Dr. Reddy’s Laboratories Ltd has announced that the Drugs Controller General of India (DCGI) has given the company approval to carry out the phase 3 clinical trial for the Sputnik V vaccine in India.

The trial will be conducted on 1500 individuals as part of the randomized, double-blind, parallel-group, placebo-controlled study in the country. The Data and Safety Monitoring Board (DSMB) had earlier reviewed the safety data from the phase 2 clinical trial of the vaccine and had recommended phase 3 recruitment. The DSMB had concluded in its report that there were no safety concerns and the study met the primary end points of safety… (ET Healthworld, January 16, 2021)