The Hyderabad-based Dr Reddy's Laboratories has reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined phases 2 and 3 human clinical trials of the Russian COVID-19 vaccine Sputnik V in India. The firm has now submitted a revised protocol for carrying out the clinical trials, sources said.
The Subject Expert Committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) on October 5 had deliberated on the application put up by the firm and had asked it to re-apply stating it will have to conduct both phases 2 and 3 clinical trials and cannot directly hold phase-3 trial for the vaccine in India. The pharmaceutical company had applied to the DCGI seeking permission to conduct phase 3 human clinical trials of the potential vaccine against the coronavirus infection.
The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution. Upon regulatory approval in India, RDIF shall supply to drug maker Dr Reddy's 100 million doses of the vaccine, the firm had said last month.
According to sources, it would be multi-centre, observer-blind, randomised controlled study. Sources said, meanwhile, the phase-3 trial of Sputnik V is underway in Russia since September 1 on around 40,000 subjects.
Sputnik V, a vaccine against the coronavirus, has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF. Currently two indigenously developed vaccine candidates — one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd– are in the phase 2 of the human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is conducting phases 2 and 3 human clinical trials in India.
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