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New Delhi : The Subject Expert Committee of CDSCO on Covid met on January 1 & 2, 2021, according to a PIB release.
It made the following recommendations for the consideration and final decision of the Drugs Controller General of India :
1) Grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India (SRI), Pune.
2) Grant of 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 M/s Bharat Biotech International Ltd., Hyderabad.
3) Grant of permission for conduct of Phase-III Clinical Trial Protocol to M/s Cadila Healthcare Ltd, Ahmedabad.