The Drugs Controller General of India (DCGI) has granted conditional market authorization to COVID-19 vaccines Covishield and Covaxin for use in adults. Union Health Minister, Mansukh Mandaviya, tweeted, “The @CDSCO_INDIA_INF has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.”

Under the conditions, the company will supply the vaccines for programmatic settings, with registration on the CoWin platform and submission of vaccine safety data on a six-monthly basis. Adverse events after vaccination will be monitored. The approval has been granted under the New Drugs and Clinical Trials Rules, 2019.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had recommended granting regular market approval to the two vaccines for use in adults under certain conditions on January 19… (The Hindu – ET Healthworld – PTI, January 27, 2022)