The Pune-based agency has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for growing 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 supply mentioned.
The firm had submitted an software to the DCGI in this regard on Thursday.
According to the 4 conditions set by the DCGI, the Serum Institute can have to submit a replica of the settlement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for switch of cell financial institution and virus inventory and a replica of settlement for expertise switch with Gamaleya.
Further, the SII has to submit a replica of the RCGM permission to import cell financial institution and virus inventory and a replica of the RCGM permission to provoke analysis and improvement of viral vector vaccine Sputnik V, the sources mentioned.
This licence, except suspended or revoked, can be enforced for a interval of three years from the date of its issuance on June 4.
The SII on May 18 had additionally utilized to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology in search of clearance for import of strains/seed heaps and cell banks, and for finishing up analysis and improvement, the official sources mentioned.
The RCGM has raised some queries over SII’s software and has sought a replica of fabric switch settlement between the Pune-based agency and the Gamaleya Research Institute of Epidemiology and Microbiology.
Russia’s Sputnik V vaccine is at present being manufactured by Dr Reddy’s Laboratories in India.
The SII plans to search restricted emergency use permission of the vaccine in India.