The Drugs Controller General of India (DGCI) on Friday granted permission to the Serum Institute of India (SII) to manufacture the Russian Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, according to official sources.
Pune-based SII has partnered with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia for developing Sputnik V COVID-19 vaccine in India at its licensed facility in Hadapsar.
"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, according to PTI. Earlier, on Thursday, SII had submitted an application to the drug regulator for this purpose.
DCGI has set four conditions; as per these SII will have to submit a copy of the agreement between the firm and Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and a copy of the 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 licence granted to SII will remain enforced for a period of three years from June 4 onwards unless it is suspended or revoked.
On May 18, SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for importing strains/seed lots and cell banks, and for carrying out research and development, the official sources explained.
Review Committee on Genetic Manipulation (RCGM) has raised some questions regarding SII's application. It has sought a copy of the material transfer agreement between the pharma firm and Gamaleya Research Institute of Epidemiology and Microbiology.
Serum Institute also plans to seek restricted emergency use permission of Sputnik V vaccine in India. Currently, only Dr Reddy's Laboratories is manufacturing the Sputnik V vaccine in India.