Dr. Reddy's Asked To Submit Revised Protocol For Sputnik V Vaccine Trials

According to sources, an expert panel at the Central Drugs Standard Control Organisation (CDSCO) has asked Dr. Reddy's Laboratories to submit a revised protocol for conducting phase-2 and phase-3 human clinical trials in India for the Russian Covid-19 vaccine, Sputnik V.

The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine. The Subject Expert Committee (SEC) on Covid-19 at CDSCO, asked the firm to submit a revised protocol stating it will have to conduct phase 2 and phase 3 clinical trials in a combined manner, sources told PTI. "It means that Dr. Reddy's laboratories will have to submit a new application. According to the SEC, they have to conduct both phase-2 and phase-3 clinical trials and cannot directly hold phase-3 trial for the vaccine in India," a source said.

The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V vaccine for Covid-19. Upon regulatory approval in India, RDIF shall supply Dr. Reddy's with, 100 million doses of the vaccine, the firm had announced last month. Meanwhile, phase-3 trials of Sputnik V are currently underway in Russia since September 1 on 40,000 subjects. Sputnik V has been jointly developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF.

Currently two indigenously developed vaccine candidates for Covid-19, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd, are undergoing phase 2 of human clinical trials. Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine is also conducting phase 2 and phase 3 human clinical trials in India.