National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoExecutive summary
Ver el documentoAcronyms, abbreviations and definitions
Ver el documentoWHO Regions
Abrir esta carpeta y ver su contenido1. Introduction
Abrir esta carpeta y ver su contenido2. National policy on traditional medicine and complementary/alternative medicine
Abrir esta carpeta y ver su contenido3. The regulatory situation of herbal medicines
Abrir esta carpeta y ver su contenido4. Member States, WHO and herbal medicines
Cerrar esta carpeta5. Country summaries
Ver el documento5.1 WHO African Region
Ver el documento5.2 WHO Region of the Americas
Ver el documento5.3 WHO Eastern Mediterranean Region
Ver el documento5.4 WHO European Region
Ver el documento5.5 WHO South-East Asia Region
Ver el documento5.6 WHO Western Pacific Region
Ver el documentoReferences
Ver el documentoAnnex 1. Text of survey instrument
 

5.5 WHO South-East Asia Region

Countries that responded to the survey: South-East Asia Region

All 10 countries of the WHO South-East Asia Region responded to the Global Survey. Table 8 summarizes the development of national policy and regulation of TM/CAM and herbal medicines in the South-East Asia Region, with comparative figures for all of the responding countries and the global percentages. The figures and percentages represent those countries responding positively to the questions. The survey response figures represent all of the responding countries either in the region or globally as indicated.

Table 8. WHO South-East Asia Region: positive responses

 

Member States in the South-East Region responding positively with the following

Regional survey % that responded positively
(10)

Global survey % that responded positively
(141)

National policy on TM/CAM

8

80%

32%

Law or regulation on TM/CAM

7

70%

38%

National programme on TM/CAM

9

90%

28%

National office for TM/CAM

10

100%

53%

Expert committee on TM/CAM

9

90%

43%

National research institute on TM, CAM or herbal medicines

7

70%

41%

Law or regulation on herbal medicines

7

70%

65%

Registration of herbal medicines

9

90%

61%

There is a strong commitment among the countries of the region to developing research and national policies on TM/CAM. With over 70% of these countries having every level of policy and regulation as well as research bodies and institutes, this region clearly leads the world in TM/CAM and herbal medicine research and policy development.

Bangladesh

In the People’s Republic of Bangladesh, a national policy on TM/CAM was issued in 1995. National laws and regulations are currently in development. The national programme was issued in 1998. The national office was established in 1990 as part of the Ministry of Health. An expert committee was established in 2003. No national research institutes on TM, CAM or herbal medicines have yet been established.

Regulation of herbal medicines was introduced in 1992; the same laws and regulations apply to herbal medicines and conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. They may be sold with medical, nutrient content and structure/function claims.

The Bangladesh national formularies on unani and ayurvedic medicine are legally binding. No national herbal monographs are in development.

Regulatory requirements for herbal medicine include adherence to information contained in pharmacopoeias and monographs, GMP rules for conventional pharmaceuticals and special GMP rules. The Drug Administration is in charge of ensuring the implementation of these requirements; however, no detailed information about the specific mechanisms is available. Safety requirements are the same as for conventional medicines, with the addition of traditional use without demonstrated harmful effects. No specific information about the type of control mechanism for these requirements is available.

There is a registration system for herbal medicines; however, the number of registered products is not available. No post marketing surveillance system exists or is currently being planned. Herbal medicines are sold in pharmacies as prescription and over the counter medicines and by licensed practitioners.

Bhutan

The national policy on TM/CAM of the Kingdom of Bhutan is currently being developed, as are laws, regulations and a national programme. The Institute of Traditional Medicine Sciences is part of the Ministry of Health; it was established in 1967. The Pharmaceutical and Research Unit of that Institute has served as the expert committee and the national research institute on traditional medicine since 1998.

Bhutan does not currently have laws or regulations on herbal medicines. Herbal medicines are classified as prescription medicines. Medical, health and structure function claims are made about herbal medicines. No national pharmacopoeia exists, nor is one currently being developed. National herbal monographs are currently in development.

The regulations regarding the manufacture of herbal medicines are the same GMP rules that apply to conventional pharmaceuticals; however, no control mechanism exists for these requirements. There are no safety assessment requirements. There is also no registration system for herbal medicines. As of 1998, there were 103 herbal medicines listed on the national essential drug list. A national post marketing surveillance system is currently being developed. There are no restrictions on the sale of herbal medicines.

Annual sales data for Bhutan was provided for the period 1999 2001. In 1999, national sales were estimated at 2 579 098 ngultrum (US$ 57 415). In 2000, the figures rose to 3 185 848 ngultrum (US$ 70 923) and for 2001, sales reached 4 064 439 ngultrum (US$ 90 482).

Democratic People’s Republic of Korea

The national policy on TM/CAM in the Democratic People’s Republic of Korea was issued in 1980, as were laws and regulations. No information is available about the existence of a national programme. The Department of Traditional Koryo Medicine of the Ministry of Public Health was established in 1956. An expert committee on TM/CAM was created in 1961, as were national research institutes on traditional and herbal medicines.

The Law on Medical Product Management was issued in 1999, covering both herbal medicines and conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. By law, medical claims may be made for herbal medicines.

The most recent edition of the Pharmacopoeia of the Democratic People’s Republic of Korea was published in 1996; it is legally binding. The Korean herbal medicine monographs are used, although they are not legally binding. They were published in 1986.

Manufacturing requirements for herbal medicines include adherence to information in pharmacopoeias and monographs and the same GMP rules as those required for conventional pharmaceuticals. A licensing system administered by the drug control group serves as the control mechanism for these requirements. Manufacturers require one of these licences in order to operate. Safety requirements for herbal medicines are identical to those for conventional pharmaceuticals. No detailed information is available about the control mechanism used to ensure that these requirements are met.

There are 1 195 registered herbal medicines in the Democratic People’s Republic of Korea. No information is available about the inclusion of herbal medicines on a national essential drug list. The post marketing surveillance system, including adverse reaction monitoring for herbal medicines, was set up in 1947. Herbal medicines are sold in pharmacies as prescription and over the counter medicines.

India

In the Republic of India, the national policy on TM/CAM was introduced in 1940. National laws and regulations were also issued in 1940, and updated in 1964, 1970 and 1982. The national programme was issued in 1964. The national office, the Department of Medicine and Homeopathy, was established in 1995 as part of the Ministry of Health and Family Welfare. There are a number of expert committees for different forms of TM/CAM; the earliest was established in 1962. There are also a number of national research institutes; the first was the Central Council of Indian Medicine, established in 1970.

National regulation of herbal medicine began in 1940 with the publication of the Drugs and Cosmetics Act; the laws and regulations on herbal medicines are partly the same as those for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines and dietary supplements. Herbal medicines may be sold with medical, health and nutrient content claims.

India has two multivolume national pharmacopoeias, the Ayurvedic pharmacopoeia of India and the Unani pharmacopoeia of India. Both are considered to be legally binding. Regarding national monographs, several sources are used, including a national database on medical plants used in ayurvedic medicine and monographs contained in the national pharmacopoeias.

Manufacturing regulatory requirements include adherence to information contained in pharmacopoeias and monographs and the same GMP rules required for conventional pharmaceuticals. Drug licensing, inspection and testing are employed to ensure compliance with these requirements. Safety requirements include those required for conventional pharmaceuticals, as well as special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. No control mechanism is used for these requirements, as the long standing use of herbal medicines in the ayurveda, unani and siddha systems demonstrates their safety for human use.

There are 4 246 registered herbal medicines. Essential drug lists exist separately for the three systems of traditional medicine in India; the ayurveda list has 315 herbal medicines on its essential drug list, the unani list has 244 herbal medicines and the siddha list has 98. These lists were issued in 2001, 2000 and 2001, respectively. There are currently plans to establish a post marketing surveillance system. In India, herbal medicines are sold in pharmacies as prescription and over the counter medicines, in special outlets, by licensed practitioners and without restriction. Annual herb sales figures, based on sales of 162 medicinal plants between 1999 and 2000, were estimated at 6 705 million Indian rupees (US$ 149 million).

Indonesia

In the Republic of Indonesia, the “National Policy on Development of Traditional Medicine” was issued in 2000. Laws and regulations on TM/CAM were first issued in 1993. The national programme on TM/CAM was established in 2003. The national office on TM/CAM is administered by the National Agency of Drug and Food Control; it was established in 2001. The expert committee was established in 1977. National research institutes on traditional medicine and herbal medicine were established in 1976.

Through a separate law for herbal medicines, regulation was established in 1993, and updated in 1994 and 1995. Herbal medicines are regulated as over the counter medicines, as a separate regulatory category and as traditional medicines. By law, medical, health and structure/function claims may be made.

Three editions of the Farmakope indonesia have been published, the most recent dating from 1979. The national pharmacopoeia is legally binding. The Materia medika indonesia contains 246 of the national monographs, which are legally binding. It was published between 1977 and 1995.

Special GMP rules are required for the manufacture of herbal medicines; the implementation of these requirements is ensured through inspection and certification. Safety requirements include traditional use without demonstrated harmful effects, reference to documented scientific research on similar products, toxicity data and laboratory testing. Compliance with these requirements is ensured through post marketing surveillance, inspection, sampling, laboratory testing, investigation, monitoring of adverse effects and law enforcement.

There are 8 632 registered herbal medicines in Indonesia. No herbal medicines are included on a national essential drug list. The post marketing surveillance system was established in 2002, including adverse effect monitoring. Herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, by licensed practitioners and without restriction. Herbal medicines annual sales data were provided for 2000 02. Sales in 2000 totalled US$ 144 million, in 2001 sales reached US$ 167 million and in 2002, sales reached US$ 189 million.

Maldives

In the Republic of Maldives, the national policy was issued in 1999. National laws and regulations are being developed. The national programme was issued in 1980. In 1932, the national office for TM/CAM was established within the Ministry of Health. The expert committee was formed in 1980. No national research institutes on TM, CAM or herbal medicines have been established.

Maldives does not regulate herbal medicines; herbal medicines are classified as over the counter medicines and for self medication only. No claims may be made by law. No national pharmacopoeia or monographs exist, and none are being developed.

There are no regulatory requirements for manufacturing. Safety requirements are limited to references to documented scientific research on similar products. Ten herbal medicines are registered; none is included on a national drug list. A national post marketing surveillance system is being planned. In Maldives, herbal medicines are sold in pharmacies as over the counter medicines.

Myanmar

In the Union of Myanmar, the national policy on TM/CAM was issued in 1993. The Myanmar Indigenous Medicine Act was adopted in 1953, and updated and renamed the Traditional Medicine Council Law, which serves to ensure that traditional medicine practitioners abide by established rules of conduct and discipline. The Department of Traditional Medicine was established in 1989 under the Ministry of Health and expanded, together with the research division, in 1997. It serves as both the national office and the expert committee.

In Myanmar, the Traditional Medicine Drug Law was enacted in 1996 to ensure the quality, safety and efficacy of traditional medicines. It is a separate law, solely for the regulation of traditional and herbal medicines. The regulatory statuses used for herbal medicine are over the counter medicines and herbal medicine as a separate category. By law, herbal medicines may be sold with medical and health claims. Development of a national pharmacopoeia is in progress. The Monograph of Myanmar medicinal plants was published in 2000.

Regulatory requirements for herbal medicines are limited to special GMP rules; implementation of these requirements is ensured by inspection and laboratory analysis of quality control. Safety requirements include traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. These requirements are enforced through inspection, laboratory analysis for safety and market surveys.

There are 3 678 registered traditional medicines in Myanmar. The development of national essential traditional medicines drug lists is in progress. The national post marketing surveillance system does not include adverse effect monitoring, but such a system is being planned. Herbal medicines are sold in pharmacies as over the counter medicines and without restriction.

Nepal

In the Kingdom of Nepal, the national policy on TM/CAM, the “National Ayurveda Health Policy”, was issued in 1996. Laws and regulations were issued in 1978. The national programme, the Second Long Term Health Plan, 1997 2017, was issued in 1997. The Department of Ayurveda was established within the Ministry of Health in 1981. The expert committee was formed in 2001. No national research institutes on TM, CAM or herbal medicines have been established.

The Drug Act of 1978 established regulations on both herbal medicines and conventional medicines. Further laws and regulations were issued in 1981, 1983 and 1986. Herbal medicines are regulated as prescription and over the counter medicines. Medical, health, nutrient content and structure/function claims may be made by law.

No national pharmacopoeias or national monographs yet exist, but they are in development. A number of other texts are used while the national pharmacopoeia and monographs are being prepared, and they are considered legally binding.

Regulatory requirements for herbal medicines include adherence to information in pharmacopoeias and monographs and the same GMP rules as for conventional pharmaceuticals. However, there are no manufacturing requirements for domestic manufacture. The details of the control mechanisms used to ensure compliance are not available. Safety requirements include the same requirements as for conventional pharmaceuticals and the special requirements of traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and reference to the traditional literature. Implementation of these requirements is enforced in the same way as with conventional pharmaceuticals, with special emphasis on evidence from the ancient literature.

There is a registration system in Nepal; however, the number of registered herbal medicines is not available. There is an essential drug list for ayurvedic medicine; however, the number of listed items is not available. A national post marketing surveillance system is being planned. In Nepal, herbal medicines are sold in pharmacies as over the counter and prescription medicines, in special outlets, by licensed practitioners, by street hawkers and without restriction.

Sri Lanka

In the Democratic Socialist Republic of Sri Lanka, the national policy on TM/CAM is currently in development. Laws and regulations on TM/CAM were issued in 1961, and the national programme in 1982. The Department of Ayurveda in the Ministry of Health was established in 1961. There is a national expert committee, and a national research institute on traditional medicine, complementary medicine and herbal medicines was established in 1962.

No national laws or regulations on herbal medicines have been issued. Herbal medicines do not have any regulatory status; they are sold with medical, health, nutrient content and structure/function claims.

The national pharmacopoeia, the Ayurveda pharmacopoeia, was published in 1979. The Compendium of medicinal plants contains 100 national monographs; it was published in 2002. The information contained therein is considered to be legally binding.

Regulatory requirements for manufacturing include adherence to information in the pharmacopoeia and monographs and the same GMP rules that apply to conventional pharmaceuticals. No control mechanism exists for these requirements. There are no safety requirements.

There is no national registration system, nor are herbal medicines included on a national essential drug list. A post marketing surveillance system is being planned. In Sri Lanka, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Thailand

The national policy and programme on traditional medicine of the Kingdom of Thailand was issued in 1993, when the Institute of Thai Traditional Medicine was officially established under the Department of Medical Services. In 2002, the institute was placed under the newly established Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health. Meanwhile, the national policy on CAM was issued in 2002, when the Division of Complementary and Alternative Medicine was established under the Department for Development of Thai Traditional and Alternative Medicine. Medicinal Plant Research Institute, The Department of Medical Sciences is one of the national research institutes conducting complete cycled research on medicinal plants to develop into single herbal medicines and setting up standard specifications of medicinal plant materials. Meanwhile, the Institute of Thai Traditional Medicine is responsible for research on the body of knowledge of Thai traditional medicine and evaluation of the therapeutic efficacy of certain practices and recipes.

National laws and regulations on traditional medicines were issued in 1967 under the Drug Act B.E. 2510, which is divided into two parts covering modern and traditional medicines, and was later amended four times in 1975, 1979, 1984 and 1987. There are national expert committees on traditional medicine that oversee the registration of different types of traditional medicines. Certain aspects of the law and regulation of herbal medicines are similar to those for conventional medicines, i.e. the licensing of manufacturers, vendors and importers of TM. Registered traditional medicines can be divided into prescription medicines or over the counter medicines (household traditional medicines). Medical, health and structure/function claims may be made about herbal medicines.

As of 2003, the Thai herbal pharmacopoeia, published by the Department of Medical Sciences, comprises two volumes containing 21 monographs; however, the information is not considered legally binding. There are five other traditional formularies of herbal medicines that the Food and Drug Administration of Thailand uses as standard references for herbal medicine registration. The information in these formularies is considered legally binding.

Manufacturing regulatory requirements include adherence to information in pharmacopoeias and monographs, special GMP rules (only on a voluntary basis) and other Food and Drug Administration regulations. Control mechanisms for these requirements include pre marketing control using the Food and Drug Administration’s licensing and registration process, and post marketing control by quality control analysis of randomly sampled herbal medicines from the market. Safety requirements include traditional use without demonstrated harmful effects, references to documented scientific research on similar products, and toxicity studies. Control mechanisms for these safety requirements are pre marketing control through the licensing and registration process and post marketing control by means of adverse reaction reports.

There are over 2 000 herbal medicines registered in Thailand; a total of 16 herbal preparations (three traditional recipes and 13 preparations from five single herbs) are included in the national list of essential drugs, A.D. 1999. A post marketing surveillance system with adverse reaction monitoring was established in 2001. General herbal medicines are sold in pharmacies as over the counter drugs, or licensed practitioners may make their own herbal preparations and sell them to patients. For registered household herbal medicines, there are no restrictions on sales.

Sales figures for imported and locally produced herbal medicines were provided by Thailand for the period 1997 99. In 1997, herbal imports totalled 177 million baht (US$ 4.46 million); locally made product sales were 252 million baht (US$ 6.35 million), making a total of 429 million baht (US$ 10.81 million). In 1998, imports fell to 100 million baht (US$ 2.52 million), and sales of locally made products rose to 486 million baht (US$ 12.2 million), making a total of 586 million baht (US$ 14.8 million). In 1999, import sales rose to 114 million baht (US$ 2.87 million) and sales of locally made products reached 550 million baht (US$ 13.9 million), making a total of 664 million baht (US$ 16.7 million). The total figures were only 1.8%, 2.0% and 1.2%, respectively, of the annual sales of modern medicines in 1997-99.

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