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Dr Reddy’s Laboratories was granted approval by the drugs regulator to conduct Phase III trials of single-dose COVID-19 vaccination Sputnik Light.
According to Hindustan Times, the subject expert committee (SEC), of the Central Drugs Standard Control Organisation CDSO (CDSO), had recommended to the Drugs Controller General of India(DCGI) that approval be granted to conduct Bridging Studies in India in order to support Sputnik Light.
RDIF has partnered up with Dr. Reddy’s Labs in order to distribute the first 250,000,000 doses of the Russian vaccination and conduct the necessary trials in India for regulatory approval.
In July, the Subject Expert Committee of CDSCO had denied authorisation for emergency use to Sputnik-Light. This ruling ruled out the necessity of conducting the phase III Russian vaccine trial in the country.