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Abstract Background The World Health Organization encourages governments to develop legal frameworks for the regulation of traditional medicines to ensure their safety, quality, and efficacy. There is very little published research on the availability of herbal medicine regulatory tools and the extent of compliance by manufacturers in many countries in Sub-Saharan Africa. The study assessed the current situation on traditional medicine regulatory frameworks and compliance of herbal medicinal products among people living with HIV/AIDS in Malawi and Nigeria. Methods A descriptive cross-sectional study was done using a structured questionnaire and checklist to collect data from officers, premises, 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 and sixty-six herbal medicinal products from Malawi, and twenty-eight herbal medicinal products from Nigeria were evaluated. Results The 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. The Ministry of Health, Malawi scored 28.6% while Nigeria scored 71.4% on the 7-item checklist of regulatory requirements. Both countries had no regulations on traditional medicine practice, and traditional and complementary medicine had not been integrated into the health system. Most manufacturers performed poorly on personnel hygiene (58.6%) and were non-compliant with cleaning production equipment (69.0%), inadequate storage room (72.4%), and lack of documentation on standard operating procedures (SOPs) for cleaning equipment and premises (93.1%). There was non-compliance on the list of names of active ingredients (45.5%, 93.0%, p < 0.001), list of quantities of active ingredients (12.1%, 53.6%, p < 0.001), list of side effects (9.1%, 57.1%, p < 0.001) and storage conditions (15.2%, 67.9%, p < 0.001) in Malawi and Nigeria, respectively. Conclusion Malawi lacked a well-established regulatory framework for the regulation of herbal medicines and with evidence of poor compliance with manufacturing and labeling requirements. This may have contributed to the production of more herbal medicinal products with questionable quality and safety putting the public at risk in Malawi than in Nigeria.
Mponda et al. (Thu,) studied this question.