New Delhi: The Drugs Controller General of India (DCGI) on Friday (June 4) allowed 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 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 Pune-based company had submitted an application to DCGI for the same on Thursday.
The DCGI has also set certain conditions for the vaccine manufacturers to follow.
Firstly, they will have to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for the transfer of cell bank and virus stock.
It will also have to submit a copy of the agreement for technology transfer with Gamaleya.
The Serum Institute will also have to submit a copy of the RCGM permission to import cell bank and virus stock.
Finally, it will have to submit a copy of the RCGM permission to initiate research and development of vaccine Sputnik V.
A three-year license has been granted by the DCGI to the manufacturer.
On May 18, the SII had applied the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology to seek clearance to import strains lots and cell banks, and for carrying out research and development of the vaccine.
Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India.
With inputs from PTI