CDSCO panel approves Dr Reddys phase 2 trials of Russian COVID-19 vaccine
The Indian pharma giant has collaborated with The Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.;
New Delhi: An expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting permission to Dr Reddy''s Laboratories for conducting phase 2 clinical trials of the Russian COVID-19 vaccine, Sputnik V, in India, sources said.
The Hyderabad-based pharmaceutical firm had on October 13 reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined phase 2 and 3 human clinical trials of the vaccine in the country.
In its revised protocol, firm stated that the phase 2 trial would include 100 subjects, while the phase 3 would involve 1,400 volunteers, the sources said.
The subject expert committee (SEC) on COVID-19 deliberated on the application on Friday.
"Following deliberation, the SEC has recommended the grant of permission for the phase 2 clinical trial of the potential vaccine first. After they submit the safety and immunogenicity data of the first phase, they then would be allowed to proceed for the phase 3 of the trials," a source said.
Read also: Dr Reddys submits revised protocol to DCGI for Sputnik V phase 2,3 trials
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