Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 6- although herboristerias were controlled by law, the sale of medicinal plants through other distributionchannels was completely uncontrolled, which might be of critical importance where potentially toxicplants are sold;- although pharmacognostic methods are described in the Pharmacopea Nacional Argentina, nomethods for the determination of active principles, e.g., quantitative assay, were indicated;- there was no official definition of what is a medicinal plant and what is not, some plants being usedas food although they were included in the pharmacopoeia; and- with respect to the Law No. 16.463, it was not clear which requirements had to be fulfilled to apply forregistration of a new medicine based on medicinal plants.Although scientific knowledge on medicinal and toxic plants was growing, it was necessary to gain moreinformation about the utilization of 700-800 species. There was no academic specialization for the control andthe processing of medicinal plants [15].For these reasons, the need for future legislation to remedy the unsatisfactory situation relating to medicinalplants became evident [15].In November 1993, a regulation for registration and commercialization of medicinal plants was published bythe Health Ministry of the Provincia de Buenos Aires. With this regulation, an obligation for the registration ofmedicinal herbs was established. The herboristerias had to register their products within 180 days, togetherwith documentation containing e.g., name of the plant, part of the plant, active principles, identification, andindications. In the case of a mixture of herbs, the benefit of the combination had to be demonstrated. Thecertificate issued by the Laboratorio Central de Salud is valid for five years, and a prolongation must be appliedfor 30 days before expiry [16].The Pharmacopea Nacional ArgentinaWithin the Pharmacopea Nacional Argentina, there are three categories of plants and their preparations: crudedrugs; extracts or fractions with a complex chemical composition extracted directly from a medicinal plant, e.g.,fixed or essential oils or resins; and pure active principles. The total number of such monographs is 899. Themonographs do not consider pharmaceutical preparations such as extracts, tinctures, aromatic waters etc. Ofthe 899 monographs, 56 describe crude drugs, and 33 describe extracts or fractions [15].CanadaHerbal medicines are regulated as drugs in Canada and must therefore conform to labelling and otherrequirements as set out in the Food and Drugs Act and Regulations, which means that, in contrast to the USA,large numbers of herbal medicines with indication claims are legally on the Canadian market. Prior toassignment of a registration or drug identification number, scrutiny of the composition and the labelling ofmedicine is required.On 13 August 1987, following a long discussion between interested parties and experts, an Information Letterwas issued by the Canadian Health Protection Branch containing a list of herbs considered hazardous orrequiring cautionary labelling. It was reported that products may be sold as foods, drugs or even cosmeticsdepending on their properties, claims and the manner in which they are used. At that time, herbs andbotanicals were acceptable as drugs on the basis of acknowledged claims and quantitative statements of theactive ingredient. As a general practice, herbal remedies used for minor self-limiting conditions may beallocated Drug Identification Numbers (DIN), based on a logical pharmacological rationale and bibliographicreferences which include verified traditional uses that have not been superseded by more recent research andstudy. Furthermore, the need to provide a specific framework for the registration of herbs and botanicalpreparations has been identified, and a concept of review involving "Standardized Drug Monographs (SDM)"has been proposed to facilitate registration of those drugs containing herbs that meet the requirements of themonographs. Products making reference to such an SDM would require less individual pre-market scrutiny ona product-by-product basis and would result in more rapid issuance of DIN, but would be balanced withadditional post-market compliance monitoring and activity. Combinations of herbs outlined in suchmonographs would be accepted if justified on sound therapeutic principles. Claims in respect of prevention ortreatment of serious diseases and those which are inappropriate for self-diagnosis and treatment areprohibited within this procedure [17].On 5 January 1990, another Information Letter was issued to clarify the policy of the Health Protection Branchon herbal medicines, to outline the regulatory requirements, and to advise on the mechanisms for applicationsfor DIN for these products. It was clearly stated that the most important factors in determining whether a herbal