Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Close this folderSouth East Asia
View the documentIndia
View the documentIndonesia
View the documentNepal
View the documentThailand
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the documentIV. REFERENCES
 

Indonesia

The use of traditional drugs in Indonesia can be traced back to the fifteenth century during the era of the Mataram kingdom. The reliefs on some temples such as Borobudur, Prambanan, Penataran show the pictures of many medicinal plants used at that time. Because written documentation was rarely available, knowledge of the use of these plants was not developed properly.

Legal Status

After national independence, much research was undertaken by the Ministry of Health in various institutions. In 1975, the Directorate of Traditional Drug Control was established under the Directorate General of Drugs and Food Control of the Ministry of Health. At that time, the government gave guidance on all aspects of traditional drugs development. Since 1976, the government has set many requirements for traditional drugs and crude drugs:

- production, distribution and labelling of traditional drugs;
- procedure for registration of traditional drugs and imported crude drugs;
- licensing of traditional drugs and imported traditional drugs; and
- control requirements, such as for a production code, labelling and advertisement [111].

In accordance with a Decree of the Minister of Health dated 17 September 1976, imported crude drugs marketed in Indonesia must be registered at the Ministry of Health by the importer [112]. For this registration a number of requirements have to be fulfilled, e.g., the Latin name of the crude drug must be given on the label according to the Indonesian Pharmacopoeia. The foreign name has to be given, the Latin name of the plant, family name, information on efficacy of the crude drug, description, macroscopic and microscopic elucidation, chemical identification method, check for impurities, assay, region of origin, and information on the label of the crude drug. The delivery, sale, storage, offer for sale or the sale of imported crude drugs that have not been registered and approved by the Minister of Health is prohibited [112].

The import and the distribution of imported crude drugs and licensed traditional drugs have been regulated in specific guidelines of 2 November 1983 [113]. In principle, foreign traditional drugs are not permitted to be imported into Indonesia, except in the case of a licence being granted. After obtaining the approval, it is allowed for one year to import the traditional drug as a finished drug from the country of origin, the packaging being done in Indonesia. During the following one to two years, the holder of the licence must already have produced these "foreign" traditional drugs in Indonesia using the imported crude drug as raw material. The imported crude drug has then to be substituted by an Indonesian crude drug, and the respective plants have to be cultivated in Indonesia. After this, the import of the traditional drug, in the form of the finished product, is not allowed anymore. Finally, a certificate for marketing is granted after a thorough examination by the National Quality Control Laboratory of Drug and Food [113]. A new decision of the Director General of Drugs and Food Control was issued in 1984 describing more detailed provisions for the registration of imported crude drugs [114].

To protect the public, the Ministry of Health published a Decree dated 31 July 1992 to prohibit the production and distribution of traditional drugs used intravaginally as suppositories or as eye drops. Those products were withdrawn from the market within a period of two months [115]. Drugs or traditional drugs containing more than 1% ethanol have to indicate the ethanol content on the label [116]. A special decree regulates traditional drugs in capsules or tablets [117,118]. These products have to be manufactured under control of a pharmacist in accordance with special requirements on stability, extraction liquid and extraction conditions such as temperature and method of drying.

Besides the "Indonesian Farmacopea", the Directorate General of Drugs and Food Control has also published six volumes of the "Materia Medika Indonesia". These publications discuss the formal requirements for crude drugs and give further information which might be needed e.g., local name, section microscopic drawing, crude drug powder and a crude drug colour picture. The Materia Medika Indonesia (Volumes I to VI) contains 350 crude drug monographs and is used as the formal quality requirement book for crude drugs in Indonesia [111].

Labelling

Since 1985, special guidelines on labelling of traditional drugs have been issued [119]. It is required that the labelling states the correct information, that the label is clear and easy to read and that the explanation of traditional drugs is written in the Indonesian language and in Latin letters. Traditional drugs are characterized by a special emblem, e.g., a leaf. The registration number has to be included on the label together with the 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. Similar information is required for the package leaflet.

Good Manufacturing Practices

A Decree of the Minister of Health dated 30 October 1991 regulates Good Manufacturing Practices of Traditional Drugs (GMPTD) [120]. These rules cover the aspects related to the production of traditional drugs with the objective to guarantee that the product always fulfils the requirements. There are general requirements regarding the employees, the responsible persons in the technical field, training in GMPTD, the premises, the area and equipment (machinery and laboratory). Processing and packing also must be carried out with special methods. A periodic self-inspection has to be made and everything has to be documented clearly. If there are concerns regarding safety or quality, these have to be checked and, if no longer adequate, the product has to be withdrawn from the market.

In 1993, the Directorate General of Drugs and Food Control published an English translation of all the regulations relevant for traditional drugs [121]. This book was intended to provide guidance for manufacturers, distributors or institutes, on traditional drugs and crude drugs with respect to their production and distribution so as to ensure products of good quality.

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