Image Source : PTI Bharat Biotech will get licensing permission to fabricate Covaxin
The Central Licensing Authority on Sunday granted permission to Bharat Biotech to fabricate Covaxin on the market and distribution, hours after the Drug Controller General of India (DCGI) permitted the coronavirus vaccine for restricted emergency use.
The Hyderabad-based firm has been requested to submit security, efficacy and immunogenicity information from the continuing section I, II and III scientific trials until the completion.
“The firm should provide the protocol for rolling out for the restricted use of the vaccine in emergency situation. The firm should provide the updates prescribing information/package insert and summary of product characteristics for whole virion inactivated coronavirus vaccine (BBV152b) and also disseminate the necessary information, instructions and educational materials through their website,” the DCGI mentioned in the present day.
“The firm should submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II and III clinical trials till the completion of trials as per requirement of New Drugs and Clinical Trials, 2019,” it additional said.
The Central Licensing Authority additionally requested Bharat Biotech to submit danger administration plan, and ongoing stability of economic scale batches of drug substance and drug product.
READ MORE: Covaxin generated wonderful security information, says Bharat Biotech
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