The Serum Institute of India (SII) has got permission to manufacture Russian Sputnik V Covid vaccine in India. The official sources reported on Friday that the Drugs Controller General of India (DCGI) has given a go-ahead to SII to produce Sputnik V in the country.
The Pune-based firm has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for producing Sputnik V at its licensed Hadapsar facility. An official source said, “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.”
On Thursday, the company had presented an application to the DCGI in this regard. As per the four conditions set by the DCGI, the Serum Institute will have to present 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 a copy of the agreement for technology transfer with Gamaleya.
According to the sources, the SII has to submit a copy of the RCGM agreement 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. On May 18, the SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology inquiring clearance for import of strains/seed lots and cell banks, and for carrying out research and development.
Over SII’s application, the RCGM has raised some queries and has asked for a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology.
Currently, Russia’s Sputnik V vaccine is being manufactured by Dr. Reddy’s Laboratories in India. The SII plans to seek restricted emergency use permission of the vaccine in India.
Post Your Comments