Good Clinical Practice (GCP) is an international ethical and quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that providesassurance that the rights, safety, and well-being of human research participants are well protected, data and reported results are credible and accurate.
Creating awareness of GCP is mandatory when it comes to innovation in medicine and healthcare. The recent launch of the New Drugs and Clinical Trials Rules, 2019 (NDCT), on March 19, 2019, opens up a new set of opportunities to accelerate innovations in India. Alongside are the challenges to ensure that the rules are widely disseminated, properly explained and correctly interpreted. Poor understanding of the current regulatory requirements (mainly the do’s and don’ts) mixed with inadequate compliance to best global practices may lead to delays and failures (financial & non-financial loss) which can be significantly reduced through awareness and empowerment through such programmes.