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DCGI approves Russian vaccine Sputnik V for emergency use in India

Our Bureau New Delhi | Updated on April 13, 2021

Decision comes at a time when India recorded the highest surge in Covid-19 cases at 1,68,912 on Monday

Amid a sharp rise in coronavirus cases, Russian vaccine Sputnik V has received approval from the Drugs Controller General of India for emergency use. This is the third vaccine against the novel coronavirus, after Covishield of Serum Institute of India and Covaxin of Bharat Biotech, which got the nod from the drug regulator. With this, India has also become the 60th country to approve the vaccine.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended the vaccine on Monday that uses the adenovirus platform, very similar to that used by Covishield, a week after seeking additional data from Dr Reddy’s Laboratories. Dr Reddy’s is carrying out the bridge Phase 2/3 trials for Russian Direct Investment Fund (RDIF), which is the force behind Sputnik V. Dr Reddy’s will also be marketing the vaccine in India.

Also read: Dr Reddy's gets DCGI nod for Covid vaccine Sputnik for restricted emergency use

Sputnik V vaccine will be manufactured by six Indian pharma companies under licence from RDIF. These are Dr Reddy’s Labs, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech. The decision comes at a time when India recorded the highest surge in Covid-19 cases at 1,68,912 on Monday.

“The Russian vaccine has efficacy of 91.6 per cent and provides full protection against severe cases of Covid-19 as demonstrated by the data published in one of the leading medical journals, The Lancet,” Kirill Dmitriev, CEO of the RDIF, was quoted as saying in a statement

He further added that RDIF has created partnerships with a number of leading pharmaceutical companies in India for production of Sputnik V, which will provide for both vaccination of the population in India as well as global distribution of the Russian vaccine. Over 850 million doses of Sputnik V will be produced in India annually, sufficient to vaccinate more than 425 million people around the world.

Published on April 13, 2021

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