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The Russian Sputnik V vaccine against Covid-19 will be tested in India on 100 volunteers, the Indian Central Drugs Standard Control Organisation’s Drug Controller General (DCGI) told Sputnik on Thursday.
DCGI has granted permission to pharmaceutical giant Dr Reddy’s Laboratories for conducting tests. However, the date and time of the test will be determined by the company.
Sputnik quoted the organisation as saying that the vaccine will be tested in the second phase of its clinical trials before moving on to phase 3.
Last week, the expert committee of DCGI had recommended granting permission to Dr Reddy’s Laboratories for conducting phase 2 clinical trials of Russian Covid-19 vaccine candidate, Sputnik V, in India.
According to a 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 analysed by the expert panel and then they can proceed for the phase 3 trial,” the official added.
On October 13, news agency 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 Covid-19 vaccine.
It may be noted that on October 5, the Subject Expert Committee (SEC) 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 drugmaker 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 the RDIF, it will supply 100 million doses of its potential Covid-19 vaccine to India drug company Dr Reddy’s Lab.
