Medicinal plants are important for pharmacological research and drug development, not only when plants having chemical constituent, but also they are primary source of many pharmacologically active compounds. Therefore it is essential to establish internationally recognized guidelines to regulate their purity to ensure their availability for future.
The United Nation convention states that the standardization is a critical importance for meeting the food, health and other needs of the growing world population.
There is no legal control model over medicinal plants. There are different ways in which countries define medicinal plants or products derived from them, and countries have adopted various approaches to licensing, dispensing, manufacturing and trading to ensure their safety, quality and efficacy.
The legal situation regarding herbal preparations varies from country to country. In some countries phytomedicines are well-established, whereas in others food and therapeutic claims are not allowed. Developing countries, however, often have a great number of traditionally used herbal medicines and much folk-knowledge about them, but have hardly any legislative criteria to establish these traditionally used herbal medicines as part of the drug legislation.
For the classification of herbal or traditional medicinal products factors applied in regulatory system include-
(a) Description in a pharmacopoeia monograph,
(b) Prescription status,
(c) Claims of a therapeutic effect,
(d) Scheduled or regulated ingredients or substances,
(e) Periods of use.
In some countries there is a distinction between "Officially approved" products and "Officially recognized" products so that they can be marketed with out any scientific assessment by the authority.
Various legislative approaches for herbal medicines may be of followed categories-
- Some regulatory requirements for all products,
- Some regulatory requirements for all products, with certain types of evidence not required for herbal / traditional medicines,
- Exemption from all regulatory requirements for herbal / traditional medicines,
- Exemption from all regulatory requirements for herbal / traditional medicines concerning registration / marketing authorization,
- Herbal / Traditional medicines subject to all regulatory requirements,
- Herbal / Traditional medicines subject to all regulatory requirements concerning registration / marketing authorization.
Where herbal medicines and related products are neither registered nor controlled by regulatory bodies, a special licensing system is needed which would enable health authorities to screen the constituents, demand proof of quality before marketing, ensure correct and safe use, and also to oblige license holders to report suspected adverse reactions within a post-marketing surveillance system.
WHO Policy and Activities
The WHO Traditional Medicine Programme
The World Health Assembly (WHA) has adopted a no. of resolutions drawing attention to the fact that a large section of population in many developing countries still relies on traditional medicine.
In 1978, the declaration of Alma-Ata recommended, inter alia, the inclusion of proven traditional remedies into national drug policies & regulatory measures.
The policy of the WHO regarding traditional medicines was presented in the Director General's report on traditional medicine and modern health care to the 44 WHA 1991, which stated that "WHO collaborated with its member states in the review of national policies, legislation and decision on the nature and extent of the use of traditional medicine in their health systems".
Based on the relevant WHA resolutions, the major objectives of the traditional medicine programme are-
-To facilitate the integration of traditional medicine into national health care systems,
-To promote the rational use of traditional medicine through the development of technical guidelines and international standards in the field of herbal medicine and acupuncture,
-To act as a clearing house for the dissemination of information on various forms of traditional medicine.
In resolution WHA42.43 (1989), the health assembly urged member states-
-To make a comprehensive evaluation of their traditional system of medicine,
-To make a systemic inventory and assessment of the medicinal plants used by traditional practioners and by the population,
-To introduce measures for the regulation and control of medicinal plant products and for the establishment and maintenance of suitable standards,
-To identify those medicinal plants or remedies derived from them, which have a satisfactory efficacy/side-effect ratio and which should be included in the national formularies or pharmacopoeias.
In recent years, many developed countries have shown growing interest in alternative or complementary systems of medicine, with a resulting increase in international trade in herbal medicines and other types of traditional remedies. A stimulus consequently exists, in both development and developing countries, to assess and rationalize practices, and to control commercial exploitation through over-the-counter sale of labeled herbal and other "natural" medicines.
Herbal medicines have been included in the International Conference on Drug Regulatory authorities (ICDRA) since the 4th Conference in 1986.
Workshops on the regulation of the herbal medicines moving in the international commerce were held at the 4th and 5th ICDRA Conferences in 1986 & 1989, both confining their deliberations the commercial exploitation of traditional medicines through over-the counter labeled products. It was concluded that the WHO should consider preparing model guidelines containing basic elements of legislation and registration.
A WHO consultation in Munich, Germany, JUNE 1991, drafted Guidelines for the Assessment of Herbal Medicines which were adopted for general use by the 6th ICDRA in Ottawa, October 19191.
These guidelines (WHO/TRM/91.4) define criteria for the evaluation of quality, safety and efficacy of herbal medicines to assist national regulatory authorities, scientific organizations, and manufactures to undertake an assessment of the documentation, of submissions and/or the dossiers in respect of such products.
These guidelines contain basic criteria for the assessment of quality, safety, and efficacy and important requirements for labeling and the package insert for consumers information.
The WHO Guidelines are intended to facilitate the work of regulatory authorities, scientific bodies and industry in the development, assessment and registration of herbal medicines, reflecting scientific results which could be the basic for future classification of herbal medicines and would also accommodate cross-cultural transfer of traditional herbal medicinal knowledge between different parts of the world.
In 1994, the WHO Regional Office for the Eastern Mediterranean published Guidelines for Formulation pf National Policy on Herbal Medicines. According to that it has been recommended to countries that a National Expert Committee be established, which would be the appropriate authority to identify the steps and plans needed to formulate national policy in this area and then to develop, direct and monitor the various phases of its implementation.
As most herbal medicines still need to be studied scientifically, Member States have been seeking the cooperation of WHO in identifying safe and effective herbal medicines for use in their national health care systems.
To develop criteria and general principles to guide research work on evaluating herbal medicines, the WHO Regional Office for the Western Pacific, in1992, organized a meeting of experts to develop guidelines for research on herbal medicines. The guidelines provide a basics for Member States to develop their own research guidelines, and for the exchange of research experience and other information so that a body of reliable data for the validation of herbal medicines may be built up. The adoption of such policy was intended to help to overcome legal barriers against the use of herbal medicines.
Research should differentiate between herbal medicines with a long documented experience and those the "traditional" use of which has not yet been established.
In accordance with the WHO Guidelines for the Assessment of Herbal Medicines (WHO/TRM/91.4), traditional experience with the respective preparation, which includes long-term use as well as the medical-historical and ethnological background, should be taken into consideration as a general rule in conducting research.
The summary and recommendation of 6th ICDRA prompted WHO to continue to develop pharmacopoeial monographs on herbal medicines on the basis of the Guidelines for the Assessment of Herbal Medicines.
In response to the request from Member States, WHO's Traditional Medicine Programme decided to prepare a technical document entitled "WHO Monographs on Selected Medicinal Plants" for primary health care.
A WHO consultation on "Who Monographs on Selected Medicinal Plants" took place in Munich, Germany 1996.After discussion and review, 28 monographs were adopted. The 28 monographs were presented at the 8th ICDRA meeting in Bahrain, November 1996. Another 32 monographs are being prepared.
Market Importance and Use of Herbal Medicines
In India it is difficult to quantify the market size of the traditional Indian system since most practitioners formulate and dispense their own recipes; according to a study on the attitude of modern medicine practitioners towards ayurvedic products general practiotners are relatively unfamiliar with ayurvedic products even though some are prescribe. They are willing to try ayurvedic products if its efficacy is scientifically proven and if no model medicinal remedies are available. People use self medication for minor ailments such as cough, cold, stomach pain etc. Patent & Propriety ayurvedic medicines are sold over the counter in the pharmacy. These products represents major share of branded traditional product in India.
Ayurveda needs the support of modern medical science & innovative research to make it credible & acceptable and to define advantages of traditional system of medicines with respect to safety & efficacy.
In India there are about 250000 rmp of ayurvedic systems & 1/3rd of the governmental medical post are occupied by physicians belonging to traditional systems.
About Author / Additional Info:
I am m.pharm in cognosy and M.sc in chemistry