Serum Institute of India seeks DCGI's nod to manufacture Russian COVID-19 vaccine Sputnik V

SII has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, for developing Sputnik V at its Hadapsar, Pune, facility.
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The Serum Institute of India (SII) has applied to the Drug Controller General of India (DCGI), seeking permission to manufacture the Sputnik V COVID-19 vaccine for examination, test, and analysis at its licensed Hadapsar facility in Pune, official sources said on Thursday.

The Pune-based vaccine manufacturer has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, for developing Sputnik V at its Hadapsar facility.

On May 18, the SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology, seeking clearance for the import of strains or seed lots and cell banks for carrying out research and development, sources said.

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The RCGM has raised certain queries over the SII's application and sought a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology.

Once these approvals are received, the SII plans to seek restricted emergency use permission for the vaccine in India.

At present, Dr Reddy's Laboratories is manufacturing Russia's Sputnik V vaccine in India.

The SII has already told the Indian government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.

The vaccine was given emergency use authorisation (EUA) by the DCGI in April.

A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday.

(Disclaimer: Additional background information has been added to this PTI copy for context)

Edited by Suman Singh

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