GOOD CLINICAL PRACTICE IN PHARMACOVIGILANCE

Clinical research is a mechanism or a process that provides convincing evidence that the new treatments or therapies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of medicine. Good Clinical Practice (GCP) is an ethical and scientific quality standard for designs, operations and recordings involving the participation of human subjects. Accompanying the Guidelines pledges to the public that the ethics, integrity and welfare of humans participating in the trials are protected. India has experienced distinct opportunities for clinical trials for clinical trials compared to ethical patients, major medical institutions with fewer and more equipped investigators and fewer patient voices than regulated countries, with larger patient counts. However, our Indian guidelines were needed to ensure a uniform standard of clinical research across the country and to provide data for registration for new drugs before use in the human population in India. Junctions guidelines were developed by a complete committee set up by CDSCO with clinical experts. This article explains the importance of good clinical practice from an Indian clinical research perspective, while defining and outlining the goals and objectives of the GCP. It addresses the historical events that led to the emergence of good clinical practices and examines the current scenario with respect to the application of GCPs in clinical trials in India. Finally, the article addresses the challenges to maintaining a best and competitive system and will suggest a way forward to increase the credibility and efficiency of good clinical practice in clinical research.