Traditional medicine regulation status and challenges in Malawi and Nigeria.

backgroundThe World Health Organization encourages governments to develop legal frameworks for the regulation of traditional medicines to ensure safety, quality, and efficacy. There is inadequate published research on the traditional medicine legislative tools and Good manufacturing practices compliance by manufacturers in many countries in Sub-Saharan Africa. The study assessed the traditional medicine regulatory status and challenges in Malawi and Nigeria.

methodsA descriptive cross-sectional study was done using a structured questionnaire and a checklist of regulatory requirements to collect data from officers, manufacturing facilities, and herbal medicinal products. Twenty-three officers from the Medicines Regulatory Authorities and Ministries of Health from Malawi and Nigeria were interviewed. Thirty-one small-scale manufacturers, sixty-six herbal medicinal products from Malawi, and twenty-eight herbal medicinal products from Nigeria, that were used by people living with HIV and AIDS, were evaluated.

resultsThe Pharmacy and Medicines Regulatory Authority scored 7.7% in Malawi while the National Agency for Food and Drug Administration and Control in Nigeria, scored 77.0% on the 13-item regulatory checklist of regulatory requirements. The Ministry of Health, Malawi scored 28.6% while Nigeria scored 71.4% on the 7-item checklist of regulatory requirements. Both countries have no regulations on traditional medicine practice, and traditional medicine has not been integrated into the healthcare system. Most Malawian manufacturers showed poor compliance, with deficiencies observed in personnel hygiene (58.6%), cleaning production equipment (69.0%), storage rooms (72.4%), and documentation on standard operating procedures for cleaning equipment and premises (93.1%). Labelling non-compliance was observed in Malawi and Nigeria, respectively, for the list of active ingredient names (45.5% vs. 93.0%, p < 0.001), quantities of active ingredients (12.1% vs. 53.6%, p < 0.001), side effects (9.1% vs. 57.1%, p < 0.001), and storage conditions (15.2% vs. 67.9%, p < 0.001).

conclusionMalawi lacks a strong regulatory framework for herbal medicines, with poor compliance to current Good Manufacturing Practices standards in manufacturing and labelling, posing serious public health risks. Urgent action is needed to establish comprehensive regulations, including guidelines for registering herbal medicines used by people living with HIV and AIDS. While Nigeria has a more developed regulatory framework, enforcement remains a challenge. Strengthening inspections and ensuring adherence to safety and quality standards for herbal products is critical to safeguarding public health and building consumer confidence in both countries' traditional medicine industries.