NEW DELHI Hyderabad-based Dr. Reddy’s Laboratories applied to India’s Comptroller General of Drugs for permission to conduct phase 3 human clinical trials of Russian Sputnik V vaccine against COVID-19 in India, sources said.
The Indian pharmaceutical giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V, as well as its distribution.
Following regulatory approval in India, RDIF will supply drug maker Dr. Reddy with 100 million doses of the vaccine, the firm said last month.
“Dr. Reddy’s Laboratories has requested permission from DCGI to conduct phase 3 human clinical trials of the Russian-developed Sputnik V vaccine against COVID-19. DCGI will conduct a technical evaluation of the application prior to giving approval.” a source told PTI.
Sources said it would be a multicenter randomized controlled study, blind to the observer.
The phase 3 trial of Sputnik V has been underway in Russia since September 1 on around 40,000 subjects, they added.
Sputnik V has been developed by the Gamaleya National Research Center for Epidemiology and Microbiology and RDIF.
Currently, two candidate vaccines, the one developed indigenously 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 to manufacture the Oxford COVID-19 candidate vaccine, is also conducting Phase 2 and 3 human clinical trials in India.
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