Drugs Controller General of India (DCGI) on Sunday said the permission given to Bharat Biotech's COVAXIN is "for restricted use in an emergency situation" and it is given in "public interest as an abundant precaution" as the vaccine is still in clinical trial mode.
"This permission is for restricted use in an emergency situation in the public interest as an abundant precaution in clinical trial mode. The firm should provide the protocol for rolling out for the restricted use of the vaccine in an emergency situation," the drug regulatory body said in the official notification.
It said that Bharat Biotech would have to provide the updated prescribing information, package insert, and summary of product characteristics (SmPC) for 'Whole Virion Inactivated Corona Virus Vaccine' (BBV1526) and also disseminate the necessary information, instructions, and educational materials through their website.
"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 the requirement of 'New Drugs and Clinical Trials, 2019'," it stated further.
DCGI also asked the biotech company to submit safety data including the data on Adverse event following immunization (AEFI) and Adverse event of special interest (AESI), with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of 'New Drugs and Clinical Trials, 2019'.
It also asked Bharat Biotech to submit a risk management plan.
"The firm should submit ongoing stability of commercial-scale batches (real-time and accelerated) of drug substance and drug product," DGCI said and added that the permission is subject to the condition of satisfactory evaluation and lot release by Central Drugs Laboratory, Kasauli.
"Further, each batch/lot of Whole Virion Inactivated Corona Virus Vaccine, (BBV152B) shall be released from Central Drugs Laboratory, Kasauli" it added further.
( With inputs from ANI )
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