Abstract
Echinacea purpurea (L.) Moench (E. purpurea) is a flowering plant belonging to the Asteraceae family that originates from North America. It is composed of active compounds such as caffeic acid, alkamides, phenolic acid, and rosmarinic acid. These compounds are said to have many health benefits, such as the reduction of inflammation and an improved immune system. A global increase in the use of Complementary Medicines (CMs) largely attributed to the dissatisfaction with allopathic drug side effects, the high cost of drugs, problems with chronic conditions, and perceived dangers associated with the use of medicinal substances with adverse side effects has led to inevitable questions raised about their quality, safety, and therapeutic efficacy.
The South African Health Products Regulatory Authority (SAHPRA) (previously the Medicines Control Council (MCC) was established in 2018 to monitor, evaluate, investigate, inspect, register, and review all health products in South Africa and has, together with the Minister of Health, implemented controls specific to Category D medicines (CMs). While permitted continued rights of sale all qualifying unregistered medications must meet the labelling standards outlined in regulations 10, 11, and 12 of the General Regulations of the Medicines and Related Substances Act 101 of 1965 (the “General Regulations”).
This study aimed to conduct a review of the degree to which medicines consisting of E. purpurea on the South African market are compliant with regulatory requirements as stipulated by the Medicines Act and SAHPRA by assessing labelling compliance, product risk profiles and indications with verification against relevant recognised monographs and scientific sources where required.
This non-experimental quantitative study consisted of the evaluation and descriptive analysis of the regulatory compliance related to the labelling of 19 CMs which only contain E. purpurea as an active ingredient. Products containing E. purpurea were purchased from pharmacies and health shops in Johannesburg and online outlets. Each product label and indication were assessed according to the criteria set out by the SAHPRA.
The study concluded that out of the 19 CM products reviewed, none of them were completely compliant with the mandatory minimum labelling requirements prescribed in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), (the “Medicines Act”) and the
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SAHPRA labelling Guidelines in terms of the immediate product container label, professional information (PI) and patient information leaflets (PIL).
The study recommended that further similar studies be carried out to ensure full compliance with the SAHPRA labelling Guidelines for CMs on the South African market to ensure quality, efficacy and user safety.