In the latest development, the expert panel of the Controller General of Medicines of India (DCGI) has directed the pharmaceutical giant Dr Reddy’s Laboratories (DRL) to submit a revised protocol to conduct phase 2.3 clinical trials of the Russian Covid vaccine. -19 (Sputnik V) in India, said a government official.
Recently, Dr. Reddy’s laboratory had submitted an application to the top drug regulator seeking approval to conduct clinical trials for the Russian Covid-19 vaccine in India.
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“The Subject Matter Expert Committee (SEC) conducted a thorough evaluation of the application submitted by Dr. Reddy’s laboratory. The SEC has sought the revised protocol from Dr. Reddy’s lab along with more information and now Dr. Reddy’s lab has to provide a new protocol to DCGI, ”said a government official.
The Indian pharmaceutical company (Dr. Reddy’s Lab) has partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine and its distribution.
According to RDIF, it will supply 100 million doses of its potential Covid-19 vaccine to the Indian pharmaceutical company Dr Reddy’s Lab. “Before giving permission, the drug regulator will carry out a technical evaluation of the application submitted by Dr. Reddy to conduct phase 2, 3 clinical trials in India of the Russian covid19 vaccine, “the official said.
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Last month, Kirill Dmitriev, executive director of RDIF, reported that Russia is in close dialogue with the Indian government and Indian drug manufacturers regarding the location of the production of its Sputnik V vaccine in India.
Likewise, a prestigious medical journal ‘The Lancet’ has published the results of the Phase I-II clinical trials of the Russian vaccine demonstrating its safety and efficacy.
On August 11, the Sputnik V vaccine jointly developed by RDIF and the Gamaleya National Research Center for Epidemiology and Microbiology was registered by the Russian Ministry of Health 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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