DCGI Approves Serum Institute’s ‘Covishield’ , Bharat Biotech ‘Covaxin’ Vaccines for Emergency Restricted Use

India’s drug controller Drugs Controller General of India(DCGI) has approved Serum Institute of India’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ for restricted emergency use.

This was informed by Dr VG Somani, the Drugs Controller General of India, in a press conference on Sunday.
Serum Institute of India(SII) sought approval for the ‘Covishield’ vaccine developed by Oxford-AstraZeneca. Bharat Biotech developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with Indian Council of Medical Research(ICMR) and National Institute of Virology, Pune.
Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.

The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.

“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III”, Dr Somani, the DCGI, told the press.

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