The Drugs Controller General of India (DCGI) on Friday granted the Serum Institute of India permission to manufacture Russian Covid-19 vaccine Sputnik V in India.
The Serum Institute of India (SII) has been granted approval to manufacture the vaccine for examination, test and analysis with certain conditions at its licensed facility in Hadapsar, Pune. The SII had submitted an application to the DCGI in this regard on Wednesday.
The Pune-based company has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia to develop Sputnik V in India.
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SII is already producing the Oxford AstraZeneca Covid-19 vaccine under the name ‘Covishield’ and has told the government it will supply 10 crore doses of it in June. The Serum Institute is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the US.
SPUTNIK V IN INDIA
Russia’s Sputnik V was given emergency use authorisation (EUA) by the DCGI in April. After Hetero Biopharma, Gland Pharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech, SII is the sixth pharmaceutical company that will manufacture Sputnik V in India.
Meanwhile, Hyderabad-based Dr Reddy’s Laboratories is in a pact with the Russian Direct Investment Fund to sell the first 250 million imported vials of Sputnik V in India.
The imported doses are priced at Rs 995.40 per dose and Dr Reddy’s has indicated prices would be lower once local supplies begin.
The first lot of Sputnik vaccines made in India received clearance on Tuesday from the Central Drug Laboratory, Kasauli.
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