Panel recommends regular market approval for Covishield, Covaxin

India has granted regular market approval to Covid vaccines Covishield and Covaxin. A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions. Both SII and Bharat Biotech confirmed that and an approval has come in from the subject expert committee (SEC). Central Drugs Standard Control Organisation (CDSCO) also took to Twitter to confirm.

SEC of CDSCO has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions In adult population ,DCGI will evaluate the recommendations and give its decision.

— CDSCO_INDIA_INFO (@CDSCO_INDIA_INF) January 19, 2022

"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech's application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions," an official source said. Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective Covid-19 vaccines Covishield and Covaxin.