Dr Reddy’s Laboratories will have to submit a revised protocol for conducting trials for the Russian vaccine against COVID-19, Sputnik V. An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has asked, the company to conduct both phase 2 and phase 3 human clinical trials in India.
The Hyderabad-based pharmaceutical company had on Friday applied to the Drugs Controller General of India for permission to conduct phase-3 clinical trials of the Russian vaccine. In a meeting held on Monday, Subject Expert Committee (SEC) on COVID-19 at the CDSCO, deliberated on the application and asked the firm to resubmit a revised protocol as it was not satisfied with the data of Phase II trials submitted by the company, sources told ET. According to the SEC, Dr Reddy’s will have to conduct both phase-2 and 3 clinical trials and cannot directly hold phase-3 trial for the vaccine in India,” added the source. (Source : economictimes.com)
