Thailand

 

Policy

The National Institute of Thai Traditional Medicine was established as a division of the Department of Medical Sciences in Ministry of Health in 1993. Traditional Thai and Ayurvedic practitioners must register with MOH in order to practice Thai massage, reflexology and acupuncture.

Traditional medicines and herbal remedies are managed by a sub-committee appointed to assist the 19 members of the Drug Committee.

THAILAND POLICIES

Contact

Food and Drug Administration Thailand,
Tel: 66- 2590-7160, 66- 2590-7171         

Fax: 66-2591-8390, 66-2591-8489, 66-2590-7170                                                
Website: http://www.fda.moph.go.th/eng

 

Thailand T&CM Policy

 

National Policy on Traditional Medicine and Alternative Medicine

The national policy to promote the use of Thai traditional medicine (TTM), indigenous medicine and alternative medicine in the health care system and in primary health care by people in the communities was stated in key related national plans; namely, the National Economic and Social and Development Plan and the National Health Development Plan developed in line with the former, National Health Act, Statute on National Health System, and National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Healthy Lifestyle.

 

National Economic and Social and Development Plan and National Health Development Plan
Thailand’s Ministry of Public Health included a policy to promote the use of medicinal plants in PHC since the time of the 4th National Economic and Social Development Plan and the 4th Health Development Plan (1977-1981).  Government policy on the promotion of the use of herbal medicine, research and development on herbal medicines for primary health care was stated in the 5th-7th National Economic and Social Development Plan (1982-1996).  The policies to promote the development of Thai traditional medical knowledge and personnel, research and development, and the integration into the health care system were stated in the 8th-11th National Health Development Plan (1997-2016).1

The 10th National Health Development Plan (2007-2011) and “Sufficiency Health System” Strategic Plan were formulated under the 10th National Economic and Social Development Plan of which the framework and the direction for the development of the country’s macroeconomics have been based on King Bhumibhol Adulyadej’s philosophy of “Sufficiency Economy”.  The 10th National Health Development Plan aimed at achieving good health, good service, sufficiency life style and peaceful society.  One of the desired characteristics of sufficiency health system is the use of technology appropriately and wisely with the emphasis on the use of Thai traditional medical knowledge and being self-reliant.  “The development of alternative forms of healthcare by knowledgeably blending Thai wisdom with international wisdom” is one of the six strategies of the 10th National Health Development Plan.1,2

The 11th National Economic and Social Development Plan and the 11th National Health Development Plan (2012-2016) will continue to implement the key elements of the “Philosophy of Sufficiency Economy” placing “people at the center of development”.  According to the 11th National Health Development Plan, one of the key strategies to achieve healthy society is “to strengthen the roles of the people, communities, and health-related partner networks in health promotion, disease prevention, and self-health care as well as to promote self-reliance on health based on the knowledge of Thai traditional medicine, indigenous medicine, and alternative medicine”.3 As a result of the current Health Development Plan, one of the current policies of the Minister of Public Health under the present government is “to promote the use of Thai traditional medicine and alternative medicine in all levels of public health service system”.4

 

Contact Details

Bureau of Policy and Strategy
Office of Permanent Secretary
Ministry of Public Health
Tiwanont Road, Mueang, Nonthaburi 
Thailand 11000
Tel: + 662 5901387
Fax: + 662 5901393
Website: http://bps.ops.moph.go.th/webenglish/index1.html

Reference:

  1. Petrakard P, Chankittiwat V. National policy and strategy on Thai traditional medicine, indigenous medicine and alternative medicine.  In: Chokevivat V, Wibulpolprasert S, Petrakard P. eds. Thai Traditional and Alternative Health Profile: Thai Traditional Medicine, Indigenous Medicine and Alternative Medicine 2009-2010. Bangkok: War Veterans Organization Office of Printing Mill. 2012. p. 65-97.
  2. The 10th National Economic and Social Development Plan (2007-2011) and the 10th National Health Development Plan.  Public Health Calendar 2007. Bangkok: Sahaprachapanich. 2007. pp.25-32.
  3. Bureau of Policy and Strategy Ministry of Public Health. The 11th National Health Development Plan (B.E. 2555-2559). [cited 2012 Oct 6]. Available from: http://bps.ops.moph.go.th/Plan10/condition/ร่างplan11(2).html
  4. Bureau of Policy and Strategy Ministry of Public Health. Policies of Ministers of Public Health. [cited 2012 Oct 6]. Available from: http://bps.ops.moph.go.th/moph/moph2.html

 

Thailand Statute on National Health System B.E. 2552(2009)

Chapter 7 of the Statute on National Health System B.E. 2552 (2009) prepared by the National Health Commission entitles and deals with the “promotion, support, use and development of local health wisdom, Thai traditional medicine, indigenous medicine, and other alternative medicine”.6,7 The chapter which covers principles (Section 53), goals (Section 54-60), and measures (Section 61-67) is shown in Annex 1.

In addition, on 18 December 2009, the Second Session of the National Health Assembly passed resolutions on seven issues, one of which or ‘Resolution 7’ was on the “Development of Thai traditional medicine, indigenous medicine and alternative medicine to be mainstream health care system in parallel with modern medicine”.  Resolution 7 of the Second National Health Assembly requested the National Commission on Traditional Knowledge Development for Health, Department for Development of Thai Traditional and Alternative Medicine, and the Division of Medical Registration (now Bureau of Sanatorium and Art of Healing) to serve as core agencies to work together with other relevant agencies and networks in the public sector, academia, and civil society in carrying out actions according to Chapter 7 of the 2009 Statute of National Health System.[1] Various measures and actions were proposed for implementation to achieve the goals set in the Statute as shown in Annex 1.  Resolution 7 also requested the Secretary-General of the National Health Commission to report the progress in the implementation of the resolution to the 4th National Health Assembly. [1][2]

 

Contact Details

National Health Commission 
National Health Commission Office of Thailand
National Health Building, 3rd Floor,
88/39, Tiwanont 14 Rd., Muang District,
Nonthaburi 11000 Thailand.
Tel: +66-2832-9000 
Website: http://en.nationalhealth.or.th/ 

Reference:

  1. The Statute on National Health System B.E. 2552 (2009). The Royal Gazette. Vol. 126, Part 175. 2 December 2009.
  2. National Health Commission Office of Thailand. Statute on National Health System B.E. 2552 (2009).  [cited 2012 Oct 6]. Available from: http://en.nationalhealth.or.th/sites/default/files/fromNHCThailand/data/statute_nh_system_en.pdf

 

Thailand National Health Act B.E. 2550 (2007)

The National Health Act B.E. 2550 (2007) issued on 3rd March 2007 states in Section 46 that the National Health Commission will be responsible for the preparation of the “Statute of National Health System” to be used as a framework and guideline in making policy, strategy, and activities on national health to be submitted for the approval of the Cabinet.  Section 47 of the Act indicates that ‘the promotion, the support, the use, and the development of local wisdom relate to health, Thai traditional medicine, indigenous medicine and other forms of alternative medicine’ must be one of the essential elements of the Statute of National Health System.

Under National Health Act B.E. 2550, “Health Assembly”, which can be divided into 3 categories; namely, the locality-based health assembly, the issue-based health assembly, and the National Health Assembly, shall be organized as an instrument and a learning process to develop participatory public policies on health and pushing for practicability.  The issue-based health assembly on Thai traditional and alternative medicine was organized several times on various related issues.  The statute and the assembly are a significant forum for drawing up policy recommendations and guidelines for the development of traditional medicine, indigenous medicine and alternative medicine using a broad-scale participatory process.1

 

Contact Details

National Health Commission 
National Health Commission Office of Thailand
National Health Building, 3rd Floor,
88/39, Tiwanont 14 Rd., Muang District,
Nonthaburi 11000 Thailand.
Tel: +66-2832-9000 
Website: http://en.nationalhealth.or.th/

Reference:

  1. The National Health Act B.E. 2550.The Royal Gazette. Vol. 124, Part 16a. 19 March 2007.

 

Thailand National Strategic Plan on the Development of ‘Tai’ Wisdom and ‘Tai’ Healthy Lifestyle 

On 12 June 2007 the Cabinet approved “National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Healthy Lifestyle B.E. 2550-2554 (2007-2011)” which determines the directions and the roles of indigenous medicine, Thai traditional medicine and alternative medicine in the national health system and requires the participation from various sectors involved to implement the plan.1 This National Strategic Plan is composed of five strategies related to indigenous medicine, Thai traditional medicine and alternative medicine (IM/TTM/AM), namely: -

  1. Development and management of knowledge of IM/TTM/AM
  2. Development of health system
  3. Development of workforce
  4. Development of Thai traditional medicines and herbal medicines
  5. Protection of Thai traditional knowledge related to indigenous medicine, Thai traditional medicine and Thai herbs.1

“The 2nd National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Healthy Lifestyle B.E. 2555-2559 (2012-2016)” was prepared by “Subcommittee on the Preparation of the National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Healthy Lifestyle” and “National Committee on the Development of Local Wisdom on Health” and was approved by the National Health Commission and later by the Cabinet on 20 May 2012.  The strategic plan continues with the development on indigenous medicine, Thai traditional medicine and alternative medicine in the national health system.  It also formed the framework for the participation from various sectors involved to implement the plan in order to help people being self-reliant on health care.  This National Strategic Plan is composed of six strategies related to IM/TTM/AM, namely: -

  1. Knowledge development and management
  2. Development of community health system and health service system
  3. Development of workforce in IM/TTM/AM
  4. Development of herbal medicinal products and herbal products system
  5. Development of the system and mechanism for the protection of Thai traditional medical knowledge
  6. Public communication in the areas of indigenous medicine, Thai traditional medicine, and alternative medicine2

The Plan set up strategy/measures, key performance indicators, goals for each strategy to achieve at the end of 5-year period, institutes responsible for collaborating or implementing each strategy, and implementation plan.2

 

Contact Details

Subcommittee on the Preparation of the National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Healthy Lifestyle” and “National Committee on the Development of Local Wisdom on Health
National Health Commission 
National Health Commission Office of Thailand
National Health Building, 3rd Floor,
88/39, Tiwanont 14 Rd., Muang District,
Nonthaburi 11000 Thailand.
Tel: +66-2832-9000 
Website: http://en.nationalhealth.or.th/

Glossary:

* “Tai’ Wisdom means knowledge, technology, practices and biodiversity existing in Thailand covering the context of Thai traditional medicine, Thai indigenous medicine and alternative medicine.
# “Tai’ Healthy lifestyle means pathways that lead to health and allow people to be free from sickness, unhappiness, and all kinds of stress 

Reference:

  1. Wibulpolprasert S. (ed.). National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Ways of Health B.E. 2550-2554. Bangkok: War Veterans Administration Printing. 2007.
  2. The Second National Strategic Plan on the Development of ‘Tai’ Wisdom, ‘Tai’ Healthy Lifestyle B.E. 2555-2559 (2012-2016). Nonthaburi: National Committee on the Development of Local Health Wisdom, National Health Commission Office. 2012.

Laws

Dietary supplements and botanicals are regulated by the Food and Drug Administration.  Legislation is currently being revised with the phasing out of The Drug Act of B.E. 2510 (1967), the promulgation of the Drug Act of B.E. 2546 (2003) and the revision of the Drug Act of B.E. 2530 (1987). These changes in legislation will allow for three categories of products - prescription only, pharmacy-dispensing and household remedies.

Guidelines cover all aspects of manufacturing, sales and marketing, distribution and changes are imminent in each area.  These changes will be posted to the Food and Drug Administration’s website.

Licensing (Pre-market) Separate licenses are required for the manufacturing, sales and distribution of all herbal products.  Applicants must submit applications to the Drug Control Division and then following an inspection, they will either be granted or denied a license.

(Post Market) All manufacturing facilities are regularly inspected and any changes in procedure must be determined to safe.  Adverse events are monitored with manufacturing procedural changes.

THAILAND LAWS AND REGULATIONS

Contact

Food and Drug Administration

Tel: 66- 2590-7160, 66- 2590-7171         

Fax: 66-2591-8390, 66-2591-8489, 66-2590-7170                                             

e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

http://www.fda.moph.go.th/eng

 

Thailand: Practice of the Art of Healing Act B.E. 2542 (1999) and the Licensing of Practitioners

Under the Practice of the Art of Healing Act; B.E. 2542 (1999), the Ministry of Public Health officially recognizes 3 types of TM/CAM as branches of “the Art of Healing”; namely, Thai traditional medicine (TTM)10, traditional Chinese medicine (TCM)2, and chiropractic2

According to the Act, the art of practice of TTM can be divided into 2 categories; i.e., Thai traditional medicine and applied Thai traditional medicine.  The ‘Profession Commission in the branch of Thai traditional medicine’ and the ‘Profession Commission in the branch of applied Thai traditional medicine’ are responsible for the registration and issuing or revoking the license of TTM and applied TTM practitioners, respectively.1 The Bureau of Sanatorium and Art of Healing, Department of Medical Service Support, Ministry of Public Health serves as the secretariat office of the two profession commissions.  In addition, the commissions are also responsible for the control of professional practice by setting up the standards and code of professional practice, reviewing and approving the teaching curricula of academic institutions, and considering professional misconduct of practitioners and appropriate measure of punishment.1  In order to become a licensed practitioner, a person must take a licensing examination given by the commissions in the branch that he/she was trained for.  Similarly, there are also Profession Commissions in the branch of TCM and chiropractic that have the same responsibilities in their branch of practice.  Therefore, any person who would like to practice any of the three branches of TM/CAM recognized by the Practice of the Art of Healing Act; B.E. 2542 (1999); namely, TTM, TCM or chiropractic must be registered with respective profession commission and pass licensing examination offered by the profession commission to become a licensed practitioner before he/she can legally practice.1

Licensing of TTM and applied TTM practitioners

As previously mentioned, according to the Practice of the Art of Healing Act B.E. 2542 (1999), the art of practice of TTM can be divided into 2 categories; i.e., Thai traditional medicine and applied Thai traditional medicine.  In order to become a licensed applied TTM practitioner, a person with Bachelor’s degree in applied Thai traditional medicine must pass a licensing examination that cover all areas of TTM; namely, Thai traditional medicine, Thai traditional pharmacy, Thai traditional midwifery and Thai traditional massage (Nuad Thai).  Licensed applied TTM practitioners will be able to practice all areas of TTM under one license.  In contrast, in order to become a licensed TTM practitioner, a person who is qualified to take a TTM licensing examination (completed apprenticeship training or received degree or certificate from certified academic institution) needs to pass separate licensing examination for each filed of TTM practice to obtain separate licenses to practice in each of the four fields of TTM.1

According to Article 33(1) of the Practice of the Art of Healing Act, in addition to the requirement to pass licensing examination to become a licensed practitioner, there is another procedure that a person with a long practical experience in Thai folk massage can be registered and licensed as a TTM practitioner; namely, by being certified by a government office and passing the evaluation process under the conditions set by the Profession Commission in the branch of Thai Traditional Medicine.1  This system of licensing is based on two Notifications of the Profession Commission in the branch of TTM issued on July 13, 20044,5 involving

  1. The evaluation of a person whom a government office certified as one with experience in Thai indigenous medicine for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai traditional medicine4; and
  2. The evaluation of a person whom a government office certified as one with experience in Thai massage for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai massage5

These Notifications gives folk healers who have never has a license for the practice of Thai traditional medicine but have long experience and knowledge in Thai indigenous medicine (folk medicine) or folk massage and have used their experienced knowledge of Thai indigenous medicine or folk massage to treat various symptoms or diseases of people in their communities for many years an opportunity to be registered and licensed as TTM practitioners in the field of Thai traditional medicine or Thai traditional massage after passing the evaluation by the Profession Commission.4,5

The Notification of the Profession Commission in the branch of Thai traditional medicine specifies the qualifications of a person who has the right to be nominated as one with experience in Thai indigenous medicine or Thai massage as follows4,5

  • Has Thai nationality
  • Resides in Thailand
  • Has experience in Thai indigenous medicine for not less than 20 years
  • (For experience in Thai massage) Has one of the following qualifications or experiences: -
  • is a TTM practitioner in the field of TTM with experience in Thai massage for not less than 12 years, is a teacher of Thai massage for not less than 7 years and is at least 32 years of age, or
  • is one with experience in Thai massage for not less than 14 years, is a teacher of Thai massage for not less than 9 years, and is at least 37 years of age, or
  • is one with experience in Thai massage for at least 20 years.
  • Does not have forbidden characteristics described in the Article 32(3)-(7) of the Practice of the Art of Healing Act B.E. 2542.Table 6 shows the number of licensed TTM and applied TTM practitioners as of 20 September 2011.

In pursuance of the above-mentioned notifications, the guideline for the screening and evaluation of folk healers, qualifications of folk healers, and criteria for the evaluation were set up.  The information required for the evaluation of a folk healer is divided into three parts; namely, 1) personal history including how one obtain or gain knowledge on folk medicine and his/her area of expertise; attitude, belief, and conduct as a folk healer; 2) case studies of patients who received treatments by the folk healer (qualitative study in at least 10 cases & quantitative study); and 3) study on the acceptance of the folk healer by his/her community.6

The first group of licensed TTM practitioners in the field of Thai massage (81 people) was issued the license by this method on 29 September 2005.  As of October 2012, there have been 161 folk healers who passed the evaluation by TTM Profession Commission and became licensed TTM practitioners in the field of Thai traditional medicine.

Table 6 shows the number of licensed TTM and applied TTM practitioners as of 20 September 2011.7

Table 6: Number of licensed TTM and applied TTM practitioners as of September 2011.16

Types of practitioners Cumulative number of licensed practitioners

Fiscal year 2011

(Oct 10-Sept 11)

New Total
1. Thai traditional medicine 49,038 5,159 54,197
1.1 Thai traditional medicine 17,779 1,184 18,963
1.2 Thai traditional pharmacy 23,951 2,105 26,056
1.3 Thai traditional midwifery 6,780 493 7,273
1.4 Thai traditional massage 528 1,377 1,905
2. Applied Thai traditional medicine 826 396 1,222

Source: Bureau of Sanatorium and Art of Healing, Department of Health Service Support. Statistics of practitioners of the art of healing, fiscal year 2011 (as of 20 September 2011).

Draft Thai Traditional Medicine Profession Act 

During the past three years, attempt has been made by civil society sector to draft and propose a new Act entitled “(Draft) Thai Traditional Medicine Profession Act (B.E…)” to the parliament.  This draft Act (along with two other versions of the draft Act proposed by the House of the Representatives) was considered, revised, and eventually passed by the House of the Representatives.  Currently, the draft Act is being considered by an Ad Hoc Committee of the House of the Senate and is expected to be considered and reviewed by the House of the Senate in late 2012.  It is estimated that the reviewed Act will finally be passed by the House of the Senate and the Act will be promulgated before the end of the year 2012.  After the Act becomes effective, there will be a major change on the regulation of the practice of Thai traditional medicine practitioners as they will become “Thai traditional medicine doctors” and the licensing and the regulation of the practice will no longer be under the authority of the two Profession Commissions but will be under the authority of the Thai Traditional Medical Council that will soon be established.

 

Licensing of traditional Chinese medicine practitioners

The Ministry of Public Health by Bureau of Sanatorium and Art of Healing, Department of Health Service Support is responsible for organizing TCM licensing examination once a year.  As of September 2011, the Ministry of Public Health has issued license for the practice of TCM to 388 qualified persons.  Among these, 309 are TCM doctors who learned TCM from their ancestors and lived in Thailand for more than 3 years, while 79 are TCM doctors who received Bachelor’s Degree in TCM from universities in Thailand or abroad.8
In addition, to TCM practitioners, modern medicine doctors or physicians who passed the three-month course on acupuncture certified by the Ministry of Public Health can also give acupuncture treatment for the patients in health service facilities.  As of September 2011, there were 1,004 physicians who completed this three-month training course on acupuncture.8

 

Licensing of the practitioners of chiropractic

Even though chiropractic is another branch of the art of healing recognized by the Ministry of Public health, it is not available in the public health service facilities.  The practice of chiropractic is available in private clinics or hospitals where the practice of chiropractic will be under the supervision of licensed physician(s) according to the Practice of the Art of Healing Act12.  As of 20 September 2011, there were only 19 licensed chiropractic practitioners in Thailand.7

 

Contact Details

Bureau of Sanatorium and Art of Healing
Department of Health Service Support
Ministry of Public Health
Tiwanont Road, Muang, Nonthaburi 
Thailand 11000
Tel: +662 590 1331, +662 589 0757
Fax: +662 590 1332, +662 5901 8844 #303
Website: http://mrd-hss.moph.go.th/mrd/

Reference:

  1. Practice of the Art of Healing Act B.E. 2542 (1999). Thai Royal Gazette, Vol. 116 Pt. 39 A. 18 May 1999.
  2. Ministry of Public Health Notification (No.1) B.E. 2543 (2000) on “Permission of a person to practice the art of healing based on traditional Chinese medicine”. Thai Royal Gazette, Vol. 117 Pt. 71 D. 5 Sep 2000.
  3. Ministry of Public Health Notification B.E. 2549 (2006) on “Permission of a person to practice the art of healing based on the science of chiropractic”. Thai Royal Gazette, Vol. 123 Spec. Pt. 100 D. 28 Sep 2006.
  4. Notifications of the Profession Commission in the Branch of Thai Traditional Medicine on “Evaluation of a person whom a government office certified as one with experience in Thai indigenous medicine for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai traditional medicine”.Issued on July 13, 2004.
  5. Notifications of the Profession Commission in the Branch of Thai Traditional Medicine on “Evaluation of a person whom a government office certified as one with experience in Thai massage for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai massage”. Issued on July 13, 2004.
  6. Kulsomboon S, Ubolkhao P, et al. (eds.). Handbook on the evaluation of folk healers. 2nd ed. Bangkok: SamcharoenPanich. 2011.
  7. Bureau of Sanatorium and Art of Healing, Department of Health Service Support. Statistics of practitioners of the art of healing, fiscal year 2011 (as of 20 September 2011). [cited 2012 Oct 7]. Available from: 203.157.6.204/Admin/filestat/54.xlsx
  8. Techadamrongsin Y, Hazanine T, Jirapinijwong S (eds.).  Development of traditional Chinese medicine in Thailand. Bangkok: Union of Agriculture Cooperatives in Thailand Priniting.2554. 64 pages.

 

Thailand Drug Act B.E. 2510 (1967)

According to Drug Act B.E. 2510 (1967)1, drugs are classified into two major groups; namely, Modern drugs and Traditional drugs.  “Traditional drug” was defined as a drug intended for use in the practice of the traditional medicine or the cure of an animal disease which appears in a pharmacopoeia of traditional drug notified by the Minister, or a drug notified by the Minister as a traditional drug, or a drug of which formula has been registered as that of a traditional drug.

 

Types of registered herbal medicines

Thai FDA classified herbal medicinal products into four categories, namely: -

  1. Traditional drugs.  These are Thai traditional medicines or traditional Chinese medicine of which the indication, therapeutic claims, dosage and administration are based on traditional knowledge that have been passed on from generation to generation or from traditional textbooks recognized by the ministerial regulation.  The dosage forms of traditional drugs are not different from traditional dosage forms.
  2. Modified traditional drugs.  These are traditional medicines of which the indication, therapeutic claims, dosage and administration are based on traditional knowledge as in the first group but the dosage forms have been modified into modern dosage forms, e.g. capsules or tablets, for the ease of use and an increased compliance.
  3. Modern herbal medicines or Phytopharmaceuticals.  These are herbal medicinal products that are composed of active plant materials in the form of semi-purified compounds derived from scientific research and are classified as modern medicines.  The indication, therapeutic claims, dosage and administration of herbal drugs are usually based on clinical trial evidence.  This group of drugs is usually made of standardized herbal extracts prepared into various modern dosage forms.
  4. New drugs.  These are new drugs from herbs developed through complete drug development process and are in the form of purified isolated active substances of which the chemical structures were identified as new chemical entities; hence, this group of drugs is classified as modern medicines.

According to this classification, most of Thai traditional medicines and herbal medicines available in the market in Thailand fall into the first three categories of herbal medicinal products.

The registration of traditional medicinal products, the licensing of traditional medicine manufacturers, and post-marketing surveillance are the responsibility of Thai Food and Drug Administration (FDA), Ministry of Public Health.  Herbal medicines that are prepared from single or several herbal materials into different dosage forms have to be registered with the FDA prior to manufacturing and selling.  Medicinal plant materials or crude drugs are exempt from registration in order to make it easy for the public to use herbs for health care.  Prior to the production of any traditional medicine, the manufacturers must apply for manufacturing license from the FDA and have their manufacturing facilities well prepared and well equipped for the inspection by the FDA.  Licensed manufacturers can then file for the registration of their traditional medicines prior to the production.  The information submitted by the manufacturers for the registration of traditional medicines will then be considered by the subcommittees appointed by the Drug Committee. 

Similarly, the importers of traditional medicines must apply for import license from the FDA first.  Licensed importers can then file for the registration of the traditional medicines that they would like to import into Thailand.

Duration of registration of traditional medicines is about 160 working days

In addition to drug samples, the following information is required for the registration of traditional medicines: -

  • The appearance and color of the product
  • The name of the product
  • Packaging size & type of container
  • Label containing required information, e.g. name, registration number, content, Lot No., manufacturing date, manufacturer, city & country, importer, etc.
  • Package insert
  • Drug recipe indicating the ingredients and amount in metric unit or as percentage in the recipe.  Specifications are needed for other pharmaceutical necessities, preservatives, flavoring agents added.
  • Manufacturing process
  • Manufacturer or importer and license number and signature

For imported products, the following documents are also needed: -

  • Certificate of Free Sale issued by national authority
  • Official document from national authority to certify that the manufacturing plant is certified or permitted to produce the product.

The Drug Act of B.E. 2510 (1967) is currently stilled in effect.  Attempts to revise the Drug Act have been painstaking and time-consuming; when it becomes effective, many features will be changed.

New regulation on the production, sale, or import of traditional medicines according to ASEAN harmonization of regulations and standards of traditional medicines

To comply with ASEAN harmonization of rules and regulations on product registration, production standards, and quality control of traditional medicinal products, Thai FDA recently issued Ministry of Public Health Regulation on Submission for License and the Issuance of License for the Production, Sale, or Import of Traditional Medicines into the Kingdom B.E. 2555 (2012) that was published in the Royal Gazette on 4 July 2012.  This Ministerial Regulation indicated in Item 7 that licensed manufacturers of traditional medicines shall produce medicines that meet the quality standards specified by the Minister of Public Health and shall manufacture using GMP of traditional medicines specified by the Minister of Public Health that will be published in the Royal Gazette.  To enforce the above-mentioned Ministerial Regulation, Ministerial Notification on GMP of Traditional Medicines is currently under consideration and formulation.  Before the Ministerial Notification will be issued, manufacturers are required to follow the GMP guideline 2005.

Contact Details

Bureau of Drug 
Food and Drug Administration
Ministry of Public Health
Tiwanont Road, Muang, Nonthaburi 
Thailand 11000
Tel: + 662 590 7162, +662 590 7163-4
Fax: +662 590 7164
Website: http://drug.fda.moph.go.th/eng/

Reference:

  1. Drug Act B.E. 2510 (1967). [cited 2012 Oct 6]. Available from: http://thailaws.com/law/t_laws/tlaw0071_1.pdf

 

The Protection and Promotion of Thai Traditional Medicine Knowledge Act B.E. 2542 (1999)

The scope of this law is to protect the wisdom of Thai traditional medicine, including traditional drug formulas and Thai traditional medicine textbooks, and Thai herbs which are the herbs per se as well as the areas of their sources.

According to this Act, the Thai traditional medicine knowledge and wisdom is classified into three types:

  1. Traditional Thai drug formulas or Thai traditional medicine textbooks of the nation;
  2. General Thai traditional drug formulas or general Thai traditional medicine textbooks; and
  3. Private Thai traditional drug formulas or personal Thai traditional medicine textbooks.

The monitoring and protection of each type of Thai traditional medicine wisdom involve different criteria; the use of the country’s Thai traditional drug formulas for commercial purposes has to get permission with an agreement on benefit sharing, right limitation, procedures and conditions as specified in the ministerial regulations.

Regarding the protection of herbs, herbs are divided into three groups; namely. herbs deserving research, herbs of economic importance, and herbs nearing extinction or endangered herbs.  The control and utilization measures will be different according to the type of herbs.  According to the law, herbs do not include only plants, but also animals, microorganisms, minerals, and original extracts from plants or animals.

The control of access to herbs under this law is carried out using two methods:

  1. issuing a notification of “controlled herbs” especially those valuable for research, of economic importance or nearing extinction (Section 44); and
  2. issuing a notification of a “protected area for herbs” in case such an area is the provenance or origin of herbs, or its biodiversity may be damaged, or the nature of herb utilization is at risk of becoming extinct or declining genetically, or the state intends to use such an area for promoting public participation in the management, development and utilization of herbs in the area, whereas the area has not been declared as a conservation zone as per Section 61.  After the “protected area for herbs” has been declared, ministerial regulations will be issued to specify various protection measures related to access, utilization, management procedures, etc.[1,2]

Contact Details

Bureau of Protection TTM Knowledge and Medicine Plants
Department for Development of Thai Traditional and Alternative Medicine
Ministry of Public Health
Tiwanont Road, Muang
Nonthaburi, 11000 Thailand
Tel: +662 590 2608
Fax: +662 149 5607
Website: www.dtam.moph.go.th 

Reference:

  1. Petrakard P, Chankittiwat V. Protection of Wisdom of Thai Traditional Medicine.  In: Chokevivat V, Wibulpolprasert S, Petrakard P. eds. Thai Traditional and Alternative Health Profile: Thai Traditional Medicine, Indigenous Medicine and Alternative Medicine 2009-2010. Bangkok: War Veterans Organization Office of Printing Mill. 2012. p. 313-14.

  2. The Protection and Promotion of Thai Traditional Medicine Knowledge Act B.E. 2542 (1999). [cited 2012 Oct 6]. Available from:http://thailaws.com/law/t_laws/tlaw0294_3.pdf

 

Thailand Plant Varieties Protection Act, B.E. 2542 (1999)

This Act classifies plant varieties into four types: wild plant variety, general domestic plant variety, local domestic plant variety, and new plant variety.  The access to and use of each type of plant variety have to be carried out in accordance with the criteria, procedures and conditions prescribed by law.

Regarding the conditions for accessing and using general domestic and wild plant varieties, the law provides that the collection, procurement, or gathering of a plant variety or any part of plant for the purposes of breeding, experimental research or commercial research have to seek permission from the competent official; and an agreement has to be made on benefit sharing, from which the proceeds will be remitted to the Plant Varieties Protection Fund (Section 52). In the case of non-commercial undertakings, the procedures will have to be as per the regulations prescribed by the Plant Variety Protection Commission (Section 53).

In this connection, the plant variety protection law has provisions for the protection of community’s agricultural local wisdom, especially “local domestic plant varieties”, 7 farmers’ rights protection, traditional practices [such as the exchange of seeds among farmers/communities, storing of seeds for the next crop season (Section 33)] , and local wisdom development/promotion by establishing a plant variety protection fund to finance or subsidize community’s activities related to plant variety conservation, research, and development (Section 55).[1,2]

Contact Details

Department of Agriculture 
Ministry of Agriculture and Cooperatives
50 Phaholyothin Rd., Ladyao, Chatuchack
Bangkok Thailand 10900 
Tel. +662 2579 0151-8
Website: http://www.doa.go.th/th/index.php

Reference:

  1. Petrakard P, Chankittiwat V. Protection of Wisdom of Thai Traditional Medicine.  In: Chokevivat V, Wibulpolprasert S, Petrakard P. eds. Thai Traditional and Alternative Health Profile: Thai Traditional Medicine, Indigenous Medicine and Alternative Medicine 2009-2010. Bangkok: War Veterans Organization Office of Printing Mill. 2012. p. 313-14.
  2. Plant Varieties Protection Act, B.E. 2542 (1999). [cited 2012 Oct 20]. Available from: http://www.doa.go.th/pvp/index/pvp2542%20eng.pdf