Serum Institute of India prepares for the manufacturing of Sputnik V vaccines in India

The Serum Institute of India(SII) has received a green signal from the Drugs Controller General of India(DGCI)to manufacture the Sputnik V Covid-19 vaccine in India.

An official on Friday informed that the vaccine would be manufactured for examination, test and analysis with certain conditions.

There has been a collaboration between the Gamaleya Research Institute of Epidemiology and Microbiology in Russia and the Pune-based firm for developing this vaccine at its licensed Hadapsar facility.

The four conditions set by the DGCI required the Serum Institute to submit a copy of the agreement made between the Serum Institute and the Gamaleya Research Institute of Epidemiology and Microbiology to transfer of cell bank along with the virus stock.

In the next phase, to import cell bank and virus stock, the SII will have to submit a copy of RCGM permission. Another copy of RCGM permission will be necessary for initiating research and development of the viral vector vaccine Sputnik V.

The manufacturing license will be effective for a time span of 3 years from June 4 unless suspended or revoked mid-term.

To carry out research SII applied to the Review Committee on Genetic Manipulation Department of Biotechnology on May 18 to request strains/seed lots and cell banks.

Originally from Russia, this vaccine is being manufactured in India by Dr Reddy's laboratories.

Restricted emergency use permission of the vaccine in India will also be requested by the SII.