Serum Institute seeks DCGI’S nod to manufacture Sputnik V
The Serum Institute of India (SII) has applied to the Drug Controller General of India (DCGI) seeking permission to manufacture the Sputnik V Covid-19 vaccine for examination, test and analysis at its licensed Hadapsar 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.
The RCGM has raised certain queries over the SII’S application and sought a copy of the material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology.
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,” an official source said.
Once these approvals are received, Serum Institute 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 Drug Controller General of India in April.
A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday.
Meanwhile, on Monday, the Serum institute of India will raise production of the Astrazeneca Covid-19 vaccine to about 90 million doses in June from about 65 million a month now, a company spokesman said.