New Delhi, October 18 : The Drug Control General of India has granted approval to Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Ltd to conduct late-stage clinical trials of the Russian Covid-19 vaccine, Sputnik V, in India, the sovereign wealth fund said on Saturday.
The DGCI had earlier put a stop on Dr Reddy’s Laboratories conducting clinical trials for the Russian coronavirus vaccine Sputnik V. According to Reuters, the drug regulator had said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated.
On October 13, the Hyderabad-based pharmaceutical firm had reapplied to the Indian drug regulator seeking permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country, according to news agency PTI.
Now, following a new agreement, India will carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF was quoted by Reuters as saying.
Under the deal, Dr Reddy’s will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr Reddy’s.
Sputnik V, a vaccine against the novel coronavirus, has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and the RDIF.
Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates.
According to Reuters, RDIF, which is marketing the vaccine abroad, has reached agreements with Indian manufacturers to produce 300 million doses of the shot.
A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.
Interim results are expected to be published in early November.
Drug regulators in India have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.
Russia has also reached an agreement with the biotechnology department of India’s Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, Reuters quoted the source as saying.
Currently, two indigenously developed vaccine candidates, one by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and another one by Zydus Cadila Ltd are in the phase 2 of the human clinical trials.
Pune-based Serum Institute of India (SII), 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.
(With inputs from PTI and Reuters/India Today)
