Need for stable quality control and drug pharmacopeia in African pharmaceutical settings: a new way to independent drug production

Abstract

For years now, Africa are on the verge of a shortage of drug production1,2, quality control of traditional/indigenous plants, and imported drugs due to limited stable pharmacopeia availability specifically for African herbs, drugs, and plants. Therefore, we write this piece to raise and put African Union stakeholders into action to see the need to have a stable quality control drug pharmacopeia in Africa. In the course of advancing sustainable drug discovery and development, many countries are making indelible efforts through the implementation of policies regulating medicines. Pharmacopoeia is a reverenced compendium of regulations and official standards for the qualitative and quantitative compositions of medicines and manufacturing of drugs3. Unlike the British Pharmacopoeia (BP), United States Pharmacopoeia (USP), and European Pharmacopoeia (Ph. Eur.), the African Union (AU) has 2 pharmacopeias: the African Pharmacopoeia (169 traditional plants) and African Herbal Pharmacopoeia (51 traditional plants), which have detailed botanical description of medicinal plants and quality control protocols of traditional medicines that should be followed for chemical analysis and medicinal development of the selected African traditional plants4,5. However, this pharmacopeia does not have regulations and official standards for the quality and quantitative composition of other unlisted indigenous plants and imported drugs for quality control analysis in African settings. The limitations of the indigenous continental monograph silently promote the deindustrialization of pharmaceutical manufacturing and productivity in Africa. Lack of indigenous regulatory compendial influences poor manufacturing practice and inappropriate processes in the supply chain that support substandard and falsified medicines in many low-middle incomes countries in Africa6. The AU Commission and other indigenous pharma experts should take the lead and actions toward the development of full standard pharmacopeia for all indigenous/traditional plants to promote pharma industrialization and improve standardization of quality medicine7, and quality control of drug composition and traditional medicine in Africa, and for Africans without compromising on international standards. A collative review of the USP, Ph. Eur., and BP can provide the right direction for a start to look inward as Africans to provide a working draft that could advance the frontiers of good manufacturing practice, quality controls, proper marketing authorization and appropriate supply chain of medicines and herbal products in the AU. Regular training for experts or professionals would support the drive and sustainability of these regulations to help the government and other competent authorities in various African countries. Ethical approval None. Sources of funding None. Author contribution V.N.N.: conceptualized the study. V.N.N., A.T.A., and F.A.A.: draft manuscript, review editing, formatting, and referencing. Conflict of interest disclosure The authors declare that they have no financial conflict of interest with regard to the content of this report. Research registration unique identifying number (UIN) N/A. Guarantor Victor N. Nweze. Provenance and peer review Not commissioned, externally peer reviewed.