bybyDra. Kustantinah, Apt., M. App.Sc.Dra. Kustantinah, Apt., M. App.Sc.Workshop on Herbal Medicines at the 

14th ICDRASingapore, 30 November 2010

NATIONAL AGENCY OF DRUG AND FOOD CONTROL NATIONAL AGENCY OF DRUG AND FOOD CONTROL THE REPUBLIC OF INDONESIATHE REPUBLIC OF INDONESIA

20102010

CHALLENGES AND OPPORTUNITIES IN CHALLENGES AND OPPORTUNITIES IN REGULATING HERBAL MEDICINES    IN REGULATING HERBAL MEDICINES    IN 

INDONESIAINDONESIA

NATIONAL CURRENT SITUATION (1)NATIONAL CURRENT SITUATION (1)Indonesia is one of the mega centre for biological diversity with more than ± 25.000 plant species or 10 % of flora in the world (Jeffrey, 1992), over 180 species  have been widely used as traditional medicines. 

Jamu has been empirically used for generations and culturally acceptable in Indonesia; each ethnic group has its own ethno‐medicines.

Based on Socio‐Economic National Survey, the use of Jamu was increasing: 20% (1980), 23% (1986), 32% (2001), 33% (2004) and 49% (2007)1980 1986 2001 2004 2007

NATIONALNATIONAL CURRENT SITUATION CURRENT SITUATION (2)(2)

Law No. 36/2009  on Health  Regulatory  framework : pre‐market and post‐market control of Traditional Medicines  (TM).

National  Policy on TM ,2007 : TM is a part of the National  Health Care and their existence should be safeguarded for basic health care.

All TM should be registered , except TM made by traditional healers with no label , extraporenous preparation made by Jamu peddler and raw materials in simplisia and galenic preparation.

3  (three)  Catagories of Indonesian TM  :  (1) jamu,  (2) standardized herbal medicines, and  (3) phytopharmaca.

Regulation on Scientification of Jamu ,2009: to synergize and integrate TM into the National Health Care System

CHALLENGES  AND  OPPORTUNITIES (1)   CHALLENGES  AND  OPPORTUNITIES (1)   CHALLENGESCHALLENGES

1. Threats from illegal products, such as un-registered and counterfeit products

2. Adulterated products containing prohibited materials or chemicalsubstances.

2006 2008 2009 2010 (August)

• Despite of decreasing number of adulterated TM, the number is still significant in particular of un‐registered (mostly imported) products which illegally entered the country

• The  trend  of adulteration pattern has changed from analgesic & rheumatism  products to aphrodisiac & stamina  products ( in last 2 yrs).

3. Excessive claim and advertisement4. Lack of public awareness on the risk of using non compliance

products5. Limited number of standard of raw materials and TMs available.

CHALLENGES AND  OPPORTUNITIES  (2)  CHALLENGES AND  OPPORTUNITIES  (2)  

OPPORTUNITIES :

1. WHO has encouraged the use of TM

2. In Indonesia, integration the use of TM into formal health care system has been started by the scientification of jamu in 2009.

3. Law enforcement in the national level is strengthened in particular for illegal products

4. Synergistic coordination has increased between relevant institutions on R&D of Jamu (empiric) to move forward into scientific approach.

5. Change of disease pattern, from generative to degenerative diseases .