NAFDAC seeks collaboration on herbal medicine standardization
By Temitope Obayendo –
To bridge the gap between the discovery and clinical development of herbal medicines in Nigeria, the Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Dr Paul Orhii, has called for a strong collaboration between the research & development institutions and pharmaceutical companies.
This, according to him, would help to bridge the gap between the discovery and clinical development of herbal medicines in the country.
The NAFDAC boss made the call in Abuja at the opening ceremony of the recently held HerbFEST 2013, a herbs, health foods and natural products expo, which also featured a workshop on bio-entrepreneurship and investment opportunities for herbal, food and natural products.
Speaking on the topic: “Registration, Regulation and Development of Herbal Medicinal/Natural Food Products: Hidden Strategies to Making It Work”, DrOrhii said a close and complementary relationship between the academic community and the industry is critical to ensuring a robust national pharmaceutical research capacity for the development of medicinal products.
“The relationship between the academia and the pharmaceutical companies is complementary and naturally lends itself to the formation of joint research enterprises,” he stated.
Explaining further, he said while the academia brings strong insight into the fundamental mechanisms of disease along with expertise in patient care and clinical practice, the industry possesses the knowledge and tools to translate basic research discoveries into practical applications in patients. Collaboration between both sectors will therefore indicate a synergistic relationship between academic research and commercial activity.
The agency helmsman also urged the research institutions and the pharmaceutical industries to learn from the examples of India and China, by embarking on indigenous phytomedicinesstandardisation and have a local agenda for such research and development.
On standardisation and quality control of herbs in Nigeria and Africa, as a whole, he noted that there was a need for deliberate policy on medicinal plants standardisation, including the procedures and methods for sourcing, collecting, drying, processing, packaging etc. of raw materials from the field to the bottle, covering planting, manuring, tendering to harvest and storage of raw materials.
“We must have QC (quality control) and standardise extraction procedures and preparation of biomass to dosage form. Factors such as the use of fresh plants, age and part of plant collected, period, time and method of collection, temperature of processing, exposure to light, availability of water, nutrients, drying, packing, transportation of raw material and storage, can greatly affect the quality, and hence the therapeutic value of herbal medicines,” he stressed.
He also noted the indispensability of regulation, asserting that since herbal medicine is multicomponent, it would be difficult to isolate each plant. This therefore validates the need for standardisation, a strategy the Indians adopted for their Ayuvedic medicine and China for their TCM.
Orhii, who also appealed to manufacturers and processors of natural products to abide by the agency’s guidelines on registration of their products, decried the difficulties encountered in the process of regulating the activities of product manufacturers.
“Although Nigeria has a national policy on traditional medicine and NAFDAC regulations cover requirements for registration of natural products, with guidelines, getting manufacturers/ processors to comply is still a herculean task, as control is incorrectly perceived to be ”discouragement” and “bottlenecks”. However, we cannot continue to lament on the ”burden” of regulatory compliance, because it is a necessary tool for guaranteeing safety and quality,” he pointed out.