Regular market approval granted for Covishield, Covaxin for use in adult population
The Hindu
Both the vaccines were granted Emergency Use Authorisation (EUA) on January 3.
India’s drug regulator on Thursday granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said.
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-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.
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