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AntiCounterfeit Workshop for Pharmaceutical Products

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Northern : Myanmar & Lao P.D.R.. Southern : Malaysia. Eastern : Lao P.D.R. & Cambodia ... Western : Myanmar. Capital City : Bangkok. Provinces : 76. Population: ... – PowerPoint PPT presentation

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Title: AntiCounterfeit Workshop for Pharmaceutical Products


1
Anti-Counterfeit Workshop for Pharmaceutical
Products
Dr. Siriwat Tiptaradol Secretary General, Thai
Food and Drug Administration Ministry of Public
Health, Thailand
2
Consequences of counterfeit medicines (1)
  • In 1995, around 2,500 people are believed to have
    died in Niger after they were given a fake
    meningitis vaccine.
  • In 1999, at least 30 people died in Cambodia
    after taking counterfeit antimalarials prepared
    with sulphadoxine-pyrimethamine (an older, less
    effective antimalarial) which were sold as
    Artusenate.
  • The consumption of medicines prepared with
    glycerin that mixed-up/contaminated with
    diethylene glycol (a toxic chemical used in
    antifreeze) led to several hundreds deaths around
    the world during 1937 to 2006.

3
Consequences of counterfeit medicines (2)
Glycerin/Propylene glycol contaminated/mix-up
with Diethylene glycol
4
The extent of the problem (1)
  • Researchers at Oxford University in the United
    Kingdom reported in April 2005 that 15 percent of
    all drugs sold worldwide are fakes.
  • This means the annual global market value of
    counterfeit medicines is 35 billion, close to
    the U.S. FDA. estimate of 32 billion.
  • The Centre for Medicines in the Public Interest,
    in the United States, predicts that counterfeit
    drug sales will reach 75 billion globally in
    2010, an increase of more than 90 from 2005.

5
The extent of the problem (2)
  • Most developed countries with effective
    regulatory systems and market control currently
    have a very low proportion, i.e. less than 1 of
    market value.
  • Many developing countries of Africa, parts of
    Asia, and parts of Latin America have areas where
    more that 30 of the medicines on sale can be
    counterfeit. Other developing markets, however,
    have less than 10 overall, a reasonable
    estimate is between 10 and 30
  • Many of the former Soviet republics have a
    proportion of counterfeit medicines which is
    above 20 of market value.

6
The extent of the problem (3)
  • Medicines purchased over the Internet from sites
    that conceal their actual physical address are
    counterfeit in over 50 of cases.
  • Many Internet pharmacies are based in countries
    known for high levels of pharmaceutical
    counterfeiting.
  • Governments must cooperate domestically and
    internationally to stop the global spread of
    counterfeit medicines

7
The Declaration of Rome
  • political will, adequate legal framework and
    implementation commensurate to the impact of this
    type of counterfeiting on public health and
    providing the necessary tools for a coordinated
    and effective law enforcement
  • inter- sectoral coordination based on written
    procedures, clearly defined roles, adequate
    resources and effective administrative and
    operational tools
  • creating an awareness about he severity of the
    problem among all stake holders and providing
    information to all levels of the health system
    and the public
  • development of technical competence and skills in
    all required areas and
  • appropriate mechanism for ensuring vigilance and
    input from healthcare professionals and the public

8
The International Medical Products
Anti-Counterfeiting Taskforce (IMPACT)
  • There are 5 strategies recommended to be explored
    and implemented which are
  • Legislation
  • Regulation implementation
  • Technology
  • Communication
  • Enforcement

9
Thai FDA Vision
  • The vision of the Thai FDA focuses on the
    increasing consumers' confidence in health
    products. It states that
  • By the year 2007, the FDA will be the principal
    and most trusted organization in Thailand in
    public health protection by ensuring the quality
    and safety of health products and promoting
    proper consumer behavior through reliable
    scientific evidence and appropriate technology .

10
Thai FDA Mission
  • Regulate and monitor health products to meet
    quality and efficacy standards.
  • Promote Good Manufacturing Practice in the
    production and quality control of health products
    to ensure consumer safety and to encourage
    exports.
  • Research and develop the effectiveness of the
    consumer protection system for health products.
  • Promote and support the capability of health
    product consumers and society to be able to
    protect themselves and be self-reliant.
  • Encourage and enable all stakeholders and
    non-government parties to share in the consumer
    protection role.

11
THAILAND
  • Location South East Asia
  • Boarder line
  • Northern Myanmar Lao P.D.R.
  • Southern Malaysia
  • Eastern Lao P.D.R. Cambodia
  • Western Myanmar
  • Capital City Bangkok
  • Provinces 76
  • Population 63 Millions

BANGKOK
12
Thais Strategy to combat counterfeit medicines
(1)
  • establish the new import-export control office in
    the border provinces of Thailand
  • strengthen our enforcement by stringent
    inspection at the port of entry which we have
    arrested many cases last year ( detailed of
    number and amount will be added later)
  • performing our duties governed by Law and
    Regulation by cooperation within country and
    international level.

13
Thais Strategy to combat counterfeit medicines
(2)
  • Work closely with other national drug authorities
    agencies such as
  • Provincial Health Offices (Local monitoring and
    surveillance agency)
  • Department of Medical Science (National Control
    Laboratory)
  • Work closely with national law enforcement
    agencies such as
  • The Royal Thai Police
  • The Customs Department.
  • Immigration Bureau

14
Thais Strategy to combat counterfeit medicines
(3)
  • Foster bilateral agreements with neighbor
    countries (e.g. Lao P.D.R., Cambodia, Myanmar and
    Malaysia) in particular with countries sharing
    common borders to prevent cross boarder trade and
    smuggling.
  • Foster multilateral agreements with ASEAN
    countries developing common strategies,
  • timely exchange of information and Rapid Alert
    System,
  • harmonization of measures to prevent the spread
    of counterfeit drugs

15
Thais Strategy to combat counterfeit medicines
(4)
  • Foster cooperation with international
    organizations,
  • coordinating function for WHO activities in the
    Mekong countries.
  • Encouraging the societys involvements
  • Educate the public
  • Disseminate information
  • Establishing of Center for Combating Counterfeit
    Drug

16
Center for Combating Counterfeit Drug (1)
17
Center for Combating Counterfeit Drug (2)
  • Provide data and pictures of illegal medicines
    founded in Thailand
  • Counterfeit medicines (1998-present)
  • Smuggling medicines (Non-register in Thailand)
  • Banded medicines
  • Situation along border line Cambodia and Thailand
    in 2004
  • Suspected counterfeit case report form
  • Email complain_at_fda.moph.go.th.
  • Relate Links.
  • http//wwwapp1.fda.moph.go.th/drug/eng/zone_counte
    rfeit/fak001.asp

18
Thais FDA Policy and Direction
  • amendment of law and regulation that will
    support more efficient work of combating the
    counterfeit medicines including more stringent
    penalty for law violation.
  • establishment of more import-export office in
    border provinces
  • capacity building in performing the preliminary
    test at the import-export office at the port of
    entry such as screening test for suspected
    medicines.
  • strengthen cooperation at all level from
    officers, regional and international agency
  • capacity building in investigation technique
  • facilitate and support the manufacturer to comply
    with GMP

19
Drug Act, B.E. 2510 (1967)
  • All drug manufacturing, importation and
    distribution activities are carried out in
    premises approved by the Drug Regulatory Agency,
    and that individuals and companies engaged have
    license to operate such activities.
  • All drug are assessed and registered before they
    are introduced to the market.
  • Legislation prohibiting the manufacture,
    importation, exportation, distribution and sale
    of counterfeit drug.

20
Penalty for Manufacture, Import and Sell
Counterfeit medicines
  • Manufacturer
  • Imprisonment for a term from three years to life
    and fine from ten thousand to fifty thousand
    Baht.
  • Importer or Seller
  • Imprisonment for a term from one to twenty years
    and fine from two thousand to ten thousand Baht.

21
Conclusion
  • There is no simple solution or remedy that can be
    applied to eliminate counterfeit medicines nor
    can the problem be solved by an individual
    company or government.
  • Combating counterfeiting of medicines is ? shared
    responsibility to which all interested parties
    have to contribute.
  • The problem has reached ? global dimension and
    needs ? global approach.
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