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The Drug General of India on Sunday gave their final nod on use of covid-19 vaccine for emergency use in India. The expert panel few days back recommended Oxford vaccine ‘Covishield’ and Bharat Biotech’s ‘Covaxin’, however now the both company has got the final approval.
The recommendation for Bharat Biotech’s vaccine came a day after the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation cleared the Serum Institute of India’s emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield.
As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.
The Subject Expert Committee recommended a grant of permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune.
Restricted use in emergency situation
It recommended “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 Bharat Biotech,” the health ministry stated.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.
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