Abstract:
Background: Ineffectiveness of traditional medicine practices regulation has been a major challenge worldwide especially in the developing world. In Tanzania, regulation to traditional medicines has not been well documented regarding the extent to which it meets the WHO (2016) requirement. Although the Traditional Medicine Act was enacted in 2002, there are no studies that have focused on the functioning and effectiveness of the traditional medicine regulatory framework. This study therefore aimed at exploring regulatees’ awareness and adherence to TAM regulations and obstacles/barriers face by both regulatees and regulators in fulfilling the regulatory requirement in Tanzania. Objective: To assess awareness and adherence of the regulatory process among regulatees and challenges faced by regulators in implementing the the regulatory process in Tanzania. Materials and Methods:: A cross-sectional study design was used employing qualitative data collection approach and analysis. A purposive and snowballing sampling were used to select participants. In-depth interviews were conducted with regulators and regulatees. Dthematic data analysis started with organizing, breaking it into manageable units, synthesizing and searching for patterns, discovering what was important to be learned and coded them into nodes. Results: The findings of the study revealed that awareness of the regulatory framework among the traditional/ alternative medicine practitioners is low and still a challenge that needs to be addressed in order to promote the subsector. Non-adherence to regulations was also revealed to be pronounced among regulatees. Non-adherencees is influenced by both regulatees’ awareness of the process and their ability to comply with the regulatory requirements; there is lack of direct public private partnership in regulating traditional and alternative medicine sub sector; and lack of enough manpower was reported to be a hindrance in implementing the regulatory process. There is lack of infrastructure, transport and human resources; and also regulators interviewed revealed lack of professional knowledge, proper task scheduling and interest on traditional/ alternative medicine. Conclusion and Recommendation: The study concludes that some regulatees are not aware of the regulatory framework; non-adherence is a problem among regulatees. Lack of professional human resources, interest, skills, and means of transport are the problems that affect the capacity and effectiveness of the regulators. So we recommend more frequent education provision on regulatory framework to regulatees by the regulatory body and regulating body should appoint regulators who are interested in TAM to improve efficiency and effectiveness in regulating TAM subsector.
