South Africa: Regulation of Complementary Medicines Under Scrutiny

The regulation of complementary and alternative medicines in South Africa has been hotly contested in recent decades, including in court rooms. In his latest column for Spotlight, Dr Andy Gray unpacks the legal background and the current state of this still unfolding regulatory saga. Multivitamin and mineral supplements are commonly found in many South African retail outlets, from pharmacies to health shops and supermarkets. Some outlets will stock a wider range of medicines, perhaps on shelves marked as "complementary", or among other non-prescription medicines available for self-service. Are these medicines regulated in the same way as other medicines, including those available on prescription? The concept of a "call-up notice" Follow us on WhatsApp | LinkedIn for the latest headlines When South Africa's medicines legislation was first passed in 1965, there were already many medicines on the local market which had not been assessed for safety, efficacy or quality. As all such medicines could not be immediately "called up" for registration, a stepwise approach had to be followed. Between 1967 and the mid-1980s, medicines were identified for registration by pharmacological classification. The remnant of that approach is still evident in section 14(1) and (2) of the Medicines and Related Substances Act, 1965: (1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine, ... which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered. (2) (a) The Authority may from time to time determine that a medicine, ..., or class or category of medicine, ... or part of any class or category of medicine, ... mentioned in the declaration, shall be subject to registration in terms of this Act. (b) Any such declaration may also relate only to medicines, ... which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines, ... which were not then so available. The declaration that a category or class of medicine is subject to registration is referred to colloquially as a "call-up notice". A notice could be applied to those medicines already marketed, or only to those not yet marketed. Medicines which were already marketed but exempted from a full registration process were then regulated as "old medicines". They are still subject to control according to their scheduling status and their production still needs to be in accordance with Good Manufacturing Practice. In time, new brands of some of the "old medicines" have been registered. By the mid-1980s, the process of working through the pharmacological classifications was concluded. Thereafter, every new medicine would need to be registered before being marketed. In other words, a manufacturer or importer would need to provide sufficient evidence of the medicine's safety, efficacy and quality to justify registration. However, an important exception was created in 1986, which exempted homeopathic medicines from the full registration process. Two important restrictions were included. Firstly, no medical claims could be made for the medicine. Secondly, the following wording was to be included on the label of such medicine: "Homeopathic Medicine" and "WARNING: Use only as directed by a medical practitioner, pharmacist or homeopath". The provision applied to homeopathic mother substances and so-called "minute-dose forms" made in accordance with homeopathic principles. Broadening the scope of complementary medicines Homeopaths are one of several complementary and traditional health professions regulated by the Allied Health Professions Council of South Africa. Medicines legislation has been amended to accommodate this wider range of complementary and traditional medicines. A separate South African Health Products Regulatory Authority (SAHPRA) web site is dedicated to what are termed Category D medicines, also known as co