Registration and utilization of herbal remedies in some countries of Eastearn, Central and Southern Africa

OLAWAYO AKERELE,
Programme Manager, Traditional Medicine
World Health Organization, Geneva

Introduction

Traditional medicine has been practised for the last several thousand years, although it found a place in the WHO programme only twelve years ago.

Traditional medicine is widespread throughout the world in a variety of forms. Its practices are based on beliefs that were in existence, often for hundreds of years, before the development and spread of modern scientific medicine, and that are still prevalent to day.

The recent development and resurgence of traditional medicine activities in the African Region grew out of the political events of the 1960s. With the advent of political independence, Africans felt the need to rediscover their sociocultural identity, and traditional medicine, an integral part of their heritage, and benefited from this return to the fountain-head. In reality, the masses had never stopped making use of traditional medicine, despite the imposition of modern medicine by the colonial powers. Moreover, economic circumstances were making imported techniques and drugs less and less accessible, forcing the authorities to take a fresh look at the problem and study the possibility of using traditional medicine to improve the health of their populations.

In most cases, however, it was necessary to convince the political decision-makers that traditional medicine had something to offer. To this end, the World Health Assembly and the Executive Board passed a number of resolutions in support of traditional medicine globally. In addition, the Regional Committee for Africa passed a number of resolutions reflecting this political will.

Three periods which correspond to very definite political and economic development stages can be distinguished in the development of traditional medicine in the African countries. These are, first, the pre-colonial period, when traditional medicine reigned supreme. Unfortunately, there was no record of traditional practices and materia medica, even though these have contributed to the modern-day therapeutic arsenal. The examples of physostigmine from the Calabar bean and the life-saving vincristine from the African periwinkle, illustrate past and present contributions. The colonial period was marked by the introduction of modern medicine and the suppression of Africa's traditional systems of medicine. Finally, the post-colonial period is represented by a renewed cultural awareness of, and pride in, traditional medicine and its values.

Primary health care has been adopted by all WHO member states, including those on the African continent, as the appropriate strategy, for developing national health systems. This approach has become imperative for technologically less advanced countries, given their present economic crisis. However, even the primary care demands the use of therapeutic preparations, and in the face of declining foreign exchange earnings, governments are finding it increasingly difficult to make essential drugs available to their rapidly growing populations. The use of medicinal plants in traditional medicine thus Finds its natural expression, and further development in primary health care, where in many cases they bridge the gap between the availability of and the demand for essential drugs. It is, however, at this level that the transition from traditional practice to medical care can most readily be made.

In our common efforts to extend coverage of the health services to improve medical care and to control major endemic and epidemic diseases we have often not fully recognized just how important a role medicinal plants play in the health of the peoples of the world. In developing countries, about three-quarters of the population rely on medicinal plants for their primary health care. In technologically advanced societies, consumers preference is shifting from synthetic to natural products and this is dictating the pace of the resurgence and expansion of the use of medicinal plants in therapy in industrialized countries. It is only logical for WHO to collaborate with others to develop activities in this exciting area of manufacture and promotion of the use of new drugs of plant origin by encouraging countries to make fuller use of the natural wealth of medicinal plants, which most of them possess. Some of the currently known herbal medicinal products could substitute imported drugs, which currently require foreign exchange for their purchase. In addition, plants used in traditional medicine hold a great, but still largely unexplored potential, for the development of new drugs against major diseases, such as AIDS, for which no safe, effective treatment is as yet available.

As part of those efforts by WHO, a workshop was organized by the Organization's Programme for Traditional Medicine, in collaboration with the Danish International Development Agency (DANIDA) and hosted by the Ministry of health of Zimbabwe. It was held from 26 June to 6 July 1989 at Kadoma, Zimbabwe.

The workshop was attended by participants from East, Central and Southern Africa and included scientists from Botswana, Kenya, Lesotho, Malawi, Swaziland, United Republic of Tanzania, Zambia and Zimbabwe, representing a variety of disciplines that are crucial to initiating multidisciplinary research in drug development from herbal remedies. These include: pharmacy, pharmacology, phytochemistry, health administration, and clinical sciences.

The workshop was the first of a series for the African Region and was intended to address issues hindering the introduction of traditional remedies into national health systems. Key issues discussed included ensuring safety and efficacy of traditional remedies, as well as associated problems of standards, stability, and dosage formulation. Safety is, indeed, a crucial issue. It is often erroneously believed that products that are natural carry no risk to the consumer. Nothing could be further from the truth. Much of our present-day powerful therapeutic arsenal is derived from plants and plant products.

This workshop was designed to establish a logical "thought process" for decision-making that is related to the utilization of herbal preparations as drugs. The workshop began with presentations from each participating country on the use of traditional medicine. A summary of the current situation with regard to traditional practitioners and the registration of herbal remedies is given below: a series of formal lectures followed, addressing areas such as the importance of medicinal plants in therapy; development of a traditional medicine pharmacopoeia; types and sources of information available on medicinal plants and their chemical constituents; how the information can be evaluated; safety and toxicological testing procedures; and the planning of clinical studies. All participants were then provided with copies of original articles on commonly used plants and challenged to decide whether each could be introduced into their national health system. Using a well-defined decision-making process, the participants answered questions about the safety and efficacy of the plants and categorized them as meriting acceptance without further study, requiring further work, or meriting outright rejection on grounds of toxicity.

It is widely believed that the use of medicinal plants in health care is increasing in the African region, and that trade in these substances is on the rise. However, no valid data are currently available on utilization and trade patterns. Plant-derived remedies currently in use range from traditional preparations such as decoctions to locally manufactured modern formulations in the form of syrups, tablets and capsules, as well as products imported from Asia. This increase in intercontinental trade in plant- derived substances has triggered concern for regulation in countries of East, Central and southern Africa. No regulations related to the use of plant-derived remedies currently exist in these countries. However, national drug legislation to cover manufacture of herbal remedies is being contemplated in all the countries. The necessary registration process should be contingent upon review of available sources of information, quality control of raw material, modern toxicology testing, and good manufacturing practices. In addition, one of the chief contributions that traditional medicine has made and continues to make to health, is the discovery of plants of medical value. "Save Plants that Save Lives" is a call to safeguard this heritage, and regulations should therefore cover conservation measures.

Country presentations at the Workshop described the current regulatory status of traditional medicine and practitioners. This information is summarized below.

Current regulatory status in some countries of East, Central and Southern Africa

Botswana

No regulation related to the use and practice of traditional medicine exists. A provisional council has been appointed to decide what to do, and will probably propose some draft legislation regarding traditional medicine. Modern medicine must be registered in the country of origin.

Kenya

There is no regulation regarding the practice of traditional medicine. The Ministry of Culture and Social Services issues certificates to traditional practitioners, but they must also obtain the permission of the area chief to practise. There is no regulation concerning the manufacture and or use of traditional remedies.

Lesotho

National drug legislation is being formulated and will create some controls for traditional remedies. The proposed regulation will lead to the registration of traditional medicines for an initial period of 8-10 years, based on safety as the sole criterion. Subsequently, registration of traditional remedies will have to be based on efficacy as well as safety.

Malawi

The Pharmacy Medicine and Poisons Act of 1988 does not have any provision regarding the use of traditional medicinal remedies. Since traditional practitioners are not used in the health services, the need to register them has never arisen. Some other provisions of the Act are related to the exclusion of traditional practitioners from practice. For example, "no person shall sell by retail, or supply in circumstances corresponding to retail sale or administer, other than to himself, a medicinal product of a description or a class specified by Order made by the Minister and published in a Gazette except in accordance with prescription given by an appropriate practitioner," which excludes traditional practitioners.

Similarly, Section 17(1)(b) of the Act indicates that "except as is provided by this Act, no person other than a person registered as a pharmacist under this part shall in the course of any trade or business prepare, mix compounds, or dispense any medicinal product or poison except under the supervision of a registered pharmacist". Thus, it can be deduced from this provision that traditional healers should not practice their trade. In practice, however, people are not imprisoned for administering traditional remedies.

According to section 42(2)(a) of the Act, no one is allowed to "sell or supply any product for the purpose of a clinical trial unless that person has a product licence and a clinical trial certificate". This makes it very difficult to assess the efficacy of traditional remedies without following the standard procedures. However, a number of modern medical practitioners have tested the efficacy of some traditional remedies used in Malawi.

Swaziland

There is no government regulation on the use and manufacture of traditional remedies. Modern drugs require registration. Traditional practitioners have been registered since 1974. A list of traditional practitioners is kept by the Swazi National Council, a traditional executive body under the King. In 1981 a Commission for Traditional Medicine was formed by the Minister of Health. The Commission was to recommend ways of organizing the regulation of traditional practitioners and their work as well as to act as a body through which their views are communicated to the government and to the general public.

Tanzania

The legal status of traditional medicine in Tanzania is governed by two statutes namely:

(i) Medical Practitioners and Dentist Ordinance Act, caption 409, section 37, and

(ii) Pharmaceutical and Poisons Act 1978, stipulating that substances used in local systems of therapeutics should be utilized in the communities where "the traditional practitioners belong, provided they are not detrimental to the people's lives and health".

The traditional practitioner is registered by a regional or district cultural officer and his drugs are only known to him or herself. The drugs are not registered. Modern drugs are regulated by law.

Zambia

There are no laws prohibiting the practice and use of traditional medicine. However, traditional practitioners must be registered at provincial level and must adhere to laws governing the practice of modern medicines. There is no regulation in respect of the use of traditional remedies.

Zimbabwe

The government has instituted controls over the practice of traditional medicine through the Traditional Medical Practitioners Act 1981. This made provisions for the formation of a Traditional Medical Practitioners Council and the registration of practitioners. An Association of Traditional Practitioners was formed in 1980. It promotes professionalization and gives direction and support to member practitioners.

There is no drug regulation specifically applicable to traditional remedies. Modern drugs circulating in the country must be registered under the Drugs and Allied Substances Control Act (Chapter 320) 1949.

Conclusion

In all of the participating countries, the general feeling is that the future of traditional medicine is bright, because it is widely used and respected, especially by the rural population that constitute the majority. Although no specific studies have been made, costs are considered to be low.

Legislation is needed in all of the countries to recognize and legitimize traditional practitioners. The traditional practitioners should group themselves into associations through which they could interface with the formal system, whether or not they are formally part of it. An association of this nature could be a regulatory body in relation to ethical and professional matters. Without this formal structure, the chaos that exists now is likely to continue.

Steps need to be taken to list the herbal remedies used in each country and their medical indications and properties. This needs to be done before the disappearance of indigenous people, who hold the key to identifying medicinal plants that may result in new drugs of inestimable benefit to the global community. The establishment of their safety, based on published data and/or preclinical scientific studies, should precede the use of manufactured medicinal plants for both self-medication and in national health services. When quality control has been assured, studies for efficacy may then be initiated.

While these are not unrealizable goals, their attainment will require the establishment of an organizational structure that is coupled with dedication and rational analysis of the situation in each country.

Many African countries are focusing on actions at national level that seek to obtain maximum benefit from their natural plant resources. However, medicinal plants should not be valued solely because of the possibility that they offer from import substitution, but because traditional medicine is an avenue to greater self-reliance, based on appropriate technology in accordance with a country's cultural heritage and national resources. As African countries attempt to revitalize and rationalize this heritage, they can look for support from the World Health Organization in their endeavours.

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