A review on role of quality control and quality assurance system in regulation of herbal drugs

Abstract

Medicinal plants constitute a source of raw material for both traditional system of medicine and modern medi- cine. Herbal medicines have the potential for improving public health at low cost and comparison with modern medicines, the occurrence of undesirable side effects seems to be less frequent. In most countries herbal products are launched in to the market without proper scientific evaluation and any mandatory safety, toxicological studies. Each country or area should adopt a regulatory system to manage the appropriate use of herbal medicines. Adopt- ing a regulatory mechanism will help ensure that herbal medicines have acceptable quality, safety and efficacy. The WHO guidelines for the assessment of herbal medicines should be consulted when assessment for herbal me- dicines are being prepared. Quality control for the safety and efficacy of herbal drug is essential. The quality con- trol of phytopharmaceuticals may be defined as the status of a drug, which is determined either by identity, puri- ty, drug contents and other physico-chemical properties and biological parameters or by the manufacturing process. Quality assurance of herbal medicinal product is not only the responsibility of manufacturers but also the regulatory bodies. The assurance of the safety of an herbal drug requires monitoring of the quality of the consum- er information on the herbal remedy.