Serum Institute gets DCGI’s nod to manufacture Covid vaccine Sputnik V in India: Report

Days after applying to the Drug Controller General of India seeking permission to manufacture the Sputnik V coronavirus jab for examination, test and analysis, the Serum Institute of India has been granted permission by the DCGI.

"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 told news agency PTI.

The Pune-based SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility, the report added.  

The company had submitted an application to the DCGI in this regard on Thursday. 

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.

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 sources said.

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

The RCGM has raised some queries over SII's application and has sought a copy of material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology.  

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

The Russian vaccine is to be administered in two dosages at a gap of 21 days according to initial reports. Gamaleya had announced that the two doses of Sputnik V have an efficacy rate of 91%, while the single dose has 79.4% efficacy.

Gamaleya maintains that the vaccine has been approved in over 65 countries till now.

Sputnik V, which was launched in May by DRL is at the time the second most expensive vaccine at ₹948 per dose that goes up to ₹995.40 per dose after adding the 5% GST slab.

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