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Serum Institute bags DCGI nod for Covid vaccine Sputnik V
New Delhi: The DCGI has granted permission to 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 Pune-based 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 Covid-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 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, the 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, the official sources said.
The RCGM has raised some queries over SII's application and has sought a copy of 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 SII plans to seek restricted emergency use permission of the vaccine in India.
serum institute of indiaserum institute of india newsdcgisputnik vrussian covid vaccinecovid-19coronavirusgamaleya research institute of epidemiology and microbiologysii
Source : PTIRuchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
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