Overview on Pharmacovigilance: Ensuring Medication Safety

Abstract

Pharmacovigilance plays a pivotal role in ensuring drug safety by monitoring and evaluating the effects of medications before and after their market launch. In India, a rapidly expanding pharmaceutical industry coupled with a diverse patient population and growing drug consumption necessitates robust pharmacovigilance measures. This abstract highlights the need for pharmacovigilance in India, emphasizing factors such as the expansion of the pharmaceutical sector, diverse patient demographics, increased drug consumption, limited awareness and reporting, regulatory compliance, globalization of clinical trials, and emerging safety concerns. The Pharmacovigilance Programme of India (PvPI) serves as a cornerstone for patient safety, focusing on data collection, signal detection, capacity building, and regulatory collaboration. Reporting adverse drug reactions (ADRs) to PvPI is crucial, and various reporting methods, including online reporting, Vigiflow software, ADR reporting forms, direct communication, telephone reporting, and email, are discussed. Additionally, advice on what to report, who can report, where to report, and the handling of submitted information is provided to encourage effective ADR reporting. Overall, pharmacovigilance in India is essential for ensuring the safe and effective use of pharmaceutical products, protecting public health, and minimizing risks associated with medications.