New Delhi: Pharma major Dr Reddy’s on Tuesday said it has received regulatory approval for emergency use of Sputnik V, which will be imported from Russia, paving the way for the third COVID vaccine in India.
The Russian Direct Investment Fund said more than 850 million doses of Sputnik V are going to be produced annually in India — the 60th country to approve the vaccine.
The company has received permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations, Dr Reddy’s said in a regulatory filing.
“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 Dr Reddy’s Laboratories Co-chairman and MD GV Prasad.
Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators, Dr Reddy’s said.
In September 2020, the company had partnered with the RDIF to conduct the clinical trials of Sputnik V and distribute the vaccine in India. In addition to the trials conducted in Russia by RDIF. Phase II/III clinical trials of the vaccine were carried out by the company in India, Dr Reddy’s said.
Sputnik will be the third vaccine to be used in India against coronavirus. In January, DCGI had given the emergency use authorisation for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.
RDIF has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech) aimed at production of more than 850 million doses per year, Russia’s sovereign wealth fund said.
“Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production”, RDIF CEO Kirill Dmitriev said.
The Russian vaccine has efficacy of 91.6 per cent and provides full protection against severe cases of COVID-19 as demonstrated by the data published in one of the leading medical journals, The Lancet, he added.
“India is a vaccine-manufacturing hub and our strategic partner for production of Sputnik V. RDIF has created partnerships with a number of India’s leading pharmaceutical companies for production of Sputnik V which will provide for both vaccination of the population in India and global distribution of the Russian vaccine,” Dmitriev said.
The price of the vaccine is less than US$ 10 per shot and it uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots, RDIF said.
The Sputnik V vaccine can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure, it added.
Shares of Dr Reddy’s Laboratories were trading at Rs 4,831.95 per scrip on BSE, down 3.15 per cent from its previous close.
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