DGCI asks Dr Reddy’s lab to revise protocol to conduct Russian Covid-19 vaccine Sputnik V trials

In the latest development, the Drugs Controller General of India (DCGI) expert panel has directed the pharma giant Dr Reddy’s Laboratories (DRL) to submit a revised protocol for performing phase 2,3 clinical trials of the Russian Covid-19 vaccine (Sputnik V) in India, a government official said.

Recently, Dr Reddy’s lab had submitted an application to the top drug regulator seeking their approval to conduct clinical trials for the Russian Covid-19 vaccine in India.

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“The Subject Expert Committee (SEC) had a thorough evaluation of the application submitted by Dr Reddy’s lab. The SEC has sought revised protocol from Dr Reddy’s lab along with more information and now Dr Reddy’s lab has to furnish a fresh protocol to the DCGI,” a Government official said.

The Indian Drugmaker (Dr Reddy’s Lab) has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.

As per RDIF, it will supply 100 million doses of its potential Covid-19 vaccine to Indian drug company Dr Reddy’s Lab. “Before giving permission, the drug regulator will conduct a technical evaluation of the application submitted by Dr Reddy’s lab to conduct phase 2, 3 clinical trials in India of Russian covid19 vaccine,” said the official.

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Last month, Kirill Dmitriev, CEO of the RDIF informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding the localization of production of its Sputnik V vaccine in India.

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 Covid-19.

According to Russian researchers, Sputnik V is a human adenoviral vector vaccine that fights against coronavirus disease.

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