Regulatory reforms and GCP clinical trials with new drugs in India

Abstract

Current Indian drug regulations do not allow for toxicology testing and clinical trials in India with compounds or molecules discovered abroad, except for treatments of tropical, cancer and cardiovascular diseases as part of global studies. The number of GCP Phase II/III trials by foreign sponsors has increased dramatically since 1995, attesting to the potential of India for lower cost trials and reduction in drug development costs and time, due to rapid patient recruitment. However, there have been problems with regard to intellectual property protection and adherence to informed consent guidelines. Starting in 2005, a series of regulatory reforms and patent protection will be instituted that are designed to address many of these concerns; the nature of these reforms are presented and discussed. However, sponsors need to pay close attention to informed consent and other ethical issues in Indian trials, which enroll mainly poor and uneducated patients.

Clinical Research Environment in India: Challenges and Proposed Solutions

“…The multiplicity and overlapping nature of the regulations (the three aforementioned guidelines) and sometimes ambiguous wording represent additional challenges [11,13,48]. This results in lengthy turnaround times for clinical trial approvals and under-enforcement of quality standards, which are features that have the potential to dissuade foreign sponsors from conducting clinical trials in India and may have contributed to the reduced number of clinical trials and departure of international collaborators [26,27,49].…”