QUALITY CONTROL OF SELECTED TRADITIONAL ETHIOPIAN PHARMACEUTICAL FORMULATIONS

To treat diseases and improve their health, people in Ethiopia do not only use synthetic drugs, but also traditional African medicines. However, information on the safety, efficacy and quality of the latter are missing. For this reason, quality control needs to be carried out according to established principles. A reliable system of quality and safety control is crucial to save lives and improve health by promoting access to medicines that meet quality, efficacy and safety standards. There exists a general misunderstanding that herbal products are safe and without risks. However, these arguments are often commercially misused to increase the trade. Medicinal products from plants may be prepared with poor starting products and/or contaminated with excessive or banned pesticides, microbial contaminants, chemical toxins, etc. Some are even adulterated with modern drugs. In Ethiopia, though the policy on traditional medicines gives enough recognition and encourages research in this domain, it lacks strong regulation despite herbal medicines are being sold with medical claims. Regulatory requirements for manufacturing or safety assessment are only at their draft phase. There is no formal registration system and herbal medicines are not included in an essential medicine list nor is there a post marketing surveillance system. There is no restriction on the sale, no national pharmacopoeia or monograph for herbal medicines in Ethiopia. Consequently herbal medicines with low or no safety, efficacy and quality have been flooded to the local market. People with chronic illness commonly use herbal medicines as alternative medicine. With increased consumer usage and increased media promotion, expectations by the public have also been increased leading to a more stringent demand for quality. Moreover, it is also important that the government imposes certain quality demands, based on the results of this project. Analytical methods will be developed and validated to evaluate the quality of some commonly used traditional medicines , evaluation of safety and quality of commercially available herbal preparations in the local market and formulary preparation with major guidelines to explain how to prepare good quality products. Samples will be collected, as well as background information related to the preparation of the products. analytical methods will be developed, optimized and validated. Moreover, chromatographic separation techniques will also be used. Developed and optimized method will be validated in terms of specificity, sensitivity, linearity, precision, accuracy and robustness (preferably using an experimental design) according to the ICH (International Council on Harmonization) guidelines. At the end, ranking of the products will be worked out on a scale from excellent, good, sufficient to unacceptable. It is expected to find a reasonable correlation between the quality of the final product and the ingredients /excipients/way of preparation, which can be utilized to draw up directions. Products prepared with respect to these directions can be given a quotation or quality label.