DECISION OF THE HEAD OF NATIONAL AGENCYOF DRUG AND FOOD CONTROL
No. HK.00.05.4.03961

CONCERNING
PROHIBITION TO PRODUCE AND DISTRIBUTE TRADITIONAL DRUGS AND FOOD SUPPLEMENTS
CONTAINING EPHEDRA 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 side effects that are harmful to the health from the use of traditional drugs/food supplements which contain Ephedra plant have been reported;
• c. that the side effect as contemplated in item b abover is related with heart attack and stroke;
• d. that, therefore, it is necessary to prohibit the use of Ephedra, both as materials and in the form of processed products of traditional drugs and food supplements.

In view of:

• 1. Law RI No. 23/1992 on Health;
• 2. Government Regulation RI No. 72/1998 on Safety of Pharmaceutical Products and Medical Devices;
• 3. Presidential Decree RI No. 103/2001 on Position, Tasks, Authorities and Non Departmental Government Organizational Structure;
• 4. Regulation of the Minister of Health RI No. 246/Menkes/Per/V/1990 on Industrial Business Licence 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 Ephedra plant.

Second:

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

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 stipulation date.

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