Dr Reddys submits revised protocol to DCGI for Sputnik V phase 2,3 trials
Recently, the expert panel of DCGI had recommended that Dr Reddy's Lab submit a fresh application to the top drug regulator seeking its consideration.
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New Delhi: Indian drug maker Dr Reddy's Laboratories (DRL) has submitted a revised application to the Drugs Controller General of India (DCGI) seeking his approval to conduct phase 2 and 3 clinical trials of the Russian COVID-19 vaccine Sputnik V in India, a government official said on Tuesday.
Recently, the expert panel of DCGI had recommended that Dr Reddy's Lab submit a fresh application to the top drug regulator seeking its consideration.
Last week, the Subject Expert Committee (SEC) did a thorough evaluation of the previous application submitted by Dr Reddy's lab. Thereafter, the SEC had directed the pharma company to apply with a revised protocol with more information.
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 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 trial in India of Russian Covid19 vaccine," said the official.
Last month, Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding the localisation of production of its Sputnik V vaccine in India.
A prestigious medical journal, The Lancet, has also published the findings of clinical trials of the Russian vaccine demonstrating its safety and efficacy.
On August 11, the Sputnik V vaccine developed jointly by the 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.
Read also:Russian COVID Vaccine Clinical Trial in India: DCGI asks Dr Reddys to submit fresh protocol
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