Covaxin, Covishield, cleared for regular, full market approval

NEW DELHI: Bharat Biotech's Covaxin and Serum Institute of India's Covishield, India's two key vaccines, received regular market authorisation on Wednesday.

Covishield and Covaxin, which are now only approved for emergency use in India, were recommended for regular market approval by an expert panel of the Central Drugs Standard Control Organisation (CDSCO), India's regulatory agency for pharmaceuticals, medical devices, and cosmetics, on Wednesday.

"Covishield and Covaxin's status has been upgraded from restricted use in emergency cases to new medication approval with conditions in the adult population, according to the CDSCO. The DCGI (Drugs Controller General of India) will weigh in on the suggestions and make a decision "In a tweet, CDSCO stated. Serum Institute of India and Bharat Biotech, two Indian vaccine manufacturers, had applied to the DCGI for regular market authorization for their respective Covid vaccines.

On October 25, last year, Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute, filed an application with the DCGI. The DCGI had requested further data and documentation from the Pune-based firm, and Singh recently responded with additional data and information.

While seeking normal market authorisation for Covaxin, Hyderabad-based Bharat Biotech presented detailed information on chemistry, manufacturing, and controls, as well as pre-clinical and clinical data.

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