Covaxin, Covishield granted regular market approval in India

The Drugs Controller General of India (DCGI) on Thursday granted regular market approval for Covid-19 vaccines — Covishield and Covaxin — for use in the adult population subject to certain conditions. The approval was granted under the New Drugs and Clinical Trials Rules, 2019.

However, it is important to note that the market approval does not mean that the vaccines will be available in medical shops. People will have to buy Covishield and Covaxin from hospitals and clinics. Vaccination data has to be submitted to DCGI every six months. Data will have to be updated on CoWIN app.

Informing about the market approval for the two Covid-19 vaccines, Union Health Minister Dr Mansukh Mandaviya tweeted: "The @CDSCO_INDIA_INF [Central Drugs Standard Control Organisation (CDSCO)] 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."

Covaxin maker Bharat Biotech and Covishield maker Serum Institute of India, or SII, had given data of ongoing clinical trials to the regulator, which approved the market sale after a subject expert committee on COVID-19 on January 19 recommended approval.

Reportedly, hospitals and clinics registered under the government’s National Health registry and/or approved by the National Accreditation Board for Testing and Calibration Laboratories (NABL) will be allowed to keep stock of these vaccines.