Definition of counterfeit medical product

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Definition of counterfeit medical product

• Drug Act B.E. 2510 (1967)
• Section 73 The following drug or substances are
  counterfeit drugs
• A drug or substance which is wholly or partly an
  imitation of a genuine drug
• A drug which shows the name of another medicine,
  or an expiration date which is false
• A drug which shows the name , or mark of a
  producer, or the location of the manufacture,
  which is false
• Drug which falsely shows registered number which
  is falsely
• Product with active substances which quality or
  strength lower than the minimum or higher than
  the maximum standards prescribed in the
  registered formula under Section 79 by more than
  20 .

WHO definition
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Definition of counterfeit medical product

• Medicine is categorized as sub-standard, if there
  is genuine packaging incorrect quantity of
  ingredient (not deliberate) with the amount of
  active ingredient lower than the minimum or
  higher than the maximum amount that declared in
  the registered formula but not more than 20 .
• Example

The registered formula declared 90-110 labeled
amount
Sub-standard
Sub-standard
Counterfeit
Counterfeit
Standard
90
110
72
132
20
20
maximum amount that declared in the registered
formula
minimum amount that declared in the registered
formula
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Penalty for Manufacture, Import and Sell
Counterfeit medicines (1)
1. Drug Act B.E. 2510 (1967)

• Manufacturer
• Shall be liable imprisonment for a term from
  three years to life and fine from ten thousand to
  fifty thousand Baht.
• Importer or Seller
• Shall be liable imprisonment for a term from one
  to twenty years and fine from two thousand to ten
  thousand Baht.

Present

• Manufacturer
• Shall be liable imprisonment for a term from
  three years to life and fine from three hundred
  thousand to five million Baht.
• Importer or Seller
• Shall be liable imprisonment for a term from one
  to twenty years and fine from one hundred
  thousand to two million Baht.

Future

• Compensation
• Shall be justified and payable to those who posed
  risk from counterfeit medicine

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Penalty for Manufacture, Import and Sell
Counterfeit medicines (2)

• 2. Trademark Act B.E. 2543 (2000)
• Section 108 Any person who counterfeits a
  trademark, service mark, certification mark or
  collective mark registered in Thailand by another
  person shall be liable to imprisonment not
  exceeding four years or a fine of not exceeding
  four hundred thousand baht or both.
• Section 110 Any person who
• (1) imports, distributes, offers for
  distribution..
• (2) gives or offers a service under a
  counterfeit service mark, shall be
  liable to the penalties provided in those
  Sections.

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National coordination

• Establish National Committee on Suppression and
  Anti-counterfeit since 2000
• Members
• Royal Thai Police
• Royal Thai Custom
• PReMA
• TPMA
• Other relevant institution
• 2. Establish Counterfeit Information Center
• to discriminate / to publicise those counterfeit
  / illegal medicines via internet
• receive suspected information of counterfeit
  medicines via internet and 24 hours hot line
  service number 1556

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Counterfeit Drug Information Center

• Provide data and pictures of illegal medicines
  founded in Thailand
• Counterfeit medicines found in Thailand
  (1998-present)
• Smuggling medicines (Unregistered in Thailand)
• Recalled medicines
• Drugs whose formula registration has been ordered
  cancelled by the Minister
• Counterfeit/ Unregistered veterinary medicines
• Suspected counterfeit case report form
• Email complain_at_fda.moph.go.th.
• http//wwwapp1.fda.moph.go.th/drug/zone_counterfei
  t/fak001.asp

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Number of cases
How where these cases detected?
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Number of cases

• 2005
• Counterfeit 2 cases 31,100 tabs.
  (Imported)
• Viagra 1 case 31,000 tabs. (Imported)
• Artesunate 1 case 100 tabs.
  (Imported)
• Vaccine H5N1 H5N9 7 cases 2,097 x 250 ml.
  (Parallel importation)
• Unregistered 8 cases (Parallel importation )
• 2006
• Counterfeit 3 cases 13,928 tabs.
  (Imported)
• Viagra 13,178 tabs (Imported)
• Cialis 750 tabs. (Imported)
• Vaccine H5N1 H5N9 2 cases 450 x 250 ml.
  (Parallel importation )
• Unregistered 8 cases (Parallel importation )
• ED medicines from China 45,970 tabs.
• 2007
• Counterfeit 8 cases 609 tabs. (Imported)
• Viagra 485 tabs (Imported)
• Cialis 64 tabs. (Imported)
• Levitra 60 tabs (Imported)
• Vaccine H5N1 H5N9 1 cases 1,800 x 250 ml.
  (Parallel importation )

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8 ?????? 2549 ?????????????????? 1 ???. ???????
???. ????????????????????????????????
?????????????????????????? ???????????? 22
?????? ???????? ?? Longer Viagra , ?? Sex
Drops , ?? Woman Generau ??? ???????? 110,350
???? ???????????????? 10 ???????
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• 5 ??????? 2549 ?????????????????? 3 ???.
  
  ???????????????????????????????????????????
  ???????? ????????????????????? ??????
• 1. ????? EPREX 4000 EPOEFIN ALFA 0.4 ml. ?????
  54 Syringes
• 2. ?? CELLCEPT MYCOPHENOLATE MOFETIL 250 ml.
  ????? 8,000 ??????
• 3. ?? ZYPREXA 10 mg OLANZAPINE ????? 980 ????
• ????? DECA-DURABOLIN (NANDROLONE DECANOATE 100
  mg) ???? 1 ml. ampoule ????? 4,900
  ampoules
• ??????????????????? 600,000 ???

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18 ??????? 2550

???. ??????????????
???????? ? ???????? ???? ?? Kamagar ,
?? Sandimmun Neoral, ??
Zyloric-300 ??? ????????? 64,300 ????
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5 ??????? 2550
?????????????????? 3 ???. ??????? ???.
????????????????????????????????????????
??????????????????????????????????
??????????????????????????
?????????? 2,0 00 ??. ?????????? 7 ???????
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Smuggling ED Drugs (Sildenafil) groups from China
and India
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NUMBER OF PROSECUTION / CONVICTIONS / PENDING

• The legal process takes long time to get final
  decision.
• March 20, 2002 Mr.Gokhan Ozhek, a Turk hiring
  the Thai employees to do the production of
  counterfeit Viagra has been arrested, and then
  all of the employees were exterminated as well
  following (final sentence on 28 March, 2005
  imprisonment for 10 years)
• The employees living at the lodging in Bangkae
  District were captured along with Viagra 100 mg
  (50,000 tablets approximately), raw materials,
  packaging materials and production equipment.
  (imprisonment for 6 years and 8 months)
• The employees , who sold or distributed
  counterfeit Viagra to the disguised police.
  (imprisonment for 3 years)

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PROPOSALS FOR ACTION
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PROPOSALS FOR ACTION