SII Sought Permission to Manufacture Sputnik V
NEW DELHI, June 3: The Serum Institute of India (SII) has applied to the Drug Controller General of India (DCGI) seeking permission to manufacture the Sputnik V Coronavirus vaccine for examination, test and analysis at its licensed facility in Pune, official sources said on Thursday.
The Pune-based firm has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow for developing Sputnik V at its Hadapsar facility.
On May 18, the SII had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for the import of strains or seed lots and cell banks and for carrying out research and development, the sources said.
Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India.
“The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture COVID-19 vaccine Sputnik V for examination, test and analysis at its licensed Hadapsar facility,” official sources said.
Once these approvals are received, the SII plans to seek restricted emergency use permission for the vaccine in India.
The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.
The vaccine was given emergency use authorisation (EUA) by the DCGI in April.
(Manas Dasgupta)
