The drugs controller general of India (DCGI), VG Somani, on Tuesday approved the Covid-19 vaccine developed by Russia’s Gamaleya Research Institute, Sputnik V, for emergency use in India, a day after the regulator’s subject expert committee (SEC) recommended that there was enough data to grant the vaccine emergency use authorisation.
India is the 60th country to approve the vaccine.
The vaccine will initially be imported and marketed by Dr Reddy’s Laboratories, a process that is expected to start within weeks. The first local supplies are expected by July. The imports, it is expected, will strengthen India’s supply pipeline.
During the weekly Covid-19 briefing on Tuesday, Dr VK Paul, member (health), Niti Aayog, said the approval for Sputnik V was a significant step. “This vaccine approval has been a result of a collaborative effort between the two governments, and is a significant step,” he said.
Union health secretary Rajesh Bhushan said it was too early to comment on procurement, distribution and pricing. HT learns that Dr Reddy’s will start suppling imported Sputnik doses to the government by April-end.
“We are looking at producing 50 million doses or more a month of Sputnik V by this summer, or end of summer, in India. India has a significant production capacity; we have already announced tie ups with five local companies for mass production of Sputnik V, and we intend to have several more tie-ups that will announce soon,” said Kirill Dmitriev, CEO, Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund that is marketing the vaccine globally.
{{/usCountry}}“We are looking at producing 50 million doses or more a month of Sputnik V by this summer, or end of summer, in India. India has a significant production capacity; we have already announced tie ups with five local companies for mass production of Sputnik V, and we intend to have several more tie-ups that will announce soon,” said Kirill Dmitriev, CEO, Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund that is marketing the vaccine globally.
{{/usCountry}}Dr Reddy’s, which is conducting clinical trials in India on behalf of the makers of Sputnik V and has the distribution right for the vaccine in India, released a statement on Tuesday stating that it has received the national regulator’s emergency use approval.
“We are very pleased to obtain the emergency use authorisation for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population,” said GV Prasad, managing director and co-chairman, Dr Reddy’s.
In September 2020, Dr Reddy’s partnered with RDIF to conduct the bridging trial of Sputnik V and distribute the vaccine in India. Sputnik V uses two different vectors for the two shots in a course of vaccination. The efficacy of Sputnik V was determined to be 91.6%, as per a published article in the Lancet.