Abstract

PRESENT SCENARIO IN REGULATORY ASPECT FOR CLINICAL TRIALS IN INDIA

*Ankit Darji, Dr. P. D. Bharadia

ABSTRACT

India has developed as a global hub for outsourcing clinical trials for many pharma giants situated in developed countries. The CDSCO, headed by the DCGI, constituted the regulatory control for the conduct of clinical trials in India. But this trend has changed from 2011 because most of the trials were being outsourced to other countries like China, Russia and Philippines. The clinical trial conduction process, regulations applicable in India and the quality of data generated may be the cause. There is a small number of reviews which gave a brief summary of the changes in the regulations of clinical trials introduced from then on. In today‟s scenario of the pharmaceutical industry, it is very important to continuously update our knowledge regarding regulatory changes. Thus, this review delivers an insight into the recent changes with respect to the regulations of clinical trials and its impact on the clinical research industry in India.

Keywords: Clinical Trials, Drug Regulatory, Ethics Committee, Serious Adverse Event.