A significant increase in the use of herbal medicines in the past decade has also seen a resurgence of interest in herbal medicines in developed countries due to a preference for products of natural origin. In addition, manufactured herbal medicines from their countries of origin often follow in the wake of migrants from countries where traditional medicines play an important role.

Herbal drug regulation basically needs to fulfill the following objectives:

• Establish a regulatory pathway for approval of multi-component botanical products such as pharmaceutical drugs.
• Availability of up-to-date and authoritative information on the beneficial properties and possible harmful effects of all herbal medicines to both consumers and health care authorities.
• Draft guidelines at national and international level for the assessment of herbal medicines based on a large corpus of data on how medicinal plant materials and their products should be handled, starting from the collection of materials, through manufacturing, to clinical trials. These shall facilitate the work to be carried out by regulatory authorities, scientific bodies and industry in the development, assessment and registration of herbal products.
• The WHO guidelines so developed should reflect the scientific results gathered in past years in each field of activity related to herbal medicines serving as the basis for future classification of herbal medicines in different parts of the world.
• Identification of categories of medicinal plant-related products in trade as ‘traditional medicines’ from classical texts, well-known herbal medicines of long-established folklore usage, newer combinations/formulations based on traditional plant drugs etc.
• Taking into account the medical, historical and ethnological background of these products, draft regulatory requirements including the clinical and non-clinical testing and other manufacturing requirements to ensure development of consistent quality herbal products.
• Ensure effective regulation and control of herbal medicines moving in international commerce through close liaison with appropriate national institutions that are able to keep under regular review all aspects of their production and use.
• Address concerns of efficacy, toxicity, safety, acceptability, cost and relative value of herbal drugs by subjecting them to evaluative studies compared with other drugs used in modern medicine.
• Developing system of Good Manufacturing Practices (GMP) covering all aspects of production from starting materials, premises and equipment to the training, personal hygiene of staff, standard operating procedures, work environment, quality assurance, and packaging, storage and waste disposal to ensure reproducibility and establish product consistency.
• Formulate procedures for the registration of herbal drugs after evaluating information on tests conducted, clinical trials, QC methods etc. furnished by the manufacturer.
• Develop standards to ensure control of information supplied as propagation material including labels, product pamphlets or any other type of broadcast statements ruling out misleading information due to misrepresentation of facts.
• Provide assurance of quality and safety through adequate follow-up by appropriate pharmacovigilance to facilitate report of adverse drug reactions occurring either through prolonged use or by inappropriate self-medication.

Despite the fact that the therapeutic benefit and safety of many herbal medicines have been qualitatively established, their potential as drugs has not been fully realized due to lack of economic incentives, absence of strict manufacturing controls, and lack of rigorous proof of efficacy.