HYDERABAD: Dr Reddy’s Laboratories Ltd on Tuesday said it has received permission from the Drug Controller General of India (DCGI) to import Sputnik vaccine into India for restricted use in emergency situations.
The permission has been granted as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act, it said in a regulatory filing to the bourses.
Commenting on the development, Dr Reddy’s Laboratories co-chairman and managing director GV 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.”
In September 2020, Dr Reddy’s had partnered with the Russian sovereign wealth fund, Russian Direct Investment Fund (RDIF), to conduct the clinical trials of Sputnik V and distribute the vaccine in India.
Dr Reddy’s carried out Phase II/III trials of the vaccine in India on 1,600 volunteers in addition to the larger trials conducted in Russia by RDIF.
Sputnik V, the first Covid-19 vaccine to be registered in the world in August 2020, uses two human adenoviral vectors– adenovirus 26 (Ad26) and adenovirus 5 (Ad5) – that are administered 21 days apart.
The Russian vaccine is now approved for use in 60 countries around the world and ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators, it said.
The vaccine demonstrated an efficacy rate of 91.6% as per interim analysis data of phase III clinical trials, which included 19,866 volunteers in Russia, published in the British medical journal The Lancet.