Tangkeo

Slide1 : Global to Local Overview of Counterfeit Pharmaceuticals Ms. Werawan Tangkeo Deputy Secretary General, Food and Drug Administration Ministry of Public Health, Thailand


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. (28’s) 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 (14’s) 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. (4’s) Batch number A031410and A041410, expiry date 06/2006 (23 Aug, 2004) The problem is increasing and it is affecting both developed and developing countries (1)


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


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


Counterfeit Drug Cases Opened by US.FDA per Year : Counterfeit Drug Cases Opened by US.FDA per Year


What are the different types of counterfeit drugs that WHO have been reported? : What are the different types of counterfeit drugs that WHO have been reported?


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. What kind of products are counterfeited most?


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. Strategy to combat the problem?


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 Strategy to combat the problem?


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) Strategy to combat the problem?


Strategy to combat the problem? : Encouraging the society’s 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.) Strategy to combat the problem?


Collaboration among involved organizations : Collaboration among involved organizations Import & Export Inspection Division Food and Drug Administration Provincial Health Offices – 76 provincials Police Station Permanent Secretary Royal Thai Police Lamchabang Shipping-Port Klong Taey Shipping-Port Airport Border lines Inspection Division Aranyaprathate (Cambodia) Chiang-san (Lao) Mae Sod (Burma) Sadao (Malaysia) Bangkok Provincials


Counterfeit Drug Cases Investigated by Thai FDA per Year : Counterfeit Drug Cases Investigated by Thai FDA per Year


Thai Metropolitan Police Bureau : 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.


Thai Crime Suppression Division : 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.


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 Examples of Import Smuggling


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


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


Smuggling Sildenafil groups from China : Smuggling Sildenafil groups from China


Slide20 : Smuggling Sildenafil groups from China and India


Produce Other Own Products : 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.


Center for Combating Counterfeit Drug (1) : Center for Combating Counterfeit Drug (1)


Slide26 : 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. Situation along the border


Counterfeits found in Thailand : Counterfeits found in Thailand 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 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)


Counterfeit Artesunate Tablets (1) : Counterfeit Artesunate Tablets (1)


Slide30 : L/C No. 184815 Mfd. 25-03-05 ยาสิ้นอายุ 25-09-08 15 g.


Slide31 : 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 : 0-2590-7315, 0-2590-7325-6 Fax : 0-2591-8489 E-mail : prakool@fda.moph.go.th, or praphonang@yahoo.com When found suspicious products (1)


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. When found suspicious products (2)