The expert committee of Drugs Controller General of India (DCGI) on Friday recommended granting permission to Dr Reddy's Laboratories for conducting phase 2 clinical trials of Russian COVID-19 vaccine candidate, Sputnik V, in India, government officials said.
According to the government official, Dr Reddy's Lab has stated that in phase 2 clinical trial--"would include 100 subjects and for phase 3, it would take 1400 subjects."
"Once the pharma company would submit the safety and immunogenicity data of phase 2, it would be analyzed by the expert panel and then they can proceed for the phase 3 trial," the official added.
On October 13, had reported that Dr Reddy's Laboratories re-applied fresh protocol to DCGI in order to seek its approval for conducting phase 2 and 3 clinical trials of the Russian COVID19 vaccine.
It may be noted that on October 5, the Subject Expert Committee had done 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 along with more information.
The Indian drug maker 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 India drug company Dr Reddy's Lab.
"Before giving permission, the drugs 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 COVID-19 vaccine ," said the official.
Last month, Kirill Dmitriev, CEO, RDIF informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding localization of production of its Sputnik V vaccine in India.
Also, a prestigious medical journal The Lancet had 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 candidate 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.
( With inputs from ANI )
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