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NEW DELHI: The Drugs Controller General of India V.G. Somani late on Monday gave emergency use license to Covid-19 vaccine Sputnik V, the Russian Direct Investment Fund said in a statement early Tuesday. The decision came hours after an expert panel recommended emergency licensure to the vaccine.

Sputnik V is now the third vaccine to get an emergency authorisation in India after Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.

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The vaccine has been registered in India under the emergency use authorisation procedure based on results of clinical trials in Russia, interim analysis of which an efficacy of 91.6%, as well as data from RDIF's Indian partner Dr Reddy's additional phase 2 and 3 clinical trials in India.

“We appreciate the decision of India’s regulatory bodies to grant authorization for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production," said RDIF CEO Kirill Dmitriev.

For RDIF, the global commercialising partner for the Sputnik V, India is the 60th country to give emergency authorisation to the vaccine. Securing regulatory authorisation in India is also significant because it is the biggest manufacturing hub for the vaccine.

While Dr Reddy’s Laboratories is expected to distribute up to 250 million doses of the vaccine in India, RDIF also has manufacturing agreements with Gland Pharma, Hetero Biopharma, Stelis Biopharma, Virchow Biotech and Panacea Biotec to produce more than 850 million doses of Sputnik V in the country for the world.

However, production is likely to be delayed as Hetero Biopharma, which was expected to start production at the beginning of 2021 is yet to do so, while Panacea Biotec is likely to start manufacturing only as early as next month.

The remaining manufacturing partners are likely to start production anytime by September. Dr Reddy's will be importing vaccines initially to meet India's demand.

Also prices of the vaccine are being negotiated between the Indian government and companies, with RDIF earlier announcing that Sputnik V will be prices at lower than $10 ( 750) per dose.

The development comes at a time when some states are facing shortages of Covishield and Covaxin and Covid-19 cases are surging amid a second wave. Both Serum Institute and Bharat Biotech, however, are struggling to expand capacity and have sought government aid for it.

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