Ministry: 3 vaccine candidates under active consideration

Covid crisis has stabilised with active cases showing a clear-cut declining trend

New Delhi, Dec. 8: Three Covid-19 vaccines candidates, developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India’s drug regulator and there is hope that early licensure is possible for all or any of them, the Union health ministry said on Tuesday.

Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their potential Covid-19 vaccines.

At a press briefing, NITI Aayog member (Health) V.K. Paul said the Covid-19 situation in India has stabilised with active cases showing a “clear-cut declining trend” even though the pandemic situation in many other countries is becoming quite serious. The concern and anxiety that arose following an increase in daily cases of infection in Delhi has also settled now, he said.

Asked what steps would be followed by the DCGI in the absence of a watertight emergency use authorisation law for granting licence to vaccine makers, Union health secretary Rajesh Bhushan said not all countries’ regulatory framework or rules and acts mention emergency use authorisation.

“So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that specific country does not have an enabling provision to accord an approval which is early and which is distinct from a regular market approval. India’s regulatory framework has a specific provision for grant of emergency use authorisation. Although this phrase is not used,” he said.

The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval.

“This is our law. Similarly other countries also have their legislations,” Bhushan said. Giving a bird’s-eye view of the Indian landscape of Covid-19 vaccines, Bhushan mentioned that eight vaccines are at different stages of development.

One is Covishield, which is being manufactured by Serum Institute of India in collaboration with AstraZeneca. Phase two and three clinical trials of this vaccine is underway and the firm has applied form emergency use authorisation.

Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and is presently in phase three of clinical trials. It has also applied to the DCGI seeking emergency use authorisation.

The third one is ZyCOVD, being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with central government’s Department of Biotechnology and is in phase two of the trials.