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India Being World’s Third largest Covid Vaccine Maker: Will All Indians Benefit?

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Apprehensions on the time of availability notwithstanding, equitable access to Covid vaccines for all, remain the best hope to leash the deadly virus, as the pandemic overwhelms the world. According to the World Health Organization (WHO) ‘Coronavirus Update 37’ of October 06, 2020, as of October 02, 2020, there are 42 COVID-19 candidate vaccines in clinical evaluation of which 10 in Phase III trials.

Recently, the article, published in the Harvard Business Review on April 02, 2020, also flagged this critical area – ‘A Covid-19 Vaccine Will Need Equitable, Global Distribution.’ The paper highlighted: ‘The time to prepare for globally distributing a Covid-19 vaccine in a way that is effective and equitable is now. It will have a long-term payoff by helping to prevent future pandemics, which scientists predict will be more common as the earth’s climate warms.’

Even Bill Gates’ article, published in The New England Journal of Medicine (NEJM) on February 28, 2020, expressed a similar apprehension. The article is titled - ‘Responding to Covid-19 – A Once-in-a-Century Pandemic?’ Gates also articulated: “During a pandemic, vaccines and antivirals can’t simply be sold to the highest bidder. They should be available and affordable for people who are at the heart of the outbreak and in greatest need. Not only is such distribution the right thing to do, it’s also the right strategy for short-circuiting transmission and preventing future pandemics.”

He too urged all concerned to ensure that during a pandemic, vaccines and antivirals aren’t ‘simply be sold to the highest bidder.’ On the contrary, these should be made available, affordable and accessible to all. ‘Not only is such distribution the right thing to do, it’s also the right strategy for short-circuiting transmission and preventing future pandemics,’ he asserted.

Does any authority pay heed to these suggestions? The question remains unanswered. Interestingly, on September 17, 2020 by a Press Release, Oxfam International reported, ‘leading wealthy nations representing just 13 percent of the world’s population have already cornered more than half (51 percent) of the promised doses of Covid-19 vaccine candidates.’ This is regardless of where these vaccines are manufactured, including India.

These prompt one to wonder, ‘Would India’s possible rise as the world’s third largest vaccine manufacturer benefit all Indians, with affordable and equitable access to Covid prevention shots? In this article, I shall dwell in this area.

India emerges as the world’s third largest Covid vaccine producer:

According to August 24, 2020 edition of the Nature publication, if all of the frontrunner candidates of Covid vaccines are approved, more than 10 billion doses could be available by the end of 2021. Most of these vaccines will be made in the North America and Europe. The top Covid vaccine manufacturing countries are estimated to be the United States, followed by the United Kingdom, India, Norway and France, the report highlights.

However, wealthy countries have already struck deals to buy more than two billion doses of Coronavirus vaccine in a scramble that could leave limited supplies in the coming year. For example, as the above Nature article indicates, publicly announced estimated capacity to 2021 of Oxford/AstraZeneca Covid vaccine, is 2.94 billion. Interestingly Serum Institute of India (SII) signed an agreement to manufacture over I billion doses in 2021.

Whereas, another report of September 29, 2020, stated that SII will make available 200 million doses by 2021, at $3 dose to a group of at least 62 ‘low- and middle-income countries (LMIC)’ that includes India. This arrangement does not make clear how many of the 200 million doses will be made available in India. Curiously, SII reportedly, is also one of the global partners for the production of Britain’s Covid-19 vaccine on a large scale, once it gains regulatory approval.

Growing ‘vaccine nationalism’ needs to be prevented:

Thus, if one looks at the macro picture, a small group of rich nations, representing just 13 percent of the global population has bought 51 percent of the supply of leading Covid-19 vaccine contenders, according to the above Press Release of Oxfam International.

Many public health experts have expressed grave concern on such developments. They have also articulated in multiple forums that the world is not going to get rid of the pandemic until it gets rid of Covid-19 from everywhere. Terming this approach vaccine nationalism, the Director General of the World Health Organization (WHO) urged all concerned, at his August 18, 2020 briefing that this needs to be prevented by all, urgently.

No clarity yet, on whether the vaccine will be free for all Indians:

Although, there is no reported ‘vaccine nationalism’ in India, thus far, for understandable reasons, there isn’t any clarity, either, on whether Covid vaccines will be free for equitable access to all in India. As reported on October 27, 2020, Dr. V.K. Paul of NITI Aayog, who heads the Centre’s expert committee on vaccines confirmed this by saying:

“We’ll have more clarity in the weeks ahead when trial data from the ongoing trials (phase 3) of the Serum Institute of India (which is testing the Oxford AstraZeneca vaccine) is available. The success of it and the other candidates will determine the availability and the dosage required and then we can discuss financing.”

Interestingly, free Covid vaccination for all in Bihar, has featured in ruling party’s the election manifestos, if they win the recent state assembly poll. This raises a doubt for the common man, whether or not this vaccination will be free to all in other states, as well, where such promises are not being made.

Ambiguity also on how much it will cost to the nation:

As on date, avoidable ambiguity prevails in many areas of Covid-19 vaccination process in India, for various reasons. For example, ‘Will India have Rs 80,000 crore for Covid-19 vaccine,’ asked the top vaccine maker in India, on September 27, 2020. Whereas, as reported on October 23, 2020, ‘the government has set aside about Rs 50,000 crore ($7 billion) to vaccinate Indian citizens.’

The same report also wrote, the Coronavirus vaccine, once available, will be distributed under a special Covid-19 immunization program. The Centre will procure the vaccine directly to make it available to the ‘priority groups’ free-of-charge through the existing network of states and districts. States have been asked not to chart separate pathways of procurement. This is expected to coveraround 25 Crore people by July next year, according to the Union Health Minister of India.

This also appeared in the Bloomberg/Quint article of October 17, 2020. It reported, India is identifying 300 million people who will receive the initial dose of a coronavirus vaccine. Priority will be given to workers in high-risk sectors such as police, health care, sanitation, elderly people and those with co-morbidities. The beneficiaries of vaccine in the first phase will receive an estimated 600 million doses and implementation plan aims to cover over 23 percent of the population.

Assuming that Rs. 50,000 Crore will be the vaccination cost for only 23 percent of the Indian population, what will it cost to nation to vaccinate 100 percent of the population against Covid? How will rest of Indians get access to Covid vaccination? Will the citizens be inoculated sans any out of expenditure for the same? If so, why free Covid vaccination has been promised only for Bihar, in the recent Assembly election, only in case the ruling party returns to power, as stated above?

Humongous logistics challenge for India: 

Even if, India plans to administer Covid-19 vaccine to just 23 percent of the population, covering its high-risk population, across the country, in the first half of 202, it will involve 400-500 million doses. Will SII be able to deliver so many doses by June 2020? However, maintaining uninterrupted ‘cold chain’, in the entire logistics process – including local transportation and storage, wherever required, till these are administered to people, will be a humongous task for India.

While the required storage temperature of Oxford-AstraZeneca vaccine is -20 degree Celsius, some of the most promising candidates, such as, Moderna and Pfizer-BioNTech’s Covid-19 vaccines need to be stored at as low as -80 degrees Celsius, till administered.  

Covid vaccination cost is not just the cost of a vaccine:

To vaccinate 1.3 billion people of India, the Government needs to train in advance, a large number of health workers to accomplish the task. Alongside, the supply chain, including a demanding and uninterrupted countrywide ‘cold chain’ will also need to factor in other costs. These will include, availability of ancillary items like syringes, among others.  The complexity of vaccine logistics further increases manifold, as 70 percent of the country’s population lives in rural India. Thus, the net outlay for Covid vaccination will be much more than a vaccine cost.

What happens, if these are not achieved with military precision, much before vaccine manufacturing commences? In that case, I reckon, it is quite likely that efficacious COVID -19 vaccines may not be made accessible even to 23 percent of the high-risk people, such as police, health care and sanitation staff, elderly people and those with serious co-morbidities.

Conclusion:

The economic, social and health care concern over Covid pandemic continues in India. As of November 01, 2020 morning, India recorded a staggering figure of 8,184,082 of Coronavirus cases with 122,149 deaths. During this health crisis, among several other critical areas, India is also still learning – the hard way, how fragile is its public health care infrastructure. Covid pandemic has possibly caused the worst ever health care catastrophe in the country, due to years of negligence – that continues even today.

Besides above legacy issues, meager deployment of resources, low overall health awareness for Covid, inadequate number of health care personnel, insufficient Covid testing kits to detect the virus and prevent it from spreading, is still playing havoc. Moreover, many epidemiologists continue to suggest that India’s real infection rates are far higher.

In this setting, if, as and when subsequent Covid waves will strike, the number of cases is likely to grow exponentially – again. Thus, inoculating the entire population with Covid-19 vaccines is the most desirable way out, for India to prevent this health calamity from lingering too long. As Mark Feinberg, head of the International AIDS Vaccine Initiative in New York City had said in the August 24, 2020 edition of Nature publication: “We’re not going to get rid of the pandemic until we get rid of it everywhere.”

Here comes the importance of equitable access to Covid vaccination for all in India. Although, a number of international organizations, including the W.H.O and Gavi, are working hard to reduce this threat, the concern over inequitable access to Covid vaccines, still remains a real one. Intriguingly, despite India being positioned as the world’s third largest Covid-19 vaccine producer, no one is still sure due to multiple reasons, whether all Indians will benefit from it – probably not even the Government of India.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

Union Budget 2017-18: ‘Modicare’ Remains A Pie In The Sky

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Universal Health Care (UHC), as narrated in the National Health Policy (NHP) 2015 (NHP 2015 Draft) of Narendra Modi Government, making health a ‘Fundamental Right’ for Indian citizens, was considered a profound step by many, both in its both content and intent.

Being enormously enthused with this development, in my article of April 06, 2015 in this blog, titled “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”, I also termed this new draft health policy as ‘Modicare’, just as a few others did. If implemented both in its letter and in spirit, NHP 2015 has the potential to overshadow even the ‘Obamacare’ of the United States, almost hands down. Although it’s an altogether different story that under the new President Donald Trump’s administration, this Act faces a real threat of extinction, at least, in its current Avatar.

Is health care also a serious political issue?

Prompted by what has been happening in the oldest democracy in the world, the above fundamental question does surface. Its answer could be both, ‘yes’ or ‘no’, depending on the voters’ awareness on the subject, and the importance attached to it for individual well-being, including work productivity.

However, in this article, to impress upon how important are the promises on health care to the common citizens in the oldest democracy, I shall draw two back to back examples of pre-election campaign promises related to universal health care in the Unites states, where the answer to the above question has been an emphatic ‘yes’. Thereafter, I would explore what is happening in India in this area to fathom what could its answer possibly be in the largest democracy of the world.

The United States:

On November 4, 2008, Senator Barack Obama of Illinois was elected as the president of the United States. Just in a year’s time ‘The Patient Protection and Affordable Care Act’ popularly known as ‘Obamacare’, was passed in the Senate on December 24, 2009, and passed in the house on March 21, 2010. It was signed into law by President Obama on March 23rd, 2010 and upheld in the supreme court on June 28, 2012.

By enacting this historic health care reform legislation, President Obama fulfilled his election campaign pledge to provide healthcare to all in the United States of America, almost immediately after coming to power.

Similarly, during his 2016 election campaign, Donald Trump pledged to repeal the ‘Affordable Care Act (Obamacare)’, if elected, calling it a “total disaster.” Accordingly, on January 20, 2017 – the same day of becoming the 45th president of the United States, in his first executive order, President Trump, told government agencies to scale back aspects of the Affordable Care Act – fulfilling his pledge to undo Barack Obama’s signature healthcare law that made medical services accessible to millions of Americans.

Whether, it is a good or bad decision may not be a point of discussion in this article, but so far as the pre-election pledge on health care reform is concerned, both the Presidents – Obama and Trump indeed ‘walked the talk’.

India:

Besides the above two examples, the general expectation of the stakeholders in India was that in the priority agenda of the new Government health care will feature much higher than ever before. This was because the main ruling party of the Government in power now had promised to deliver a robust healthcare reform in its Election Manifesto 2014, if it is voted to power. Let me just reproduce below some of those critical promises:

  • India needs a holistic health care system that is universally accessible, affordable, effective and drastically reduces the out of pocket spending on health.
  • The Party accords high priority to the health sector, which is crucial for securing the economy.
  • As NRHM has failed to meet the objectives, it will be radically reformed.
  • The overarching goal of health care would be to provide, ‘Health Assurance to all Indians and to reduce the out of pocket spending on health care’, with the help of state governments.
  • The current situation calls for radical reforms in the health care system with regards to national health care programs and delivery, medical education and training and financing of health care.

The manifesto then goes into the details of each reform areas, after stating, “the last health care policy dates back to 2002; India now needs a comprehensive health care policy to address the complex health care challenges, keeping in view the developments in the health care sector and the changing demographics. The party will initiate the New Health Policy.”

This expectation flickered yet again:

This expectation flickered yet again, when just on the eve of the 2017-18 Union Budget Session, no less than the President of India, honorable Pranab Mukherjee on the last Tuesday reportedly reiterated that his Government assures ‘Health care for all’.

It’s about three years since the new Government is firmly placed on the saddle, after being voted to power. Regrettably, much promised, the new and comprehensive health care policy of India is still not in place. Could it mean, unlike in the US, pre-election political pledges on health care is still not considered a top priority area for quick implementation either by the Indian voters or the winning political parties, post-election? Probably, it doesn’t also sound as vote catching as a plethora of other ‘developmental activities’, ‘Foreign Direct Investments (FDI)’ and ‘GDP growth’ do, for winning a national election in our soil.

In India, most of the population think or feel about medical treatment and prevention of diseases mostly when we ourselves, or our near and dear ones suffer from serious morbidity, or are almost in a dying condition from serious ailments. At that moment of truth, most of us face almost an insurmountable barrier to treatment access due to individual ‘affordability’ condition. In the absence of enough decent public health facilities, one is compelled to go for private medical services that cost a bomb, most of which being out of pocket. At other times, it does not seem to matter much to many, or becomes an integral part of a burning social, political or economic agenda. It has thus far remained a dormant need, which needs to be brought to open by creating greater awareness in ambitious India, even during and after bringing a Government to power.

The fastest growing nation incurs lowest public health expenditure:

Even post ‘Demonetization’ exercise in the country, India would continue to remain the fastest growing large country in the world. However, the Government allocates just around one percent of GDP on public healthcare expenditure, ranking among the lowest in the world, in this area. Regrettably, there does not seem to be an adequate realization both among the public, corporate head honchos, including a large section of the country’s highly partisan media that sans sharp focus on health care, this immaculate growth story can get adversely impacted, in the long run.

Incoherent union health budgets sans any report card on achievements:

Be that as it may, in this article, I shall present before you a snapshot of the health care budgetary measures announced by the Finance Minister in his Budget speech both in 2016-17 vis-a-vis in 2017-18. Thereafter, I would try to explore how incoherent these are, and without any comprehensive status report on time-bound set goals. This is important, as taxpayers hard earned money was spent on those ‘goodies’, probably to give an impression that health care has not been totally left out by the Government during its annual budgetary allocation.

To demonstrate how incoherent and ad hoc these health budgets are, let me place before you what were the key areas of Union Budgetary allocations in 2016-17. If I may refer to my article of March 07, 2016 in this Blog titled, “Healthcare: Unwrapping The Union Budget (2016-17)”, we shall find that the key features were as follows:

The previous Union Budget of 2016-17:

  • The Government will launch a new health protection scheme, which will provide health cover up to Rs. One lakh (Rs. 100,000) per family. For senior citizens, age 60 years and above, belonging to this category, an additional top-up package up to Rs. 30,000 will be provided.
  • To reinvigorate the supply of generic drugs 3,000 stores under Prime Minister’s Jan Aushadhi Yojana will be opened during 2016-17.
  • Starting a ‘National Dialysis Services Program’ to provide dialysis services in all district hospitals. The funds were to be made available through PPP mode under the National Health Mission. To reduce the cost, the budget proposed exemption of certain parts of dialysis equipment from basic customs duty, excise/CVD and SAD.

I am not sure how many stakeholders, if any, are aware of the exact status report on those proposals of the last year’s Union Budget allocation for health care. If that’s the prevailing situation, we now get another small bundle of different sets of ‘goodies’ in the Union Budget 2017-18, as follows:

Current Union Budget of 2017-18:

Even in the absence of a comprehensive National Health Policy, there are many other health related critical issues that may eventually impede the GDP growth rate of the country. A few examples of which are as follows:

  • The estimated premature deaths caused by cardiac ailments, stroke and diabetes, reportedly, will result in a loss of national income of over US$ 250 billion in the coming decade,
  • Mental health becoming a silent epidemic, affecting around 13 percent of the population and just 10 percent of them getting treatment,
  • Millions of families are unable to get access to secondary and tertiary care services for diagnosis and treatment of serious diseases, such as cancer, as they cannot afford private facilities, which gets compounded as India records one of the highest out-of-pocket health expenditure in the world, higher than even many lower income, lower-middle income, as well as the middle-income countries.

Nevertheless, the Union Finance Minister in his 2017-18 budget proposal announced a strong resolve for elimination of:

  • Kala-azar or Leishmaniasis and filaria by 2017
  • Leprosy by 2018
  • Measles by 2020
  • Tuberculosis by 2025

Unquestionably, these are grossly inadequate, especially, in young and ambitious India. Moreover, very people industry watchers would know whether the deadline set for each is achievable, and a periodic report card on the same will be made public or not.

Similarly, the government’s determination to reduce Infant Mortality Rate (IMR) to 28 by 2019 (39 in 2014) and Maternal Mortality Rate (MMR) to 100 in 2020 (167 in 2011-13) is also praiseworthy. However, both these, including tuberculosis prevention, diagnosis and treatment interventions, were a part of the Millennium Development Goals (MDGs) for India. These are an ongoing exercise set out in the Millennium Declaration in 2000. Moreover, why annual budgetary allocation only for those two now, out of 8 MDG goals?

A few other equally ad hoc health care measures, probably picked up at random, and announced by the Union Finance Minister in his February 01, 2017 budget speech were the following:

  • Rs 6,000 financial aid for pregnant women to cover hospital admission, vaccination and nutritional food.
  • Two new All India Institute of Medical Sciences (AIIMS) at Jharkhand and Gujarat.
  • 1.5 lakh health sub centers to be converted to Health Wellness Centers
  • Amendment of the Drugs and Cosmetics Rules to ensure availability of drugs at reasonable prices and promote the use of generic medicines
  • New rules for regulating medical devices to be formulated, which will be internationally harmonized and attract investment into this sector
  • Structural reforms in the medical practice and education.
  • For senior citizens, Aadhar based Smart Cards containing their health details. A beginning will be made through a pilot in 15 districts during 2017-18.

By all these, the government has proposed 27.7 percent increase in allocation for Ministry of Health and Family Welfare to Rs.47, 352.51 Crore in the latest budget from Rs 37,061.55 Crore in 2016-17, on the current abysmally low base of around 1 percent of GDP. A sizeable chunk of this budget is expected to go towards setting up of two new AIIMS and for conversion of 1.5 lakh health sub centers to Health Wellness Centers. The National Health Mission (NHM) for the entire nation, which the Government earlier said is not working, receives an increase of Rs. 3,000 Crore. According to media reports, the Public Health Foundation of India (PHFI) also considers this budget allocation as a frugal one.

Besides the general expectation for the beginning of a Universal Health Care (UHC) regime in India, pharma industry had generally expected the following immediate term relief, which also found no mention in the budget:

  • Corporate tax cut
  • Extension of time line for weighted deductions of R&D expenditure and adding filing fees and clinical trial expenses under the exemption.
  • Rationalization in excise duty for APIs to bring it on par with formulations.
  • Changes to excise duty due to impending implementation of goods and service tax (GST) Withdrawal of service tax on health insurance
  • Exemption of input service tax on support services

Conclusion:

The reason why I brought ‘Modicare’ in my budget discussion is that it needs well-articulated budgetary allocation, even for just the beginning of its implementation, besides having a robust policy in place. Even on the eve of the 2017-18 Union Budget Session, no less than the President of India had reiterated that his Government assures ‘health care for all’ – further rekindling this hope.

In the absence of a well-charted pathway for public health care in India, no wonder that this budget, in my opinion, demonstrates a clear lack of direction, incoherent and inconsistent, just as the previous ones.

I hasten to add that the Government’s focus on rural infrastructure and development, providing financial benefit to farmers, help building affordable houses, creating new jobs, ensuring ease of doing business, putting more disposable income in the hands of the people are well appreciated. However, none can possibly refute the dictum, especially in the young and highly ambitious India that: “It takes a healthy nation to build a wealthy nation”.

The bottom line, therefore, is, the fastest growing nation of the world continues to feel wise and smart with its lowest expenditure on public health. It also leaves a general impression that the Government has removed from its list of priority all the pledges made on health care, before, during and after having a firm grip on the leash of power. Consequently, this has made ‘Modicare’ no more than a pie in the sky, as it were, for many, even after years of sustenance of an indomitable hope of it coming to fruition.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.