ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

A+| A| A-

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.

Dear Reader,

To continue reading, become a subscriber.

Explore our attractive subscription offers.

Click here


To gain instant access to this article (download).

INR 59

(Readers in India)

$ 6

(Readers outside India)

Published On : 15th Feb, 2024

Support Us

Your Support will ensure EPW’s financial viability and sustainability.

The EPW produces independent and public-spirited scholarship and analyses of contemporary affairs every week. EPW is one of the few publications that keep alive the spirit of intellectual inquiry in the Indian media.

Often described as a publication with a “social conscience,” EPW has never shied away from taking strong editorial positions. Our publication is free from political pressure, or commercial interests. Our editorial independence is our pride.

We rely on your support to continue the endeavour of highlighting the challenges faced by the disadvantaged, writings from the margins, and scholarship on the most pertinent issues that concern contemporary Indian society.

Every contribution is valuable for our future.