DCGI to review Covaxin, Covishield full market approval today

January 14, 2022 13:47

Drugs Controller General of India (DCGI)'s Subject Expert Committee will review applications of Bharat Biotech and Serum Institute of India (SII) for full market approval to Covaxin and Covishield respectively on Friday, sources said.

The SII of India had applied for market approval for the Covishield vaccine in December 2021 and Bharat biotech has also applied for the same 10 days ago.

Further, Bharat Biotech has informed that Covaxin is now a universal vaccine for adults and children. "Our goals of developing a global vaccine against COVID-19 have been achieved and all product development for licensure has been completed," it said.

However, both Covaxin and Covishield are currently authorized for emergency use only.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) met on January 1 and January 2, 2021, and made recommendations in respect of the proposal for Restricted Emergency Approval of COVID-19 virus vaccines of Serum Institute of India and Bharat Biotech.

The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, pediatrics, internal medicine, etc. -- PTI

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