Traditional herbal medicine is widely used globally. Despite its extensive use, there are no proper regulations on standardization and use of herbal medicinal products. Nepal has a rich biodiversity and demography comprising of different socio-ethnic groups. Herbal medicines are utilized prominently in Nepalese communities. These herbal products may cause side effects and adverse effects, such as nephrotoxicity, neurotoxicity with the heavy metal toxicity associated with their powdered dosage

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... rms. The side effects of using herbal products have been documented, such as bleeding with use of Ginkgo biloba and increase in blood pressure with use of Ephedra. Regulation of herbal products is essential to promote their optimal and rational use. Standard tools are available for assessing adverse effects of herbal products from health authorities, like the World Health Organization. In Nepal, self-medication practice using traditional herbal medicines is common and includes the concomitant use of allopathic. There is no focal point to address the regulatory issues on herbal products currently in Nepal. The Department of Drug Administration in Nepal is nominated as a national pharmacovigilance center and there are no reports on adverse events from the use of herbal medicines so far. However, not having any reports does not ensure the absolute safety and effectiveness of herbal products, so vigilance is warranted. Herbal pharmacovigilance is needed for Nepal to ensure safe and effective use of herbal medicines as the current pharmacovigilance ecosystem does not capture those cases. In the Nepalese context, the absence of reporting mechanisms may have underreported adverse cases of herbal products. The present opinion article aims to discuss the use of herbal products in Nepal, the challenges associated with the adverse reaction due to herbal medicines, and recommendations to overcome these challenges