Phnom Penh on May 29, 2014

ACTIVITIES OF DDF-MOH TO IMPROVE THE QUALITY OF MEDICINES IN CAMBODIA

Heng Bun Kiet, Pharm.D Director of Department of Drug and Food, Cambodia Ministry of Health

Chief of Secretariat of Interministerial Committee for combating counterfeit and substandard medicines in Cambodia.

Presentation outline

1. Definition of Counterfeit drugs

2. Current situation of drugs channel, drugs outlets and drugs

registration in Cambodia

3. How to ensure the Quality of Medicines

4. Summary of Actions Taken and Joint- Collaboration with anti-

economic crime police in confiscating counterfeit and smuggled

medicines.

5. Raising awareness about medicines quality issues

6. Possible factors facilitating the circulation of Counterfeit and

Substandard Medicines.

7. Challenges

Definition of Counterfeit Drugs

Cambodian Definition

A Counterfeit drug is a medicine:

• deliberately produced with incorrect quantity of active ingredient, or wrong

active ingredients.

• without active ingredients, or with amount active ingredients that are

deliberately outside the accepted standard as defined in standard

pharmacopoeias.

• deliberately and fraudulently mislabeled with respect to identity and/or source.

• fake packaging, repacked or produced by unauthorized person.

May 14 3

Substandard Drug is a registered product which its

specifications are outside of defined pharmacopoeias or accepted

standard.

Current Drug Distribution Channel in Cambodia

4

Illegal

drug

Outlets

Illegal

health

services

Clinic /

Cabinet

of

Consult-

ation

C O N S U M E R S

Depot A/B

smuggled drugs

Pharmacies

Distributors/whole sellers

Manufacturers/ importers

May 14 5

Evolution of drug outlets in Cambodia

Type 2008 2009 2010 2011 2012 2013 Apr. 2014

Manufacturer 7 8 8 8 9 9 9

Import-Export Company

146 156 174 187 228 277 281

Pharmacy 519 568 670 726 913 1119 1142

Depot A 126 129 117 117 113

110 109

Depot B 744 583 675 657 652 566 563

Unlicensed drug outlets

1420 1052 99 00 00 00

00

How to Ensure the Quality of Medicines

May 14 6

Cambodia DDF-MoH, in collaboration with NGO partners, has:

• Conducted regular Drug Inspections to drug outlets, pharmaceutical

companies, and manufacturers .

• Conducted regular Post Marketing Surveillances (PMS)

• Developed and disseminated GMP, GDP, GSP, GPP and Recall Products

Guidelines, and Conducted trainings to all relevant institutions.

• Enforced all importers and manufacturers to register their products before

distributing to Cambodian Market.

• Collaborated with MoI to seize counterfeit medicines and smuggling medicines.

Strengthening The registration of medicines

Cambodia MoH had issued an

official declaration to obligate

all pharmaceutical companies

to put the registered code

(vignette) on the outer box

the purpose is to differentiate

the legal importation and

illegal importation.

May 14 7

Medico Trading CAM N 0011 IP-11

Medical Supply CAM N 0057 LP-12

Vimpex CAM N 0068 IH-12

Sample of Vignettes

C.H.R Co., Ltd CAM N 0368 IM-12

10% (1231)

90% (11161)

PaKryénkarcuHbBa¢ika-Tidæakarplitpl»sfkñúgRsuk nig»sfnaMcUl KitRtwm 22-01-2014

Percentage of Local Products and Imported Products (22-01-014)

Local Products (1231) Imported Products (11161)

Total 100%

(12392)

India, 3769

Cambodia, 1231

Thailand , 920

France, 896

Korea , 732

Malaysia , 708

China, 518

Vietnam , 507

Germany, 456

Indonesia, 424

Other Countries, 2231

bNþaRbeTscuHTidæakar-bBa¢ikaplitpl»sfeRcInCageK KitRtwm 22-01-14

Countries with High Range in No. Products Registered in Cambodia (22-01-14)

0

50

100

150

200

250

300M

S.

PP

M

Ch

eaC

ham

nan

…

CP

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o.,

Ltd

.

B. F

.La

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rato

ries

Gen

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arm

a

293 267

186 175 149

108

42

shRKasplit»sfkñúgRsuk nigplitplcuHTidæakarKitRtwm 22-01-2014

Local Manufacturers and its registered products (22-01-2014)

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00% 30.41%

9.93%

7.42% 7.23% 5.91% 5.71% 4.18% 4.09% 3.68% 3.42%

RbeTs10EdlnaMmuxeK kñúgkarcuHTidæakar-bBa¢ika»sfkñúgRBHraCaNacRkkm<úCa

Top Ten Countries with High Range in No. Products Registered in Cambodia

Summary of action taken 2010

Year Joint project GFR6 and PQM JPMA project

2010 Banned 5 manufacturers label

claimed:

1. VKP Pharmaceutical Co. Ltd.

(Thailand)

2. China Southern

Pharmaceutical Co. Ltd.

(China)

3. Shen Wei Pharmaceutical

(China)

4. Fu Li Pharmaceutical (China)

5. SG. Pharmaceutical (China)

Remove Registration number of 9 items:

1. Amocal 500/125mg (Amoxicillin 500mg/Clavulanic acid

125mg) from PPM, Cambodia

2. Clavomid 625 (Amoxicillin 500mg/Clavulanic acid

125mg) from Remedica, Cyprus

3. Lamoxy-CV 625 (Amoxicillin 500mg/Clavulanic acid

125mg) from Lyka Labs, India

4. Clavamox (Amoxicillin 500mg/Clavulanic acid 125mg)

from Kalbe Farma, Indonesia

5. Cimetidine 400mg from Bailly-Creat, France

6. Cimetidine 400mg from Labo Umedica, India

7. Cimetidine 400mg from Labo Bright Future, Cambodia

8. Cimetidine 400mg from PPM, Cambodia

9. Metrogyl 250mg (Metronidazole) from Labo Unique

Pharma, India

Summary of action taken 2011

Year Joint project GFR6 and PQM JPMA project

2011

Remove registration number of 3

items:

1. Azith 250mg from Zee

Laboratory /India

2. Cloxacap 250mg from

Hovid/Malaysia

3. Tetracyclin 250mg from

Visali/India

Remove Registration number of 5 items:

1. NEUCLAR 250 (clarithromycine 250mg) from

AMBALAL SARABHAI Enterprise, India

2. COTRIM 480 from EPHAC, Cambodia

3. COTRIM 960 from PPM, Cambodia

4. KAMAGRA 100mg (Sildenafil) from AJANTA

PHARMA(India)

5. VEETAB 100mg (Sildenafil) from Sai Mirra

Innopharm Pvt(India).

Summary of action taken 2012 Year Joint project GFR6-PQM JPMA project

2012 Remove registration

numbers of 2 items:

1. Cloxa-Ms from

Medical Supply

Enterprise/ Cambodia

2. Cloxa-EPHAC from

Laboratory EPHAC/

Cambodia

A. Ban the selling of Omyl 20 mg (Omeprazole) from Lyka Lab, India, which is not registered at the Ministry of

Health.

B. Remove registration numbers of 20 items :

1. Omeprazole-AGIO 20mg (Omeprazole 20mg) from AGIO Pharmaceutical, India

2. Omemax-20 (Omeprazole 20mg) from AXON Drugs Pvt, India

3. Omep (Omeprazole 20mg) from BAL Pharma, India

4. Ulcergo (Omeprazole 20mg) from Burgeon Pharmaceutical, India

5. Lomac-20 (Omeprazole 20mg) from CIPLA, India

6. Zosec (Omeprazole 20mg) from Emcure, India

7. Omprez 20mg (Omeprazole 20mg) from Global Pharma Health Care, India

8. Omezole 20mg (Omeprazole 20mg) from Hovid, Malaysia

9. Klocid-20 (Omeprazole 20mg) from Klokter, India

10. Omepral-20 (Omeprazole 20mg) from Medical Supply, Cambodia

11. Poraz (Omeprazole 20mg) from Medley, India

12. Ompalen-20 (Omeprazole 20mg) from MIHIKA Pharmaceuticals, India

13. Pleom®-20 (Omeprazole 20mg) from Plethico, India

14. Omepsa (Omeprazole 20mg) from PSA, India

15. Omegard 20mg (Omeprazole 20mg) from UMEDICA, India

16. Aziclar 250mg (Clarithromycin) from Flamingo Pharmaceutical, India

17. Aziclar 500mg (Clarithromycin) from Flamingo Pharmaceutical, India

18. CIaricin 250mg (Clarithromycin) from Medical supply, Cambodia

19. Promet-400 (Cimetidine) from Millimed, Thailand

20. Cimetidine 400mg of Shijiazhuang Pharma, China

C. The MoH bans registration of new products, from 4 manufacturers namely:

1. Flamingo, India

2. Lyka, India

3. Umedica, India

4. Hovid, Malaysia

Summary of action taken 2013

year USP/PQM Project

2013 1. Remove Registration number of 2 items:

• Levoflacin (Levofloxacin 500mg ),

manufactured by Flamingo Laboratory-India.

• Terizine (Cetirizine 10 mg), manufactured by

Troikaa Laboratory, India.

2. Ministry of Health removed all items registered

by Flamingo Laboratory-India (120 items).

Summary of action taken 2013 (Continued) year JPMA project

2013 1. Ministry of Health (MoH) banned new products registration by:

• Plethico Pharm. Ltd., India

• Zee Laboratories, India.

2. Banned 2 counterfeit products with label claimed from 2 manufacturers

• Ceftriaxon-K inj. (Ceftriaxone 1g) B/10 Vials, manufacture by Kyung Dong Pharma, Korea

• Locepin Sodium for injection (Ceftriaxone 1g) B/10 vials, manufactured by Shijiazhuang Pharma.

Group Zhongnuo Pharma, China.

3. Removed Registration Numbers of 10 items:

Gramocef 1000 (Ceftriaxone Sodium 1g), manufactured by Micro Labs Limited, India

Ceftrox 1000 (Ceftriaxone anhydrous 1g), manufactured by Phlethico Pharm. Ltd., India

Sterile Ceftriaxone Sodium Inj. 1g (Ceftriaxone Sodium 1g), manufactured by CJ Chil Jedang

Corporation, Korea

Es-Care 40 (Esomeprazole Magnesium 40mg), manufactured by Zee Laboratories, India

Alton 40 (Esomeprazole 40 mg), manufactured by General Pharmaceutical Ltd., Bangladesh

Esonix 20 (Esomeprazole 20 mg), manufactured by Incepta Pharmaceutical Ltd., Bangladesh

Esonix 40 (Esomeprazole 40 mg), manufactured by Incepta Pharmaceutical Ltd., Bangladesh

Espra 20 (Esomeprazole 20 mg), manufactured by CCL Pharma Pvt., Ltd., Pakistan

Grasozole 20 (Esomeprazole Sodium 20 mg), manufactured by Gracure Pharma, India

Medirium 40 (Esomeprazole 40 mg), manufactured by Labo Medicraft Pharmaceutical Pvt. Ltd,

Pakistan.

Summary of action taken 2014

year DDF-MoH Project

2014 1. Remove Registration number and recall of 3

items:

• Min 50 mg (Atenolol 50 mg), manufactured by

Yuong Il Pharm, Korea.

• Min 100 mg (Atenolol 50 mg), manufactured by

Yuong Il Pharm, Korea.

• Domperidone 10 mg (Domperidone 10 mg),

manufactured by Bright Future Laboratories

Summary of action taken 2010-2014

Years Actions Taken 2010 • Banned 5 counterfeit manufacturers label from China and Thailand

• Removed registration number of 9 products (relevant to APIs: Co-Amoxicillin/Clavulanic acid, Cimetidine and Metronidazole)

2011 Removed registration number of 8 products (relevant to APIs: Azithromycin, Cloxacillin, Tetracyclin, Clarithromycin, Cotrimoxazole and Sidenafil)

2012 • Removed registration number of 22 products (relevant to APIs: Cloxacillin, Omeprazole, Clarithromycin, and Cimetidine)

• Banned the selling of Omyl 20 mg (Omeprazole) from Lyka Lab, India, which is not registered at the Ministry of Health.

• Banned the registration of new products, from 4 manufacturers namely Flamingo, Lyka, Umedica, and Hovid.

2013 Removed registration number of 12 products (relevant to APIs: Levofloxacin, Cetirzine, Ceftriaxone and Esomeprazole).

removed all items registered by Flamingo Laboratory-India (120 items) Banned new products registration from Plethico Pharm. Ltd. and Zee Laboratories, India. Banned 2 counterfeit Ceftriaxone 1g injectables (Ceftriaxon-K & Locepin Sodium) with label

claimed from 2 manufacturers : Kyung Dong Pharma-Korea and Shijiazhuang Pharma. Group

Zhongnuo Pharma - China.

2014 • Removed registration number of 3 products (relevant to APIs: Atenolol and Domperidone)

Joint-Collaboration in with anti-economic crime police confiscating counterfeit and smuggled medicines

Recent confiscating of smuggled and counterfeit drugs, and illegal producer

2012 1. Seizure on March 08, 2012: 40 cartons of illegal Chinese traditional medicines, equal to 772 Kg and

packaging materials.

2. Seizure on September 22, 2012: 42 items of smuggled and counterfeit medicines, equal to more than 2

tons.

3. Seizure on September 30, 2012: 16 items of smuggled and counterfeit medicines equal, to 3,019 Kg.

Joint-Collaboration with anti-economic crime police in confiscating counterfeit and smuggled medicines (cont’)

Recent confiscating of smuggled and counterfeit drugs and illegal producer (cont’)

2013 4. Seizure on March 1, 2013: Confiscate about 5 tones of raw material to produce cosmetic products

and 353 cartons of finished products, and seizure of materials such as mixer machine, filling machine, packages etc.

5. Seizure on April 13, 2012: Confiscated illegal production of counterfeit medicines that falsify mostly

French Brand Names products (i.e Laroscorbine inj., Becozyme inj. etc.) and its finished products.

Confiscate materials for productions (i.e machine for laminating blister of injectable medicines, machine for cutting vial glass, printer, printed sticker and label etc.)

May 14 21 Illegal drug store in a market located in Kampong Thom province (2009)

22

Illegal drug stores in

Kampong Thom province

(2009)

Seizure of illegal producer and counterfeit

medicines on September 30, 2012

Di-Antalvic

(Paracetamol+ Dextropropoxyphen)

Seizure of Counterfeit Cosmetics

on March 01, 2013

Seizure of illegal producer and

counterfeit medicines on April 13, 2013

Raising awareness about medicines quality issues

Raising awareness about medicines quality issues

Raising awareness about medicines quality issues

Possible factors facilitating the circulation of Counterfeit and Substandard Medicines

May 14 29

1. Lack of moral and ethical standards among drug sellers

2. Gaps in oversight of border authority checkpoint that

smugglers successfully evade

3. Limited mandate to confiscate illegal products for justice

polices and to carry forward cases for prosecution

4. Law enforcement is still limited

5. Limited communication between countries

Challenges

1. Communication within local and regional

countries is still limited.

2. Law enforcement action is still limited.

May 14

Thank you very much for your attention !

May 14

For further information please contact :

hengbunkiet@yahoo.com

edararath@gmail.com