Govt expert panel recommends regular market approval for Covishield, Covaxin


The Subject Expert Commitee (SEC) of India’s central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin, which are currently only authorised for emergency use in India, subject to certain conditions, people in the know told ET.

The SEC had met last Friday, January 14, but could not finish the review of the ‘huge amount of data’.

“The review continued in the meeting today and the SEC found the data sufficient for the grant of full licensure. The SEC recommended that the companies be granted full market approval,” people in the know told ET.

Last week, Hyderabad-based Bharat Biotech had 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.

A market authorisation label for a vaccine means it can be authorised for use without any reservations or conditions.

Earlier, Pune-based Serum Institute of India (SII) 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 Indian government’s vaccination drive. About 88% of the eligible population has received Covishied. Covaxin accounts for 12 per cent of the total Covid-19 vaccines administered in India since January 2021. It is so far the only jab that is being administered to youngsters in the age-group of 15-18 years, for whom vaccination started on January 3.

Both the vaccines were granted Emergency Use Authorisation (EUA) on January 3 last year.

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