Covaxin, Covishield get regular market approval

New Delhi: The Drugs Controller General of India's (DCGI) on Thursday granted regular market approval for Covid-19 vaccines Covaxin and Covishield for use in adult population, sources said. The vaccines, however, will not be available at medical stores.

As per certain conditions set by the drug regulator, hospitals and clinics can purchase vaccines and the vaccination data has to be submitted to the DCGI every six months and updated on the CoWIN app.

Under the said conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting. Monitoring of adverse event following immunisation will be continued. The DCGI's 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. 

"The 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," Union Health Minister Mansukh Mandaviya said on Thursday.