Serum seeks DCGI nod to manufacture Sputnik V in India
The Serum Institute of India (SII) has applied to the Drug Controller General of India (DCGI) seeking permission to manufacture Covid-19 vaccine Sputnik V in the country, sources said on Thursday.
The Pune-based firm has also sought approval for test analysis and examination.
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
"The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture the Covid-19 vaccine, Sputnik V, in India," a source said.
The SII has already told the 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.
The vaccine was given emergency use authorisation (EUA) by the DCGI in April.
A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday.
Dr Reddy's Laboratories is currently in a pact with Russian Direct Investment Fund to sell the first 125 million people doses (250 million vials) of Sputnik V in India.
Dr Reddy's Laboratories has received approval from the Indian drug regulator for restricted emergency use of Sputnik V.
Dr Reddys, which had earlier received over two lakh vaccines from RDIF, recently soft-launched Sputnik V and tied up with Apollo Hospitals for piloting the vaccine.