Dr Reddy’s Lab gets DCGI nod for Sputnik Phase 2 & 3 trials
Dr Reddy’s Laboratories on Saturday said it along with Russian Direct Investment Fund (RDIF) 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.
“This will be a multi-centre and randomised controlled study, which will include safety and immunogenicity check,” the Hyderabad-based drug major said in a statement.
“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.
Prime Minister Narendra Modi today reviewed the pandemic situation and preparations for vaccine delivery, distribution and administration.
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.
The country’s active Covid-19 caseload fell below eight lakh for the first time in one-and-a-half months and account for merely 10.7 per cent of the total cases, the Health Ministry said on Saturday. There are 7,95,087 active cases as on date. The active caseload was below the 8 lakh mark last on September 1.