Herbal medicinal products

Abstract

Throughout most of the history, plants have been a source of medicines for the treatment of a wide array of diseases. Plant parts and plant extracts have been traditionally used to prevent or cure diseases. During the recent years there has been resurgence in the use of herbal products, which may be due to growing consumer dissatisfaction with conventional medicines, progress in chemical, pharmacological and clinical evaluations, development of newer dosage forms and increase in automedication. Herbal Medicinal Products (HMP) are those medicinal products that contain exclusively as ingredients herbal drugs (e.g. parts of plants) or pharmaceutical preparations there of (e.g. extracts, essential oils, etc.). The World Health Organization (W.H.O.) encourages, recommends and promotes traditional/herbal remedies in national health-care programs because these drugs are easily available at low cost, comparatively safe, and have increasing public faith in them.WHO has publishedmonographs on the quality, safety, and efficacy of selected medicinal plants [1–4], as well as recommendations on the cultivation of medicinal plants [5], on the quality control [6], and safety and efficacy [7] of herbal medicinal products. Part of this paper has been abstracted from the previous publications and workshop proceedings [8–11]. In addition, many EU Directives and Guidelines were consulted for the preparation of this Chapter [12–22]. It is important to define various terms used for herbal medicinal products. Table 1 gives definitions of common herbal terminology used in Europe. In the United States, these products are called “Botanical Products”, and are defined as finished, labeled products that contain vegetable matter as ingredient which may include plant materials (A plant or plant part as well as exudates thereof), algae, macroscopic fungi or combination of these. A botanical product depending on its labeling and intended use may be a food, dietary supplement, a drug, a medical device (e.g. gutta-percha), or a cosmetic under the Dietary Supplement Health and Education Act of 1994 (DSHEA) [23]. Food and Drug Administration (FDA) has issued a “Guidance for Industry: Botanical Drug Products”