India News | Dr Reddy's Laboratories Seeks DCGI Permission to Conduct Phase III Trials of Russian COVID-19 Vaccine
Get latest articles and stories on India at LatestLY. Indian pharma giant Dr Reddy's Laboratories (DRL) has submitted an application to the Drugs Controller General of India (DCGI) for its approval to perform Phase III clinical trials of the Russian COVID-19 vaccine Sputnik V in India, a government official said on Friday.
By Priyanka Sharma
New Delhi [India], October 2 (ANI): Indian pharma giant Dr Reddy's Laboratories (DRL) has submitted an application to the Drugs Controller General of India (DCGI) for its approval to perform Phase III clinical trials of the Russian COVID-19 vaccine Sputnik V in India, a government official said on Friday.
Dr Reddy's lab had recently joined hands with The Russian Direct Investment Fund (RDIF) to conduct Sputnik V vaccine's clinical trials as well as its distribution.
As per RDIF, it will supply 100 million doses of its potential coronavirus vaccine to the Indian pharma company.
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"Before giving permission, the drugs regulator will conduct a technical evaluation of the application submitted by Dr Reddy's lab to conduct Phase III clinical trials in India of Russian COVID-19 vaccine," the official said.
According to officials, it would be multi-centre, observer-blind, randomised controlled study.
Last month, Kirill Dmitriev, CEO of the RDIF, said that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding localization of production of its Sputnik V vaccine here.
Also, a prestigious medical journal The Lancet has published the results of clinical trials of Phase I-II of the Russian vaccine demonstrating its safety and efficacy.
On August 11, the Sputnik V vaccine developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against the novel coronavirus.
According to Russian researchers, Sputnik V is a human adenoviral vector vaccine which fights against coronavirus disease. (ANI)
(The above story is verified and authored by ANI staff, ANI is South Asia's leading multimedia news agency with over 100 bureaus in India, South Asia and across the globe. ANI brings the latest news on Politics and Current Affairs in India & around the World, Sports, Health, Fitness, Entertainment, & News. The views appearing in the above post do not reflect the opinions of LatestLY)