Traditional Medicines: Current Developments and Issues That Need Addressal

International Conclave on Traditional Medicine

16-17th November, 2006

New Delhi, INDIA

Organized by In Collaboration with

CHAPTER 1

Overview of the Current Scenario on Traditional Medicines

Introduction:

Traditional medicine is defined by WHO as health practices, approaches, knowledge and beliefs incorporating plant, animal and mineral based medicines, spiritual therapies, manual techniques and exercises, applied singularly or in combination, to treat, diagnose and prevent illnesses or maintain well-being (WHO, 2003).

The term traditional medicine is applied due to the fact that they had their origin in the remote past and most of these are still practiced almost in the same manner as have been in the past, maintaining the tradition. The basic principle involved in traditional medicine is that these are holistic in nature and rather than treating in isolation they are believed to eradicate the root cause of the disease.

Medical knowledge systems have developed over centuries within various communities before the era of modern medicine by the knowledge gained by trial and error process and also by observing the behaviour of the diseased animals. Perhaps the earliest use of plants has been documented in Vedas about 4,500 to 600 years BC. This represents the oldest repository of human knowledge, and comprises 67 plant species. In China, Sheng-Nongs Herbal book is thought to be one of the earliest sources of folk knowledge on the use of herbals; it comprises 365 plants, animals and minerals useful as medication from the period of Sheng-Nong (3000 BC) (Pei 1987, 2001). Studies on Tibetan Medicine have shown that the earliest literature on Tibetan medicine is dated eighth century AD (Yang 1988).

The experts at W.H.O. have identified and enlisted more than 100 types of traditional medicine practices, which are in use throughout the world. These forms of medicine are variously known as traditional medicine (as most of these are practiced from time immemorial), complementary medicine (as these medicines supplement the Allopathic medicines in many-a-cases or as they differ from the orthodox medicine), holistic medicine (most of the alternative medical systems consider the human body as a complete being comprising of physical mental, social and spiritual dimensions), ethno medicine (as these traditional health care systems are closely associated with the life and culture of the masses), natural medicine (as these methods of treatments are based on the laws of nature and natural substances are used to treat the patients).

Some examples of the Traditional Medicine Systems practiced in different countries include acupuncture by the Chinese; magnetic healing by the French; Heilpraxis by the Germans; Herbalism by the Swedish; Ayurveda, Siddha, Unani and Yoga by Indians; Shiatsu in Japan; So-wa Rig-pa in Bhutan, etc. Some of the most popular systems of alternative medicine are Ayurveda, Unani, Siddha, Naturopathy, Yoga, Acupuncture, Acupressure, Shiatsu, Medical herbalism, Meditation, Hydropathy, Diet Therapy, etc.

Popularity of Traditional Medicines (TM)

Countries in Africa, Asia and Latin America chiefly use traditional medicine (TM) to help meet some of their primary health care needs. Even industrialized countries are turning towards TM for health care purposes. TM, thus has not only maintained its popularity in all regions of the developing world, its use is rapidly spreading in industrialized countries which is exemplified from the following facts:

·  In China, traditional herbal preparations account for 30%-50% of the total medicinal consumption.

·  In Ghana, Mali, Nigeria and Zambia, the first line of treatment for 60% of children with high fever resulting from malaria is the use of herbal medicines at home.

·  WHO estimates that in several African countries traditional birth attendants assist in the majority of births.

·  In Europe, North America and other industrialized regions, over 50% of the population have used complementary or alternative medicine at least once.

·  In San Francisco, London and South Africa, 75% of people living with HIV/AIDS use TM/CAM (Complementary and Alternative Medicine).

·  70% of the population in Canada have used complementary medicine at least once.

·  In Germany, 90% of the population have used natural remedies at some point in their life. Between 1995 and 2000, the number of doctors who had undergone special training in natural medicine had almost doubled.

·  In the United States, 158 million of the adult population use complementary medicines and according to the USA Commission for Alternative and Complementary medicines, US $17 billion were spent on traditional remedies in 2000.

·  In the United Kingdom, annual expenditure on alternative medicine is US$ 230 million.

·  The global market for herbal medicines currently stands at over US $ 60 billion annually and is growing steadily (WHO, 2003).

The popularity and renewed interest in the traditional systems of medicine is due to the following reasons: (i) lesser side effects as compared to allopathic medicines, (ii) affordability of traditional drugs by large number of people of the third world countries, and (iii) the effectiveness of these time tested systems, particularly for diseases which are chronic in nature or not adequately addressed in the modern system of medicine.

Besides the above primary reasons, there are some subsidiary or secondary reasons of the growing popularity of the traditional medicines such as: (i) cultural links in many rural areas to the traditional medical systems lead to easy acceptance, and (ii) simplicity of remedies and practices attracts people.

National Policies on Traditional Medicine (TM)

The concept of national policy primarily involves three key elements, which are firstly a definition for TM/CAM, secondly provision for the creation of laws and regulations, and thirdly consideration of intellectual property issues. Besides these key elements, national policies can reflect the strategies that the Government may adopt for achieving the objectives of the policy, and may also include laws and regulations on TM/CAM (WHO, 2005).

In a global survey carried out by WHO (WHO, 2005), wherein data was collected from 141 Member States, 32% countries were found to have national policies on TM/CAM, whereas 64% countries do not have a national policy and 4% countries did not provide a satisfactory reply. However, 56% countries have indicated that such policies are in the process of development. This study indicates that developing of a national policy is prerequisite for further growth of TM in these countries. It was also noticed in the study that the national policies on TM/CAM increased significantly in the last decade. There is a growing trend in the recent past for member states to establish national policies on TM/CAM. The trend is likely to continue as more Member States are likely to have their national polices shortly.

Laws and Regulations on TM/CAM

The structure and comprehensiveness of laws and regulations on TM/CAM varies from country to country, and furthermore in Member States where no policy exists, laws and regulations cover different areas of TM/CAM.

A Law is the first stage of the legislative procedure and is the rule of conduct imposed by the authority. A law establishes necessary conditions under which TM/CAM needs to be organized in line with the national or other relevant policies. The law may cover various areas in the TM/CAM field including education of professionals, licensing of practitioners and manufacturers, manufacture and trade of products used in TM/CAM, sales practices, etc. (WHO, 2005)

A Regulation is the second stage of the legislative procedure, specifically designed to provide the legal machinery required to achieve the administrative and technical goals of law. Many activities such as description of obligations and responsibilities of licensed practitioners, the penal sanctions if the rules are conravened, the obligations of incumbents on manufacturers of TM/CAM products, etc., come under regulations (WHO, 2005).

The study carried out by WHO indicates that 38% countries have laws or regulations whereas 60% countries do not have laws or regulations.

Countries face major challenges in the development and implementation of the regulation of traditional medicines. These challenges are related to regulatory status, assessment of safety and efficacy, quality, control, safety monitoring and lack of knowledge about TM within national drug regulatory authorities.

Before manufactured drugs came into widespread use, herbal medicines played an important role in human health. There are great differences between Member States in the definition and categorization of herbal medicines. A single medicinal plant may be defined as a food, a functional food, a dietary supplement or a herbal medicine in different countries depending on the regulations applying to foods and medicines in each country. This makes it difficult to define the concept of herbal medicines for the purposes of national drug regulation, and also confuses patients and consumers.

The global survey conducted by WHO (WHO, 2005) on Regulation of herbal medicines particularly on the regulatory status of herbal medicines, regulation requirements, number of registered herbal medicine products and quality control requirements such as GMP, monographs, etc. gave the following results.

Before 1988, there were only 14 Member States with regulations relating to herbal medicines, but the figure increased to 53 Member States (37%) having laws and regulations in 2003. Of those Member States without current laws or regulations, 42 (49%) declared that these regulations were in the process of being developed. Such results show that Member States are increasingly involved in developing the regulation of herbal medicines;

The questions about the regulatory status of herbal medicines also show, interestingly, that in most Member States (97 out of 142 respondents) herbal medicines are sold as over-the-counter medicines, in contrast to 50 Member States where herbal medicines are also sold as prescription medicines. Medical claims, health claims and nutrients contents claims are the most common types of claims with which herbal medicines may legally be sold (90 Member States allow medical claims, 62 allow health claims and 49 allow nutrients content claims)

The collected information about herbal medicines also shows that 86 Member States (61%) have a registration system for herbal medicines and 17 have 1000 or more registered herbal medicines. Judging from these data, many Members States are giving the regulation of herbal medicines careful consideration. (WHO 1995).

National Programme on TM/CAM

This refers to any programme performed at local or national level so as to achieve the objectives in line with national policies or legislation. The response on this study by WHO indicates that 28% countries do have national programmes whereas 66% countries do not have any national programme. However, 33%countries indicated that such a programme was in process of being established (WHO, 2005).

National Offices and Expert Committees for TM/CAM

The WHO study indicates that 53% countries have national offices whereas 43% countries do not have any national offices out of which 19 countries indicated that such an office is being planned. Expert Committees, formed by national governments for the purpose of reviewing and making policy and recommendations exist in 43% of the countries.

Standardization, Quality Control and Safety of Traditional Medicines

The safety and efficacy of Traditional Medicines as well as quality control have become important concerns for both health authorities and the public. Diverse TM practices have been developed in different cultures and in regions, but without a parallel development of international standards and appropriate methods for evaluating traditional medicines.

Requirements and methods for research and evaluation of the safety and efficacy of traditional medicines are more complex than those for conventional pharmaceuticals. A single medicinal plant may contain hundreds of natural constituents, and a mixed herbal medicinal product may contain several times that number. If every active ingredient were to be isolated from every herb, the time and resources required would be tremendous. Such an analysis may actually be impossible in practice, particularly in the case of mixed herbal medicines.

The safety and efficacy of herbal medicines is closely correlated with the quality of the source materials used in their production. The quality of source materials is, in turn determined by intrinsic factors (genetic) and extrinsic factors (environmental conditions, cultivation and harvesting, field collection and post harvest/collection transport and storage). Therefore, it is very difficult to perform quality controls on raw materials of herbal medicines. In the quality control of finished herbal medicinal products, particularly mixed herbal products, it is more difficult to determine whether all the plants or starting materials have been included.

Good Manufacturing Practice (GMP) lay down many requirements for quality control of starting materials, including correct identification of species of medicinal plants, special storage and sanitation as well as cleaning methods for various materials.

Adverse events arising from consumption of herbal medicines may be due to any one of a number of factors including, the inadvertent use of the wrong species of plant; adulteration of herbal products with other, undeclared medicines; contamination with toxic or hazardous substances; overdose; misuse of herbal medicines by either health care providers or consumers and use of herbal medicines concomitantly with other medicines. Analysis of adverse events related to the use of herbal medicines is more complicated than in the case of conventional pharmaceuticals. Furthermore, herbal medicines are often used for self care; thus, there is a great need to educate consumers and public in their proper use.

The general lack of knowledge about traditional herbal medicines within national drug authorities and the lack of appropriate evaluation methods are factors that delay the creation or updating of national policies, laws and regulations for traditional medicines. In order to meet these challenges, the WHO TM Strategy 2002-2005 was developed, with four primary objectives: framing policy; enhancing safety, efficacy and quality; ensuring access; and promoting rational use. Resolution on Traditional Medicine was adopted at the Fifty sixth World Health Assembly held in May 2003. The resolution requested WHO to support Member States by providing internationally acceptable guidelines and technical standards and also evidence based information to assist Member States in formulating policy and regulations for the safety, efficacy and quality of traditional medicines (WHO, 2005).

In view of the above, there is an urgent need for standardization and evaluation of safety and efficacy for wider use of traditional medicines particularly in the developed countries. Plant-based traditional systems of medicine have substantial usage data spanning over centuries indicating safety and efficacy. Some of the reasons why standardization, quality control and safety are essential are enumerated in the following paragraphs.