Health DCGI gives nod to Serum Institute to manufacture Sputnik...

DCGI gives nod to Serum Institute to manufacture Sputnik V COVID-19 vaccine in India

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The Drugs Controller General of India (DGCI) on Friday granted permission to the Serum Institute of India (SII) to manufacture the Russian Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, according to official sources.

Pune-based Serum Institute has partnered with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia for developing the Sputnik V vaccine in India at its licensed facility in Hadapsar.

“The DCGI has granted permission to the Serum Institute to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis at its licensed Hadapsar facility with certain conditions,” an official source said, according to PTI. 

DCGI has set four conditions; as per these SII will have to submit a copy of the agreement between the firm and Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and a copy of the agreement for technology transfer with Gamaleya.

Serum Institute also plans to seek restricted emergency use permission of Sputnik V vaccine in India. Currently, only Dr Reddy’s Laboratories is manufacturing the Sputnik V vaccine in India.

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