The Serum Institute of India on Wednesday sought permission from the Drug Controller General of India to manufacture Russian Covid vaccine Sputnik v locally. The institute has submitted an application for test analysis and examination. Once these permissions are received, an emergency use authorisation (EUA) would be required.
Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories.
Russia’s Covid-19 vaccine Sputnik V is first foreign vaccine to be approved in India after the approval of SII’s Covishield and Bharat Biotech’s Covaxin. With this, the SII will manufacture 2 of 3 Covid vaccines approved by India.
Recently, India received its latest consignment of nearly 3 million doses of the Sputnik V from Russia, making it the third and largest delivery of the imported Covid-19 vaccines. The doses arrived on specially-chartered freighter at Hyderabad Airport in Telangana.
Earlier government sources had said that six lakh imported double-dose of Sputnik-V will be available in May 2021, one crore imported doses in June 2021 and 2.8 crore doses (2.4 Crore imported and 40 Lakh manufactured in India) in July 2021. August 2021 onwards, locally manufactured Sputnik V vaccine will be available in the domestic market and technology-transfer arrangement for manufacturing of Sputnik-V vaccine has been firmed up with six Indian manufacturers, sources added.
Currently, Dr Reddy’s Laboratories has a tie-up with the Russian Direct Investment Fund (RDIF) to make the Sputnik V Covid vaccine in India. Dr Reddy’s received the EUA for Sputnik V in India on April 13 and also permission from DCGI to import the Russian vaccine. The first lot of the vaccines has been imported with three million units arriving in the country on Tuesday.
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SII has committed to make 100 million Covishield vaccines a month from June. It has started manufacturing the Novavax vaccine, in small batches, at its Pune plant, even as it awaits regulatory clearance in the US and subsequently in India.