Pharma major Dr Reddy’s Laboratories Ltd has been permitted by the Drugs Controller General of India (DCGI) to import the Covid-19 vaccine made by Russia, Sputnik V, into India.
In a release issued on Tuesday Hyderabad-based Dr Reddy’s announced that it had received permission from the DCGI 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.
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“We are very pleased to obtain the emergency use authorisation for Sputnik V in India,” GV Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, said.
“With the rising number of 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,” he added.
In September 2020, Dr Reddy’s had partnered with the Russian Direct Investment Fund (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 Dr Reddy’s in India.
Sputnik V is now approved for use in 60 countries around the world. It ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators. 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 per cent as per a published article in The Lancet, one of the world’s oldest and most respected medical journals.