Implementability analysis of the low-cost QMS/QC model for herbal medicines regulation in Uganda

Abstract

More than 60% of Ugandans rely on herbal medicines for their healthcare needs as per the statistics published by the Ministry of Health of Uganda. However, unregulated, and poorly regulated use of herbal medicines presents unacceptable health risks to the public and therefore, whilst the matter of herbal medicines regulation remains highly contentious and sentimental, there is need to regulate the sector none the less. Use of novel and evidence-based models that are tailor made to specific countries or regions may offer sustainable gains as these facilitate both growth and protection. However, there are no published models of regulation for developing countries except for the model recently developed by Naluyima and Ssenyange in 2020. While this model, when piloted at a local herbal manufacturing facility in Uganda yielded promising results, its roll out and integration into policy requires generation of evidence concerning its implementability. In this study, an adapted and bespoke GLIA tool was derived and deployed to assess the implementability QC-QMS model. The evaluation was constituted by a team of experts in regulation of herbal medicines. An overall implementability score of 4.2 was obtained for the overall model indicating a high potential of implementation success. However, low scores were also observed in areas compatibility, flexibility and executability. Therefore, before adoption, it is prudent that the model is refined to address the issues surrounding these parameters to facilitate an even high implementability success.