This document discusses counterfeit medicines in the Philippines. It begins with definitions of counterfeit medicines from the World Health Organization, which can involve incorrect ingredients, insufficient ingredients, or fake packaging. It then outlines current Philippine legislation on counterfeit drugs, including Republic Act No. 8203 which prohibits activities related to counterfeit medicines. The document also discusses the local incidence of counterfeiting, particularly popular medicines, lifestyle medicines, and patented medicines. It describes the FDA's product verification process for suspected counterfeit medicines, which involves collection, evaluation including physical checks and laboratory analysis, and potential enforcement action. The goal is to increase awareness of counterfeit drugs through a national consciousness week.

1. Republic of the Philippines
Department of Health
Food and Drug Administration
Counterfeit Monitoring
Product Research and Standards Development Division
Center for Drug Regulation and Research

2. Presentation
Outline
• Counterfeit Medicines
• Current Legislation on Counterfeit
medicines
• Local incidence
• Product Verification Process
2

3. What are counterfeit drugs?
World Health Organization (SSFFC)
Substandard
Spurious
Falsely Labeled
Falsified and
Counterfeit Medical Products
3

4. What are counterfeit drugs?
It is a drug which is deliberately and
fraudulently mislabeled with respect
to identity and/or source.
(World Health Organization)
4

5. What are counterfeit drugs?
(World Health Organization)
5

6. What are counterfeit drugs?
correct ingredients
wrong ingredients
without active ingredients
insufficient ingredients
fake packaging
(World Health Organization)
6

7. Republic of the Philippines
Department of Health
Food and Drug Administration
Current Legislation on
Counterfeit medicines

8. Republic Act No. 8203
Special Law on Counterfeit Drugs
• Enacted on 06 September 1996
• Effective on 27 October 1996
Generally prohibits activities related to
the importation, manufacture, sale,
distribution or mere possession of
“counterfeit drugs”
8

9. Refers to medicinal products
correct ingredients but not in the amounts as
provided
wrong ingredients
without active ingredients
insufficient quantity of active ingredient
reduction of the drug’s safety, efficacy, quality,
strength or purity
Counterfeit drug/medicine
9

10. Counterfeit drug/medicine
Bearing without authorization
the trademark, trade name or
other identification mark or
imprint or any likeness to that
which is owned or registered in
the Bureau of Patent, Trademark
and Technology Transfer
(BPTTT) in the name of another
natural or juridical person
10

11. Counterfeit drug/medicine
refilled in containers
by unauthorized
persons if the
legitimate labels or
marks are used;
11

12. Counterfeit drug/medicine
an unregistered
imported drug product
(with registered
counterpart brand in the
Philippines)
EXCEPT drugs brought
in the country for
personal use as
confirmed and justified
by accompanying
medical records
12

13. a drug which contains no amount of or a different
active ingredient or less than eighty percent
(80%) of the active ingredient it purports to possess as
distinguished from an adulterated drug including
reduction or loss or efficacy due to expiration.
Counterfeit drug/medicine
13

14. Manufacture, sale, or offering for sale,
donation, distribution, trafficking,
brokering, exportation, or importation
Prohibited Acts
14

15. Possession of any such counterfeit drugs
Prohibited Acts
15

16. Forging, counterfeiting, simulating or
falsely representing, or without proper
authority, using any mark, stamp, tag,
label or other identification mark or
device authorized or required by
Republic Act No. 3720
Prohibited Acts
16

17. • Manufacturer, exporter or importer of the counterfeit drugs and their
agents
• The seller, distributor, trafficker, broker or donor and their agents
• The possessor of counterfeit drugs
• The manager, operator or lessee of the laboratory or laboratory
facilities
• The owner, proprietor, administrator or manager of the drugstore,
hospital pharmacy or dispensary, laboratory or other outlets or
premises
• The registered pharmacist of the outlet where the counterfeit drug is
sold or found, who sells or dispenses such drug to a third party and
who has actual or constructive knowledge that said drug is
counterfeit
Parties Liable
17

18. Any person may file a complaint
IRR of 8203
RULE IV: PROCEDURE IN THE FILING OF
ADMINISTRATIVE COMPLAINT
Filing Of Administrative
Complaint
18

19. Filing Of Administrative
Complaint
Brand owner
Affidavit of complaint
Consumer
19
Letter of complaint
Submitted together with samples

20. Letter of complaint
–Name of product
–Source or the name and address of the
person from whom the product was
acquired
–Mode of acquisition
–Reason or fact giving rise to the suspicion
Filing of Administrative Complaint
20

21. Republic of the Philippines
Department of Health
Food and Drug Administration
Local Incidence

22. Commonly counterfeited
• Popular medicines with high demand
– Antihypertensive, Antibiotics
Local incidence
22

23. 23
Local incidence
• Lifestyle medicines
- slimming products
- products for erectile dysfunction containing ingredients
present in Viagra or Cialis

24. • Patented medicines
Local incidence
24

25. • Leading branded-generic medicines in the market
Local incidence
25

26. 26
Unregistered Drugs

28. • Licensing requirements for drug establishments
• Post market surveillance and enforcement
• Internal Collaboration (CDRR, RFO, CHDs, LSSC, REU)
• In-house lab testing of drug products
Strategies in place
28

29. • Collaboration with local enforcement agencies
(PNP/NBI/CIDG)
• Collaboration with stakeholders/companies
• International collaboration (ASEAN, WHO, Interpol)
• Consumer advisories to increase public awareness
Strategies in place
29

30. • Active Surveillance
– Stimulated reporting (Enforcement agencies)
– Data gathering (FDA Routine PMS)
• Passive Surveillance
– Consumer/Stakeholders Complaints
Source of Reports for Suspected
Counterfeit Drug Products
30

31. Republic of the Philippines
Department of Health
Food and Drug Administration
Verification of Suspected
Counterfeit Products

32. Suspected Counterfeit
Products
32
1
• Collection/Receipt
2
• Evaluation
3
• Enforcement Action

33. Sources:
• FROO, CHDs
• PNP/NBI
• Reports from Concerned Citizen
• Reports from company
• Central Laboratory
33
1
•Collection/Receipt of Report
Referral Letter + Sample

34. What are the necessary information?
• Information on Samples :
– Name
– No. of samples submitted
– Batch No./ Lot No.
– Manufacturer/Distributor
– Date of Manufacture
– Expiry date
Submission of Reports
34

35. What are the necessary information?
• Name of Source
• Location/Address
• Sales invoice/Official documents
• If available
– Date of sampling
– Requesting Officer
Submission of Reports
35

36. Center for Drug Regulation and Research
36
2 •Evaluation

37. References
– Republic Act 8203
– Administrative Order No. 55 s. 1988
– Department Circular No. 2011 – 0101
– Product Dossier
Evaluation of Suspected
Counterfeit Product
37

38. Evaluation of Suspected
Counterfeit Product
38
Referral Letter + Sample
Validate the information
Physical Evaluation
Can
conclude?
Certification
Verify from MAH
Laboratory AnalysisYes
No

39. Section 3 of the IRR of RA 8203
The Center [Regulation Division I] may also require the registered brand-owner of the
suspected counterfeit drug to certify whether or not the suspected drug product has
been manufactured, imported and/or distributed by them; or whether they own the
Lot Number and Expiry Date of the same suspected drug product. The certification
issued by the registered brand-owner shall be supported by the batch, production
and distribution records. However, the brand-owner's certification shall be validated
for evidentiary purpose.
Evaluation of Suspected
Counterfeit Product
39
Verify from MAH

40. Evaluation Results
• Unregistered drug product
• Unregistered with registered
counterpart brand
• Counterfeit drug product
40
2 •Evaluation

41. Evaluation Results
• Registered and compliant to approved
label/ labeling requirements
• Registered but non-compliant to approved
label/ labeling requirements
• Out of specifications
41
2 •Evaluation

42. Most common signs that a medicine is unregistered:
purchased in an
unlicensed
outlet/establishment
and was not issued
with an official
receipt

43. no name and address
of any drug
establishment licensed
in the Philippines
no drug registration
number
foreign markings

44. Basis:
• Republic Act No. 3720: Food, Drug, and
Cosmetic Act
• Administrative Order No. 55 s. 1988
• Bureau Circular No. 05 s. 1997
Generic Labeling Exemption

45. Grounds:
• Administrative Order No. 55 s. 1988
– Primary pack is enclosed in transparent covering
and the particulars are clearly visible
– Compounded by a pharmacist
– Investigational Products
– Donated Products
Generic Labeling Exemption

46. Grounds:
• Bureau Circular No. 05 s. 1997
– Service item
– Specially packed
– Low volume of importation
• < 500 units/ month or 6000 units/ yr
– Drug product requires special handling
Generic Labeling Exemption

47. 47

48. 48

49. 49

50. 50

51. • Appropriate Administrative Sanctions
• Closure of Case
FROO - RFO
REU
LSSC
51
3
•Enforcement Action

52. Republic of the Philippines
Department of Health
Food and Drug Administration
National Consciousness Week
Against
Counterfeit Medicines
16 – 20 November 2015
Presidential Proclamation No. 2082 dated 15 June 2010

53. Republic of the Philippines
Department of Health
Food and Drug Administration
Mamamayan Makialam,
Pekeng Gamot Labanan.

54. Republic of the Philippines
Department of Health
Food and Drug Administration
Thank you!