Serum Institute Gets DCGI's Nod To Manufacture Russia's Covid Vaccine Sputnik V In India

The drug controller has allowed SII to manufacture Sputnik-V jabs jab for examination, test and analysis. 

(File Photos/ AFP)

New Delhi: The Drugs Controller General of India (DCGI) on Friday granted permission to Serum Institute of India (SII) to manufacture Russian Covid-19 vaccine - Sputnik V in India. 

The drug controller has allowed SII to manufacture Sputnik-V jabs jab for examination, test and analysis. 

"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 told news agency PTI.

According to reports, 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 approval came a day after Serum Institute applied for the same on Thursday.

However, before starting the manufacture of vaccines, DCGI has set four conditions for Serum in this regards. The pharma giant 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 agreement for technology transfer with Gamaleya.

Additionally, SII will also have 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.

Sources close to the development said this licence granted to SII, unless suspended or revoked, will be enforced for a period of three years from the date of its issuance on June 4.

Russia's Sputnik V vaccine is currently being manufactured by Dr Reddy's Laboratories in India. The SII also plans to seek restricted emergency use permission of the vaccine in India.