India: Dr Reddy's Lab Gets DCGI Approval For Sputnik V Vaccine

On Saturday, Dr. Reddy's Laboratories Limited and the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, announced that they had obtained Drug Control General of India (DCGI) permission to perform late-stage clinical trials in India for the Sputnik V vaccine.

On October 13, according to the news agency, the Hyderabad-based pharmaceutical company sought permission from the Indian drug regulator to perform combined phase 2 and 3 human clinical trials of the vaccine in the region.

India will now perform an adaptive phase II and III human clinical trial involving 1,500 participants under a new agreement, RDIF, which is marketing the vaccine abroad.

Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates are also being performed by Russia, the first country to offer regulatory approval for a novel coronavirus vaccine. RDIF has signed agreements to produce 300 million doses of the shot with Indian manufacturers.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories, said “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic."

Dr. Reddy's will carry out clinical trials and distribute the completed vaccine in India. Dr Reddy's will be supplied with 100 million doses by RDIF. A Phase III study involving 40,000 participants is currently underway in Moscow, with the first dose of the two-shot vaccine having already been received by 16,000 people. It is expected that the interim results will be released early in November.

Two indigenous vaccine candidates, one from Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and another from Zydus Cadila Ltd, are currently undergoing phase 2 human clinical trials.