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Friday, June 18, 2021

Serum Institute of India seeks DCGI’s nod to manufacture Covid vaccine Sputnik V

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

By: PTI | New Delhi |
Updated: June 3, 2021 5:04:13 pm
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 development of viral vector vaccine Sputnik V, the sources said. (Photo: Reuters/Representational)

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 firm 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 and for carrying out research and development, the sources said.

TheGM 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.

Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India.

“The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture COVID-19 vaccine Sputnik V for examination, test and analysis at its licensed Hadapsar facility,” an official source said.

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

The SII has already told the 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.

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