Sputnik V import: India in price talks, DRL to import initial doses after regulatory nod

The government is negotiating the price at which it will procure imported doses of Russia’s Covid-19 vaccine Sputnik V, which is at an advanced stage of the regulatory approval process in India.

Dr Reddy’s Laboratories has a tie-up with the Russian Direct Investment Fund (RDIF), which backed the development of Sputnik V, and will import the initial doses of the vaccine once it gets approval from the drug regulator. Subsequent doses of the vaccine will be manufactured in India.

The government procures the Covishield vaccine from Serum Institute of India and Covaxin from Bharat Biotech at ₹150 per dose.


RDIF and Dr Reddy’s said in September that they will cooperate on clinical trials and the supply of 100 million doses of Sputnik V vaccine to India.

‘Local Manufacturers to Come into Play Later’
While Dr Reddy’s will market the vaccine in India, RDIF has tied up with other Indian companies to produce 850 million doses of Sputnik V in the country every year. The first partnership was with Hetero Biopharma in November and collaborations with Gland Pharma, Stelis Biopharma and Vichrow Biotech were announced last month.

“In the initial days, the plan is to import the product from Russia by Dr Reddy’s, depending on what quantities they can get into the country. Then Indian manufacturers will come into play, manufacture it and provide it to Dr Reddy’s for marketing,” said an industry executive.

Prices of Sputnik V are expected to drop when local production starts.

“The local manufacturers will be able to scale it up. The combined capacities of those manufacturing Sputnik V will be much larger than that of any of the vaccine manufacturers in India,” the government official said.

However, local manufacturers may have to carry out bridging trials before the vaccine can be approved for use in India. A bridging trial is a study conducted in a new region or country that builds on clinical data from another region.

“The bridging trials are mandatory under the law and so far such trials have not been waived… We will have to see if the regulator makes some changes like allowing a common trial,” a company executive said on the condition of anonymity.

Dr Reddy’s has conducted a bridging trial involving about 1,500 participants to check the safety and immunogenicity of the Sputnik V vaccines that will be imported.

Sputnik V’s efficacy is confirmed at 91.6% and it is one of three vaccines with an efficacy of over 90%. It was the first Covid-19 vaccine to be registered globally and has been approved for use in 55 countries. The vaccine was developed by the Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow with backing from RDIF, Russia’s sovereign wealth fund.