Pune-based Serum Institute of India has got a preliminary approval of the country's drugs regulator to manufacture Russia’s Sputnik V COVID-19 vaccine.
The Serum Institute has been given a test licence Drug Controller General of India (DCGI) which allows it to develop and manufacture the product for testing, but it cannot sell it.
"We have got preliminary approval for Sputnik V. But actual manufacturing will take several months. In the meantime, our focus remains Covishield and Covovax," Serum Institute of India's (SII) spokesperson said.
Also read: India in talks with US giants Pfizer, Moderna, J&J to explore local production of vaccines
The company is currently manufacturing around 70 million doses of the AstraZeneca-Oxford COVID vaccine under the Covishield brand which has been the mainstay of India’s inoculation campaign. The Serum Institute has also told the government that it will be able to manufacture and supply 100 million Covishield doses in June.
SII also has also signed a collaboration agreement with US pharma giant Novavax for producing its vaccine and marketing the shots once they are approved for use. This vaccine will be branded as Covavax.
Dr Reddy's Laboratories and five other Indian pharma firms also have a tie- up to produce Sputnik V vaccine which is being imported into India and is the third vaccine being used in the country’s inoculation campaign along with Covishield and Bharat Bitotech’s Covaxin.
Also read: Serum Institute of India too seeks nod to produce Russia’s Sputnik V vaccine
Sputnik V has already been soft launched in India, with the first dose administered in Hyderabad on May 14 by Dr Reddy’s Laboratories which was the first Indian company to tie up with the Russian Direct Investment Fund (RDIF), which markets the shot internationally. Dr Reddy’s Labs will start manufacturing the vaccine from next month.
The vaccine is priced at ₹995.40 per shot in the market, but the price is expected to come down once local production starts.
The Russian Direct Investment Fund (RDIF) has already signed deals with five Indian companies to produce 750 million doses a year of Sputnik V in India.
Indian biotech firm Panacea Biotec Ltd began production of Sputnik V vaccine in the last week of May, the Russian Direct Investment Fund (RDIF), which markets the shot internationally, had said.
The first batch of doses made by the Indian company will be shipped to Gamaleya, the Moscow institute which developed the vaccine, for quality controls, RDIF said in a statement.
Full-scale production is expected to begin this summer, RDIF added. Panacea Biotec plans to produce 100 million doses of Sputnik V annually, RDIF had said in April.
The Sputnik V Covid-19 vaccine was first approved in Russia on August 11 last year. With an efficacy of 91.6%, as published in the Lancet Medical Journal, the vaccine has been cleared and approved for mass use in more than 50 countries.
