DCGI grants permit to SII for mfg of Sputnik V

Serum Institute of India

The Drugs Controller General of India (DCGI) on Friday granted the Serum Institute of India permission to manufacture Russian Covid-19 vaccine Sputnik V in India.

The Serum Institute of India (SII) has been granted approval to manufacture the vaccine for examination, test and analysis with certain conditions at its licensed facility in Hadapsar, Pune. The SII had submitted an application to the DCGI in this regard on Wednesday.

The Pune-based company has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia to develop Sputnik V in India.

SII is already producing the Oxford AstraZeneca Covid-19 vaccine under the name ‘Covishield’ and has told the government it will supply 10 crore doses of it in June. The Serum Institute is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the US.

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