Dr Reddy’s seeks DCGI approval for Phase 3 clinical trials of Sputnik V in India
The Indian pharma company has partnered with RDIF to conduct clinical trials Russian COVID-19 vaccine
Dr Reddy’s Laboratories has sought permission from the Drugs Controller General of India (DCGI) to conduct phase-3 human clinical trials of Sputnik V, Russian coronavirus vaccine against COVID-19 in India, informed sources.
“Dr Reddy’s Laboratories has applied to the DCGI seeking permission to conduct phase-3 human clinical trials of the Sputnik V vaccine against COVID-19 developed by Russia. The DCGI will carry out a technical evaluation of the application before giving its approval,” a source informed PTI.
The Indian pharma company has partnered with Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V as well as its distribution.
Upon regulatory approval in India, RDIF will supply to Dr Reddy’s 100 million doses of the vaccine, the firm said last month.
(Edits by EP News Bureau)