SII to manufacture Sputnik V in India

New Delhi: Official sources on Friday stated that the DCGI has given approval to the Serum Institute of India (SII) to produce Sputnik V in India for the purpose of examination, test, and analysis with particular conditions.

For the manufacture of Sputnik V at the Hadapsar facility, this firm in Pune has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow.

An official stated, “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.”

On Thursday, the company has submitted an application in this matter to DCGI.

As per the four requirements that the DCGI has presented forward, the Serum Institute is required to submit a copy of the agreement made between the company and the Gamaleya Research Institute of Epidemiology and Microbiology for transferring cell bank and virus stock and submitting the copy of the agreement for technology transfer with Gamaleya.

Moreover, the SII needs to submit a copy of the RCGM permission for the import of cell bank and virus stock and to initiate research and development of viral vector vaccine Sputnik V, according to the sources.

On May 18, the SII has applied to Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology for the clearance of import of strains or seed lots and cell banks and also for pursuing research and development, the official sources stated.

The RCGM has found out some issues with the application of SII and asked for a copy of the material transfer agreement between the firm from Pune and the Gamaleya Research Institute of Epidemiology and Microbiology.

Presently, Dr. Reddy’s Laboratories is manufacturing Sputnik V of Russia in India.

The SII is deciding to grant emergency use permission to the vaccine in India.