Ruslan Aspan Deputy of Traditional Drug, Cosmetics and Complementary Product Control

1. EVALUATION OF PHYTOPHARMACA Product IN Indonesia Ruslan Aspan Deputy of Traditional Drug, Cosmetics and Complementary Product Control NATIONAL AGENCY OF DRUG AND FOOD CONTROL

2. EVALUATION OF PHYTOPHARMACA Product In Indonesia DEF : Substances or mixture of substances forming from herbals, plants, animal parts and/or mineral raw materials, galenic preparation that has long historical used (It is the sum total of the knowledges, skills and practices based on the theories, beliefs and experiences indigenous to different cultures) empirically being used for the maintenance of health as well as in the treatment use. TRADITIONAL MEDICINE 2

3. EVALUATION OF PHYTOPHARMACA Product In Indonesia INDONESIAN TRADITIONAL MEDICINES (JAMU) • Jamu have been recognized and used in Indonesia for many ages, as part of Indonesian culture • It has been used for health purpose, including promotive, preventive, curative and rehabilitative purposes. • At 18th century, as order of Sunan Pakubuwono (King of Surakarta Kingdom) was written a compilation of traditional medicines recipees (The book is known as “Serat Centini”) 3

4. EVALUATION OF PHYTOPHARMACA Product In Indonesia INDONESIAN TRADITIONAL MEDICINES (JAMU) • “Minum Jamu” (Jamu Drinking) is Indonesian habit, done every morning before go to work, for maintain their health. • At the beginning jamu was made from fresh plants at household, since the 20th century, jamu has been produced by industries, using modern technologies as well as hygiene sanitation aspect. 4

5. EVALUATION OF PHYTOPHARMACA Product In Indonesia According to the SUSENAS 2001 (National Economic Survey), 31.7% Indonesian citizens are practicing their health maintenance through traditional medicine utilization, wich made by: • Home made  3.7 % • Jamu peddlers  14.5 % • Industries  13.5% 5

6. EVALUATION OF PHYTOPHARMACA Product In Indonesia Currently, there are 1.046 traditional medicines industries in Indonesia (big, small and micro scale industry). 47 pharmaceutical industries also produce traditional medicine 6

7. PT. Nyonya Meneer in Central Java. PT. Sido Muncul in Central Java. PT. Martina Berto in Jakarta. PT. Mustika Ratu in Jakarta. PT. Deltomed in Central Java PT. Jamu Jago in Central Java. PT. Air Mancur in Central Java. PT. Simona in Central Java. PT. Sari Sehat in Central Java. PT. Sinde Budi Sentosa in Jakarta EVALUATION OF PHYTOPHARMACA Product In Indonesia Example of some big scale of traditional medicine industries: 7

8. EVALUATION OF PHYTOPHARMACA Product In Indonesia Some examples of pharmaceutical industries which produce traditional medicine: • PT. Indo Farma • PT. Kimia Farma • PT. Phapros • PT. Soho • PT. Dexa Medica 8

9. EVALUATION OF PHYTOPHARMACA Product In Indonesia JAMU SELF MEDICATION PHYTOPHARMACA FITOFARMAKA • General Practitioner • Community Health • Center • Hospital EVIDENCE BASE 9

10. EVALUATION OF PHYTOPHARMACA Product In Indonesia INDONESIAN HERBAL MEDICINE EMPIRICAL EVIDENCE TRADITIONAL medicines JAMU PRE-CLINICAL TRIAL & STANDARDIZATION OF PLANT MATERIALS STANDARDIZED HERBAL MEDICINE CLINICAL TRIAL PHYTOPHARMACA 10 Badan Pengawas Obat dan Makanan

11. PROCEDURE OF REGISTRATION AND EVALUATION TWO STEPS OF REGISTRATION AND EVALUATION : • Pre evaluation step : To determine evaluation path, completeness and validity of registration documents, registration and evaluation fee. • Evaluation steps: Submission of registration documents and evaluation process. 11

12. FLOW OF REGISTRATION PRE EVALUATION STEPS • Determination of registration path • Check completeness and validity • of registration documents i.e. • administrative doc • technical doc Application of Registration documents INCOMPLETE OR UNCORRECT DOC PRE EVALUATION RESULT COMPLETE & CORRECT DOC ADITIONAL OR CORRECTION OF DATA RESPONS IN WRITING TO PAY THE REGISTRATION FEE 12

13. NATIONAL COMMITTEE OF TRAD. DRUG. & FS EVALUATION EVALUATION / REEVALUATION CRITERIA REGULAR MEETING TECHNICAL EVALUATION & RECOMMENDATION HEARING APPEAL REJECTION APPROVAL FLOW OF REGISTRATIONEVALUATION STEPS APPLICANT COMPLETE DOC EVALUATION TEAM ADDITIONAL DATA SAFETY, EFFICACY, TECHNOLOGY, LABELING EVALUATION REGISTRATION DATA 13

14. EVALUATION OF PHYTOPHARMACA Product In Indonesia CLAIM LEVEL A. General Claim Supported by: At least has one of these references: • Pharmacopoeia • Monograph or “Materia Medika” • 3 difference references on traditional medication history • It has been approved for being used in one country Or scientific data • Descriptive study, case studies or report from relevant expert committee Example : “To help maintaining liver function” “ Traditionally use for …..” 14

15. EVALUATION OF PHYTOPHARMACA Product In Indonesia CLAIM LEVEL B. Moderate Claim Supported by: At least have two of these references: • Pharmacopoeia • Monograph or “Materia Medika” • 3 difference references on traditional medication history • It has been approved for being used in one country Or Scientific data: • Analytical study including epidemiological cohort study and case control or • Multiple time serial study without or with intervention including population study in one country and inter country Example : “To help recovery stamina” 15

16. EVALUATION OF PHYTOPHARMACA Product In Indonesia CLAIM LEVEL C. High Claim Supported by: • Systematic review from all of Randomized Controlled Trial (RCT), which lead to indifferent significantly result of clinical trial, (meta-analysis) • Double Blind Randomized Controlled Trial Example : “For Treatment of hypertension” “For Treatment of erectile disfunction” 16

17. EVALUATION OF PHYTOPHARMACA Product In Indonesia PHYTOPHARMACA SAFETY PRODUCT SHOULD ACHIEVE QUALITY, EFFICACY AND SAFETY STANDARD THERAPEUTICAL EFFECT IS REACHED IF APPROPRIATELY USED AS INDICATED 17

18. EVALUATION OF PHYTOPHARMACA Product In Indonesia STEPS FROM TRADITIONAL MEDICINE INTO PHYTOPHARMACA RESEARCH SUPPORT • PRECLINICAL TRIAL • Toxicity test (safety test) • Pharmacodynamic test (efficacy test) • PHARMACEUTICAL TECHNOLOGY • CLINICAL TRIAL Responsibility and true Research protocol Ethical clearance 18

19. EVALUATION OF PHYTOPHARMACA Product In Indonesia Traditional Drugs Development • PRECLINICAL TRIAL : • Toxicity test/Safety : • Acute toxicity test : to decide an acute potencial toxicity/LD50, clinical disorders, toxicological spectrum effect and lethal mechanism • Longterm toxicity test : to study toxic effect of traditional medicine long term usage • Pharmacodynamic test/Efficacy : to study toxic effect of the traditional drugs-sample. Experiment methods are perfomed on expected therapeutic activity. Animal experiment (in vivo) and specimen (in vitro) is perfomed in a healthy animal or unhealthy-manipulated animal. Observation of expected respon after treatment (can also be observed in another respon) • PHARMACEUTICAL TECHNOLOGY : • to standardized Phytopharmaca product (simplisia, ekstract, dosage form, standard parameter of quality of raw material, extract, dosage form). • 3. CLINICAL TRIAL : • Clinical trial conducted in compliance with the requirement to GCP (Good Clinical Practise) • Design to be used are : Randomized controlled trial 19

20. EVALUATION OF PHYTOPHARMACA Product In Indonesia Traditional Drugs Development Long term toxicity test 20

21. EVALUATION OF PHYTOPHARMACA Product In Indonesia OBAT HERBAL TERSTANDAR 21

22. EVALUATION OF PHYTOPHARMACA Product In Indonesia FITOFARMAKA (1) 22

23. EVALUATION OF PHYTOPHARMACA Product In Indonesia FITOFARMAKA (2) 23

24. EVALUATION OF PHYTOPHARMACA Product In Indonesia FITOFARMAKA (3) 24

25. EVALUATION OF PHYTOPHARMACA Product In Indonesia FITOFARMAKA (4) 25

26. EVALUATION OF PHYTOPHARMACA Product In Indonesia FITOFARMAKA (5) 26

27. THANK YOU 27