Abstract

Neelam Thakur*, Harsh Thakur, Kavita Pathania, Pooja Sharma

ABSTRACT

Background: Pharmacovigilance (PV) used to deal mostly with synthetic drugs, yet now it also covers herbal medicines because their use keeps growing worldwide. A lot of people still think “natural automatically equals safe,” and that idea is genuinely risky. Herbal treatments are not fully safe. They may contain complex chemicals that can cause serious adverse drug reactions (ADRs), even severe organ toxicity. Objective: This review looks at the urgent need for dedicated herbal pharmacovigilance, using Papaver somniferum (the opium poppy) as the main clinical example to show the real pharmacological strength, narrow therapeutic range, and serious herb-drug interactions (HDIs) found in plant-based medicines. Scope of Review: The study looks at global systems used to monitor herbal safety, with close attention to the WHO Programme for International Drug Monitoring, VigiBase, and the Indian Pharmacopoeia. It also examines why standard causality tools like the WHO-UMC scale often do not fit multi-compound botanicals very well. Then it compares uneven regulations, especially the European Union’s THMPD and the United States’ DSHEA. Key Findings: The assessment points to chronic underreporting, natural chemical variability, and some pretty serious regulatory loopholes as the main obstacles to botanical safety. Even so, the field is moving into “Vigilance 2.0.” This shift leaves passive reporting behind and leans on technology-driven surveillance, using molecular fingerprinting, AI-based signal detection, social listening, and pharmacogenomics to catch hidden toxicities and prevent dangerous synergistic interactions. In conclusion: bringing herbal medicine into modern healthcare needs strict and shared scientific oversight. Current problems won't be solved without better global regulation, the use of Real-World Evidence (RWE), and more honest communication between clinicians and patients. In the end, stronger pharmacovigilance is what makes traditional botanicals safer without putting public health at risk.