Ministry of Health sets up panel to formulate clinical trial policy
The Ministry has set up a seven-member expert committee to formulate the policy framework.
New Delhi, February 13, 2013: The Ministry of Health & Family Welfare has set up a seven-member expert committee to formulate the policy framework for the approval of new drugs and clinical trials.
Pharmacologist Ranjit Roy Chaudhuri-headed panel is expected to fix the standard protocol for clinical evaluation of new drugs. It would also study the feasibility of conducting clinical trials in local population for drugs which have already been approved in other regulated markets such as the US, Japan and Europe.
In addition, the panel will also recommend guidelines for post marketing trials – a mechanism to ascertain the impact of drugs which have been already launched in the market.
The expert committee is also expected to look at the modalities of clinical rial inspections and suggest how they should be carried out and how clinical trial sites and investigators should be accredited.