Paper Title
PHARMACOVIGILANCE

Abstract
Pharmacovigilance (PV) is a vital scientific discipline encompassing activities focused on detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It plays an indispensable role in safeguarding patient safety and public health, especially in a nation as vast and diverse as India, with its complex healthcare system. This is because unforeseen side effects might not become apparent during the more controlled and limited environment of pre-market clinical trials. Continuous monitoring is crucial to ensure a drug's benefits continue to outweigh its risks throughout its entire lifecycle in the real world.Recognizing the critical need for a robust, centralized, and sustainable national system, the Central Drugs Standard Control Organization (CDSCO) officially launched the Pharmacovigilance Programme of India (PVPI) in July 2010. Initially, the All-India Institute of Medical Sciences (AIIMS) in New Delhi served as the National Coordinating Centre (NCC). However, to provide institutional stability and ensure long-term growth, the Indian Pharmacopoeia Commission (IPC) took over the role of the NCC for PVPI on April 15, 2011.ThePVPI operates through an extensive and continually expanding network of Adverse Drug Reaction Monitoring Centers (AMCs), primarily located in medical colleges and tertiary hospitals across the country. The number of AMCs has grown substantially, from approximately 250 in the early years of the program to over 346 by 2020–2021. AMCs collect Individual Case Safety Reports (ICSRs) through spontaneous, stimulated, and active surveillance. Reports are uploaded into VigiFlow and, after validation, forwarded to WHO-UMC’s global database, VigiBase.India’s ICSR output rose significantly—from ~11,000 (2006–2008) to 78,000 (2014) and over 113,000 in 2022–2023. Also,PVPI has implemented a toll-free helpline (1800-180-3024), an SMS feedback system, and a dedicated mobile application, “ADR PVPI,” launched in 2017.Use of the ADR PvPI app increased sharply, with app-based reporting rising from just 3.55% in 2017 to 96.45% in 2018.Despite these substantial efforts, underreporting of ADRs persists as a critical challenge, often attributed to lingering gaps in awareness and knowledge among health care professionals.Strengthening PV systems enhances public trust, improves therapeutic decision-making, and ultimately contributes to safer and more effective use of medicines worldwide. Thus, pharmacovigilance remains a cornerstone of modern healthcare and an essential component of patient safety and regulatory sciences.