Indian government looks to fast-track approvals for clinical trials
01-Oct-16, The Economic Times
As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now.
%20The%20Economic%20Times.jpg "Indian government looks to fast track approvals for clinical trials (c) The Economic Times")
Image: The Economic Times
The central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisations (CROs) involved in the tests comply with stricter quality and compliance checks.
This comes two months after the drug regulatory agency eased rules related to clinical research - a move that was frowned upon by patient rights groups. These rules let investigators undertake as many trials as approved under the watch of the designated ethics committee.