Global to Local

1
Global to Local Overview of Counterfeit
Pharmaceuticals
Ms. Werawan Tangkeo Deputy Secretary General,
Food and Drug Administration Ministry of Public
Health, Thailand
2
The problem is increasing and it is affecting
both developed and developing countries (1)

• The MHRA, with assistance offered by Pfizer Ltd.,
  is recalling Counterfeit Lipitor? Tablets 20 mg.
  (28s) Lot.No. 004405K1 Exp. date 11/2007 and
  Lot.o.067404K3 Exp. date 05/2007 (19 July 2006,
  03 August 2006)
• The MHRA, officials seized 5000 packets of
  counterfeit Tamiflu in early 2006, estimated to
  be worth 500 000.
• The MHRA, with assistance offered by Abbott
  Laboratories Ltd., is recalling the counterfeit
  Reductil? 15 mg. Capsules (14s) Batch no. 65542
  expiry date 01/2007 (02 Sep, 2004)
• The MHRA, with assistance offered by Lilly ICOS
  UK Ltd., is recalling the counterfeit Cialis? 20
  mg. Tablets. (4s) Batch number A031410and
  A041410, expiry date 06/2006 (23 Aug, 2004)

3
The problem is increasing and it is affecting
both developed and developing countries (2)

• A Dutch consumer bought Tamiflu 75 mg. capsules
  on internet . (Lactose ascorbic acid) (21
  December 2005)
• US FDA issued an alert about fraudulent flu
  remedies, including counterfeit prescription
  Oseltamivir (Tamiflu) medication. (January 2006)
• U.S Customs Seizes 51 shipments of Fake Tamiflu
  (generic) at an air mail center in San Francisco,
  California. (Nov., 2005)
• US FDA Warns Consumers About Counterfeit Viagra
  and Lipitor purchased between the Maxico
  border, (May,2005)
• US FDA Warns Consumers About Counterfeit Drug
  purchased in Maxico July 30, 2004 (Zocor 40
  mg. Lot. K9784 exp. Nov. 2004 Lot. K9901 exp.
  Dec. 2004 Carisoprodol 350 mg. Lot. 68348A)

4
The problem is increasing and it is affecting
both developed and developing countries (3)

• Counterfeit Armillarisni A injection (treating
  acute or chronic cholecystitis and chronic and
  atrophic gastritis) in northeast China's, 11
  people died. (BEIJING Xinhua, May 19, 2006)
• Counterfeit Viagra 580,000 tabs. seized in China
  (December, 2005)
• The largest ever underground drug-manufacturing
  ring and seized as much as 550,000 counterfeit
  drug pills worth NT 300 million in the market.
  (Viagra 50,000 Cialis 70,000 Zantac 20,000
  Reductil 50,000 and unknown drug pills 360,000)
  (Taiwan, December 2005)
• Counterfeit Velocef tabs, Zantac tabs,
  Augmentin 2 kgs. seized in India (October, 2005)
• Counterfeit artesunate and mefloquine in
  Cambodia, 30 died (1999)

5
Counterfeit Drug Cases Opened by US.FDA per Year
6
What are the different types of counterfeit drugs
that WHO have been reported?
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What kind of products are counterfeited most?

• Until recently, the most frequently counterfeited
  medicines in wealthy countries were new,
  expensive lifestyle medicines, such as hormones,
  steroids and antihistamines.
• In developing countries the most counterfeited
  medicines have been those used to treat
  life-threatening conditions such as malaria,
  tuberculosis and HIV / AIDS.
• As the phenomenon spreads, more and more
  medicines are counterfeited, including expensive
  ones, such as anti-cancer drugs, and those highly
  in demand, such as anti-viral drugs.

8
Strategy to combat the problem?

• Strengthening post-market surveillance
• Sampling test enhanced (annual sampling plan)
• Drug quality bulletins on a regular basis
• Plan for implementation of GDP GSP
• Monitoring drug quality and Licences of
  manufactures, distributors pharmacies
• Inspecting and monitoring of drug advertisements.
• Controlling of on-line drug information service
  transaction
• Penalties by warning, confiscating, fine,
  withdrawing approvals, suspending revoking
  Licences for illegal activities.

9
Strategy to combat the problem?

• Strengthening other regulatory areas
• Test of imported drugs at customs
• Marketing authorisation for all drugs/imported
  drugs
• GMP certification programme
• Routine GMP inspection plus investigational
  inspection

10
Strategy to combat the problem?

• Co-operation with other government bodies
• Criminal punishment for manufacturing/
  importing/selling of counterfeit drug, working
  with Thai Crime Suppression Division
• Control of smuggling, working with Custom
  Department
• ASEAN Post-Marketing Alert System (ASEAN PMAS)

11
Strategy to combat the problem?

• Encouraging the societys involvements
• Educate the public
• Disseminate information
• Establishing of Center for Combating Counterfeit
  Drug (since 1997)
• National Post-Marketing Alert System (to
  hospitals, drug stores, Provincial health
  offices, medical clinics, etc.)

12
Collaboration among involved organizations
Food and Drug Administration
Permanent Secretary
Inspection Division
Provincial Health Offices 76 provincials
Import Export Inspection Division
Airport
Klong Taey Shipping-Port
Lamchabang Shipping-Port
Police Station
Royal Thai Police
Border lines
Chiang-san (Lao)
Bangkok
Mae Sod (Burma)
Provincials
Sadao (Malaysia)
Aranyaprathate (Cambodia)
13
Counterfeit Drug Cases Investigated by Thai FDA
per Year
14
Thai Metropolitan Police Bureau

• January 2006 Inspector of Thai FDA arrested
  counterfeits of Reductil 10 and 15 mg at the drug
  stores in front of Siriraj Hospital.
• October 5, 2005 Inspector of Thai FDA arrested
  drug store in Thonburi district sold counterfeit
  Primobolan Depot 25 and smuggling counterfeits of
  Sildenafil (Viagra group) from India.
• July 15, 2005 Inspector from Thai FDA and Tak
  province arrest drug store in Mae sod district
  sold counterfeits Artesunate.

15
Thai Crime Suppression Division

• October 31, 2002 The smugglers distributing the
  amount of Viagra 100 mg of 60,000 tablets has
  been arrested with all packaging materials.
• March 20, 2002 Mr.Gokhan Ozhek, a Turk hiring
  the employees to do the production of counterfeit
  Viagra has been arrested, and then all of the
  employees were exterminated as well following the
  below
• The employees living at the lodging in Bangkae
  District were captured along with Viagra 100 mg
  (50,000 tablets), raw materials and production
  equipment.
• The employees living at the lodging in Nonthaburi
  province were captured along with Viagra (40,000
  tablets), Valium 10 mg (2,038,000 tablets),
  production equipment, packaging materials and
  containers.

16
Examples of Import Smuggling

• January 8, 2007 The Custom Department found the
  smuggling counterfeits of Sildenafil (Viagra
  group) from China amount of 110,000 tablets.
• December 25, 2006 Thai Narcotics Suppression
  Bureau arrested smuggling drugs from Singapore,
  such as Kamagra 10,600 Tabs. (Sildenafil),
  Plavix clopidogrel 7,518 Tabs., Nolvadex-D 25,000
  Tabs.
• June 28, 2005 A Japanese who was traveling to
  and fro between Thailand and Cambodia for 19
  times totally has been arrested by immigration
  officers of Sra-kaew province, along with the
  counterfeits of Viagra group in the amount of
  3,000 tablets i.e. Viagra Lot no. 3098603 Exp.
  Sep.2006, Lot no. B214837311 Exp. Jan.2008,
  Cialis 20 mg Lot no. A031410 Exp. Aug. 2006

17
Import Smuggling arrested by Import Export
Inspection Division, Thai FDA (1)

• November 5, 2006 A Pakistani passenger who fled
  to Thailand from Dubai with Indian-drugs which
  contain Sildenafil Citrate as Active Ingredient.
• June 8, 2005 A Chinese passenger who came from
  Hong Kong at the Bangkok International airport,
  Don Muaeng airport, with the counterfeits of
  Viagra (11,700 tablets) and Cialis (1,300
  tablets).

18
Import Smuggling arrested by Import Export
Inspection Division, Thai FDA (2)

• May 4, 2005 A Pakistani passenger who arrived
  Thailand by Cathay Pacific airline has been
  arrested along with many kinds of drug products
  i.e. Deca Durabolin injection 5,685 vials,
  Norigest injection 3,124 tubes, Polution Depot
  2,393 tubes, Progynon Depot 1,914 tubes, Cellcept
  250 mg 1,200 capsules, and Neoral 10,800
  capsules.

19
Smuggling Sildenafil groups from China
20
Smuggling Sildenafil groups from China and India
21
Produce Other Own Products

• October 31, 1998 The inspectors of Thai FDA
  found punches and dies used to produce fake drug
  products in the manufacturer, in other words, to
  copy other own products e.g. Lasix 500 mg,
  Betaloc 100 mg, Fulcin 500 mg, Halcion 0.5 mg,
  Theo-Dur 200 mg.
• January 1999 The inspector of Thai FDA arrested
  drug store in Samutprakarn province counterfeit
  Lasix 500 mg.

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Center for Combating Counterfeit Drug (1)
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Situation along the border

• Counterfeit products found along the Thailand -
  Cambodia boarder during 2004.
• Labeled "Made in Thailand" or show Thai address
• All of the products showed fake name and address
• None of them are in Thai Drug Regulation System.

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Counterfeits found in Thailand

• 2006 1. Viagra (Sildenafil)
• 2. Cialis (Tadanafil)
• 3. Reductil 10, 15 mg.
• 4. Myda-B 5 gm.
• 2005 1. Viagra (Sildenafil)
• 2. Cialis (Tadanafil)
• 3. Primobolan Depot 25, 100 mg.
• 4. Reductil 15 mg
• 5. Counterfeit Herbal Medicine
• 2004 1. Viagra (Sildenafil)
• 2. Cialis (Tadanafil)

• 2003 1. Lasix 500 mg
• 2. Postinor
• 3. Primolut N
• 4. Proscar
• 5. Viagra
• 2002 1. Artesunate
• 2. Valium 10 mg
• 3. Viagra
• 2001 1. Actifed Syrup
• 2. Atarax syrup
• 3. Bisolvon Elixer
• 4. Rhinathiol Syrup
• 5. Artesunate

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Counterfeit Artesunate Tablets (1)
30
15 g.
L/C No. 184815 Mfd.
25-03-05 ?????????? 25-09-08
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When found suspicious products (1)

• Immediately report to the authorized person
• Provincial Health Offices, or
• Center for Combating Counterfeit Drug, Food and
  Drug Administration, Ministry of Public Health,
  Nonthaburi 11000
• Tel [phone]
• Fax [phone]
• E-mail prakool_at_fda.moph.go.th, or
  praphonang_at_yahoo.com

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When found suspicious products (2)

• To inform as much more details of the
  characteristics of each product as possible, e.g.
• Name and its concentration,
• Lot number,
• name and address of the manufacturer,
• name and address of the place where each product
  was found.
• To transfer the suspicious drug products to the
  authorized person.
• Using of these drug products should be cancelled.