Drug major Dr Reddy’s Laboratories on Tuesday said it has received approval from Indian drug regulator for restricted emergency use of COVID-19 vaccine Sputnik in the country.
The company has received the permission from the Drug Controller General of India (DCGI) to import the Sputnik 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, Dr Reddy’s said in a regulatory filing.
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.
Dr Reddy’s Laboratories Co-chairman and managing director GV Prasad said: “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.
Dr Reddy’s said 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.
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