Experts Voice Concerns On India’s Covid-19 Vaccine Approval Process
A Covid-19 vaccination center, in Delhi, on Jan. 2, 2021. (Photographer: T. Narayan/Bloomberg)

Experts Voice Concerns On India’s Covid-19 Vaccine Approval Process

India’s drug regulator on Sunday approved the Covid-19 vaccines manufactured by Serum Institute of India Ltd. and Bharat Biotech International Ltd. for restricted use in emergency situation.

The approval by the Drugs Controller General of India was given on the basis of recommendations submitted by a Covid-19 subject expert committee of the Central Drugs Standard Control Organisation.

DCGI’s VG Somani said the overall efficacy of the AstraZeneca-Oxford University shot being produced locally by the Serum Institute as ‘Covishield’ was found to be 70.42%.

On Bharat Biotech’s ‘Covaxin’, the DCGI said the vaccine is “safe and provides a robust immune response.” The approval for this vaccine has been given even as, Somani said, “The clinical trial ongoing within the country by the firm will continue.” Unlike his statement on the Serum vaccine, Somani did not offer a data point on the efficacy of ‘Covaxin’.

Experts, however, have voiced concerns on the approval process, and the lack of publicly-released efficacy data for Covaxin.

‘Covaxin Has No Clinical Efficacy Data’

- Dr. Gagandeep Kang, Professor, CMC, Vellore.

“I thought I knew something about the process of licensure of vaccines, but clearly I do not. I do not understand what ‘the grant of permission in emergency situation in public interest as an abundant permission, in clinical trial mode,’ means — either you are doing a clinical trial or you are not. As far as I am aware Covaxin has no clinical efficacy data whatsoever at this time, so I fail to see how the DCGI can consider this an efficacious vaccine.”

Not The First Time CDSCO Has Capitulated

- Dinesh Thakur, Public Health Activist

“Unlike processes followed by the U.S. FDA and the MHRA, which were specifically designed to inspire confidence in the decisions that were being made in approving vaccine candidates, the CDSCO, true to its character, was opaque and unaccountable toward the people of India in its decisions. Not only is the outcome of the decisions published by the DCGI not grounded in law (it does not quote specific clauses within either the Drugs and Cosmetics Act, 1945, or the New Drugs and Clinical Trial Rules of 2019 under which these approvals were granted), it fundamentally redefines what is acceptable from a clinical point of view for human therapeutic use. Approving a vaccine candidate without any efficacy data from well designed phase-3 studies is a first anywhere in the world. On top of that, not taking any questions or explaining its rationale why it came to the decisions it did during the briefing meeting fundamentally undermines the confidence of the people who are expected to be the beneficiaries of these vaccines.”

“Sadly, this is not the first time that the CDSCO has capitulated to interests other than scientific. There is a long and sordid history of malfeasance by the regulator. Transparency and accountability seem to be alien concepts when it comes to decision making by the DCGI.”

‘Credibility Of Regulator At Stake’

- Murali Neelakantan, Healthcare Lawyer

“The issue with using terms like emergency use authorisation and restricted emergency use, that are alien to Indian regulations, is that it causes confusion among the doctors and patients about the basis for the approval and the limitations of the data used to grant approvals. This lack of transparency could lead to a lack of trust in the vaccine. Contrast this with the U.S. FDA which live streamed the whole regulatory review process and issued a detailed memo on the vaccine, with all relevant data, including restrictions.

The credibility of the regulator is at stake and this is especially telling due to the history of the regulator acting contrary to the regulations in the past. India has had a troubling history of new drug approvals.”

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