SEC recommends regular market approval for Covishield and Covaxin

SEC recommends regular market approval for Covishield and Covaxin

By: IPP Bureau

Last updated : January 20, 2022 8:08 am



However, these won’t be available at the nearest chemist store soon


The Subject Expert Committee (SEC), of the Central Drugs Standard Control Organisation(CDSCO), in India has recommended that Covishield and Covaxin vaccines be granted regular market approval but with certain conditions, the CDSCO tweeted.

The Serum Institute of India (SII) and Bharat Biotech had submitted their respective applications to the country’s drug regulator, the Drugs Controller General of India (DCGI), seeking full market authorisation for their vaccines. The vaccines are currently only authorised for emergency use in the country.

The DCGI is expected to announce its decision in a day or two.

A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions. For full market authorisation, the regulator would need to evaluate more data about the vaccines collected over a longer period of time.

However, this does not mean that the vaccines will be available at the local medical stores.

SEC CDSCO Serum Institute of India Bharat Biotech

First Published : January 20, 2022 12:00 am