Abstract
The review explores the vital dimensions of pharmacovigilance (PV) and adverse drug reaction (ADR) reporting in the healthcare industry, highlighting their importance for public health and patient safety. The review follows the development of PV from its historical beginnings in India, highlighting significant turning points and legislative frameworks that have influenced modern practices. Sibutramine, a well-known medication, is investigated to highlight the significance of watchful PV systems. Meanwhile, ADR reporting is significant in healthcare because it directly impacts public health and patient safety. However, there is still a need to address issues like healthcare providers' ignorance and underreporting. The suggested solution is to establish Regional Reporting Centres (RRCs), with successful models demonstrating the benefits they provide, including improved data collection and regional assistance. Despite the advantages, setting up RRCs has its share of difficulties, such as coordination and resource allocation. Effective RRC implementation improves ADR reporting, as shown by case studies and success stories. In order to improve ADR reporting and PV procedures, the research ends with suggestions for the future that call for more regulatory assistance, more training for healthcare workers, and public awareness campaigns.
Keywords: Pharmacovigilance, Regional reporting centers, Drug safety, PvPI, Sibutramine, ADR adverse drug reaction, Tragedies.