Dr. Reddy’s Laboratories Ltd has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trial for the Sputnik V vaccine in India.

The phase 3 clinical trial of Sputnik V will be conducted on 1,500 subjects as part of the randomized, double blind, parallel group placebo controlled study in India.

G. V. Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the Phase 3 study within this month and will continue to fast track our efforts to bring in a safe and efficacious vaccine for the Indian population.”

In September 2020, Dr. Reddy’s partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the established human adenoviral vector platform. The vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia.

Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.