Traditional Herbal Medicine Regulation in Ethiopia: A Critical Evaluation of Legal Basis and Its Implementation

Abstract

Background: The majority of Ethiopians' primary healthcare relies on herbal medicine (HM) based traditional medicine (TM) products and practices. Therefore, the presence of adequate regulatory framework for traditional herbal medicines (THMs) and its effective implementation is vital to improve the quality and standard of public healthcare system in Ethiopia. Objective: To assess the traditional herbal medicines regulation legal basis and its practical implementation in Ethiopia from November 2021 to March 2022 Methods: An institutional-based descriptive cross-sectional study design mixed with qualitative approach (in-depth interviews) was conducted. The study data was obtained from archival review of legal basis, a survey of random selected 237 regulatory personnel, and in-depth interview conducted with purposely- selected 25 regulatory officials and 15 herbalists. Quantitative data analyzed by SPSS version 26, and a thematic analysis approach was utilized to analyze qualitative data. The study results were presented in text, tables, and figures form. Results: Ethiopia has now regulated THMs based on the 1993 medicine policy and, 2019 proclamation of Ethiopian Food and Drug Authority (EFDA). Current medicine law of Ethiopia has inadequateness on TM/HM product and practice recognition; TMs executive bodies name, power and functions; and regulated TM/HM product sources, categories and requirements. The presence of exclusive regulation (80.7%, n=57) and registration (89.5%, n=57) system for TMs products at EFDA were reported. The majority of EFDA and regional health regulatory (RHR) study participants agreed on the absence of authorized TMs products and manufacturer, and pharmacovigilance (PV) regulation systems. Most of RHR workers were informed the existence of a system for most THM practice and providers basic regulatory activities. Functionality of herbalist registration (97.8%, n=180), and THM practice regulation (87.8%, n=180) were reported. (70.2%, n = 57) of EFDA and 41.7% (n=180) of RHR respondents believed as THM regulatory activities were poorly enforced by their respective offices. The indicators of THM weak practical regulation identified by study participants were HM sells without restriction, registered herbalists small in number, THM not regulated in some regions‟, most THM regulatory tools not available, presence of quack herbalists, and ignorance of THM regulation at rural. THM regulation mainly challenged by weak legal enforcement, weak government commitment and supports, regulatory resources constrains, TM regulatory administrative and activities fragments, and regulatory tools inadequateness. Moreover, the presence of TM healers over suspicion, regions level TM regulation inconstancy, THM regulatory requirement difficultness, federal and RHR offices weak cooperation, HM research and development negligence, and TM healers‟ association weakness were identified common challenges of THM regulation