article · Frontiers in Pharmacology
Around 80 percent of people in Ethiopia rely primarily on herbal medicines for their basic healthcare needs. However, growing concerns exist regarding the safety, quality, and efficacy of these treatments because robust regulatory oversight is missing. This study evaluated the existence and enforcement of regulatory frameworks governing traditional herbal medicines in Ethiopia through interviews with 25 regulatory officials and 15 traditional practitioners across national and regional bodies. The findings show that the current national medicine proclamation is insufficient for overseeing traditional herbal treatments. Although a single agency oversees both conventional pharmaceuticals and herbal remedies, enforcement remains weak. Primary obstacles identified include limited governmental commitment, inadequate regulatory tools, insufficient resources, and weak legal mechanisms. Stronger coordinated efforts among regulatory authorities are required to properly regulate traditional herbal products.
Millions of people depend on herbal remedies, yet absent or weak regulation risks patient safety, product quality, and treatment efficacy. Identifying the administrative and legal gaps helps policymakers, healthcare authorities, and practitioners create safer standards, better monitoring, and reliable oversight mechanisms for widely used traditional medicines.
This research provides baseline policy evidence rather than a commercial product or technical service. It directly informs healthcare regulators, standardisation bodies, and public health authorities seeking to develop functional oversight tools, licensing pathways, and quality assurance frameworks for traditional herbal products. While relevant to pharmaceutical policy, the abstract does not indicate a direct commercial application pathway.
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<b>Background:</b> Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. <b>Methods:</b> The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. <b>Results:</b> The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. <b>Conclusion:</b> Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.
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DOI: 10.3389/fphar.2024.1392330
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