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bybyDra.Kustantinah,Apt.,M.App.Sc.Dra.Kustantinah,Apt.,M.App.Sc.WorkshoponHerbalMedicinesatthe

14thICDRASingapore,30November2010

NATIONALAGENCYOFDRUGANDFOODCONTROLNATIONALAGENCYOFDRUGANDFOODCONTROLTHEREPUBLICOFINDONESIATHEREPUBLICOFINDONESIA

20102010

CHALLENGESANDOPPORTUNITIESINCHALLENGESANDOPPORTUNITIESINREGULATINGHERBALMEDICINESINREGULATINGHERBALMEDICINESIN

INDONESIAINDONESIA

NATIONAL CURRENT SITUATION (1)NATIONAL CURRENT SITUATION (1)Indonesiaisoneofthemegacentreforbiologicaldiversity withmorethan 25.000plantspeciesor10%offloraintheworld(Jeffrey,1992),over180specieshavebeenwidelyusedastraditionalmedicines.

Jamuhas beenempiricallyusedforgenerationsandculturallyacceptableinIndonesia;eachethnicgrouphasitsownethnomedicines.

BasedonSocioEconomicNationalSurvey,theuseofJamuwasincreasing:20%(1980),23%(1986),32%(2001),33%(2004)and49%(2007)1980 1986 2001 2004 2007

NATIONALNATIONAL CURRENT SITUATION CURRENT SITUATION (2)(2)

LawNo.36/2009onHealth Regulatoryframework:premarketandpostmarketcontrolofTraditionalMedicines(TM).

NationalPolicyonTM,2007:TMisapartoftheNationalHealthCareandtheirexistenceshouldbesafeguardedforbasichealthcare.

AllTMshouldberegistered,exceptTMmadebytraditionalhealerswithnolabel,extraporenouspreparationmadebyJamupeddlerandrawmaterialsinsimplisiaandgalenicpreparation.

3(three)CatagoriesofIndonesianTM:(1)jamu,(2)standardizedherbalmedicines,and(3)phytopharmaca.

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

CHALLENGESANDOPPORTUNITIES(1)CHALLENGESANDOPPORTUNITIES(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)

DespiteofdecreasingnumberofadulteratedTM,thenumberisstillsignificantinparticularofunregistered(mostlyimported)productswhichillegallyenteredthecountry

Thetrendofadulterationpatternhaschangedfromanalgesic&rheumatismproductstoaphrodisiac&staminaproducts(inlast2yrs).

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.

CHALLENGESANDOPPORTUNITIES(2)CHALLENGESANDOPPORTUNITIES(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 .

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