Will Regulatory Approvals Slow Down the Covid-19 Vaccine?
The news has been bubbling with updates about a Covid-19 vaccine. Will Indian regulations pose a challenge?
For the last few days, everyone has been talking about Pfizer’s Covid-19 vaccine. Like me, if you aren’t a fan of the “new normal”, this comes as a massive ray of hope.
As soon as the vaccine was announced, a friend got a message. A travel company was offering medical tourism to America and even promised early access to the vaccine. If you think I’m joking, check this out.
Why is this happening? The truth is that the agency is playing on a very real fear i.e. the vaccine will take ages to reach India. A part of this is practical. There will be a limited supply of vaccines after all.
But what about the law? Will regulatory requirements slow things down? That’s what we uncover today.
Law of Vaccines
Vaccines are regulated under the Drugs and Cosmetics Act, 1940, and more specifically under the New Drugs and Clinical Trial Rules, 2019 (‘CT Rules’).
These rules govern the manufacture and import of vaccines. Typically, a new vaccine would undergo a long, painstaking approval process. This would involve –
(a) ethics committee approvals;
(b) clinical trial application;
(c) three stages of clinic trials; and,
(d) post-marketing trials and monitoring for long-term side effects.
Even in a best-case scenario, the process would take several years. But no one has that much time.
Time to Ship
Thankfully, the Indian government has recognised this. It has already announced a rapid response framework (‘Framework’) to facilitate development of a Covid-19 vaccine.
For one, the Framework explains how tests and trials conducted outside India will be used. It clarifies that data generated abroad can be considered if such data is complete and satisfactory. While this seems promising, it would still be interesting to track the extent of checks that the Indian government will carry out before approving the vaccine.
It should be noted that this Framework is recommendatory. This means that it doesn’t give a free reign for anyone to develop their own vaccine. Individual applications will be examined basis the type of vaccine and data generated.
The Balancing Act
Strict regulations like the CT Rules exist for a reason – you don’t want people selling fake cures, especially in such times.
But even such regulations carve an exception for emergencies. The CT Rules provide relaxations for “diseases of special relevance to the Indian scenario or unmet medical need in India, disaster or special defence.” Such a provision is useful in times of war, famine, and even a pandemic.
The fact is that the legislature had always contemplated the need for expedited approvals in trying times. In this case, what needs to be weighed is the urgency of the situation versus potential safety concerns of granting a premature approval.
On its part, the government seems to be getting ready to distribute vaccines whenever they’re ready. States are forming high level committees to create a roadmap for vaccine administration. Will the regulations pose a hurdle?
For a change, maybe not.
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