Pharma giant Dr Reddy's Laboratories on Thursday said Sputnik V vaccine, which is developed by the Gamaleya National Research Center of Epidemiology and Microbiology and Russian Direct Investment Fund (RDIF), will take several months away from its launch.
In an interview to CNBC-TV18,GV Prasad, co-chairman and managing director, said the company is at the beginning of phase-III process, "So we will have to submit our application to the government of India, get their approval, do the trials and then apply for approvals."
Prasad said Dr Reddy's doesn't have the infrastructure ready to manufacture the vaccine, "However, RDIF and Dr Reddy's are talking to several players in India to manufacture the product. Our responsibility is to do clinical trial jointly with RDIF, do the registration and distribute the product."
"This won’t be a independent phase-III in India but it will be part of the global phase-III that RDIF is going to conduct and is in the process. Typically, a vaccine has tens of thousands of people on the phase-III trial and I would assume this is the same, and India will be a subset of that, around thousand plus. We are still yet to get the conversation going with the drug controller and the agency will decide how many patients we needed with us," Prasad further mentioned.