The Union Health Ministry is planning to review the Schedule Y of Drugs and Cosmetics Act in a bid to harmonise it with that of the ICH Guidelines. The Drugs Technical Advisory Board (DTAB) of the Health Ministry has in principle approved the proposal at its meeting held recently in Delhi.

The review will have a major impact on the burgeoning clinical research organisations (CROs) in the country as they have to meet more stringent guidelines to meet the international standard. Though Schedule Y is the crux of the ICH Guidelines, once the Schedule Y is reviewed to match with the ICH guidelines, the CROs will have to work strictly on international standards.

The Health Ministry's decision comes in the wake of the reports that the mushrooming CROs in the country are not meeting the required standards to match with that of the international standards. Once reviewed, the Schedule Y will define in detail the role and responsibility of each individual involved in the clinical research. On several issues, the present Schedule Y is vague which will be cleared after the review. Another major area will be that of documentation and study monitoring. The CROs have to strictly file the documents before, during and after the trials.

Clinical research, which has immense business potential in the country, has been growing at a rapid pace during the last more than a couple of years. Among the various factors, contributing to this upward swing is the patient enrolment rate and the lower cost of research in the country.

There are apprehensions in the minds of outsourcing companies about the quality of data and acceptance of such data by the global regulatory authorities in general and the US FDA in particular. And this apprehension stems from the fact that only a fraction of about 500,000 doctors are trained in ICH-GCP, which could mean inadequate documentation and inaccurate safety profiling of the New Chemical Entity (NCE).

As per the ICH guidelines, the "safety" consideration must take precedence over the "efficacy" consideration of NCE. Another major aim of these guidelines is to safeguard the rights and well being of the trial subjects.