Counterfeit and Substandard medicine in Laos Report country

General situation Areas –Area: 236,800 sq. km. –Capital: Vientiane Border –China, Burma, Vietnam, Thailand, Cambodia Population –6.5 million Provinces –17 provinces

Legislative infrastructures (1) The legislation is used to against counterfeit medical products: –Drug Law: Regulation: –Drug registration, –Drug import-Export –Drug selling : hologram, using of bill –Civil Law: Article 133: Produce, sell bad quality drug (3 months to 3 years for sanction).

Legislative infrastructures (2) National definition of counterfeit medical product: –In drug law, at article 11 defined a counterfeit drug as: Counterfeit drug is a traditional or modern drug was mimicked, copied from genuine drug which was registered. –Definition from WHO was also used

A 250 mg B 250 mg A 250 mg B 250 mg fake A 250 mg B 250 mg A 250 mg C 250 mg fake A 250 mg B 250 mg C 250 mg fake A 250 mg B 250 mg A 250 mg B 250 mg genuine

A 250 mg B 250 mg A 200 mg B 120 mg fake A 250 mg C 250 mg fake C 250 mg fake A 250 mg B 250 mg A 250 mg B 250 mg genuine A 250 mg B 250 mg A 250 mg B 250 mg

A 200 mg B 120 mg fake Sub standard genuine A 250 mg B 250 mg A 250 mg B 250 mg 球 A 250 mg B 250 mg A 250 mg B 250 mg A 200 mg B 120 mg A 250 mg B 250 mg A 250 mg B 250 mg

Legislative infrastructures (3) The gaps in current legislation Implementation, following to law and regulations were still not strictly, activities to fill the gaps : Registration and surveillance Reliable enforcement Punishment by capital law Information campaigns

Supported organizations: WHO USPDQI Welcome Trust Global fund SIDA (KTS) Coordination among government institutions National Coordination (1)

Drug regulator in Laos Importation Market Relevant org. Post marketing inspection

Problems/Limitations of coordination: –Lack of team work Effect of coordination: –Need more improve National Coordination (2)

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Previously reporting on counterfeit OrganizationSamplesSub-StandardFake SIDA+Gov (17%)7 (0.9%) EU(anti-malaria)17055(32%)10(6%) USPDQ(anti-malaria)21520(9.3%)18(8.4%) JICWELS481

14 I.Counterfeit Medicines 1. Artersunate 50mg, Tablet, Lot No.: , Exp.: 06/2009, China 2. Artersunate 50mg, Tablet, Lot No.: 50232, Exp.: 02/2009, China 3. Artersunate 50mg, Tablet, Lot No.: , Exp.: 02/2009, China II. Sub-Standard Medicines 1. Metronidazole 250mg, Tablet, Lot No.: 00206, Exp 10/2010, Manufacturer : Pharmaceutical Factory No. 2 Laos 2. Erythromycine 250mg, Tablet, Lot No.: ,Exp 03/2010, Manufacturer: CBF Pharmaceutical Factory Laos

15 Action Taken 1. Saravan Province: - 05/07/2007: Received report from FDQCC - 06/07/2007: Informed Saravan Provincial Health Office for Investigating and taking action Thavysab Pharmacy Owner & Conduct an inspection of other pharmacies in the whole province. - 06/07/2007: Informed all Provincial Health Offices in the whole country to conduct an Inspection of counterfeit Artesunate Lot No , 2 weeks later, receiving reports from Six Provinces, not founded any counterfeits. 08/07/2007: Informed Saravan Provincial Health Office again to conduct investigation and taking action of Thavysab Pharmacy as follow by FDD Form

16 Action Taken 1. Khammouane Province: - 12/09/2007: Received report of analysis from FDQCC - 12/09/2007: Informed Khammouane P H O for Investigating and taking action to Anoulak Pharmacy Owner and Conduct an inspection of other pharmacies in the whole province. - 09/10/2007: Receiving report from Khammouane P H O. -Founded more counterfeits at pharmacies, Khammouane Drug Import Export Company, Sebangfai Dist. Hospital and Prov. Hospital, - Total amount: 44 blisters, Conducted investigation, knowing source of counterfeit came from private Vietnamese, pharmacy and company - Confiscated all amount of Counterfeits.

17 Action Taken -Luang Namtha Province: - 01/10/2007: Receiving report of analysis from FDQCC - 08/10/2007: Informed Luangnamtha P H O to conduct an inspection of Military Hospital of Luangnamtha province, other pharmacies and making Investigation. FDD did not receive report yet until now.

18 Action taken 1.Attopeu Province: - 23/07/2007: Receiving from Dr. Paul Newton - 26/07/2007: Informed Attopeu P H O to conduct an Inspection of Hospitals and Pharmacies - 15/08/2007: Receiving report from Province Not founded any Counterfeits.

Thank