The emergency use authorisation from the Drugs Controller General of India (DCGI) for Sputnik V paves the way for import and use of the Russian COVID-19 vaccine in the inoculation programme in the country.
Though on the cards, the timing of EUA assumes significance in the context of reports that stocks of the two approved vaccines are fast running out in many locations across India, amid more people turning eligible and evincing interest in getting the jab. Several State governments had in recent days also appealed to the Centre to replenish the vaccine supplies.
Sputnik V, developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, will join Covishield and the indigenous Covaxin that were approved and used since India launched what arguably is one of the largest inoculation programmes globally in January. Within weeks of Sputnik V becoming the first COVID-19 vaccine to be registered globally, by Russia in August, the Russian Direct Investment Fund announced a partnership with Dr. Reddy’s Laboratories for clinical trials as well as distribution of the first 100 million doses in India.
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Announcing receipt of the EUA, Dr. Reddy’s on April 13 said the development paves the way for import of the vaccine.
“Dr. Reddy’s Laboratories has received permission from the Drugs Controller General of India to import the Sputnik [V] vaccine into India for restricted use in emergency situations as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act,” a statement from the Hyderabad-based drugmaker said. A top level executive of the pharma major had also confirmed, a few months ago, that the vaccine will initially be imported.
Co-chairman and managing director G.V. Prasad said “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.”
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Since announcing its partnership with Dr. Reddy’s in September, the sovereign wealth fund of Russia went ahead and forged manufacturing pacts with five companies to produce an estimated 850 million doses of vaccine based on the human adenoviral vector platform. While Hetero Biopharma, Gland Pharma, Stelis Biopharma, Virchow Biotech and Panacea Biotec are firms with whom it has announced production partnerships, sources say a few more may get added to the list in coming days.
On Sputnik V production process in the country, sources said the process involves the technology transfer, production of batches for approval and on getting the go ahead from the central laboratory seeking manufacturing licence from DCGI. It could take at least a couple of months, with the first Sputnik V produced in India likely to be made available in June.
The Russian vaccine, whose efficacy is pegged at 91.6% as per a publication in The Lancet, has now been approved for use in 60 countries. It uses two different vectors for the two shots in a course of vaccination. According to RDIF, the price of Sputnik V is less than $10 per shot “making it affordable around the world.”