Quality Control of Herbal Medicinal Products

The quality control of medicinal agents derived from natural sources is of paramount in ensuring safety and efficacy. The major hindrance in the acceptance of herbal medicines into modern medical practices is the lack of scientific and clinical data on the safety and efficacy of the herbal products. In general, there is a lack of strict guideline for quality control of herbal medicinal products used for the treatment of various human diseases. In recent years, due to enormous increased interest in herbal medicine, we need strict quality control parameters for safe and efficacious herbal medicine. Several quality control parameters (e.g. organoleptic, morphological, physico-chemical, chromatographic and toxic substances) are mentioned in Pharmacopoeias like Indian Pharmacopoeia (IP), British Herbal Pharmacopoeia (BHP), Ayurvedic Pharmacopoeia of India (API) and WHO guidelines etc. Chromatographic techniques, such as TLC, HPTLC, HPLC, GC-MS; and toxic substances such as aflatoxins, heavy metals, pesticide residues, microbial load determinations, are important parameters considered for quality control of herbal drugs. This book chapter provides a critical overview of different quality control parameters of herbal drug, which are necessary for compliance of regulatory guidelines of several developing and developed countries.

Keywords: HPTLC, Herbal Products, Pharmacopoeia, Quality Control, Standardization, WHO Guidelines.