E. Wondemagegnehu

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Drug regulation counterfeits experience of
countries

• Workshop on GMP and Quality Assurance of
• Anti-malarial Medicines
• Bangkok, Thailand
• 18 -22 October 2004

Eshetu Wondemagegnehu Technical Officer Focal
Person for Counterfeit Drugs Quality Assurance
SafetyMedicines World Health Organization
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Framework of the presentation

• How do countries define counterfeit drugs?
• Examples of counterfeit drugs reported
• Examples of measures taken by some countries to
  combat counterfeit drugs
• What should governments, industry and other
  stakeholders do to address the problem?

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In pure legal terms a counterfeit medicine is

• A medicinal product made by someone other than
  the genuine/legitimate manufacturer
• by copying/imitating a genuine product produced
  by legitimate manufacturer
• without authority or right
• to deceive/cheat
• by passing the copy/forged medicinal product for
  that which is original

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The WHO definition of a counterfeit drug

• "A drug which is deliberately and fraudulently
  mislabelled with respect to its source and/or
  identity"
• It applies to both generic and a branded products
• A counterfeit product may include products
• with the correct ingredient (s)
• with the wrong ingredient (s)
• without ingredient (s)
• with incorrect quantities of active ingredient
  (s)
• with fake packaging
• Could be an imitation or a copy of a genuine
  product or not

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In the United States, a counterfeit drug is
"A drug which, or the container or labelling of
which without authorisation bears the trademark,
trade name, other identifying mark, imprint, or
device or any likeness thereof, of a drug
manufacturer, processor, packer, or distributor
other than the person or persons who in fact
manufactured, processed, packed, or distributed
such drug and which thereby falsely purports or
is falsely represented, to be the product of, or
to have been packed or distributed by, such other
drug manufacturer, processor, packer, or
distributor.
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In Philippines it means (1)

• A drug deliberately fraudulently mislabelled
  with respect to its source and/or identity
  (similar to WHO definition)
• a product with incorrect amount of active
  ingredients
• a product with wrong ingredients
• A drug or the container or labelling bearing
  without authorisation trademark, trade name or
  other identification mark or imprint or any
  likeness to that registered (similar to the US
  definition)

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In Philippines it means (2)

• A product imported without being
  registered(specific to Philippines)
• A product containing less than 80 of the
  labelled amount (specific to Philippines)
• A product refilled in a container by unauthorized
  person if the legitimate labels or marks are used
  (specific to Philippines)

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In Australia-counterfeit therapeutic goods
(medicines) are (1)

• Goods containing false representation in any of
  the following
• any advertisement for the goods
• any documentation or record relating the goods or
  their manufacture
• False representation involves
• The identity or the name of the goods, the
  formulation, composition or design specification
  of the goods
• The presence or absence of any ingredient or
  component of the goods
• The strength/size of any ingredient/component of
  the goods
• The sponsor, source of manufacture, or place of
  manufacture of the goods, etc

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In China, the term includes any one of the
following (1)

• The ingredients in the drug are different from
  those specified by the national drug standards
• A non-drug substance is simulated as a drug or
  one drug is simulated as another
• A product the use of which is prohibited by
  regulations by the regulatory department under
  the State Council
• A product produced or imported without approval
• A product marketed without being tested as
  required by law

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In China the definition includes (2)

• A product which has deteriorated
• A product which is contaminated
• A product produced by using a drug substance
  without approval number as required by law
• A product bearing indications or functions which
  are beyond the specified scope

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In Viet Nam counterfeit drugs are products used
for cheating purposes when

• They do not have or have very little
  pharmaceutical ingredients
• They contain pharmaceutical ingredients that
  contradict to which stated on the label ( to mean
  different)
• Label package are identical or nearly identical
  to those of other products ( to mean
  imitation/copy)

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In Cambodia a counterfeit drug is

• A drug which is deliberately produced with
  incorrect or wrong active ingredients
• A drug without active ingredients or which
  contains quantities of active ingredients outside
  the defined pharmacopoeial standards
• A drug which is deliberately and fraudulently
  mislabelled with respect to identity or source or
  with fake packaging (similar to WHO)
• A drug repacked or produced by unauthorized person

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In Lao the definition applies to

• A modern or a traditional medicine which is
  deliberately produced to be fake, or copied from
  another product that has been produced and
  distributed and registered officially.

In Thailand a counterfeit drug is

• Any modern/traditional medicine which is faked
• An imitation of a drug which is produced,
  distributed and legally registered

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What do we learn from these definitions?

• All countries consider counterfeiting a criminal
  activity
• A counterfeit drug is
• a copy or imitation of a genuine product
• a product which contains little or none of the
  active ingredient (s) mentioned on the label
• a product which contains different ingredient
  from the one mentioned on the label
• a product with fake packaging
• Some countries do not differentiate substandard
  from counterfeit drugs

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Examples of counterfeit drugs reported (1)

• Diethylene glycol poisoning in USA (1936),
  Nigeria, (1990), Haiti (1996/97), India,
  (1998)..etc
• Dummy contraceptive pills in Brazil. About 200
  unwanted pregnancies(1998)
• Fake Tarivid (ofloxacin) in Hong-Kong
  contained-glucose and penicillin (1998)
• Counterfeit artesunate and mefloquine in Cambodia
  (1999)

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Examples of reported counterfeit cases(2)

• 240,000 packs of medicines and 2 tonnes of raw
  materials worth 1 million US seized in Italy
  (2000)
• Counterfeit ampicillin in Tanzania, (2000)
• Counterfeit Serostim (Somatropin) , Neupogen
  (Filgrastim) and Nutropin AQ (Somatropin) in USA
  (2001)
• In India, in one factory police found 660 kg of
  fake drugs, 1000 kg of raw materials boxes
  bearing the logo of a reputable firm (2001)
• 2001-2002 in Shantou, Pu Ming and Chengzhou
  cities several counterfeit drugs were detected
  including Sandostatin and Neoral

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Examples of reported counterfeit cases (3)

• Russia MOH reported 80 cases of counterfeit
  drugs, 2002
• Counterfeit Combivir, Ziagen, Gamimmum, Epogen
  reported in USA (2002)
• Counterfeit Lipitrol (atorvastatine) and Procrit
  (epoetin alfa) detected in USA (2003)
• Counterfeit Reductil (sibutramine) and Cialis
  (sildenafil) found by UK Medicines and Healthcare
  products Regulatory Agency (2004)

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(No Transcript)
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Cases detected in USA
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Counterfeit artesunate-contained no active
ingredient (2003)
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Counterfeit Neupogen - no active ingredient
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Counterfeit Viagra - no active ingredient
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Counterfeit anti-malarial-hard to differentiate
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Chloramphenicol unknown manufacturer (it is
not only branded products that are affected)
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Illegal manufacturinga good source of
counterfeit drugs
Making capsules in a private house
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Repacking to hide the identity and true source
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Medicines sold in market places with bananas,
fish,.. etc
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Smuggling - a source of counterfeit drugs
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Examples of measures by some counties to address
the problem

• USA
• Established special task-force to combat
  counterfeit drugs
• Posted cases of counterfeit drugs detected on web
  site
• Tightened control system at ports of entry
• Initiated public awareness and education
  programme
• Established a rapid alert system
• Nigeria
• Passed a special act against fake and counterfeit
  drugs
• Established taskforce against counterfeiting
• Barred importation from suspected/black listed
  countries and manufacturers

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• Australia and UK
• Created special enforcement unit -
  police/criminal investigators within their
  national drug regulatory systems
• Enacted penal sanctions
• Strengthened surveillance and enforcement
• China
• Enacted a new Drug Administration Law with penal
  sanctions against counterfeiting of drugs
• Established the State Food and Drug
  Administration
• Created a special programme on cracking
  counterfeiting of drugs
• Special website for online complaint on
  counterfeit drugs
• Public awareness programme using radio and TV

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Measures that need to be taken
National level

• Increase awareness of government decision-makers
  to gain political support for strong drug
  regulation
• Enact special drug legislation on counterfeit
  drugs with deterrent penal sanctions
• Control the manufacture, importation, exportation
  and distribution of drugs-regular inspection and
  quality surveillance programme
• Improve enforcement by cooperating with other
  national law enforcement agencies - customs,
  police and prosecutors

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Measures that need to be taken
National level

• Sensitise the public to prevent buying drugs from
  unauthorized premises and peddlers
• Disclose names of individuals companies that
  have been prosecuted and convicted
• Stop trade of drugs through free-ports Internet
• Promote cooperation with stakeholders-DRA,
  manufacturers, distributors, health
  professionals, civil societies, etc to combat
  counterfeit drugs
• Seek international cooperation e.g. WHO,
  INTERPOL, the World Customs Organization

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Measures that need to be taken
Inter-country and region level

• Promote cooperation between countries sharing
  common boarders to prevent smuggling and
  cross-boarder trade
• Promote inter-country, sub-regional, regional
  co-operation in the fight against counterfeit
  drugs
• Ensure that export-drugs are regulated to the
  same standard as drugs domestically used

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Measures that need to be taken
Global level

• Cooperation between countries to develop common
  definition and harmonized measures
• Global framework to control trade in counterfeit
  drugs
• Timely exchange of information between countries
  and international organizations such WHO,
  Interpol, World Custom Organization

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Counterfeit drugs
Thank You