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DGCI Green Signal to Dr Reddy’s for Clinical Trial of Sputnik V

DGCI Green Signal to Dr Reddy’s for Clinical Trial of Sputnik V


NEW DELHI, Oct 17: India can hope to get an early Corona vaccine with the Drug Controller General of India finally giving the nod to Dr Reddy’s Laboratories to conduct phase 2/3 clinical human trial of Sputnik V, the Covid-19 vaccine that makes Russia the first country to have come up with a vaccine. The DGCI had earlier turned down Dr Reddy’s first proposal for clinical trials of Sputnik V because Russia had not undertaken enough trial to ensure the vaccine to have taken the safe stage and worth trying for trial among a bigger population in India.

 “This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study,” a joint statement issued by Dr Reddy’s and Russian Direct Investment Fund (RDIF) said. At present, Sputnik V is currently undergoing post-registration phase 3 clinical trial engaging 40,000 participants in Russia.

In September, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, India will get 100 million doses of Sputnik V.

 “We acknowledge DCGI’s scientific rigour and guidance in the entire process. 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,” G V Prasad, co-chairman and managing director, Dr Reddy’s Laboratories, said.

The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11 making Russia the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform.

Russia has also claimed to have developed two more vaccines for Corona with the final trial expected to be completed by December.

(Manas Dasgupta)