Serum Institute and Bharat Biotech Covid19 vaccines get CDSCO approval; Phase-III trials permit to Cadila

New Delhi: The Subject Expert Committee of CDSCO met on 1st and 2nd January, 2021 and 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, 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