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INDIA

DCGI Approves SII to Manufacture Sputnik V in India

The Drugs Controller General of India (DCGI) has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik V Covid-19 vaccine in India for examination, test, and analysis with certain conditions, official sources said on Friday. The company had submitted an application to the DCGI in this regard on Thursday.
According to the four conditions set by the DCGI, the SII will have to submit a copy of the agreement between them and the 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.


The SII on May 18 had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for import of strains/seed lots and cell banks, and for carrying out research and development, the official sources said. The RCGM has raised some queries over SII’s application and has sought a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology. Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India. The SII plans to seek restricted emergency use permission of the vaccine in India. The SII plans to seek restricted emergency use permission of the vaccine in India.

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