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DCGI allows SII to manufacture Sputnik V vaccine in India

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eMediNexus    05 June 2021

The Serum Institute of India (SII) has received permission from the Drugs Controller General of India (DCGI) to manufacture the COVID-19 vaccine Sputnik V in India for examination, test and analysis under certain conditions, revealed official sources.

SII is working with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow to develop Sputnik V at its Hadapsar facility. The DCGI has set four conditions which include that the Serum Institute is required to submit a copy of its agreement with the Gamaleya Research Institute of Epidemiology and Microbiology on the transfer of cell bank and virus stock. The company also has to submit the copy of agreement for technology transfer with Gamaleya. The SII is also required to submit a copy of the Review Committee on Genetic Manipulation (RCGM) permission for import of cell bank and virus stock as well as a copy of the RCGM permission for research and development of Sputnik Vvaccine… (ET Healthworld – PTI, June 5, 2021)

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