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13 th ICDRA, Berne, 16-19 th September 2008 By EISAH A RAHMAN Ministry of Health Malaysia Pharmaceutical Services Division Ministry of Health Malaysia www.pharmacy.gov.my
13th ICDRA, Berne, 16-19th September 2008By
EISAH A RAHMANMinistry of Health Malaysia
Pharmaceutical Services DivisionMinistry of Health Malaysiawww.pharmacy.gov.my
Introduction◦ Present Situation
Current Regulatory System◦ Organization
Strategies in Combating Counterfeits◦ Multi-pronged approach
International Collaboration◦ Regional & Global
Conclusion
13th ICDRA, Berne, Sept 2008 3
Current Scenario◦ Global Reports
Industrialized countries (USA, EU, Australia, Canada, Japan, NZ) – 1% market valueAfrica, Asia & Latin America – 30% Other developing markets 10-30%Soviet Republics – 20%Internet sales – 50% cases
5.28% - Market Study on Self-Medication Products in 19974.8% - Market Survey by Pfizer on Innovator Drugs (Viagra, Norvasc & Lipitor)245 of 32,067 products seized in 2006129 of 13,774 products seized until June 200767% public awareness on illegal products including counterfeit medicines – Study in northern states
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◦ StructurePractice & Development PharmacyPharmacy EnforcementRegulatory Pharmacy
◦ ResourcesPersonnelFinancePlanning & Development Training
◦ InfrastructureFacilities
◦ Quality SystemKPI, ISO
14 states Deputy
Director Of Health
PharmaceuticalServices
Pharmacy Enforcement
Pharmacy Practice &
Development
Chief PharmacistKL Hospital
Pharmacy Board
Poisons Board
Medicines Advertisement
s Board
Regulatory Pharmacy (National
Pharmaceutical Control Bureau)
Drug Control Authority
(DCA)
Carried out by NPCB:Product EvaluationProduct AnalysisGMP Inspection & LicensingPost-Marketing Surveillance & ADR
Control of Drugs & Cosmetics Regulations 1984
Registration
Pharmacovigilance
Surveillance
Analysis
Licensing
Education
Inspections
Enforcement
613th ICDRA, Berne, Sept 2008
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Legislation◦ Sale of Drugs Act◦ Poisons Act◦ Registration of Pharmacists Act◦ Medicines Advertisements & Sale Act◦ Pharmacy Act (new Bill)◦ Medical Devices (new Bill)◦ Traditional & Complementary Medicine (new
Bill)◦ Trade Description Act◦ Patent Act◦ Multi-media Act
13th ICDRA, Berne, Sept 2008 8
Regulatory System◦ Evaluation of products◦ Registration◦ Inspection of premises◦ Licensing◦ Analytical testing◦ Certification◦ Post market surveillance◦ Regulatory information
Product categoryProduct category TotalTotal
Prescription 11,805
Non-prescription(OTC)
9,098
Natural Products (Traditional)
18,200
Cosmetics 136,643
TotalTotal 175,746175,746
7% 5%10%
78%
PrescriptionNon-prescriptionNatural ProductsCosmetics
Effective 1st January 2008 Registration of Cosmetics replaced by Procedure of Notification
9Pharm Enforcement Conference 2008
180
149
90
161
85
447
0
50
100
150
200
250
300
350
400
450
500
Pharm Trad Cos
Product Type
Premises
Manufacturer Importer
Licensed Premises Licensed Premises -- 20072007
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11
2004 2005 2006 2007
Samples taken
3094 2483 2748 2538
Labels checked
1792 1428 2631 2413
Products recalled
179 74 108 144
Warnings issues
81 42 41 62
Product complaints
297 269 317 361
13th ICDRA, Berne, Sept 2008
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Operations◦ Inspections◦ Surveillance◦ Punitive actions
Protection & Prevention◦ Control of advertisements & promotion◦ Consumer education◦ Quality initiatives
Licensing◦ Import & export control◦ Precursor control
Legislation◦ Prosecutions◦ Acts & Regulations
665
524
699
774
342
0
100
200
300
400
500
600
700
800
Premises
2004 2005 2006 2007 2008(till
June)Year
Raids
1313th ICDRA, Berne, Sept 2008
25,884,137
16,694,02717,079,428
35,836,036.00
13,986,595
0
5,000,000
10,000,000
15,000,000
20,000,000
25,000,000
30,000,000
35,000,000
40,000,000
Value (RM)
2004 2005 2006 2007 2008(till
June)Year
Value of SeizuresValue of Seizures
1413th ICDRA, Berne, Sept 2008
13,26611,815
30,034
24,046
4,650
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
Seized
2004 2005 2006 2007 2008(till
June)Year
Products SeizedProducts Seized
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Category 2007 2008(till June)
Sex stimulants 40 6Traditional medicines 23 62Prescription items 18 24Slimming products 10 1Cosmetics 6 5Psychotropics 2 1Others 1 1
1613th ICDRA, Berne, Sept 2008
0
10 0
2 0 0
3 0 0
4 0 0
5 0 0
6 0 0
7 0 0
8 0 0
S a m ple s 3 9 7 2 8 9 4 6 2 4 0 9 3 2 6 7 2 8
A dulte ra nts 10 6 6 3 2 3 10 2 8 3 9 7
2 0 0 2 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7
Sildenafil & AnaloguesDexamethasoneAntihistamineWhitening Agents
HydroquinoneIbuprufenSlimming Agents
SibutramineTadalafilPhenylbutazoneSteroidsProgesteroneMinoxidilMetforminCombinations
Sildenafil + GlibenclamideSildenafil + Paracetamol
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187
473
361
402
601
326 311
505
0
100
200
300
400
500
600
700
2005 2006 2007 2008 (till June)
Year
Prosecutions
Casescompleted
ProsecutionsProsecutions
1813th ICDRA, Berne, Sept 2008
“Know Your Medicine”CampaignPosters/post-cardsCalendars with message NewspapersTV and radio talksSchool exhibitionsOpen DayRoad-showsMedia announcements
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0
20
40
60
80
100
120
140
160
Talks 30 58 63 100 123Exhibitions 50 106 80 155 149Dialogues 10 18 6 11 5
2004 2005 2006 20072008 (till
June)
13th ICDRA, Berne, Sept 2008
Consumer Education & DialoguesConsumer Education & Dialogues2004 2004 –– 2008 (till June)2008 (till June)
20
Ministry of Domestic Trade & Consumer Affairs
Customs Department
Police Department
AG Chambers
Immigration
Chemistry Department
Industry Associations
Consumer Groups
Health Professionals
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◦ ASEAN ASEAN Consultative Committee for Standards & QualityASEAN Working Group in Pharmaceutical DevelopmentBilateral Arrangements
◦ WHO ICDRAIMPACT
◦ United NationINCBUNODC
◦ Others InterpolWCO
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Applications◦ Security devices
HologramsDecoders Microscopes
◦ Information & Communication TechnologyQUEST, SPPFTelecommunication
◦ Forensic ExaminationAnalyticalInstrumental
Adulterations traced to manufacturer through serial number on MeditagTM
Counterfeit products detected with fake holograms.Strengthen enforcement & improve imagePromote trade & economy Assurance of quality & safety Tracking of illegal - parallel importationPublic awareness
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International Benchmarking◦ Good Manufacturing Practice – PIC/S◦ Good Clinical Practice – ICH◦ Good Laboratory Practice – OECD◦ Good Regulatory Practice & Good Review Practice –
ASEAN/EU/US◦ Good Pharmacy Practice & Good Distribution & Storage
Practice – WHO
9th Malaysia Plan◦ Human resource development◦ ICT enhancement
Streamlined structureContinuous professional developmentCompulsory service◦ Increase manpowerPost-graduate studies◦ Masters in LawIncentive allowance◦ Critical & specialQuality initiatives◦ QAP, KPIResearch◦ Studies
2613th ICDRA, Berne, Sept 2008
Forensic laboratoryMobile test kitsNew PCsAwareness programsIntegrated computerized network systemNew Pharmacy Bill
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ASEAN Healthcare Integration Roadmap
ASEAN Technical Cooperation in Pharmaceutical Development
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ASEAN Healthcare IntegrationFormalise a post-marketing alert system for defective and unsafe pharmaceutical products
Objectives of PMA SystemShare information relating to defective or unsafe cosmetics, health supplements, traditional medicines and pharmaceutical medicinal products Major safety concerns can be acted upon in timely manner
Pilot project launched in April 2005. Initiated by Singapore & Malaysia
ASEAN PMAS adopted by Pharmaceutical Product Working Group (PPWG) in February 2006
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Alerts raised for a total 69 productscosmetics, pharmaceuticals & traditional medicines
no reports on health supplement
Percentage of Alerts vs Types of Products
Traditional medicines
28%
Pharmaceuticals31%
Cosmetics42%
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Breakdown of the types of alerts
Types of Alerts
47.80%
15.90%
14.50%
4.30%2.90%
1.40%
8.70%
Adulteration Withdrawal/suspension Failed specificationUnpermitted colourings Microbial contamination Labelling changeExcessive heavy metals
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ASEAN Working Group for Technical Cooperation in Pharmaceuticals (AWGTCP) long establishedMalaysia – Training Centre for Quality Assurance of PharmaceuticalsNow called ASEAN Working Group in Pharmaceutical Development (AWGPD)Regular border meetings – Brunei, Indonesia, Malaysia, Singapore & Thailand (BIMST)Agenda◦ Collaborative studies◦ Combating counterfeits ◦ Sharing and exchange of information◦ Training
13th ICDRA, Berne, Sept 2008 34
Strengthen national legislationEnsure regulatory complianceImprove collaboration among governmental entitiesDevelop communication strategyCreate awareness – decision makers, health professionals & consumersTraining of regulatory & enforcement officers
Counterfeiting a global issue◦ International collaboration◦ Information sharing
Serious public health concern◦ Political will◦ Commitment
Multi-pronged strategies◦ Infrastructure◦ Regulations ◦ Enforcement◦ Collaboration◦ Innovation
13th ICDRA, Berne, Sept 2008 35
TERIMA KASIHTERIMA KASIHTHANK YOUTHANK YOU
3613th ICDRA, Berne, Sept 2008
