Counterfeit and Substandard medicine in Laos Report country.
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Transcript of Counterfeit and Substandard medicine in Laos Report country.
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 mgB 250 mg
A 250 mgB 250 mg
fake
A 250 mgB 250 mg
A 250 mgC 250 mg
fake
A 250 mgB 250 mg
C 250 mg
fake
A 250 mgB 250 mg
A 250 mgB 250 mg
genuine
A 250 mgB 250 mg
A 200 mgB 120 mg
fake
A 250 mgC 250 mg
fake
C 250 mg
fake
A 250 mgB 250 mg
A 250 mgB 250 mg
genuine
A 250 mgB 250 mg
A 250 mgB 250 mg
A 200 mgB 120 mg
fake
Sub standard
genuine
A 250 mgB 250 mg
A 250 mgB 250 mg
球
A 250 mgB 250 mg
A 250 mgB 250 mg
A 200 mgB 120 mg
A 250 mgB 250 mg
A 250 mgB 250 mg
Legislative infrastructures (3)
• The gaps in current legislationImplementation, 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 LaosDirector GeneralDeputy Directors
Adm. Div Drug C Div.QA. Div Food C Div.
Food inspection Unit.
Drug inspection Unit
Law enforcement Unit
Adm. Unit
Registration Unit Import licensing
Importation
MarketMarket
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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Substandard and Fake drugs 1997 - 2002
0
5
10
15
20
25
30
35
40
45
50
SV97 SV98 ADB2000 EU02 Sida02
Per
cent
SubstandardFake
Previously reporting on counterfeit
• 2002-04Organization Samples Sub-Standard Fake• SIDA+Gov. 800 136(17%) 7 (0.9%)• EU(anti-malaria) 170 55(32%) 10(6%)• USPDQ(anti-malaria)215 20(9.3%) 18(8.4%)• JICWELS 48 1
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I. Counterfeit Medicines1. Artersunate 50mg, Tablet, Lot No.: 060207,Exp.: 06/2009, China2. Artersunate 50mg, Tablet, Lot No.: 50232, Exp.: 02/2009, China3. Artersunate 50mg, Tablet, Lot No.: 060232,Exp.: 02/2009, China
II. Sub-Standard Medicines1. Metronidazole 250mg, Tablet, Lot No.: 00206, Exp 10/2010, Manufacturer : Pharmaceutical Factory No. 2 Laos2. Erythromycine 250mg, Tablet, Lot No.: 010307,Exp 03/2010, Manufacturer: CBF Pharmaceutical Factory Laos
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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 ThavysabPharmacy 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. 50232,
2 weeks later , receiving reports from Six Provinces , not founded any counterfeits.
08/07/2007: Informed Saravan Provincial Health Officeagain to conduct investigation and taking action of Thavysab Pharmacy as follow by FDD Form
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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 AnoulakPharmacy 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.
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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.
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Action taken
1. Attopeu Province:
- 23/07/2007: Receiving Email 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 ProvinceNot founded any Counterfeits.
Thank