MONITORING OF COUNTERFEIT MEDICINES IN MALAYSIA :

PUBLIC-PRIVATE SECTOR COOPERATION

DR. SALMAH BINTI BAHRI, R.Ph.

Director of Pharmacy Enforcement

Pharmaceutical Services Division

Ministry of Health Malaysia

Lot 36, Jalan Universiti,

46730 Petaling Jaya, Selangor,

Malaysia

Outline of Presentation

• Introduction

• Control of Pharmaceutical Products in Malaysia

• Control & Monitoring of Counterfeit Medicines

• Implementation of Meditag Hologram

• Consumer Awareness Activities

• Impact and Outcome

• The Way Forward

• Collaboration With Other Stakeholders

• Knowledge Sharing

• Conclusion

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COUNTRY PROFILE

Total Land Area 329,961.22 km2

Population (2015) 30.7 million (Urban: 71%)

Life expectancy (2013) Male: 72.6 yrs Female: 77.2 yrs

Age ≥ 60 years 10.3%

GDP per capita MYR 34,126 (USD10,902.87)

Estimated labour force (2013) 12.9M

(44% of the total population)

Total Expenditure on Health2011 (Public & Private) (in million)

MYR 37,542 (USD 11,994)

Total Expenditure on Health as a Percentage of GDP (current prices) (2011)

4.3%

COUNTRY PROFILE - MALAYSIA

Source : 1. Department of Statistics, Malaysia,

2. Economic Planning Unit, Prime Minister’s Department and Malaysian Economy 4th Quarter Document, MOF

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Malaysian National Medicines Policy (MNMP)

Quality Use of Medicines

Access to Medicines

Governance in Medicines

Quality, Safety and Efficacy of

Medicines

Partnership & Collaboration for Healthcare

Industry

5

To improve health outcomes of Malaysians through:

Promoting equitable access to essential medicines

Ensuring availability of safe, effective and affordable medicines of good quality

Promoting quality use of medicines by healthcare providers and consumers

Objectives of MNMP

CONTROL OF

PHARMACEUTICAL PRODUCTS

IN MALAYSIA

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• 4617 license issued to pharmacists practising in 2766 pharmacies • 2086 license issued to importers and wholesalers of controlled items

148 Public Hospitals

2765 Public Clinics

6,801 GP Clinics 1686 Dental Clinics

Control of Pharmaceutical Products in Supply Chain

214 Private Hospitals

2015/3/43/4/2015 8

POLICY Good governance, practices, conduct and professionalism shall be

emphasised within the healthcare industry towards achieving optimal health outcomes

Policy 1: Governance in Medicines

STRATEGIES

• Health professional bodies and relevant

stakeholders shall have codes of conduct

and be responsible for ensuring

compliance by its members with the code.

• Stakeholders shall perform in accordance

with the standards of practice developed by

appropriate authorities or relevant

professional bodies.

• Compliance with the standards shall be

supported by legislation where appropriate.

• Relevant legislation/

regulations shall be

developed and reviewed

regularly to ensure an

efficient supply chain

network and integrated

medicines management to

safeguard the public

2015/3/43/4/2015 9 9

POLICY Only safe, efficacious and quality medicines that meet

approved standards and specifications shall be registered and made available for sale and use by the consumers in Malaysia

Policy 2: Quality, Safety and Efficacy of Medicines

STRATEGIES

LEGISLATION AND REGULATIONS

• National Pharmaceutical Control Bureau (NPCB)

• Regulating Premises that supply medicines

• Effective Enforcement

• Medicines Advertisement and Promotion

• Counterfeit Medicines

PHARMACEUTICAL QUALITY ASSURANCE

• Post-Marketing Surveillance

• Management of Complaints about Medicines

2015/3/43/4/2015 10 10

POLICY Partnerships and collaboration in the implementation and

strengthening of relevant areas in the healthcare industry shall be established among various stakeholders at the national, regional and international levels

Policy 5: Partnership and Collaboration for the Healthcare Industry

STRATEGY 5.2.3: Technical Collaboration & Partnership

• Technical collaboration and partnership shall include all areas in regulatory practices, training and human resource development, medicines accessibility, quality use, and research and development

• Effective networking shall be established to provide a framework for exchange and sharing of information.

• Referencing against best practices and standards shall be established and reviewed regularly.

• Partnerships, coordination & cooperation with all relevant stakeholders shall be strengthened.

PENCAPAIAN LEGISLATIONS

(ACTS & REGULATIONS)

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1. Registration of Pharmacists Act 1951 (revised 1989) & Regulations 2. Poisons Act 1952 (revised 1989) & Regulations 3. Sale of Drugs Act 1952 (revised 1989) & Control of Drugs and Cosmetics Regulations 1984 (revised 2006) 4. Dangerous Drugs Act 1952 (revised 1980) & Regulations 5. Medicines (Advertisement and Sale) Act 1956 (revised 1983) & Regulations

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PHARMACY ENFORCEMENT DIVISION

Legislation, Inspection & Prosecution

Licensing, Inspection & Entry Point Control

Intelligence, Surveillance & Operation

Advertisement & Innovation

Prevention & Consumer Awareness

Consists of 5 Branches in HQ and 15 State Offices •450 Pharmacy Enforcement Officers

14 14

• Adulterations

• Counterfeit medicines • Illegal activities

Manufacturing

Importation

Sale

• Online trading & cyber crime

• Medicines & chemicals abuse

• Control of psychotropics

Precursors

Diversions

• Intelligence gathering

• Legislation

Current Scenarios & Challenges

CONTROL & MONITORING OF COUNTERFEIT MEDICINES :

PUBLIC-PRIVATE SECTOR COOPERATION

2015/3/43/4/2015 16 16

POLICY Only safe, efficacious and quality medicines that meet approved

standards and specifications shall be registered and made available for sale and use by the consumers in Malaysia

Policy 2: Quality, Safety and Efficacy of Medicines

STRATEGY 2.2.1.5 Counterfeit Medicines

• Appropriate legal and technical framework for concerted efforts in the enforcement of laws and regulations by the Ministry of Health and other relevant authorities relating to market surveillance shall be further enhanced to overcome the problem of counterfeit medicines.

• Suitable security measures for authentication, traceability of counterfeit medicines and public education shall be implemented and continuously enhanced.

Counterfeit Medicinal Products Definition (WHO) 1992

A product that is deliberately and fraudulently mislabeled with respect to identity or source to make it appears to be a genuine product

May include products with Correct or wrong ingredients, without active ingredients, with incorrect quantity of active ingredients or with fake packaging

Counterfeiting can apply to both branded and generic

product and sold under product name without proper authorization

Counterfeit Medicines

Substandard/Spurious/ Falsely-labelled / Falsified/ Counterfeit

(SSFFC)

Medicinal Products

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New Terminology by WHO (2011)

SSFFC Medicinal Products

Substandard Below the usual or required standard

Spurious Not being what it claim to be; false or fake

Falsely-labelled

Declaring what is untrue, tending to deceive or mislead, not genuine

Falsified Incorrect or false- especially to deceive i.e pass themselves off as real

Counterfeit Imitate fraudulently, fake

• All pharmaceutical products have to be registered with the Drug Control Authority (DCA) before it is marketed and sold to consumers.

• Assessment of safety, quality and efficacy based on adequate and scientific data is the prerequisite for registration

• Any products that passed the evaluation and approved by the DCA will be given a unique registration number starting with ‘MAL’

• SSFFC medicinal products are currently deal as unregistered products under Sale of Drugs Act 1952

Control of Pharmaceutical Products in Malaysia

MAL 12095678 A, X, T OR N

A Controlled Medicine Only dispensed by doctors & pharmacist

Eg: Antibiotics, Anti-Hypertensive

X General/Over the counter Medicine Eg: Fever medicines, Antacids

T Traditional Medicine Eg: Jamu, Liniments, Minyak Gamat

N Health Supplement Eg: Cod Liver Oil, Multivitamins.

‘MAL’ Registration Number:

Product Registration 1985-2014

Product Category Total Registered Currently

Registered

Control Medicines (Prescriptions)

14,140 7,101

Non-prescriptions (OTC)

10,144 4,172

Natural Products (Traditional Medicines)

22,867 12,052

Veterinary Products 385 509

Health Supplement 509 385

Total 48,045 24,219

(50.39%)

Limitation of ‘MAL’ Registration Number

• Through market surveillance, Pharmacy Enforcement Officers detected the existence of pharmaceutical products using fake registration numbers or registration numbers that belong to other products.

• The registration numbers are easily copied and consumers are finding it hard to verify its authenticity in the market

• The huge number of products registered make it difficult for consumers to determine the exact status of the pharmaceutical products at the point of sales

IMPLEMENTATION

OF

Meditagtm Hologram

Malaysia is the first country in the world who implements the

use of a single security hologram label for all

pharmaceutical products sold in the country.

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All registered products are required to display their product registration number and Meditag hologram

security label on its packaging. Any products that do not carry both of these

features will be considered as unregistered products

Registration Number MeditagTM Hologram

Implementation of Hologram Technology

• An additional safety measure was adopted on the 1st May

2005 with the introduction of the Meditag hologram sticker

on all pharmaceutical products.

• This first Meditag hologram reflects our commitment and

seriousness in controlling the medicinal products in

Malaysia. • The implementation of the Meditag scheme shows how modern technology can be a key

to curbing fake drugs. • The Meditag hologram can help reduce sale of counterfeits and aid in the prosecution of

offences against adulterated and fake drugs.

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The characteristics

that can be seen with

naked eye of

consumers

Features of the First MEDITAG® HOLOGRAM

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MeditagTM II (2006)

MeditagTM III (2012)

Upgrading security features

in the hologram to keep

abreast with rapid

advancement in technology

IMPROVING CURRENT SECURITY FEATURES

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Control on MeditagTM Hologram

•Only supplied to importers and manufacturers licensed by MOH Malaysia.

•Meditag holds 10 digits alphanumeric serial code, each hologram is serialized and the serial number is recorded in a computerized system - MTOS.

•Meditag can be related to a particular manufacturer or importer base on its serial number. They will be held responsible on how the labels are kept and used.

•Enforcement officers can login into the system and identify the rightful owner of any genuine Meditag Hologram.

Formats of Meditag™ Hologram

• Sheets

–100pcs Meditag™ labels

per sheet

• Rolls

–15,000pcs Meditag™ labels

per roll

Meditag™ Security Concept

• Public

– Immediate visual identification

– Point of sale verification with decoder

• Inspectors

– Tool kits

• Forensic personnels

– 100% certainty/Nanograph®

3 levels authentication and control

Visual Aid Device – Meditag Decoder

1st Edition 3rd Edition 2nd Edition

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PLACEMENT 0F MEDITAG DECORDER

• Available at all pharmacy

throughout the country

• Encourages the public to check

the authenticity of their medicinal

products.

• Promotes and encourages the

public to obtain medicines from

licensed Pharmacist

•Encourages the Pharmacist to

check the product sold in their

premises.

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Using Meditag Decorder

35

Click to edit Master title style

Polapen® Enhanced Tool

•Mediharta has developed a Polapen® as a tool to identify the Polarigraph feature of the genuine Meditag™ label.

•The Polapen® is distributed to all Pharmacy Enforcement Officer

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Example – Fake Hologram

ORIGINAL COUNTERFEIT

Example – Fake Hologram

Effectiveness – Moving In The Right Direction

• The implementation of Meditag hologram is an added advantage and has certainly facilitated in enforcement activities particularly with respect to product authentication.

• Easier to identify and differentiate the genuine from fake medicinal product

– It serves as a deterrent to the counterfeiters.

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SEIZURES & RAIDS

40

Detection of Counterfeit/Unregistered Medicines

42

BEFORE

AFTER

Meditag Hologram

facilitate detection of

counterfeit drugs and their

removal from the market

44

Consumer Awareness

CONVENTIONAL METHOD :

•Informative Poster/postcard/leaflet/pen

•Informative Calendar

•Lectures – students, NGOs, enforcement officers

•Exhibitions – school, office, shopping complex, etc

•Dialogues – target groups

•Roadshows and Carnival

•Announcement/article in media – newspaper, tv, etc

•Advertisement in media & public transport

•TV & Radio talks

•Billboard and bunting

45

Awareness and Public Education Activities

46

Campaign at Hypermarkets

Tesco

Selayang

Seremban

Kulai

Tebrau

Prai

Mergong

Sungai Petani

Puchong

Tanjung Pinang

Mydin Subang Jaya

Mydin Meru Raya

Various location throughout the country

Educating the Industry

• Dialogues and briefing sessions with the associations.

• Training the pharmacists, wholesalers and retailers on how to identify genuine holograms and how to verify using the decoder.

• Meditag decoders were given free to all pharmacies, wholesalers and certain retails outlets dealing with medicinal products.

• The decoders must be placed visibly on the counter for easy access to the public

Consumers & Industry Awareness Activities

2009 – 2014

49

Innovation – in line with the new era

Enhancement of Awareness Activities using various new means and channel :

•Dissemination of Information through :-

– Official Websites

– Social Media

•Smartphone App – Meditag Checker

•Online verification of registration number

•Informational videos on Youtube

•Submission of complaints or information through :

– Email

– Official Website

50 50

Official Website

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Social Media – Online Awareness Platforms

IMPACT & OUTCOME

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Seizure of Unregistered Products

Year

No of Items

seized (a)

No of counterfeit

items seized (b)

No of unregistered

items seized (c)

% of counterfeit items seized (d) (c/a x 100= d) %

2009 10,478 234 10,244

2.23%

2010 11,934 362 11,572 3.03%

2011 17,768 344 17,424 1.94%

2012

27,836 116 27,720 0.42%

2013 26,567 52 26,515 0.20%

Malaysia was awarded the “GLOBAL ANTI-COUNTERFEITING AWARD 2013” by The Global Anti-counterfeiting Group Network (GACG) presented during the World Anti-Counterfeiting Day in Paris, France on the 28th of May 2013

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The Way Forward

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• Enactment of the new Pharmacy Bill to address the issues and lacunae in the existing legislation and stiffer penalties:

Clearly define counterfeit medicinal products

Impose up to 10 times higher penalty -imprisonment of not less than 4 years but not exceeding 15 years and will be fine up to RM 2 million

• Close collaboration with other stakeholders (National, Regional and International)

– Operation Pangea

– Operation Storm

• Review and study of new security features/ safety mechanism to further improve the current safety label on medicinal products

The Way Forward - Malaysia

New Pharmacy Bill supported by the Government – political will

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Collaboration

with other

Stakeholders

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Collaboration with other Stakeholders

PANGEA :

‘An International Internet Week of Action (IIWA) involving Law Enforcement Agencies and Medicine Regulators targeting the illegal on-line supply of medicines including counterfeit and unlicensed products to the public’

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Objectives

•Safeguard public health

•Raise public awareness of the risk of buying medicines from fraudulent websites

•Seize counterfeit & illicits medicines and medical products and remove them from the market

•Close down fraudulent websites & remove advertisements

•Identify the producers & distributors of counterfeit and illicit pharmaceuticals and medical products.

Operation PANGEA

–Pharmacy Enforcement Division, MOH

–15 State Pharmacy Enforcement Offices

–Royal Malaysia Customs

–Malaysian Communications and

Multimedia Commission

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Local Collaboration

1. INTERPOL

2. WORLD CUSTOMS ORGANIZATION

3. Permanent Forum of International Pharmaceutical crime (PFIPC)

4. Working Group on Enforcement Officers (WGEO)

5. EUROPOL

6. Pharmaceutical Security Institute (PSI)

7. Center for Safe Internet Pharmacies (CSIP)

INTERNATIONAL COOPERATIONS

• Monitoring at Entry Points

– Airports (Cargo and Passenger)

– Postal & Courier Hubs

– Border Checkpoints

– Ferry Terminals

• Monitoring 0f Websites and Social Medias

• Inspections and Raids

• Consumer Awareness Activities

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Activities Conducted In Malaysia

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Activity Pangea V Pangea VI Pangea VII

2014 (113 countries)

Websites monitored/ investigated

96 134

236

Social media monitored/ investigated

97

Parcels inspected 1,260 888 9,014

Parcels seized 67 21 204

Value (RM) 49,830 76,600 259,346

Consumer Awareness Activities

2 2 28

Results & Achievements (Malaysia)

65 65

Collaboration With Other Stakeholders

No Activities Conducted

1 Inspection on licensed & unlicensed premise (pharmacies, clinics, drug store, sundry shops, etc)

2 Comprehensive entry point monitoring on all entry points into Malaysia.

3 Surveillance and raiding on premises involved in illegal sale of medicine

4 Monitoring of websites / social media selling medicines online

5 Monitoring of advertisement

6 Intelligent Sampling and test on medicine / food with medical claims.

7 Awareness Campaign and dissemination on information through all channel (websites, facebook, etc)

Operation Storm V (13 countries) in 2014

• Premises inspected

• Pharmacies

• Clinics and Hospitals

• Pharmaceutical Manufacturers and Wholesalers

• Traditional Medicine Shops

• Sundry shops, Mini markets

• Business Kiosks, Stalls and Night Markets

• Beauty Saloons

• Other premises dealing with pharmaceuticals 66

STORM V : Malaysia

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No. of Entry Points 30

No. of Parcels inspected 23,767

No. of premises inspected 559

No. of cases investigated 17

No. of Parcels seized 190

No. of items seized 865

Value of item seized at Entry Points

RM 45,359 (USD 13,820)

Results & Achievements

68 68

Other Activities Quantity

Products sent for analysis 252

Consumer Awareness Activities

89

Dissemination of information through Social Media

76 new postings

Websites investigated 29

Results & Achievements

69 69

Total Seizures

Quantity of Item Seized (pill, vial, tablet, etc.…)

851,500

Value of item seized :

RM 1,204,441

(USD 363,627)

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Knowledge Sharing

KNOWLEDGE SHARING : Case Study 1

Modus Operandi

1. Ordering done by a company in Singapore.

2. Products sent from India to Kuala Lumpur International Airport International Hub.

3. Products sold online through various websites.

4. SMMR will receive customer info and re-pack the products

5. Products delivered to customer through courier services.

Seized Items

2 premises related to the business were raided

•181 medicinal products (mostly generic Erectile Dysfunction and antihypertensive drugs and antibiotics,) were found and seized

•Total value = RM 7.5 million ≈ USD 2.34 million

Seized Items

FILAGRA 100 (Sildenafil)

AVANA & SUPER AVANA

(Avanafil)

TADALIST (Tadalafil)

Seized Items

POST MORTEM & OBSERVATION

• Products were kept in transit and stored inside the

airport compound, declarations with customs are not

required.

• Products delivered to other countries as health

supplements without its original packaging/ information

about its identity.

• Difficulty to trace or gather evidence (unregistered,

counterfeits, adulterated food supplements) to

successfully prosecute the offenders as the actual

transactions were done in other countries

COLLABORATION WITH PHARMACEUTICAL INDUSTRY

s • Pharmacy Enforcement Division also work closely

with Pharmaceutical Security Institute (PSI) and Pharmaceutical companies (Pfizer, Eli Lilly, etc.) to further enhance our control mechanisms.

• Pharmaceutical companies do provide assistance with test purchases and surveillance activities while the Enforcement Division will follow up with raids and prosecutions.

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CONCLUSION • Implementation of the security hologram has proven to

be a practical and effective tool to facilitate enforcement activities particularly with respect to product authentication.

• Enforcement agencies must keep vigilant on the continuous change of tactics. R&D on enforcement activities should be strengthened together with new strategies to educate and empower the consumers.

• New invention and advancement in the security label technologies should be considered and integrated to further improve the current system.

• Structured local, regional and global public-private collaboration is the way forward.

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TERIMA KASIH Thank You