The Drug Controller General of India (DCGI) has given its approval to a global pharmaceutical company headquartered in India, Dr Reddy`s 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 the Sputnik V Covid-19 vaccine in India.
“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,” Co-chairman and Managing Director of Dr Reddy`s Laboratories G.V. Prasad in a statement said.
“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 RDIF had stated that deliveries is likely to begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
Russia became the first country to officially register the COVID-19 vaccine.
On August 15, the Russian Health Ministry announced the launch of the vaccine production.
It is to be noted that the vaccine was licensed before completing large-scale Phase III trials. Many scientists and doctors have raised concerns about the efficacy, safety of COVID-19 vaccine.
(With IANS inputs)