Dr. Reddy's Laboratories Ltd. announced Tuesday that it has been authorized to import Russian-made Covid-19 vaccine Sputnik V into India for restricted emergency use. Sputnik V becomes the third coronavirus vaccine to be approved for use in India, after Covishield and Covaxin.
In a statement, the India-based pharmaceutical company said it received the permission from the Drug Controller General of India or DCGI for the import of Sputnik from Russia as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act.
In September 2020, Dr. Reddy's had partnered with the Russian Direct Investment Fund or 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 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."
Sputnik V is now approved for use in 60 countries around the world. The efficacy of Sputnik V was determined to be 91.6 percent as per a published article in the Lancet.
The RDIF recently signed an agreement with Panacea Biotec to produce 100 million doses per year of Sputnik V vaccine in India.
India reportedly has given more than 100 million doses of its already approved vaccines Covishield and Covaxin to date.
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