The DCGI has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik C-19 vaccine in India for examination, test and analysis with certain conditions, official sources said.
The firm has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility.
“The DCGI has granted permission to the Serum Institute to manufacture the Sputnik C-19 vaccine 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, the Serum Institute will have to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and submit the 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, sources said.
The SII on May 18 had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for import of strains/seed lots and cell banks, and for carrying out research and development, informed official sources.
The RCGM has raised some queries over SII’s application and has sought a copy of the material transfer agreement between the firm and the Gamaleya Research Institute of Epidemiology and Microbiology.
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