New Delhi: Bharat Biotech has provided adequate data to the satisfaction of India’s drug regulator and hence the USFDA’s decision, though respected, won’t make any difference in India, said Dr VK Paul Member-Health, Niti Aayog on USFDA rejecting emergency use authorisation for Covaxin.
“Every country’s regulatory system might have some things in common with others & some things different. We respect it. A scientific framework is same but its nuancing is as per context, said Dr Paul.
He further said “These are scientific considerations & keeping those in mind, the nuancing might be different, especially in those countries where science is strong. Our manufacturing is strong. They have decided this, we respect it.”
“We expect that our manufacturers will be able to comply with it. It has no impact on our own program. Our regulator has approved it.We have so much data on safety & phase 3 trial. I’m being told that publication of their phase 3 trial will be done sometime in 7-8 days,” Dr VK Paul further stated.