An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has asked Dr Reddy’s Laboratories to submit a revised protocol for conducting both phase-2 and 3 human clinical trials in India for the Russian vaccine, Sputnik V, against COVID-19, sources said.
The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.
The Subject Expert Committee (SEC) on COVID-19 at the CDSCO, which held its meeting on Monday, deliberated on the application and asked the firm to submit a revised protocol stating it will have to conduct combined phase 2 and 3 clinical trials, the sources told PTI.
The firm has been asked to provide some other information as well.
“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 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 as well as for 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 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 also is conducting Phase 2 and 3 human clinical trials of the candidate in India.