The Hyderabad-based Dr Reddy’s Laboratories 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, sources said. The Indian pharma giant has collaborated with The Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as its distribution.
Upon regulatory approval in India, RDIF will supply to drugmaker Dr Reddy’s 100 million doses of the vaccine, the firm said last month.
“The 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,” a source told PTI.
Sources said it would be multi-centre, observer-blind, randomised controlled study.
The phase-3 trial of Sputnik V is underway in Russia since September 1 on around 40,000 subjects, they added.
Sputnik V has been developed by Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF.
Currently, two vaccine candidates, 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.