- It will be a randomised controlled Phase 3 trial of Sputnik V: Researchers
- Before permitting, the drugs regulator will conduct a technical evaluation
- 100 million doses will be supplied to Dr Reddy's Laboratories by Russia
New Delhi: 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.
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.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
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