South Africa: Inside the Box With Dr Andy Gray | Are Complementary Medicines Effectively Regulated in South Africa?

The regulation of complementary and alternative medicines in South Africa has been a contentious issue, with legal disputes playing a significant role. Dr Andy Gray, writing for Spotlight, examines the legal context and current state of this ongoing regulatory effort. These medicines are frequently encountered in various retail establishments across South Africa, from pharmacies to health shops and supermarkets.

Some outlets display a broader range of these medicines, sometimes labeled as complementary or sold alongside other over-the-counter remedies.

When South Africa's medicines legislation was initially enacted in 1965, many medicines were already circulating in the local market without assessment for safety, efficacy, or quality. Consequently, a phased approach was adopted to address this. Between 1967 and the mid-1980s, medicines were categorized pharmacologically to determine which needed registration.

This method continues to influence section 14(1) and (2) of the Medicines and Related Substances Act, 1965. The Act stipulates that unless otherwise declared, no person can sell a medicine unless it is registered. Declarations can target specific medicines, classes, or categories, and can be issued for either those already on the market or those not yet available.

Old medicines, those already on the market when a declaration is made, are regulated under existing laws and must adhere to Good Manufacturing Practice. New brands of these old medicines may subsequently be registered. By the mid-1980s, the process of cataloging medicines by pharmacological classification was completed, necessitating full registration for all new medications moving forward.

However, a notable exemption was established in 1986, exempting homeopathic medicines from the full registration process. This exemption included restrictions: no medical claims could be made, and specific labeling requirements were mandated. Homeopathic medicines and their minute-dose forms, produced according to homeopathic principles, fall under this category.

Over time, complementary and traditional health professions, including homeopathy, have been regulated by the Allied Health Professions Council of South Africa. SAHPRA oversees Category D medicines, also known as complementary medicines, through its dedicated website. The Medicines Act defines complementary medicines as health supplements and medicines used according to a specific discipline determined by the Authority.

This definition encompasses various disciplines such as aromatherapy, homeopathy, phytotherapy, traditional Chinese medicine, unani medicine, western herbal medicine, combination products, and other herbs. Health supplements included in these medicines range from amino acids to vitamins.

The aim has been to gradually bring all complementary medicines under regulation using a risk-based approach, focusing initially on those claiming antiviral properties, treatments for diabetes, cardiac issues, and cancer. Despite these efforts, no complementary medicines have been registered, and initial call-up notices have been rescinded.

The process has been impacted by legal challenges, notably a case brought by the Alliance of Natural Health Products of South Africa, which was decided by the Supreme Court of Appeal in 2022. The court ruled that SAHPRA should not have regulatory authority over substances not meeting the medicine definition. Preparations intended to supplement diets or provide nutritional benefits are classified as foodstuffs, not medicines.

Recent amendments to the 2017 General Regulations, influenced by this court decision, have been published for public comment but remain pending final issuance.