Pharmacovigilance program: History, Development and Organization

Pharmacovigilance is a critical scientific discipline dedicated to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) associated with medication use. This comprehensive overview traces the evolution of pharmacovigilance from its historical roots, particularly following the Thalidomide tragedy, which underscored the limitations of pre-marketing clinical trials and the necessity for robust postmarketing surveillance. Key global initiatives, such as the World Health Organization's Programme for International Drug Monitoring and the establishment of the Uppsala Monitoring Centre, have laid the groundwork for international collaboration in drug safety monitoring. In India, the Pharmacovigilance Programme of India (PvPI) was launched in 2010, significantly enhancing the country's drug safety framework through a network of Adverse Drug Reaction Monitoring Centres. The integration of modern technologies, including electronic health records, mobile applications, artificial intelligence, and data mining, has transformed ADR monitoring into a proactive, realtime process. Despite notable advancements, challenges such as underreporting, data quality issues, and the need for greater public engagement persist. The future of pharmacovigilance is poised to focus on predictive monitoring, patient-centered approaches, and the incorporation of pharmacogenomics, ensuring the safe and effective use of medical products globally.