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DCGI (India) approves Sputnik V COVID 19 vaccine for emergency use in India – Dr Reddy’s Laboratories
Dr. Reddy’s Laboratories Ltd. announced that it 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 Clincial Trials rules, 2019 under the Drugs and Cosmetics Act.
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% as per a published article in the Lancet, one of the world’s oldest and most respected medical journals.