Regulatory Bottleneck Stalls Safety Reviews for Complementary Medicine Products in South A

SAHPRA’s complementary medicines registration process has yet to assess a single product for safety or efficacy since South Africa’s formal regulatory roadmap was established.

The South African Health Products Regulatory Authority has put interim controls in place, including licensing requirements and labeling restrictions, but the core registration system that would require full safety and efficacy assessment remains unapplied across the entire complementary medicines sector. The gap between what was planned and what has been delivered is wide.

South Africa’s medicines legislation dates to 1965, when thousands of products already circulating in the market had never been assessed for safety, efficacy or quality. Rather than halting all unregistered products immediately, authorities adopted a phased approach using “call-up notices” to systematically identify categories requiring formal registration. Between 1967 and the mid-1980s, medicines were processed by pharmacological classification. By the mid-1980s, that initial work was largely complete, and new medicines entering the market thereafter were required to undergo full registration before sale.

Complementary medicines received a distinct pathway. In 1986, homeopathic medicines were exempted from full registration, though manufacturers faced two key restrictions: they could not make medical claims about their products, and labels had to carry specific warnings directing users to consult a medical practitioner, pharmacist or homeopath. That exception reflected the status of homeopaths as regulated health professionals under the Allied Health Professions Council of South Africa.

Over subsequent decades, the scope of complementary medicines expanded well beyond homeopathy to include Western herbal medicine, traditional Chinese medicine, Unani medicine, aromatherapy, phytotherapy and various combination products. Health supplements, including vitamins, minerals, amino acids and probiotics, were also incorporated into the category, formally designated Category D medicines.

In 2013, SAHPRA announced its intention to progressively bring all complementary medicines under effective regulation using a risk-based approach. The initial focus targeted medicines claiming antiviral properties and those intended to treat diabetes, cardiac conditions and cancer. No complementary medicines have been registered through this process. The original call-up notices issued in 2013 were subsequently repealed.

Litigation compounded the disruption. The Alliance of Natural Health Products of South Africa challenged the complementary medicines regulatory scheme, and the Supreme Court of Appeal decided the case in 2022. The court found that SAHPRA should have no regulatory authority over substances and preparations that do not meet the legal definition of a medicine, ruling that a preparation designed to supplement a diet or provide nutritional benefit constitutes a foodstuff, not a medicine. Draft amendments to the 2017 General Regulations, informed by that judgment, were published for public comment in March 2023 but have not yet been finalized.

Meanwhile, SAHPRA has implemented what interim controls it can. All manufacturers, wholesalers and distributors of complementary medicines must be licensed by the authority, though this process relies on applicants’ attestation of compliance with minimum requirements rather than the full Good Manufacturing Practice inspections applied to other medicine manufacturers. SAHPRA retains the right to conduct inspections where warranted. The authority updated its overall regulatory roadmap in 2021 and has issued a series of guidelines to govern the sector in the interim.

Unregistered complementary medicines must carry a label statement declaring: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.” The framework distinguishes between low-risk and high-risk claims. Low-risk claims cover general health enhancement without reference to specific diseases, health maintenance, or relief of minor symptoms unrelated to disease. High-risk claims, including those using terms such as “clinically proven,” may trigger individual call-up notices requiring registration.

Health supplement manufacturers face particular restrictions. They may only make low-risk claims, and specific annexures to SAHPRA guidelines detail allowable ingredient levels and permitted claims for each supplement type. A single-component vitamin B3 product for adults, for example, cannot exceed 500 milligrams per dose and can only claim to help metabolize carbohydrates, fats and proteins, contribute to normal growth and development, or serve as a factor in maintaining good health.

SAHPRA’s complementary medicines website maintains a searchable database of 117 licensed manufacturers, importers and exporters, along with details of their products, ingredients, recommended doses and intended uses. The public can lodge complaints about complementary medicines through the site, including anonymous complaints.

Significant operational gaps remain. The risk-based call-up process has not commenced. Moving from attestation-based licensing to confirmed compliance with current Good Manufacturing Practice standards is still pending. Proprietary brand names for complementary medicines are not pre-approved by SAHPRA, and many violate naming guidelines applied to other medicines. Effective oversight of advertising and marketing practices remains limited. African traditional medicines are not currently captured in the Category D definition at all, leaving an important segment of the complementary medicine market entirely outside the regulatory system. Whether the finalization of the 2023 draft amendments will provide the legal foundation needed to close these gaps remains the central question for SAHPRA’s implementation work ahead.