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DCGI nod to Russian Covid-19 vaccine; Sputnik V to enter trial space in India

02:35 AM Oct 18, 2020 | FPJ News Service

India’s drug regulator has granted approval to Hyderabad-based pharma major Dr Reddy's Laboratories to conduct the Phase 2 and 3 clinical human trials of Sputnik V, a Covid-19 vaccine made by Russia.

On September 16, the Russian Direct Investment Fund (RDIF) and Dr Reddy's had agreed to cooperate on clinical trials and distribution of Sputnik V in India. The green signal by the Drug Controller General of India (DCGI) will enable RDIF to supply 10 crore vaccine doses to Dr Reddy's.

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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.

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Co-chairman and MD of Dr Reddy's GV 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.”

The development comes at a time when India has reported over 74 lakh infections since the pandemic broke out. In an encouraging sign, the country’s hospitals have less than 8 lakh patients at the moment which is little above 10% of the overall caseload.

"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 a 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.

PM warns against complacency

New Delhi Calling for full preparedness to ensure speedy access to COVID-19 vaccines for every citizen, Prime Minister Narendra Modi on Saturday suggested developing a vaccine delivery system on the lines of conduct of polls and disaster management while involving all levels of government and citizen groups. The PM cautioned against any complacency at the decline in positive cases. At the same time, the government cited two studies to suggest that the virus has shown no major mutation.

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