Traditional Medicine Regulatory Framework and Legal Basis in Ethiopia: A Critical Evaluation of Challenges and Opportunities for policy Implementation

Abstract

Abstract Background The efficacy, quality and safety of traditional medicine used by the Ethiopian population may be questionable. The strict regulation is crucial to protect the public from unsafe and inefficacious traditional medicine. Objective The primary aim of the study was to assess the legal framework and its practical implementation status for the regulation of traditional medicine in Ethiopia. Methods An institutional-based cross-sectional study was conducted from November 2021 to March 2022. Archival review, literature search, and survey of regulatory personnel and traditional medicine practitioners were applied for data collection. Data were analyzed using IBM® SPSS version 25.0, USA. The result was presented using descriptive and inferential statistics at < 0.05 significance level and 95% confidence interval. Results Ethiopia is regulating traditional medicines based on the Medicine Policy of 1993 and the Food and Drug Authority of Ethiopia's Proclamation No. 1112/2019. About 70.2% of federal regulatory officers and 41.7% of regional regulatory officers responded that a traditional medicine regulatory activity in Ethiopia is weak. The study found that there is no registered traditional medicine manufacturing firms, products, or pharmacovigilance systems in Ethiopia, Barriers include poor governance, resource limitations, lack of stakeholder cooperation, and weak legal enforcement. Weak legal enforcement (AOR = 0.21, 95% CI: 0.10–0.47) and resource constraints (AOR = 0.27, 95% CI: 0.13–0.59) have had the most significant associations with weak regulatory implementation. Conclusion The current Ethiopian traditional medicine regulation framework is inadequate to ensure quality, safety, efficacy, and rational use of traditional medicine. Enhancing the framework is crucial for a more effective and accessible implementation of regulation.