Dr Reddy’s Laboratories get DCGI nod for Sputnik Phase 2 & 3 trials

Dr. Reddy’s Laboratories announced it along with Russian Direct Investment Fund (RDIF) that it has received approval from the Drug Control General of India (DCGI) to conduct Phase 2 and 3 human clinical trials for Covid-19 vaccine Sputnik V in India.

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Hyderabad-based drug major said, “This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity check,”

“This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic,” Dr. Reddy’s Laboratories co-chairman and managing director GV Prasad said.

PM Narendra Modi also reviewed the pandemic situation and preparations for vaccine delivery, distribution and administration.

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Noting that there was a decline in the daily cases and the growth rate, he cautioned people against complacency and asked them to keep up efforts to contain the pandemic.

-PTC News