PHCOG REV.

REVIEW ARTICLE

Legal regulations of complementary and alternative

medicines in different countries
Ajazuddin, Shailendra Saraf
University Institute of Pharmacy, Pt. Ravi Shankar Shukla University, Raipur, Chhattisgarh, India

Submitted: 25-03-2011 Published: 23-08-2012

ABSTRACT
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.
Key words: Efficacy, legislation, quality, safety, traditional medicines

INTRODUCTION hit US$ 5 trillion by 2050. The market is growing at 7% per annum
(The Times of India, 7-4-2000).
During the past decade, complementary and alternative medicines
A common feature of most systems of traditional medicine
have become a topic of global importance. Current estimates
(TM)/complementary and alternative medicine (CAM) is
suggest that in many developing countries, a large proportion
that they take a holistic approach to promote health, prevent
of the population relies heavily on traditional practitioners and
disease, and help the individual treat disturbances by regulating
medicinal plants to meet primary healthcare needs. Although
his/her physical, emotional, and mental aspects and living
modern medicine may be available in these countries, herbal
environment. According to its characteristics and concepts,
medicines (phytomedicines) have often maintained popularity
TM/CAM can be used not only for curing disease and relieving
for historical and cultural reasons. Concurrently, many people
symptoms but also for the regulation, improvement, and
in developed countries have begun to turn to alternative or
promotion of the function of the human body. Few plant
complementary therapies, including medicinal herbs. World Health
species that provide medicinal herbs have been scientifically
Organization (WHO) estimated that the world market for herbal
evaluated for their possible medical application. Safety and
medicines and herbal products is worth US$ 62 billion and would
efficacy data are available for even fewer plants, their extracts
and active ingredients, and the preparations containing them.
Address for correspondence: Furthermore, in most countries the herbal medicines’ market
Mr. Ajazuddin,
University Institute of Pharmacy, Pt. RSU, Raipur, Chhattisgarh,
is poorly regulated, and herbal products are often neither
India.E-mail: write2ajaz@gmail.com 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.
Access this article online
Both the general consumer and healthcare professionals need
Quick Response Code: Website: up-to-date, authoritative information on the safety and efficacy
www.phcogrev.com
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
DOI:
10.4103/0973-7847.99950
on TM/CAM has become an important concern for both
health authorities and the public. Providers of TM/CAM,

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 Ajazuddin and Saraf: Legal regulations of complementary and alternative medicines in different countries

other healthcare professionals, and TM/CAM consumers Traditional Chinese medicine

alike are calling for regulations that can ensure the safety of Traditional Chinese medicine has been used by Chinese people
TM/CAM therapies and products, promote recognition of from ancient times. Although animal and mineral materials have
these systems and modalities, and further define their role in been used, the primary source of remedies is botanical. Of the
modern healthcare systems. National policies and regulations more than 12,000 items used by traditional healers, about 500
on TM/CAM could ensure the safety, quality, and efficacy of are in common use.[4] Botanical products are used only after
these therapies and products and function as important steps some kind of processing, which may include, for example,
toward integrative healthcare systems. However, relatively stir-frying or soaking in vinegar or wine. In clinical practice,
few countries have developed policies and regulations on traditional diagnosis may be followed by the prescription of a
TM/CAM so far. Only 25 of WHO’s 191 countries have a complex and often individualized remedy. Traditional Chinese
national policy on TM/CAM and only 64 countries regulate medicine is still in common use in China. More than half the
herbal medicines.[1] population regularly uses traditional remedies, with the highest
prevalence of use in rural areas. About 5000 traditional remedies
To assist countries in the development of TM/CAM policies and are available in China; they account for approximately one-fifth
regulations of herbal medicines, WHO has published a series of of the entire Chinese pharmaceutical market.[4]
technical guidelines and reviewed regulations on herbal medicines
in the document “Regulatory Situation of Herbal Medicines: Japanese TM
a Worldwide Review.”[2] The purpose of the document is to Many herbal remedies found their way from China into the
share national experience in formulating policies on traditional Japanese systems of traditional healing. Herbs native to Japan
medicinal products, introduce measures for their registration and were classified in the first pharmacopoeia of Japanese TM in
regulation, and facilitate information exchange on these subjects the ninth century.[5]
among Member States.
Indian TM
In present review, we have compiled name of various regulatory Ayurveda is a medical system primarily practised in India that
authorities made for herbal medicines in different countries with has been known for nearly 5000 years. It includes diet and herbal
their major responsibilities and year of establishment which remedies, while emphasizing the body, mind, and spirit in disease
will definitely help the new researchers working in the field of prevention and treatment.[6]
quality control and standardization of TM/CAM.

The role of herbal medicines in traditional healing WHO GUIDELINES FOR HERBAL MEDICINES
The pharmacological treatment of disease began long ago with
the use of herbs.[3] Methods of folk healing throughout the These guidelines recognized the importance of herbal
world commonly used herbs as part of their tradition. Some medicines to the health of many people throughout the world,
of these traditions are briefly described below, providing some stating: “A few herbal medicines have withstood scientific
examples of the array of important healing practices around testing, but others are used simply for traditional reasons to
the world that used herbs for this purpose.[4] protect, restore, or improve health.” Most herbal medicines

Table 1: Different WHO guidelines with their major resolutions and year of establishment
WHO guidelines Major resolutions taken Year Ref
Quality control methods for medicinal plant Emphasized the need to ensure the quality of medicinal plant products 1998 [7]
materials by using modern control techniques and include suitable standards and
limits for contaminants are included.
WHO guidelines on safety monitoring of Provide technical guidance on the principles of good pharmacovigilance 2004 [8]
herbal medicines in pharmacovigilance and the inclusion of herbal medicines in existing national drug safety
systems monitoring systems.
Guidelines for the Regulation of Herbal This guideline aims to facilitate the registration and regulation of herbal 2003 [9]
Medicines in the South-East Asia Region medicines by establishing the foundation for a harmonized regulatory
standard to meet the common demands of the region.
General Guidelines for Methodologies on Harmonize the use of certain accepted and important terms in TM, 2000 [10]
Research and Evaluation of Traditional summarize key issues for developing methodologies for research and
Medicine evaluation of TM, improve the quality and value of research in TM, and
provide appropriate evaluation methods to facilitate the regulation and
registration of TMs.
National policy on TM and regulation of herbal Main objectives of this report are framing policy for safety, efficacy, and 2005 [11,12]
medicines Report of a WHO global survey quality of herbal medicines and its promoting rational use.
WHO guidelines on good agricultural and Quality assurance of medicinal plant materials used as the source 2003 [13]
collection practices for medicinal plants for herbal medicines, and encourage and support the sustainable
cultivation and collection of medicinal plants of good quality.

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 Ajazuddin and Saraf: Legal regulations of complementary and alternative medicines in different countries

Table 2: Legal status of different countries for herbal drug regulation

Country Legal status/policy Major responsibilities Year of Ref
establishment
Australia Therapeutic Goods Act The overall objective of the Act is to ensure the quality, safety, and 1989 [16,17]
(Commonwealth of Australia, efficacy of therapeutic goods, including medicines and medical
2001a) devices available to the Australian public.
Argentina Health Ministry of the Provincia Regulation for registration and commercialization of medicinal 1993 [18]
de Buenos Aires plants.
Austria Herbal medicine regulation Marketing authorizations. 1989 [19, 20]
Law No.541 Issuing of license.
Belgium Ministry of Health Under the law, proof of quality, safety, and efficacy became an 1995 [21-23]
essential precondition for the registration of drugs.
Canada Natural Health Products Ensure that the herbal medicinal plant product is safe under the 2004 [24-27]
Regulations recommended conditions of use without a prescription, effective
for the proposed claims, and of high quality.
Chile Unidad de Medicina Tradicional Incorporating TM with proven efficacy into health programs and 1992 [28]
of contributing to the establishment of their practice.
China The Drug Administration Law Encourages the development of both modern and traditional 1984 [18]
ofthe People’s Republic of China drugs, protects the resources of wild herbal drugs, and
promotes domestic cultivation of herbal drugs.
Colombia Ministry of Health Issuing of license. 1990 [29]
Documentation on the manufacturing process, quality control,
and, if necessary, toxicity studies.
Denmark Danish Ministry of Health Order Proof of quality, safety, and efficacy must be given; a 1992 [30, 31]
No. 790 bibliographic application with respect to therapeutic use is
accepted if it contains descriptions in the relevant scientific
literature of Europe or North America.
Egypt National Applied Research Medical, health, and nutrient content claims made by law. 1995 [18]
Centre for Medicinal Plants and Rules of GMP are implemented for herbal medicines.
National Organization for Drug
Control and Research
Estonia Medicinal Products Act To maintain the documents concerning chemical, 1996 [32]
pharmaceutical, biological, pharmacological-toxicological, and
clinical information of the herbal drugs.
Fiji Pharmacy and Poisons Act of Fiji Permits importation of TMs for use by ethnic communities 1994 [33,34]
Finland Administrative regulation 9/93 Quality and manufacture of herbal remedies 1993 [35]
(Marketing Authorization, 1993)
France French Medicines Agency Marketing authorizations [36]
Germany Medicines Act of 24 August 1976 Herbal finished drugs have to comply with the same criteria for 1976 [37-39]
quality, safety, and efficacy as all other finished drugs
Greece Ministry of Health Issuing of license, documentation on the manufacturing 1994 [40]
process, and toxicity studies.
Hungary Law on Public Health, Chapter Herbal drugs regulated as over the counter medicines for self- 1996 [41]
IV, Section 104 medication purposes and by law, medical claims, and health
claims may be made.
India Drugs and Cosmetics Act of 1940 Regulate the import, manufacture, distribution, and sale of 1945 [42]
and the Drugs and Cosmetics drugs and cosmetics.
Rules of. 1945
Indonesia Directorate of Traditional Drug Production, distribution and labeling of traditional drugs, and 1975 [18]
Control licensing of traditional drugs and imported traditional drugs.
Ireland Guidelines for Application for Licensing of manufacturers and authorization of herbal products 1985 [43,44]
Product Authorization of Herbal
Products" issued by National
Drugs Advisory Board
Italy Italian Health Authority Grant licensed and ensure the quality, safety, and efficacy. 1981 [45]
Japan Ministry of Health and Welfare Improve quality control of Kampo drugs 1972 [46]
Korea The Ministry of Public Health and Regulate and rule on the herbal medicines and their 1969 [47-50]
Social Affairs preparations.
Malaysia National Pharmaceutical Control Manufacturing, import, supply, or sailing of the TMs. [18]
Bureau, Ministry of Health
Mali Traditional Medicine Department Postmarketing surveillance and adverse effect monitoring of 1968 [18]
under the Ministry of Health herbal medicines.

Table 2 Contd.

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 Ajazuddin and Saraf: Legal regulations of complementary and alternative medicines in different countries

Table 2: Legal status of different countries for herbal drug regulation

Country Legal status/policy Major responsibilities Year of Ref
establishment
Mongolia Traditional Medicine Department Production, development, and investigation of TMs. 1989 [51]
under Mongolian National
Medical University
Nepal Department of Drug Price approval, safety, efficacy, and quality of products. 1996 [52]
Administration under the Ministry Authorization for import, export, and distribution of the product,
of Health and the mode of distribution and promotion.
New Medicines Act of 1981 Control of active ingredients and excipients, method of 1981 [18]
Zealand manufacture, control tests of the finished product, labeling,
stability, etc.
Nicaragua The national pharmaceuticals Safety assessment 1998 [53]
law-292
Oman Ministry of Health Grant of license for manufacturing and import permission 1995 [54]
Pakistan The Drugs Act of 1962 Controls the regulation of herbal medicines as regards 1962 [18]
advertising and prevention of misuse
Portugal Portugal Drug Act Regulation of herbal medicines in the same laws as those 1995 [55]
covering conventional pharmaceuticals.
Qatar Ministry of Public Health By law, medical, health, nutrient content, and structure/function 1990 [56]
claims may be made about herbal medicines.
Saudi Ministry of Health, KSA Medical, health, nutrient content, and structure/function claims 1996 [18]
Arabia may be made
Singapore Traditional Chinese Medicine Marketing authorization and licensing of manufacturers. 2000 [57,58]
Practitioners Act
South Medicines Control Council Safety assessment requirements include traditional use without 1994 [2]
Africa (MCC)/ Dietary Supplement demonstrated harmful effects, reference to documented
Health and Education Act of scientific research on similar products, and clinical data.
Spain The Spanish Medicinal Products Objective of the Act is to ensure the quality, safety, and efficacy 1990 [59, 60]
Act No. 25 of therapeutic goods, including herbal medicines.
The Swiss Agency for Marketing authorization. And implementation of GMP rules. 2002 [61]
Switzerland Therapeutic Products
(Swissmedic) under Federal
Department of Home Affairs
Thailand The Drug Act B.E. 2510 Premarketing control, licensing and registration process, and 1967 [18]
postmarketing control by quality control analysis.
United Medicines and Healthcare Postmarketing surveillance 1968 [62-66]
Kingdom products Regulatory Agency Licensed medicinal products require evidence of quality, safety,
(MHRA) and Medicines Act 1968 and efficacy and are regulated by the Medicines
Control Agency.
United Food Drug and Cosmetics Act Ensuring that a dietary supplement is safe before it is 2000 [67-70]
States Dietary Supplement Health and marketed, and the United States Food and Drug Administration 1994
Education Act is responsible for taking action against any unsafe dietary
supplement product after it reaches the market.

still need to be studied scientifically, although the experience The below mentioned WHO guidelines [Table 1] stressed the
obtained from their traditional use over the years should not need for assessment of efficacy including the determination of
be ignored. As there is not enough evidence produced by pharmacological and clinical effects of the active ingredients,
common scientific approaches to answer questions of safety cultivation and collection of the medicinal plants, and labeling
and efficacy about most of the herbal medicines now in use, which includes a quantitative list of active ingredient, dosage,
and contraindications.
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 THE EUROPEAN UNION
studies. In this regard, WHO has issued guidelines for the
The European Pharmacopoeia was created in 1964; its efforts
assessment of herbal medicines. These guidelines defined the
have resulted in the creation of 83 monographs on herbal drugs
basic criteria for the evaluation of quality, safety, and efficacy of that are used either in their natural state after desiccation or
herbal medicines with the goal of assisting national regulatory concentration or for the isolation of natural active ingredients.
authorities, scientific organizations, and manufacturers in The Association of the European Self-Medication Industry
assessing documentation, submissions, and dossiers in respect has carried out a study for the European Commission on
of such products. herbal medicinal products in the European Union (EU). The

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 Ajazuddin and Saraf: Legal regulations of complementary and alternative medicines in different countries

following summary is taken from this report.[14] The importance medicinal plants themselves and the products derived from
of herbal medicinal products varies from one country to them. Regulations in countries for the assessment of the quality,
another. These products are not a homogeneous group. In safety, and efficacy of medicinal plants, and the work of WHO
general, they are either fully licensed medicinal products and EU in supporting the preparation of model guidelines
with efficacy proven by clinical studies or by references to in this field, have been helpful in strengthening recognition
published scientific literature (in accordance with Article 4.8 of their role in health care. It is hoped that assessment of
a (ii) of Council Directive 65/65/EEC)[15] or are available these traditional remedies could become the basis for a future
as products with a more or less simplified proof of efficacy classification of herbal medicines, as well as for evaluative
according to their national use. Many Member States have studies on their efficacy and safety, and their potential use in
these two categories, but there are major discrepancies between national healthcare systems in different parts of the world.
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 AKNOWLEDGEMENT
authorization. According to Council Directive 65/65/EEC,[15]
The authors acknowledge the University Grant Commission
which has been implemented in national law in all Member [F. No. 34-131/2008 (SR)], New Delhi, India, for financial support.
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
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