Chapter 21 Regulation of herbal medicines in Nigeria: the role of the National Agency for Food and Drug Administration and Control (NAFDAC)

Abstract

Abstract In most developing countries, including Nigeria, the majority of the populace lives in the rural areas, where the use of herbal medicines is common. The use of herbal medicines in the urban areas is on the increase, arising from the global inflationary trend, which hampers the sustainable supply of orthodox medicines and reduces the purchasing power of the populace. The Nigerian Government has recognized the need and shown political will by approving and adopting guidelines for the practice of traditional medicine. The regulatory authority, the National Agency for Food and Drug Administration and Control (NAFDAC), has also taken steps to protect the health of consumers by drafting the ‘Guidelines for the Registration and Control of Herbal Medicinal Products and Related Substances in Nigeria’. Three broad classes are defined in the Guidelines, and preparations will be considered under four categories, each of which has its protocol. Extemporaneous preparations are only to be listed and not registered or advertised. Post-listing evaluation/monitoring is, however, mandatory. Herbal medicinal products manufactured on a large scale, whether imported or locally manufactured, must be registered and their advertisement messages and scripts approved by NAFDAC prior to their marketing. Homeopathic medicinal products must be registered and their advertisement messages approved prior to marketing. Post-registration evaluation/monitoring is also mandatory for both large-scale herbal medicinal products and homeopathic products.