activities ddf-moh to improve the q m c · 2011 removed registration number of 8 products (relevant...
TRANSCRIPT
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
E
Eph
ac C
o.,
Ltd
.
B. F
.La
bo
rato
ries
Gen
Ph
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
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