The Drugs Controller General of India (DCGI) has granted permission to vaccine manufacturer Serum Institute of India (SII) to manufacture Russian Sputnik V Covid vaccine in India.
As per reports, the Pune-based company has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia to develop Sputnik V in the country.
SII has been permitted to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis at its licensed Hadapsar facility with certain conditions.
The company had submitted an application to the DCGI in this regard on Thursday.
According to the four conditions set by the DCGI, the Serum Institute 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 company 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 SII on May 18 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 Direct Investment Fund (RDIF), or Russia’s sovereign wealth fund, had earlier tied up with Indian pharmaceutical firms such as Gland Pharma, Hetero Biopharma, Panacea Biotec, StelisBiopharma and Virchow Biotech to make more than 850 million doses a year.
Sputnik V has been granted approval for emergency use by India’s drug controller.
The Russian vaccine was registered in India under the emergency use authorisation procedure on April 12 and use of the Russian vaccine started on May 14.
RDIF and Panacea Biotech have agreed to produce 100 million doses a year of Sputnik V.
Sputnik V has so far been registered in 66 countries with a total population of more than 3.2 billion.
RDIF and Gamaleya Center have said the efficacy of Sputnik V is 97.6 per cent, based on analysis of data on coronavirus infection rate among those vaccinated in Russia with both doses of Sputnik V from December 5 last year to March 31 this year.