The Subject Expert Committee (SEC) of Central Drugs Standards Control Orgsation on Saturday made recommendations to the Drugs Controller General of India to grant permission for restricted emergency use of SII, Bharat Biotech's vaccines.
As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of accelerated approval process request of Serum Institute of India (SII), Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.
"Grant of permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune," it said.
The SEC recommended granting permission for restricted emergency use, as an abundant precaution, especially in the context of infection by mutant strains to Bharat Biotech International Ltd.
"Grant of permission for restricted use in the emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd, Hyderabad," it stated further.
The committee asked DCGA to grant permission to Cadila Healthcare Ltd, Ahmedabad to conduct phase-III clinical trial protocol.
The SII has partnered with global pharma giant AstraZeneca and Oxford University for the vaccine candidate 'Covidshield'.
Moreover, COVAXIN is an indigenously developed coronavirus vaccine developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR).Zydus Cadila's is also developing a vaccine candidate called 'ZyCoV-D', which is still in a trail phase.
( With inputs from ANI )
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