Covid-19 vaccine Sputnik V gets DCGI nod; may be available by May

Russian Covid-19 vaccine granted restricted emergency-use authorisation in India

Sputnik V, the Russian Covid-19 vaccine with close to 92 per cent efficacy, is likely to be available in India by the first half of May.

Speaking to reporters, Kirill Dmitriev, chief executive officer (CEO) of the Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund working with Indian manufacturers to bring Sputnik V here, said “we believe by the end of April or first part of May Sputnik V will be available in some quantities here”.

He said the ramp-up at Indian manufacturing sites would take a couple of months to reach peak capacity and by the end of July, it was expected “tens of millions of doses” of Sputnik V would be available in India.

Calling Sputnik V an “Indian-Russian vaccine”, Dimitriev said they had been working with Indian players and expected the production of Sputnik V to be more than 500 million doses or so per year. “We have partnerships with five companies here and we are looking for more,” Dimitriev added.

Sputnik V is likely to have two different prices -- one for the Indian government’s procurement and one for private or commercial sales.

“It is one of the most affordable vaccines globally. Over the next two weeks, we will have discussion with the Indian government on pricing,” he added. “In any country that we have been to, we do say that we want to be 25-30 per cent of the market. Each country should have a portfolio of Covid-19 vaccines,” the RDIF CEO pointed out.

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India’s drug regulator approved Sputnik V for “restricted use in emergency situations” in India a day after the expert panel gave its clearance. Hyderabad-based Dr Reddy’s Laboratories (DRL) has collaborated with the Russian health ministry for obtaining regulatory approval for importing the vaccine here in India. 

The Subject Expert Committee (SEC) had given its nod on Monday.

DRL has collaborated with the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation for obtaining regulatory approval for import for marketing in India.

The vaccine prevents Covid-19 in individuals of over 18. It should be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days, and has to be stored at -18°C. The vaccine comprises two components I & II, which are not interchangeable.

“After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). DRL will import the vaccine for use in the country,” the Union health ministry said.