ABSTRACT

Herbal product development and characterization involve robust quality assurance systems and commitment. These include document and record control for all stages of development, from raw materials to the market. Various qualification tests conducted include phytochemical, bioactivity, and toxicity tests against preset standard specifications. However, large-scale 242production of herbal products remains a dream even after centuries of use and years or research on the same. More of these products are found with no controls, fewer regulations, and no scientific evidence of claims they carry along. Their characterization is poor largely due to lack of appropriate documentation of tests, protocols, as well as systems A large pool of herbal products is available out there, but no strong impact is felt to the point that herbal products still do not reach the prescription stage. The culture and unmethodical approach in herbal product development is found wanting in many ways, which challenges its legitimacy over the years and make it fail to grow into huge investment operations as are conventional pharmaceuticals product developments. There is a need to modify the approach taken in the practice and focus on quality and safety (Q&S) systems, as well as regulatory standard development, which will start strengthening the legitimacy of these products, which is already there by not shown off. This work has outlined basic steps for the characterization of herbal products in regard to product development. Now is time that investors relook at this potential health area and move from mere phytochemical screening to huge industrialization of herbal products. This requires a meaningful collaboration among stakeholders.