The subject expert committee (SEC), a body under the Drugs Controller General of India (DCGI),will meet again to review applications filed by Bharat Biotech and Serum Institute of India for full market approval of their respective Covid vaccines – Covaxin and Covishield. The SEC had met on Friday but could not finish the review of the ‘huge amount of data’, people in the know told ET.
“The data is huge which has to be reviewed and it needs a considerable amount of time. The SEC will meet in the next 1-2 days to finish the review,” the same person said.
On Thursday, Bharat Biotech sought regular market approval from the drug regulator for its indigenous Covid-19 vaccine Covaxin, which is at present authorised for emergency use in the country.
“The review is going on and will continue. It can’t be done in a single day,” the person said, speaking on condition of anonymity.
The experts will meet again soon. “We will meet at the earliest- in the next 1-2 days,” he added.
A market authorisation label for a vaccine means it can be authorised for use without any reservations or conditions. Earlier, Serum Institute of India had also filed a similar application for Covishield.
In response to the application, the DCGI had sought more information which, according to sources, was submitted last week.
Covishield and Covaxin are the main Covid-19 vaccines used in the government’s vaccination drive. About 88% of the eligible population has received Covishield. Covaxin accounts for 12% of the total Covid-19 vaccines administered in India since January 2021. It is so far the only jab that is administered to youngsters in the age-group of 15-18 years, for whom vaccination started on January 3.
