The Central Licensing Authority on Saturday granted permission to Hyderabad-based Bharat Biotech to manufacture Covaxin for sale and distribution, after the indigenous coronavirus vaccine received regulatory approval for emergency .
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Bharat Biotech gets licensing permission to manufacture Covaxin
The Central Licensing Authority on Sunday granted permission to Bharat Biotech to manufacture Covaxin for sale and distribution, hours after the Drug Controller General of India (DCGI) approved the coronavirus vaccine for restricted emergency use.Â
The Hyderabad-based company has been asked to submit safety, efficacy and immunogenicity data from the ongoing phase I, II and III clinical trials till 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 said today.Â