Covishield, Covaxin Receive Conditional Market Approval
Business Standard|January 28, 2022
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.
Ruchika Chitravanshi

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 available, whichever is earlier.

The approval, DCGI said, reflects India's proactive and agile Covid management.

Even with market approval, all vaccinations within the country will have to be recorded on the COWIN platform.

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