people languish and continue to beg or demand or live off such schemes. There is no stimulation in such a situation to inculcate and exhibit desire for hard work, attaining their best in terms of self-­ actualization and becoming an honorable equal with others. The reality that surfaced rapidly in 2019 was for reservations on purely economic grounds with social backwardness added. There will/should not be any objection to this. Earlier this notion was not acceptable since it would apply to the higher castes among Hindus, which the SCs and STs resisted. This may change now. The 10% reservation declared for poor upper-caste Hindus in 2018 by the Modi government was passed without a hint of opposition from any group. The limit of family income to be idenitified as a Creamy Layer family among Dalits has been raised from Rs. six to eight hundred thousand. If it exceeds the higher limit of Rs. 800,000  they will be excluded from the benefits of reservations like admission to a medical college. Another notion about this category was benefits for three generations and then exclusion so that more Dalits could then be admitted. The massive silent marches by the Maratha Community of Maharashtra in 2016 and 2017 articulated the demand for removal of the creamy layer but not of Dalit reservation and to consider economic as well as social backwardness as the main criteria. It was an admirable stand. Against this background of reservations the same is discussed in connection with reservation at both the undergraduate and postgraduate entry level. 1. The percentage of reservation should be proportional to the percentage of the population of these ‘Original Castes and Tribes’ in each of the states. The 2011 Census will be useful in deciding the proportions of the various castes deserving reservations. 2. The third generation of the creamy layer with family income above INR 800,000  should be excluded from the concessions in the entrance to the medical colleges at both the undergraduate and postgraduate level. The children of the creamy layer will have to

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fight in the open category to become more acceptable to the other upper-caste students. If by any chance the number of seats allocated to “Original Castes and Tribes” is not filled on a year-on-year basis, a few rules should be abided by to give maximum benefit to other meritorious students. Find economically backward students in the open merit list to be given preference to fill the quota. Alternatively, give admission to the students from these “Original Castes and Tribes” from other backward states such as those in the North East. It may be a good idea to create a pool of these segments nationally and accommodate them. However, if the numbers are not filled even through these measures, then the remaining reserved seats in the quota can be preferentially filled first through merit students who have marginally missed the admissions, using their marks from the highest going down the list, on a year-on-year basis so that no backlog remains. A national debate would be welcome on these matters as a whole. At present there is a complicated system of compulsory reservation for students from other states in each college supposedly with the intention of freer movement of student fraternity, to inculcate feelings of national integration. This system has two unhealthy ramifications. First, it is open for manipulation. Second, there is a running rivalry between the students from different states and those from the native state in multiple combinations. The assaults that were witnessed in New Delhi on the students from the North Eastern states in 2014 are a fairly convincing example of this ramification. It is a culture clash due to the greatly differing attitudes of North and South Indians and those from the North East. It might be a good idea to abolish this system. The political vote bank game of getting a community stamped as backward should stop forthwith. It will anyway be quashed by the Supreme Court.

Even More Contentious Issue of Postgraduate Reservation in Medical Colleges This demand stems from the politicians having Dalit backing. The politicians with a base in upper castes and the upper caste people, both strongly voice their claim on higher merit against the alleged inferiority of intellect

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or low  performance level of the reserved caste students  in  the graduate examination and upper caste students admit under merit being more eligible for postgraduate courses.  The argument is  that  higher levels of education demands higher intellectual capacity which the reserved students do not have. The same logic has been extended to objecting to the reservation policy in the faculty pool of the medical colleges. Dalits do not want this to happen. Getting in to faculty opens a way to avenge the age-old torture and insults inflicted by the upper castes. Entry of the reserved category in faculty positions is allegedly claimed to have lowered educational standards. This issue is discussed in more detail in the volume India’s Public Health Care Delivery: Policies for Universal Health Care in the chapters related to medical colleges (Kelkar, ibid.). The idea that these SC/ST students are inferior in their intellectual capacity is abhorrent. The difference is between the level and duration of exposure to education these two groups have had. And this difference is rapidly disappearing in the age of mass communication. It is sad that those coming from better circumstances of nutrition, wealth or education for 1000 years do not consider it a duty or at least simple human dignity to help those in need. This claim also presupposes that the remaining doctors from the unreserved category are going to do much better on a one-to-one basis or as a group. This is unacceptable, absurd and abject nonsense, besides being socially unjust, because this is simply not true. Are the same issues and arguments equally true for reserving the quota for higher or postgraduate studies? At best this can be answered through a case-based study of randomly chosen medical colleges. As a nation we should have the courage to conduct such a study. We can then debate and decide whether the quality and effort to impart education bears this out or reveals any radical differences. Then only can a rule be passed in anyone’s favor or the idea be rejected of the reservation of seats for the postgraduate level. As an indication of the changing times came a significant Supreme Court judgment. On October 27, 2016 (Kunal Anand, Indian Express, October 28, 2015) Justices Dipak Misra and PC Pant noted that “there should really be no reservation” and asked the government to end quota-­ based reservations. The Supreme Court bench noted that “even though there had been several reminders to make super-specialty courses seats available primarily on merit, reservation is still very much … ‘unchanged’ as if [it is] to compete with eternity.” Quality of medical services and the need to improve higher education were cited as the reasons for this

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statement. The BJP government at the center, however, spoke in defense of reservation, stating that it “…very firmly supports the Constitutional reservation for the SC, ST, OBC, backwards and extremely backward classes,” as “reservation is important for the social, education and economic development of these groups” (2015, ibid.). There was more economics involved in these debates from the 1970s to the 1990s with the Brahmins and upper castes feeling that they were being squeezed out of the job market. For over three decades since, there has been a feeling internalized by the Brahmins and upper castes to shun and move away from government, government jobs and government quotas. Since the beginning of the new millennium the governments have no longer remained the largest employer, as it was during the heyday of the welfare model of governance. Now a proportionately much higher number of jobs, and far more and diverse and often intellectually challenging and thrilling jobs and well-paying careers, are available in non-­governmental spaces. The Times Are Changing for the Better In the wake of liberalization Indians have had quite a few challenges to face to survive, which they have and are now outperforming and competing worldwide. Not all of them are Brahmins; people from other castes as well are rising from economically low family status. While the people of the reserved categories generally speaking went into government, the upper castes, better equipped in terms of family background or economic support, moved into the private and international spaces. This situation is also changing. The historical outcome of an ever-expanding process for the last 65 years has benefited the nation and its population. These opportunities have created an elite class and overall uplift of the lower castes. It has led to the lower and upper castes sharing an environment earlier denied to the lower castes. After years of the hate campaign against the Hindu upper castes of the right wing, Dalits have gradually realized that they can join the upper-­ caste groups on their terms, and that they will be respected and given a place. Republican Party of India, a party of Dalits preferred to join the right wing Bharatiya Janata Party in 2014, which has come back with a thumping majority. On an even higher level of unprecedented social engineering, Mayawati has shown the courage to call in large numbers of Brahmins, Kshatriyas

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and Baniyas to the party of Dalits, reversing her slogan to Tilak, Talwar aur Taraju (meaning the vermillion mark, the sword and the weighing balance, respectively, indicating the three upper castes), creating a social engineering of politics of massive and impressive dimensions. Mahatma Jyotirao Phule, sounded the bugle against everything that represented oppression of lower castes, including the upper castes (particularly Brahmins) over a century ago. Over a period of eight decades the RSS has remained for them the epitome of Brahmanism. The fourth and fifth generations of the direct descendants of Mahatma Phule participated in a full-­ regalia RSS rally of 100,000 in Pune on January 3, 2016, claiming that they experienced real equality for the first time here. In conclusion, it may be stated that Clinical Establishment Act and its passing leaves many questions unanswered, and requires more detailed consideration regarding the points raised in this chapter. The change in the reservation policies should be transitional. The focus has to shift from a mix of ‘tribes versus meritocracy’ to economic backwardness plus meritocracy. Until then we must deal with these arrangements with justice and a strong hand if needed.

References Clinical Establishment (Registration and Regulation) Act, The Gazette of India, August 19, 2010, no. 31. Minister of State for Health Anupriya Patel quoted in PTI | December 28, 2018, 16:37 IST. Gadre Arun, Kaifiyat, Manovikas Publication, Pune, 2015. IMA press release 28th November 2012. Phadke Anant Dr, December 9, 2012 10:36 PM on email ‘Clinical Establishments Act, 2010’: IMA’s Opposition to ‘Clinical Establishments Act, 2010’:Taking a look at the facts. Katara Paramanand v. Union of India (AIR 1989 SC 2039). Padke Anant, Gadre Arun, More Abhijit, Chaudhury Leni, Gogulwar Satish, Kolhekar Suhas Drs, Sanr Bandu, Adv, Jain Kajal, Konde Shripad, Jan Arogya Abhiyan (People’s Health Movement), in a letter to Dr. Deepak Sawant, Minister for Public Health and Family Welfare, Government of Maharashtra State, 24/01/2015. Pachpore Virag, 2015, Personal Communication to the author in an article. As quoted by Kunal Anand, Indian Express, October 28, 2015.

CHAPTER 8

The Western Model in Disease and Health Care Delivery

Western Model of Health Care and Disease: Evolution and Characteristics As the Western health care model evolved in the 1960s and even more dominantly after the late 1980s it came under criticism from various quarters for various reasons. Those who saw the diseases as a disease-poverty-­ disease cycle, or poverty-disease-poverty cycle, including in it ignorance, lack of education and traditional behaviors, did not like the disease-­ centered, technologically oriented, costly model that was skewed economically to be available only to a few and not to the masses. One such criticism is that the idea of preserving the health of the healthy in Western thinking does not go to the depth to which Ayurveda does. It is a disease-oriented model (Hegde 2009). Ayurveda, according to Hegde, talks of lifestyle changes and concomitant preventive medication. It aims to prevent a disorder from developing, which is not exactly preserving the health of the healthy. Others have been critical of modern drugs, characterizing them as relievers of symptoms, not cure of a disease process from the root. Modern drugs have been accused of undesirable side effects and serious toxicity, as if all other drugs used by different pathies were without any such effect while being effective. These are fundamentally incorrect perceptions and are discussed in the chapter on integration of medical systems.

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Mahatma Gandhi, for example, abused modern science, and every time his desi or native methods could not cure him and his condition worsened, he was rescued by the then allopathic methods. People have boasted of their ability to keep cancer tumors controlled without surgically removing them, but have failed. The patient psyche in India largely did not accept Western medicine for a long time, and to date some people suspect it of being harmful to the patient. Believing in the traditional or other non-­ allopathic systems, ready to suffer for long and unquestioningly by accepting the claims of its practitioners, is a faith the people never accorded to the allopaths. It was only in 2015 that the National Sample Survey Organization (NSSO) showed that 90% of people prefer allopathy (Singh Mahendra, TNN Updated 05:08 IST, n.d.).This has come at a time when we are just starting to have a healthier view of Ayurveda and other health sciences. Objections to the Western Model Many other intellectual objections have been raised. It is better to summarize all of these here so that the further discussions will be facilitated. Medical science has become truly statistical. It predicts in a generalized manner the probabilities of what can happen to a mass of human beings. However, it is incapable of predicting what will or can happen to a particular single individual. It can only indicate a probability by grouping him with others likely to have the same fate. This is called a high-risk group. This happens because modern medicine still thinks of the body in a piecemeal linear manner. The unpredictability of outcomes exists because the body does not behave or respond in a linear fashion; it is a non-linear dynamic system which reacts as a whole, and not in fragments. Like Ayurveda, Western medicine does not consider an individual an entity completely different from all others. There is nothing like Prakriti Pareeksha (the characterization of the individuality of each person) in allopathy since it understands the body in terms of measurable indices of each and every organ separately (Hegde, ibid.) (see more about Prakriti Pareeksha in the chapter on integration of medical systems in this volume). The way in which modern medicine has already progressed does take into consideration the wisdom of the body with and within the environment but only in a highly superficial way. The Western system wants to completely take over the body functions throughout the illness. Beyond a point it does not allow the natural functions to arrange themselves as the

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resolution of the disease process sets in. Blockade of an operating natural system within the body is the main method of treating the sick. The real issue, which will be dealt with later, is the relentless drive to find people in greater numbers who can be labeled as having a disorder and then treat them. This is typically the game of modern medicine and not the other systems. The ascendency of Western or modern medicine began with the discovery of germ theory and the birth of penicillin and later of streptomycin followed by other antibiotics, their success in the ligand and receptor discovery and later the decoding of DNA and molecular biology that gave tremendous insights into the human body and its functioning. Up until then medieval Western medicine in many ways was quite horrific. The other indigenous medical systems around the world did not have major curative powers. The Western approach to sciences, however, was the key to the discoveries that followed. It was based on the grand principle of reductionism and resulted in rapid development of allopathy. Since the 1990s and the development of high technology there has been unquestioned obedience to new discoveries and the values which come with them. Allopathy bases itself on both the new discoveries and the different values accorded to all new data. The clinicians who practice it have incorporated the same two ideas in their DNA. This was not the phenomenon of the past. Today it has been with us for so long that we do not even realize that this unquestioned obedience is deeply entrenched in our psyche. Challenging the Unquestioned Obedience The bottom line of modern therapeutics and risk estimation is randomized clinical trials (RCTs). Epidemiological evidence tends to fortify this. Edwin Gail, the editor of one of the most prestigious journals, Diabetologia, for many years illuminated the machinations of modern science. During a lecture he delivered in Kolkata in 2012, those few who could follow the logic realized what sort of value and philosophical orientation they were following with such implicit beliefs. Gail criticized the almost unreasonable faith in the results of the trials. Trials are statistically interpreted results of highly controlled experiments in an artificial situation, in a narrow manner which provides evidence of what will happen and establishes overall probabilities and not individual certainties within it. Gail does not have a problem with this.

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This high-cost exercise finally indicates how the drugs should be used, with what precautions and whether one drug is more or less efficacious or the two are equipotent, and how this knowledge should be used in dayto-­ day clinical practice. These experiments are repeated by others to increase the validity of the results, or to refute the earlier conclusions. These experiments are of extremely high value from the perspective of knowledge. Without doubt this is a powerful tool to streamline the therapeutic practices. It is modern reductionist science at best. It is also unfortunate that the research and rigor basic to the practices of allopathy are not understood by non-allopathic clinicians and the lay public. It is disappointing that these people do not believe in allopathy. These people also do not accept that there is a need to subject the ancient science to this rigorous modern manner of experimentation to remove what is not useful. They do not understand that it will put the older sciences on a stronger foothold. At the same time clinical trials are a tool much abused by many stakeholders to selectively quote what suits their purpose and to over-interpret the results, especially associated with newer therapeutic options in the same class or different classes of drugs, or for newer indications within the same class of drugs or new drugs of a different class. Gail points out that the trials do something else as well. They deal with the increased probabilities or a disorder within the disorder being studied and its potential benefits if treated and the ill effects that may arise in a certain number (never too high) if all such disorders are not treated by the various options. More often than not, these increased benefits or warnings are marginal compared to control groups (Gail 2012). Hence if people like Professor B M Hegde, a great scholar, a fine clinician, cardiologist and an experienced researcher in allopathic medicine, call this a randomized statistically based control trial interpreted as Evidence Based Medicine (EBM) there is sense in it. Hegde has also called it Evidence-Burdened and not Evidence Based Medicine, more on which will be written later. Since the methodology is based on statistics, various measuring parameters are brought in to show that these small differences are so significant that to avoid the complication befalling a set of a few people with a certain low percentage probability, we need to treat a large number of individuals conforming to this superficial physiognomic characterization or profile. The question is: How far should one go to treat such numbers, particularly of disorders within disorders? This is a factor that clinicians do not often consider. Everything is treated for every possibility. That is to say,

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should we be treating each and every disorder within the disorder every time, and how vigorously? The clinical trial model is not just artificial; it is also rigid. That is at once the fundamental feature of such research and its great strength. As pointed out above, it cannot identify an individual who needs treatment to avoid disaster. This is because there is no way by which the clinicians or the trials can gauge who will progress, or what changes that progression may simultaneously create, either leading to more complications or to mitigation of the same. Age factors are considered in trials but related factors such as family situations and their economic conditions cannot be included in the trial. These factors, however, should guide the clinicians to calibrate the intensity of the treatment or otherwise, outside the trial context but in real-life situations. This implies weighing the possibility of more and newer adversities which may or may not develop with or without treatment. This issue must be sorted out in the minds of clinicians before more drugs (or even investigations) are ordered. Next is the cautious but unburdening follow-up (more clinical than investigative) to watch for these developments. Unfortunately, this is a neglected aspect in clinical practice since neither the patient nor the physician has time, among other reasons (see the chapter on corporate hospitals in this volume). It is not actively considered. The trial possibilities are taken too far, leading to excessive treatment schedules to reduce this intellectual burden of follow-up. There is also an unthinking or blind faith in trials. The trial data is used in defending prescription of more and more drugs. While prescribing many drugs1 the clinicians probably do not consider the factor termed NNT, or the Numbers Needed to Treat. NNT is the number of patients to be treated to avoid one and the first episode in one individual among the trial patients. The lower the NNT, the more universal the application of such therapeutic interventions. Thinking about this in the personal situation of the patient will make the practice of allopathy much more rational. Not all trials are constructed to always answer this

1  In every place drugs are mentioned this will also include the investigation aspects regarding the drug’s excessive, unreasonable and ill effects. These practices today are best illustrated in the treatment of non-communicable diseases which occur in a conglomeration of diabetes, blood pressure, abnormal lipid profiles and kidney disorders and so on which continue to deteriorate, leading to increased risk.

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question. High costs and adherence failure or compromise on treatment schedules for many reasons could lead to more and not fewer problems. In corporate work the role played by money in this kind of practice to scare the patients is already discussed in detail to scare the patients. The whole chain of such thinking is sordid, as if doing everything for everybody will save those few individuals from further deterioration, newer disorders or death. It will not. This is patent nonsense. Hence we are essentially treating probabilities within the probabilities, further complicating probabilities in numbers much smaller than reality and not based on real disease. This is a powerful argument. The Women’s Health Study was one such major blunder that deprived millions of women for over 10 years the succor of post-menopausal hormone therapy. Here sensationalism won hands down over science and failed to give the right verdict. Interpretations were too broad, sub-group analysis was poor, and the conclusion and recommendation for stopping the therapy once and for all were completely unacceptable (Herrington 1999, Sep 21; 131(6):463–6). One need not wander far to realize that the stakes of various industries in trials and their interpreted results are high. A brief exposé of the same can be found in the discussion of clinical trials in the chapter on perspectives on the pharmaceutical industry in this volume. Once the statistical significance and hence the subsequent risk are established then the treatment-monitoring-treatment and more treatment starts. Guidelines and Protocols in Brief If all guidelines issued in a year were printed, it is claimed that the combined weight would be 30 kilograms. This emphasizes that there are simply too many of these per year. Gail had many severe comments on the unvarying hegemony of the guidelines and protocols with power over clinical decisions worldwide, irrespective of the fact that the genetic profile and other environmental as well as social and economic factors would vary. He further indicated that these systems have the power to create guilt and fear if they are not followed, even if the clinical judgment of the treating physician is that every recommendation need not be followed. It is not a crime if one does not follow them in toto. They are just a road map. The guidelines are presented surreptitiously as the gold-standard, final repository of wisdom, which they are not. This leads to a somewhat blind acceptance of RCTs. Guidelines produce fear if they are not followed for

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various reasons, and awe in medical professionals. The guidelines are practiced to shield themselves from reactions in case of an untoward outcome. If an inquiry is set up in the case of an adverse outcome or the objections by the insurance companies are to be cleared, it is hoped that guidelines will help. These are major issues regarding the way in which the Western model is constructed and operates. It is not just a simplified description of the disease-centered model; it has far broader ramifications. Today the guidelines are published on digital platforms which often change rapidly. Attempts are being made to embed the guidelines within electronic medical record systems and mobile devices to be accessible at the point of care. The supporting evidence, which is not placed in detail with the guidelines, is to be assumed to be first class. This kind of pure information overload by too many agencies, with real-time modifications, is not desirable for practicing doctors. These items are potentially fluid. Clinical medicine does not change so often and as rapidly. It takes time to develop newer practices which may prove to be better only after a long period. Physicians of the older generation like me have been apprehensive about one more change which may arise. In half a dozen years the emerging methods in medicine are going to overrun the clinician’s better and keener or closer judgment (see below). Even when the RCTs and meta-analysis rule, ‘supreme research’ can still be designed in a manner that brings out the result predetermined by the funding agency. It may also be stated that most modern medicinal research is repetitive. Evidence-Based Medicine The volume of research on which the idea of evidence based/burdened medicine stands is large. There are 25,000 biomedical journals in print which pour out 8000 articles per day (Bazian Data 2001/2003). Ninety-­ five percent of these studies from among the indexed and non-indexed journals cannot reliably guide clinical decisions. At least a third of the research in the world is not available to English-speaking clinicians (Kapur 2003). The Major bibliographic databases cover less than half of the world’s literature and are biased toward English. Out of these only a fraction can be found by the average searcher. The textbooks, editorials and reviews that may not have been prepared systematically may be unreliable.

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Much evidence is unpublished, but may be important. More easily accessible research reports tend to exaggerate the benefits of interventions. An average clinician practices for 10 to 14 hours and sleeps for 7 hours. There is also their family, socialization and conferences to attend to. Assuming he reads at night, it will probably be with a tired brain. Yet he is supposed to make good judgments based on bad evidence. Will he be in a position to decide on the quality of information? The accuracy/verifiability, authorship/affiliation, content/purpose, and currency and objectivity of the topic researched also decide the quality of the research. He should weigh this also. How Far Will the Evidence- and Protocol-Based Medicine Go? A certain madness has been observed in Western researchers originating in their evidence and the organ protection mentality. It was boldly contended that irrespective of the fact or the mere probability that organs such as kidney, heart and brain are going to be damaged seriously in about a third of the patient subset of diabetes in 20 years, these organs should be protected even before any sign of their getting afflicted occurs, irrespective of the years such treatment may go on. The best physicians have advocated combinations of ingredients covering all possible complications as starting therapy in one pill in low doses. It has been proven that all these drugs reduce/prevent complications or their acceleration in affected patients. The question is whether in the absence of evidence patients should be treated for potential development of disease. Even then, how and why should this be considered rational? The last argument in such a case would be that in disorders affecting multiple organs such as diabetes, a complete and ‘a monolithic’ therapeutic regime must be established so that ultimately there will be no need to have as many doctors as we have. We have to first detect if something that needs treatment exists or not. Second—how high the possibility of its coming in to existence in, justifying preventive treatment from beforehand. If we are not going to expend energy on these matters and decide then prescriptions can be mechanically written by computers. There is only one way to achieve better care. This is the radical and time-honored change back to the earlier practices of doctors. The possibilities arising from a diagnosis must be given weight to lead the management of disorders, be this through investigation or treatment. The physician must be freed from the burden, guilt and consequences of not

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using the protocols, guidelines or evidence. He should be made aware of these instruments, where to find them and how to use them. These measures must come after the clinical processes and reasoning for assessment are completed and any uncertainties remain even after that.

Clinical Trials Clinical trials have evolved over decades, with blunders committed and disasters faced that have led to their continued improvement. These refinements have reached a stage where which trial or which evidence arising from it is unassailable and should be followed and how is to be determined. This understanding will remove the fear, get rid of sub-standard research or guidelines, and reduce the sphere of knowledge to a manageable quantum. What is lacking is the precise idea of these matters in the mind of the clinician. Today the best design of a clinical trial worth considering is the multi-­ center, long-term, (meaning at least three years), prospective, randomized, double-blind, controlled, crossover trial with a washout period with active comparator. Any published research not meeting these standards can simply be ignored. The first two levels of evidence IA, meta-analysis of well-designed clinical trials and IB, a single trial well designed alone are worth considering. If doubt remains, the Cochrane database is the final answer to guide practice. Randomized Control Trials (RCTs): Against the Guidelines The guidelines are just that: guidelines.2 They are a derivative product of RCTs. Guidelines are simpler to read, and more or less common to different bodies. To mainly follow RCTs is an intellectually tiring matter for doctors. However, it is still recommended that RCTs should be perused more often for guidance. Ultimately, one must pay attention to the maximum comfort of the patient in treatment administration. Needless to 2  In 2007, an ingenious Indian doctor calculated that if all the monitoring parameters advised in all foreign guidelines for diabetes had to be followed for a year at a moderately priced private practice in a metropolis, it would cost INR 147,000 at the then rupee value. I have heard him speak in person. Like the guidelines mentioned above of whatever the veracity it underlines, the point that just too many of the recommendations from too many sources are taken too seriously and implemented without scant respect to the time, money, the relevance and benefit to the patient. All of it is a colossal waste.

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say, the lure of doing things for beneficiaries other than the patient may be difficult to resist, but must be achieved. The last and most diabolical effect is the forced or willing abandonment of one’s clinical judgment about how much should be achieved and what tools to use. Guidelines intruding through technology are considered to increase the harmonization of guidelines with other organizations in the US and abroad, to result in minimizing the confusion and to enhance adherence to the recommendations. If all guidelines had most aspects in common there would be no need for so many from so many organizations. All this is highly objectionable since the grade of evidence assigned to the guidelines is the lowest. Additionally, guidelines as published on electronic media do not provide the evidence from which these are derived. It has to be assumed that it is first class. The clinician needs time to think about these. Bombarding him will not help. If there are wide variances within common guidelines, which one should he follow? It is insulting to clinicians all over the world who have systematized their practices using their experience and other standard materials like the above. Assessing the Quality of Trials for Implementation in Practice The conclusions reached by trials are made on the basis of statistical significance about one finding over another. There are many other factors which must be carefully noted before the conclusions are accepted. 1. How the two groups, control and treatment, are constituted: the demographic details and the kind of comparability they have and variation of the ranges between the two, or whether age matched or sex matched or both age and sex matched and whether these two resemble each other without necessarily being absolutely identical. The last one in particular should ring a bell of caution if these are identical without variation. These details decide the quality of randomization to avoid bias which seeps in though minute cracks. 2. This exercise of trials involves millions of dollars. If an equally efficient result compared to the other drugs exisiting surfaces then it will be harder to choose one drug over another, except in terms of newness, not necessarily the best choice. If a drug proves to be inferior to an established one, it is tantamount to pharmaceutical/ economic suicide. Earlier this was the reason why placebo trials were rampant since the active drug will most of the times show better results.

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3. Frequency of severe adverse reactions with and without dropout percentage must be paid attention to as it represents potential dissatisfaction in practice if trial drugs are prescribed. In analyzing a trial one must ascertain that the data on both these factors is presented adequately and truthfully. 4. Doctors generallly do not reads the section on methods and materials where the value of the research article could be judged first and fairly decisively. This includes simple criteria of primary and secondary end points, the sample selection, method of randomization, and indications of quality which may go missing. 5. Three years as the minimum duration of the study and the reasons for its termination beforehand shed light on the acceptability of the conclusions. 6. The appearance of an article in a prestigious journal is not an automatic guarantee that the study will be worthwhile. Many of these are sub-standard or superficial, printed out of some other consideration. 7. The clinician needs training in deciphering what has not been mentioned in the written trial, held back from being revealed, before making a final judgment on the quality of the evidence. The important issue is that what is claimed is most important to scrutinize, but what is being concealed is even more important. 8. The design faults, inadequacies and quality of life issues are also equally important, evident in the section of materials and methods. 9. Trials give concrete data arising in highly specific, artificial experimental conditions which are not found in clinical practice. Hence, reflex extrapolation of the trial results deciding the choice of therapy in the clinical practice is somewhat risky and not so simple. Clinicians must think before acting. 10. The entire discussion above is intended to establish only one point. The so-called Evidence Based Medicine, Guidelines or Protocols and even RCTs are not applicable in every clinical situation. One need not feel bound to follow them. The clinical acumen must reign supreme. The totality of the person’s life has to be established where disease is a part of the life and not vice versa. For that we need doctors who are trained differently.

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Limitations of RCTs, Guidelines and Protocols The Cochrane Collaboration mentioned in the chapter on the pharmaceutical industry and clinical medicine is the final aid for decision making. The majority of clinicians do not have a good idea of the Cochrane Collaboration or an easy access to it. If they have it, it will save doctors a lot of stress over decision making, in fact decrease their prescription length. The Cochrane Library provides high-quality information to people providing and receiving care and those responsible for research, teaching, funding and administration at all levels. Here nothing less than full-fledged randomized, controlled, double-blind active comparator and crossover trials and earlier meta-analysis are accepted for scrutiny. The opinion is the evidence is sufficiently strong for the option to be utilized in therapy, or this is not the case. Or there is no evidence of work available over this issue and it needs to be generated. These opinions decide whether a drug can be or cannot be recommended. Thus it is extremely difficult to receive an endorsement from the Cochrane Database for what the clinicians are doing in routine practice. Algorithms similarly cannot and do not take one too far in general medicine. In practice majority of the situations are fairly simple. To expect that the clinician should turn each disease entity into an algorithmically diagnosable entity, that too by using fixed tables and the computer as a process, is insulting. It is potentially harmful since it takes away the active role of the brain in establishing a suitable algorithm each time it processes a disease entity, whereas the unvarying algorhythm will be mindlessly repeated by the computer on one’s side. On the other hand the algorithm should be used if one gets stuck in the process of differential diagnosis. Along with this will also arrive a lack of totality which our senses provide us when we are looking at a person, talking to him and trying to think out what it is that we should be doing. The major problem a few years down the line in practice for all medicos in India at least will be the blurring, mixing, chaos and disappearance of critical clinical reasoning and its articulation in day-to-day practice on each occasion of treating patients. These kinds of computerized processes cannot ever cover the spectrum of symptoms in the disease complex. In terms of the enormous variations within every individual, the algorithmical process if used will take away the doctor–patient relationship. It will also take away the capacity of the brain to think, leading to atrophy.

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Now we will turn to other aspects introduced by modern/Western medicine.

Information Technology in Health Care Delivery and Corporate Hospitals One great thing technology does is create human independent systems which if used properly will lead to more complete and much less erroneous data entry, and the functions it generates and controls. Today there is a lot of hype about it in the media, from blogging to holding national and international conferences by expert technologists and gadget gurus. The base line theme is constant. More and more technology will solve more and more issues and problems; the best thing is already at the doorstep or around the corner. There is no doubt expressed about its great utility and that it must be accepted to remain at the cutting edge and so on. The reader, however, must also understand that it is a situation comparable to darkness below a light source. We have not solved the basic human interest issues, and the purpose of these two volumes is to discuss and suggest strong and doable solutions. And the discussion is about technological sophistication as the key to solve the same. One of the fallouts of this is the use of information technology in the direct delivery of curative services. It has expanded and has covered numerous aspects of health care delivery. There is an interaction of human factors, both patient and doctor first, with the technological matrix coming in later. Technology tends to add more processes and complicates itself at higher workloads, making it more and more intractable and difficult to comprehend as a whole. It tends to fragment and the users become dependent on the technicians who understand little about health care. Technology also increases the distance between the caregiver and the patient. Health care providers immerse themselves in working through computers to address the patient’s needs. This alienates patients from the human interaction-based, trust-­based experience they want and need. The danger of technological invasion and its underlying assumptions in doctor—patient interaction should be understood as follows: 1. It is allegiance to and assumed superiority of the technology, above human intelligence.

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2. It supports the notion that a doctor today (in spite of having a human brain) functions so poorly that he needs to be supplied with these tools to deliver proper care. This is where the excessive dependence on Western thinking begins. 3. Such processes also dehumanize a doctor dealing with a patient since he will always be looking to the computer to decide on the next question he should ask the patient. 4. The warmth and empathy of the doctor–patient relationship disappears in such a setting a tragedy as it is half the cure. 5. This much of technology is not required in the majority of cases. 6. Wholehearted acceptance of IT systems is accepting defeat for the medical college education system and teaching. 7. It is akin to stating that deficiency of what is not taught does not matter, and that even if you have learnt nothing, here is what you can easily practice with predictable accuracy and deliver results. 8. In practice there are always symptoms and other information that is not revealed for personal reasons such as embarrassment. These often lead toward the solution of the real problem which the technologically driven interaction has not revealed. For that to happen, the doctor should not be occupied with a computer but rather should be engaged in face-to-face dialogue with the patient.

Reasons for Technology Intruding upon Care Process These systems evolve on account of the exactitude of care from the beginning to end that the insurance systems demand in Western countries. They are not concerned with what the patient needs. 9. While it may be useful, it also creates a conflict within a doctor wanting to act in complex situations. He is also worried that the insurance system and its algorithms may not indicate or accept his actions for reimbursement. 10. If this happens, there will be partial reimbursements and conflicts between the three parties described in chapter on health insurance in this volume. 11. Many of these treatment algorithms have been created based on sources outside India such as the initiative of the British Medical

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Journal. The insurance company may not be following that system in India, again leading to conflicts. 12. Thus its adaptation to the Indian situation becomes necessary, which in itself is not an easy option. 3. These systems may not be able to guide the interim steps of the 1 treatment until such time the diagnosis is fully arrived at.  ow Much Protocol and How Far Can It Take Us? H How far modern medicine can be defined and effectively controlled by following the algorithmic or protocol-dependent systems is a question tantamount to asking when artificial intelligence will start either dominating or replacing the human beings. This is a classical Western paradox. When the discussions on how outmoded the several characteristics of Smoke Stack Economies and Corporations based on he idea of standardization have become and have been consigned to flames of history, here is the most unmatchable system of life, the brain which is being standardized. We are made to believe that it is possible to determine from the computer everything from the symptom level to management of the action and remedies. This hypothesis is no doubt attractive. In actuality, it is the robotization of doctors. Two points must always be remembered even if one wants to use these technologies. The first is that everything a person should and can know, think or use in whatever manner cannot be fully codified. And the second is that the final judgment should always be human. At best these technologies should be looked into ass ‘error avoiding device.’ Service Coverage and Obstacles of Information Technology The outdoor as well as indoor care are covered through IT-based systems. Individual electronic health records have been difficult and less userfriendly in indoor care. On one hand, seamless indoor case paper records in electronic format must be introduced. On the other, there are the various interfaces to execute in order to achieve this with the indoor case paper. Some of this is discussed in the chapter on corporate hospitals regarding outdoor care and IT systems. Here the situation of IT-based indoor care is discussed.

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The indoor papers that record the patient’s progression over time are generally sub-standard, sketchy and not able to draw a picture of the patient as he lies in a ward in India at least. Giving importance to proper records has not become a habit despite the consumer complaints which have risen. The question of how to do this and how much of this must be translated into electronic form is not easy to answer. Detailed discharge reports can best summarize the progress of the patients but the quality of this is poor. The consultants do not pay attention to it and the residents are not capable of grasping the important and key elements of the case or logically describing it. The larger problems of electronic health records (EHRs), however, lie at the interfaces between the nurses executing the orders, the data from the laboratory and imaging services, administrative matters, theaters and so on. It is far more unsatisfactory than one may think. The difficulties listed below come from the US.  No systematic study was found in the literature on India. A letter received by Karen B.  De Salvo, MD, MPH, National Coordinator for Health Information Technology in Washington, DC, on January 21, 2015 raises some of these issues. Twelve of the major clinicians’ organizations in the US have signed this letter. (Matt Reid, January 21, 2015, Corresponding author of the letter). It is a long letter. There are many issues raised; some important ones are reviewed below which in the main will cover the intent of the letter. This will apply to any EHR system the user has to deal with in clinical care. Make Testing Clinically Plausible The algorithm of the EHR is developed on its own and then varies according to the needs of the workflow in real situations. The higher the number of people who can use algorithmical data within and across EHRs the betters. However, it is a difficult proposition to implement in practice. A few more observations made by the 12 organizations emphasize rethinking alternative software testing methods and incorporate exception handling into EHR certification. In the best medical center in the world, the Mayo Clinic, each department over time developed its own systems as per their needs. Thus there is no common system and it is impossible to create one (Nair Sreekumaran 2010). But what is even more interesting is that this is not necessary. It does not add value and world-class research is still produced at Mayo.

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Discretion of use and human domination over how and when to use technology for valid reasons is the answer. This letter together with a press release by California Nurses and observations by Divan Dave and others clearly lists the difficulties in the working scenario (Press Release | California Nurses Association | July 11, 2013). It will give a complete picture of this dissociation. If this is the case in the US then it is less likely that this understanding will have percolated down to Indian IT managers in a large hospital setup. The considerable difficulties that arise from insistence on implementation of EHR are listed below. 1. Approximately 70% of practicing physicians are dissatisfied with existing EHR systems due to cost and poor system functionality (Dave Divan, December 2, 2014, Health Care Business Today Team). Specialists find it cumbersome, and it does not meet their workflow needs, decreases efficiency and has limited interoperability. 2. Most EHR systems comply with government demands but do not ease the work. The reasons are understandable. EHR, like most computer programs, has automated processes, yet these are not designed ­differently for different specialties, an elementary and commonsense need. This results in the filling of hundreds of cells or squares completely irrelevant to the work. Other basic tasks such as investigations and prescriptions on the other hand allegedly have not been well automated (Divan, ibid). 3. Training of staff on the system takes time. Rapid attrition and employee turnover lead to retraining, and computer glitches are of great significance in a practice (Divan, ibid). 4. Patient care concerns included (a) (b) (c) (d) (e) (f)

delays in timely administration of medications contact with physicians ability to properly monitor patients other delays in treatment from inputting and accessing data electronic work sharply cuts down on time with patients frequent complaints from patients about not seeing the nurse over long periods (g) the time to interact with the patients with computerized systems is excessively low. (Press Release California Nurses Association July 11, 2013) 5. The system is so cumbersome

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(a) that we often feel as though we are caring for a computer, not a patient (b) electronic records are naturally counter-intuitive (c) if it not designed in concert with nurses and physicians, it creates inefficiency (Thorild Urdal, July 11, 2013). 6. Care is affected due to primacy of information systems as indicated below: (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) (n) (o) (p) (q) (r)

in transferring patients to the intensive care unit delays in obtaining blood for a medical emergency insulin orders set erroneously by the software missed orders for lab tests for newborn babies little time for nurses to teach new mothers about proper breastfeeding before patient discharge lab tests not done in a timely manner frequent short staffing of nurses due to time consumed by computer work orders incorrectly entered by physicians delays in tracking physicians before tests to be done or starting of medication discrepancies between the software of nurses and pharmacies errors on medication labels causing delays in procuring and administering medications slots missing for patient information, including vital signs programmed computer responses (without any leeway for correction) computers crashing patient needs or conditions and its accurate charting multiple problems leading to fatigue because of time required inability to take rest breaks.

The axiom that you have not done the work if you have not documented it has come full circle. Now it is ‘first document and then do the work as soon as possible.’ EHR, considered a panacea for reducing medical errors and cutting costs, has not fulfilled either promise satisfactorily at the daily operational level. The US Food and Drug Administration receives hundreds of reports

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of problems with the record system itself and of numerous patient injuries and deaths (Mark W. Friedberg, et al. 2013). EHRs do not improve doctor—patient relations and patients’ experiences at clinics. Hence physicians are looking for solutions to solve the problems created by EHR solutions (Divan, ibid.). The Mid-Way to Solve the EHR-Related Issues The technology is not denied. The on-paper care continues. EHR need not sit between the doctor and the patient. The requirement for data entry operators was long denied before they started being hired since no one foresaw their utility or considered it cost ineffective. What is the massive business of medical transcription that has given employment to thousands of people in India but data entry? This may create the impression that the criticism of technology has been carried too far by me here. The information in the section immediately following may be considered in this respect. A Couple of Key Issues Not Discussed Yet The following are observations arising from my long years of experience in corporate hospitals in India. The integration of the data generated in different places for a particular patient does not occur because every such place is a standalone module with a limited sphere accompanied by its own system of operation, the famous Standard Operating Procedures (SOPs). This is universally present. It is easy to create. But nowhere is there any orderly, interlinked, ramifying, centripetally reuniting, smooth and seamless process of actually taking a patient through the disease management with maximum comfort. In any system that uses systemic protocolization or operating manuals as the basis of functioning one important aspect must be attended to. Any person anywhere in the hierarchy has people functioning in different capacities below him, at the same level as himself, and above him at various levels, to which his functioning is essentially tied. The isolated protocol will never tell him what his relation to all these people is, how this interlinks with the work he does, how to do the work and why the work should be done in a particular manner. If he does not understand this he will never realize how by not discharging his work well and in time he can affect the gears which are so intricately interlinked. This sense of totality is not provided by any hospital. Technology makes each function

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independent, but those who create or implement it never have the faintest idea of the much tougher and more important work of smooth and integrated care mentioned above is. The importers of the technology assume that these are commonsense issues and that there is no need to establish the reason for the functions being carried out. It is stating the obvious. The error is precisely here. Establishing the total context in the minds of workers through procedural manuals is stating the obvious and assuming the absence of common sense and imagination. In other words, the protocols or the working system need explanations and reasoning about why a function should be followed. It is exactly like mechanical execution of orders by ward nurses without understanding a word of why it has to be done the way it has been ordered. These issues will come up again in my volume on India’s Public Health Care Delivery: Policies for Universal Health Care published with this one. In addition, the protocols are incomplete. Each of these hospitals will boast about their automation but few live up to it. This is more a cultural issue than the issue of techniques and software. The Indian psyche and work culture compound these problems enormously. The primary grateful emotion that this work is giving sustenance at least today is absent. There is no concern about the suffering human beings who the system is trying to help. The third reason is even more important. It is the way the recruited people are trained to handle the software. It is a highly fragmented training. The message is clear—this is the (only) work you have to carry out and stepping out of that perimeter is not welcome. The result is that the workers do not develop a sense of totality of the work which lies in front of them. The suffering of humanity is simply transferred from one computer desk to another and no one is involved in handholding of the patient or his relatives to make their progress in the hospital smoother. It then falls upon the doctor to help his patients through this while others watch. Inevitably the health care managers and administrators, especially from the lower and middle levels, who have to operate the technology for which they are trained have a surreal image of themselves. But equally inevitably the fact remains that these very managers have poor knowledge of health itself, health issues, the human body, diseases and processes constituting health care, the most primary of these being doctor—patient interaction. Indians do not exert energy in facilitating somebody else’s work but rather obstruct it, taking great pleasure in telling the person opposite him that his work cannot be done right now and that he is not the one who is

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supposed to do it. Somebody else is. The person will not be directed to that other person. No information about who to go to and where will be volunteered. There is no initiative, imagination and intelligence applied. There is no way you can get an Indian sitting in the chair of a deliverer behind a window or a computer (it means the same thing) to be proactive, sympathetic or purposeful. The introduction and insistence on technology does not foster these elements of work. To take him to a higher level of interdependence is the challenge, not so much technologically but in terms of the human element which does not want to look beyond its own limit lest he has to do more work. A comprehensive Standard Operating Procedure (SOP) interlinked within the IT platform is the most elementary need, but is the most difficult. A constant threat among the handlers of technology is that their work efficiency is now measurable. This creates a typically governmental psyche of avoiding getting caught or blamed, of which bureaucratization, apathy and listlessness is the immediate fallout. Another advantage the Indian psyche quickly grabs is to find out from the systems which aspects are not their job so that they can defy anybody by not doing it, idle more and bother less. These tendencies develop easily, almost automatically, and lastly, entrench and increase. The greatest future challenge for managers imposing technology will be to create this sense of the Corporate Whole, making the care delivery wholesome, reassuring and efficient, reflecting the quality of the outfit. Doctors, the key generators and the originators of the processes of the delivery of good care, do have some idea about this issue. Doctors realize early on that they have no control or power to improve the system and will not be listened to by the managersand willl not be obeyd by the lowerranks (see also the chapter on corporate hospitals). Their feeling is—the care function was better when doctors were the key propellants of the work to be done. They had the authority to get it done when these technologies had not fragmented and complicated the care delivery! That authority having disappeared, does not work better; in fact it is worse, in the post-technology era. This is because the technology is at variance with the clinician-directed processes. Some will in fact run counter to it. The corporates have succumbed to the fascination of the so-called systematic, elaborate protocolized processes and soon realize the power they have over each worker and over doctors in particular, which they enjoy enormously (for more gory details see the chapter on corporate hospitals).

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Information Technology by Itself It is said that computers have solved only those problems which they have created. One of the characteristics of technology is that it is self-perpetuating and self-proliferating in terms of the difficulties that may arise in managing it. Moreover, these systems are growing more alike, reducing the possibility to tweak them for the better. In health care it is becoming sacrosanct and inviolable and a huge deterrent not just to the care aspect but also to the overall satisfying experience of the consumer. This is what technology has done to care. We will have to rethink our obsession with it or find a system which while being specialty specific is also integrated. Information Technological Invasion In these exciting days what could once only be seen on TV or be done by opening a computer is made easier by the large-scale availability of Wi-Fi networks, which now exist on sophisticated phones, commonplace especially in young hands. Technology impinges on the mental space of all, reducing their engagement with others and blocking out reasoning. Arguably, there should be a case for such devices to store patient information in different formats, simply because its volume is enormous. For example, there are divisions in medicine such as bio-informatics where molecular and gene information and data on their structure and comparability is stored and analyzed only through help from a computer. It is far beyond the human brain’s capacity. In the context of health or health care provider units these remote technologies are being used for keeping in touch with patients, reminding them of their appointments, opening call lines for 24 × 7 help and so on. Each one is pulling the patient in the direction of their outfit to retain him in their circuit so that revenue generation continues and marketing can continue to boast about their concerns for their patients. As is most logical, in this era of democratization of technologies, if one person possesses a certain technology then others will have it within two days; there is congestion in the virtual space of people’s lives. The banks are keeping in touch, as well as hotels, restaurants and many health care facilities. In this outward movement of running health care, the attention, the effort and the careful improvements in the services on the ground receive less attention. One reason for this is that the lines between

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administration and marketing are blurred. The hullabaloo over technology and the sense of how well we are doing shifts the focus from the ground to the air. Future Challenges of IT in Indian Health Sector The characteristics of technology, the human factors and their interaction form the matrix of these challenges. The challenge of converting the data on patients admitted in wards with various levels of complexity of a clinical problem is much less satisfactorily solved, because of the extremely diverse pieces of data. There are many algorithms which outline the investigations that should be carried out, as well as the treatment schedules to be used. This may prove to be more useful as a referable repertoire when there are choices of drug/s or dose determination issues for various reasons. This is an area where EHR scores over books because of the computer function ‘Find Next.’ It is not these new systems I oppose but rather the excessive use and dependence on them, supplanting the earlier methods, and the excess penetration of these systems, which reflects our awe and reverence for these new sciences (which in truth are merely technologies). We are virtually reducing medicine to a robotic science. More and More Technologies How much more technology do we need? Will superfine technologies which may disrupt the medical care methods prove their utility? The danger is that in India there will always be people who will buy these from those who bring them over and spin money. In preparing this volume I have carefully perused scores of these reports and I have come to the firm conclusion that the fundamental flaws of our system from top to bottom will never be rectified in this way. People everywhere are talking about higher and simpler and more impressive technologies without thinking about how to improve the ground-level delivery. This is a tragedy to be avoided, and this undue adulation, worship and marketing of such tools, increasing the costs to the patient and making delivery of health more complex without solving the structure function defects, particularly of public but also of private health care, should be fought from within. The bottom line is clear. We have to have an Indian system solution for our problems. This lies in the education of the professionals and

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restructuring the health care delivery in a sensible utilitarian manner without bothering about populist features and welfare activities. The volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one has discussed exactly that. Newer IT Challenges in Health Care 1. One major challenge is the security breaches and theft of Personally Identifiable Information (PII). If this happens high volumes of patient information is stolen. The increase in Ransomware attacks have forced large patient data systems to close down to remedy the situation, which obviously disrupts the EHR based patient care for indeterminate periods. Increasing patient privacy is paramount. Patient data is now also on patients’ own mobiles and this also requires constant management for bandwidth issues. 2. Cost reduction, regulatory and legislative mandates, and process changes using technology for a competitive advantage and improving overall network performance are the future challenges for IT to resolve. 3. Company mergers and acquisitions (M&A) between hospitals and clinics are also creating network integration issues (Keith Bromley ET Health World June 20, 2017, 07:54 IST). 4. The procurement/supply chain is also governed by the IT system. The reasons for it being suboptimal in handling this are presented in the chapter on corporate hospitals. The latest challenges are the Goods and Services Tax (GST), a mechanism now well established, and government policies particularly with respect to medicines which will reduce the bottom line of expenses to a lower level, as well as vendor management. The reader is referred to the abovementioned brilliant article by Bromley for an in-depth view of IT challenges in the health industry. The methods of solving these issues are complex and need not be mentioned here. The point, however, is one made in this chapter—the complexity of IT systems make the actual providers more dependent on the techies, which had never happened before the arrival of IT.

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The Worst Exploitation of Technology The infamous kidney transplant rackets have been well known for the last many years. One of the shining examples of technology is assisted reproduction, but what goes on in its name has a much darker side. What follows is an account related to me on condition of preserving anonymity and confidentiality from many sources, briefly presented for those enamored by technology. Assisted Reproductive Technologies (ART) include in  vitro fertilization, a common term, but there are many other ‘techniques’ involved. First of all it is and is made in to an extremely costly treatment. False hopes and highly inadequate information are given to the patients about the treatment, the failure rates and the side effects. The information is also sketchy. Safer and less costly treatments are not offered since these bring in less money, but costly ones are suggested in abundance. Even untested ones such as immunotherapy are offered. Important questions on the quality of the embryo or how many eggs were produced during treatment are not clearly answered for those concerned. Age, biology and the ever-changing treatments never allow for a clear view to be presented about what is going on and about the risks. Everything is geared to increase false hopes and repeated cycles to make more and more money. Implanting more than a single embryo to a achieve higher success rate is common. This can result in twins and triplets. It certainly brings along the issues of the health of these children being compromised and pregnancy becoming more risky. Today it is no longer a compassionate science but is centered on more money, exploiting people’s desire to have a biological child of their own. It is a highly unregulated industry. The dime a dozen infertility clinics opening anywhere and everywhere have extremely high failure rates. The adequacy of training, experience and understanding of the process on the part of those running them clinics is certainly doubtful. Clinics are known to manipulate data and to adapt aggressive sales techniques to market it, with massive amounts of money coming in. It is said about these techniques that resulting children can have a strong likelihood of genetic diseases, and the quality of life of these children should become a consideration. The industry is vast. Thousands of eggs and embryos are stored but there are failures of equipment to maintain them and they are wasted and may no longer be viable.

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The risk of breast cancer in post-ART mothers and information and longitudinal follow-up on children born as a result of these treatments are important issues, but no information is available. Such unclear information may not feature in informed consent. The myth spread by the media of ART being 100% successful only creates high pressure for childless couples to spend large amounts of money with unrealistic expectations. The worst scenario is of those couples who are healthy with delayed conception. These clinics, instead of guiding them to have a normal pregnancy with a higher likelihood than ART, push them into this money racket. The high chances of success are used to create a good reputation and keep the money coming in. Often eggs from one donor are given to the wrong couple without consent, in order to boost success rates. Methods are adapted to produce false pregnancy tests and then declare a miscarriage. The obsession with having a fair-skinned child has been exploited by bringing in young women from metropolises with fair skin, admitted and hormonally induced to produce many eggs which are then offered with assurance to couples that they will have a fair-skinned child. There are other issues that are far more complex regarding surrogate pregnancies but these fall outside the scope of this volume. The section above is aimed solely to expose what obsession with technology can lead to.

The Patterns of Care in India under the Western System Western medicine demands much less effort from the patient. The patient believes that he just has to take medicines and then can do what he wants (the reader will find more information about this in the chapter on corporate hospitals in this volume). If holism is needed it is in this era of multiple super-specialties, more drugs and investigation without a sobering central control and coordination of care. Insurance in Western Medical Care This is one more Western invention that has come to India and is growing in popularity. It takes many forms. India needs insurance but with it there have to be many more structures built in, to become viable and satisfactory over a long period of time. However, there are two contradictory elements in the Western insurance world. One is the scrutiny of bills evaluated on the basis of evidence

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and protocols followed by the company. This ignores the fact that medical science and its practice are not linked to mathematics and hence there will be variations in the way a patient is treated. The actual treatment will be based on knowledge, a logical perspective, experience, the situation at the time and intuition. Intuition in reality is an unconscious rapid process of reasoning by the person who uses it. Scrutiny of bills leading to full payment within the limits set is not routine. On the other hand, the fundamental assumption of doctors is that the insured patient is a cash cow and bills are inflated as maximally as possible. This is justified by the argument that the patient is a potential litigant if something were to go wrong. Insurance in health as a whole and more related aspects of its consequences are discussed in greater detail in the next chapter and elsewhere in the volume. Online Teaching and Certification Technology This fad started in different forms many years ago. The need for sound basics during the years of training in medical colleges is a prerequisite for learning from these modules. These are super-structures which can fully sink in only after. This is discussed in more detail in the context of medical education in the volume India’s Public Health Care Delivery: Policies for Universal Health Care in the chapter on medical education. Will such on line attempts give the medicos a quality understanding of the subject? Such attempts should come as part of a continuum of rigorous face-­to-­ face training. Otherwise it will increase the numbers of people who are ‘certified,’ but quality…? At worst this is tantamount to saying that multiple choice questions are the best way of judging knowledge.

Reductionism and What It Has Done to Us The success of modern sciences was an inevitable result of reductionism, its main weapon. Modern sciences including medicine are based on the ability to reliably reproduce any function or action or proposition involved in a condition. The more we understand molecular biology in its myriad details, the more mechanistic or deterministic our life view will become.3 This throws out the window one of most contested claims in philosophy—the existence of free will. Determinism alone works. It reduces all 3

 The only place full of only uncertainties today is quantum mechanics.

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the non-materialistic spiritual or other kinds of philosophies which are the basis of holism to naught, leaving us in a bare physical world where all the fun of living is taken away. The various processes and principles of standardization, reproducibility and predictability have taken different names in medicine: algorithms, evidence in life sciences and protocols. The damage caused by these in intelligently practicing medicine is discussed in various places in this volume. It is the excess of these methods and not the processes that is causing harm. Reductionism vs Holism, a Perennial Debate There could not have been any progress in material life without the reductionist ideas and methods. Reductionism fragments, classifies and isolates, forcing one to see life in segments. More importantly, it also fragments thinking. Reductionism is analytical; it is not always able to synthesize all the fragments into a corporate whole. It is deductive but not inductive; it is narrow and hence deficient which may thus be conceded. What is not acceptable is the claim of superiority of holism over reductionism. In its most lenient form, holism is a necessary development when reductionist ideas have reached a great depth, width and height. There cannot be any holism unless there is reductionism. Hence neither is the need for holism a deficiency of reductionism nor is it superior to reductionism. Holism can be reached through reductionist ideas extended toward synthesis and wholeness. But holism does not have the capabilities of reductionism, and this means that holism alone cannot produce such stupendous progress. There are, however, situations where holism could still work for the better and lead to progress. Occidental or Western thinking is dominated by reductionism hence is fragmented is an old objection. The free fallout of the same is the compartmentalization of human being in an economic or a socially gregarious, a religious, an emotional-non-rational or a rational man and so on. All these facets are supposedly present in the same single individual. The second natural fallout is the segmented thinking about the issues he faces, the narrow and segmented solution that he offers or accepts due to this fragmented thinking. Both objections are true. But the idea or the principle of reductionism is not to be blamed for this. It is not a limit of reductionism or its potential. It is the limitation of human intellect if humans cannot synthesize the various parts of reductionism into a synthetic corporate whole. The Gestalt is a useful idea—the sum of the parts of an entity is greater than the sum of the value of each part.

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I have serious doubts about how far the holism will take us to the heights of spiritual attainment, but the role of holism arising from a sound knowledge of reductionist processes is vast in medicine, in human sustainability and hence in environmental stability. By looking at human beings holistically I do not intend to invoke the spiritual powers of both the doctor and the patient so that they can better deal with their illness once the holistic gate is opened by the doctors. Holism here is a practical, rational, synthesizing idea that is non-spiritual and hence must be undertaken since it helps people. In conclusion, there is an imbalance and inability between the extensive knowledge in the reductionist form and inability to apply the same in a holistic manner to the entire process of treatment of illness by doctors. The technology that is creating this has pervaded the smallest detail in this regard. Evidence-based medicine in all its forms unless subordinate to clinical medicine will robotize doctors. This would be a massive defeat of all stakeholders today.

References Hegde, BM Prof, What they do not teach in the medical school, Paras Publication 1st Edition, 2009. Singh Mahendra, n.d. Times News Network TNN Updated 05:08 IST Gail, Edwin, ex editor Diabetologia, in his lectures in IDEA conference Kolkata, 2012. Herrington DM, The HERS trial results: paradigms lost? Heart and Estrogen/ progestin Replacement Study, Ann Intern Med. 1999 Sep 21;131(6):463-6. Bazian Data 2001/2003, www.bazian.co quoted by Anil Kapur University of Newcastle diabetes course. Kapur, Anil 2003, lecture in University of Newcastle diabetes course. Nair Seerkumaran, Faculty Mayo Clinic, Rochester, USA personal conversation in December 2010. Dave Divan, Why One-Size-Fits-All doesn’t work for EHR, December 2, 2014, Healthcare Business Today Team. Nurses Warn Epic EHR Causes Serious Disruptions to Safe Patient Care at East Bay Hospitals, Press Release | California Nurses Association | July 11, 2013. Thorild Urdal, Alta Bates Summit’s hospital, Berkeley Press Release | California Nurses Association | July 11, 2013. Friedberg Mark, Chen Peggy G, Van Busum Kristin, M Frances, Pham Aunon Chan, Caloyeras John P, Mattke Soeren Pitchforth Emma, Quigely Denis D, Brook Robert H, Crosson Jay F, Tutty Michael, Factors Affecting Physician Professional Satisfaction and Their Implications for Patient Care, Health Systems, and Health Policy pp. 8, RAND Corporation, 2013. Bromley Keith, ET Health World June 20, 2017, 07:54 IST.

CHAPTER 9

Health Insurance, National Health Protection Scheme, Public—Private Partnership

Ayushman Bharat: The National Health Protection Scheme This is the largest government-funded health scheme in the world. It rests on the twin pillars of health and wellness centers and the indoor care. Since the announcement of this scheme various nomenclatures have been used in different contexts: Ayushman Bharat or AB, Pradhan Mantri Jan Arogya Yojana (Prime Minister’s People’s Health Scheme) and National Health Protection Scheme (NHPS). This may be confusing to the reader. The three terms are parts of the National Health Mission, earlier called the National Rural/Urban Health Mission (NRHM). The National Health Agency is the implementing agency. There should be a State Health Agency as well. It is proposed here to use NHPS as the most suitable abbreviation for all matters that concern indoor treatment. The second pillar of the scheme is related to the primary care through wellness centers and non-hospital services and will be referred to by the general name Ayushman Bharat throughout this chapter. Under the Ayushman Bharat (AB), 150,000 health and wellness centers would bring health care closer to people, so that every Indian can have timely access to health care, including diagnostic services and free essential drugs and comprehensive primary health care services. NHPS will provide secondary- and tertiary-level care requiring hospital admissions (PTI |

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September 3, 2018, 18:12 IST). The original idea was that of an insurance scheme. Later it was made into a free health scheme for designated segments of poor people. Two Basic Mechanisms and Concepts of Insurance Schemes Insurance schemes are run through either the trust model or an insurance company. Under the trust model, the premium will not be paid to an insurance company, but will be pooled into a trust. The trust will manage and administer the health scheme and also pay the claims. Under the insurance model, the state will pay premiums to an insurance company as is done for any insurance. The responsibility is on the insurer to administer and pay the claims. Both insurance and trust models depend on two basic principles: pooling of risk and law of large numbers. Pooling of risk simply means that a large number of people with relatively low risk of something untoward happening come together to insure themselves and contribute to a pool which will cover the event for the contributor and as a corollary anyone among them who suffers from an event. This reduces the risk of loss to everyone by spreading itself out among all the people facing the risk but affects only a small percentage of persons among them who will be compensated if it happens. Law of large numbers states that larger numbers wanting to avoid adverse selection improve the predictability of a risky event. It also helps to decide the individual contribution in a more exact way. AB NHPS provides insurance cover to 100 million families or 500 million people, or 40% of India’s population. Not all 500 million are going to fall sick in a short period of time. This is what the Ayushman Bharat model depends on given that this is what it is meant for (Deepti Bhaskaran, mint-­india-­wire, August 27, 2018). It is estimated that 2,000,000 people are likely to be admitted for treatment over a year (Phadke Dr Anant, Loksatta Team | March 3, 2019 12:21 AM). The AB NHPS Scheme It was announced by India’s Prime Minister on August 15, 2018. It rolled out on September 25, 2018, the birth anniversary of Deendayal Upadhyay, the friend, philosopher and guide of Bharatiya Jan Sangh, now the Bharatiya Janata Party. In total, 85.9% of poor rural households and 82% of poor urban households have no access to health insurance/assurance

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(71st round of National Sample Survey Organization (NSSO), November 21, 2015). More than 24% of households in rural India and 18% of the population in the urban areas have met their health care expenses through some sort of borrowing, the survey states. NHPS aims to provide secondary/tertiary health care to individuals from poor and deprived rural/urban families. A total of 8.03 crore families in rural areas and 2.33 crore in urban areas have been identified in an exhaustive exercise of updating and validating the data from the Socio Economic and Caste Census (SECC). The scheme reaches out to approximately 40% of the country’s population. There is no cap on family size and age in the Ayushman Bharat scheme, ensuring that nobody is left out. Existence of previous diseases is no bar. Eligible people can avail the benefits in government and listed private hospitals. For the urban poor it identifies an occupational category of urban workers’ families to include them in the scheme. SECC data was to be shared with all gram panchayats in every state (Indo-Asian News Service, IANS | March 23, 2018, 11:59 IST).The entitlement is on the basis of deprivation criteria and the deprivation categories D1, D2, D3, D4, D5 and D7, in the SECC database. For the urban areas, the 11 occupational criteria will determine entitlement. It was simultaneously launched in 445 of the more than 650 districts of India. Those who are eligible will be provided a cover of INR 500,000 for secondary and tertiary health care. It will span 1347 procedures in 20 different specialties covering items such as coronary bypass, knee replacements and stentings. The expenses under it will be borne by the center and the states in 60:40 ratios. It is good to see that zero is not being invented again, as is the case with most activities not only in government but almost everywhere, by updating and validating the already existing data. The sharing of data is honest, transparent and a deterrent to the lower-rung agencies to use it with mala fide intentions. It follows what Modi keeps saying—cooperative and competitive federalism. The Brick and Mortar of NHPS NHPS in its early stages was an insurance scheme and premiums were calculated for each family, but later this idea was abandoned and the scheme was turned into an entitlement scheme. NHPS is now a paperless, cashless and IT-based health mission which will validate the target audience eligible to avail the benefits, hopefully controlling the smart card

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misuse as well as fraud mitigation that happened with RSBY and other schemes. The eligible families do not have to pay any premiums. Technology will be the strongest point of the National Health Protection Scheme, with big data mining to solve day-to-day problems, bringing transparency and addressing beneficiary grievances, states the National Institution for Transforming India (NITI Aayog), the premier policy think tank of the Government of India, providing both directional and policy inputs. The operational guidelines were drafted by seven working groups and will be shared with the states along with the model of the tender and the contract (Panagariya Arvind, 2018). An Aadhar card is not mandatory. One would only need to establish one’s identity and eligibility during the process to avail benefits under the scheme, which can also be done through a voter ID card or ration card. All the beneficiaries will be given letters having QR codes which will be scanned and a demographic authentication conducted for identification and to verify his or her eligibility to avail the benefits of the scheme (Dey Sushmi et al., PM launches world’s largest state-funded Ayushman Bharat health scheme, September 24, 2018). Thus the people will come under a social security net and will also have mobile health cards so that the beneficiary can avail treatment in any part of the country by going to an empaneled or government hospital. In case of hospitalization, members of the beneficiary families do not need to pay anything under the scheme (Dey Sushmi et al., ibid.). The Backdrop for NHPS There are about 16 states/Central government-backed insurance schemes where either the beneficiary or another agency for the beneficiary pays the expenses through premium payments. NHPS is the last to be added, though it is not an insurance scheme but an entitlement scheme. These schemes fall outside the various programs which the Ministry of Health and Family Welfare carries out. The beneficiaries covered need not necessarily be only the indigent poor; others who are socially and economically better off are also included. For example, Yeshaswini in Karnataka includes members of 31,000 cooperatives. This factor will have to be sorted out when attempts are made to subsume as many state schemes as possible. Those eligible for NHPS will have to be separated from the non-eligible group so that one person does not reap the benefit of two schemes.

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The second major challenge is to bring under the same umbrella or share with states the NHPS.  Seven states, including Tamil Nadu and Kerala, are yet to agree to implement AB-NHPS, and Odisha is its fiercest critic. The unpardonable Mamata Banerjee has disallowed its implementation in West Bengal where the health care status is horrific. The point in favor of the many state schemes is that all are paid for by the beneficiaries or somebody else and hence these schemes are likely to be more stably self-financing than the one-way expenditure of NHPS. A couple of schemes are fully backed by only government money and have met with disaster (see below). Taking NHPS on will thus be an additional burden to the state exchequers since the center is required to pick up only 60% of the tab; the rest is borne by the states. One way to solve the issue is to transfer the population under the state schemes which fulfill the criteria for NHPS while retaining the remaining under the scheme. This is a purely financial matter, not to be mixed with the quality issues. These steps will serve one principle—that one person cannot be a beneficiary of two schemes. The third issue is sharing the hospitals used by the states to service the insurance schemes which pass the NHPS criteria. In this way the hospitals will continue to have work under two arrangements. If this is not done it will increase duplications, underutilization, multiple agencies doing the same work in disparate frameworks, with different criteria which are common mishaps, along with crowding and malpractice. To judiciously utilize the limited funds this danger lurking in the background should be scrupulously prevented. The NHPS product mix of packages is much more comprehensive than many schemes. The presence of NHPS may prompt these schemes to match their product mix to NHPS which will cost more than the pooled resources can pay. Lessons to be learnt, most importantly from RSBY and also from major six government-sponsored states schemes which the central government has studied will help reduce the clutter and economical implementation of NHPS and state schemes. Private sector insurance will make strong inroads in the near future and its impact on NHPS should be anticipated in monetary terms. The impact on the central and state government schemes could be good, bad or indifferent. NHPS will then have to consider how to continuously improve and adapt to the situation.

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Different Tunes and Different Strokes Within Health Insurance Sector The sub-nationalism of states in India is very strong and could be a deterrent especially for the merger/partial segregation of the population of the state insurance schemes with NHPS. It is up to them whether they want their current schemes to be subsumed within the NHPS or act individually. And for this reason the government cannot ensure 100% enrolment. At the same time, the state government adamancy will simply be bypassed and people will avail the NHPS scheme directly, as happened in West Bengal.

NHPS Status vis a vis Agreements with States and Other Insurance Schemes As per the Health Ministry, 33 states/UTs have signed a Memorandum of Understanding (MoU) for implementing PMJAY, out of which 29 have already launched the scheme (IANS | January 9, 2019, 07:37 IST, https:// pmjay.gov.in/sites/default/files/2019-­09/Annual). In addition, the Rashtriya Swasthya Bima Yojana (RSBY) and beneficiaries in states where it is active are also included. The Central Government Health Scheme and the Employees State Insurance Corporation schemes will be merged with AB NHPS (The Economic Times, February 25, 2019). The merger of RSBY will eliminate a great deal of paperwork and make substantial data on beneficiaries available to the other datasets to decide on eligibility. The RSBY template will also help the IT core system to be more accurate and will eliminate some of the procedural and conceptual difficulties of RSBY, for example the delayed system of payment from the center to the state. Some salient factors operating in the Central Government Health Scheme (CGHS) and Employee’ State Insurance Corporation (ESIC) schemes are discussed below. The question of merging other state health insurance schemes will be discussed later. Central Government Health Scheme or the CGHS This earliest scheme was utilized for reimbursement and certification of illness or fitness. The private sector was surveyed for advice. There was no dedicated hospitalization system to it and was a free for all territory for

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referral to any hospitals. CGHS was a non-performing scheme and should have been considered for closure to save money years ago. Its incorporation in NHPS is a via media to reduce number of schemes under central government. ESIS or the Employees’ State Insurance Scheme This is a straightforward and contributory insurance scheme where both labor force from any organized sector and the owner deposit a 1.75:3.75% ratio of salaries to the state for health benefits. It has an entire health care delivery structure encompassing dispensaries to middle-/higher-level treating hospitals in urban locations, pharmacies and laboratory facilities and so on. This will be helpful for NHPS by utilizing these built-in strengths. The bed occupancy in all the ESIS hospitals is approximately 50%; in the remote areas it is 30%, increasing the cost per bed. NHPS will bring this to its full utilization saving money. ESIS, like any closed system, is unenthusiastic about developing above-average excellence in treatment capacity, technology and further training. Now the process of becoming eligible for NHPS will hopefully start and the easy referral to avoid work will stop. ESIS/C generally does not utilize its fund allocation fully due to a small patient base (Ashtekar, 2015). This fund will now be available. There was a suggestion earlier to include the unorganized sector of labor in the ESIS (Ashtekar, 2015, ibid.). It is now included as a beneficiary among the 11 categories for the urban poor. One recent addition is the All India Service Card which labor can avail anywhere in the country under the ESIS Mission (Ashtekar, ibid.). It conforms to the portability principle of NHPS. As elsewhere, the ESIS also suffers from poor management related to construction, delays and disturbing levels of corruption (Annadate Amol, December 26, 2018, Lokmat Daily, Nagpur). Managing this will be another challenge for NHPS. A few unclear issues are: What would be the status of ESIS labor force and owners paying for treatment within NHPS? Will that system continue alongside? If it does, then can employees in the organized sectors belonging to the state/center/quasi-government enterprises and so on where the manpower number is large be brought under it and the financial terms aligned to ESIS?

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There are important lessons to be leant from the insurance schemes operating before Rashtriya Swasthya Bima Yojana (RSBY) and NHPS. A summary of RSBY and three such schemes and lessons learnt are given below. Rashtriya Swasthya Bima Yojana This scheme, once subsumed by the NHPS, will be an enabling input. Rashtriya Swasthya Bima Yojana (RSBY) can be accurately translated as ‘National Health Insurance Program.’ Admittedly, it was the best among them all. It was run by the Labour and Employment Ministry of the Central government and not by the Health Ministry, as a health coverage plan for India’s poor, giving cashless cover for hospitalization in both civic and private hospitals. A total of 23 million family units were registered until February 2011. RSBY was operational in 398 districts of 25 states, later reduced to 14 states. A total 10,116 hospitals were empaneled, of which 5941 are private sector hospitals and 4175 public sector hospitals, a good balance. During FY 2013–2014 approximately 25 million families were in possession of active RSBY cards. However, it had registered a meager 10% of the eligible population of India until March 31, 2011 (Guidelines for Revamp of RSBY—Operational Manual for Phase I Released on July 16, 2014). Each ‘below poverty line’ (BPL) unit carried a yellow biometric permitted smart card. This was recorded in the IT system. Inpatient care of up to INR 30,000, around US$ 670, was provided to each family year on year in any of the empaneled clinics. All pre-existing illnesses were not a bar. The family head, spouse and maximum of three dependent children or parents were included. NHPS has no cap on numbers in a family. Like all other schemes there was no outpatient coverage. The disease coverage was comprehensive, and this was the best feature of RSBY, unlike many other schemes described below. Even the high-value private insurance schemes have endeavored to exclude as many of the previous illnesses as possible and have tried to sell insurance from the beginning. The IT-enabled system of RSBY worked well in all of its functional aspects. The money used to be received fairly accurately. However, the cycle needed to be monthly but was tri-monthly. The Central and state governments shared the expenses 75:25. The motive of decent profit was present for every outfit that would qualify to render care. The revamped

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manual mentioned above was an excellent operational guide which controlled the scheme. The plan won applause from the World Bank, the United Nations (UN) and the International Labor Organization (ILO), as being among the world’s finest health coverage plans. Germany showed curiosity about the smart card-dependent model for refurbishing its own community safety scheme, replacing its present coupon-based scheme. The Indo-German Social Security Program, formed as part of a collaboration deal between the two countries, is steering this team work. The same applause is now being accorded to NHPS (RSBY Guidelines, 2014, ibid.) Scams involving ineligible rich people included under political hooliganism at the village or taluka level, non-portability of RSBY and disbursement issues, and the need for rate revisions from time to time for which there certainly was room finally rendered this fine scheme dysfunctional. Rajasthan’s Bhamashah Swasthya Bima Yojana (BSBY) 1. Taking beneficiaries enrolled in the National Food Security Act (NFSA), it created a comprehensive population dataset, the first of its kind. The RSBY database was also used. The female head of the household was made the chief of the family to establish other identities. 2. The ideas behind it were financial inclusion and effective government service delivery (direct transfers and non-cash benefits) which would help policy decisions later and women’s empowerment in a totally digitized mechanism. 3. The benefits to patients were available through 475 public health facilities and 568 empaneled private hospitals across the state. As of January 2018, 1.4 million people were helped under 1715 health conditions. 4. The New India Assurance Company was appointed, eliminating the Third Party Administrator (TPA) in order to reduce costs (Kamal Swati, blog site Swarajya,—March 12, 2018, 1:24 PM). 5. The private sector was encouraged to open hospitals in rural areas, to provide health care in the rural areas, reducing the burden on government facilities. NHPS may have taken a clue from it and refined the idea further.

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BSBY recognized the need to provide competent secondary care, the non-availability of which leads to a critical care situation. The numbers of non-critical cases requiring secondary-level care are far higher than critical care numbers. BSBY, as expected, was criticized as favoring the predatory private sector, a result of lobbying by several corporate hospitals—in order to corner public health funds. It opened all public health functions to these, including tertiary care (Gupta Narendra and Pachauli Chhaya, Economic and Political Weekly, December 12, 2015, vol l no. 50). This typical left of center myopic rhetoric against anything done by any government involving the private sector completely ignores the reality that the efforts recommended for decades by them for primary and secondary public health care have almost all failed. What is the issue if a government tries to give secondary or tertiary care? Instead of criticizing inclusion of the private sector the critiques could have suggested stricter and more effective solutions to regulate it. Solutions were not provided. Further criticism came regarding the poor quality of services, meager awareness and so on. Jan Swasthya Abhiyan (JSA), Rajasthan, was hit hard by the widespread promotion of government health insurance at the cost of compromising with other health programs (TNN | February 3, 2017, 10:52 IST). Brief analysis reveals that assessments made are not neutral and that their bias is known. Aarogyasri Community Health Insurance Scheme Undivided Andhra Pradesh’s Aarogyasri Community Health Insurance Scheme was the first public health insurance scheme launched in the country, in April 2007, for those living below the poverty line (BPL), later covered under the RSBY. The scheme was skewed to tertiary care services to reduce the burden and subsequent pauperization under massive debts and loss of life assets under these. It covered 65 of 76 million people, according to existing data on BPL card holders, residing in 27,138 villages. It was funded by the state’s general tax revenue in full. As of January 20, 2013, a total of 17 lakh surgeries and therapies had been performed (Kamal Swati, February 23, 2018).

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Vajpayee Arogyashree Scheme The Vajpayee Arogyashree Scheme (2010), again highly skewed, was established to offer free care for high-complexity disorders (Sood Neeraj, September 25, 2014). Yeshaswini again from Karnataka also was skewed in favor of complex surgical procedures scheme without a medical component which is many times more compared to surgical conditions. It however had a much larger spectrum for surgical conditions. Common Factors in Appraisal of These and Other Schemes These schemes catered to high-complexity conditions but excluded all other lesser forms of medical assistance that are far more prevalent (Kamal Swati, March 1, 2018). An inadequate health care model evolved without any real impact on the health needs of the population. Adding to the misery was the bureaucratic inertia and disinterest. It was aimed to benefit from the private sector, which alone could tackle these conditions. Large amounts of money could then be transferred to them with solid kickbacks. This was considered the motive behind making it a tertiary care scheme with the massive involvement of the private sector. These are not just misguided schemes but jokes, deliberately and cruelly perpetrated on the poor and gullible population of the country for money and votes. In the Universal (Free) Health Care proposed by some we can see this happening on a colossal level that could wreck the economy. However, due to space constraints this has not been discussed here. There are also more such misdirected schemes having much in common with these prototypes but these are not discussed. The state health care system, with nothing admirable about its ability in any way, suffered due to lack of funds in the bargain. Over-medicalization and unnecessary surgeries were rampant. The cost to government escalated. Serious doubts about its sustainability were raised. The center refused the request for financial assistance on the grounds that insurance schemes are turning out to be a ‘cash cow’ for corporate hospitals (N Purendra Prasad and P Raghavendra, Economic and Political Weekly, Vol. 47, Issue No. 43, October 27, 2012). Of the total expenditure, 77.8% was accrued by the private sector in Arogyashree (Sunita Reddy, Immaculate Mary, June 2013). Discrimination, unsatisfactory quality of care, care-related complications, charging patients for diagnostics, and unsatisfactory follow-up

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procedures were the main flaws (Vasan Akhila et al., Social Development Report, Oxford University Press, 2014). In 2014, in spite of so much facilitation these hospitals rebelled over prices. This interfered with their unregulated ways of performing unnecessary procedures and charging exorbitant rates. Later the tertiary care was extended to all citizens of Karnataka, under a fixed tariff for 447 procedures (N Devadasan, P Bore Gowda, March 7, 2014, the BMJ Opinion). The stark and common reality that surfaced was the poor status of state health services. Gandhi Hospital, Hyderabad, for example, had the capacity to perform 1000 surgeries per year. However, only 85 surgeries were performed within six months after its inauguration. Is this the way to handle health care? The reasons for poor public health care are discussed in detail in several chapters in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one (Kelkar Sanjeev, 2020). Qualitative upliftment of the public health care delivery system into the hinterland is a must to finally regulate the health sector and reach care for all. Any insurance scheme, including NHPS, that depends predominantly on the private sector will never be viable without it. Manning the hinterland with specialist services in the public sector is the answer for almost all the shortcomings of any insurance scheme in India. How to achieve this equitably, in an affordable way with quality, justice and accessibility, is the theme of the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020).

Steps Taken to Build the NHPS 1. It will come under the National Health Agency led by an independent CEO.  The registration and operationalization of it is complete. Since April 14, 2018, the Health Ministry and the Gram Swaraj Abhiyan (Freedom/Self-Rule for Village Movement) of the Rural Development Ministry jointly carried out zonal meetings with the states to discuss this scheme. Inter-ministerial coordination and co-working have been insisted upon by the Modi government right from the beginning in 2014. The above is a good example of this. 2. Design and testing of the IT system was done by May 30, 2018 and finalization in June 2018.

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This period may appear too short but obviously the center has a few fairly good IT-based models such as RSBY, upgradation through which so far should be helpful in achieving this seemingly difficult task (see below). The Telangana IT infrastructure for its Arogyashree Insurance scheme is also a good template which NHPS will use. 3. Completion of training of district officials and award of tenders by the states was to be completed in June 2018. Given the speed with which NHPS has shot forward and is performing without any noise this training appears completed by now. Matters are being handled in a meticulous way, the finest example of which is the Goods and Services Tax (GST). There were differences of opinion over GST but as of June 2019 it was a settled system after all the initial hiccups, and it will continue to improve. 4. The idea behind NHPS is, or should be, to bring together all the existing health schemes under one banner (Kant Amitabh, CEO, NITI Aayog PTI June 10, 2017). The aim is to strengthen health systems, improve access to free medicines and diagnostics, and reduce catastrophic health care spending.

Financial Aspects and Early Usage of NHPS Ayushman Bharat or NHPS (National Health Protection Scheme) was initially considered as an insurance scheme where the beneficiary contributes. In March 2018 it was reported that the Ayushman Bharat scheme was considered likely to cap the premium at INR 2000 per family. A policy of INR 500,000 costs INR 3500/4000, which was to be subsidized (M Saraswathy, Ayushman Bharat scheme likely to cap premium at Rs 2000 per family, March 23, 2018 01:16 PM IST Source: Moneycontrol.com). INR 1765 per family, based on the average total medical expenditure for treatment per hospital, was another figure that appeared (Jehani Binaifer, August 10, 2018).This idea has now been abandoned. It was anticipated that in the first year of its implementation, a total cost of Rs 10,000 crore would be incurred, of which Rs 6000 crore would come from the center and the remaining Rs 4000 crore would be borne by the states (Jehani Binaifer, ibid.). As a result of all this, in the first 100 days of NHPS 685,000 patients were treated. On average 5000 claims have been settled every day since its rollout. Services were provided at rates 15–20% cheaper than the Central Government Health Scheme (CGHS). The cashless, paperless scheme has been relatively problem-free in these 100 days (Ayushman Bharat a ‘game

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changer’; 6.85 lakh patients treated in 100 days: Jaitley Arun PTI January 1, 2019, 19:42 IST). Cited as a game changer, this initial upsurge is expected when thousands of hospitals are ready to treat. Indians are generally alert about getting something for much cheaper and rush to attain it. The surge will initially continue for about two years, as shown below. Dinesh Arora, the deputy CEO of AB NHPS, has said that the National Health Agency has already paid out 3.12 billion in INR to meet the expenses of hospital bills. This is huge. As an entitlement scheme with only government money footing the bills of private hospitals, the sustainability of NHPS will be subject to serious concern, even doubt. This happened previously with RSBY, Rashtriya Swasthya Bima Yojana, in 2011. In and around 2008 a scheme by BharatiAxa in then Andhra Pradesh suffered from an unprecedented load of patients in serious financial difficulties. It was also found that people availed the benefits just because they were available, and that this was not always justified in terms of the necessity, urgency or severity of disease (HEALTHCON 08, November 19, 2008, Hyderabad). But frugality and thrift are not Eastern characteristics. This can happen to NHPS as well. The unmet needs of large sections of people under the present health care delivery systems, both public and private, are abundant. Hence such surges are expected. And yet the early contours of the NHPS seem not to restructure the public health care system but give it the pleasant name of 150,000 wellness centers that will be established. This will be discussed further under the section on health and wellness centers. There is no doubt that the budgetary quanta have been increased on two occasions since September 2018. But the outgoings are simply too large. Early Appraisal of NHPS by the Parliamentary Committee While the government had difficulties in implementing the (existing and various) health care schemes, it announced the launch of a larger health care program in its Union Budget for 2018–2019 (parliamentary panel to look into implementation of Ayushman Bharat.

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This fits the penchant the governments have for creating multiple, multilateral schemes and agencies to do the same work as a dozen agencies may be doing already. A parliamentary committee also commented that the Modi government had released less than half of the budgeted allocation for health insurance for poor families in fiscal year 2017–2018. The revenue allocation of Rs 975 crore for the Rashtriya Swasthya Bima Yojana (RSBY) was reduced to Rs 565 crore and, as the year progressed, the actual release was just Rs 450 crore—less than half of the budget estimate. While AB NHPS was being formulated, another scheme was also making the rounds and the state governments stopped implementing RSBY in anticipation of something else coming their way. This is why the RSBY allocations the government argued were reduced (PTI Last Updated: October 8, 2018, 03.32 PM IST, ibid.). Two things clearly stand out. First, the government departments are working in an ad hoc independent manner, doing much the same: the right hand not knowing what the left is doing. This was not expected from the Modi government. Second, on the whole the issue of adequacy of funds is not addressed satisfactorily. The parliamentary committee did not fail to point out, “yet in the same breath it promises to step up coverage with the proposed launch of AB NHPS.” The then Union Health Minister J P Nadda assured the committee that there would not be any shortage of funds, which is bit peculiar and somewhat difficult to believe. The CEO of NHPS Indu Bhushan also continues to say with the Minister that funds are not an issue. An outgoing of 3.12 billion INR in 100 days certainly raises the possibility of sustaining the scheme for long. Parliamentary Standing Committee Observations on Possible Failures of NHPS The observations of the committee are addressed below. Observation 1: The committee reported that “the enrolment in RSBY …(is)… only 57 per cent of eligible …and less than 12 per cent of the eligible persons got their hospitalization covered through RSBY.” In addition, citing a comprehensive review of various studies on RSBY, the panel said that in 8 out of 14 states there was an increase in out-of-pocket expenditure related to RSBY, while only 2 of 14 studies showed reduction in expenditure.

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Observation 2: The parliamentary panel stated, “What would indeed have been a step forward is if it covered out-patient treatment as well, but that is lacking”. This recommendation is not valid anymore since NHPS is now an enttitlement scheme. However past experience of out patient insurance is given below for better understanding of the idea. RSBY tried to lessen part of the out of pocket (OOP) expenses by giving money for return passage on discharge from the hospitals, and included an extended course of drugs at discharge till the next review. But it does not and cannot possibly reduce the amount of outpatient expenses  beyond a point. For example, if the hospital has facility for food included for one attendant also during hospitalization it may be cost saving for the patient. There also could be other ways—as a general rule the hospitals should have the capability to reduce the services required from outside to an absolute minimum and make these reimbursable where authenticity is not in doubt. Outpatient and inpatient treatments are different ball games. The outpatient (insurance) model can be built as a standalone without much difficulty in a single NHPS but is irrelevant now. Outpatient insurance model can be made operative, as was successfully implemented by me with the initiative of CARE Hospital Hyderabad in 2008  in Yeotmal district in Maharashtra. In addition to this a number of suggestions have been made about handheld devices to be given to community health workers in the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020). In brief, each operational segment of outpatient care can be converted into a billing item, gets included until the quantum promised under health coverage is reached. AB NHPS is a composite scheme. Ayushman Bharat is its outpatient wing, also coming under free treatment (this will be discussed separately below). The point to be noted is that the abovementioned mechanisms of outpatient insurance will be useful in billing the care as cost within the entitlement of 500,000 per family. This money spent should also be accounted for.

Hospitals Under NHPS By June 2018 end, hospital empanelment and all testing was to be finished so that the system would be robust and reach everyone (the situation today with additional remarks is presented below). The pilot launch of the scheme involved over 1280 hospitals. So far 22,000 hospitals have been

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empaneled. Railway hospitals with inpatient facilities across 16 zones will be empaneled to provide secondary (and tertiary) care where available. Given that the railways are the largest communication network, it makes sense to include them in NHPS. People traveling by rail can receive help when needed. If the hospitals are underutilized, this will add work. Hospitals under the New Delhi Municipal Council and the North Delhi Municipal Corporation will soon provide treatment for eligible families (PTI | January 25, 2019). ESIC hospitals will also be added. NHPS must be congratulated for taking these steps so quickly for interdepartmental, interagency cooperation. It follows the commonsense rule ‘Start with what you have.’ The types of hospitals to be a part of NHPS consist of Doctor Owner (30 to 50 beds), Doctor-Manager-Partnership-Multispecialty (100 beds) and Multispecialty (100 beds or more) (Health and Family Welfare Ministry, 2018). The private sector has been regularized to build, design, finance, manage, operate and maintain the same with quality standards, and to take market risk and provide services at NHPS rates. The government authorities will provide unencumbered land on lease or through bidding, and facilitate various permissions and clearances through special windows with timelines, as well as compulsory empanelment of the hospitals for NHPS. These are commendable steps. However, looking out for fraud in this area should be borne in mind by the government since land concessions have frequently come under severe criticism. As mentioned in the volume India’s Public Health Care Delivery: Policies for Universal Health Care there are numerous hospitals with infrastructure lying defunct. Reviving them will be more cost effective than developing new ones (Kelkar Sanjeev, 2020). However, the central criticism of NHPS remains its excessive dependence on the private sector. The ‘one and only opposition’ I have to NHPS is that in the long run this is not an economically sustainable model. And this effect will be manifest in less than two years from June 2019 as this volume is prepared for publication. There is no convincing evidence that the government has paid attention to more than 5000 community health centers located in far-flung communities with a certain level of infrastructure but devoid of personnel. Developing them to suit the community’s needs, and doing this in an ‘economical manner’ without further burdening the budget allocations and the numerous purposes they serve to improve health care all round, is

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described in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Undertaking this exercise will incidentally also serve the needs of NHPS more adequately than the private sector can and will reduce the outgoings to the private hospitals (Kelkar, ibid.). Referring to the same volume mentioned above, it should be reiterated that a parallel structure is being created as is the wont of any government, without paying any attention to improving the existing one. Nor is there any mention that the resources are locked and blocked there, however few, or how their utilization for the grand purpose of NHPS will/can be done. NHPS or no NHPS, the fundamental principle of any new way of solving the issue of health care should be that the public health care structures which are situated inside the community and deep hinterland should solve the majority of problems. When more help is needed NHPS and arrangements under it should be brought in. If this is a tacit admission from the Modi government, as it was from the progenitors of NRHM, that there is no way to improve public health care, nothing could be more unfortunate. The entire volume on India’s Public Health Care Delivery: Policies for Universal Health Care is devoted to a practical model to shake the government out of this admission (Kelkar Sanjeev, 2020, ibid.). The unfortunate fascination with the primary health centers as the key block for good health care persists. The volume mentioned above argues for its dismantlement. PHCs are surfacing in NHPS in an unstable manner, which will be discussed in detail later. As on June 2019, 66% of beneficiaries availed treatment in private hospitals and 34% in public hospitals (Press Trust of India | New Delhi, November 27, 2018). Most of the patients came from Gujarat, Tamil Nadu, West Bengal and Madhya Pradesh.1 Two-thirds of the total 22,000 hospitals empaneled under Ayushman Bharat are not accredited. Accredited hospitals are unwilling to join AB NHPS where more complex conditions can be treated. (Mani Veena | Business Standard, New Delhi, November 27, 2018 06:38 IST). To interpret it as having resulted in general medical treatment much more than complex interventions is incorrect. The ground situation of 1   The West Bengal government, as was a certainty, has excluded itself from AB NHPS. However, it features in the most utilized services by patients. Disconnect between what the people want and the chief minister foolishly denying this for political expediency is clear.

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health in all non-affording communities is the poor quality of public health services even if these re free. These people are unable to pay even ordinary (read: not accredited) hospitals for general medical care which requires admission. These numbers are the largest. Complex disorders are a relative rarity in daily life. What the AB NHPS seems to have achieved in its early days is the fulfillment of this need. In addition, the idea that accredited hospitals are NOT joining the scheme to a large extent (Mani Veena, ibid.), hinting at defects in the AB NHPS, is patent nonsense. The reason for non-participation is reduced money received, which the greedy hospitals do not want. These hospitals gamble for the work avoided by them to come as emergency work in future. Remaining independent gives them a chance to squeeze the same patient they should have treated at reduced cost. This is an ugly and shortsighted approach, and in fact a stupid one. Only 34% of public hospitals across the country capable of delivering the required care under NHPS is the main worry in many forms. Only a few government medical colleges, as well as certain high-functioning and well-equipped large municipal or district hospitals, would qualify for entry. The next rung on the ladder is the public health care hospitals, the community health centers which are qualitatively poor enough to be included in NHPS. The pitiable condition of these facilities has been illustrated in detail in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. This leaves the NHPS to empanel hospitals outside public health care. These mainly come from the private sector, as shown above. Suitable hospitals in the voluntary sector would be few. The India Christian Mission and other religious bodies running hospitals suitable for NHPS have to be sought out. High-cost corporate hospitals, as noted above, have already expressed resistance. These will be required to render extremely complicated cases, for which it cannot be denied that they are competent. NHPS and its initial heavy dependence on private players is inevitable, notwithstanding the criticism that it is public taxpayer money given to fill the pockets of private players. WHO Chief Dr Tedros Ghebreyesus has (also) pointed out that care should be taken so that “private profits do not come from people” (Sharma Yogita Seth, WHO lauds National Health Protection Scheme, Ayushman Bharat, ET Health Bureau March 2018). Most public health care hospitals are ineligible. They face an economic burden since their expenses continue while NHPS adds substantially to them. As of yet there is no consideration of how to make these hospitals worthy of inclusion or how to stop the expenditure by liquidating them.

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How to achieve their eligibility is discussed in India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar 2020, ibid.). Tariffs Under NHPS and the Quarrels The private sector has fought with the government on every scheme presented so far. This happens repeatedly and unexpectedly and will disrupt health services for poor people every now and then for varying periods. The private sector has done this to all major health insurance schemes across the country and there is no reason to suppose that it will not keep happening. Private care centers under negotiation to agree on tariffs have raised protests and doubts elsewhere in the past, as well as vilification, as seen in these two volumes in other places as well (Kelkar, ibid.). This can lead to a total unwillingness to treat any such patients. Fraud under third-party payments has been found to be increasingly resorted to, as discussed in earlier Chap. 2 in this volume. NHPS has fixed the tariff and closed one end of negotiation. Judging by the speed with which claims are being settled, it appears that a mechanism that has been established to get rid of the old acrimonies and other vested interests has made claim settlement a headache. It is hoped that there are attempts being made to limit the scope for fraud in the claim settlement process. In an emergency meeting, the IMA claimed that “the package rates, 15–20 per cent cheaper than the Central Government Health Scheme (CGHS) were ‘unacceptable’ as they are exposing the patients to danger in hospitals… At such low rates the quality of services being provided will … be compromised” (that is to say, even the minimum-quality services are costlier than this), “and will put patient safety at stake…and will only breed corruption.” Suneeta Reddy, Managing Director of Apollo, quipped, “It is important that policy makers understand that there is a cost of quality” (Sunita Reddy, Immaculate Mary, Aarogyasri Scheme in Andhra Pradesh, India: Some Critical Reflections; Social change 43(2):245–261, June DOI: 2013 10.1177/0049085713492275). Quality should be rewarded. The rate fixation is trapped between the ‘value’ of quality in rupee terms and the perception of quality in non-­ rupee terms. This can be resolved proactively. No one can deny that if you throw peanuts you will only get monkeys. As has been repeatedly expressed in these two volumes, the private sector still does not understand that medicine is a high-turnover and not a high-profit margin business. Building quality is not tied up only with

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money earned or offered or desired. Largely the sources of quality are not monetary but cultural. Draft Model Tender Document Under the 205-page draft model tender document which was shared with the states in May 2018, knee and hip replacements were fixed at Rs 9000 each, stenting at Rs 40,000, coronary artery bypass grafting (CABG) at Rs 1.10 lakh, caesarian delivery at Rs 9000, vertebral angioplasty with single stent at Rs 50,000, and hysterectomy for cancer at Rs 50,000. The coronary stents price has already been capped. The tariff offered for it should be looked at from that point of view. This rate may not be the most reasonable and it could be raised through negotiations. The bypass route the private hospitals took after capping the stent price was to increase other headings unjustifiably to recover losses. This route gets blocked with this rate, and hence there is anger. The argument will be similar for CABG. Knee and hip replacement rates are rejected on the same grounds since the implants have also been brought under the price cap and maneuvers to increase billing amounts under unjustifiable labels will no longer be possible. Incidentally, an earlier argument raised was the quality of materials that will be lowered if low rates are accepted. In a later development it was found that implants supplied by no less than the multinational giant Johnson & Johnson (J &J) affected 67 patients and compensation was ordered  in    May 2019. The  implants were supplied when the  caps  on them had not been announced. None of these arguments about quality being affected hold water. All these efforts are made to avoid losing the excess money doctors were recovering from patients, which is precisely what the government wants to prevent. This objection may arise from the lack of stringency and frugality in efficient care. As shown in the chapter on corporate hospitals, maximization of billing is the chief concern of doctors today, and this may be restricted under the NHPS model, which does not pay attention to stringency or frugality. As long as the medical profession does not agree to display their fixed rates in the private sector, the first effective step toward a satisfactory collaboration between the private and the public sector will not occur. It is hoped that display of tariff is given high priority in the draft shared by the Central government.

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The resistance faced by the Clinical Establishment Act (CEA) all over the country from IMA and other bodies, where rate fixation and display is also an aspect, more than adequately shows that doctors are in no way concerned with poor people’s health in this country, and will want to continue to resort to extortions (see the chapter on the Clinical Establishment Act in this volume for more details). Morally speaking, the hospitals should not be coerced or be under any obligation to accept the rates provided by NHPS or CEA.  The same morality demands that they fix their value in their own eyes and also take into consideration the capacity of the large numbers of people who require their services. It is simple market economics in two ways. The work is going to increase sharply if they make a tie-up. If IMA and doctors understand that this will lead to a much higher turnover at a rapid rate with lower margins of profit but equal money than high profit margins and no additional work if they do not tie up???. Whether or not the satisfaction of serving the needy matters is their prerogative. NHPS cannot be implemented or succeed without the private sector in the short run as it will become unaffordable. IMA pressure has apparently been compelling and the government has come out with two alternatives (Vicky Pathare | Pune Mirror | July 18, 2018, 05:47 IST). The first is to reconsider the package rates in a periodic fashion. The other was interesting—to establish a performance-linked payment system2 designed to incentivize providers to continuously improve quality and patient safety. An additional performance-linked payment was an ingenious idea. The government has cleverly yielded on the National Accreditation Board for Hospitals and Healthcare Providers (NABH) certification as ‘not mandatory.’ But it added that NABH approval will earn 10–15% more for them.

2  There are major difficulties in agreeing on the way performance should be judged and payments based on it should be given in a way that will be acceptable to both parties. The National Health Service of England has evolved an extremely complex matrix on scores of criteria to judge and reward a performance-linked payment. In the US cardiologists have evolved 199 elements in the context of which physicians should work (see the chapter on the Clinical Establishment Act and reservation policy for details). In contrast, the NABH accreditation is advantageous since it judges and helps with systematization to improve the performance of the hospitals as a whole, not by a single doctor alone. Aarti Shahade, a physician in Pune, has carried out such an exercise along with 471 establishments in Pune and has reacted to it as described above.

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The private sector hospitals serving in difficult areas were also offered this incentive.3 Throughout these two volumes quality has been emphasized as the main fulcrum by which matters have to be balanced and developed many times over. In the tariff war the most disgruntled are the specialists insisting that the rates are not only low but ridiculously so. This arrangement will probably ease that ire. Now IMA has become a party to decide the tariff structure, which is welcome. The two likely outcomes of this partnership are worth noting. As discussed in the chapter on CEA, one of the bones of contention in opposing it was the compulsion to display (by first agreeing to it) the tariff of any hospital/establishment. With NHPS rates accepted, the rates in the non-insurance sector of their practice will have to show some alignment with these. This will not only lower generally applied rates but the objection to display rates and the major opposition to CEA will also vanish. If nothing else, this shows the immaturity of the IMA in its blind and blatant opposition to everything the government tries to do, as in the case of the AYUSH doctors, detailed in Appendix B  in the volume India’s Public Health Care Delivery: Policies for Universal Health Care (Kelkar Sanjeev, 2020). Another example of this irrationality and blindness is the opposition to banning irrational fixed dose combinations, discussed in the chapters on the pharmaceutical industry in this volume. Different types of cities in different locations, at geographical levels and with varying economic strata should have stratified rates. This may further ease the opposition of bodies such as IMA. Viability Gap and Inconsistent or Doubtful Monetary Support from the Governments is an important challenge to government. These apprehensions as perceived by the private sector should be discussed in more detail. The cost is as much an issue of perception as that of actual expenses. Referring to the rates offered by the government as lower, the private sector by a sleight of hand wishes to establish that the rates in the private sector are the gold standard. In this ‘gold standard’ there is enormous variation and thus there is no reason why this contention should be 3  Decades ago there was a fad, race and competition among hospitals to be accredited by ISO 2000 and so on. It looks certain that when a ready supply of patients under NHPS is established the hospitals will find it attractive to receive NABH accreditation.

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accepted. The same private sector has helped CGHS with its own rates for over 60 years now. Before worrying about the ‘low reimbursement rates’ it might be a good idea for the private sector to reevaluate their own cost/expense/ profit and efficiency status. This will help to decide if their profit margins are too high or the rates offered are too low to empanel. The costs are not limited to cost of items and salaries and other overheads. Costs increase fairly substantially also due to wastage and inefficiency, which no one measures. The Association of Healthcare Providers (India) (AHPI), like IMA, has complained that rates are too low for some critical procedures and it is obvious that the package rates have not been set scientifically (Raghavan Prabha et al., ET Bureau | August 17, 2018a). This is negotiable. The Central government has already shown its willingness to negotiate rates with flexibility and has made IMA a partner in rate fixation. “NHPS is expected to contribute 30-40% of the actual cost of hospital operations … (which) may not encourage private hospitals to expand to underserved areas” (Raghavan, ibid.). The rates may be too low for AHPI members, but the more than 15,000 applications for setting up hospitals in underserved areas tell a different story. AHPI  could be unrealistic and detached from the ground realities. The initial IMA opposition even denied that it had backed this scheme as claimed in the media (PTI | June 24, 2018). IMA maintained that its fundamental objections had not been addressed. It disagreed with the insurance model, claiming that billions of rupees would go to the third party settling the claims. This will not keep the health care system intact and it will collapse. It wants an exclusive trust model. The government has no objection to the trust model. It has explicitly stated that either model can be used. IMA, however, appreciated the government’s decision to empanel the hospitals from 10 beds onwards (PTI | June 24, 2018, 23:51 IST), but in the same breath it stated that NHPS in its present form will also lead to elimination of small and medium hospitals. But even if this happens, NHPS will not be the reason for it. Rather, this will be caused by the many systemic elements which have been allowed to grow and have not been reined in.

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IMA, India’s largest body of doctors, until June 2018 alleged that NHPS would be a “non-starter” due to its “abysmal” package rates. Without doubt, this was a knee-jerk reaction of the well-nurtured mentality discussed in many places in these two volumes, without even trying to find out more about it. IMA has now partnered with the government to play a more “active” role in the implementation of the scheme and costing committee to encourage hospitals to apply for body empanelment, calling it a “visionary” mission after the scheme was clarified. “In India, we have not seen a scheme of this scale yet, so it is bound to evolve,” says Bhushan. “If we’re wrong, we’ll change it, but we have to start somewhere”4 (Swagata Yadavar, Before expanding, need to consolidate: | IndiaSpend Last Updated at December 15, 2019 01:12 IST).

A Few Big Challenges in Delivering Ayushman Bharat/NHPS A few challenges that could be tougher than one might expect in delivering NHPS health care to 65 to 70% of the indigent population out of 1.3 billion are discussed below. The first is the backend online IT system and platform of NHPS since it is a paperless scheme. There are three assets possessed by the government. The first is the RSBY IT platform-based system, which was well designed and worked well. I worked with it for two years in West Bengal. The second is Telengana’s IT architecture for its Arogyashree health scheme. This is being replicated nationally under Ayushman Bharat-­ NHPS.  The third is the vast experience of Indu Bhushan, CEO of NHPS. He has taken years to build such a system for Thailand. With these assets it is not difficult to build this system much faster and better than one may expect. Previous Experience Politically agreeing with the Modi government or calling the GST implementation botched up is an individual choice. However, it should be accepted as fact that this government is not afraid of thinking big and doing big even at the risk of messing things up a little. If the reader has 4  The French were asked ‘Why do you kiss the hand first?’ The French replied ‘You must begin somewhere.’

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followed the discussions on DD News with Dr Hasmukh Adhia, the then in charge of implementing GST (as I have done) the care, competence, perseverance and thoroughness in developing as flawless backend computerized operations of GST with continuous improvement as time went by, should be highly appreciated.5 The third major challenge is effectively extending NHPS to tier 2 and 3 cities. NITI Aayog seems to have provided an answer by stating that the private sector has been regularized to build, design, finance, manage, operate and maintain with quality standards, take market risk and provide services at NHPS rates. Incidentally, this is an idea expressed in this chapter and in the volume India’s Public Health Care Delivery: Policies for Universal Health Care in a slightly different form, much before the above measure was discussed. Observations Made by the Doubting Thomases and Naysayers About NHPS Observation 1: This is a rush job without adequate preparation, and there may not have been time to iron out the details. Expressed with good intentions, this has not been found to be correct. Two years of work and discussions have gone into the preparation. So far there is no noise at all about NHPS operations. Observation 2: Health financing cannot work isolated from a ‘comprehensive’ health care system that links primary, secondary and tertiary care, and it is the health financing that should ideally act as the bedrock of affordable health care for all (Raghavan Prabha et al. | ET Bureau | August 17, 2018b). The above route has not worked for the last 40 years with ever-­declining health budgets. The linkages between the primary, secondary and tertiary care centers did not work because the models used were faulty and needed a complete change. The faults incrementally built into the public health care system and how to rectify the public health care delivery in India are

5  Among all the protests against the GST the major quantum was on provisions, which were responded to and improvements and changes made, but far fewer on the computerized operation. NHPS is a similar big idea. There is reason to believe that in a government which seems to be a learning one this will happen. Apart from Bhushan and his team, credit also goes to NITI Aayog as it has been able to structure a common template for states.

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discussed in India’s Public Health Care Delivery: Policies for Universal Health Care. Observation 3: Currently, the primary care system is skewed toward mother and childcare, and it lacks a “strong referral system” (which requires second-level care centers within public health care delivery) that will take years to develop (ibid., Raghavan Prabha, 2018b). Not only is the primary care skewed more in some areas but the emphasis on primary care at the cost of total neglect of secondary and tertiary care has been excessively skewed for over 40 years now. The worry as expressed above is the paucity of such centers in the public domain of health. There has also been a significant lack of ideas on the part of government to rectify this situation. Instead of making any effort from within, the private sector is being dragged in to achieve this. However, it cannot and will not go far enough to produce a system that solves these difficulties, nor can it sustain itself for long. The West and WHO have offered us solutions that have been of little help. One could even wonder if any agencies were interested in these problems being sorted out at all. When something like NHPS is undertaken the disquiet that follows is entirely understandable since there is a possibility that the path to problems being sorted out will have begun. Private participation on terms set by the government is one method NHPS is trying. Some evidence of reverse engineering is already present. Modi has encouraged the development of affordable health care facilities for disadvantaged people in sophisticated hospitals, for example in Jamnagar for cancer and eye diseases. He has expanded one of the largest civil hospitals in the country in Ahmadabad and is talking of including the district hospitals in super-specialty hospitals (February 2019) to precisely address the referral problems. It is not a question of increase in budgetary allocations. It is a question of how to utilize the units already budgeted for but not doing their job properly. This is the question no one has asked so far, and it is answered in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Observation 4: The traditional thinking and conventional wisdom is focusing on budgetary “allocations being jacked up only by 11.2% as being paltry, 2.16% of its total expenditure of INR 24.42 trillion for the year. No surprise then that around 80% of the poor’s acute medical needs at the primary level is “overwhelmingly” met by unqualified medical

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practitioners” (Raghavan Prabha et  al., Can Indu Bhushan deliver PM Modi’s promise of health care? | ET Bureau | August 17, 2018c). The tragedy and irony of this comment is that it comes from a former secretary of health. One might ask this person what she has done to solve this problem in her career. This is a typical example of a bureaucratic ploy to pass the responsibility onto someone else without realizing or accepting the guilt of one’s own failure. It is the poorly disguised unhappiness of a solution being offered now for which the bureaucracy did nothing for decades. Budgetary allocations are not the only way to solve the problem. The difficulties over money supply will have to be faced in the near future. Another way of looking at expenses is to eliminate wasteful, incompetent structures which do not seem to be making any difference. Another way is to use monetary provisions made for but not utilized. For example, large number of vacancies exist in public health care structure. This money remains unutilized year on year. Diverting it to areas in need of money will reduce the pressures on fresh allocation year by year. Scores of examples of such wasted money have been given which can cut huge expenses reducing the pressure on budgetary allocations which may then become adequate. In addition there are absurd recommendations with which NRHM is replete which when cut out will save enormous amount of money. No one has looked at the problem this way. I have dealt with this in great detail (Kelkar, ibid.). Narendra Modi comes from a state whose people are steeped in business acumen. The Ujjwala free cylinder scheme was started using the money earned by 16.2 million people giving up their subsidy. The government is not spending much there and it is easy to see that there are other sources for money generation. Ujjwala is a starkly powerful answer to the belief that especially primary care medicine should solve the problems. No amount of education on respiratory diseases in rural people would have solved the health issues the women have been facing for millennia. Toilets have become another example of non-medical solutions for health issues for which money has not come from health allocations. Commentators must have a wider view on these matters. Observation 5: Over 50% of households either do not use or do not have access to government facilities, because of a shortage of doctors. This patently false, facetious logic dictated by vested interests and supported by conventional wisdom, is demolished in the chapter on Capitation Fee Colleges, has been even more completely demolished in India’s Public Health Care Delivery: Policies for Universal Health Care.

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Observation 6: “Late diagnosis, (lack of clarity on) … who can send the patients to the proper hospitals, (are two issues…) this hospital oriented indoor care insurance scheme is not able to address,” states Ms Shailaja Chandra (see above). NHPS has bypassed the need for referral. The portal registers a patient if he is eligible under well-defined criteria and he receives a QR-coded letter. Then he goes to the empaneled hospital and is treated. Six hundred and eighty-five thousand patients being treated in 100 days with no noise raised about it makes the referral system irrelevant. As noted earlier, NHPS no longer remains an insurance scheme and rather it is an entitlement scheme for the poor. It cuts at the root of the observation about confusion over sending patients. Does Ms Shailaja know that people in the hinterland die because they do not have a good hospital they can go to and pay for. If NHPS is ‘hospital oriented’ then it is only serving a dire need which has been lacking terribly in public health delivery for last 70 years. Notwithstanding what is written above, the sad and grave reality is that competent public health care to which there is easy access in remoter places simply does not exist. Observation 7: There is a need for a proper monitoring structure. All that the governments have done so far is monitor the situation but they have done nothing to rectify what they have found. Observation 8: Heightening prospects of bottlenecks and inefficiencies These are all-time problems. Can this government be blamed for whatever measures it has taken to simplify the process to avoid bottlenecks and inefficiencies even if the success is only partial? As an outside example, within the direct income tax procedures the Central government has made 160 changes to make the process as simple as possible (M Parkhani, Income Tax Lawyer, 2018). Observation 9: Challenges in empaneling hospitals Are the objectors aware that the qualifications of a hospital in tier 2 and 3 cities have already been developed and implemented? Eventually many more private hospitals will work to gain eligibility to empanel in NHPS. The owners will certainly be members of the IMA. The countercurrent to empanel despite IMA opposition will start from within. This fierce opposition could also decrease after IMA’s involvement, mentioned above. The owners will not take long to realize that instead of struggling for work it is better to get more work from those population segments these hospitals would never receive, setting in motion the smaller profit cycle as mentioned above with better utilization of fixed expenses as well.

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The number of private hospitals empaneled will be much higher than that of the public hospitals in NHPS, proving it to be too costly, a problem also faced by RSBY which stopped the wheel from turning. The only answer is to establish as many public health care hospitals as possible and keep the number of private hospitals as low as possible. The grim situation of the community health centers, best suited for NHPS, is the weakest link. The contents of the volume India’s Public Health Care Delivery: Policies for Universal Health Care will be the answer for this. Observation 10: Identifying beneficiaries With well-defined criteria 10.3 crore families have already been identified by using existing data. Observation 11: Potential for fraud A massive 1,100,000 false PAN cards and 350 million false ration cards have been eliminated from the system. Three hundred thousand shell companies have been clamped down upon. The record of government seems to be adequately strong to weed out fraud even from this area. The NHPS document describes the well-placed measures to detect fraud. (https://pmjay.gov.in/sites/default/files/2019-­09/Annual). Fraud has been discovered in substantial numbers and de-empanelment has taken place. Observation 12: The government would also have to pump in at least Rs 2.5–3 lakh crore, compared to the Rs 10,000 crore allocated to it, which is not going to achieve any health goals or financial protection goals, Only time and the progression of NHPS will reveal the outgoings. The fear is real. However, Indu Bhushan, CEO of NHPS, asserts that resources are hardly a challenge. His own estimate puts the requirement at Rs. 20,000–Rs 30,000 crore, 60% of which will come from the center. However, the distinct possibility raised in these pages more than once that NHPS will become too costly in a couple of years and that maintaining it may become impossible cannot be pushed aside (Swagata Yadavar, ibid., December 15, 2019 01:12 IST). Observation 13: Even this allocation is much less than total out-of-­ pocket expenditure on health care. Out-of-pocket expenses (OOP) become an issue when disadvantaged people meet an extortionist system. Instead of regretting OOP it is better to build up a system where a meager expense on the part of the poor give

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them facilities many times over and still remain satisfactory for those who can pay. A free system has many disadvantages.

NHPS and Insurance Companies There are 31 large insurance companies which have a range of products in health care. These are available for anyone who wishes to buy them and seek protection. Their own products will be on the back foot if the trust model is preferred by the states. These companies will have to concentrate on nearly 1350 NHPS products. The effort to sell their products to people not eligible for NHPS may also be affected. If the states opt for a trust model the insurance companies will be left out of the largest drive in the world to ensure health. With 33 of 38 states and UTs planning to implement NHPS, the loss to the insurance companies would be proportional to the extent of the trust model being used. “After the announcement of NHPS the insurance companies have quoted aggressively while bidding… and are hoping that … there could be a shift from trust to insurance, to check frauds and control costs, which it perceived to be much more likely in the Trust Model.” NHPS will increase awareness about health insurance (Jehani, ibid.). It will be a moot point whether they will adopt the contours of their existing schemes to match the expectations of NHPS and sideline the trust model. Is it possible to build a mix of trust and insurance models? This is a question beyond my competence. However, is it possible for such a mix to keep a check on expenses and fraud while keeping the process simple? This is worth knowing. Having sensed the large package under the government scheme of NHPS more companies will get into the arena. The maximum liberalization for the FDI in the insurance sector will further boost them. An increase in the number of companies will lead to each one having a smaller slice of NHPS.  These will then concentrate on the private insurance market. In addition to the existing 31 insurers, PolicyBazaar is set to enter the health care tech and services space. It has earmarked approximately $100 million for the new venture (Gooptu Biswarup | ET Bureau | March 12, 2018, 11:54 IST). It will directly compete with Practo and Sequoia Capital-backed 1mg Technologies. PaisaWiki is another player.

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The cost of health care could either go up or come down. The experience has been that health care costs go up when insurance enters health. In the private practice and insurance interface, corruption is also likely to increase (Gadre 2018). In view of larger monetary benefit working with private insurers the private sector will cooperate less with the governments for implementing NHPS by various tactics to open rebellion as is its wont. PaisaWiki expected to launch its first insurance product, covering the out-patient department (OPD) market by September 2018, has not made any progress till December 2020. It will be an interesting development and its success will be watched in the future. It is not so easy to create this type of product, implement it and dovetail it with the indoor treatments. Practo Technologies was also recently reported to have partnered with ICICI Lombard General Insurance to offer OPD-dedicated insurance products. The logic applied by these ventures is that the Indian health care system has a $100 billion out-of-pocket expense market. This market is expected to grow to $200 billion by fiscal 2020. These initiatives will enter into tie-­ ups with hospitals and place their representatives there to help consumers to show the expense on premium ratios. This leads to the inevitable conclusion: No government insurance scheme will ever succeed financially until the public sector increases the ability of the secondary-level care structures to deal with critical care, is able to take the maximum load of the secondary care, and to the extent possible and  keep the costly business of entitlement schemes to a bare minimum. How to achieve this is discussed in India’s Public Health Care Delivery: Policies for Universal Health Care over a couple of hundred pages, and it is shown to be economically more viable for the governments (Kelkar, ibid.).

The Large Newly Emerging Market Under AB NHPS Money makes the mares go. Thus far it has been shown how each and every move of the government to rationalize costs, the Clinical Establishment Act, conditions to become a part of NHPS indoor care, utilizing the human resources of the AYUSH system, rationalization of the drug industry, particularly weeding out of irrational drugs, creating a National List of Essential Medicines, making these available at lower cost, emphasis on generic medicines, and effective steps taken in this direction have been strongly opposed by the private sector. However, the NHPS is

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so mammoth in its outlay that, all opposition notwithstanding, various agencies are now in a cooperative mood. Lowering Prices of Drugs and Diagnostics With 10 crore families coming under an insurance scheme no one is likely to ignore this enormous market and will not think of inappropriately costing their products and not maximize the sale. As recent as February 2019 the Central government had brought 391 anti-cancer drugs under price control. Multinational pharmaceutical companies like Pfizer, GlaxoSmithKline Pharma and Abbott have proposed to launch a low-priced ‘second brand’ of their products which can be introduced into the government’s flagship AB NHPS program. The US India Business Council (USIBC) asked the government for some price fixing within it (TNN | October 16, 2018, 06:54 IST). The large Indian drug makers will also produce biosimilars and complex vaccines at much lower cost. NHPS has brought in a paradigm shift in the outlook of the most powerful entities of the world. Accused of profiteering without the public good in mind in the chapters on pharmaceuticals in this volume, pharmaceutical companies are now willing to step down on prices in high-value areas such as anti-cancer drugs. The costly diagnostics may also be produced at a much cheaper rate to help NHPS achieve its mission. GE Healthcare and SAMEER, an R&D unit of IIT Mumbai, Department of Electronics and Information Technology, are collaborating on research, design and development of a 1.5T MRI platform. SAMEER has received funding of $6 million from the government to build the first prototype. The clinical trial is expected to start by end of 2019. No one seems to mind losing the high cost of monopoly diagnostics and making it cheaper (Rajagopal Divya | ET Bureau | October 9, 2018). GE has acknowledged that it can lower costs and help health care tremendously. GE can develop “systems in healthcare that can lower the cost and will be … greatly beneficial for healthcare around the world.” The higher volumes it will achieve at a lower profit margin with a satisfactory product is economically sound. And it serves the poor for whom such services have previously been out of the question (Rajagopal Divya | ET Bureau | October 9, 2018).

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The high-cost devices companies, earlier purely focused on profits, are collaborating to produce low-cost versions. It is thus not surprising that bodies other than GE are also anxiously looking at the success of NHPS as a low-cost health care model to be implemented in other parts of the world. The Future on NHPS The CEO of AB-NHPM (Ayushman Bharat and National Health Protection Mission) Indu Bhushan wants it to be a success. It will be the stepping stone toward something bigger—universal health coverage.6 This idea will be discussed more in the pages to follow. “Bhushan,” says Erik A Bloom, senior economist and his colleague from the Asian Development Bank, “is the only one who can manage such a massive challenge.” The NHPS seems to come with a long-term goal to invest in health, including the aging population which is going to increase in another three decades. The then Union Health Minister J P Nadda has called this ‘smart investment.’ Provision of affordable, quality health care through the public health system will be its focus. Additional help will come from the private sector (IANS, Newsletter | May 17, 2015, 19:23 IST). This claim does not withstand the evidence existing on public health care with the few entities that can qualify the demands of NHPS. This is going to be the central lacuna and the government seems to have few ideas as to how to bring public health care to this level. Suffice it to say that a large public sector in health is far less expensive than private health care. Overdependence on the latter will be an economic disaster. The public health care delivery structures are far more effective and much more equitable both geographically and socially, to keep the balance right between preventive, promotive and curative care. Implementation of rational practices can also be easier. Nadda further states that “[public sector and schemes like NHPS)] protects the poor from the exploitative health promotion of the private sector and the marketing machinations it employs for excessive profits with no holds barred. A well developed public [health] sector, if it can meet the exploitation by an alternative power mechanism the state can then take on the unfair markets.” Nadda has also elaborated upon the age-­ old idea of intersectoral coordination, replacing it with the term convergent action for improving the other factors needed for better health indices such as water, sanitation, women’s empowerment, education, nutrition, and social and gender inequalities (IANS, 2015, ibid.).

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The understanding of developing the public health sector should have circumscribed the idea that it is the curative area which is so badly run in the public health sector that needs to be improved. The speech would then have made far greater sense. Without this, it is obvious that some old bureaucrat pushing this WHO-led idea of intersectoral coordination through the health machinery for decades has written the speech. It makes for good conventional wisdom which everyone nods at and feels happy about (also because the trap continues without solving the problems). I have spent scores of pages refuting this idea of convergent action and the harm it has caused, and its emphasis on public care as the panacea for all health, keeping the curative powers impotent, in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Whether one is talking in Geneva or at a five star-conference on hospitals in Mumbai, these misleading statements should be carefully weeded out and shown for what they are worth. At the risk of repeating myself, it must be stated again that unless a mid-level curatively powered community health center-like structure is not developed NHPS will fail. And the government, as this speech makes quite clear now, has no idea about the issue as a whole and thinks it can deliver the goods by fee for services through the private sector. The notion that India is looking at the future of an aging generation to come as a long-term plan also derives from the same bureaucrat who has introduced many more functions into the primary care structure regarding all kinds of tasks, added by the fanciful Indian Public Health Standards, another unrealistic document. There is a barebones analysis and serious criticism of these ideas in the volume on public health care repeatedly mentioned here. The full blueprint of how to achieve what is necessary for the public good and the success of NHPS is given there. It is hoped that the government takes serious note of this, especially the Health Minister Dr Harsh Vardhan. One more initiative mentioned by Nadda in Geneva will also receive applause. “STOP TB by 2025 in India,” he urged, adding a nutritional component to it, a welcome idea but not enough certainly (IANS, 2015, ibid.). The same volume also talks about how the Revised National Tuberculosis Control Programme should be redeployed in the changed public health structure, providing a substantial answer to achieving something close to ‘STOP TB by 2025’ (Kelkar Sanjeev, 2020).

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Then the volume mentions the vision of universal screening for prevention and management of five common non-communicable diseases—hypertension, diabetes and three common cancers of oral cavity, breast and cervix across the country. Universal screening of all diseases in India in itself is an impossibility. Moreover, this has an ethical dimension. Discovering a disease on a mass scale should involve a mechanism to answer the problem for which the people are going to come to the health center. Then there is a little proud boast about the ‘unique initiative’ called AMRIT Deendayal, an acronym for Affordable Medicines and Reliable Implants for Treatment (TNN | October 16, 2018, 06:54 IST). It is somewhat odd that implants are being used as the sine qua non of health issues. The capping of stents and implants and bringing these under the National Essential List of Medicine is a step no other country has taken. All the efforts to reduce the cost of medicines are laudable. However there is a limitation to it. Cancer medicines, cardiovascular medicines and stents are made cheaper. Yet, there are few or no curative centers within the public health care system which can use these effectively further lowering the costs. All of it gets used in private sector, without making large cost difference to the patients, as shown earlier. The NHPS has to get it done from the private sector using fee for service principles the sheer economic burden will be unbearable soon. It is likely to cooperate with the government today but there is no guarantee that it will not turn against it tomorrow. The most important point, however, is that treatment, even for significant disorders, can happen only if the services are in close proximity to people’s homes, and thus it must be prevented from deteriorating to reduce the need for sophisticated centers. There is a stark absence of this and an even starker absence of ideas about how this should be done within the government. These are more likely to succeed if public health care becomes a much larger component of NHPS for in-hospital care, as mentioned above. The future of NHPS is not as bright as it is painted. However, there are numerous ways to save it, as described in the volume India’s Public Health Care Delivery: Policies for Universal Health Care.

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Ayushman Bharat: Primary Care through Health and Wellness Centers (HWC) This comes with the usual rhetoric—transforming primary health care centers and sub-centers, along with comprehensive health care from selected health centers. The beneficiaries of NHPS are included. Services List: Health and Wellness Centers (HWCs) Planned but Not Yet Organized Child birth and pregnancy, infant health, neonatal health, adolescent health, childhood health, reproductive health, family planning services, ear, nose and throat problems, basic ophthalmic services, oral health services, mental health-related problems, palliative and geriatric health, medical services during emergency, general and communicable disease management, and Yoga facilities are all offered as a promotional event under the health wellness centers and teleconsultation. It is obvious that the entire sub-center and the primary health center personnel, their unwieldy work profiles have been retained in Ayushman Bharat. These elements have been described in great detail in my volume on India’s Public Health Care Delivery: Policies for Universal Health Care, published with this one have been retained. On top of that many more have been added to the list of functions. But this is a failed model. The scheme has therefore inherited the extremely faulty planning under the National Rural Health Mission (NRHM). The chapter on primary care, government planning and NRHM in the volume India’s Public Health Care Delivery: Policies for Universal Health Care is devoted to this issue. The conclusion is that such a mechanism will not work. Scheme Plan Under Ayushman Bharat One hundred and fifty thousand primary health centers and sub-centers are to be upgraded to the status of HWC (PTI | March 6, 2019, 04:54 IST). This number represents the number of sub-centers in the primary care government parlance. With primary health centers (PHCs) added, the number should be more than 175,000. It is not clear whether the sub-­ centers as well as the primary health centers, as they develop, will be upgraded.

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The chapter mentioned above and four more along these lines in the aforementioned volume have described in great detail how to modify and restructure these sub-centers and PHCs, with the major suggestion that the primary health centers should be liquidated and community health centers restructured to get the best out of them. NHPS is going to take too long to implement the suggestions for improving the CHC capabilities, and may still not be able to implement them. It is likely that considerably more money will have to be spent to get this infrastructure upgraded for newer functions. But this will not solve any of the issues unless five basic specialties are also present there. The Staffing Pattern of HWC To the existing personnel is added the post of ‘Ayushman Mitra,’ who is supposed to assist the patients in the HWC. Such incremental changes will also not solve the issues. This is typical bureaucratic advice. They are the experts at refurbishing old models which have failed completely over 40 years. This is what happens when matters are left to bureaucrats now that people like Dr Arvind Panagariya, the earlier vice chair of NITI Aayog, are no longer there. The recommendation is to consider forming an Ayushman Council, along the lines of the GST Council, to improve coordination between the beneficiaries and the government. Creating multilevel hierarchies, multilateral, multiple authorities, agencies within the existing bodies and making it into a holy or hell of a mess is what the finest brains in the Indian bureaucracy have been doing for the last 70 years. They have managed it again. These people need to be dismissed from service for viciously misdirecting the government in creating such mazes.  In the long run these centers are going to be manned by BAMS graduates who will undergo a course in modern medicine and pass an exit examination. This issue is discussed in Appendix B on controversies about the AYUSH systems of medicine and in the four chapters on structure and function in India’s Public Health Care Delivery: Policies for Universal Health Care. It is too complex and lengthy an explanation and needs to be read in full, and thus it will not be repeated here. Having 150,000 AYUSH doctors to man these centers will be a decadal project.

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HWCs with a Provision for Pre- and Post-Hospitalization This is a sensible suggestion within the purview of NHPS, but the fact remains that the envisaged structures will not be able to efficiently deal with it (see above). HWC and its development will involve those sub-centers which do not have a building of their own or a rented facility. There is a ridiculous provision and stipulation made in the NRHM that 56,000 buildings will be constructed under it for SCs and PHCs. With a high-cost NHPS incurring daily expenses in the millions how will AB NHPS address this issue, which without doubt will consume enormous amounts of money? This is a dead horse, and flogging it will only result in aching shoulders. AB NHPS will fail miserably, and a dream will be shattered due to bureaucratic foolishness. We hope somebody takes note of this thinking, as it is not being reflected in any way by this wellness center idea.

More About Different Kinds of Health Insurance This chapter has so far been dominated by the NHPS. But there is one type of insurance that operates outside the NHPS purview. It would be better to describe it in some detail to complete the understanding of health insurance. This is the high-value insurance paid for by high-net worth individuals. High-Value Premium Private Insurance The beneficiaries buying this insurance are in much higher earning brackets, are better connected and educated, and can negotiate various arrangements and percentages of the premium to be paid with their employers and receive services. The burden of pre-existing diseases, whether covered or not covered, was an issue for high-level premium payers where disorders such as diabetes in particular initially became a barrier for some time. The lower premiums were offered by excluding diabetes. It was initially believed that the diabetes burden was so large that if an insurance company agreed to cover it the scheme would collapse. Now diabetes is also included, with understandably higher premiums. It is so ubiquitous in these groups that excluding it will bring the numbers down and the scheme will become unviable.

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It also became necessary to accommodate people who are diagnosed with diabetes after a reasonable period of being insured. This is an enterprise primarily driven by profit motive. The corrupting practices of the people who float them, those who benefit from them and the doctors are not uncommon. Hence, the tendency is not to honor the claims or try to settle for as little money as claimed by creating clauses that this or that will not be covered. The packages may or may not take into consideration differential package rates for treatment in, say, Mumbai or in Gonda in Uttar Pradesh. Thus it may end up being around 60% of the bills in a city like Mumbai that the insurance companies dish out. In smaller places they may have more tricks up their sleeves and will pay as small an amount as they can get away with. It is here that the insurance money will be utilized by a licentious approach to admitting patients to get costly investigations done or prescribing more drugs than are necessary. One common experience cited is the unwelcome and threatening arrogance of patients lead to extremely unpleasant incidences (and does) if something goes wrong and/or a patient’s desire is ignored (Gadre 2018). This high-value Private Voluntary Health Insurance is delivered through the third-party administrators (TPAs). TPAs have a tough time if the insurance company objects to the payment. This makes the patient most unhappy since he has paid high-value money to the insurance company and has now become entangled in who should pay the hospital and how much. The extra payment then has to come from the patient. On the other hand, it displeases the hospital which has treated the person who has not paid, since insurance companies are supposed to pay through the TPA and there is the cause for the above disputes. If a patient has insurance coverage for serious illnesses this is a matter of great joy for the doctors who treat them. It becomes a matter of doing many things that are not required or procedures that are not frequently carried out. Such actions are converted into a bill item which brings revenue to the hospital and a portion to the treating doctor. Such behavior on one side may lead to a dispute between the hospital and the insurance companies. If the matter is handled by the third party assessors even exorbitant bills will be cleared by the TPA with certain understanding from the hospital (Gadre, 2018, ibid.). There are many private practitioners who have also claimed that creating false documents, and getting the money and getting it distributed among the TPAs, the hospital and the patient is

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not rare (Gadre, 2018, ibid.). There is a shortsighted approach to get as much out of insurance now that the patient is in their hands without a thought to spare for his insurance money for future illnesses. These are the factors which lead to acrimony, litigations and so on, making things in general far more expensive. Due to the multiplicity of companies and plans, health care becomes fragmented and does not remain under the control of market forces, nor can it be brought under control otherwise. There is enormous wastage and these are less meritorious than the public health insurance systems. The insurance business is a breeder reactor for greed, operating more frequently than one may suspect. Even in a tightly controlled economy such as China, the introduction of insurance has actually stimulated the greed of doctors to make inflated bills and try to get more money for themselves. It has been stated categorically that the cost of treatment in China has become unaffordable, the drugs cost the earth and most people cannot afford the treatment; many more procedures are being done once the patient has insurance which would not have been done if he was without coverage, without much loss (WB Policy Research paper 3741; October 2005). In the case of high-value insurance premiums there is violence that sometimes spreads. The patient dictates to the caregiver to receive an MRI or another costly investigation. He is not prepared to listen to the doctor about the utter lack of any reason or necessity as well as the small issue of risk. These patients think that their wealth is unlimited to pay yearly insurance and threaten the doctor that if they do not conduct the procedure they will go to another doctor who will do it willingly (Gadre, 2018, ibid.). Low-Cost Insurance The second type is the small amounts people pay for their insurance for admissions or cases in which they do not pay at all but get certain services in lieu of insurance. The numbers eligible under this category are large and most will still remain outside it. The real concerns are about the unorganized sector, scattered poor villagers with low population densities, remotely placed in more than 600,000 villages and hills of India. Yet, most attempts at low-cost insurance so far have been for marginalized, indigent people. There are many difficulties in providing this security and these are discussed briefly below (Purohit Bhaskar, Health, 2014, 6, 1237–1245, Published Online May 2014 in SciRes).

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Low-cost insurance will generally require some subsidy or external funding. Often a donor is involved in such missions. Among other reasons listed below, many poor people cannot even afford the minimum premium expected under Community Based Health Insurance (CBHI). As a result their needs are not converted into demands. In such insurance schemes the structure is limited. The coverage is low and scattered and access as well as wider facilities will not be optimum. These do not or cannot cover other costs such as loss of wages, travel, food and incidental costs during hospitalization. RSBY covers some of these. Often these costs are detrimental to people who are daily wage-earners and poor. The process of premium collection and claim settlement could be rigid, inefficient and could cause difficulty for the patients and relatives (Ahuja Rajeev, June 2005). These missions take the help of local nodal agencies such as NGOs or members of various local agencies such as Grameen bank account holders and so on to make the insurance more acceptable. Nodal agencies carry out the work of conveying the ideas, canvassing for them, collecting premiums, and verifying and settling the claims, at a much lower cost by a factor of 20% (Ahuja Rajeev, March 2004). The four southern states are more focused and organized in this regard. These four have 76% of all nodal agencies, leaving the other underdeveloped states starved of the funds they need. The continuation and renewal of premiums is fraught with difficulties. Community Based Health Insurance (CBHI) in India CBHI typically works in such situations. A whopping 93% of the population, according to the 2012–2013 data from the National Sample Survey Organization (NSSO), are either self-employed or employed in the unorganized sector. The most difficult task is to reach and help such scattered people in a cost-effective manner. However, CBHI schemes have proved to be effective in reducing catastrophic health expenditure (CHE) (Purohit Bhaskar, ibid.). CBHI uses a piecemeal approach in extending health insurance; it cannot cover a large number of people since it cannot create a larger risk pool who will contribute. CBHI missions also find it difficult to develop its design and to make its benefit package as comprehensive as can be to show the economic and non-economic benefits that can be perceived by

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enrollees. The next step is to establish a link to the health system. The inability to afford to use a distant health facility and the poor quality of health services, which includes long waiting times, are the ground-level obstacles. Even if some numbers exist under a CBHI, the abysmal primary and secondary public health care quality does not help the poor and illiterate workers who have their own cultural beliefs and lack of health-seeking behavior. The CBHI as such thus cannot inspire the confidence of such people, resulting in most of them not enrolling and most who are severely ill not renewing the premium. The Many Scattered Insurance Missions These missions target people who participate in micro-financing activities such as self-help groups for insurance and sell them this insurance. Despite all the paeans sung for these micro-finance activities there are serious reservations. Micro-finance at the rate of 21% interest has merely replaced the old merciless sahukars, the village money lenders who held people in debt for generations. At best the face of micro-finance is more human. One reason that it has continued to grow is the success of the self-help groups (SHGs). Wherever one goes, these SHGs are seen working wonders and able to sustain such interest rates. Once again the better-off groups (no doubt due to their own abilities) can obtain better access for themselves to such missions. This is the principal problem with CBHI or any such scheme for which no one had previously suggested a model that could work within public health care close to these indgent people. In some ways NHPS could be the solution to these problems; however, as shown above, NHPS will work for them only if it can be provided competent services for indoor care within public health care near people’s homes. The primary care model has not been and will not be successful or helpful. Untrustworthy managers, mismanagement, lack of oversight mechanisms, excessive delays in claim settlement, especially in rural areas, and corruption are the main reasons for the failure of CBHI.  In addition, people do not see any health or economic benefits of joining the scheme. They would rather use health services as and when needed than subscribe to insurance. There is distrust about such schemes because of past experiences.

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Government financing is the most equitable approach as it separates contributions from utilization. AB NHPS has done precisely this notwithstanding the long-term sustainability as mentioned in many places in this chapter. Governments thus far have not been able to raise enough to protect and cover such a large poor population. This is due to the subsidy raj under Rajiv Gandhi and the massive scams post 2011. With demonetization followed by the Goods and Services Tax the tax base continues to widen and considerably more money is now coming into the treasury on a month-on-month basis. The situation has changed and NHPS-like schemes can now be introduced. A Word About the Mixed Type of Health Insurance Between the high-end private insurance and the low-cost insurance, a recommendation for the mixed kind of insurance has been made (Ashtekar, 2015, ibid.). Seven of the most developed nations in Western Europe have experimented with this for over 100 years. Here the people as well the government contribute to the mission and then health care is made available to the payee members. Many countries once under the domination of USSR have accepted this format since 1990. In some other forms, the contributions are part of the taxes paid by the people. Another variant is a Health Management Organization (HMO in the US) (Ashtekar, 2015, ibid.). It is difficult to agree with this proposition due to the major differences between the European countries and India. Most of the countries are nowhere near as populous and are much smaller than even the moderate-­ sized states of India. These countries will have a baseline competent health care system which will be much superior to the Indian baseline health care, especially public. There is 100% tax payment in developed countries by those taxable, whereas the tax base in India is not only 6% compared to the population numbers. Tax evasion is so common in India among those who have more than considerable wealth. For example, there are certain communities who deal strictly in cash even today. Even when their businesses are large, selling high-value goods, they do not maintain bank accounts (Parkhani, ibid.). GST will hopefully bring them in somehow.

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The Public—Private Partnership This is a topic talked about for long and characterized variously, the most cutting remark being—public money for private profits. The initial discussion to follow will be about perceptions of the idea of PPP so far. After that various ideas that have been put forward since 2014 will be discussed. HEALTHCON 08 was published by CII Hyderabad on November 19, 2008 for both the NRHM and the government of Andhra Pradesh at a conference, and it has been widely used in writing the sections below, with comments on changes if any since then. The Negative Balance in Public Health Service All categories of health worker including doctors seem to have an irrepressible desire to join the public health system as soon as they get a chance or think that their academic career has reached where it should. A doctor working under the public health system will sooner or later detach himself from it, in spite of the easy money, the non-accountability and the bribes he gets so easily. Sooner or later everyone will either suffocate there or will want to have a double income or want to fulfill the primordial desire in simple terms to have something he can call his own. He/she will use the government resources to feather the nest and finally leave without having made any contribution  to the health care goals. Those who remain in public service after certain years serve in the medical colleges or in administration of public service. The most corrupt or simple status quoits also continue. Thus the talent within the public health is not comparable with those outside. The idea of public—private partnership needs to be discussed against this background. Under the poorer quality people in public health here, the simple idea of the public—private partnership acquires a different meaning. Now it means that those who have left the public system or those who never opted for the public health system are the ones to be brought back from outside. The arrangement will generally be part time for some of the functions not available in the public health system. These functions may have to be surrendered to them or should be shared with them by bringing them in. Philosophically speaking, the public—private partnership assumes a relatively equal position between the two parties. But there is an attitudinal

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chasm. In actuality the government feels it is below its dignity to partner with these entities. The NRHM document, the first ever proponent of PPP, indicates how the government attitudes described above persisted even in 2012. There is no reason to believe that they have changed them even today. On the other hand, having always hated it or having come out of it, the private players find the idea wholeheartedly unwelcome. They have deep distrust about the government, bordering on contempt. Other than coercion the government is likely to employ, the private person does not find any reason to cooperate with the government. The relationship is not only unequal but it is unbalanced. If any compliments are due regarding this initiative of PPP, then it is also a fact that from independence until 2005/2012, the latter year being when the NRHM was revised, these two streams ran parallel because of the arrogance, condescension and indifference of the governments, across all levels of medical professionals and health care. None of the privateers were ever given a chance to contribute to the general cause. The government has always made it apparent that it does not need them. They know and do what is right in the best manner.6 Hence the one system the private people would not trust is the government. These two  are being brought together. Promotion of PPP for Achieving Public Health Goals If the new Central government is going to approach this via the NRHM view and feels that this will help improve things a great deal, most certainly this will not happen. The decades-long grudges are not going to go away. The negotiation process for taking the private practitioners on board will be unpleasant at best and insulting at worst. If at all the terms are finalized the compliance from the government side, especially for payments, will have to be scrupulously observed so as not to allow the mutual distrust  Unwillingness of the government to listen, leave alone accept a suggestion, especially from non-government or private people is well entrenched for decades now. In 1985 in a conference organized by Medico Friends Circle on Tuberculosis in Bangalore officers from National Tuberculosis Institute Bangalore were invited. The debate was about x ray diagnosis also is a valid diagnosis even if sputum is not showing AFBs. Their resistance to this was obdurate for which we could not see any justifiable cause. It almost demoralized the clinicians who regularly diagnose Tuberculosis not on sputum test and treat it successfully only on the basis of X rays. 6

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and disrespect to surface. This will lead to a complete breakdown in the relationship within months. Against this background it is encouraging to hear the central Health Minister J P Nadda say that “there is need to work on PPP model…,” which indicates that he does not take it as either a fait accompli or something easily doable (PTI | August 19, 2015). He identified teaching and training of doctors as well as paramedics as an area with vast scope, and the government would welcome PPP projects in this area (see above). “The government is working both in secondary and tertiary medical sector … to lessen the healthcare burden of common man,” Nadda stated. We hope the numerous suggestions made in this and the volume India’s Public Health Care Delivery: Policies for Universal Health Care reach the ministry and the department for consideration. The government stated clearly that …the PPP is welcome, but insisted on partnerships as a way of strengthening the public system, a means to widen the range of professionals available for meeting public health challenges, insisting that while there being no getting away from a well funded, well functioning, effective and efficient public sector in health care at all levels from the village,… to the district level. (Draft Report of The Reconstituted Task Group on Public Private Partnership Under NRHM, Ministry of Health and Family Welfare, Government Of India 2014)

Some Examples of What the Government Is Doing for PPP Both the center and independently the states are trying to contract in, or contract out services or personnel or out sourcing management of hospital facilities  to  leading NGOs.  They may  hire  staff  in private sector for service delivery, including family planning services, MTP, treatment of Sexually Transmitted Infection (STI), or Respiratory tract infection (RTI). The Disease Control programs make use of NGO partnerships in a big way. Franchising and social marketing are two other kinds of PPP. The Central Health Ministry also has strong relations with the Federation of Obstetric and Gynecological Societies of India (FOGSI), IMA and the Indian Public Health Association (IPHA). The last one is a professional health organization working for public health since 1956, for dissemination of information, advocacy, creating awareness and human

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resource development. States such as Maharashtra have partnered with GE Healthcare in addressing the problem of inadequate screening centers by outsourcing lab tests through a public—private partnership (PPP) model (ET Health World, October 14, 2015). Cancer seems to be particularly serviceable by PPP.  Bihar Medical Services & Infrastructure Corporation Ltd (BMSICL) has made arrangements for providing cancer diagnostic and treatment services by setting up ‘cancer clusters’ in Bihar based on the ‘build and operate’ concept (ET Health World, October 14 2015, ibid.). Bihar needs to be congratulated and the hope must be extended that it will cover other large areas in PPP. The role of the Bihar government is to provide space, buildings and other infrastructural facilities, whereas the private partner will have to be responsible for equipment, manpower and facility management. The division of the expenses, both initial and recurring, and the terms of employment are not clear, but let us assume that it will be of help to poor patients and the public at large. If the government is not paying for the poor, then this is not the PPP; it is selling people out. Contracting Private Person IN the Public Service There are many areas of contracting in. Laboratories, imaging services, specialist consultations and anesthesia are a few of these. The public health care system is a bottomless pit. The numbers of professionals needed is large and they are not there. For our purposes the most important step would be to contract the private person into the system to run the resources and facilities already created, ensuring the full capacity utilization of the same and saving them from lying idle and therefore valueless. There are mutual benefits. PPP agreements are far more advantageous to the government since they augment the limited human skills of the system and the private sector lends a hand on human resources issues. Here the government decides the fee for the private partner without creating any cost to the beneficiaries. PPP IN the government system gives the private partner access to the public system in a variety of ways—existing health care facilities or leveraging the technological advances existing in the private sector in the public sector. The private sector can gain access to an additional market segment previously not available to it. The private professionals may also use PPP to strengthen their already existing relationship with the governments. However, there may be resistance to bringing people in from outside to

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do certain jobs, for this will lead to fear among the insiders of losing their jobs, or of shrinkage of their role in the government in the health arena. PPP may also lead to allowing a private partner to charge extra for his services from the beneficiaries directly, thereby removing the financial burden on the government to pay these individuals. But this leads to an unjust and iniquitous arrangement for poorer people. When the government asks the beneficiaries, that is, the poor people, to go out and utilize equipment or resources situated elsewhere without any control over the fees charged, the accusation of favors to the private parties becomes the truth. The best method of developing a PPP is to get an outside expert IN the system to use it. Contracting OUT the Public Service to Private Parties The government may contract out certain services to the private parties, for which there is a budgetary provision. This means that the government should be able to pay for those services poor people may have to go and get. It could be the service areas like reproductive and child health (RCH) within a territory to promote once-monthly contraceptives injections. The other type is when a built-up facility and its services are contracted out, say, a PHC. Given the government attitude, it is likely to choose the most dysfunctional ones for this. The most frequent examples of these dysfunctional government facilities are those with extended unfilled vacancies, high absenteeism and consistently low or poor performance over many years. It is another matter if the private players will accept such dysfunctional units. The chances are that they will not. The public health-owned buildings with equipment, materials and even staff may still be contracted out by making a detailed deed with the private partner. It may include some important items—the government may directly or indirectly pay the salaries. This means that the cost structure lowers substantially in the contract. If it is not paying the salaries for the staff recruited, the tariff will have to be negotiated with much greater care so that those who are expected to pay for these services are not subjected to exorbitant charges. NHPS and its acceptance, made a part of the contract, will at once give more work to such outsourced facilities and the payments will be within decent limits and will help the real poor near their homes. If it is imperative for a service to be contracted out, then the arrangement should also be such that the patient does not pay anything to the

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private person and rather the government compensates him. This will remove the greatest fear among the people of being extorted, and will leave no ground for the critics to counter or to blame the government for selling out the poor. NHPS attempts to do this. But it will cause anxiety in the private persons about being promptly paid to continue the services. Delays happen. Among the other options available to such a private provider (or a group of the same), he could take over only the physical structure at a fee which will be far lower than the cost if he had to erect it on his own. He is then, under a negotiated tariff which is reflected in the contract, able to afford lowered costs of services. Between the two, first the non-paying arrangement can be made more reliable by using government missions such as NHPS by attaching the population to its outsourced facility and paying for services. There were serious difficulties in connection with RSBY, discussed earlier in the chapter with a caution that NHPS should not have to face the same, particularly a fund crunch to pay the dues. Today, however, newer administrative methods such as direct bank transfers have eliminated the corruption in having one’s own money released, be it a hospital receiving it or any other government payment to the other party. Even then there will be some inevitable delay in these payments.8 Motivation Such an arrangement raises the question of what will motivate the private person to take over any facility. The private party must realize that he is getting this infrastructure without having to take loans, and thereby not facing pressure to repay, and hence he should not and cannot afford to charge high rates. He in fact may or can get some budget from the government to run the place to take care of the government employees working there earlier, thereby reducing his burden further calling for a lower tariff in the contract that reflects this. If he decides not to employ these workers, for their inherent attitudes, always an anathema to the private mind, it should be acceptable to both parties. If he decides to employ his own manpower he can negotiate his tariff with what the government will give him in money terms for specified population segments. He will still be able to serve the people who can pay for low tariffs without adversely affecting his and the patient’s life.

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The private partner should clearly state what he can and cannot do. For example, if the government as a general policy wants that he should carry out primary care. For that he must appoint ANMs who may comprise population likely to be covered under the center. If such a person taking over a public care facility has no inclination to do this kind of work or only a limited work it should come clearly stated in the contract. The private party can develop his own service delivery model that he is competent in and comfortable with, and the range of services and the freedom to practice them. Mutual Commitment for Objectives Agreed Upon Here the suspicion of the private person deepens before he agrees to anything at all. Several questions arise in the mind of the private provider. Will the agreement restrict my freedom to do something I am doing? Will the agreement restrict my time in a manner not agreeable to my business or profession? Will the government stick to its commitment when I do to mine? Or will I have to use pressure to get the government to act upon their commitment, or will it be simply hopeless to try to obtain what I need? Various Scenarios Under the PPP The worry is whether the government will walk the talk. There is suspicion and apprehension about public health care receiving continued short shrift, forcing people to go to private health care rather than trying to achieve what they have said in the draft report quoted above. The governments are often accused of giving prime land to private hospital projects with financial guarantees and partial financing as well to build big hospitals. The accusation is not false. Alternatively, the government may build, operate and then transfer the hospital facility to maintain quality service but also to ensure reasonable rates for the poor. Once the facility is received these hospitals may not serve the poor, follow the contract conditions of reasonable tariffs for the poor, reserve beds for the poor or implement missions such as RSBY, now NHPS. NHPS has attempted to solve this issue by developing clear norms about new development of hospitals in tier 2 and tier 3 cities, mentioned previously. It would be a matter of interest, time and study as to whether and how this has succeeded or not. To its credit, NHPS has met it head on.

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The Necessity of Carefully Drawn Contracts in PPP A balance of good incentive for the person or agency to make decent money, while avoiding the agony of exorbitant pricing of services, is achievable through carefully written contracts that go into great detail. The possibility of an exploitative system developing with government connivance and its understanding with the private player should be avoided at all costs through concrete clauses in the contract. On the other hand, the costs to the people should be eminently affordable for the government as well to pay second hand. There should also be mechanisms to catch transgressions and unlawful money making by the doctors. The PPP model is more likely to fail than succeed if the PPP framework fails to specify the areas that are being offered up for partnership, or does not clearly state the objectives of the partnership as detailed above. A detailed and clear framework is needed to be able to appropriately bring together various departments within the government who handle the PPP process on the same platform. This is a rigorous exercise. Given the reputation of any government where the right hand does not know what the left hand is doing, securing interdepartmental cooperation was not a strong suit of the previous government. The governments so far may have treated all such aspects from the ‘regulator’s’ view point. This has to change to a facilitators view point, as promised by the then Commerce and now the Finance Minister Nirmala Seetharaman in 2014. Such a framework will have to incorporate various types of PPP including one-time / short-term donation of land, money or equipment, capacity building exercises as in the National Skill Development Corporation, and service-oriented agencies, or by contracting health care providers, or helping with mobile van services, carrying out Information, Education and Communication (IEC) activities by contracting them out to NGOs. Other PPP contract areas are infrastructure from building to maintenance, providing vehicles, or managerial and system development inputs. These are the principle ones that have to be included in the PPP policy framework. Typically, the document HEALTHCON 2008 talks of monitoring and supervising the private partners’ work. With changing times the framework will have to include how to monitor the work. In that case, there must be a mechanism to decide whether the government has also fulfilled its responsibility and not just the private provider. The government often outsources this work since it has no capacity to do it. Such agencies which can do this work will have to be identified and brought into the framework.

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The mechanism of the redressal of grievances does not normally find a place in the policy framework or contracts in PPP arrangements, which it should. In its absence the government starts to appear dominant and does not bother about fulfilling its commitments since there is nothing in the contract that enforces it do so. That may make the aggrieved party resort to courts with interminable delays, waste of time, non-performance of contract and other such undesirable matters which finally affect the patients under such arrangements. Incorporating this mechanism is not difficult and sufficient material is available on it, and the processes of arbitration and reconciliation can be made use of. Milestones for payment not clearly defined in the contract are often the critical stumbling blocks in the path to success of PPP. Payments could be so delayed that the partners may abandon the work or they are forced to do this. Other than the injustice of these failures it is the permanent loss of both the government’s and the private partners’ credibility with the community which then suffers. This is the worst consequence. The last important factor is the costing of the services. This is a challenging area since it is so difficult to understand how much anything really does cost. In the PPP system, especially when a person or a facility is being contracted in, there are many costs which must be carefully calibrated for day-to-day services, but there must be some formulae for depreciations, and the time of next replacement, breakdowns in case of equipment, variable consumption of the consumables, the schedule of the individual, his own transport costs, time and such other considerations would make the costing not difficult but more careful and just. What is important is for the person contracted IN to feel that due consideration is being extended and respect accorded to his services. Accreditation Indians do not like to be examined about how they are doing their work and far less to be accredited for the quality of the work. The parties to be contracted must agree to be compulsorily as well as periodically accredited by independent agencies. Giving the party a financial incentive to undergo the process of accreditation should be part of the contracts. The National Accreditation Board for Hospitals (NABH) is a sound option which still takes the process seriously and handles it in an uncorrupt manner. This was the recent experience in the investigations I carried out in medical colleges with the National Assessment and Accreditation Council (NAAC), as mentioned in the chapter on capitation fee colleges in this volume.

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Finally, the onus of successful PPP lies with the governments. As long as the government does not deal in a transparent manner, does not shed its big brother attitude, does not acknowledge the superior strengths of the private parties, does not become a facilitator, does not shed its distrust of the private partners and does not behave in a way to leave any ground for the private party to remain deeply suspicious of the government, no model of PPP, no matter how well drawn the policy framework and contract and all other aspects discussed above, will succeed. This is the classical way in which India and especially the government, wherever it comes into the picture, works: callous about the populace to benefit, miserly about information sharing, uninterested in spending time with people to motivate them and with no concern about the money wasted. The first matter of concern for the bureaucracy is whether, how and how well their individual interests are served. The next is how to bedazzle the ministers and the rest into believing that nothing is possible within the framework. Hence the need is to create something different which the populace should not be viewing as another (failed) government mission. Using the PPP Model for Poor People for the Services Made Available in CHCs The idea of transforming the community health centers from their currently dilapidated state has been discussed extensively in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. This consists of one of the five PHCs to be converted into a CHC, closing down all the PHCs below it, transferring the manpower and equipment to the CHC and making it a specialist hub of five basic specialties. It develops further in a cluster of five CHCs where other smaller specialties not operating elsewhere work. Some of these can even become specialist institutes. The difficulties in making all specialties consistently available with adequate paramedics and the mechanisms to overcome these have also been discussed. Even after this the CHCs could still have difficulties intermittently for specialists over longer intervals. PPP is a good idea to make up for the deficiencies of the major specialties. In a cluster of five CHCs, that is, a population of about 900,000 and a nearby district hospital, hundreds of practitioners as well as specialists will be working. Theoretically speaking, such services can be arranged to be brought in, which is better than being contracted out.

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One way of utilizing these specialists, especially the surgeons, gynecologists and anesthetists, is to share in the beginning for a considerable period of time for planned surgeries. The reasons are that both the parties come to know each other as people, and to know each other’s needs and oddities better over a period of time. The visiting specialists also come to know the facilities, their shortcomings and the capabilities of the people from the CHC to know what and how much to expect even in the crisis period and vice versa. This period also decides whether the two agencies and their personnel are compatible and can become friends or whether their characters are not going to match. In the last case especially the CHC personnel should decide whether to continue calling people just because they are nearby even when they do not have chemistry. It would be better to make arrangements with people whose chemistry matches even if they have to come from a distance. Once these arrangements evolve emergency work becomes a matter of helping a friend. The rock over which these relationships break badly is the indifference to the person who is making his services available, taking such a person for granted, or continual disrespect and delays in payment. One has to remember that timely payment is more a recognition of the value they contribute in terms of saving a patient than the actual money given. If we consider that a private practitioner, however good, cannot but be a bloodsucker and an extortionist this is doing an injustice to them. On the other hand, if such a prejudice leads us to believe that the specialists working in public health are angels and are not incompetent or are not bloodsuckers and extortionists the laurels are wrongly placed. Examples of these attributes occur on both sides. Those who have not worked in harsh rural realities year on year like me will never realize this. Hence it is a matter of discernment, good judgment and intentions on the part of those running the public health services to choose properly from among the outside help available. As expected, the PPP model has come under criticism due to the deep-­ rooted prejudices of the enemies of privatization. A small note must be added here. The criticism is justifiable when the public service deliberately, fraudulently and with the goal of unsavory financial gain forces the poor people to go to the private sector even when the service of a privately practicing person can be made available within. The golden but often unrecognized principle of the PPP model is to bring the private partnership INTO the public health system and not reverse it by displacing poor people into the outside private world.

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What Exactly Should the Arrangement Be? The failure of having no specialists in a competent structure on the periphery to take care of the majority of the more serious problems within public health care is the core lacuna in the system. Based on all the systems or arrangements discussed so far, those systems which will be conceived in the future must have their thinking built around how to solve this issue. As a guiding principle a mantra of five words is all that one needs— Accessibility, Affordability, Quality, Equity and Justice with human dignity. How this can be built into thinking is explained clearly in the volume India’s Public Health Care Delivery: Policies for Universal Health Care. Attitudinal Changes Needed One important input that must come from the government is the redefinition of its traditional role of a ‘doer’ for people in the welfare state model, the dominating one. Today the redefinition is made—the government will be a facilitator catalyst agency rather than a doer or regulator. Achieving this kind of psychic reorganization will not be easy for the governments and the bureaucracy. One such place where this attitude from the government’s side is most needed is in curative health, where the people’s initiatives are evident in the form of voluntary agencies doing good work and upgrading themselves. These should be encouraged and facilitated. In conclusion, health insurance is an important activity for better health care of poor people, and should be carefully constructed, but schemes such as NHPS are not likely to succeed unless the bulk of the curative needs of people are satisfied within the public health care structure and only as little as necessary; anything beyond its capacity should go to the private sector. An entire structure can be erected in an equitable and economic way with many collateral gains, which are equally or even more important. In conclusion, the public—private partnership is a pragmatic measure when due diligence and vigilance is maintained for it to remain non-­ exploitative but complementary for public benefit.

References min read. Updated: 27 Aug 2018, 09:23 AM IST, Deepti Bhaskaran, mint-­india-­wire Phadke Dr Anant, Loksatta Team | March 3, 2019 12:21 AM 71st Round of National Sample Survey Organization (NSSO) November 21, 2015

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Indo-Asian News Service, IANS | March 23, 2018, 11:59 IST Panagariya Arvind, 2018. https://economictimes.indiatimes.com/industry/ healthcare/biotech/healthcare/who-lauds-national-health-protectionscheme-ayushman-bharat/articleshow/63310006.cms?utm_source=content ofinterest&utm_medium=text&utm_campaign=cppst Indo-Asian News Service, IANS | January 09, 2019, 07:37 IST The Economic Times, 25 February 2019 Ashtekar Dr Sham, 2015, Chikitsa Arogya Sevanchi, (Analysis of the Health Services) Manovikas Publications, Pune Annadate Amol, 26th December 2018, Lokmat Daily, Nagpur Guidelines for Revamp of RSBY – Operational Manual for Phase I Released on 16th July 2014 Kamal Swati, blog site Swarajya, – Mar 12, 2018, 1:24 PM Gupta Narendra and Pachauli Chhaya Privatizing Healthcare in Rajasthan, Economic & Political Weekly Vol l, no.50, EPW, Oct 10, 2015) Times News Network | February 03, 2017, 10:52 IST Kamal Swati, for Swarajya, Lessons for Modicare from the Aarogyasri Community Health Insurance Scheme in Andhra Pradesh, February 23, 2018, 4:21 PM Sood Neeraj, Government Health Insurance for People Below Poverty Line in India: Quasi-Experimental Evaluation of Insurance and Health Outcomes. BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5114 (Published 25 September 2014) Kamal Swati, Key Takeaways from Yeddyurappa’s Vajpayee Arogyashree Scheme For a Comprehensive Modicare – Mar 01, 2018, 4:18 pm Dey Sushmi et  al., PM launches world’s largest state-funded Ayushman Bharat health scheme, September 24, 2018 N Purendra Prasad and P Raghavendra, A Study of Aarogyasri in Andhra Pradesh, Healthcare Models in the Era of Medical Neo-­ liberalism, Economic and Political Weekly, Vol. 47, Issue No. 43, 27 Oct, 2012 Reddy Sunita, Immaculate Mary, Aarogyasri Scheme in Andhra Pradesh, India: Some Critical Reflections; Social Change 43(2):245-261. June 2013 https:// doi.org/10.1177/0049085713492275 Vasan Akhila, Karpagam Sylvia and Seethappa Vijaykumar, Design Implementation, and Patient Experiences of the Rashtriya Swasthya Bima Yojana and Vajpayee Arogyashree Scheme: A qualitative Study from Bangalore District, Karnataka” in Social Development Report, Oxford University Press, 2014 N. Devadasan and P Bore Gowda: Private healthcare providers threatened by the Vajpayee Arogyashree Scheme March 7, 2014, BMJ Opinion Kant Amitabh as quoted by PTI | June 10, 2017, 04:44 IST M Saraswathy, Ayushman Bharat scheme likely to cap premium at Rs 2,000 per family, Mar 23, 2018 01:16 PM IST | Source: Moneycontrol.com] Jehani Binaifer, Business Standard, August 10, 2018 15:19 IST Jaitley Arun, as quoted by PTI | January 01, 2019, 19:42 IST

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HEALTHCON 08 published by CII Hyderabad on 19th November 2008 Indo-Asian News Service, IANS | March 13, 2018, 14:59 IST PTI | January 25, 2019, 14:03 IST Health and Family Welfare Ministry, 2018, http://www.pib.gov.in/ PressReleaseIframePage.aspx?PRID=1518544 Press Trust of India | New Delhi, Last Updated at November 27, 2018 21:09 IST Mani Veena | New Delhi Last Updated at November 27, 2018 06:38 IST Pathare Vicky | Pune Mirror | July 18, 2018, 05:47 IST Raghavan Prabha, Sharma Aman & Sinha Shilpy, Thomas Alex, President, quoted by | ET Bureau | August 17, 2018a, 03:27 IST PTI | June 24, 2018, 23:51 IST Raghavan Prabha, Sharma Aman & Sinha Shilpy, Anuska Kalita, quoted by, | ET Bureau | August 17, 2018b, 03:27 IST Raghavan Prabha, Sharma Aman & Sinha Shilpy, Shailaja Chandra as quoted by | ET Bureau | August 17, 2018c, 03:27 IST M Parkhani, Income Tax Lawyer, 2018 Gooptu Biswarup | ET Bureau | March 12, 2018, 11:54 IST Times News Network, TNN | October 16, 2018, 06:54 IST Rajagopal Divya, Kieron Murphy, quoted by | ET Bureau | October 09, 2018, 04:57 IST Indo-Asian News Service, IANS, Newsletter | May 17, 2015, 19:23 IST Press Trust of India, PTI | March 06, 2019, 04:54 IST Gadre Arun, Dissenting Diagnosis, Penguin India, 17 May 2018 WB Policy Research paper 3741; Oct 2005 Purohit Bhaskar, Health, 2014, 6, 1237–1245, Published Online May 2014  in SciRes. http://www.scirp.org/journal/health, doi:10.4236/ health.2014.611152 Rajeev Ahuja, June 2005, Working Paper No. 161 Health insurance for the poor in India: An Analytical Study, Indian Council for Research on International Economic Relations Core New Delhi Website: www.icrier.org Rajeev Ahuja, March 2004, Working Paper No. 123 Health insurance for the poor in India, Indian Council for Research on International Economic Relations Core New Delhi Website: www.icrier.org Press Trust of India, PTI | 19 August 2015 Draft Report of The Reconstituted Task Group on Public Private Partnership Under NRHM, Ministry of Health & Family Welfare, Government of India 2014 Economic Times, ET Health World, 14 October 2015 Kelkar Sanjeev, India’s Public Health Care Delivery: Policies for Universal Health Care, Palgrave Macmillan, 2020

CHAPTER 10

Integration of Medical Systems: A Theoretical Perspective and Practical Blueprint

Introduction Broadly speaking, Eastern people are considered to have a synthesizing kind of thinking and a better holistic vision, whereas Westerners or Occidentals are believed to be highly analytical and critical and reductionist, in their approach. With the well-developed communication channels and the cultural fluxes to which the world is subjected today, and India in particular, it is inevitable that the two have to meet at many points and are possibly heading for a broadly common culture. Medical systems also cannot escape this. People in India have voiced various opinions about the existing medical systems in the world. The opinions range from a body of fanatic belief to fragmented or isolated thoughts about each system. But the broad principle which appears to be surfacing in all these currents is that there should be an integration of medical systems, especially the Indian Ayurvedic with the Western allopathic. When we think of such an integration many of its definitional or descriptive aspects must be first understood: (1) what exactly we mean by integration; (2) the desirability or otherwise of integration; (3) the attitudes involved, as regards this word; (4) the processes we are going to follow, and (5) the barriers to that endeavor/process, on both the allopathic and the Ayurvedic side.

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Integration of Medical Systems Meaning of Integration Integration can be considered as bringing two dissimilar entities together on certain common grounds of utmost importance, taking something from and giving something to each other without losing their special identifying features of noble virtues, developing later into something ‘Homogeneous New’ and ‘Not Uniform New.’ There is no doubt that Ayurveda and allopathy are dissimilar. Yet there are many broad areas which are more or less the same and which can be explained in terms of each other’s terminology, and methods that can be adopted from each other, as will be shown below. The give and take will be easy there. Therefore some common ground already exists. This is not the case with homeopathy, where there are fewer similarities. However, there is scope for exchange. When two dissimilar things are brought together, a bias exists; it must also be shed in order to come to an agreement and discover common ground. This aspect will be dealt with later. The identity loss is only partial in such fusions. The distinctive features of the noble values of either science need not be obliterated at all. In fact, these distinctive features are those which need to be woven into one fabric. Neither of the systems is an ‘equipotential’ alternative to the other, nor a ‘fully supplanting’ alternative. In short, we have to discover areas where strengths are added for a better life. Further, the identity loss will be in the areas where knowledge may prove to be incorrect or obsolete, or both, in either pathy. To this extent no one need grudge the identity loss. The above words ‘Homogeneous’ and ‘Not Uniform’ are important. It can be further stated that we are for ‘Unity’ and not for ‘Uniformity’ or ‘Regimentation.’ When the distinctive features come to stay side by side, these do not assume the characteristics of the other pathy, nor is there any clash or antagonism between them. Desirability of Integration There is an explosive growth of physical sciences from the West. Thinkers have stated that there are realms beyond science in which extensive manifest knowledge has existed in India (forming the basis of Ayurveda limited to this context). The science must further develop to its own possible limits. The two thus have to come together. The question as to whether it

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is desirable to integrate is superfluous; it is a foregone conclusion. Certain aspects of this desirability of integration need further elucidation. Allopathy is an effective, proven science, in disease alleviation in many areas, most importantly in critical care, and has shown enormous potential for growth due to its research orientation. Ayurveda on the other hand is primarily a science of and for health. But it has an exceedingly good understanding of the curability, controllability, impossibility and effort required in treating people. To get Ayurveda reflowing in the channels of exploration of this past wisdom more thoroughly and deeply, plans for new experiments are needed. A common basis needs to be formed for both sciences. This will make things more intelligible to medical professionals of all types. One must also realize that allopathy is not a complete science. Its approach is aimed at the tissue and cellular level. Allopathy has developed tremendously as regards elucidation of structural changes, and even chemical changes which also are in a way structural. This knowledge needs to be utilized by others. The forces of mind, intellect, subconscious and unconscious existence, supramental consciousness, and soul have not been examined by allopathy and do not find much place in it. The Ayurvedic orientation is substantial in these realms of existence. That can be used for developing more mature attitudes in people toward disease entities and life itself. These two have to meet somewhere again for this to happen. Thirty years ago, it was debated whether spiritualism and yoga practices, however well developed, could prevent a disease state. Today these are areas that are so well studied and documented that there need be no doubt about their importance in the areas of treatment researched, also setting the boundaries of achievement. Allopathy in its higher forms is costly, hospital oriented, and comparatively distant and somewhat beyond the reach of the common man. Nevertheless, in more unmanageable disease states the answers allopathy appears to offer have shown greater promise than other pathies. This power should not be deprecated, just because of cost, or on the basis of bias alone, as long as new  answers with fewer inconveniences are not found. On the other hand, our ancient sciences have helped India to survive and have endured the onslaught of the powerful Western sciences for the last 120 years and despite a millennium of slavery blocking the free flowing knowledge channels. As the historian Will Durant states, “if anything survives, it must have something good in it” (Will Durant in Our Oriental Heritage Part 1, Simon and Schuster, 1936). Note that he does not say that because something is good it has survived.

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Then this must be worth its while, to rediscover and to bring it to the forefront of new development in Ayurveda as well. For example, there is a logical attempt at arrangement of data in our older sciences, citation of past experiences, learning and teaching, just as modern medicine does. It is necessary for Ayurvedic physicians to know about these ways and processes in their true forms to be able to practice Ayurveda better. On the other hand, definite areas have been demarcated in allopathy where the etiology, the study of causes of diseases, is being rapidly discovered in its physical basis but better treatment alternatives remain elusive for many disease entities. It is worthwhile to discover its solution in other pathies also for the benefit of mankind.

Attitudes Involved in the Idea of Integration Faith Allopathy has created awe among patient populations, but no faith. People in India have had an unshakeable faith in the powers of systems other than allopathy. This faith in Ayurveda leads people to think that it is the panacea for all ill health. This does not mean that Ayurveda as a science shares these beliefs. It is realistic about what it can and cannot do in various disease situations. It is worth proving that such faith comes with limits. If this can be done, we will have delineated the merits and erased a great deal of irrationality. We can then state the limits and the potentialities of Ayurveda as a science. Attitude to Research in Ayurveda It is possible to change existing attitudes with the research methodologies described in the following pages. It means that the entirety of Ayurveda will have to be restated regarding where it fails, where its applications are limited, where its powers must be recognized, and where it can supplant or supplement allopathy or vice versa. In today’s world where developments are taking place in modern medicine through research, the information can be applied to explain ideas from other sciences. Ayurveda is capable of withstanding such analysis and application, as will be shown below. Ayurveda will very soon make its most significant contributions in many areas allopathy has not entered into in depth. As the following pages will reveal, the prevalent research ideas in allopathy need certain

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adaptations to be able to deal with Ayurvedic research to make this happen. Integration will be a corollary to the above attempt and many other effects that will follow from these efforts. Cost In terms of cost, homeopathic science is definitely far cheaper, although it is time consuming in its process of diagnosis and can be practiced (genuinely, that is) as a ‘consultant-level activity.’ It would be beneficial to rediscover this science as well. It is uncertain whether cost wise and when that cost includes loss of man-days from work Ayurveda is in any way cheaper than allopathy for general or outpatient practice. Lowering costs could be an important research objective. In allopathy high costs are justifiable if it is practiced rationally for critical illnesses because the allopathic methods are hospital oriented and certain treatments cost a great deal. Allopathy has a high cost-benefit ratio on an individual critical disease level, not achievable in other pathies as of now. If Ayurvedacharyas can identify definite areas where patients can be helped for disease control and avoid or substantially delay treatment without worsening the situation or sending patients for high-cost hospital treatments, this will be humanitarian work. Promising that everything is possible under any one pathy will only lead to great harm, as it does today. A practice of ‘researched’ modern Ayurveda will go a long way to achieving this. It will also be helpful to shed certain weaknesses, inferiority complexes and harmful attitudes, at times found in Ayurvedacharyas and more generally among allopaths. These attitudes are discussed in the volume India’s Public Health Care Delivery: Policies for Universal Health Care published with this one, in Appendix B. Research for cost reduction of either pathy will be a by-product, a corollary of the concept of integration through research, and hence desirable. Other Trends for Acceptance or Resistance There is high acceptance of Ayurveda not only in its philosophical forms but also in its practical forms of indigenous remedies and methods through a large pool of traditional Vaidyas (Ayurvedic physicians). There are remedies about which nothing is known generally. The Vaidyas hide their knowledge and mystify the whole process from diagnosis to management

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and prognostication and try to create patient dependence on treating agencies. These tendencies became markedly manifest in allopathy too. Pseudoscientific explanations of disease processes and their treatment is another problem area. Happily there are protesting voices. Health is becoming a concern, at times out of proportion, especially in urbanites as communication media are pouring in materials, in the lay press and online, on modern science to educate people (and boost sales). Even then it is a positive scenario, because these are attempts at demystification. Such attempts at demystification are lacking in Ayurveda, with honorable exceptions at the personal level. The obscure sources of knowledge used by the Vaidyas to understand disease cannot be allowed to go to waste or go extinct. At the same time its quality has to be improved. To achieve this, these indigenous remedies should be collected and experimented upon. Some rationalization will have to be achieved. Once these sources and information are brought to light and are made known to people practicing medicine, the reach of medicine will increase, in more acceptable ways. Therapeutic armamentarium will increase. All doctors will become more effective. To derogate other pathies is a firmly rooted tendency among practitioners of all pathies that should be eliminated. Let us put all medical sciences on a firm footing, particularly Ayurveda and allopathy, to know their strengths, weaknesses and limitations. They should be put through a research model to allow each to develop within its own newly acquired strengths. Let us supplement or complement each other where necessary, for the alleviation of our suffering brethren. India is the only land in the world which has declared: ‘Truth is one, sages call it variously.’ This attitude should be inculcated in life and practices. Let us be free from bias. Let us orient ourselves toward truth.

Causal Cures Or Symptomatic Cures and Suppressed Illnesses There is an almost universal belief in the Indian nation that Ayurvedic cures are delayed but permanent since they root out the disease from the body. Even highly intelligent Ayurvedacharyas subscribe to such belief which their science does not. There is also a strong belief in homoeopathy. This irks the allopaths. In contrast, people hold the idea that allopathic cures may be quick but are symptomatic, not causal, that they suppress the

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illness, and that the disease remains dormant in the body. Neither viewpoint is acceptable. In most clinical situations in both allopathy and Ayurveda, there are only controls to be achieved by continuous medication or through diet, yoga, massage, change of environment and certain other practices. The disease cannot really be removed from the body in the majority of cases. Allopathy is judged by the orthodox by its occasional failure and Ayurveda by its successes in these few cases. Compared to the situation prevailing 30 or 40 years ago, many of these misconceptions about allopathy have largely lessened. The persistence of this belief which continues among some is due to their lack of understanding about allopathic thinking. Allopathic Etiopathogenesis and the Ayurvedic Tridosha (Three Defects) Etiopathogenesis Allopathy has established the physical basis of illness on the structural side by demonstrating the structural changes or deviations from normal structures carrying out a particular function. There is a spectrum of normalcy of structures. The immune system, receptor theory and germs as we understand it in allopathy, is largely the basis of the allopathic concept of why disease occurs. Allopathy laid out the structural defects arising out of functional deregulation in far clearer terms and their effects on the whole body more than 60 years ago. The structural and/or functional deviations, beyond the normal ranges, established by allopathy constitute disease. The Tridosha theory was believed to have a lack of demonstrated physical basis. It is believed that it has not been demonstrated in Ayurveda in terms of anatomy and physiology. Allopathy therefore does not concur with the Tridosha (three defects) theory. Any disease process was thought to be pervasive in the body, not localized. The allopathic etiopathogenesis was hence not accepted by Ayurvedacharyas in the past. Ayurvedacharyas are afraid that if they have to replace their basis of understanding of the causation of disease, by accepting this unity and uniqueness of the structure function view, there will be a permanent and probably a total loss of the identity of Ayurvedic sciences and all the subsequent buildup on Tridosha. I do not believe this to be the case. It is for the same reason that allopaths have not accepted the disease theory in Ayurveda—the lack of physical basis. There is also a simultaneous lack of understanding about Tridosha theory among allopaths. One

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more issue with modern research methodologies is that these always keep changing their earlier conclusions. For the reductionist science of allopathy it is progress. For a holy and holistic science which believes what the sages have given to mankind cannot be subjected to any scrutiny, it is true for all time. These are seemingly incompatible attitudes, but this can be overcome through better understanding of each other and modified research forms in Ayurveda. Structural Basis of Tridosha Could Ayurveda still be practiced by accepting a structural basis for Tridosha as a ‘school of thought’ in the causation of disease? This is a very complicated issue. A deeper study of the structure function abnormality with its biochemical components, if undertaken by Ayurvedacharyas, may result in their being able to also ascribe physical, anatomical locations or bases to the Tridosha theory of Vata-Pitta-Kapha, the wind, bile and phlegm of Greek medicine. As an allopath, when I tried to understand the Vata, with the help of Vaidya Jayant, I could see that many symptoms (lakshanas) of the Vata can be interpreted as electrical currents or electron flows, the very basis of neurological functioning as well as cellular reactions. At other places the Vata looks like the endocrine hormones, secretions of glands without ducts, which are directly present in the blood and flow throughout the body. Even by this sort of elaboration, the essence of the Tridosha theory need not change. The Vital Force, Tridosha and Its Physical Basis The vital force of life in homeopathy is called the élan. In Ayurveda it is Chaitanya, which may be loosely defined as a portion of divine energy present in living beings. Allopathy contains no such idea, nor does it talk of this functional, non-tangible side of causation of disease by impairment in vital force, and this is the argument against allopathy. The theory of vital force being disturbed is considered the cause of the disease process  in Ayurved and Homeopathy. The same is considered to be a deficiency of allopathy. Now if one says that in an infection allopathy identifies the derangement in the vital force as the failure of the immune system and its response, it may be accused of and ridiculed as having finally subscribed to the functional theory of Ayurveda. The pity is that the Ayurvedacharyas or homeopaths will not applaud Allopathy for giving a physical basis to their theory of vital force. This is an unfortunate attitude.

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Allopathy tries to elevate the powers of the immune system, one form and part of the elan. Homeopaths and Ayurvedacharyas may claim to have reawakened the vital force, elan  or the Chaitanya. These are the same thing in different terms. There will be other manifestations of the vital force which not many allopaths know much about. All in all, it is a question of attitudes on both sides. It is only by collaborating with each other in an effort toward rediscovery that the understanding can progress. Defining Cause of Disease and Criteria for Cure What constitutes cure depends on the theory of causation of disease and the concept of cure. One could say that pneumonia is cured when all the dead bacilli are expelled from the lung and the inflammatory debris is removed by immune cells leaving the lung intact. A disease diagnosed by Tridosha theory can also be considered cured by using Tridosha methods and its cure concept. As we compare these two processes a physical basis may be discovered, and this will help in the progress of the synthesis, rather than hampering it. Theories of causation being different, the question of defining ‘what is cure’ almost never arises in Ayurvedacharyas when they come to claiming cure due to their medications. It is a deficiency of knowledge of the truth of their science and not of the science. In Ayurveda all diseases are classified as Sadhya, or curable; Kashtasadhya, or curable/controllable with effort; Yapya or those which need definite therapeutic intervention (perhaps for long periods) or Asadhya, that is, impossible to cure. The word cure is precisely defined in Ayurveda as Samprapti Bhana. Jaundice can be taken as a single, simple case which can on these bases judge the true cure due to these occult medications if any. The criterion of cure in diabetes is a similar excessively claimed confused state in minds of people and Ayurvedacharyas. Ayurveda describes as many as nine types of Pramehas, that is, diabetes, which in the most identical description clearly states which of them can be helped, most being only controllable. A cure in simplest terms is a state in which there are no symptoms, the laboratory parameters are normal and there is no need to take medicines or follow restrictions. Talking specifically of, say, jaundice, one of the great and most respected treatises on Ayurveda, Madhavnidan, describes jaundice as kamala. It also describes well the symptoms of incurable jaundice (Madhav. Nidan. 3/16—20). Being clear about the definition of cure is the first need for the revival of science.

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The natural course of the disease has been outlined not only by allopathy but also by Ayurveda in most instances. It also depicts the variations of the course of a disease after the administration of or in the absence of drug intervention. This is a great contributing factor for understanding each other. Therefore, when evaluating Ayurvedic drugs, the criteria for and definition of cure can be outlined and then a drug trial can be undertaken far more easily (see below). In such settings the Ayurvedic methods will gain more precision, and the Ayurvedacharyas will be able to evaluate for themselves the strength of their therapies, their own claims, success rates and failure rates. In allopathic terms, when standardized methods do not exist in any science, this is termed an empirical science. The propositions originating from empirical science are considered to need stricter proof. This is not a derogatory way of looking at empirical sciences. It is just the way allopathy thinks. It has to be brought to the level of non-empirical, reproducible results with standardized methods, to be able to designate it as science in the true sense. Ayurveda is considered to be an empirical science. This is not the case. Everything it states comes after years of observation, attempts through different methods to see how well this leads to normalcy, the limitations of the therapy and so on. This valuable method needs to be rewritten in the present language of science and efforts need to be made to make it a little more precise. The Question of Symptomatic Cures and Suppressed Illnesses Consider the cause of a simple headache for which there are no serious underlying diseases such as a brain tumor or hypertension. A simple aspirin or paracetamol clears it away in a few hours. For some reason prostaglandins are liberated, headache is caused, and once you inhibit the prostaglandins by some means the headache stops and everything is alright. Do we call this a symptomatic cure? Or do we believe that prostaglandins as the cause of headache now stand eliminated from the body and hence this is a causal cure? But what was the reason that prostaglandins were liberated? Have we removed this cause? The chain keeps going back ad  infinitum. Or, not knowing what directly caused the headache, should we treat it as a mere symptomatic and hence impermanent cure and assume that the headache will return? Going further, the allopathic aspirin and another A from Ayurveda are used for the same symptom which disappeared in both cases,

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so why should the Ayurvedic cure be considered causal and the allopathic cure symptomatic? This is not a reasonable conclusion. What can stop us from saying that both have suppressed the cause and not cured it, or that both have cured it? For the consideration of those who wish to shoulder the enterprise of integrating medical systems a few more issues are discussed below.

Difficulties Existing ‘For’ and ‘Against’ the Integration Enterprise 1. There still lingers a superiority complex in Ayurvedic physicians and allopaths alike. 2. Allopaths secretly harbor the conviction that Ayurveda is rooted in superstition, and is a bogus science, which is obviously false. No research has supported this convictions and hence this is totally unacceptable in this context. 3. On the other hand, there is a smarting inferiority complex, especially in younger Ayurvedic physicians, which should have no place in their minds. 4. Ayurvedacharyas have a definite stand that methodical research is not necessary as their science is ‘divine’ or Apourusheya, not arising from human agency. On the grounds of reason this is an unacceptable attitude. The progress in Ayurveda has been slow for millennium because of this attitude. 5. Ayurvedacharyas are reluctant to submit Ayurveda to research along the modern lines, even when Ayurveda itself does not have these reservations. On the contrary, there are applicable Ayurvedic research models available. This is extremely important. 6. In fact, the claim of some Ayurvedacharyas is that the Western concepts of receptor theory or immunity may not be wrong, but that they are not particularly relevant to Ayurveda. That is not correct. When a drug is used, be it a root or a leaf or an extract of it or a pure chemical, it will work by combining with a receptor. We do not know which receptor and what intracellular actions it is stimulating or suppressing when Ayurvedic preparations are used. This could be a fundamental research area initiated by the study of Ayurveda. 7. Ayurvedacharyas have also gone to the extent to say that the application of the Western model to Ayurvedic research may include a

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basic fallacy in the entire process. They agree that the Western model without being wrong in its own scientific evaluation has served itself admirably. The reason stated for the unsuitability of the Western model is that Ayurvedic biology is different. This is also not true. The Western methodology can be adapted to suit the particularity of Ayurvedic science. It is eminently possible. 8. Ayurveda is also based on a concept of life which is different than the way allopathy views it. ‘Life’ is not just what allopathy or modern medicine ‘sees.’ It does not take cognizance of the soul and the ultimate reality, or the source of the vital force. Allopaths should accept this position. This in itself does not negate the research process. . Ayurvedacharyas do not appreciate the importance of statistical 9 methods, which are extensively used in modern methods of science. This kind of stance results in the inability to define the limits of successes and failures of research/integration in the clinical setting. Advantages Existing For the Integration Enterprise 1. Most allopaths, having softened their derogatory attitudes toward the older medical sciences, are now keenly in search of methods to make good, or eliminate the limitations of their science. They have become more aware of these limitations as they have been practicing the profession longer. 2. Computer-aided designer molecular development has probably lessened the search for plant-based remedies, which have a massive repertoire in Ayurveda. 3. The elucidation of structural changes and their demonstrable reversal, and the reversal of biochemical parameters, while regaining normalcy, were not present until about 100 years ago even in allopathy. It has now expanded rapidly in this area in the last 30 years. Hence the absence of these in Ayurveda need not give an impression of its inferiority. 4. Although parameter testing is an important issue for clinical research, in Ayurveda there are well laid out ways in which such information can be interpreted. 5. Innumerable variations of symptoms and physical signs, investigational and other parameters, concomitance of other disease states, contraction of a new disease on top of this, and other such factors have been listed in Ayurveda as they have in allopathy.

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Background Considerations for Research Methodologies One way of examining these various factors is to analyze the more discrete disease label in allopathy, say, pulmonary tuberculosis or pneumonia, essentially as a localized disease after the systemic aftermath is over.1 One could look at the Ayurvedic symptomatology and body examination to look for a similar disease described on the basis of the Tridosha theory for comparison to determine which disease surfaces, how similar it is to one of these labels or how completely different it turns out to be. The disease label Rajyakshma for tuberculosis already exists. This exercise can be conducted in reverse by taking a disease label from Ayurveda and finding a comparison in allopathy. Making an attempt to establish some diagnostic equivalence among the various diseases described in these two sciences obviously under different names is a helpful factor. Consider a disease like systemic lupus erythematous (SLE). One might assume that Ayurveda does not have any idea about this kind of disease, when in fact it does (Madhav Nidan 52/25). It is closest to what is described as Visarpa. And it is declared by Madhavnidan as impossible to cure as in allopathy. This is theoretical research for which Ayurvedacharyas are probably better suited as they understand allopathy much better than an allopath can understand Ayurveda. An allopath can work under them. This is good subject matter for research papers. An outline of how this could be done will be presented in the methodology of research to follow. Historically in allopathy the syndromic representation of similar diseases has been the first stage. The syndromes, meaning a group of diseases with symptoms, common to many diseases.  When structural/functional and chemical studies progressed, symptoms were broken down into more specific disease entities. This was further substantiated by making the associations of prior occurrences with development of more severe disease. For example, the diagnoses of acute glomerulonephritis and rheumatic heart 1  The allopaths may think that Ayurveda and the infection theory may not have anything to do with each other. They are in that case completely off the mark. Ayurveda describes how a disease develops in the body—first how it gets established in a part of the body, produces its effects locally and systemically, then creates complications and either kills or gets cured. This Ayurvedic understanding fits best with the infections and the autoimmune diseases.

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disease are almost always associated with minor throat infection couple of weeks ago, which subsides even without treatment. These associations form a basis for diagnosis and have considerable importance. Vaidya Jayant Deopujari showed me how the grouping of diseases in large syndromes with some differentiation into individually labeled disease is a process well laid out in Ayurveda for millennia. For historical and other reasons the more minute differentiation of the syndromes into more discrete individual diseases may not have reached the scale that now obtains in allopathy. This is not a shortcoming of Ayurveda. Adding details is a process. Many Indian channels of wisdom were blocked for historical reasons for over 1200 years. Ayurveda was one of these. This calls for a relook to open the channels once again. Deopujari is holding a position in AYUSH ministry equivalent to the chairman of National Medical Commission in Government of India.  Defining cure or the desired level of control is essential in clinical settings, if the treatment has to be evaluated. The definition of cure or satisfactory control is the greatest difficulty when it comes to a crossover double-blind trial involving two different systems, and hence there are not just two different diagnoses and two drugs from two sciences to be evaluated. In day-to-day practice the temporal variation of symptoms is one way to understand whether diseases are continuing, worsening, being cured or being controlled. Allopathy certainly does this, and adds to it the power of investigations to show which of the four trajectories the disease is taking. As will be shown later, Ayurveda has the capability to use this power of investigation in defining the disease progress. When lay people or the Ayurvedacharyas claim cure without taking this temporal element as essential, this is treachery. The Peculiarities of Ayurvedic Drugs Unlike the Allopathic Drugs and Research Methods One deeply engrained element in allopathic medicine is the isolation of the agents which can cure or control diseases, and hence the use of drugs in pure form. In this way it is possible to attribute the control or cure to a specific agent. This gives rise to the allopathic drug action sequence, especially in case of its main actions, other actions, side effects and dangerous reactions. The last two have been censured by Ayurvedic specialists and laity alike.

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Ayurvedic drugs, on the other hand, are a motley mixture of dozens of identified/unidentified substances and are supposed to have no side effects. This question needs to be answered in several ways so that we can use Ayurvedic drugs in research vis a vis allopathic drugs, as shown below. 1. Can isolation of the active principles in Ayurvedic medicines be carried out and studied? The answer is yes. The Central Drug Research Laboratory (CDRL) in Lucknow has been doing this work for a long time. 2. Or, as claimed by followers of Ayurveda, can we accept that their medicines will not act if these are isolated, but can only act as they are prepared in a mixture and use them in trial work? I feel that this position is eminently acceptable. 3. Vaidya Jayant has cited examples of where the known active ingredient was isolated and administered but would not act. In the timehonored way of administering it, it acts. Such an observation actually simplifies the research methodology enormously since we take the entire mix of substances as a single drug just as we do in allopathy using single pure chemical. 4. Vaidya Jayant also holds that active substances to which other ingredients are added prevent side effects. If it is not mixed, side reactions do occur. This is the common reality of Ayurvedic drugs. This position is also fully acceptable. It should be considered a marvel of the thorough and deep observational strengths of the Acharyas, or sages. 5. Among the many ingredients found in Ayurvedic medicine some have been found to be bio-availability enhancers, added to reduce side effects and toxicity. 6. Can the active main principle ingredient in Ayurvedic medicines be isolated and labeled in allopathic style and can other ingredients be allowed to coexist as such? This will be possible after long years of painstaking research. 7. Do we need to standardize all the ingredients these drugs contain or should we consider this unnecessary as long as they can be vouched for, as having been prepared correctly to the last detail as prescribed by the sages in the ancient scriptures? This is also an acceptable position for research. In this case the only criterion would be whether they act, or do not act, for the specific purpose for which they are used.

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8. This will lead us to a comfortable position of accepting all such mixed drugs or any drug from the scriptures as one drug for research. 9. This eliminates the need for subjecting its individual contents to trials, which is cumbersome and is a necessity which may only arise after years of research in the above fashion or not at all. This question of isolation and standardization of the likely active ingredients is reportedly being tackled by the Central Council for Scientific Research in Ayurved (CCSRA) in Ghaziabad, near New Delhi. There are numerous theoretical difficulties in this endeavor, as shown by the practitioners of allopathy, explained below. 1. The Sanskrit names of the plants are likely to be changed when they are translated into the vernacular, since there are about 25–30 main vernacular languages in India. 2. Have these names been handed down correctly, even in the vernacular? This need not be seen as impossible or even debatable—it is eminently possible in India where the Vedas themselves have been handed down orally over hundreds of generations. Rectification of names handed down can be streamlined. 3. It is debatable whether the genera of these plants would have remained more or less the same or whether they have undergone epigenetic changes over hundreds of years. In case of epigenetic changes  have the species of those genera been transplanted and nurtured in the most suitable ways, in climates in which they are supposed to grow at their best and correctly? Or were they collected from an environment not identical to the ideal conditions and is this acceptable? 4. Then the question arises as to environmental effects on their genera. It is conceivable that plant chemistry may change, to a greater or lesser extent, due to soil variation, climatic variation, presence or absence of other plants, sewage, human inhabitation, and modern-­ day chemical and fertilizer pollution. 5. If these are found to vary in their chemical composition, the question of standardization of their effectiveness will come up. With it will arise the issue of how to decide if the changes caused by the abovementioned factors have changed their effectiveness. This objection will be raised if the same drug is not found to be effective in the same or similarly designed trials.

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6. The minute attention Ayurveda gives to the nurturing of medicinal plants makes it a more difficult science in today’s world of producing large quantities. Thus the main action of the  drug becomes further debatable in different climatic situations. This also relates to the problem of standardization of the likely active ingredients of one plant, with whatever constituents it has. There are steps taken by the government of India and the AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) Ministry which are discussed in some detail in Appendix B  in the volume on India’s Public Health Care Delivery: Policies for Universal Health Care. 7. Testing of one drug which may contain  30 to 50 plant parts are processed and added. The likely variations of constituents are almost infinite. Moreover, having no chemical identity in modern terms, it is almost impossible to standardize Ayurvedic drugs. The status of the headway made in this regard should be determined. Yet the research must still be undertaken in spite of these difficulties partly described above, for a long time to come, and the time to start is now. 8. We further anticipate that it would be an almost impossible task for one lifetime to test drugs by grouping certain constituents together, or by eliminating one or more constituents at a time to see whether the remaining constituents do the same work in the same indication in all its dimensions. The hallmark of modern science being Reproducibility, this will require many researchers and many institutions, working in collaboration with systematic, predesigned ways of conducting similar trials, to arrive at a reasonably uniform conclusion for others to accept it. This has to be taken up simultaneously to the best possible extent to save the generational time required for this purpose. This is how allopathy has developed. 9. Further, the question of the same combination of the same drugs will have to be studied in order to identify its other indications. Such research again will likely take many years to complete one test. At the beginning this is not particularly necessary. 10. The theoretical difficulties in testing Ayurvedic drugs for therapy as noted by the practitioners of allopathy are as explained above. These cannot be brushed aside. This so-called Western approach has given allopathy its standardized drugs. Paul Ehrlich, who discovered sulfa, tested no fewer than 600 chemicals in his search for the antibacterial

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activity of a substance, when he found it first in Sulfa groups. This is an untiring attitude which must be recognized. 11. To state the cursory observation that the rishis (sages) with divya drishti (transcendental vision) have provided these combinations, that these are good and that no more research is necessary for their verification is not fully commendable in this age of science. 12. At the same time, it should be clearly understood that the above difficulties have been explained not to dissuade people from the idea of research, but to open the vista on what may have to be done. One would also find that to initiate research several positions have been clarified below which could make the job much easier than might be expected on a first reading. New Facilitatory Ideas for Ayurvedic Drug Research 1. The concepts of reverse pharmacology and network pharmacology, which are gaining popularity, should be considered favorably for research. The experiential phase in reverse pharmacology includes robust documentation of clinical observations of the biodynamic effects of standardized Ayurvedic drugs by meticulous record keeping. In conventional drug research, this comes at the end (Vaidya Dr Ashok D.B., 2014). 2. Ayurvedic pharmacoepidemiology is the study of the acceptability and efficacy of Ayurvedic drugs in a large number of people across multiple centers. This idea resembles the phase IV trial in the market giving a helicopter view of how the drug is performing. 3. Observational therapeutics and reverse pharmacology paths have led to significant hits, leads and drug candidates for several diseases. The active phytomolecules will also provide novel scaffolds for medicinal chemists to enhance efficacy and reduce toxicity (Vaidya 2014 ibid.). 4. Network pharmacology involves application of network analysis to determine the set of proteins most critical in any disease, and then chemical biology to identify molecules capable of targeting that set of proteins. These ideas are being pursued at the highest levels in India through the Indian Council of Medical Research (IMCR) (Deopujari 2013).

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5. Ayurvedic Aushadhashalas (pharmacies) under the supervision of experienced Ayurvedacharyas can prepare the drugs which have to be committed to research. At least a few may be hand-picked by common consent. Once this facilitated position on Ayurvedic medicines is understood, on the practical plane, the main purpose of trying out a greater number of drugs for the benefit of mankind, of finding drugs where remedies are not available, and also of finding better remedies if there already are some, will be achieved. Preamble to Research Methods to Discover Good Drugs Allopaths know which are the good drugs and which are bad. Allopathy is always in search of better drugs. It looks to Ayurveda as the source of drugs which are likely to do an excellent job when allopathic drugs, good or bad, do the same job imperfectly or dangerously. If the Ayurvedic practitioners and followers have the same attitude, working together is easy. For this purpose, Ayurvedic practitioners must be aware of the research system proposed here. This will lead to a collaborative research attempt. Allopathy will be willing to go a step further and say that to supplement or even supplant allopathic drugs, let there be research on Ayurvedic drugs. Drugs are needed for diseases that are untreatable by allopathy. Ayurvedic drugs should be studied for that purpose as well. Ayurveda is a science of and for attaining health, better called Swasthya, and preserving it in positive and preventive ways. Many Ayurvedic insights and methods, such as Swasthyavrittam, that is, how to remain healthy; Dinacharya, that is, daily practices; Ritucharya, or seasonal practices; Kutipraveshika or Kayakalpa, that is, rejuvenation, are immensely important to study to understand and practice them. However, this is not the subject matter at hand. Some of these practices are difficult and costly. Some could be simply adopted in daily life as a sensible way of living. In this chapter, however, we are only discussing medicinal research. Research Methodology to Rediscover Ayurvedic Drugs Below I discuss the variety of facets of this process of research for the consideration of all concerned. They are allopathic models, yes. These are used since no better models than these are available or known to allopathy.

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All the groups involved, if matched for age and sex, increase the value of the study. A minimum disease severity will also achieve this. Many determinants of good clinical trials have been discussed extensively in chapter on the 5  pharmaceutical industry and clinical medicine which will be strictly applicable here also. Further, the criteria with which to judge the quality of trials and the reliability of the results, as discussed in Chap. 8 The Western Model in Disease and Health Care Delivery are also fully applicable here. These models are as follows: 1. Simple Model of Evaluation of Open Single Trials: a. It can be conducted for simple day-to-day diseases such as cold, headaches and body pains which have no potential serious significance. Attempts could be made for such symptoms as sweating of palms, excessive sweating in general, dryness of skin, itches and so on with remedies from Ayurveda. Note that allopathy does not have effective drugs for these seemingly simple symptoms. The efficacy may or may not be obvious. Still, with good record keeping meaningful results can be drawn. Additionally, habits of good record keeping, a fundamental requirement of research will be inculcated among the new researchers. This enterprise will earn Ayurvedic remedies a rightful place in the usage of common man with the pleasure of flavors absent in allopathy. Allopathic tablets for headache and cold as well as other allopathic remedies have captured the market, as these are experientially accepted by people as considerably more effective even without flavors. Many Unani medicines are even better in terms of flavor and taste. 2. Simple Models of Evaluation of Open Label Double Trials: These can be conducted where the two groups of patients are to be treated differently. a. The first group consists of patients with a discrete disease entity with an allopathic diagnosis, for example pneumonia or bacillary dysentery, and is treated with allopathic medicines. b. The second group has the same disease with the same severity. This group is treated with Ayurvedic medicines and an addi-

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tional Ayurvedic diagnosis is also attached to each patient. There can be a variety of Ayurvedic treatments. c. Cure in both groups will be in terms of time and how the patients feel. The parameter testing as used in the first group will be applied to the second group as well though the treatment will be different. d. Since they are simpler and cost effective, diseases which are of short duration would be easier to evaluate and more fruitfully. If the cure is delayed in either group, a reasonable time will be given to either in which to complete the cure but it will have a negative rating as well. This will be the basic method for all the subsequent models, described hereafter. 3. The Model of Evaluation described above is reversed: a. The first group must have a constant, matching Ayurvedic diagnosis and will be treated with Ayurvedic medicines which may not vary. b. The second group consisting of the same Ayurvedic diagnosis may/will have different diagnoses from the allopathy point of view and may be treated differently, preferably using a single modern drug for each patient. c. The absence of a diagnostic equivalence in the two groups will have to be contained within all the other research processes as well, described below. d. In both of these models the drugs given are known to both patients and doctors, and some bias will have to be evaluated and eliminated from final analysis. e. However, we have deliberately described these simpler models to be employed at the college level to make the students familiar with these simpler methodologies. f. The study, as detailed above, will have the following conclusions to draw: percentage cure and efficacy of drug in each group compared to the other, duration to achieve cure, side effects and costs. It may also indicate that a single Ayurvedic diagnosis of disease and its Ayurvedic treatment may bring relief for a number of Allopathic diseases.

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4. Another Model of Evaluation: This is like the above two models. The characteristic differentiating feature of this model is that the drugs used are known to both patients and doctors, but are not known to the evaluator, who is a third person involved in the trials of this third model. The evaluator is an additional person aside from the physicians, involved in the treatment and cure, one on each side. These evaluators have the power to interrupt a particular treatment if he or she thinks that there is unacceptable deterioration in a patient’s condition in either arm or both. Such a person can even decide if the entire trial is reaching counterproductive results and can terminate it. Only a neutral person can do this since those involved in treating patients may find it difficult to accept that their therapy is failing or causing more damage. This is a more refined form of trial, and as such is valued highly in allopathic circles. It is not as complicated as it seems, and is useful.

Parameter Testing In all the abovementioned Open Double Trial Models, irrespective of diagnosis or treatment, there will be parameter testing schedules, or, if serious deterioration develops, modern laboratory methods will be used. This is an important step giving an early idea as to whether the trial is progressing satisfactorily. The main criteria used will be allopathic, with Ayurvedic criteria included in records and considered in analysis. In any trial there is a high level of concern for early detection of deterioration. Naturally such intermediary and intermittent evaluation can indicate normalcy or improvement as well, and also form the baseline indicators to decide what exactly should be considered as improvement. Thus the parameter testing at the end of every trial model will finally decide whether the parameters have been improved significantly or any organ has been damaged since there is a change for the worse in the parameters. Standard systems of parameters to be tested are available, and as such it is not necessary to go into details of these standard systems here. The hallmark of modern science is reproducibility. Ayurvedic physicians adopting these techniques and adapting to them, and conducting trials again and again with the same design, will serve this hallmark of science.

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Other Ways of Testing Ayurvedic Drugs a. Hopeless cases which cannot be cured with allopathy, chronic cases that are unresponsive to allopathic or any other treatment, can be taken up for treatment with Ayurvedic drugs. It is an open admission that modern science does not have an answer, and it is in desperation that allopathy turns to Ayurveda or AYUSH. It is not the remotest intention to challenge others with something impossible to achieve and ridicule them for failing. Here the important criterion is not just cure but improvement in quality of life. Cure can come later. A significant level of palliation achieved and improvement in tolerating diseases, even while on treatment without significant improvements, can be considered more important than cure. And this need not include drugs alone but ayurvedic dietetics, other non-drug methods of treatment such as Pancha Karma, that is, five procedures to which the body is submitted, baths, naturopathic procedures or yogic exercises which can be instituted to evaluate whether quality of life parameters are improving. If there is cure it is a great boon. Then the particular agent and/or the practices will have to be taken up for the toughest form of trial (see below). b. The prospective study of already established or newly promising drugs in Ayurveda can be undertaken with or without an Ayurvedic counterpart as an active comparator group. A trial can be constituted where several remedies are available for a particular disorder. Here the prime requirement will be to have a much larger number of patients treated with a particular drug to know the percentage variation in the extent of cure. With a fixed diagnosis each one could form one arm of a trial and be evaluated along the lines of the United Kingdom Prospective Diabetes Study (UKDPS), which had three arms. Initially it could be the Single Open Trials, slowly progressing through the Double Open and Blind, and then crossover trials. This may establish the best of the drug for a given disease label. c. Keeping the demands of a reductionist model in mind, one can reduce the number of ingredients in Ayurvedic medicines. This can be achieved by using a single constituent drug of which many varieties are available. Or a single part of a plant can be used as a single

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drug, Eka Moolika Prayog, that is, a single root is administered experimentally. Similarly, double Dwi Moolika, or multiple roots, Bahu Moolika, combinations can be used. Carrying These Ideas Forward The logistics of the enterprise may seem daunting. They are not. In the hundreds of our medical colleges of all pathies these simple methods can be taught to students and trials can be designed for short terms for dissertations. At present the dissertations are so stale and lackluster that such an infusion of ideas and methods will rejuvenate them completely. The first step of this enterprise is the training of the present-day faculty and brainstorming for ideas that can be taken up for different forms of trial. A combined forum of researchers of high quality such as Chittaranjan Yajnik and Jayant Deopujari could form such an apex team. This effort will lead to clearer definitions of the indications for research, the end points to reach, what methodology to employ at each step, who will administer the trial, what will be observed, and how to and who will decide the outcome. This will make the trial more intelligible to the modern medical profession than it does today. It will establish in the long run equally good or better or poorer alternatives in comparison with any other system offering an alternative. Such experiments could reveal important findings of whether it eliminated the need for long periods of hospitalization, or was found to be capable of eliminating symptoms better, or could help to decide the place of a therapy in the pharmacopeia. The last one in itself is a precision, increasing the value of evidence to use particular therapies. Postscript This is the outline of research in Ayurveda. The abovementioned ideas have evolved over many years. The long and innumerable dialogues I have had the pleasure of having with Vaidya Jayant Deopujari have resulted in the crystallized observations and situations described so far. These are important since they indicate serious lacunae long prevailing in the system that need to be addressed. There are positive changes to the otherwise antagonistic or indifferent attitude at all levels. International Yoga Day has come about and is gaining growing worldwide acceptance. These ideas will rejuvenate Ayurveda and by implication here AYUSH.  Some important

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remaining issues related to those trained in the alternate AYUSH system and what is happening within this system are discussed below.

AYUSH as It Stands Today. What Do We Do with It? AYUSH as a system and the AYUSH doctor are an asset and not a liability. AYUSH represents a large pool of human resources trained in medicine. The AYUSH graduate has a place in the scheme of things. Here the change of the title from Ayurvedic to AYUSH need not be surprising, the reason being that all the methods of research and the considerations involved in it, from an allopathic point of view, are the same for the other systems included in AYUSH. Similar methods should also be applied to make the other AYUSH systems better. There is great potential in all these pathies. Additionally, I believe that these fresh graduates have a tremendous role to play in India’s health care delivery as a whole, spanning all three levels of care. The following considerations are important in the present AYUSH scenario. These are briefly mentioned here and have been covered extensively in the volume India’s Public Health Care Delivery: Policies for Universal Health Care in Appendix B (see also the chapters on reorganization of public health care delivery in the same volume. 1. Improving the dismal state of AYUSH colleges along the lines of medical colleges, as discussed in the volume mentioned above; 2. The quality of training leading to improvement in the quality of the AYUSH graduate with additional methods if necessary, as discussed in the chapters on medical education and shortage of doctors for allopathy medical colleges in the volume mentioned above; 3. Training to increase the AYUSH graduate’s knowledge and proper practice of modern medicine. This is dealt with extensively in the chapters on community health centers and the reorganization thereof in the abovementioned volume. 4. It is important since such a graduate can play a much better role in the deeper hinterlands, assist the primary- and secondary-level health care described in it; he is still likely to settle in more remote setting where a good base of allopathy will help. This will make him an asset to the rural society;

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5. The Yatwatmak, or occult, often unseemly, superstitious and bewildering supernatural practices reflected in miracles and occult powers, are carried out by the Tantriks, Mantriks and Ozas. The Indian psyche responds to all this and thus we certainly need to know more about it. These practitioners have a role to play in the health care delivery system elaborated in the volume mentioned above. The peripherally spread AYUSH doctors are likely to understand this better and can also be a bridge between the public health functions and functionaries and the occultists. 6. This is not a fantasy. On the border of the US and Canada, the original land of the First Nations peoples, these traditions exist. Doctors and psychologists of First Nations origin have studied these methods and found positive elements. A whole volume has been recently published on this (Ecopsychology, Ed Barbara Rylko-Bauer, School for Advanced Research, 2009).

History of Integration of Allopathy and Ayurveda The first such attempt was made by the British in 1824, who established the Sanskrit College in Calcutta where Ayurveda was taught along with allopathy. Gurukul Kangadi started an integrated course in 1921. The Banaras Hindu University (BHU) integrated course was established in 1928 (Deopujari 2013). The Chopra Committee, 1948, stated that integration of modern and Ayurvedic medicine was not only possible but practicable, though it would be time consuming and not easy. The committee believed that these two systems should be in harmony. It suggested that “the curriculum must be carefully worked out so that where one system is in apparent deficiency the other system should make it up; there are many unnecessary contents which should be cut off… the one area where the integration needs to focus strongly is allopathic diagnosis and all the gadgetry it uses for it” (Deopujari ibid.). The state of integration today is half-baked and ridiculous. For example, in their third year BAMS graduates join coaching classes for modern pharmacology and later for the theory of allopathic medicine, which is useful, but they do not learn biochemistry and pathology, which gives them a poor understanding of everything. The same graduates then go to work in modern hospitals to learn. Their approach remains mechanical and not rooted in the patho-physiology of disease.

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One objection is that teaching two paths together will make the syllabus so bulky as to be confusing and impossible to learn. This objection appears sound but the LIM degree at Madras University and the integrated course at Banaras Hindu University, which students have been taking for generations, have not reported such confusion. The legitimate outcome of this possibility is that there are many matters and content which can be segregated from the routine curriculum at the undergraduate level and not taught at all.

Improving Ayurvedic Understanding Terminology This is one of the major issues which can be and needs to be tackled intelligently in attempting integration. Terminology evolves with a science and its language and carries specific meanings (like the terms in law), and this should be carefully deployed in integrating the two sciences. For example, a common term for itching mainly means allergic disorder in allopathy and Kapha with Manjistha as its remedy in Ayurveda. The issues will be similar when newer concepts from one science are added to another science (Deopujari ibid.). Ayurvedic Curriculum According to the Chopra committee recommendations, the curriculum should be uniform in the country and the textbooks should be unified. When Ayurvedic and Unani systems and their training institutes were studied, wide variations were found. The major finding was the poor understanding of the basic subjects. This led the proposers to suggest that a full course in modern medicine should be the basis, onto which the entire system of Ayurveda or Unani should be grafted for those who want to learn one of the AYUSH branches as a special field of interest and practice. (This actually means that the AYUSH systems should be like Post graduate Courses, which in itself is quite sound.) (Deopujari ibid.) However, India needs to make many more immediate improvements before this. Such a step is too disruptive to the present system and would cause massive and unnecessary damage. When allopaths study AYUSH informally this condition is fulfilled. There are those who believe that those who undergo special learning in Ayurveda (or AYUSH in general)

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after being an allopathic doctor should be financially incentivized during their training. These doctors should be selected carefully with an eye to creating the kind of teachers and research workers Ayurveda needs today. If these doctors opt for such a career they should be well compensated. Curricular Ad Hocism The Ayurvedic courses, syllabi and teaching pattern sometimes follow the pattern of allopathy, ignoring the peculiarities of Ayurveda; sometimes the syllabus is changed to facilitate Ayurvedic graduates to practice allopathic medicine and sometimes to make it convenient for the management of the private Ayurvedic colleges. It is never designed for proper teaching of Ayurveda through which there could be upliftment of Ayurveda to progress as a scientific stream. The central body also strongly worded its disapproval of the current status of the concurrent manner in which the so-called integrated curriculum was drafted. Making clear its point of view, it states that anything and everything in Ayurveda that is scientifically testable and can be proved should be incorporated in the Allopathic system (Deopujari ibid.). There is no integration at the syllabus level; it is a mixture. Anatomy and physiology were added ad hoc. But it does not achieve the desired understanding that the method of teaching the patho-physiology in Ayurveda does. In Ayurveda functional anatomy and applied physiology are taught in a different way. There is no emphasis on understanding the normal physiology either. Allopathy goes from normal to abnormal; Ayurveda goes from disease or abnormality to normalcy. The teaching of Ayurveda should bear this in mind. As discussed below, Problem Based Learning (PBL) is therefore an effective way to teach Ayurveda (see the chapter on medical education in the volume India’s Public Health Care Delivery: Policies for Universal Health Care for a detailed discussion on PBL). Similarly, the AYUSH graduates could be given grounding in public health, and the provincial governments should make available opportunities for them to participate in the health care delivery system. By implication this means their participation in public health care right up to the primary health centers or sub-center level. (This idea is discussed extensively in the volume mentioned above. However, from the AYUSH side it came independently while this chapter was under discussion.) Expectations from formal education in Ayurveda or AYUSH:

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In medicine, whichever system is being used should be relevant to the present understanding of the world as taught in today’s education at large or through which the world is understood today. It should be relevant to the society which is going to use it. In its final form, it should suit and fulfill some of the national requirements and should be effective enough to achieve a satisfactory financial status. Ayurvedic (or AYUSH in general) education should be progressive and compatible with the progress in the other fields which decide the growth and evolutionary direction of the society. Such education should have the capacity to foresee future challenges and face them. It should be research oriented and should be able to give sound logical insight into the system to avoid rote learning in order to be practiced intelligently. This education should enable the practitioners to make additions to the science itself (Deopujari 2013). Efforts to Make Ayurvedic Education Better Attempts are being made to resurrect the Gurukul system by which Ayurveda was taught in ancient times. This has become necessary in special situations in Ayurvedic education since this system was replaced by the college and university system by the British. The Rashtriya Ayurveda Vidyapeeth (National Ayurveda University/Knowledge Center) sends selected students to renowned Vaidyas for one year. There is a scheme for Vaidyas—a science fellowship run by the Foundation for Revitalisation of Local Health Traditions (FRLHT), Bangalore. In addition, Samhitas are taught in Pune in a Gurukul Paddhati (system). The proposed model for the Gurukul is a four-year course admitting 20 students every year with an examination every 2 years. It should have an OPD, an indoor facility with ten beds, a dissection hall and an Aushadhi Nirman Shala, or drug preparation school. It is expected to be run by privately practicing Vaidyas but should be recognized by the government and supported monetarily. Paninian Sanskrit should be the language of instruction. Today the entire structure of Ayurvedic education in India has been made uniform, although the teaching may happen in the vernacular. All the different degrees have been standardized. New textbooks have been written but the Samhitas, the foundational writings handed down since

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millennia, have been downgraded to a mere non-clinical subject (Deopujari 2013). Different standards for the faculty to student ratio prevail in private (which are the majority) Ayurvedic colleges and government Ayurvedic colleges. An extremely small number of colleges have the required number of faculty, beds and other prescribed norms. The Central Council for Indian Medicine (CCIM) and the AYUSH team inspects all the colleges yearly and can withhold permission if there are lacunae. CCIM and AYUSH have come up with new quality standards which have been disapproved by most people connected with AYUSH colleges. Textbooks One major requirement of Ayurvedic education is textbooks, rewriting Padarth Vignyan and Ashtang Sangraha (both commonly understood as physics) since these are at variance with the understanding of modern physics possessed by the young person who gets admitted in an Ayurvedic college. Unlike modern physics, the Padarth Vignyan has a philosophical basis in Vaisheshik and Sankhya philosophies, of which the former is pure physics. An attempt also needs to be made to recover what we have lost, the ways in which our ancestors thought about mathematics, astrology, astronomy and Ayurveda, to know its evolution. The understanding of Padarth Vignyan should become deeper and wider so that additions can be made in Ayurveda. We need to revive Tantrayukti, that is, applied physiology on shareer (body function related), develop a new Nighantu, that is, an Ayurvedic pharmacopoeia, revive the skills of Panchanidana, that is, the five types of diagnosis, or Ashtavidh Pariksha, that is, eight types of examination methods, or for that matter develop new Rasakalpas, that is, the science of various salts from different metals such as gold, silver and mercury (Deopujari ibid.). Some textbooks like Abhinav Shareer (New Applied Physiology) were written which added material from allopathy to Ayurvedic texts on that subject where the earlier texts on Shareer mentioned above were found inadequate. A new textbook was written by C Dwarakanath on Padarth Vignyan, or Physics. But the textbooks on Nidan (diagnosis), Chikitsa (treatment) and Shalakya (that is) surgical procedures were allegedly poor in quality (Deopujari ibid.). Government agencies such as the Central Council for Research in Ayurvedic Sciences (CCRAS), AYUSH and the National Institute of

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Science Communication and Information Resources (NISCAIR) have published monographs on different herbs, diseases and Panchakarma, that is, five procedures which should be included in the reference books for the syllabi. The idea of monographs is particularly attractive since it chooses an important subject and then collects information from diverse sources and arranges it in a logical fashion. There are no demands regarding size or such other rigid criteria and hence they should be encouraged for choosing the subjects wisely. The late Acharya Priyavrat Sharma rearranged the Charak Samhita according to the division of subjects as they are taught today. Such a massive effort must find its parallels and should be widely appreciated. Sanskrit Today’s Ayurvedic education does not demand or insist on good to very good knowledge of Sanskrit, though all the major sources of Ayurvedic knowledge are in Sanskrit and it is inseparable from Ayurveda. This is a major deficiency. Unani learning prefers that the student know Arabic and the Siddha graduate must have a good knowledge of Tamil. The Samhitas are replete with precise shlokas which must be understood properly as only then is further elaboration possible, in the vernacular or any other language. Ayurveda contains a great deal of terminological precision. The translations from Sanskrit into the vernacular have been characterized to be of poor quality, and fail to translate and then transform the implied meaning of the terms in a clear and standard way. In addition, a great deal of attention needs to be paid to how Ayurveda is being taught in various colleges since this does not provide an adequate and proper base from which to practice Ayurveda in the clinic. Encyclopedia and Dictionaries According to Vaidya R M Nanal, Ayurveda needs an encyclopedia of terminology (just as there is one  in Western philosophy), which is quite understandable. It should also have dictionaries like those we have in modern medicine. One such dictionary has already been created and published.

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Modern Diagnostic Methods There is a growing need for the modern methods of diagnosis to be included in the Ayurvedic curriculum. They can be given an Ayurvedic interpretation. For example, the electrocardiogram can be interpreted on the basis of Panchaprana Gati—the movement and speed of the five vital sources. Endoscopic findings can be described as Kanti (complexion), Varna (color), Prabha (luminescence), Valipradurbhava and Valinasha, (pain and its relief) and Vrana (ulcer.) There is a specific way of testing various abnormalities of urine and stools which Ayurveda has described. If the abnormal specimens are not available, the abnormality can still be demonstrated by other simpler methods. Bacteria can be studied using Ayurvedic nomenclature of Doshas, that is, defects or abnormalities in Ayurvedic terms. There are ongoing attempts to interpret modern biochemical investigations using the Ayurvedic terminology of Sama–Niram Bheda, that is, normal or even and abnormal or uneven differences. This is an impressive concept and encourage the examination of diseases and research at newer depths and heights. I affirm that it is eminently possible to do so. It underlines increased use of laboratory testing and imaging in the practice as well as the research of Ayurveda. Even after this training in modern methods of diagnosis, the diagnosis can still be through Ayurvedic means. Verification as to whether any remedies that fit the Ayurvedically diagnosed conditions are present and whether these can be made and applied in the situation can be easily undertaken. The theory of disease based on Tridosha and Vinshati Gunas (the 20 attributes) as per the Ayurvedic terminology of disease causation can be explained in allopathic terms (see above). Allopathic medicines can be studied on the basis of Rasa (taste), Guna (attributes), Veerya (power) and Vipaka (effect). There is scope to study the Panchabhoutikatwa or the properties of medicines that are manifest in the five great principles which form the world—Earth, Water, Air, Fire and Sky. It may be astonishing to the reader but there is an Ayurveda-based software developed by C—DAC Pune, Tilak Maharashtra Vidyapeeth and Nanal Foundation.

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Problem Based Learning (PBL) Formats and Ayurvedic Teaching One major aspect of Ayurvedic teaching is its amenability to be taught clinically or experimentally in a hands-on session. This is the method adopted by the modern Problem Based Learning. Ayurveda can be taught more effectively in the Problem Based Learning (PBL) Formats which the allopathic medical colleges have started using, however are elementary presently. PBL is a guarantee of learning being enjoyable, focused on the mechanisms of how things happen, leading to critical clinical skills, making one a self-learner, stimulated by enthusiasm to do things. A considerable part of the practical side could go into preparation of different Ayurvedic medicines, of which there is an impressive array. (Fortuitously, this thought came from a different channel after I had written extensively about Problem Based Medicine in the other volume cited above.) A Brief Note on the Subjects to Be Taught in Undergraduate Ayurvedic Education 1. Sanskrit with a Paribhasha Prakaran (chapter on terminology) attached to explain the Ayurvedic terminology; 2. Newly designed experimental methods to test Tridoshas and Gunas (properties); 3. Application of Tantrayukti (applied physiology) should be carefully demonstrated; 4. Contemporary sciences such as Vriksha Ayurveda (related to trees) and Gaja Ayurveda (related to elephants) could be added or placed in other sciences where they may be appropriate; 5. Ancient chemistry, mathematics, Soopashastra (the science of extraction) or Pakashastra (science of cooking) should find a place in the curriculum; 6. Monographs on physiology of different organ systems (with or without any reference to the modern physiology); 7. In-depth study of Samhitas. All the original insights are given in them. 8. Experimental testing, through research assessment, through the idea of Ekal Dravya Chikitsa (single substance/plant/root application), will open a rich and immediately testable research field for allopathy (see above also). 9. Information on various aspects of the plant kingdom such as pharmacology, phytochemistry, medicinal herbs verified botanically, or

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such plants which have proved to be of value after undergoing the rigor of modern research should be consolidated through crossindexing in separate monographs and should be available to the Ayurvedic student; 10. Study of 200 neutraceuticals identified by AYUSH; 11. Basic principles and practice of herbal extraction; 12. Parad Samskaras (technology) to create administrable medicines out of mercury, silver and gold and the creation of Bhasmas (oxidized compounds) out of soft metals; 13. Information available on Ayurvedic pharmacotherapeutics such as Aushadhi Gunadharma Shastra (science of the properties of medicinal herbs) by Acharya Gangadhar Shahstri Gune should be available. Similar books must be available in other languages in India; 14. Posting in government medical colleges to understand common modern poisons and their treatment and antidotes; 15. Independently written treatises of value, for example Triskandha Kosha by Gadgil and Laxan Kosha for differential diagnosis, exploring diseases of women as understood in Ayurveda, much of which is far better than even the allopathic remedies; 16. Greater exploration from Ayurvedic point of view of Anukta Roga, that is, the future unknown disease entities which seem to be a specialty of Ayurveda; 17. To be properly taught (not done today) are the subjects of Avarana, Ashayapakarsha, Chikitsa Sutras, preparation of Basti Kalpas, Nasya, Shirodhara, surgery and sub-branches of surgery from an Ayurvedic standpoint (Deopujari 2013).

Ayurvedic (or AYUSH) Graduate and the Public Health System All the skills that are highly desirable for the Ayurvedic graduates to be able to take care of the sub-center population of 5000 with the help of other paramedics, Swasthya Rakshaks (Guardians of Health, which is to say Community Health Workers in current parlance), can be taught in elementary Ayurvedic education. This could be one of the most satisfying jobs carried out by the Ayurvedic graduate, who very often tends to relocate in order to undertake these studies. This idea is elaborated with some reservations  in the chapter on restructuring primary health care in the volume India’s Public Health Care Delivery: Policies for Universal Health

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Care. The Central Council of Ayurvedic Research (CCAR) has given a boost to the concurrent courses, stating that they will create a good Vaidya and a basic doctor. Utilization of this cadre at the bottom level has some excellent implications, as shown below. (As discussed in the abovementioned volume it will be a substantial answer for the many ills of public health care, such as unnecessary referrals.) National Health Policy 2015 and AYUSH (Draft Suggestions of Vaidya Santosh Nevpurkar, National President Ayurved Vyaspeeth, to the Central government, adapted, abridged and modified) 1.7 The role of AYUSH in the area of non-communicable diseases should be defined (in a manner that is usable for AYUSH doctors in the Primary Health Settings); 2.12 There should be a position statement about the AYUSH drug industry, possibly in the area of drug production, quality and authenticity; 2.14 As suggested elsewhere, primary health care should be left for the AYUSH doctors. Their role should not be confined to national programs only. They should also be inducted in the delivery of secondaryand tertiary-level care using mechanisms of the upgradation of the knowledge of the AYUSH doctors and providing them legal status to work in these systems (see the volume India’s Public Health Care Delivery: Policies for Universal Health Care, Appendix B, Controversies Over the AYUSH System of Medicine; see also the chapter on the National Eligibility and Entrance Test, NEET). An elaboration on how to do this and support these graduates is discussed there. 4.3 10.3 Standardization of the Ayurvedic medicines—before going further it is necessary to compile and make available the considerable work that has already been done in this respect. Mainstreaming AYUSH This requires a great deal of discussion in a staged manner of action, without which this will lead to disaster. The main areas not covered so far are briefly mentioned here. In the early 1980s the entire field of Ayurveda was dominated by the traditional Vaidyas, who refused to allow Ayurveda to be subjected to any kind of re-examination. A couple of additional reasons were that they may

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have had to accept the greater effectivity (I desist from using the word superiority) of modern medicine, and that such effort would uncover the serious limitations of their therapeutics, and their fond beliefs and their means of survival would be destroyed. The subsequent generations sincerely believe that the re-examination process must start. It is hoped that this chapter will serve as a helpful document for the government to start a dialogue in the AYUSH colleges. Revitalizing local health traditions in the use of medicines was an idea mentioned in the NRHM 2012 document. No one disputes the need for and validity of these ideas. It is the job of the highly specialized bodies with a focus on this, but not that of NRHM. AYUSH practitioners who may settle in the vacuum created by the PHC closure (as suggested in India’s Public Health Care Delivery: Policies for Universal Health Care) can do this well. It is desirable to retain, preserve, cultivate and collect the medicinal plants of India. This should come as an additional responsibility of AYUSH and should not be under the auspices of public health care delivery. It depends upon well-formed guidelines about how is this to be done, how AYUSH doctors spread throughout communities should do this, developing medicine parks to transfer the medicines thus found and cultivated with an upward method of standardizing these drugs for large-scale manufacturers (see Appendix B, Controversies Over the AYUSH System of Medicine, in the volume mentioned above). Beyond this, there should be separate institutionalized support from where the information could be transmitted. It has to be a separate vertical unconnected with health care, carefully  thought of, which  needs long deliberations, will need a consolidation of multiple agencies doing something or the other about different aspects of what could be reasonably termed as the Revitalizing the Local Traditions. Homeopathy There is no reason to deride homeopathy or any alternate system of medicine. Every system has its incurable diseases and each system cures illnesses which the other pathies may not be able to. Each system has a way or theory of defining an ailment and naming it. Each has a defined way of looking at the etiology and how an ailment can be removed. There is also a need to understand the potency enhancement of homeopathic medicine through trituration and dilution methods, which

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permanently cause changes in its drugs  and retain the medicine in extremely small quantities (Hegde 2009). The principle of ‘like cures like’ certainly does not deserve the ridicule it sometimes receives. Homeopathy in fact could be regarded as a further in-depth extension since it goes much deeper than even the Ayurvedic Prakriti Parikshan (Hegde ibid.). In simple direct translation, Prakriti Parikshan in Ayurveda is examination of the body. It indicates something akin to the genetic makeup of the individual which goes deeper for better understanding. For such perceptions to be understood by others as well as Ayurvedic physicians, there should be more scholarly writing and elucidation of these ideas in the greatest depth possible. Like Ayurveda, homeopathy treats a person in an individualized manner and not a generalized one like allopathy. I look forward to discussing the same aspects as discussed above with reference to Ayurveda with regard to the remaining AYUSH system at another time, especially after the publication of this volume. My own familiarity with Ayurveda is why it is discussed in more depth here. Not having the in-depth knowledge of other AYUSH systems is a limitation which needs to be addressed. In conclusion, a comprehensive review about of to utilize the knowledge of AYUSH systems, the human resource behind it, how to apply and update as well as upgrade these systems, and how to put them to use in the improvement of India’s public as well as private health care delivery is presented for consideration in India’s Public health care, the volume mentioned above.

References Will Durant, Our Oriental Heritage Part 1, Simon and Schuster, 1936. Madhav Nidan, Ayurved Treatise, verse 52/25. Vaidya, Dr Ashok D.B.  Reverse Pharmacology-A Paradigm Shift for Drug Discovery and Development Current Research in Drug Discovery 2014, 1 (2): 39.44 DOI: https://doi.org/10.3844/crddsp.2014.39.44. Ecopsychology, ED Barbara Rylko-Bauer, School for Advanced Research, 2009. Deopujari J, Sharma M, Ayurvedic Education, Perspectives and Implications, Ayurved Vyaspeeth, Nagpur, 2013. Vaidya Santosh Nevpurkar, National President Ayurved Vyaspeeth to the Central Government ,Adapted and modified from the Draft Suggestions of. Hegde, BM Prof, What they do not teach in the medical school, Paras Publication 1st Edition 2009. Madhav Nidan, Ayurvedic Treatise, 3/16 – 20.

Index1

A Accountability, 44, 117, 196, 205, 231 Accreditations, xi, xv, 70, 71, 202, 211, 223, 296n2, 296n3, 326–327 Accredited Social Health Activists (ASHA), 59 Accusation, viii, 22, 195, 322, 324 Active pharmaceutical ingredients (APIs), xix, 97, 102, 109 Adhia, Dr Hasmukh, 299 Admission and Fee Regulatory Committee (AFRC), 64 Adya death case of 2018, 18 Affordability of drugs, 108 Affordable Medicines, Reliable Implants for Treatment (AMRIT), 309

African American and poor economicans, xii and structural racism, xii All drugs under price control, Italy, 112 All India Institute of Medical Sciences (AIIMS), New Delhi, x, xi, 14, 54, 187, 195 Allopathy etiopathogenesis, 339–340 misconceptions about, 339 Andhra Pradesh’s Aarogyasri Community Health Insurance Scheme, 284 Antibiotics resistance, 164 Apollo Hospitals, 11, 117 Assisted Reproductive Technologies (ART), 269, 270 Association of Healthcare Providers (AHPI), India, 298

 Note: Page numbers followed by ‘n’ refer to notes.

1

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Kelkar, India’s Private Health Care Delivery, https://doi.org/10.1007/978-981-15-9778-7

371

372 

INDEX

Aushadhi Nirman Shala (drug preparation school in Ayurved), 361 Automation, 39, 120, 264 Autonomous Boards, 182, 198–201, 213, 217 Auxiliary Nurse Midwives (ANMs), 59, 221, 324 Ayurveda, 6, 245, 246, 334–347, 345n1, 349, 351, 352, 355, 356, 358–367, 369 Ayurvedacharyas, 337–346, 351 Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) system of medicine, 207, 367, 368 Ayurvedic and modern diagnostic methods, 363–364 Ayurvedic colleges, 360–362 Ayurvedic curriculum, 359, 363 Ayurvedic drug research evaluation method, 352–354 open label double trials, 352 open single trials, 32 parameter testing, 352, 354 research methodology, 351–354 testing methods, 354–355 Ayurvedic drugs discovering good drugs, 351 isolation and standardization of, 348 network pharmacology, 350 reverse pharmacology, 350 Ayurvedic education dictionaries, 363 encyclopedia, 6, 363 expectations from, 360 samhitas, 6, 361, 363, 365 Sanskrit knowledge, 363 subjects taught in under graduate, 365–366 textbooks, 6, 362

Ayurvedic interpretation of modern medicine criterion of cure in diabetes, 341 defining cause of disease and criteria of cure, 341–342 defining cure, 346 natural course of disease, 342 peculiarities of drugs, 346–350 steps to improve understanding of, 359–366 symptomatology and body examination, 345 syndromic representation of similar diseases, 345 systemic lupus or Visarpa in, 345 terminology, 359, 364, 365 theoretical research, 345 treatment of jaundice, 341 Tridosha (three defects), 339–340 Ayurvedic research, 337, 343 Ayurvedic teaching, 364 AYUSH graduates in primary and public health settings, 360 Ayushman Bharat (AB) challenges in delivering, 299–304 deprivation criteria and categories of patients, 277 eligibility, 280 hospital empanelment, 290 premium contribution by family, 287 through health and wellness centers (HWC), 275, 288, 310–312 Ayushman Bharat (Indians Living Long Life), 5 Azad, Gulam Nabi, 58 B Balaguruswamy, E., 87 Bar code verification, 103

 INDEX 

Bedaquiline, 129, 130 Bekedam, Henk, 155 Below poverty line (BPL), 282, 284 BharatiAxa, 288 Bharatiya Janata Party, 242, 276 Bharat National Health Protection Scheme, 13 Big business, 55 Bihar Medical Services & Infrastructure Corporation Ltd (BMSICL), 321 Bioavailability, 3, 99, 115, 159, 166, 167n1, 347 Bio-availability and bio-equivalence test, 99 Blockchain technology, for drug industry as aid in authenticity and trustworthiness of literature, 120 authenticity of research review and referencing, 120 in clinical trials, 119 for confidential collaboration, 119 data integrity, 120 drug authenticity verification, 118 licensing and royalty, 119–120 patents and intellectual property with, 119 real world uses, 118–119 working of, 117–118 Bombay hospital, 11 Boston Brahmins of Medicine, 187 Brahmanism, 243 Breach Candy hospital, 11 Breast cancer risk, 270 Bridge course for AYUSH doctors, 227 Brownfield project, 133, 134 Bureau of Pharma Public sector of India (BPPI), 152–154

373

C Capitation fee medical colleges anatomy and functioning, 56–61 arguments in favour of, 61–62 cancelation of affiliation, 54, 55 closure of, 53 cost of medical education, 63 courageous path for remedies, 83–84 genesis of, 52–53 laws, legal frauds and, 85–90 legal restrictions on, 85 modus operandi to deal with, 71 nationalization of, 52 neo-rich and, 79–82 new courses, 53 NRHM and, 62 passing students, ways and means in, 74 as pathshalas (elementary schools), 61 PG training program of, 81 political devise to make money, 65 prohibition by law, options, 82–85 quality of students, 54 supply exceeds demands, 56–58 Tamil Nadu colleges, 89 Central Council for Scientific Research in Ayurved Institute (CCSRAI), 348 Central Drugs Standard Control Organization (CDSCO), 134, 164, 173–174 Central Government Health Scheme (CGHS), 280–281, 287, 294, 297 Cephalosporin group of drugs, 163 Certified drug testing laboratories, 101 China dramatic and complete recovery of, xii

374 

INDEX

Chinese Cultural Revolution 1966, 146 Chinese medicine, 59 Chromeleon Chromatography Data Software (CDS), 120 Clinical Establishment Act (CEA) background and history of, 223–225 government and, 225–230 implementation of, 234–236 Indian Medical Association and, 225–230 maintenance of Electronic Health Records in, 231 maintenance of records and reporting in, 229 minimum qualification and requirement of personnel under, 226 minimum standards of space, facilities and services under, 226 paramedics, 227 penalties for non-compliance, 228 private sector regulations, 236–238 provisions under, 230–236 registration and renewal period, 230 required displays, 229 role of State Council, 225 safety equipment in facilities, 230 standard treatment guidelines, 223 Clinical trials compensation, 172–173 compensation quantum, in clinical trials, 172 data security and, 175 and Evidence Based Medicine, 168–169 non-inferiority trials, 169 Numbers Needed to Treat (NNT) in drug trials, 172 quality of, 170–171 registration of, 171

safety and optimization in clinical trials, 2 safety of, 169 unpublished, 175–176 Cochrane Collaboration, 256 Cochrane database, 163, 253, 256 Cochrane Library, 256 Combination drugs ban on, 115 courts and ban on, 165 effects on costs, 115 effects on patients, 167 Fixed Dose Combinations (FCD), 3, 115, 165 irrational combinations, 36, 113, 165 Communication, quality of, 27–30 Communication skills, of doctors, 27–30 Community Based Health Insurance (CBHI), 315–317 Community health centers (CHCs), 199, 200, 227n2, 291, 293, 304, 309, 311, 327–329, 357 transforming, 327 Community Health Workers (CHWs), 59, 290, 366 Consultant doctors, 41–42 Consumer Protection Act in India (CPA), 30, 44, 233 Contracting out, 322–323 Contract licensing to manufacture, 123 Contract research organizations (CROs), 120, 175 Contradictions, xix, 102, 270 Control of private sector and cost, 237–238 Coronary artery bypass grafting (CABG), 295 Coronary stents price, 295 Corporate hospital regulations, 237

 INDEX 

Corporate hospitals advent, 11–15 collateral damages by, 17–18 communication, doctor and patient, trust, 27 corruption, 17 costs, escalation, manipulation of, 29 crimes, in, 25, 26 doctor to patient relationship quality of, 27–30 drug culture in, 36–37, 95 evidence and protocols in corporate practice, 45–46 evolution of, 12, 37–38 and general medicine, 16–17 ill effects of, 19 information technology in, 257–270 justification of, 11–15 market economy and, 15, 16, 47 and masses, 12–14 negatives of, 20, 23 new breed of hospital managers, v/s the doctors, 37–41 new management methods, 38–41 paradigm shift in medical practice, 21–23 saturation of corporate, 19 service and contribution of, 11 suicidal market trends-super saturation at lower levels of population, 46–49 superb professional expertise, 11 sustained quality, 12 technology made available, 11 working of, 24 Cost of education, 189n3 Cost of medical education, 63 Cost of services, 33 Counterfeit drug market, 99 Covid-19, ix–xviii, xx, xxii–xxvii Curative health care, 4, 224

375

D Dalits, 239, 241, 242–243 Dealing with infected individual, xxi–xxvi Deemed universities, 55, 65, 72–75, 82, 84, 180, 182, 184, 185 status of, 72–74 Demonetization, 54, 317 Deo, Dr Madhav, 61 Diagnostics, xiii–xv, 10, 14, 16, 22, 32, 214, 223, 275, 285, 287, 306–307, 321, 345, 353, 363 Disease, x–xii, xiv, xvi, xix, xx, 12, 13, 15–17, 21, 22, 24, 24n4, 28, 29n5, 47, 125, 128–131, 141, 143, 153, 158–159, 162, 172, 173, 223, 230, 245–273, 277, 282, 288, 301, 302, 309, 310, 313, 321, 335–342, 344–346, 350–353, 355, 358, 360, 362, 364, 366–368 Doctoral services, oversupply of, 56 Doctor patient communication, 24, 27–30 Doctor-patient relationship, 1, 27–30, 233, 256, 257 Doctor recommendation-based drug culture, 36 Doha Declaration on TRIPS and Public Health, 130 Draft National Pharmaceutical Policy, 2017 one manufacturer principle, 123 rule of origin principle, 102 Draft Pharmaceutical Policy Government of India, 2017, 96, 102, 141, 152 Drug Controller General of India (DCGI), 97, 166, 168 Drug discovery process, 125

376 

INDEX

Drug manufacturing core competency, 116 in European Union, 97 issues related to, 115–117 trends in quality, 116–117 Drugs and Cosmetics Act, 165, 172 Drugs approval related issues accelerated approval, 173 administrative, 2 breakthrough designation, 173 economic, 2 ethical, 2 fast-track designation, 173 fixed dose combinations (FDC), 115, 168 legal, 2 me too drugs, 168 priority review, 173 technical, 2 Drugs manufacturers, 97, 104, 111 Drugs Technical Advisory Board (DTAB), 165 Drug testing laboratories, 100, 101, 103 E Effluent treatment, 102, 109, 134 Electronic health record (EHR), 229, 232, 259–263, 267 problems of, 260 Electronic medical record systems, 251 Employees’ State Insurance Scheme (ESIS), 281–282 Ethical medical matters, 178–179 Evidence based medicine (EBM), 32–33, 45, 168–169, 248, 251–252, 255, 273 Examination system, 69n2, 73 F Faculty recruitment, 68n1 Fake drug, 118, 122, 124

Fast-moving consumer goods (FMCG), 121 Fee hikes, in private colleges, 64 Fee regulatory committee, 63, 64 Five star hospitals associated prestige in getting treated, 10 exorbitant charge, 10 geared to comfort, pampering and entertainment, 10 reputed doctors, 10 without serious disorder, 10 Fixed Dose Combinations (FDC) antibiotics, 164 ban on, 115, 152, 165 biological issues with, 166–167 critique of, 3, 115, 155–167 legality of, 165 ongoing fight over, 165 requirements of approval, 168 Foreign direct investment in pharmaceuticals, 133–134 Foreign Medical Graduate Examination (FMGE), 188, 189, 189n3 Fortis Memorial Hospital, Gurgaon, 18 Foundation for Revitalisation of Local Health Traditions (FRLHT), 361 G Gail, Edwin, 32, 32n6, 247, 248, 250 Gandhi, Mahatma, 246 GE Healthcare, 307, 322 Generic drugs availability, 145, 149–155 issues related with, 149–155 Jan Aushadhi, 154 popular perception about, 150–151 prescribing generic drugs, 145 role in lowering prices, 151–152

 INDEX 

Glamour Attraction Dependency Cycle, 12 GlaxoSmithKline Pharma, 306 Globalization, xxviii, xxix, xxxii, 10, 15, 96, 109, 132, 222 Good Laboratory Practices (GLP), 99, 104, 120 Good Manufacturing Practice (GMP), 97, 104, 120, 123, 124, 152 Goods and Services Tax (GST), 54, 108, 115, 268, 287, 299, 299n5, 311, 317, 318 Governance of Medical Education, 188 Government and private sector antagonism, 140, 144, 334, 356 bureaucrats and, 198, 308, 309, 311 inept handling, xxii Graduate Nurse Midwife (GNMs), 59 Great Newly Rich Middle Class of India, 10 Greenfield pharmaceutical projects, 133, 134 H Harshvardhan, Dr, 173 Health care delivery system accessibility, vii affordability, vii equity, vii fragmented in new fields, 6 greater complexities, 6 increasingly unsatisfactory to patients, 6 increasingly varied, 6 justice in, vii new powerful technologies, 6 quality in, vii Health financing, 300 Health for All by 2000, 56, 58, 60 Health institutes voluntary health work and, 5

377

Health insurance backdrop for, 278–279 basic concepts, 276 health system reimbursements, 280 merging/unifying these schemes, 280; challenges, 280 national insurance schemes, 13, 282 positives and negatives in, 5 positives and negatives of state schemes, 5 RSBY insurance scheme, 13, 278–280, 282–284, 287, 288–290, 299, 304, 316, 324, 325 state insurance schemes, 280, 281–282 in states of India, 318 in western model, 5 Health insurance Schemes Aarogyasri Community Health Insurance Scheme, 284 Bhamashah Swasthya Bima Yojana (BSBY), 283–284 Central Government Health Scheme (CGHS), 280–281, 287, 294, 297 common factors in, 285–286 Community Based Health Insurance (CBHI) in India, 315–317 Employee’s State insurance scheme (ESIS), 281–282 high value premium private insurance, 313–315 low-cost insurance, 315, 317 mixed type of health insurance, 317–318 National Health Protection Scheme (NHPS), 182, 209n7, 275–330 Rashtriya Swasthya Bima Yojana (RSBY), 13, 278–280, 282–284, 287, 288–290, 299, 304, 316, 324, 325

378 

INDEX

Health insurance Schemes (cont.) Third Party Administrators under, 313, 314 Vajpayee Arogyashree, 284–285 Yeshaswini, 278, 285 Health insurance schemes, 280, 284, 294 Health wellness centers (HWC), 310–318 staffing pattern of, 311–312 Hegde, B. M., 16, 245, 246, 248, 368 Hegde, Ramakrishna, 65 Hereditary system, in medical profession, 76 High-risk group, xiii, 246 Holism, 6, 270–273 Homeopathy like cures like, principle of, 368 vital force in, 340 Hospital management, 36–38, 40 Human development, 80 I Immunotherapy, 269 Indian Council of Medical Research (ICMR) population survey, xiv rapid antigen test, xiii–xiv role in RT-PCR test and cost, xiv Indian Council of Medical Research (ICMR), UK, xiii, xiv, xv, 175, 195, 350 Indian health care curative capabilities, 10 Indian Medical Council Act (1956), 60, 62, 180, 193 Indian Pharmaceutical Alliance (IPA), 114 Indian pharmaceutical industry achievements, 2, 95 annual turnover, 96 brown field projects, 133

contributions of, 146–148 costs of manufacturing, 98 counterfeiters, 99 doctors relationship with, 144–146 drug manufacture, 99 enhancing capacity, quality, 116 foreign direct investment in, 133–134 generics market and, 95, 96 growth rate, 95, 96 infrastructure for drug manufacturing, 97–98 issue of commercial viability, 130 issue of quality, 116–117 issues related to drug manufacturing, 115–117 knowledge processes, 147 measures for maintaining drug quality, 103–104 mergers and acquisitions, 132–133 pollution control and environmental protection, 134–135 prevention of counterfeit drugs and medical devices, 118 price capping, opposition to, 106–107 price control; examples other countries, 114; reasons for, in India, 110–112; ways of, 109 profiteering from drugs and devices, 105–106 profit margin, 112 quality of drugs, 97–99, 102–103; maintenance of, 103–104 quality testing for drugs, 99–104 R&D facilities, 131 regulatory failure, 147–148 relationships between doctors and, 144–146 supply chain technology, 119 in terms of value and volume, 95 trade-off between price and quality, 106

 INDEX 

Indian pharmaceutical sector, xviii, 94–97 Inevitable Trade-Related Aspects of Intellectual Property Rights (TRIPS), 129, 130 Infectivity of over time, vii Information technology in health care breaches and theft of personal information, 268 in care process, 258–259 in corporate hospitals, 257–270 in direct delivery of curative services, 257 in doctor-patient interaction, 257, 264 exploitation of, 269–270 future challenges in health sector, 5, 265–267 invasion of, 257, 266–267 self-perpetuating, 266 self-proliferating, 266 Institute, D Y Patil, 64 Insurance schemes, xx, 5, 13, 110, 112, 276–287, 294, 303, 306, 315 Integration of Indian and Western medical systems advantages, 344 arguments for and against, 340 attitude towards, 333, 336–338 Ayurvedic drugs, isolation, standardization for, 348 concept of integration, 337 cost, in terms of, 337 criteria of cure, 341–342 cures; causal, symptomatic, 338–343 defining cause of disease for, 341–342 desirability of difficulties in, 334–336 discovering good drugs in Ayurved for, 351

379

etiopathogenesis in Ayurved, 339–340 facilitatory ideas for Ayurvedic drug research, 350–351 faith, in terms of, 336 fragmentation, 333 haphazard opinions, 6 history of, 358 other ways of testing Ayurvedic drugs for, 354–355 peculiarities of Ayurvedic drugs in, 346–350 physical basis of Tridosha and vital force, 340–341 practical blueprint of, 333–369 question of isolation and standardization, 348 research, in terms of, 336–337 research methodologies in Ayurved, 351–354 suppressed illnesses, 338–343 theoretical perspective of, 333–369 Intellectual property (IP), 119, 126, 127 Intermediates in drug production, 102 In vitro fertilization, 269 J Jaitley, Arun, 209n7, 288 Jan Arogya Abhiyan, (People’s Health Movement) Maharashtra State, 234 Jan Aushadhi brand drugs, 153 Jan Aushadhi Yojana, 104, 107, 151, 155 Jan Swasthya Abhiyan (JSA), Rajasthan, 284 Jaslok hospital, 11 Johnson & Johnson (J&J), 129, 295 Joint National Commission (JNC), 160

380 

INDEX

K Kanzaria, Dr Hemal, 31 Karnataka Private Medical Establishments (Amendment) Bill 2017, 19 Katihar Medical College, 64 Ketan Desai Saga, 53, 177–178 Key Starting Materials (KSMs) in drug production, 102 Knee and hip replacement prices, 295 Knowledge processes, 147 Kumar, D.V. Shylendra, 64 L Laboratory Information Management System (LIMS), 120 Lady Health Visitors, 59 Liberalization, xxviii, xxxii, 10, 133, 134, 242, 305 Licentiate of College of Physicians and Surgeons (LCPS), 9 Life expectancy, 94 Policy 17 and, 100, 102–105, 108–110, 113, 115, 116, 123, 124, 133, 134, 141 Logic of care, 31–33 Lone licensing for drug manufacture abolishing it for patient safety, 123 drug quality under, 120–124 genesis, 120–122 Low cost insurance, 315, 317 Lupin Laboratories of India, 132 M Macleods Pharmaceuticals, 129 Male supervisors, 59 Malpractices, xxviii, 1, 17–19, 24, 31, 34, 44, 59, 78, 84, 87, 89, 183, 217, 229, 279 Manpower deployment problem, 188

Market economy shifted under corporate hospitals, 15 Masters of Hospital Administration, 39, 40 Maximum retail price (MRP), 43, 103, 108, 111, 114, 122, 141, 154, 155 at PMBJP outlets, 155 Mayo Clinic, xvi, 260 Medical Accreditation and Registration Board (MARB), 55, 70, 80, 198, 204–207, 210, 211 Medical Advisory Council (MAC), 70, 181, 196, 208, 215 composition of, 213–214 Medical Council of India (MCI) composition of, 4, 193–194, 218–219 as elected body, 179–180 ethical medical matters and, 178–179 functioning form of, 196 punishment for doctors; deterioration of health sector unenviable role, 3; difficulties in dissolution, 4, 179, 180, 192, 193, 197, 219 Medical education system, 57, 60, 77 quality of, 241 Medicalization of society, 137–138 Medical practice, 21–23, 46, 143 Medical profession, as hereditary phenomenon, 76 Medical Research Council, 175 Medical tourism, 15, 95, 107 Medicines handled on ground, 138–141 Melinda Gates Foundation, 175 Melmaruvathur Adhi Parasakthi Institute of Medical Sciences, 86 Mixed type of health insurance, 317–318

 INDEX 

ModiCare, 13 Money, outlook of, 79–82 Moses, Sam GP, xxxi, 17 Multinational Corporations (MNCs), 148–149 Mutation and vaccines, xi in virulence, xi N Nadda, J. P., 178, 289, 308–310, 320 Nanal, R. M. Vaidya, 363, 364 National Accreditation Board for Hospitals certification (NABH), 296, 296n2, 296n3, 327 National Assessment and Accreditation Council (NAAC), 69, 202, 202n6, 205, 214, 327 National Board of Examination (NBE), 180, 187, 188, 203–204, 213 National Board of Laboratory Accreditation no interest by private sector, viii National Commission for Human Resources for Health (NCHRH), 179 National Eligibility cum Entrance Test (NEET) admissions to super-speciality, 187 admissions to undergraduate and speciality courses, 187 aftermath of, 185–186 drastic reduction in private medical college entries, 185 history of, 184 language used, 188 objections to, 191 opposition to, 184–185 poor quality in passing unearthed, 179n1

381

postgraduate entry and, 186–187 resistance to, 184, 185 National Essential List of Medicines, 309 National Food Security Act (NFSA), 283 National Health Insurance Scheme, 13 National Health Protection Scheme (NHPS) agreements with states, 280–286 bottlenecks and inefficiencies, 303 budgetary allocations, 301, 302 central criticism of, 291 challenges in delivering, 299–304 claims, 287, 294, 308 contracts under, 323 early usage, 287–288 emerging market under, 306–310 enrolment criteria for, 280 financial aspects, 287–288 future of, 310 hospitals under, 290–299 identifying beneficiaries, 304 and insurance companies, 304–306 monitoring structure, 303 overview, 275–276 parliamentary panel observations, 288 potential for fraud, 304 premium contribution by family, 277, 287 and price control, 306 private sector participation, 301; differences over tariff, 294 steps to build, 286–290 tariffs under, 294 National Licentiate Examination (NLE), for foreign graduates objections to, 189–193 prerequisite for registration and PG entry, 4

382 

INDEX

National List of Essential Medicines (NLEM) consequences, 105 development, 106 implementation, 142 Nationally accredited laboratories, 99 National Medical Commission (draft) Bill aim of, 181 anomalies in, 216–218 composition of, 4, 193–197 criticism, 205 curriculum development, 201 exemptions, 187 institutional amendments, 202–203 Medical Assessment and Rating Board (MARB) and, 204–207 National Board of Examinations (NBE) and, 188, 203, 213 nomination of NMC members, 218–219 objections and objectors of, 214–218 Post-Graduate Medical Education Board (PGMEB), 198, 204 representations in, 187, 216 on research, 181 section 28, 204, 208–213 Under-Graduate Medical Education Board under, 198–201 National Pharmaceutical Pricing Authority (NPPA), 105, 107–108, 111, 112, 114 National Rural/Urban Health Mission (NRHM/NUHM), 13, 62, 181, 194, 211, 224, 225, 234n3, 275, 302, 311, 312, 318–320, 368 National Skill Development in health, 141 New medical colleges, 56, 58, 60–62, 208–213 NITI Aayog, 117, 218, 278, 287, 300, 300n5, 311

Non-allopathic systems, 246 Non-governmental colleges, 52 Non-governmental organizations (NGOs), 6, 153, 154, 315, 320, 321, 325 Non-inferiority trial, on drugs, 169 Non-scheduled anti-cancer drugs, 114 Novel Drug Delivery System (NDDS), 131 Nursing homes home support, 9 in larger cities, 10 need for urban people, 9 proximity of care, 9 in smaller towns infra-structurally poor, 10 O ObamaCare, 13 Online teaching and certification technology, 271 Out of pocket expenses (OOP), 47, 110, 290, 304, 306 Out-of-pocket health care expenditure India, 150 P PA Inamdar vs. State of Maharashtra, 87 Panagaria, Dr Arvind, 4 Parliamentary Standing Committee on health (PSC), 174, 179 on possible failures NHPS, 289–290 Patented Medicines Prices Review Board, France, 112 Patents, 2, 100, 113, 116, 119, 125–131, 149, 152, 168, 250, 293 Patents (Amendment) Act 2005 for Compulsory Licensing backdrop of, 126–127

 INDEX 

evergreening of patents, 127–129 Patents Act 1970, 127 patents law, 2, 100, 113, 125–131, 149, 152 process patents, 127–129 R & D expenditure, 125 section 3(e), 128 section 92A for export, 130 PATH and Bill, 175 Patient care concerns, 261 Patients hospital margins, 105 Personally Identifiable Information (PII), 268 Pfizer, 96, 131, 306 PG reservation contentious issue, 240–242 Phadke, Dr Anant, 112, 231, 232, 234, 236, 276, 285 Pharmaceutical Price Regulation Scheme (PPRS), Canada, 112 Pharmaceuticals, vii, xviii, xix, xxvi– xxix, 2, 3, 32, 41, 79, 93–135, 137–176, 178, 182, 237, 250, 254, 256, 267, 306, 307, 351 Pharmacodynamics and kinetics, 160–164 Pharmacopeial names of drugs, 139, 151 Pharmacy colleges, 138, 141 Placebo trials, 169, 254 Pollution control, 102, 109, 134–135 Polyclinics, 9 Postgraduate institute (PGI), Chandigarh, 84 Postgraduate reservation, 240–242 P2P (product to product) manufacturing, 123 Prakriti Pareeksha, 246 Pre Conception & Pre-Natal Diagnostic Techniques (PCPNDT Act), 224, 234 Prescribing drugs, practice of criteria for drug selection, 3, 142–143

383

profit motive, 145 rationally manufactured drug, 3, 143–144 role of doctors, 142–143 technology and competition, impact of, 141 tripartite interests and relationships, 144 Prevention of Corruption Act (PCA), 1988, 86, 87 Price capping, 106–107, 142 Price control after effects of, 115 examples for, 114 Price line, of medical services, 78 Price regulation mechanism for drugs, 110 Primary care system, 300 Primary Health Center (PHC) officer, 59 Primary Health Centers (PHC), 59, 199, 292, 310–312, 322, 327, 360, 368 Prime Minister’s Jan Aushadhi Yojana (PMJAY), 151, 280 Private/capitation fee medical colleges, 1, 51–90, 183, 202, 211 Private health care, vii, xvi, xxv, xxviii, 1, 224, 236n5, 267, 308, 324, 369 Private medical colleges admissions, 185 attendance, 74 in context of human development, 80 fee hike in, 64 infrastructure, 69 issue of merit, 75 proponents of, 57 reservation of seats private/ government medical colleges, 185 state of, 66–67 students passing out, 189

384 

INDEX

Private sector in pandemics general non-cooperation, xxi–xxvi general scenario, xix–xxi Private-Voluntary Health Insurance, 313 Privatization, xvi, xviii, xxviii, xxxii, 10, 15, 329 Problem based learning (PBL), 191n5, 200, 201, 360, 364 Process patents, 127–129 Procurement system of hospitals, 42 Profiteering, from drugs and devices, 105–106 Profit motive, in prescription drugs, 145 Prohibition of Collection of Capitation Fee Act, 87, 89 Prostaglandins, 342 Protection of non-affording patients, 110 Protocol Driven Care, 45 Provincial Insurance schemes, 13 Psychological illnesses, 17 Public health care delivery, xvii, xxvii, 1, 13, 22, 77, 85, 308, 357, 368 Public health care systems, 54, 79, 288, 300, 321 Public health issue, 130 Public private partnership (PPP) model to achieve public health goals, 320 benefits, 321 contracting private person in the public service, 321–322 contracting the public service out to private, 322–323 contracts under, 326 effective contributor health, 5 PPP model and community health center, 327 promotion of, 320 various scenarios under the PPP, 324–325

Public–private partnerships (PPP) diagnosis and the, xiii–xv public sector government labs, 321 Public Service Commission (PSC), 179 Q Quality by Design (QbD), 116–118 R Rajasthan’s Bhamashah Swasthya Bima Yojana (BSBY), 283–284 Randomized control trials, 169, 247, 253–257 guidelines and protocols, 250–251 Randomized statistically based control trials, 248 Rashtriya Swasthya Bima Yojana (RSBY) enrolment in, 282 hospital empanelled under, 282 software, 282–283 system of operation (SOP), 282 Rational therapeutics, 3, 142–144, 164 Reddy, Suneeta, 294 Reductionism, 6, 247, 271–273 Registered Medical Practitioners (RMPs), 9, 57, 154, 196 Regulation of medical profession, 222–230 for corporate hospitals, 228 Regulatory authorities, 148, 183, 234 Reinfection, xi Reproductive and Child Health (RCH), 322 Reservations, in medical education undergraduate, 238–240 Restricted wholesale margins, 112

 INDEX 

Revised National Tuberculosis Control Programme (RNTCP), 101, 130, 160, 309 Royalty, 119–120 RSS, 243 Rural economy, 94 S Salvo, Karen B. De, 260 Sangeetha University, 64 Scheme for Drugs for the People (Jan Aushadhi Yojana), 104 Self-protection, 31 Shah, Amit, 178 Shri Sathya Sai Medical College and Research Institute, 86 Single-drug generic production, 113 Smart contracts (under blockchain), 119, 120, 175 Soharabuddin, 178 Sri Lakshmi Narayana Institute of Medical Sciences, 86 SRM College, 64 Standard operating procedure (SOP), xxiii, 263, 265 State health care system, 285 Stent technology, 79, 105, 106, 145, 277, 295, 309 Substitution of drugs, 139 Sulphonylureas, 160 Super-saturated private care, 46 Super-specialties, 14, 17, 71 Super specialty hospitals, 10–15 Super-specialty seats, 71 Supplier induced demand in medical services, phenomenon of, 56 Supply chain life-cycle, 119 Supply chain management, 117 compliance in, 119 Symptomatic cures, 338–343

385

T Tamil Nadu Educational Institutions (Prohibition of Collection of Capitation Fee) Act, 1992, 87, 89 Teleconsultation, 310 Therapeutic efficacy of drugs, 128, 142 Third party administrators (TPA), 283, 313, 314 T.M.A Pai Foundation Case, 87 Tople, Dr Pramila, 58 Transparency Commission and Economic Committee on Medicines, Egypt, 112 Tridosha (three defects), 234, 264, 339–341, 365 U Ujjwala free gas cylinder scheme, 302 Unani systems, 359 Undergraduate capitation fee colleges, 84 United Kingdom Prospective Diabetes Study (UKPDS), 158–159, 163, 355 United Progressive Alliance (UPA), 54, 105 United States Food and Drug Administration (USFDA), 97, 98, 100, 116, 118, 126, 127, 129, 173–174, 262 Universal Free Health Care, 5 Universal medicalization, 97 Universal screening of diseases, 309 Upadhyay, Deendayal, 276 US India Business Council (USIBC), 306–307

386 

INDEX

V Vaccines claims of, xi complexities about, xii–xiii distribution challenges, xiii Vaidyas, 337–338, 361, 367 Vajpayee Arogyashree Scheme, 284–285 Voluntarism, 6 W Western models in health care characteristics, 245–253 disease-centered, technologically oriented, 245 evolution, 245–253 hegemony of; algorithms, 256; guidelines, 250–251; protocol, 250–251; technology, 269–270 invasive and pervasive, 4

logic, in clinical processes clinical thinking under, 31–33 patterns of care in India under, 270–271 reductionism and holism in, 271–273 unquestioned obedience of, 247– Women’s Health Study, 250 World Bank, 60, 283 World Health Organization (WHO) and China, vii World situation, xii X Xtreme Drug Resistant (XDR) TB, 129, 167n1 Y Yoga, 310, 335, 339