Panel urges granting Dr Reddy's permission for Russia vaccine phase 2 trial

The SEC had on October 5 asked the firm to re-apply stating it will have to conduct both phase 2 and 3 clinical trials and cannot directly hold phase 3 trial for the vaccine in India

An expert panel at the Central Drugs Standard Control Organisation(CDSCO) on Friday recommended granting permission to Dr Reddy's Laboratories for conducting phase 2 clinical trials of the Russian Covid-19 vaccine, Sputnik V, in India, sources said.

The Hyderabad-based pharmaceutical firm had on October 13 reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country.

In its revised protocol, firm stated that the phase 2 trial would include 100 subjects, while the phase 3 would involve 1,400 volunteers, the sources said.

The subject expert committee (SEC) on