Chapter 7 - Regulations for the use of herbal remedies

Abstract

The use and availability of herbal remedies and products are ubiquitous and their widespread global demand continues to grow. However, the quality, safety, and efficacy (QSE) of herbal products present major concerns and attempts by regulatory bodies to control these medicines have been a daunting challenge. In most global jurisdictions, herbal remedies and products are considered as a component of a larger category of natural products, which are classified as complementary or alternative medicines (CAMs). Allopathic medicines mainly consist of synthetic compounds whose chemistries have been well established and identified and, as a consequence, appropriate quality control and related procedures are readily implemented. Herbal medicines, on the other hand, generally consist of formulations containing complex mixtures of plant components and often also include some unidentified compounds, hence, making the application of appropriate methods to assess the quality of these medicines much more difficult. In addition, selection of plant material, formulation, and manufacturing procedures are also important aspects that must be considered. Classification, standardization, issues of adulteration and contamination, and regulatory challenges are addressed and the regulatory requirements for herbal medicines in some selected countries are provided.