Serum Institute of India has got Drug Controller General of India's green signal to manufacture Russia's Sputnik V Covid-19 vaccine in the country for examination, test and analysis with certain conditions, official sources said today.
Sputnik V vaccine, the third vaccine to be added to India's inoculation campaign after Covishield and Covaxin, is currently being manufactured in India by Dr Reddy''s Laboratories.
"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," the sources said.
"The Serum Institute of India put up an application to the Drugs Controller General of India on Wednesday seeking permission for a test licence to manufacture the Covid-19 vaccine, Sputnik V, in India," they said.
Pune-based SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, to develop Sputnik V.
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.
SII is producing Oxford-AstraZeneca's Covid-19 vaccine, Covishield, which is the mainstay of India's vaccination drive launched on January 16.
The SII has already told the Indian government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.
Sputnik V is to be administered in two doses at a gap of 21 days according to initial reports. Gamaleya had announced that the two doses of the vaccine have an efficacy rate of 91 per cent.
Gamaleya maintains the vaccine has been approved in over 65 countries so far.