The use of poor-quality antimalarials has devastating consequences, including increased morbidity, mortality, and drug resistance. Unfortunately, this issue appears to be widespread, especially in parts of Africa and Asia, jeopardizing the progress and investments already made in global malaria control in these regions. In developing countries, inadequate laws and regulatory oversight, along with the lack of human, technical, and financial resources, do not encourage the manufacture and distribution of high-quality medicines. The problem of poor-quality medicines can only be addressed by a multipronged approach that includes tackling poor regulation and ineffective/poorly implemented laws at national and international levels. In addition, pharmaceutical companies must be responsible for ensuring that the quality of antimalarials meets the stringent guidelines established by regulatory authorities, for testing their medicines accordingly and for releasing to market only medicines that pass these requirements. The chapter also discusses how the implementation of strategies such as the WHO Prequalification Program, the African Medicine Registration Harmonization initiative, and the ethical production of medicines by pharmaceutical companies help to ensure that antimalarial therapies marketed in low-income, malaria-endemic countries are quality assured.
Part of the book: Current Topics in Malaria