DCGI accords conditional market approval for Covaxin and Covishield

Firms will need to submit data of overseas ongoing clinical trials of their vaccines every 6 months

The Drugs Controller General of India (DCGI) has given its nod to the market authorisation of two Covid vaccines - Bharat Biotech's Covaxin and Serum Institute of India's (SII's) Covishield - for use in the adult population, subject to certain conditions, said a Union health ministry statement on Thursday. The approval, it said, reflects India’s proactive and agile Covid management. The approval was granted under the New Drugs and Clinical Trials Rules, 2019.

Both biotechnology companies will have to submit the data of the overseas ongoing clinical trials of their vaccines with due analysis every six months or as and when