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

New Delhi: Serum Institute of India (SII) has got approval to manufacture COVID-19 vaccine Sputnik V from Drug Controller General of India (DCGI).

The regulatory body granted SII permission to manufacture test and analysis with certain conditions, PTI said quoting official sources on Friday (June 4).

The development comes a day after the Pune-based firm submitted an application seeking DCGI’s nod.

SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility.

"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 official source was quoted as saying.

According to the four conditions set by the DCGI, SII will have to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and submit the copy of agreement for 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 report said.

Russia's Sputnik V vaccine is currently being manufactured by Dr Reddy's Laboratories in India.

Meanwhile, SII CEO Adar Poonawalla has hailed the efforts of India's Ministry of External Affairs S Jaishankar and the US for lifting restrictions on the manufacturing of COVID-19 vaccine saying that the move will boost the country's vaccine production.

Taking to Twitter, Poonawalla thanked US President Joe Biden and MEA saying, “...this policy change will hopefully increase the supply of raw materials globally and to India; boosting our vaccine production capacity and strengthening our united fight against this pandemic."