Integrated pharmaceutical company Dr. Reddy’s Laboratories has secured Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) to import Russia’s Sputnik V vaccine into India.
India got hold of the required permission as per the provisions of the New Drug and Clinical Trials rules, 2019, under the Drugs and Cosmetics Act.
Dr. Reddy’s had collaborated with the Russian Direct Investment Fund (RDIF) as recently as September 2020 to carry out the clinical trials of Sputnik V and get the vaccine supplied in India.
Apart from the clinical trials that RDIF organised in Russia, Phase II / III clinical trials of the vaccine were conducted in India by Dr. Reddy’s.
Dr Reddy’s Laboratories co-chairman and managing director GV Prasad said: “We are very pleased to obtain the emergency use authorization 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.”
Currently approved for use in 60 countries around the globe, Sputnik V ranks second among the world’s leading coronavirus vaccines, in terms of the number of approvals announced by government regulators.
For Sputnik V’s double-shot course of vaccination, two different vectors are used. An article published in one of the world’s oldest and most respected medical journals, the Lancet, determined the efficacy of Sputnik V to be 91.6%.