The Drug Controller General of India has permitted Serum Institute of India to manufacture the Sputnik V vaccine in India with certain conditions, official sources said on Friday.
The Pune-based vaccine-maker has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, for developing Sputnik V at its licensed Hadapsar facility. “The DCGI has granted permission to the Serum Institute to manufacture Sputnik V in India for examination, test and analysis at its licensed Hadapsar facility with certain conditions,” an official source said.
The company had submitted an application to the DCGI in this regard on Thursday. According to the four conditions set by the DCGI, Serum Institute will have to submit a copy of the agreement between it and the Gamaleya Research Institute for transfer of cell bank and virus stock and a copy of the agreement for technology transfer with Gamaleya. This licence, unless suspended or revoked, will be for three years from June 4.
