Complementary medicines: When regulation results in revolution

Abstract

Medicines have evolved over time and so has the realisation of the importance of quality control and regulatory processes. The regulatory practices include all the steps from the development and manufacture of the active ingredients until the medicines reach the consumer. The Medicines Control Council (MCC) is mandated to regulate medicines in South Africa. Complementary medicines were previously perceived to be unregulated, although the Medicines Act does not distinguish between allopathic and complementary medicine. As the era of unregulated complementary medicine ended, the requirements in terms of dossier content left many role-players at odds. However, the MCC has a mandate to ensure that the registration of a medicine is in the interest of the public and that complementary medicine is manufactured in a facility adhering to good manufacturing practice, according to which efficacy and safety are supported by reliable data with a known shelf-life.