CDSCO panel recommends granting approval for Bharat Biotech's Covaxin

An expert panel of India's central drug authority on Saturday recommended granting permission for restricted emergency use of the indigenously developed COVID-19 vaccine Covaxin with certain conditions, a day after giving similar direction for the Oxford COVID-19 vaccine, sources said. Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting, a source said. Bharat Biotech had applied to the Drugs Controller General Of India (DCGI) seeking emergency use authorisation for its Covaxin on December 7. On Friday, the SEC had recommended granting permission for restricted emergency use of Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India.

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