“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.