Dr. Reddy’s Laboratories based in Hyderabad has applied to the Drugs Controller General of India for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against COVID-19 in India today.
A giant Indian pharma has recently collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as will also be a part of its distribution. According to the regulatory approval in India, RDIF will supply 100 million doses of the vaccine to drugmaker Dr. Reddy’s, firm, as it said last month. The phase-3 trial of Sputnik V is underway in Russia since September 1 on around 40,000 subjects
It has been reported that Dr. Reddy’s Laboratories has applied to the DCGI seeking permission to conduct phase-3 human clinical trials of the Sputnik V vaccine against COVID-19 developed by Russia. The DCGI will carry out a technical evaluation of the application before giving its approval and it would be a multi-center, observer-blind, and randomized controlled study.
Sputnik V has been developed by Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF. Meanwhile, two vaccine candidates are in the queue, the indigenously developed by Bharat Biotech in collaboration with ICMR and the one developed by Zydus Cadila Ltd, are in phase 2 of human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in India.