- 1.COMBATING COUNTERFEIT DRUGS IN INDONESIA First ASEAN-China
Conference on Combating Counterfeit Medical Products Jakarta, 13-15
November 2007 National Agency of Drug and Food Control
Indonesia
2. BACKGROUND 3.
- 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
INDONESIA Distributed to illegal market 4. 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
NUMBER OF INTERNATIONAL PORT
5. LEGISLATIVEINFRASTRUCTURE 6. BORDER POST
- Efforts have been taken by establishing Border Posts in some
areas, i.e :
-
- MOTA AIN, NAPAN & META MAUK (TimorLeste )
-
- 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)
- To control imported goods
- To minimize illegal & counterfeit drugs entering the
country
7. Definition
- Counterfeit Drugs (CDs) 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
9. NUMBER OF CASES 10. 11. 12. 13. 14. COUNTERFEIT DRUGS FINDING
FREQUENCIES PERIOD 2001-2007(October) frequency * The data is made
from finding frequencies> 3 times Counterfeit drugs 15. NUMBER
OF CASES * 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 rupiahsYes
(injectable) Domestic 3 3 2005 No Domestic 1 1 2006 Yes Import and
Domestic 2 2 * 2007 VITAL MEDICAL IMPORTED / DOSMETIC CONFIRMED
SUSPECTED 16. HOW WHERE THESE CASES DETECTED 28,6% (2005), 20 %
(2006), 4,16% (2007) Reported by affected manufacturer NO DATA
AVAILABLE Routine checks NO DATA AVAILABLE
Enforcement/investigation work NO DATA AVAILABLE Health
professionals reports NO DATA AVAILABLE Patients complaints % or
number of cases 17. NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING
NADFC DATA - 3 (2 Sentence penalty, 1 Wanted List) - - 2005 - 1 (in
process) - - 2006 1 (in process) 1( in process) 2007 INFORMAL
SECTOR RETAILER WHOLESALER / IMPORTER MANUFACTURER 18. NATIONAL
COORDINATION 19. Mechanism of national coordination Combating
Counterfeit Drugs requires joint effort medicines Drug/National
Regulatory AuthorityHealthcare &medicine providers Civil
societies Patient Interest GroupsPatients / consumers Drug
manufacturers importers & wholesalers medicines Ministries,
police, customs, Prosecutors Government 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
- 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 ILEGAL MANUFACTURER ILLEGAL MARKET ILEGAL DISTRIBUTOR
CONSUMER
- CDs are found, mostly in illegal market
- Difficult to differenciatewiththe genuine one
- Lack of public awareness(consumers buydrugs in the illegal
market)
- Breaking up the Illegal chain
- Sustainable law enforcement with deterrent penalties
- Reveal modus operandi, identify the intellectual actors and
their network
- 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
22. REGIONAL LEVEL
- 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
- No comprehensive program on combating counterfeit drugs
- The time line of lab result is not on schedule
- 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
STRATEGY IMPLICATIONS GAPS 23. REGIONAL LEVEL
- 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
- 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
- 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
STRATEGY IMPLICATIONS GAPS 24. Proposed Project against
Counterfeit Drugs
-
- Development of common definition of counterfeit drug
-
- Development ASEAN Scheme on tackling of counterfeit drugs
-
- Development a Regional Strategy and Systematic Program
- Exchange of information by designated unit of DRA
- Develop data base of counterfeit drugs
ASEAN Project on Strengthening Collaboration on Combating
Counterfeit Drugs 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! 28. 29. 30. NUNUKAN ENTIKONG JAGAOI
BABANG SKOU back 31. MIANGAS & MARORE SUNGAI GUNTUNG TAREMPA,
SAMBU BELAKANG PADANG MOTA AIN, NAPAN, META MAUK back 32.