Regulatory mechanism for approval of plant drugs has not been in place in several countries until quite recently. In a WHO question-answer survey of 141 member states, it was found that while 92 countries (65%) have laws and regulations on herbal medicines 48 countries (34%) do not. Information provided by 77 of the member states about the year of issue of the laws/regulations indicates that herbal drug regulation is a recent phenomenon. Over the last 15 years, numbers of member states with laws and regulations on herbal medicines have increased dramatically with the highest number of laws being issued between 1996 and 1999. Herbal medicine practices have been developed in different cultures in different regions without a parallel development of international standards and appropriate methods of evaluation. Legislative controls in respect of medicinal plants have not evolved around a structured control model because of variations between countries with regard to the following:

• Medicinal, pharmaceutical and economic value of medicinal plants;
• Definitions for medicinal plants or herbs or related products;
• Approaches to licensing, dispensing and manufacturing;
• Traditional usage of herbs and trade practices;
• Availability of safety and efficacy data;
• Extent of scientific validation of traditionally used herbal drugs.

According to EU definition herbal medicinal products are ‘medicinal products containing as active ingredients exclusively plant material and/or vegetable drug preparations’. Based on their origin, evolution and the forms of current usage, herbal medicines are classified into the following categories:

Category 1: Indigenous Herbal Medicines

Historically used in a local community or region and well known through long usage by the local population in terms of its composition, treatment and dosage.

Detailed information on this category of TM, which also includes folk medicines, may or may not be available. In order to enter market outside the local community or region in the country, such drugs need to meet the safety and efficacy guidelines laid down in the national regulations of that country.

Category 2: Herbal Medicine in Systems

Traditional drugs of long-term usage such as those of Ayurveda, Siddha and Unani and documented along with their therapeutic concepts, accepted by other countries.

Category 3: Modified Herbal Medicines

Drugs of category 1 and 2, modified in form, dose, dosage form, mode of administration, herbal medicinal ingredients, methods of preparation and medicinal indications.

These drugs are to meet the national regulatory requirements of safety and efficacy.

Category 4: Imported Products with a Herbal Medicine Base

All imported herbal medicines including raw materials and products. These need to be registered and marketed in the countries of origin for which the safety and efficacy data has to be submitted to the national authority of the importing country for approval and acceptance.

Important information on the regulatory requirements for some countries is summarized below and Table 4.1 is a brief overview of the current regulatory situation of herbal drugs in a few other countries.