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Expert committee recommends Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield for emergency use in country

The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) has made recommendations for the consideration and final decision of the Drugs Controller General of India on use of Covid-19 vaccine. It has recommended to grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune.

The company has collaborated with Oxford University and pharmaceutical company Astra Zeneca for making the vaccine Covishield.

The Subject Expert Committee of CDSCO has recommended to grant permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech International Limited, Hyderabad.

Covaxin, is the first made-in-India vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.

The DCGI will take the final call on approving of the vaccine. It is scheduled to brief the media today at 11 am.

The Subject Expert Committee of CDSCO  has recommended to grant permission for conduct of Phase-III Clinical Trial Protocol to Cadila Healthcare Limited, Ahmedabad.

 

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