RUSSIAN VACCINE GETS NOD FOR CLINICAL TRIALS IN INDIA

The Drug Controller General of India ( DCGI) has granted approval to Dr Reddy’s, a global pharmaceutical company headquartered in India, to conduct phase 2 and 3 clinical human trials of the Sputnik V, a Covid- 19 vaccine made by Russia.

On September 16, the Russian Direct Investment Fund ( RDIF) and Dr Reddy’s Laboratories Limited had agreed to cooperate on clinical trials and distribution of Sputnik V Covid- 19 vaccine in India.

Sputnik V, an adenovirus vector- based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct

Investment Fund and registered on August 11.

Co- chairman and MD of Dr Reddy’s Laboratories G. V. Prasad in a statement said “This is a significant development that allows us to commence the clinical trials in India andwe are committed to bringing in a safe and efficacious vaccine to combat the pandemic.”

“On regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine. The Sputnik Vvaccine, which is based onwell- studied human adeno viral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic,” a statement fromthe Russian fund had earlier stated.