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Dr. Reddy’s gets USA for Sputnik V | India News


HYDERABAD: Dr Reddy’s Laboratories Ltd said on Tuesday that it received permission from the Controller General of Drugs of India (DCGI) to import Sputnik vaccine into India for restricted use in emergency situations.
The permit was granted in accordance with the provisions of the 2019 New Drugs and Clinical Trials rules under the Drugs and Cosmetics Act, it said in a regulatory filing to the exchanges.
Commenting on the development, Dr Reddy’s Laboratories Co-President and Managing Director GV Prasad said: “We are very pleased to obtain the emergency use authorization for Sputnik V in India. With the increase in cases in India, vaccination is the most effective tool in our battle against COVID-19.
This will allow us to contribute to our nation’s effort to vaccinate 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 Sputnik V clinical trials and distribute the vaccine in India.
Dr. Reddy’s conducted phase II / III trials of the vaccine in India with 1,600 volunteers, in addition to the largest trials conducted in Russia by RDIF.
Sputnik V, the first Covid-19 vaccine registered in the world in August 2020, uses two human adenoviral vectors, Adenovirus 26 (Ad26) and Adenovirus 5 (Ad5), which 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, he said.
The vaccine demonstrated a 91.6% efficacy rate based on data from the interim analysis of phase III clinical trials, which included 19,866 volunteers in Russia, published in the British medical journal The Lancet.

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