Covishield, Covaxin receive regular market approval for use in adult population

India's drug regulator on Thursday granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said. The approval was granted under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting besides recording all vaccinations done within the country on the CoWIN platform, the sources said.

Adverse event following immunisation will continue to be monitored as part of the conditions. The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation for Covishield. The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.