Serum gets DCGI nod to manufacture Sputnik V vaccine

Pune-based Serum Institute of India, led by Adar Poonawalla, will manufacture Russian COVID-19 vaccine Sputnik V. The SII has received preliminary permission from the country’s drugs regulator to make the vaccine.

The institute will test, analyse and then manufacture the vaccine at its Pune plant, sources said. The test licence granted to the institute means it can develop and manufacture the product for testing, but not sell it.

“The DCGI (Drugs Controler General of India) 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 told PTI.

Also read: Sputnik V vaccine rolled out in India, to cost ₹995 per shot

The SII has tied up with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V. The company had submitted an application to the DCGI on Thursday (June 3).

According to the four conditions set by the DCGI, the 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.

The SII has to submit a copy of the Review Committee on Genetic Manipulation (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, PTI quoted sources as saying.

Also read: AstraZeneca to trial COVID vaccine combination with Russia’s Sputnik V

The SII last month had also applied to the RCGM, Department of Biotechnology seeking clearance for import of strains/seed lots and cell banks, and for carrying out research and development.

Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India. The first dose of Sputnik V was administered in Hyderabad on May 14 as part of a soft launch by Dr Reddy’s Labs.

The Russian vaccine is registered for use in over 65 countries, but is yet to be cleared by the EU or US health authorities. At 91.6 per cent, Sputnik V has a higher efficacy compared to the two vaccines that are currently being administered in India — Oxford-AstraZeneca’s Covishield, manufactured by the SII, and Bharat Biotech’s Covaxin.