COVID-19 vaccine: Serum Institute gets DCGI’s nod to manufacture Sputnik V vaccine in India

Serum Institute of India has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Russia for developing the Sputnik V vaccine at its licensed Hadapsar facility.

Created On: Jun 5, 2021 13:37 ISTModified On: Jun 5, 2021 13:37 IST
SII to manufacture Sputnik V Vaccine

The Drugs Controller General of India (DCGI) has given its approval to the Serum Institute of India, Pune to manufacture the Sputnik V COVID-19 vaccine in India for examination, test, and analysis with certain conditions.

The firm based in Pune has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Russia for developing the Sputnik V vaccine at its licensed Hadapsar facility.

The application in this regard was submitted to the Drug Controller General of India by the Serum Institute on June 3, 2021.

Four Conditions set by DCGI:

As per the conditions set by DCGI, the Serum Institute of India will have to submit a copy of the agreement between it and Russia’s Gamaleya Research Institute of Epidemiology and Microbiology for the transfer of cell bank and virus stock.

Serum Institute will have to submit a copy of the agreement for technology transfer with Gamaleya.

The Serum Institute will have to submit a copy of the RCGM (Review Committee on the Genetic Manipulation) permission to import the cell bank and virus stock.

A copy of the RCGM permission will also have to be submitted by SII to initiate the research and the development of the viral vector vaccine Sputnik V.

SII applied to RCGM for clearance:

On May 18, 2021, the Serum Institute of India had applied to the RCGM, Department of Biotechnology to seek clearance for the import of seed/strains lots and cell banks and for carrying out the research and development of the Sputnik vaccine.

Some queries were raised by the Review Committee on the Genetic Manipulation over SII’s application. The Committee had sought a copy of the material transfer agreement between the Indian firm and the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, Russia.

Sputnik V Vaccine in India:

Currently, the Sputnik V COVID-19 vaccine of Russia is being manufactured by Dr Reddy’s Laboratories in India.

The Serum Institute of India also plans to seek the restricted emergency use permission of the Russian vaccine in India.  

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