History of Pharmacovigilance

The history of pharmacovigilance demonstrates the development of medication monitoring practices and the pursuit of patient safety. This chapter takes readers on a journey through time to discover the history of pharmacovigilance and to shed light on its significant impact on modern healthcare. First, a brief history of pharmacovigilance in the USA, Europe, India, and non-European nations like China and Korea has been provided, along with a summary of the key moments that shaped the foundational regulatory framework. It discusses the challenges faced, the insights acquired, the current efforts, and the impending challenges to protect public health. Furthermore, the significant events, such as the sulfanilamide tragedy, the thalidomide disaster, and the TGN1412 tragedy, are discussed. Along with the past events, some recent tragedies such as the heparin contamination, counterfeit avastin, and ranitidine tragedy, along with the tragedy of 2023, Digene antacid gel, which led to the retraction of the drugs, are highlighted. Finally, a conclusive remark about the chapter is provided. This book chapter focuses on history of pharmacovigilance and provides a comprehensive and informative overview of the topic. It emphasizes the importance of constant vigilance, collaboration, and technical innovation in maintaining public health and enhancing medication safety.