India’s two main vaccines — Bharat Biotechs Covaxin and Serum Institute of India’s Covishield — on Wednesday got the nod for regular market authorisation.
An expert panel of Central Drugs Standard Control Organisation (CDSCO) — India’s regulatory body for pharmaceuticals, medical devices and cosmetics — on Wednesday recommended granting regular market approval to Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions.
“CDSCO has recommended for upgrade of Covishield and Covaxin’s status from restricted use in emergency situations to grant of new drug permission with conditions in adult population. The DCGI (Drugs Controller General of India) will evaluate the recommendations and give its decision,” CDSCO said in a tweet.
Indian vaccines manufacturer Serum Institute of India and Bharat Biotech had submitted applications to the DCGI seeking regular market authorisation for their respective Covid vaccines.
Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute, had submitted an application to the DCGI on October 25 last year on this matter.
The DCGI had sought more data and documents from the Pune-based company following which Singh recently submitted a response along with more data and information.
Hyderabad-based Bharat Biotech had submitted complete information on chemistry, manufacturing, and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.