The Drugs Controller General of India (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 Review Committee on Genetic Manipulation (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.
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 also applied to the 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.
