A Failure of Regulatory Diligence and Communication: A Case Study of Ranbaxy
Abstract
Ranbaxy Laboratories Ltd., based in India, with sales both in India and abroad, was ironically pulled up for violations from GMP only by the United States Federal Drug Administration (USFDA). Records of any active communication of regulatory diligence by Indian pharmaceutical regulators that may have prevented the slide of this once internationally reputed company seem to be unavailable. International investigations on Ranbaxy have inevitably led to doubts on the safety and manufacturing processes and practices of the entire Indian pharmaceutical industry. While the case study dwells on lapses by Ranbaxy Laboratories, it is in parallel a critique on regulatory lapses of Indian pharmaceutical regulators.