Abstract
India is the ‘hub’ of clinical trials and ranked 4th in the world. Many prominent organizations in India, such as DCGI, ICMR, DBT, CBN, GEAC, and RCGM, play a significant role in overseeing and influencing the progress of trials in the country. India realizes many gaps in the regulations of clinical trials. To increase transparency Indian government issued The NEW DRUG AND CLINICAL TRIALS RULES 2019 on 19 March 2019 which addressed the gaps. The major changes are accelerated approval, ethics committee function and role, post-trial access, compensation, pre and post-submission meetings, and new definitions. These changes attract the leading pharma company to India and also boost the Indian clinical research quality and patient safety. This review highlights the gaps in new regulations, the history of clinical trial regulations, major shortcomings of old regulations, a comparison of new and old regulations and their impact on clinical trials.
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