The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health has has now upgraded the permission for Covid vaccines 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 informed on Thursday.
The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis, he said in Twitter.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
Earlier today, it was reported that India's drug regulator had granted regular market approval for Covid 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.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on Covid 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.
With inputs from PTI
