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FEDERAL REPUBLIC OF NIGERIA AFRICA HERBAL ANTIMALARIAL MEETING PRESENTATION BY HASHIM UBALE YUSUFU NAFDAC – NIGERIA 20 – 22 MARCH 2006 NAIROBI KENYA. ABOUT NIGERIA Population over 130 million people − Growing at about 3%/annum − Most populous nation in Africa Several languages/dialects and cultures − English official language Nigeria’s Healthcare System Primary LGA responsibility Oversees Health posts, health clinics, health centers Community health worker Secondary State responsibility. Oversees General and Cottage hospitals (One in each of 774 LGAs. Other secondary health care providers Tertiary Largely Federal responsibility Teaching and specialist hospitals − At least one in each of 36 states and FCT Few private hospitals with limited but highly specialized services HISTORY. • The use of herbal medicines' in Nigeria dates back to the earliest history of mankind, as in other cultures worldwide. • People have relied totally on traditional remedies for all their healthcare needs. • They use herbs, animal or mineral based medicines often laced with spiritual ingredients such as incantations. It is a source of livelihood for a significant number of our population. 1. The closest to the people. 2. High cost of allopathic medicines have encouraged demand. 3. Lack of adequate primary healthcare have made people resort to TMPs for their immediate treatment. As the population increases, demand for traditional medicine will increase. NAFDAC MANDATE To Control and Regulate the: • • • • • • • Manufacture Importation Exportation Distribution Advertisement Sale Use OF • • • • Foods Drugs Cosmetics Chemicals and Detergents • Medical Devices • All Packaged Drinks PROBLEMS WITH EARLY REGULATION OF HERBAL PRODUTCS. • Very little attention from Government. • Resistance and lack of co-operation of practitioners due to lack of trust of government intentions. • Insecurity due to fear of loss of traditional knowledge. STRATEGIES undertaken for successful implementation of regulation and control of herbal medicines: • Organized a workshop on Standardization and Regulation of Herbal Medicines (1997) in collaboration with BDPC and WAPF. • Consultative meeting with NIPRD, to develop draft regulations and guidelines. • Review of the draft guidelines by committee of experts leading to categorized protocol for listing/registration of traditional/herbal medicines. • In line with WHO recommendation of accepting herbal products based on long history of safe use in a locality, decided to use acute toxicity tests as safety parameter for simple herbal preparations. • Efficacy tests, detailed analysis and clinical trials for drugs for complex diseases such as Hepatitis, HIV/AIDS etc. GUIDELINES FOR REGISTRATION/ LISTING OF HERBAL MEDICINES AND RELATED PRODUCTS GENERAL RULES Herbal medicinal products to be considered for registration or listing were categorized as: – Herbal medicinal products manufactured locally. – Imported Herbal medicinal products. – Homeopathic herbal medicinal products. APPLICATION. 1. 2. Applicants shall obtain an application form upon payment of prescribed fees. The applicants/manufacturers shall submit completed application forms with relevant documents vis: - • Receipt of purchase of application form. • Certificate of Registration of Business. • An acceptable certificate of analysis testifying that the medicine is of proven quality and safety from accredited centers recognized by NAFDAC. • Appropriate Dossier Format (containing method of analysis or assay of the medicine, stability data etc) for product to get registered /listed. • Any other relevant documents. • Pre-registration inspection shall be carried out on the production premises by NAFDAC Inspectors after payment of prescribed fees to assess Good Manufacturing Practice (GMP) standards • If inspection is satisfactory, NAFDAC inspectors will collect samples for Laboratory analysis. • All herbal medicinal products must be adequately labeled before samples are sent to the laboratory. • On receipt of satisfactory laboratory report, the product is approved for listing. For full registration, satisfactory report of local clinical trials will be required. * Note that listing is for two (2) years period while registration is for (5) years. • All applicants/manufacturers shall pay the prescribed fee for registration/listing Certificate after approval. • Applicants/manufacturers shall submit mandatory post marketing surveillance report on the use and adverse reactions of the herbal medicinal products periodically. IMPORTED HERBAL MEDICINAL PRODUCTS • In addition to General rules, the following documents are required for imported herbal medicinal products. – Power of Attorney issued by the manufacturer and notarized by a notary public from the Country of Origin. – Certificate of pharmaceutical production (COPP). – Application for permit to import samples for registration/listing purpose. – Evidence of satisfactory clinical trials conducted in the Country of origin as appropriate. – Any other relevant information on the products OTHER REQUIREMENTS INCLUDE: • Applicants shall submit dossiers containing relevant information on the products format. • Oversea GMP INSPECTION will be carried out on the premises of the manufacturer of herbal medicinal products. • A mandatory local clinical Trial in an approval Institution to be funded by the applicants /manufacturers must be carried out for full registration. • On receipt of satisfactory laboratory reports, the products may be approved for registration/ listing. • Applicants shall also pay a prescribed fee for registration /listing Certificate after approval. LABELLING REQUIREMENTS • The herbal medicinal preparations manufactured locally or imported to Nigeria shall carry the following basic labeling information in English and may include other languages. • Name of the product (Not suggestive of therapeutic claim). • Generic name if applicable. • Quantitative list of Ingredients by their Botanical or common names. • Dosage for and Net contents in terms of weight/measure count. • Directions for use • Indications (shall be on the leaflet). No claim of cure is permitted until proven through clinical trial. Also subject to advertisement regulations. • Batch number. • Manufacturing date • Expiry date • Special storage conditions. • Name and full location address of manufacturer. • Provision for NAFDAC registration number. • Dosage • Mode of administration. • Duration of use (e.g. specify if expected response is not felt within a certain number of days consult your doctor) • Specific symptoms of overdose and antidote on the leaflet • Contra-indications/drug interactions • Warnings, if any. • Precautions. (E.g. use in pregnant and lactating mothers not recommended). PROMOTION OF TMP • Public Enlightenment Campaigns throughout the country • Developed a Standard Pharmacognosy Laboratory • Conducted international and local trainings to build capacity. • Sponsored the TMP to build strong associations. • Supported Research Institutions and Universities. CONTROL OF ADVERTISEMENT: • Conducted a workshop to educate the media on the dangers of advertising the claims of HMPs which have not been substantiated. • Media houses were warned that advertisement without clearance from NAFDAC will be sanctioned. • Called on the NBC to support us in the crusade. • The Director General also advocated to the State Governors to stop State Media houses from advertising the unapproved claims of herbal medical practitioners. PUBLIC AWARENESS CAMPAIGNS CONCLUSION • NAFDAC has put in place appropriate mechanisms for the regulation and control of Herbal Medicines. • We have encouraged practitioners to come out and market their products without much fear. • The Agency is building strong collaboration between the Ministry of health, Research Institutes, Universities and the Practitioners. THANK YOU Website: www.nafdacnigeria.org Email: [email protected] [email protected] [email protected] CONTACT PHONE NUMBERS FEDERAL REPUBLIC OF NIGERIA ABUJA: 234-9- 5240994-6 LAGOS: 234-1-2693104-5 GSM: 234-80 33112282 OR 234-80 441 83109 39 26