1. COMBATING COUNTERFEIT DRUGS IN INDONESIA
National Agency of Drug and Food Control
Indonesia
First ASEAN-China Conference on Combating Counterfeit Medical Products
Jakarta, November 2007

2. BACKGROUND

3. INDONESIA
located between two continents and two oceans, which is easily accessible by land, sea, or air.
some problems are still being faced, including in the field of drug control.
problems may arise from borderline areas, which are susceptible to smuggled, counterfeit medicines.
Regarding counterfeit medicines they may be
Illegally imported or
Locally manufactured by
illegal manufacturer
Distributed to illegal market

4. NUMBER OF INTERNATIONAL PORT
SEAPORT : 141
AIRPORT : 10
FREE TRADE ZONE
Free Trade Zone BATAM, including Batam Island, Tonton Island, Setotok Island, Nipah Island, Rempang Island, Galang Island and Galang Baru Island.
Free Trade Zone BINTAN, including Galang Batang Industrial Estate, Maritim Industrial Estate, and Loban Island, Senggarang Industrial Estate and Dompak Barat Industrial Estate
Free Trade Zone KARIMUN, including number of Karimun Island, Karimun Anak Island
Free Trade Zone SABANG.

5. LEGISLATIVE INFRASTRUCTURE

6. BORDER POST To control imported goods
Efforts have been taken by establishing Border Posts in some areas, i.e :
SKOU (Papua New Guinea)
MOTA AIN, NAPAN & META MAUK (Timor Leste)
MARORE & MIANGAS (Philipine)
ENTIKONG & JAGOI BABANG (East Malaysia Land)
NUNUKAN (East Malaysia Ocean)
SUNGAI GUNTUNG (West Malaysia Ocean)
SAMBU BELAKANG, PADANG & TAREMPA (West Malaysia Ocean)
Objective :
To control imported goods
To minimize illegal & counterfeit drugs entering the country

7. Definition
Counterfeit Drugs (CD’s) definition in Indonesia based on Indonesian MoH Decree No. 949/2000 :
A medicinal product which is manufactured by illegal manufacturer or deliberately mislabeled with respect to identity of registered product.

8. Basic Law and Regulation related drug counterfeiting
Law No. 1/1946 on Criminal Act
Law No. 23/1992 on Health
Law No. 8/1999 on Consumer Protection
Law No. 14/2001 on Patent
Law No. 15/2001 on Mark

9. NUMBER OF CASES

14. COUNTERFEIT DRUGS FINDING FREQUENCIES PERIOD 2001-2007 (October)
frequency
* The data is made from finding frequencies > 3 times

15. NUMBER OF CASES SUSPECTED CONFIRMED IMPORTED / DOSMETIC VITAL MEDICAL
2007
2 * 2
Import and Domestic
Yes
2006 1
Domestic No
2005 3
Yes (injectable)
* a result of joint operation whereby an illegal warehouse was found filled with thousand of boxes of 26 items of counterfeit medicines, with an estimated value of up to 25 billion rupiahs

16. HOW WHERE THESE CASES DETECTED
% or number of cases
Patients complaints
NO DATA AVAILABLE
Health professionals reports
Enforcement/investigation work
Routine checks
Reported by affected manufacturer
28,6% (2005), 20 % (2006), 4,16% (2007)

17. NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING
NADFC DATA
MANUFACTURER
WHOLESALER / IMPORTER
RETAILER
INFORMAL SECTOR
2007
1( in process)
1 (in process)
2006 -
2005
3 (2 Sentence penalty, 1 Wanted List)

18. NATIONAL COORDINATION

19. Mechanism of national coordination Combating Counterfeit Drugs requires joint effort
Drug/National Regulatory Authority
Healthcare &
medicine
providers
Civil societies
Patient Interest Groups
Patients /
consumers
Drug manufacturers
importers &
wholesalers
medicines
Ministries, police, customs, Prosecutors
Government
medicines

20. BENEFITS & LIMITATIONS OF COORDINATION
Technical support such as laboratory test, expert witness statement will be provided by NADFC if needed
If facing difficulties, force effort will be provided by the Police
Provided information of import-registered products for the custom
Several Laws and regulation as basic legal process to combat Counterfeit Drugs are available
LIMITATIONS
Lack of the reference standard available in NQCL
Lack of coordination among law enforcement agencies at all level (National-provincial-district)
On-line system is not in place
Weakness of Implementation of some Laws, such as need appeal from the manufacturing authorization holder of authentic drugs

21. STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS (CDs) in INDONESIA
CONSUMER
ILEGAL MANUFACTURER
ILLEGAL MARKET
National Program ;
Comprehensive investigation and mopping-up what is already in circulation
National Joint Operation and joint investigatin with police (in ilegal market)
Strenghtening the infrastructure
Improvement collaboration and coordination with other law enforcement agencies
Increasing comprehensive drug distribution control
Increasing public awareness and law enforcement agencies
ILEGAL DISTRIBUTOR
STRATEGIES :
Breaking up the Illegal chain
Sustainable law enforcement with deterrent penalties
Reveal modus operandi, identify the intellectual actors and their network
FACTS :
CDs are found, mostly in illegal market
Difficult to differenciate with the genuine one
Lack of public awareness (consumers buy drugs in the illegal market)

22. REGIONAL LEVEL GAPS IMPLICATIONS STRATEGY
Inter-sectoral coordination is not based on written procedure which are clearly defined roles, adequate resources and effective administrative and operational tools.
Lack of awareness about the severity of the problem among stakeholder.
No specific law on Counterfeit Drugs.
Limitation of reference standard on NQCL
No comprehensive program on combating counterfeit drugs
No deterrent sanctions
The time line of lab result is not on schedule
Develop national tskforce on inter-sectoral coordination base on written procedures, clearly defined roles, adequate resources, and effective administrative and operational tools.
Increasing awareness on the harmful/impact of counterfeit drugs through seminar for the specific target groups such as Pharmaceutical Manufacturer, Health professionals, patients, training for Law enforcement Agencies, and DRA
Assist national authorities to develop risk communication and advocacy materials
Develop draft on counterfeit drugs Law
Need collaboration to get reference atandard assist by WHO

23. REGIONAL LEVEL GAPS IMPLICATIONS STRATEGY
Lack of Information Exchange among countries, no designated person in charge at DRA
Different definition of Counterfeit Drugs among Countries
Lack of networking on Counterfeit drugs problem among ASEAN DRAs
difficulties on contacting the person in charge
Different follow up action
difficulty to know the genuity of the suspected drug
Difficulty to trace the suspect if they escape to other countries
Promote networking and collaboration among ASEAN DRA on counterfeit drugs
Develop TOR which are include discussion among ASEAN countries on :
the definition of counterfeit drugs.
Survey existing national and international legislation & requirements
Assess existing national best practices and develop model best practices
Promote secure exchange of information and alerts among ASEAN DRA

24. Proposed Project against Counterfeit Drugs
Development of common definition of counterfeit drug
within ASEAN Countries
Development ASEAN Scheme on tackling of counterfeit drugs
Development a Regional Strategy and Systematic Program
Proposed Project against Counterfeit Drugs
ASEAN Project on Strengthening Collaboration on Combating Counterfeit Drugs
OUTPUT
Exchange of information by designated unit of DRA
Develop data base of counterfeit drugs
Develop Alert System

25. CONCLUSION
No adequate data on “how where the cases detected” showed that reported mechanism is not in place as well as awareness of severity of the cases
Weaknesses on inter sectoral coordination due to some factor i.e : no written standardized procedure, no specific law on counterfeit medical product.
Lack of networking on combating counterfeit medical product in regional, i.e : among ASEAN countries.

26. EXPECTATION
Establish national and regional taskforce on combating counterfeit drugs
Combating counterfeit drugs need international support

27. still a long way to go!

30. ENTIKONG
NUNUKAN
SKOU
JAGAOI BABANG
back

31. MOTA AIN, NAPAN, META MAUK TAREMPA, SAMBU BELAKANG PADANG
MIANGAS & MARORE
SUNGAI GUNTUNG
MOTA AIN, NAPAN, META MAUK
TAREMPA, SAMBU BELAKANG PADANG
back