NAFDAC Explains Enforcement of Certification and Registration of Herbal Products

National Agency for Food and Drug Administration and Control (NAFDAC) has called on traditional medicine practitioners on the need to ensure the development of quality and safety standards for herbal medicines, saying NAFDAC is enforcing the certification and registration of herbal products in accordance with the Drugs and Related Products Registration Decree, not to witch hunt their practice.

Dr Paul Orhii, the Director General (DG) of the agency who stated this as part of activities marking this year's African Traditional Medicine Day, said to ensure the development of quality and safety standards for herbal medicines, the agency had established: standards and appropriate guidelines for the production, listing and registration of herbal medicinal products in the country; the Expert Committee on verification of claims of herbal products; regulations and guidelines for the regulation of herbal medicinal products.

This year’s event is the 13th edition with theme ‘Regulation of Traditional (Herbal) Medicine production in the African region’.

Dr. Orhii who was represented by Director, Drug Evaluation and Research Directorate, Mrs Titilope Owolabi, said to use acute toxicity alone as safety parameter for simple herbal preparations and stipulated that all herbal preparations must meet labelling, safety, quality and purity requirements in order to be registered by NAFDAC.

He added that NAFDAC had adopted the ratified WHO guidelines (1991) for the assessment of traditional medicines which has as its salient features: Quality assessment for crude plant materials, etc., Stability (Shelf life determination), Safety assessment and Assessment of efficacy by ethno medical information and biological activity evaluations.