The Serum Institute of India has been granted permission by the DCGI to produce the Russian COVID vaccine Sputnik V in India for examination and testing purposes bound by certain regulations. SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology located in Moscow in Russia for Sputnik V’s development at Hadapsar which is its licensed facility.
Sources stated that “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 application was submitted to the DCGI on Thursday for the same.
It has set four conditions that SII will have to abide by. The Serum Institute needs to submit an agreement copy of the one between it and the Gamaleya Research Institute of Epidemiology and Microbiology. This is required to transfer cell bank and virus stock and submit an agreement copy proving 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.
An application was submitted to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology on My 18th by SSI, which sought clearance for importing strains/seed lots and cell banks and conducting R&D.
Meanwhile, RCGM has sought a copy of the medical transfer between SII and Gamaleya to cater for some of its queries.