The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting regular market approval to COVID-19 vaccines, Covishield and Covaxin, in the adult population, subject to certain conditions, confirmed an official on Wednesday.
Both the vaccines are currently only authorised for emergency use in India and their application was reviewed for the second time on Wednesday before the recommendations were made, he said.
“SEC of CDSCO has recommended the upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population. The Drugs Controller General of India will evaluate the recommendation and give its decision,” tweeted CDSCO on Wednesday.
Previously, the SEC had sought more data and information from the two companies with the Serum Institute of India (SII) applying for regular market approval on October 25 for its vaccine, Covishield. The company in its application had details of the successful completion of the phase 2/3 clinical study in India, and highlighted the country and worldwide use of the vaccines safely.
Bharat Biotech also submitted complete information on its vaccine, Covaxin, including manufacturing and controls, along with pre-clinical and clinical data, while seeking regular market authorisation.
