Drugs Controller to tighten norms for clinical research
Drugs Controller General of India (DCGI) is drawing up plans to regulate clinical research organisations (CROs) and has set up a team to look into the issue, the regulator’s chief said today.
The team, largely drawn from industry and NGOs, has met twice and submitted its recommendations. “We are addressing them and putting a system in place,” Drugs Controller General Surinder Singh said at a seminar here.
As a first step, the DCGI wants to register all clinical research organisations as such an exercise would help create a registry and databank. “We will have a databank. Each and every activity will be available for public,” he said.