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)

¦½-²¾®-µ¾-¯º´--µøÈ-¦-¯-¯-쾸

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

14

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

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 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

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 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.

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 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