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 Managing Director 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 and we 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 V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic,” a statement from the Russian fund had earlier stated.
The Russian Direct Investment Fund had also said that the deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
“The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organisations to have a diversified anti-COVID vaccine portfolio to protect their populations,” RDIF added.