DCGI grants permission to Serum Institute to manufacture Sputnik V in India


File photo of Sputnik V vaccine | Photographer: Andrey Rudakov | Bloomberg


Text Size:

New Delhi: The DCGI has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, official sources said on Friday.

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 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.

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 submit the copy of 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 development of viral vector vaccine Sputnik V, the sources said.

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 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.


Also read: ‘Vaccine tourism’ resurfaces after Indians scramble to book Moscow trip for Sputnik jabs


 

Subscribe to our channels on YouTube & Telegram

Why news media is in crisis & How you can fix it

India needs free, fair, non-hyphenated and questioning journalism even more as it faces multiple crises.

But the news media is in a crisis of its own. There have been brutal layoffs and pay-cuts. The best of journalism is shrinking, yielding to crude prime-time spectacle.

ThePrint has the finest young reporters, columnists and editors working for it. Sustaining journalism of this quality needs smart and thinking people like you to pay for it. Whether you live in India or overseas, you can do it here.

Support Our Journalism