COMBATING COUNTERFEIT DRUGS IN INDONESIA

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COMBATING COUNTERFEIT DRUGS IN INDONESIA
National Agency of Drug and Food Control Indonesia

• First ASEAN-China Conference on Combating
  Counterfeit Medical Products
• Jakarta, 13-15 November 2007

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BACKGROUND
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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

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FREE TRADE ZONE
NUMBER OF INTERNATIONAL PORT

• SEAPORT 141
• AIRPORT 10

• 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.

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LEGISLATIVE INFRASTRUCTURE
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BORDER POST

• 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

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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.

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Basic Law and Regulation related drug
counterfeiting

1. Law No. 1/1946 on Criminal Act
2. Law No. 23/1992 on Health
3. Law No. 8/1999 on Consumer Protection
4. Law No. 14/2001 on Patent
5. Law No. 15/2001 on Mark

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NUMBER OF CASES
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COUNTERFEIT DRUGS FINDING FREQUENCIESPERIOD
2001-2007 (October)
Counterfeit drugs
frequency
The data is made from finding frequencies gt 3
times
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NUMBER OF CASES
SUSPECTED CONFIRMED IMPORTED / DOSMETIC VITAL MEDICAL
2007 2 2 Import and Domestic Yes
2006 1 1 Domestic No
2005 3 3 Domestic 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
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HOW WHERE THESE CASES DETECTED
or number of cases
Patients complaints NO DATA AVAILABLE
Health professionals reports NO DATA AVAILABLE
Enforcement/investigation work NO DATA AVAILABLE
Routine checks NO DATA AVAILABLE
Reported by affected manufacturer 28,6 (2005), 20 (2006), 4,16 (2007)
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NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING
NADFC DATA
MANUFACTURER WHOLESALER / IMPORTER RETAILER INFORMAL SECTOR
2007 1( in process) 1 (in process)
2006 - - 1 (in process) -
2005 - - 3 (2 Sentence penalty, 1 Wanted List) -
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NATIONAL COORDINATION
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Mechanism of national coordinationCombating
Counterfeit Drugs requires joint effort
medicines
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BENEFITS LIMITATIONS OF COORDINATION

• BENEFITS
• 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-distric
  t)
• 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

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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)

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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 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
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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
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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

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

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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.

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EXPECTATION

• Establish national and regional taskforce on
  combating counterfeit drugs
• Combating counterfeit drugs need international
  support

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still a long way to go!
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ENTIKONG
NUNUKAN
SKOU
JAGAOI BABANG
back
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MIANGAS MARORE
SUNGAI GUNTUNG
MOTA AIN, NAPAN, META MAUK
TAREMPA, SAMBU BELAKANG PADANG
back
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