Serum Institute Of India Seeks DCGI’s Permission To Manufacture Sputnik V In India

Pune, 3rd June 2021: The Serum Institute of India (SII) has sought the permission of The Drug Controller General of India (DCGI) to start manufacturing the Russian vaccine Sputnik V in India. Currently, the vaccine is being manufactured by Dr Reddy’s Laboratories.

SII has sought the DCGI’s permission to manufacture as well as for test analysis and examination of the vaccine. If permission is granted, an emergency use authorization (EUA) will be required. The Serum institute plans to manufacture 100 million doses of Covisheild vaccines by the end of June and has also been manufacturing the Novavax vaccine whose regulatory clearance is still awaited from the US.

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India has been using Covisheild manufactured by SII and Covaxin by Bharat Biotech for its vaccination drive. Amidst the vaccine crunch, there have been ongoing discussions to provide legal protection to foreign vaccine manufacturers like Moderna and Pfizer over their vaccine jabs in India. The SII has also sought legal protection against the liabilities.

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According to news agencies, all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted the same and not just the Serum Institute of India. Its CEO Adar Poonawalla has been actively advocating for the indemnity for all vaccine manufacturers, to exempt them from legal claims if there were any adverse effects from the vaccine

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