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Prime Minister Narendra Modi recently made an important statement – that self-reliance and self-sufficiency are the biggest lessons India should take away from the coronavirus experience. In these words, he acknowledges a most fundamental truth at the highest level. Clearly, self-reliance helped China rapidly control the coronavirus epidemic within its borders, while many other countries waited desperately for imports, including from China.
In the spirit of ‘better late than never’, we must address the huge shortages that plague our public healthcare system through self-reliance. This applies to government hospitals, doctors, paramedical staff, public sector research and drugs, devices, diagnostics, ventilators, protective gear, etc. Most importantly, the current race among companies and institutes to produce a vaccine against COVID-19 should prompt a revitalisation of our public sector undertakings (PSUs) capable of producing vaccines as well.
As it happens, vaccine development and production has been one of India’s strengths for over a century, and the public sector has ensured we have been self-reliant and cost-effective. However, these enterprises were undermined by globalisation, and we began to depend more on imports. At the same time, privatisation increased our immunisation cost and facilitated the backdoor entry of frivolous vaccines.
Indeed, it took a piece of public interest litigation in the Supreme Court, and castigation by a parliamentary committee, to reopen three suspended vaccine PSUs in 2012: the Central Research Institute, Kasauli; the Pasteur Institute of India, Coonoor; and the BCG Vaccines Lab, Chennai.
(The grounds for closure were failure to comply with good manufacturing practices (GMPs) under the Drugs and Cosmetics Rules 1945. But the ministry responsible for funding and facilitating GMP compliance of PSUs instead suspended them for non-compliance. When they were reopened in 2012, the government supported them to re-comply with the practices within three years.)
These three labs, plus the King Institute of Preventive Medicine and Research in Chennai, had been set up by the British from the late 19th century – around the same time Waldemar Haffkine produced the world’s first vaccine against the plague in Bombay in 1896-1897. The labs have since developed and produced vaccines and antisera against diphtheria, polio, tetanus, typhoid, smallpox, cholera, tuberculosis, Japanese encephalitis and yellow fever, among other diseases.
Their work, together with two dozen other such institutes around the country, made India a world’s pioneer in vaccine development. But their fortunes have been on the decline since the 1980s.
The trio’s suspension had precipitated a vaccine shortage for years, and the private sector couldn’t fulfil the demand even at higher prices. However, the revived vaccine PSUs are not allowed to produce combination vaccines that the government now prefers to buy. Many of them are just cocktails, but PSUs survive by producing individual vaccines, thus having been reduced to component suppliers for private firms.
On the other hand, the private sector has benefited from public sector technologies, personnel and expertise, but prefers to make new vaccines and their combinations. New and unnecessary vaccines have entered public immunisation by piggybacking on essential vaccines; some combinations are only “solutions looking for problems”. So much so that a shortage of essential universal vaccines of high demand and a glut of new vaccines of low demand coexist. Therefore, their choice of vaccines to pursue are mainly dictated by profits rather than by public health priorities.
As an illustration: Adar Poonawalla, CEO of the biggest private vaccine company in India – the Serum Institute in Pune – stated on NDTV on April 27 that his company has stopped producing some other vaccines to free up capacity for a COVID-19 vaccine being tested with the University of Oxford. What if any of those vaccines were important to protect against some of the more deadly diseases affecting Indians?
Anyway, together with policy loopholes and poor enforcement, a perfect buyers’ market – the Indian government being the biggest buyer – has often become a sellers’ market. And today, the coronavirus is a reminder of what can happen if India does not become self-reliant in matters of public health, and ignores the public healthcare sector.
Fortunately vaccine-capable public sector units can still help if we empower them immediately.
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The Government of India must revive its pre-liberalisation policy to become self-reliant in vaccine technology development and self-sufficient in vaccine production. It’s time to stop thinking that investing to modernise PSUs and helping them adhere to GMPs is a wasteful activity.
The Japanese encephalitis outbreak claimed many lives in Uttar Pradesh in 2015 due to the lack of a vaccine. India also recorded a shortage of yellow-fever vaccines, mandatory for travellers to Africa and Latin America. The Central Research Institute (CRI) in Kasauli used to be the sole Indian manufacturer of both vaccines. After its operations were suspended in 2008-2010, the government began to import JE vaccines from a non-compliant Chinese PSU. Both organisations eventually became GMP-compliant – but CRI doesn’t receive government orders for JE vaccines any more.
Indeed, currently, 80% of the Indian government’s need for vaccines is met by private firms in India and abroad. The prices are up to 250% higher than those of the public sector, as a result pushing India’s immunisation budget up seven times in only five years.
There is another reason for India.
Viruses with RNA genomes mutate more often than bacteria and higher organisms that have DNA genomes (plants and animals). This is simply because reverse transcriptase, the enzyme that copies RNA into DNA, has much lower proofreading ability, and is thus more error-prone, than DNA polymerase. So irrespective of the new coronavirus’s observed rate of mutation, a vaccine developed against the current strain may not be so effective against future strains.
(This is one of the reasons we don’t have a vaccine against HIV, which is the fastest mutating biological entity known. The second most genetically diverse virus, the influenza virus, requires an improved vaccine every year.)
This in turn means we need a constant interface between hospitals and R&D units to identify and characterise new strains as they emerge and production facilities to make them. Each such vaccine will also need regulatory approval and will need to be procured in time for public use. Considering private vaccine firms are currently better at production than research, public research is crucial to aid development. However, the secrecy and intellectual property rights regimes that enshroud the private sector makes the latter incompatible with public research. Public-sector vaccine units can synergise better with the public-sector R&D system.
There are enough and more experts at institutes of the Council of Scientific and Industrial Research, the Indian Council of Medical Research, the Department of Health Research, the Department of Biotechnology and the Department of Science & Technology. If the virus circulates long enough within the Indian population, new strains could emerge that vaccines developed for other populations – in other countries – may not be entirely effective against. (We already know this from our experience with the oral polio vaccine in some states.)
So, the PSUs’ capacity for research, development and production must be augmented, plus given the professional autonomy they currently lack. More funds for public health research and better hospital infrastructure will go a long way to create an enabling ecosystem. If our PSUs also get the advance market commitments given to their private sector counterparts, they can perform even better.
In the long run, empowering the public sector will make it cost-effective, unconditional and dependable, in turn making India self-reliant and self-sufficient.
Y. Madhavi is a senior principal scientist at the National Institute of Science, Technology and Development Studies (NISTADS), New Delhi. She specialises in vaccine policy. The views expressed here are her own.