Indias private health care delivery critique and remedies 1st ed 2021 edition sanjeev kelkar

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India’s Private Health Care Delivery: Critique and Remedies 1st ed. 2021 Edition

Sanjeev Kelkar

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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

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It is unfortunate that today’s health system benefts 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 frst 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 effciently or how many new challenges has it created for good or for ill? And fnally, what is the balance between benefts 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 fnal manuscript of this volume went into the prepublishing 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-ina-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 fght against Covid-19. It is also a lifetime opportunity for me to

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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 diffculties.

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 confned 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 fatten 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 infuenza 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 superfuous 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 frst-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 justifable 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 fnancial 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 frst 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, frst, 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 fnancial 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 fx 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 confrmation 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 confrmation. 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 confrmation for Covid-19, further widening the net for more testing. If a sample tests positive, a second confrmatory 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 indefnitely 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 defciencies 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 justifably 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 fght, 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 signifcant. 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 fscal package of the US of $175 billion will cover only about 35% of the revenue lost by the private health care sector in the frst quarter of 2020 (Thompson Dennis, May 6, 2020). This fscal allocation may be too little or too late for those hospitals located in rural areas which are already in trouble. With Corona cases faring 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 fght 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 fght 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 profteering. 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 defciencies—it is considered by many as monolithic, monopolistic and unimprovable. Many infuential 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 scientifc 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 fghting 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 fooding 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- trade/india- looks- to- lure- more- than- 1000- americancompanies- out- of- china/articleshow/75595400.cms?utm_source= contentofnterest&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 signifcant 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 fnding 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 profteering are a refex 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 fx the maximum permissible charges on a per-day basis and notify these on May 22, 2020 for a Covid-19 patient. Charges fxed 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 specifed charges using other schemes or insurance scheme rates, but it also specifed 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 frst two months of Corona, most of the fve 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 offcer 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 fxation and/or participating in the fght 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 signifcant 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 frst 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 fags 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 signifcant 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 fght 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 fnancially sustain themselves (Raghavan Prabha, April 30, 2020), or all these factors together. The last of these predicaments was because of a signifcant 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 profteering 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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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.

12. 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 sacrifce.

13. 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 defcit 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.

14. 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 proft margins have shrunk, a matter with which they are not at all comfortable.

15. 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-

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demic subsides. Bihar has more than 250 for-proft and not-forproft 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 infuenza-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 frst deemed useful and then later ineffective. Remdesivir was frst 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 infammatory 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 frms 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 proft 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

xxvii PREFACE

disappointing and deteriorated over decades. In the 1980s and 1990s the private sector brought in massive benefts 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 fve 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 refected 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 fll 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 fber 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 fnding 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 fnal 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 affrmative 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 feld 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, benefting 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 unjustifable 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

xxix PREFACE

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/foreigntrade/india- looks- to- lure- more- than- 1000- american- companies- out- ofchina/articleshow/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-billssoaring/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- thestate-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.

xxx PREFACE

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 feld. Each one of them has contributed to my growth in this as well as other felds 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 fnding 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 affuent 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

management, its economy, its practices and interaction with professionals were highly benefcial.

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 fnality 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 fulfllment of a lifetime I place this work in the hands of the reader.

xxxii ACKNOWLEDGMENTS
xxxiii 1 Introduction 1 2 Corporate Hospitals 9 3 Capitation Fee Medical Colleges 51 4 Perspectives on Pharmaceutical Industry 93 5 Pharmaceutical Industry and Clinical Medicine 137 6 Regulations and the Regulators in Health Care 177 7 Clinical Establishment Act and Reservations in Medical Education 221 8 The Western Model in Disease and Health Care Delivery 245 9 Health Insurance, National Health Protection Scheme, Public—Private Partnership 275
conTenTs
xxxiv CONTENTS 10 Integration of Medical Systems: A Theoretical Perspective and Practical Blueprint 333 Index 371

abbreviaTions

ACCME Accreditation Council for Continuing Medical Education

AEH Aravind Eye Hospital

AFRC Admission and Fee Regulatory Committee

AHPI Association of Healthcare Providers India

AICTE All India Council of Technical Education

AIIMS All India Institute of Medical Sciences

AMRIT Affordable Medicines and Reliable Implants for Treatment

ANM Auxiliary Nurse Midwife

APIs Active Pharmaceutical Ingredients

ASEAN Association of Southeast Asian Nations

ASHA Accredited Social Health Activist

AWACS Advanced Working, Action and Correction System

AYUSH 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

ABBREVIATIONS

CCAR Central Council of Ayurvedic Research

CCIM Central Council for Indian Medicine

CCRAS Central Council for Research in Ayurvedic Sciences

CCSRAI Central Council for Scientifc Research in Ayurved Institute

CDRL Central Drug Research Laboratory

CDS Chromeleon™ Chromatography Data Software

CDSCO Central Drugs Standard Control Organization

CEA Clinical Establishment Act

CEO Chief Executive Offcer

CGHS Central Government Health Scheme

CHC Community Health Centre

CHE Catastrophic Health Expenditure

CHWs Community Health Workers

CII Confederation of Indian Industry,

CIS Commonwealth of Independent States

CMIE Centre for Monitoring Indian Economy

CMJNMH College of Medicine and Jawaharlal Nehru Memorial Hospital

CPA Consumer Protection Act

CROs Clinical Research Organizations

CT Computerized Tomography

DBT Direct Bank Transfer/Department of Biotechnology

DCGI Drugs Controller General of India

DoP Department of Pharmaceuticals

DOTE Directorate of Technical Education

DPCO Drug Price Control Order

DTAB Drugs Technical Advisory Board

EBM Evidence Based Medicine

EDQM European Directorate for Quality Management

EHR Electronic Health Record

EMRB Ethics and Medical Registration Board

ESIC Employees’ State Insurance Corporation

ESIS Employees’ State Insurance Scheme

EU European Union

FDCs Fixed Dose Combinations

FDI Foreign Direct Investment alt Foreign Direct Infuence

FMCG Fast-Moving Consumer Goods

FMGE Foreign Medical Graduate Examination

FOGSI Federation of Obstetric and Gynaecological Societies of India

FRLHT Foundation for Revitalisation of Local Health Traditions

GBM Guidelines Based Medicine

GLP Good Laboratory Practices

GMP Good Manufacturing Practices

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