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DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES

POLICY OF TRADITIONAL MEDICINES. DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES MINISTRY OF HEALTH, INDONESIA. NATIONAL POLICY. TRADITIONAL MEDICINES IS AN INTEGRAL PART OF HEALTH CARE ENSURING ITS SAFETY, EFFICACY & QUALITY

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DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES

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  1. POLICY OF TRADITIONAL MEDICINES DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES MINISTRY OF HEALTH, INDONESIA

  2. NATIONAL POLICY TRADITIONAL MEDICINES IS AN INTEGRAL PART OF HEALTH CARE ENSURING ITS SAFETY, EFFICACY & QUALITY SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT OF FORMS OF TRADITIONAL MED. DEEMED SAFE & EFFICACIOUS IN ORDER TO FULFIL THE GOAL OF OPTIMAL HEALTH FOR THE COMMUNITY MoH DECREE No: 47/MENKES/SK/II/1983

  3. POLICY • PROTECT THE COMMUNITY FROM DISADVANTAGE AND HAZARDS OF SUBSTANDARD PRODUCTS • CLINICAL PROVEN TRADITIONAL MEDICINES NEED TO BE DEVELOPED AND TO BE UTILIZED IN MEDICAL CARE FOR COMMNUNITY MoH DECREE No: 47/MENKES/SK/II/1983

  4. WHO ENCOURAGES AND SUPPORTS THE INTEGRATION OF TRADITIONAL AND COMPLEMENTARY MEDICINE INTO NATIONAL HEALTH CARE SYSTEM AND TO ENSURE THEIR RATIONAL USE (LEGAL STATUS OF TCM, WHO 2001)

  5. TRADITIONAL MEDICINES should comply SAFE EFECTIVE QUALITY RATIONAL USE (WHO) LEGAL STATUS OF TRADITIONAL MEDICINE AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002

  6. CLASSIFICATION JAMU (HERBAL MEDICINES) EKSTRAK TERSTANDAR (STANDARIZED EXTRACT) FITOFARMAKA (PHYTOPHARMACY)  

  7. TM • TOXYCITY TESTACUTE (LD50) • SUBACUTE • CHRONIC • MUTAGENICITY • TERATOGENICITY • EMBRIOTOXICITY • CARSINOGENICITY • CLINICAL TEST (RCT) • (MoH Decree No: 56 / 2000) (KEPMENKES No: 650 Th 1991) SAFE EFECTIVE QUALITY • GMP-TM • (Good Manufacturing Practice – Traditional Medicines) • MoH Decree No: 659 / 1991

  8. STEPS FOR DEVELOPMENT STEP I: PRE-CLINICAL TEST TOXYICITY TEST PHARMACODYNAMICAL TEST EFFICACY SAFETY

  9. SAFETY TOXYCITY: GENERAL TOXYCITY SPECIFIC TOXYCITY ACUTE (LD50) SUB-ACUTE CHRONIC TERATOGENIC MUTAGENIC CARCINOGENIC

  10. STEP II INITIAL STANDARDIZATION STEP III PHARMACEUTICAL TECHNOLOGY WHICH DEFINE IDENTITY ACURATELY TO STANDARIZED PRODUCT

  11. STEP IV EFFICACY: CLINICAL TEST ACCORDING TO GCP (GOOD CLINICAL PRACTICES) RANDOMIZED DOUBLE BLIND CONTROL

  12. CLINICAL TEST RESULTS AS A CONDITION FOR REGISTRATION FURTHER UTILIZATION IN FORMAL HEALTH CARE EFFORTS KEPMENKES No: 56/MENKES/SK/I/2000

  13. PHYTOPHARMACY TRADITIONAL MEDICINES WHICH HAVE BEEN PROVEN SAFE, EFECTIVE QUALITY STANDARDIZED MoH Decree No: 760 / 1992

  14. PHYTOPHARMACY EQUAL TO MODERN MEDICINES ABLE TO PRESCRIBED BY PHYCISIANS ABLE TO UTILIZED IN A FORMAL HEALTH CARE FACILITIES

  15. PHYTOPHARMACY TENSIGARD PHYTODIAR RHEUMANEER X GRA STIMUNO

  16. SP3T CENTRE OF DEVELOPMENT & APPLICATION TRADITIONAL MEDICINES PERFORM CLINICAL TESTING POTENTIAL ADVANCED TO PHYTOPHARMACY (MoH Decree No. 0584/MENKES/SK/VI/1995)

  17. TRADITIONAL MEDICINES PROHIBITED MIXED/COMPOUNDED WITH MODERN MEDICINES MoH Decree 246/Menkes/Per/V/1990

  18. MoH Decree No 1147/D/SK/IV/81 23 JUNE 1977PROHIBIT PROCUCTION & DISTRIBUTIONSUPOSITORIA,INTRAVAGINAL & EYE DROPS OF TM GUIDELINE OF TRADITIONAL MEDICINES 1985 LABELLING TM 1993 REGULATION TM MoH Decree No 1516/A/81, 15 MAY 1981 TM CONTAIN ETANOL

  19. MEDICATION WITH TM SHORT TERM SAFETY PROVEN LONG TERM SAFETY & EFICACY PROVEN

  20. DEVELOPMENT STRATEGY DATA COLLECTION DEVELOP MEDICATION GUIDELINES DEVELOP PILOT PROJECT MONITORING & EVALUATION DEVELOP TO PHYTOPHARMACY

  21. NOT YET PROVEN IN SAFETY AND EFICACY ABLE TO UTILIZED OUTSIDE FORMAL MEDICAL CARE BY MEDICAL STAFF FOR RESEARCH PURPOSE COMPLY WITH GOOD CLINICAL PRACTICE (GCP)

  22. TM 

  23. TM THANK YOU TERIMA KASIH

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