AN EVALUATION OF GCP COMPLIANCE IN CONDUCTING CLINICAL RESEARCH IN INDIA VERSUS THE UNITED STATES —A CASE STUDY

Abstract

Due to globalization and competitive healthcare markets, U.S. pharmaceutical companies are conducting clinical research in emerging markets such as India and submitting data for U.S. marketing approvals. Compliance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines in India remains a critical concern to the Food and Drug Administration (FDA). To evaluate India's pharmaceutical regulatory process for compliance with GCP, Site Monitoring Visit Reports and Regulatory File Reviews were compared to those from a study conducted in the U.S. Qualitative and quantitative measurements were given to the monitoring reports and regulatory file reviews, respectively. Additionally, GCP compliance was assessed within eight GCP focus areas. This data, in conjunction with a comparison of the regulations of each country, suggests that there were differences in the conduct of clinical trials in India compared to the U.S. and that these differences may impact acceptance by the FDA.