DCGI gives nod to clinical trials of Russia’s coronavirus vaccine Sputnik V
LOGODrugs Controller General of India, DCGI has allowed Dr. Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) to conduct phase 2 and 3 clinical human trials of Sputnik 5 COVID vaccine in the country.
Sputnik 5 Vaccine has been developed in Russia where it has also undergone phase 1 and 2 clinical trials. The clinical trial in India will be a multi-center and randomised controlled study which will primarily focus on safety and immunogenicity study.
Earlier last month, Dr. Reddy’s and RDIF entered into partnership to conduct clinical trials of Sputnik 5 vaccine and its distribution in the country.
The vaccine is currently undergoing phase 3 clinical trials in Russia along with simultaneous trails in UAE.