IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. 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

2. 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

3. 3
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

4. 4
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. 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

6. CONTROL OF
PHARMACEUTICAL PRODUCTS
IN MALAYSIA

7. 7
• 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

8. 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

9. 2015/3/43/4/2015 99
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

10. 2015/3/43/4/2015 1010
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.

11. PENCAPAIAN
LEGISLATIONS
(ACTS & REGULATIONS)
11
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

12. 12

13. 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. 1414
• 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

15. CONTROL & MONITORING OF
COUNTERFEIT MEDICINES :
PUBLIC-PRIVATE SECTOR
COOPERATION

16. 2015/3/43/4/2015 1616
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.

17. 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

18. Counterfeit Medicines
Substandard/Spurious/ Falsely-
labelled / Falsified/ Counterfeit
(SSFFC)
Medicinal Products
18
New Terminology by WHO (2011)

19. 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

20. • 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

21. 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:

22. 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%)

23. 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

24. IMPLEMENTATION
OF
Meditagtm Hologram

25. 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.
25

26. 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

27. 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.

28. 28
The characteristics
that can be seen with
naked eye of
consumers
Features of the First MEDITAG® HOLOGRAM

29. 29
MeditagTM II (2006)
MeditagTM III (2012)
Upgrading security features
in the hologram to keep
abreast with rapid
advancement in technology
IMPROVING CURRENT SECURITY FEATURES

30. 30
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.

31. Formats of Meditag™ Hologram
• Sheets
–100pcs Meditag™ labels
per sheet
• Rolls
–15,000pcs Meditag™ labels
per roll

32. 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

33. Visual Aid Device – Meditag Decoder
1st Edition 3rd Edition2nd Edition

34. 34
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.

35. 35
Using Meditag Decorder
35

36. 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

37. 37
Example – Fake Hologram

38. ORIGINAL COUNTERFEIT
Example – Fake Hologram

39. 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.

40. 40
SEIZURES & RAIDS
40

41. Detection of Counterfeit/Unregistered Medicines

42. 42
BEFORE
AFTER
Meditag Hologram
facilitate detection of
counterfeit drugs and their
removal from the market

44. 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. 45
Awareness and Public Education Activities

46. 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

47. 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

48. Consumers & Industry Awareness Activities
2009 – 2014

49. 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. 5050
Official Website

51. 51
Social Media – Online Awareness Platforms

52. IMPACT & OUTCOME

53. 53
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%

54. 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
54

55. The Way Forward

56. 56
• 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

57. New Pharmacy Bill supported by the
Government – political will
57

58. Collaboration
with other
Stakeholders

59. 59
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’

60. 60
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

61. –Pharmacy Enforcement Division, MOH
–15 State Pharmacy Enforcement Offices
–Royal Malaysia Customs
–Malaysian Communications and
Multimedia Commission
61
Local Collaboration

62. 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

63. • 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
63
Activities Conducted In Malaysia

64. 64
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
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

66. • 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 pharmaceuticals66
STORM V : Malaysia

67. 67
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
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. 6969
Total Seizures
Quantity of Item Seized (pill, vial, tablet, etc.…)
851,500
Value of item seized :
RM 1,204,441
(USD 363,627)

70. 70
Knowledge Sharing

71. KNOWLEDGE SHARING :
Case Study 1

72. 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.

73. 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

74. Seized Items
FILAGRA 100 (Sildenafil)
AVANA & SUPER AVANA
(Avanafil)
TADALIST (Tadalafil)

75. Seized Items

76. 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

77. 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.

78. 78
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.

79. 79
TERIMA KASIH
Thank You