A vial of the Pfizer-BioNTech COVID-19 vaccine seen on a table at Ankara City Hospital, Turkey, April 2, 2021. Photo: Reuters/Cagla Gurdogan
In 2021, India has seen much variation in the safety standards prescribed for foreign manufacturers of COVID-19 vaccines. What started as a long guidance document with several requirements, including bridging studies and every batch of drugs being tested at the Central Drugs Laboratory, Kasauli, has since been significantly shortened. It is not lost on keen observers of these developments that the reduction in local safety assessments is taking place against the backdrop of foreign manufacturers negotiating deals with the Government of India to supply their products in the Indian market.
Why are local safety assessments important? Drugs have been known to react differently in different populations. A drug being proven effective in one country is not always a guarantee of its safety and efficacy in another, even if many of the trial results are generalisable. So the New Drugs and Clinical Trial (NDCT) Rules 2019, which provide the regulatory framework for developing vaccines and other new drugs in India, prescribes a local clinical trial for drugs being introduced in India for the first time. Such local trials are primarily to demonstrate that the drug or vaccine is safe for use in the Indian population. The Central government can, in its discretion, provide a waiver for some stages of a clinical trial for drugs developed in some countries, such as the US, the UK, Japan and the EU. However, such discretion is exercised on a case-by-case basis, depending on whether there is any probability or evidence that the drug may react differently in the Indian population.
The reason for drug trials in India involving multiple safety checks lies in the Supreme Court case of Swasthya Adhikar Manch v. Union of India (2013). Between 2011 and 2013, about 157 applications to conduct clinical trials were permitted by the Centre without appropriate risk assessment and without ensuring sufficient safety of the process. By the time a PIL was filed before the Supreme Court, at least 80 trial participants had died and 506 serious adverse events had been reported in all. The Supreme Court ordered the government to revise the drug approval process to be much more comprehensive, and the NDCT Rules were enacted in 2019. Today, as foreign manufacturers are knocking on the doors of the Indian market once again, offering products whose local safety levels have not been determined, the government seems to be slipping through the cracks of risk assessment protocol once again.
The right to health has been read into the right to life under Article 21 of the Constitution. Across a series of cases starting from the 1980s, the Supreme Court has held that the state should be able to provide both health infrastructure and facilities and guarantee safe administration of healthcare. The government therefore carries the dual burden of procuring sufficient doses of vaccines for India and ensuring that the vaccines are safe. Turning a blind eye to the safety risks of a vaccine, in order to put together a sufficient dosage count, will amount to negligence on the part of the state in ensuring safe healthcare. India has already acknowledged at least one vaccine-related death. No vaccine is 100% safe, but at the same time, we should be extra-careful about testing them instead of making do with abridged clinical trials to the exclusion of all other options.
Holding manufacturers liable for the safety of their products is one way for the government to ensure pharmaceutical companies perform necessary tests to ensure local safety. However, news reports suggest that many foreign vaccine manufacturers would like the Government of India to pay any compensation that is due to an individual who claims to have suffered an adverse event determined to be due to their vaccines. The question is: who will ensure local safety of the product when the manufacturer has no liability? If the Indian government acquiesces to the indemnity that many foreign manufacturers are seeking from the Centre, indemnified manufacturers are unlikely to make extra efforts to ensure their product is suitable for the Indian demography. The product liability regime in India anchors itself on the manufacturer taking responsibility for what they put out in the market, and compensation payouts are the stick at the other end of the carrot that ensures compliance. Additional waivers of safety checks and manufacturer liability will only result in more unknown adverse effects and possible loss of life.
Unlike many other developing countries, India is not restricted in its choices for vaccines. Undeniably, the number of doses required in India is significantly higher than most countries around the world – but with two locally manufactured and one foreign vaccine already available, the government may choose to invest in developing the production capacities of the available vaccines, rather than importing from manufacturers who place safety concerns second.
Others have argued that granting indemnity to one foreign manufacturer will open the floodgates for the government to provide indemnity to all manufacturers, domestic and foreign, for all vaccines, COVID-19 or otherwise. While the argument there has considered the financial burden on the government to indemnify all vaccine manufacturers, the safety implications of manufacturers not being held liable for their products are just too dire to consider. India is a country of diverse demographics – some people have access to nutrition and healthcare than others. If manufacturers are not compelled to consider the pharmacodynamics of their products on diverse populations, the government will potentially be looking at a case of gross human rights violations.
To maintain the balance between procuring sufficient vaccine doses for India and not risking the health of Indian citizens, the government should only agree to a highly conditional indemnity clause for any foreign manufacturer that has not conducted local or bridging trials. The manufacturer should be able to demonstrate bona fide due diligence in the pharmacovigilance process, closely monitor and follow up on any serious adverse events, collect and review safety data from all vaccination centres and submit such data to an independent data safety monitoring board. Only in cases where manufacturers can show that they have not been lax in the risk assessment of their product for the local population should the government provide indemnity. Alternatively, the manufacturer should voluntarily demonstrate through appropriate tests and trials that the safety data from their country can be extrapolated to the Indian population.
Introducing vaccines of indeterminable local risk into the Indian market is too high a safety concern for the government to ignore. Both the availability and safety of vaccines have a direct impact on the health and well-being of citizens of India, and the government must seek to strike a careful balance between both concerns.
Protiti Roy is a regulatory affairs and public policy lawyer practising in a Delhi-based law firm. All views expressed in this piece are completely personal.