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Serum Institute seeks nod for licence to manufacture Sputnik V in India

Serum Institute seeks nod for licence to manufacture Sputnik V in India

Once the company gets permission, it will have to conduct clinical trials and if successful, the Serum Institute will become the seventh company to manufacture Sputnik V

Pune-based pharma giant, Serum Institute of India (SII) has also sought DCGI's nod for test analysis and examination of Sputnik V Pune-based pharma giant, Serum Institute of India (SII) has also sought DCGI's nod for test analysis and examination of Sputnik V

The Serum Institute of India (SII) has applied for the Drug Controller General of India's (DCGI) approval seeking permission for a test licence to manufacture the Sputnik V COVID-19 vaccine, government sources said on Thursday.

The Pune-based pharma giant has also sought DCGI's nod for test analysis and examination. Once the company gets permission, it will have to conduct clinical trials and if successful, the Serum Institute will become the seventh company to manufacture Sputnik V.

"The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture the Covid-19 vaccine, Sputnik V, in India," PTI quoted a source as saying.

Hyderabad-based Dr Reddy's Laboratories is currently manufacturing Russia's Sputnik V vaccine in the country under a tie-up with the Russian Direct Investment Fund (RDIF).

RDIF has already inked agreements with five leading Indian manufacturers.

The Serum Institute had earlier told the Centre that it will be able to produce and supply 10 crore Covishield doses in June, whereas it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the US.

Russia's Sputnik V was granted EUA (Emergency Use Authorisation) approval by the DCGI in April.

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