Dr Reddy’s Reapplies to DCGI for Conducting Phases 2, 3 Clinical Trials of Russian Covid-19 Vaccine

The Hyderabad-based Dr Reddy’s Laboratories has reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined phases 2 and 3 human clinical trials of the Russian COVID-19 vaccine Sputnik V in India. The firm has now submitted a revised protocol for carrying out the clinical trials, sources said.

The Subject Expert Committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) on October 5 had deliberated on the application put up by the firm and had asked it to re-apply stating it will have to conduct both phases 2 and 3 clinical trials and cannot directly hold phase-3 trial for the vaccine in India. The pharmaceutical company had applied to the DCGI seeking permission to conduct phase 3 human clinical trials of the potential vaccine against the coronavirus infection.