Serum Institute gets DCGI's nod to manufacture Sputnik V in India for test, analysis

Serum Institute gets DCGI's nod to manufacture Sputnik V in India for test, analysis

• By Staff Writer

Serum Institute gets DCGI's nod to manufacture Sputnik V in India for test, analysis

The Pune-based firm has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility.

The company had submitted an application to the DCGI in this regard on Thursday.

According to the four conditions set by the DCGI, the Serum Institute will have to submit a copy of the agreement between it 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.

Further, the SII has to submit a copy of the RCGM permission to import cell bank and virus stock and a copy of the RCGM permission to initiate research and improvement of viral vector vaccine Sputnik V, the sources said.

This licence, unless suspended or revoked, will be enforced for a period of three years from the date of its issuance on June 4.

The SII on May 18 had likewise applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology looking for leeway for import of strains/seed parts and cell banks, and for completing innovative work, the authority sources said. 

The RCGM has increased a few questions over SII's application and has looked for a duplicate of the material exchange understanding 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.

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