Republic of the Philippines

Department of Health
Food and Drug Administration

Counterfeit Monitoring

Neriza F. Funtanares
Pharmacist II
Product Research and Standards
Development Division
Center for Drug Regulation and Research

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 FDA’s Mandate

To ensure the safety, efficacy, purity and quality

of all health products through state-of-the-art
technology, as well as the scientific soundness
and truthfulness of product information for the
protection of public health.

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 R.A. No. 8203
Special Law on Counterfeit Drugs
• Enacted on 06 September 1996
• Effective on 27 October 1996

Policy Statement (Section 2)

“To safeguard the health of the people, the State
shall provide for their protection against
counterfeit drugs.”

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 Counterfeit drug/medicine

Refers to medicinal products with the correct

ingredients but not in the amounts as provided
hereunder, wrong ingredients, without active
ingredients, with sufficient quantity of active
ingredient, which results in the reduction of the
drug’s safety, efficacy, quality, strength or purity.

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 Counterfeit drug/medicine
• It is a drug which is deliberately and fraudulently
mislabeled with respect to identity and/or source
or with fake packaging, and can apply to both
branded and generic products.

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 Counterfeit drug/medicine
It shall also refer to:
1) the drug itself or the container or labeling
thereof or any part of such drug, container or
labeling 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;

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 Counterfeit drug/medicine
It shall also refer to:

2) a drug product refilled in containers by

unauthorized persons if the legitimate labels or
marks are used;

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 Counterfeit drug/medicine
It shall also refer to:

3) an unregistered imported drug product,

EXCEPT drugs brought in the country for personal
use as confirmed and justified by accompanying
medical records;

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 Counterfeit drug/medicine
It shall also refer to:

4) 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.

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Evaluation of Suspected Counterfeit
References
Products
– Republic Act 8203 (Subject: Special Law on
Counterfeit Drugs)
– Administrative Order No. 55 s. 1988 (Subject:
Requirements for Labeling Materials of
Pharmaceutical Products)
– Department Circular No. 2011 – 0101 (Subject:
The Rules and Regulations Implementing Republic
Act No. 9711 – The Food and Drug Administration
Act of 2009)
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Suspected Counterfeit Products

1
• Collection

2
• Evaluation

3
• Enforcement Action

CDRR, RFO, CHDs, LSSC

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 Submit suspected Samples for
Evaluation

1 •Collection

• Regional Field Office

• CHDs
• PNP/NBI
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 Gliclazide (Diamicron)80 mg Tablet

Has no barcode With barcode

Label code no.

is 021531131 Label code no.
is 021521131
Company
logo & name
are smaller & Authentic
finer Counterfeit
Company
logo & name
are bigger &
bolder

Font size are Font size are

smaller & bigger & bolder
finer
Rx symbol is
bigger &
Rx symbol is darker
smaller &
lighter

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 Gliclazide (Diamicron)80 mg Tablet

Blister is fine Blister is hard

Counterfeit

Authentic

Pores on the Pores on the

blister are blister are
bigger smaller

Shelf-life is 3
years based
Shelf-life is 5 from the date
years based of mfr &
from the date expiry date
of mfr &
expiry date
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 Evaluation of Suspected
Counterfeit Products

2 •Evaluation

Center for Drug Regulation and Research

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 • Evaluation of Suspected
2 Counterfeit Products

Referral Letter + Sample

What are the necessary

Validate the information
information?

What do we look for during

Physical Evaluation physical evaluation?

Verify from MAH

Can No
conclude?
Laboratory Analysis
Yes

Certification
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 • Evaluation of Suspected
2 Counterfeit Products

What are the necessary information?

• Name of Source
• Location/Address
• Date of sampling
• Requesting Officer
• Sales invoice/Official documents
• Information on Samples :
– Minimum info: Name, No. of samples submitted, Batch No.
– Additional Info: Manufacturer, Distributor, Date of
Manufacture/Expiry

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 • Evaluation of Suspected
2 Counterfeit Products

What do we look for during physical evaluation?

Verify the label for compliance to

Generic Labeling and GLE

Sample Verify the registration status

Compare with the approve sample

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 Comparison of some
Counterfeit with the authentic
drugs

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 Ascorbic Acid (Fern-C)500 mg Capsule

Font size is smaller but clearer

Authentic
Blister is
shiny, fine &
dotted

Counterfeit
Font size is
bigger

Blister is dull,
hard & with
diamond-shape
markings
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 Ascorbic Acid (Fern-C)500 mg Capsule

Blister is
Authentic plain
Counterfeit
With
pores on
the
blister

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 Ofloxacin (Inoflox)200 mg Tablet
Authentic
Company logo is bigger with distinct colors

Rx symbol is in between the cut off line

Counterfeit

Company logo is
smaller with
overlapped colors
Label is
perfectly
laminated Rx symbol is
above the cut off
line

Plastic label is loosely

detached from the foil
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 Trimetazidine (Vastarel)20 mg Tablet

Font color is dark

Font color is red red
Counterfeit
Authentic
Rx symbol is lighter
& is closer to the
Rx symbol is generic name
clear & has wider
gap with the
generic name Company name
& logo are
Company name bigger & bolder
& logo are
smaller &
Foil is dull &
lighter
coarse
Foil is glossy &
fine
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 • Evaluation of Suspected
2 Counterfeit Products

Evaluation Results :

1. Unregistered drug product

2. Registered and compliant to labeling requirements
3.Registered but not compliant to labeling requirements
4. Cannot conclude

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 • Evaluation of Suspected
2 Counterfeit Products

Evaluation Results :

1. Unregistered drug product

 Registration number not traceable

 Does not exist in the product registry

2. Registered and compliant to labeling requirements

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 • Evaluation of Suspected
2 Counterfeit Products

Evaluation Results :

3.Registered but not compliant to labeling requirements

• Will non-compliance affect the quality and safety of
the product?
– Incorrect generic name
– Incorrect dosage strenght
If Yes: Refer to Product Recall Committee and FROO for
Collection

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 • Evaluation of Suspected
2 Counterfeit Products

Evaluation Results :

4. Cannot conclude

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 Certification
• Generic Name • Importer/Distributor
• Brand name • Source
• Dosage • Address
strength/Formulation • Date of sampling
• Registration number • Requesting Party and
• Batch/Lot No. Address
• Date of Manufacture/Expiry • No of samples submitted
• Manufacturer • Product Description
• Evaluation
• Signatories

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Suspected Counterfeit Products

1
• Collection

2
• Evaluation

3
• Enforcement Action

CDRR, RFO, CHDs, LSSC

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 3
• Enforcement Action

• Appropriate Administrative sanctions

• Closure of Case

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