The status, or conspicuous absence, of regulation of proprietary or locally manufactured African traditional medicines in South Africa: a constitutional injustice.

Despite heavy reliance on African Traditional Medicines (ATMs) by approximately 80% of Black South Africans, South Africa exhibits a conspicuous regulatory gap characterized by a complete absence of an official regulatory framework for ATMs indigenous to its borders. On the contrary, the South African Health Products Regulatory Authority (SAHPRA) provides a comprehensive regulatory framework for non-indigenous complementary medicines under Category D. This policy and practice review argues that this unambiguous dichotomy constitutes a structural and constitutional injustice. It violates constitutional rights to equality and healthcare access and exposes consumers to significant public health and economic risks. Using a document analysis, this study examines SAHPRA's current guidelines and relevant legislation and found no evidence of ATM regulation. To rectify this disparity, we propose a simplified, layered, or risk-based model like those successfully implemented in other African nations such as Ghana, Nigeria, Uganda, and Lesotho. These ensure cultural respect, consumer safety, and legal equity within the national healthcare system.