New Delhi: The Subject Expert Committee of Central Drug Standard Control Organization on Saturday recommended Bharat Biotech’s vaccine for emergency use in India.
The Subject Expert Committee of CDSCO met on January 1 & 2 and made the following recommendations for the consideration and final decision of the Drugs Controller General of India:
- Grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India, Pune.
- 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.
- Grant of permission for conduct of Phase-III Clinical Trial Protocol to M/s Cadila Healthcare Ltd, Ahmedabad.