Questionable Permission, Ineffective Programme

Anant Phadke writes:

On 3 January, Covishield and Covaxin (manufactured by Serum Institute of India (SII) and Bharat Biotech respectively) received “permission for restricted use in emergency situation subject to certain regulatory conditions.” The Drugs Controller General of India (DCGI) gave this permission despite the absence of mandatory phase III trial Indian data needed for clearly establishing efficacy of these vaccines. For Covishield, phase III data from “overseas clinical studies” (in England and Brazil) were presented by SII and accepted by the DCGI as part of the evidence for efficacy, whereas for Covaxin, no phase III data were presented at all. However, for Covaxin, the permission is restricted for use “in clinical trial mode.” This permission is difficult to justify scientifically or in terms of relevant sections of the New Drugs and Clinical Trials Rules 2019.