Bharat Biotech seeks full marketing approval from DCGI for Covaxin

Bharat Biotech has sought from the Drugs Controller General of India (DCGI) regular market approval for its COVID-19 vaccine Covaxin’, which is currently only authorised for emergency use in the country, official sources said yesterday.

In an application sent to the DCGI this week, V Krishna Mohan, Whole-Time Director, Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with pre-clinical and clinical data while seeking regular market authorisation for Covaxin.

The company, however, is yet to submit the full follow up data of clinical trial of Covaxin to DCGI, a source said.

On 25th October, Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum Institute of India (SII), had submitted an application to the DCGI seeking regular market authorisation for Covishield which is also authorised for emergency use in the country.

In response to the application, DCGI had asked for some more information following which Singh last week submitted a response along with all desired data and information to DCGI.

In addition to the successful completion of phase-II/III clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in India and worldwide, Singh is learnt to have stated in the response.

Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine, he said.

Meanwhile, Covaxin comprises 12 per cent of the total COVID-19 vaccine jabs administered in the country so far and it is the only vaccine that is being given to youngsters in the age group of 15-18 years, inoculation of whom began from 3rd January in the country.

Bharat Biotech took up the challenge to develop, produce and clinically evaluate Covaxin, from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan said in the application.

It was granted the permission to manufacture Covaxin for restricted use in emergency situations on 3rd January.

“In the current submission, all the required complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data have been provided in five modules. The information contained in the modules is uploaded on SUGAM portal for your kind perusal. We request you to kindly review the same and grant the marketing authorisation, at the earliest,” the application by Mohan read.