DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.4.03960

CONCERNING
PROHIBITION TO PRODUCE AND DISTRIBUTE TRADITIONAL DRUGS AND FOOD SUPPLEMENTS
CONTAINING ARISTOLOCHIA SP PLANT

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering:

• a. that in order to protect the public from the side effects or toxicity of the use of materials and prepared products traditional drugs and food supplements, then the safety of use of traditional drugs in circulation shall be monitored;
• b. that occurrences of advanced stadium renal failure side effects from the use of traditional drugs which contain Aristolochia sp plant have been reported;
• c. that according to scientific studies, such occurrences of advanced stadium renal failure side effects as referred to item b. above are caused by Aristolochia sp. That contains Aristolochic Acid that has potential carcinogenic;
• d. that with the existence of side effects and potential carcinogenic, then in many countries all products containing Aristolochia sp. have been prohibited from circulation, such as in: UK, USA, Germany and Malaysia;
• e. that, therefore, it is necessary to prohibit the use of Aristolochia sp. both as materials and in the form of finished preparation of traditional drugs and food supplements in Indonesia.

In view of:

• 1. Law RI No. 23/1992 on Health Affairs;
• 2. Government Regulation RI No. 72/1998 on Safety of Pharmaceutical Products and Medical Devices;
• 3. Presidential Decree RI No. 103/2001 on Status, Duties, Authorities, Organizational Structure of Non Departmental Governments;
• 4. Regulation of the Minister of Health RI No. 246/Menkes/Per/V/1990 on Industrial Business License of Traditional Drugs and Registration of Traditional Drugs;
• 5. Regulation of the Minister of Health RI No. 1297/Menkes/Per/XI/1998 on Circulation of Imported Traditional Drugs;
• 6. Regulation of the Minister of Health RI No. 382/Menkes/Per/VI/1989 on Food Registration.

DECIDES:

To stipulate:

First:

To prohibit production and circulation of traditional drugs and food supplements which contain Aristolochia sp. plant in Indonesia.

Second:

To revoke approval of registration of traditional drugs and food supplements which contain plant Aristolochia sp.

Third:

To withdraw from circulation all traditional drugs and food supplements as contemplated above within 3 (three) months as of the stipulation of decision.

Fourth:

Violation of this decision shall be disciplined in accordance with the prevailing statutory regulations.

Fifth:

This decision comes to effect as of the date of stipulation.

Stipulated in: Jakarta
On: December 26, 2001
THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,
Sgd
H. Sampurno
NIP 140087747