PERATURAN KEPALA BADAN PENGAWAS OBAT DAN MAKANAN REPUBLIK INDONESIA
No. HK.00.05.41.2803

ON
PROHIBITION OF TRADITIONAL DRUGS THAT CONTAIN CINCHONAE CORTEX OR ARTEMISIAE FOLIUM

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
OF THE REPUBLIC OF INDONESIA,

Considering:

• a. that occurrences of resistance of Plasmodium falciparum and Plasmodium vivax against anti malaria drugs have been reported;
• b. that the use of traditional drugs that contain Cinchonae Cortex or Artemisiae Folium on self-medication may result in resistance of Plasmodium falciparum and Plasmodium vivax against anti malaria drugs;
• c. that in the framework of protecting the community from the hazard of resistance of Plasmodium falciparum and Plasmodium vivax against anti malaria drugs, it is necessary to prohibit the use of Cinchonae Cortex or Artemisiae Folium as traditional drug in Indonesia;
• d. that, in consideration to letters a; b and c above, it is necessary to stipulate a Regulation of the Head of National Agency of Drug and Food Control of the Republic of Indonesia on Prohibition of Traditional Drugs That Contain Cinchonae Cortex or Artemisiae Folium.

In view of:

• a. Law No. 23/1992 on Health Affairs (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
• b. Law No. 8/1999 ton Consumer Protection (Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
• c. Presidential Decree No. 103/2001 on Status, Duties, Authorities, Organizational Structure of Non Departmental Governments as amended several times most recently by Presidential Regulation No. 11/2005
• d. Presidential Decree of the Republic of Indonesia No. 110/2001 on Organisation Unit and Duties of Echelon I in Non Departmental Government Institutions, as amended several times most recently by Presidential Regulation No. 12/2005;
• e. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM/2001 on Organization and Work Procedure of the National Agency of Drug and Food Control, as asmmended by Decision of the Head of National Agency of Drug and Food Control No. HK.00.05.21.4231/2004;
• f. Regulation of the Head of National Agency of Drug and Food Control No. HK.00.05.41.1384/2005 on Criteria and Procedure of Registration of Traditional Drugs, Standardized Herbal Drugs and Fitofarmaka.

DECIDES:

To stipulate:

REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON PROHIBITION OF TRADITIONAL DRUGS THAT CONTAIN CINCHONAE CORTEX OR ARTEMISIAE FOLIUM

First:

To prohibit production and circulation of traditional drugs that contain Cinchonae Cortex or Artemisiae Folium in Indonesia.

Second:

To revoke approval of registration of traditional drugs that contain Cinchonae Cortex or Artemisiae Folium.

Third:

To withdraw from circulation all traditional drugs as contemplated in secondly dictum within 3 (three) months as of the stipulation of this regulation.

Fourth:

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

Fifth:

This regulation shall come to effect as of the date of stipulation and will be revised in case any error is found later.

Stipulated in Jakarta
On May 23, 2005
THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA,
Sgd.
H. SAMPURNO