Hyderabad: Drugs Controller General of India (DCGI) on Sunday gave licensing permission to Bharat Biotech to manufacture India's indigenous COVID-19 vaccine COVAXIN. Bharat Biotech has been asked to submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II & Ill clinical trials till the completion of trials.
Granting permission to manufacture pharmaceutical formulation of a new drug for sale or for distribution, DCGI in a letter said, "The Central Licensing Authority hereby grant permission to Bharat Biotech International Limited to manufacture for sale of pharmaceutical formulation manufactured by a manufacturer specified."
The letter also contains details of the pharmaceutical formulation like dosage form, composition, indication and shelf life with storage condition.
Bharat Biotech gets permission to manufacture 'Covaxin' for sale "The firm should also provide the protocol for rolling out the restricted use of the vaccine in an emergency situation," DCGI instructed.
The DCGI letter also states that the pharma company should submit safety data including that of AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter as per the requirements of New Drugs and Clinical Trials.
Bharat Biotech has also been asked to submit a Risk management plan and ongoing stability of commercial-scale batches of drug substance and drug product.
Bharat Biotech gets permission to manufacture 'Covaxin' for sale On Sunday, DCGI V.G. Somani announced that Bharat Biotech's 'Covaxin' has been approved for "restricted use in an emergency situation". The approval has also been given to Serum Institute of India's 'Covishield' vaccine.
The Subject Expert Committee of Central Drugs Standards Control Organisation had recommended restricted use of Covaxin "in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains".
Covaxin has to be administered in two doses and can be stored at 2-8 degree Celsius. This is a major relief for India which has the second-highest number of infections in the world after the US.
Bharat Biotech is India's first indigenous vaccine for coronavirus. The inactivated virus vaccine is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
"Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist," Krishna Ella, Chairman and Managing Director of the pharmaceutical firm said following the approval.
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With agency inputs
