Serum Institute Seeks DCGI’s Nod to Manufacture Russian Vaccine Sputnik V in India


After Oxford-AstraZeneca’s Covishield vaccine and Novovax’s Covovax, the Serum Institute of India on Wednesday has applied to get a nod from the Drug Controller General of India (DCGI) to make the Sputnik V Covid-19 vaccine in India. Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories.

The SII has sought the DCGI’s permission for test analysis and examination. In case, it receives a go-ahead, an emergency use authorisation (EUA) would be required, the Financial Express reported.

The Serum Institute plans to manufacture 100 million Covishield vaccines a month from June. Meanwhile, the SII is making Novavax vaccine, but its regulatory clearance from US is awaited.

Recently, India received its latest consignment of nearly 3 million doses of the Sputnik V from Russia, making it the third and largest delivery of the imported Covid-19 vaccines. The doses arrived on specially-chartered freighter at Hyderabad Airport in Telangana.

A report in The Times of India quoted its sources as saying that the consignment of nearly 3 million doses as well as bulk substance that is meant for fill-finish at Panacea Biotec.

The shipment of 56.5 MT, which arrived on a specially chartered freighter RU-9450 and touched down at 3.43am at Hyderabad airport, is also the largest import consignment of vaccines to be handled in India till date, GMR Hyderabad Air Cargo (GHAC) was quoted as saying.

Earlier government sources had said that six lakh imported double-dose of Sputnik-V will be available in May 2021, one crore imported doses in June 2021 and 2.8 crore doses (2.4 Crore imported and 40 Lakh manufactured in India) in July 2021. August 2021 onwards, locally manufactured Sputnik V vaccine will be available in the domestic market and technology-transfer arrangement for manufacturing of Sputnik-V vaccine has been firmed up with six Indian manufacturers, sources added.

Dr Reddy’s Laboratories Ltd had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly called Sputnik-V, developed by Gamaleya Institute, Russia for Emergency Use Authorization. The Gam-COVID-Vac combined vector vaccine (Component I and Component II) has been developed by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and is approved in 30 countries across the world.

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