Legal regulations of complementary and alternative medicines in different countries.

Traditional medicines that formed the basis of health care throughout the world since the earliest days of mankind are still widely used and have considerable importance in international trade. Recognition of their clinical, pharmaceutical, and economic value is still growing, although this varies widely between countries and therefore regulation of exploitation and exportation is essential, together with international cooperation and coordination for their conservation so as to ensure their availability for the future. World Health Organization and European Union issued the guidelines defined the basic criteria for the evaluation of quality, safety, and efficacy of herbal medicines with the goal of assisting national regulatory authorities, scientific organizations, and manufacturers in assessing documentation, submissions, and dossiers in respect of such products. Legislative controls in respect of medicinal plants have not evolved around a structured control model. There are different ways in which countries define medicinal plants or herbs or products derived from them. The present review highlights the status of different countries adopted various approaches to licensing, dispensing, manufacturing, and trading to ensure their safety, quality, and efficacy.

INTRODUCTION

During the past decade, complementary and alternative medicines have become a topic of global importance. Current estimates suggest that in many developing countries, a large proportion of the population relies heavily on traditional practitioners and medicinal plants to meet primary healthcare needs. Although modern medicine may be available in these countries, herbal medicines (phytomedicines) have often maintained popularity for historical and cultural reasons. Concurrently, many people in developed countries have begun to turn to alternative or complementary therapies, including medicinal herbs. World Health Organization (WHO) estimated that the world market for herbal medicines and herbal products is worth US$ 62 billion and would hit US$ 5 trillion by 2050. The market is growing at 7% per annum (The Times of India, 7-4-2000).

A common feature of most systems of traditional medicine (TM)/complementary and alternative medicine (CAM) is that they take a holistic approach to promote health, prevent disease, and help the individual treat disturbances by regulating his/her physical, emotional, and mental aspects and living environment. According to its characteristics and concepts, TM/CAM can be used not only for curing disease and relieving symptoms but also for the regulation, improvement, and promotion of the function of the human body. Few plant species that provide medicinal herbs have been scientifically evaluated for their possible medical application. Safety and efficacy data are available for even fewer plants, their extracts and active ingredients, and the preparations containing them. Furthermore, in most countries the herbal medicines’ market is poorly regulated, and herbal products are often neither registered nor controlled. Assurance of the safety, quality, and efficacy of medicinal plants and herbal products has now become a key issue in industrialized and in developing countries. Both the general consumer and healthcare professionals need up-to-date, authoritative information on the safety and efficacy of medicinal plants. With the widespread use of TM as well as CAM and the rapid expansion of international herbal medicine markets, the development of national policies and regulations on TM/CAM has become an important concern for both health authorities and the public. Providers of TM/CAM, other healthcare professionals, and TM/CAM consumers alike are calling for regulations that can ensure the safety of TM/CAM therapies and products, promote recognition of these systems and modalities, and further define their role in modern healthcare systems. National policies and regulations on TM/CAM could ensure the safety, quality, and efficacy of these therapies and products and function as important steps toward integrative healthcare systems. However, relatively few countries have developed policies and regulations on TM/CAM so far. Only 25 of WHO's 191 countries have a national policy on TM/CAM and only 64 countries regulate herbal medicines.[1]

To assist countries in the development of TM/CAM policies and regulations of herbal medicines, WHO has published a series of technical guidelines and reviewed regulations on herbal medicines in the document “Regulatory Situation of Herbal Medicines: a Worldwide Review.”[2] The purpose of the document is to share national experience in formulating policies on traditional medicinal products, introduce measures for their registration and regulation, and facilitate information exchange on these subjects among Member States.

In present review, we have compiled name of various regulatory authorities made for herbal medicines in different countries with their major responsibilities and year of establishment which will definitely help the new researchers working in the field of quality control and standardization of TM/CAM.

The role of herbal medicines in traditional healing

The pharmacological treatment of disease began long ago with the use of herbs.[3] Methods of folk healing throughout the world commonly used herbs as part of their tradition. Some of these traditions are briefly described below, providing some examples of the array of important healing practices around the world that used herbs for this purpose.[4]

Traditional Chinese medicine

Traditional Chinese medicine has been used by Chinese people from ancient times. Although animal and mineral materials have been used, the primary source of remedies is botanical. Of the more than 12,000 items used by traditional healers, about 500 are in common use.[4] Botanical products are used only after some kind of processing, which may include, for example, stir-frying or soaking in vinegar or wine. In clinical practice, traditional diagnosis may be followed by the prescription of a complex and often individualized remedy. Traditional Chinese medicine is still in common use in China. More than half the population regularly uses traditional remedies, with the highest prevalence of use in rural areas. About 5000 traditional remedies are available in China; they account for approximately one-fifth of the entire Chinese pharmaceutical market.[4]

Japanese TM

Many herbal remedies found their way from China into the Japanese systems of traditional healing. Herbs native to Japan were classified in the first pharmacopoeia of Japanese TM in the ninth century.[5]

Indian TM

Ayurveda is a medical system primarily practised in India that has been known for nearly 5000 years. It includes diet and herbal remedies, while emphasizing the body, mind, and spirit in disease prevention and treatment.[6]

WHO GUIDELINES FOR HERBAL MEDICINES

These guidelines recognized the importance of herbal medicines to the health of many people throughout the world, stating: “A few herbal medicines have withstood scientific testing, but others are used simply for traditional reasons to protect, restore, or improve health.” Most herbal medicines still need to be studied scientifically, although the experience obtained from their traditional use over the years should not be ignored. As there is not enough evidence produced by common scientific approaches to answer questions of safety and efficacy about most of the herbal medicines now in use, the rational use and further development of herbal medicines will be supported by further appropriate scientific studies of these products, and thus the development of criteria for such studies. In this regard, WHO has issued guidelines for the assessment of herbal medicines. These guidelines defined the basic criteria for the evaluation of quality, safety, and efficacy of herbal medicines with the goal of assisting national regulatory authorities, scientific organizations, and manufacturers in assessing documentation, submissions, and dossiers in respect of such products.

The below mentioned WHO guidelines [Table 1] stressed the need for assessment of efficacy including the determination of pharmacological and clinical effects of the active ingredients, cultivation and collection of the medicinal plants, and labeling which includes a quantitative list of active ingredient, dosage, and contraindications.

Table 1

Different WHO guidelines with their major resolutions and year of establishment

THE EUROPEAN UNION

The European Pharmacopoeia was created in 1964; its efforts have resulted in the creation of 83 monographs on herbal drugs that are used either in their natural state after desiccation or concentration or for the isolation of natural active ingredients. The Association of the European Self-Medication Industry has carried out a study for the European Commission on herbal medicinal products in the European Union (EU). The following summary is taken from this report.[14] The importance of herbal medicinal products varies from one country to another. These products are not a homogeneous group. In general, they are either fully licensed medicinal products with efficacy proven by clinical studies or by references to published scientific literature (in accordance with Article 4.8 a (ii) of Council Directive 65/65/EEC)[15] or are available as products with a more or less simplified proof of efficacy according to their national use. Many Member States have these two categories, but there are major discrepancies between the Member States in the classification of individual herbal drug preparations and products into one of these categories as well as in the requirements for obtaining a marketing authorization. According to Council Directive 65/65/EEC,[15] which has been implemented in national law in all Member States, medicinal products require prior marketing approval before gaining access to the market. In almost all Member States, herbal medicinal products are considered as medicinal products and are, in principle, subject to the general regulations for medicines as laid down in the various national medicine laws. In many cases, a specific definition of herbal medicinal products is available, which is in line with the EU Guideline “Quality of Herbal Medicinal Products.” This includes plants, parts of plants, and their preparations, mostly presented with therapeutic or prophylactic claims. Different categories of medicinal products containing plant preparations exist or are in the process of being created. For instance, draft legislation in Spain includes the definitions “herbal medicinal products” and “phytotraditional products.” The latter are not considered as “pharmaceutical specialties” and are therefore not classified as herbal medicinal products.

Legal status of different countries for herbal drug regulation

Legislative controls in respect of medicinal plants have not evolved around a structured control model. There are different ways in which countries define medicinal plants or herbs or products derived from them, and countries have adopted various approaches to licensing, dispensing, manufacturing, and trading to ensure their safety, quality, and efficacy, and due to these reasons herbal preparations varies from country to country. In some, phytomedicines are well established, whereas in others they are regarded as food and therapeutic claims are not allowed. This article follows a generalized template that includes regulatory authorities of various countries and their major responsibilities with year of establishment [Table 2].

Table 2

Legal status of different countries for herbal drug regulation

CONCLUSION

The growth of the pharmaceutical industry and the unceasing development of new and more effective synthetic and biological medicinal products have not diminished the importance of medicinal plants in many societies. On the contrary, population growth in the developing world and increasing interest in the industrialized nations have greatly expanded the demand for medicinal plants themselves and the products derived from them. Regulations in countries for the assessment of the quality, safety, and efficacy of medicinal plants, and the work of WHO and EU in supporting the preparation of model guidelines in this field, have been helpful in strengthening recognition of their role in health care. It is hoped that assessment of these traditional remedies could become the basis for a future classification of herbal medicines, as well as for evaluative studies on their efficacy and safety, and their potential use in national healthcare systems in different parts of the world.