Quality Control, Screening, Toxicity, and Regulation of Herbal Drugs

Abstract

Medicinal plants constitute a source of raw materials for both traditional systems of medicine (e.g. Ayurvedic, Chinese, Unani, Homeopathy, and Siddha) and modern medicine. Nowadays, plant materials are employed throughout the industrialized and developing world as home remedies, over-the-counter drugs, and ingredients for the pharmaceutical industry. As such, they represent a substantial proportion of the global drug market. Most rural populations, especially in the developing world, depend on medicinal herbs as their main source of primary health care. Although most medicinal herbs are not, in their natural state, fit for administration, preparations suitable for administration are made according to pharmacopeia directions. The therapeutic potential of a herbal drugs depends on its form: whether parts of a plant, or simple extracts, or isolated active constituents. Herbal remedies consist of portions of plants or unpurified plant extracts containing several constituents, which often work together synergistically. The herbal drug preparation in its entirety is regarded as the active substance and the constituents are either of known therapeutic activity or are chemically defined substances or group of substances generally accepted to contribute substantially to the therapeutic activity of the drug. Phytochemical screening involves botanical identification, extraction with suitable solvents, purification, and characterization of the active constituents of pharmaceutical importance. Qualitative chemical examination employing different analytical techniques is conducted to detect and isolate the active constituent(s). In general, all medicines, whether they are synthetic or of plant origin, should fulfill the basic requirements of being efficacious and safe. Ultimate proof of these can only be achieved by some form of clinical research. A defined and constant composition of the drug is therefore one of the most important prerequisites for any kind of clinical experiment. Quality control for the efficacy and safety of herbal products is essential. The quality control of phytopharmaceuticals may be defined as the status of a drug, which is determined either by identity, purity, content, and other chemical, physical or biological properties, or by the manufacturing process. Compared with syn25