Indonesia

Policy

National Policy on Traditional Medicines (KOTRANAS) is a comprehensive policy on traditional medicine that serves as a guideline, direction and standards in developing and promoting quality, safe, effective and scientifically-tested traditional medicines and in anticipating various strategic changes and challenges, internal and external in harmony with National Health System.

The objectives of KOTRANAS include:

1. Promote the sustainable use of natural resources and traditional preparations as traditional medicines in effort of improving health services.

2. Ensuring cross-sectoral management of natural potentials to achieve high competitiveness as an economic source of community and sustainable income of the nation.

 3. The availability of quality, effective and safe traditional medicines, scientifically-tested and widely used for self-medication and formal health services.

4. To set traditional medicines as superior commodity providing various benefits to improve community economic growth, creating employment opportunity and poverty reduction.

 

 

Laws & Regulations

Indonesian Ministry of Health has adopted a policy for the modernization of traditional medicines, while retaining its identity. This modernization encompasses several aspects, such as diagnosis through the use of modern techniques while providing treatment by traditional methods, as well as modernization of the production processes and quality control of traditional medicines.

Herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, by licensed practitioners and without restriction. Herbal medicines are regulated as over the counter medicines, as a separate regulatory category and as traditional medicines. Legally, medical, health and structure/function claims can be made. The national pharmacopoeia (Farmakope Indonesia) is legally binding.

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.

The post marketing surveillance system was established in 2002, including adverse effect monitoring.

TM/CAM

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 program 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. There are 8,632 registered herbal medicines in Indonesia. No herbal medicines are included on the national essential drug list.

Contact

Badan POM 
National Agency of Drug and Food Control (NA-DFC)                                               
Jl Percetakan Negara No.23
Jakarta 10560 Indonesia
Tel: (021) 4259945
Fax: (021) 42889117  
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

Standards & Guidelines

Since 2nd November 1983, a specific guideline was regulated for import and distribution of crude drugs. Foreign traditional drug are not allowed to import into Indonesia unless a license being granted to do so [1].

The requirements for the special guidelines issued since 1985 includes the label should consist of correct information, clear, readable and the information of the traditional drugs is written in both Indonesian language and in Latin letters. The label also should has the registration number, name and address of the company, composition, indication, method of use and dosage, duration of administration, warnings, contra-indications, storage, expiry date and production code [1].

Good Manufacturing Practice (GMP) is technical support issued by WHO in 2007 to assure the safety and quality of herbal medicines during the manufacturing process. However, it is advisable for other countries to develop their own national GMP for manufacturing herbal medicines which suits to the country's actual situation [2].

The industries in the traditional medicine sector in countries of origin and are obliged to meet the requirements for proper production method which is Good Manufacturing Practice (GMP) proven by certificate in accordance the latest inspection data, maximally 2 years, issued by the authorized official [2].

In terms of guidelines for agricultural and collection of herbal medicine's plants, this country obey to the documents by WHO title "WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants" [3].

A guideline to examine the quality of these herbal medicines for the safe use known as "Quality control methods for herbal materials" is produced by WHO in 1998 [4].

There are approximately 8632 registered herbal medicines in Indonesia. No herbal medicines are included on a National essential drug list. Herbal medicines in this country are sold in pharmacies as over-the-counter medicines, in special outlets, by licensed practitioners and without restriction [5].

Contact

Ministry of Health Republic of Indonesia
Website: http://www.depkes.go.id/

References

  1. Regulatory situation of herbal medicines – A worldwide review. Available from: http://apps.who.int/medicinedocs/en/d/Jwhozip57e/4.5.2.html
  2. WHO. Guidelines on good manufacturing practices (GMP) for herbal medicines. Available from :http://apps.who.int/medicinedocs/documents/s14215e/s14215e.pdf
  3. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Available from: http://whqlibdoc.who.int/publications/2003/9241546271.pdf
  4. WHO. Quality control methods for herbal medicines. Available from :http://apps.who.int/medicinedocs/documents/h1791e/h1791e.pdf
  5. WHO. National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey. Available from: http://apps.who.int/medicinedocs/en/d/Js7916e/9.5.html
  6. MINISTRY OF HEALTH REPUBLIC of INDONESIA. National Policy on Traditional Medicine 2007. Available from http://www.searo.who.int/entity/medicines/topics/national_policy_on_traditional_medicines_ministry_of_health.pdf?ua=1