MODULE NINE

GLOBAL THREAT OF COUNTERFEIT MEDICINES

Williams, F. E. and Olurinola, P. F.
Faculty of Pharmaceutical Sciences, University of Ilorin, Ilorin, Nigeria

Introduction
Drug is the single chemical substance that forms the active ingredient of medicine, active
pharmaceutical ingredient (API) that produces a pharmacological activity. The term
“medicines” is used instead of “drugs” to describe pharmaceutical preparations used in
clinical health care practice. There are many definitions of counterfeit drugs. Example, a
counterfeit drug is a medicinal product with correct ingredients but not in the amounts as
provided, wrong ingredients, without active ingredients, with insufficient quantity of active
ingredients, which results in the reduction of the drug's safety, efficacy, quality, strength or
purity.

Learning Outcomes
By the end of this module, you should be able to:
(i) give a definition drug;
(ii) understand a global perspective of counterfeit medicines;
(iii) describe the magnitude of the burden of counterfeit medicines;
(iv) list factors that encourage counterfeiting of medicines;
(v) discuss the implications of counterfeit medicines; and
(vi) list and explain anti-counterfeit measures in the Pharmaceutical
industries
Main Body
Introduction
This module focuses on the threats of counterfeit drug to man. There are two units in this
module:
Unit 1: Drugs and Counterfeit Drugs
Unit 2: Implications of Counterfeit Drugs and Anti-Counterfeit Measures
Unit 1: Drugs and Counterfeit Drugs
Contents
1.0 Introduction
2.0 Learning Outcomes
3.0 Main Contents
3.1 Definition of counterfeit medicine
3. 2 Magnitude of the Burden
4.0 Summary
5.0 Self-Assessment Questions
6.0 Tutor Marked Assessment
7.0 Further Reading

1.0 Introduction
Drug is a substance used to modify physiological or pathological states for the benefit of the
recipient. It is the single chemical substance that forms the active ingredient of medicine,
active pharmaceutical ingredient (API) that produces a pharmacological activity. Also, drug
is any substance or mixture of substances manufactured, sold or advertised for use by man or
animal for the purposes of diagnosis, treatment, mitigation or prevention of any disease or
disorder abnormal physical state or symptoms thereof Restoration, correction or modification
of organic functions, disinfection, the control of vermin, insects, pests or contraception
(Pharmacists Council of Nigeria [PCN], 2009a).
The term “medicines” is used instead of “drugs” to describe pharmaceutical preparations used
in clinical health care practice (World Health Organization [WHO], 2002). Also, the non-
native English speakers frequently associate the word “drugs” with narcotic or illicit
substances (hard drugs).

2.0 Learning Outcomes

At the end of this unit, you should be to:
i. give a definition drug;
ii. explain a global perspective of counterfeit medicines; and
iii. describe the magnitude of the burden of counterfeit medicines

3.0 Main Content

3.1 Definition of counterfeit medicine
According to World Health Organization (WHO, 2003a), a counterfeit medicine (CM) is one
which is deliberately and fraudulently mislabeled with respect to identity and/or source
(WHO, 2003a). The term counterfeiting can apply to both branded and generic products. CM
may include products with the correct ingredients or with the wrong ingredients, without
active ingredients, with insufficient active ingredients or fake packaging. CM involves a
deliberate or intentional attempt to deceive (WHO, 2003a).
However WHO Member States have slight variations of the definition of counterfeit
medicines. For instance,
1. United States (U.S.) Federal Food, Drug & Cosmetics Act defines CM as a drug
which, or the containers or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or any likeness thereof,
of a drug manufacturer, processor, packer, or distributor other than the person or
persons who in fact manufactured, processed, packed, or distributed such drugs,
thereby, falsely purports or is represented to be the product of, or to have been
packed or distributed by, such other drug manufacturer, processor, packer, or
distributor (WHO, 2003a).
2. Pakistan Manual of Drug Laws defines CM as а drug, the label or outer packing of
which is an imitation of, resembles or so resembles as to be calculated to deceive,
the label or outer packing of а drug manufacture (WHO, 2003a).
3. Philippines Republic Act No. 82036 defines CM as medicinal products
with correct ingredients but not in the amounts as provided, wrong ingredients,
without active ingredients, with insufficient quantity of active ingredients, which
results in the reduction of the drug's safety, efficacy, quality, strength or purity.
The CM is deliberately and fraudulently mislabeled with respect to identity and/or
source or with fake packaging, and is can applicable to both branded and generic
products (WHO, 2003a).
4. Nigerian Counterfeit and Fake Drugs and Unwholesome Processed Foods
(Miscellaneous Provisions) Decree, defined fake drug as “any drug product which
is not what it purports to be; or any drug or drug product which is so colored,
coated, powdered or polished that the damage is concealed or which is made to
appear to be better or of greater therapeutic value than it really is, which is not
labeled in the prescribed manner or which label or container or anything
accompanying the drug bears any statement, design, or device which makes а
false claim for the drug or which is false or misleading; or any drug or drug
product whose container is so made, formed or filled as to be misleading; or any
drug product whose label does not bear adequate directions for use and such
adequate warning against use in those pathological conditions or by children
where its use may be dangerous to health or against unsafe dosage or methods or
duration of use; or any drug product which is not registered by NAFDAC in
accordance with the provisions of the Food, Drugs and Related Products
(Registration, etc.) Decree 1993, as amended (WHO, 2003a)."
Moreover, International Pharmaceutical Federation (FIP) in collaboration with
Commonwealth Pharmaceutical Association (CPA) defined CM as medicinal
products which have been deliberately and fraudulently mislabeled with respect to
identity and/or source (International Pharmaceutical Federation [FIP], 2011).
Thus, CMs include products with correct ingredients, wrong ingredients, no active
pharmaceutical ingredient (API) or fake labeling, substandard product with correct
labeling. Other terminologies such as Substandard Medicines and Adulterated
Medicines also come under counterfeiting of medicines.
Substandard Medicines (SMs) are genuine medicines also referred to as out-
of- standard (OOS) products (WHO, 2006a), but they do not meet quality
specifications set for them (WHO, 2006a, WHO, 2003a). SMs is a term used to
describe the quality status of genuine medicines. Legitimate manufacturers adhere to
official specifications laid down by official Pharmacopoeias: British Pharmacopoeia
(BP), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) for the
production of their products. Thus, SMs fail to meet the pharmacopoeia specifications
used for its formulation with regards composition and ingredients
Adulterated Medicines (AMs) are medicines in which the methods used in, or the
facilities or controls used for its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity with current Good
Manufacturing Practice (cGMP) to assure that such medicines meet the requirements
of the Food and Drugs Act as to the safety (United States Code [U.S.C.], 2010). Such
medicines do not have the identity, strength, quality and purity characteristics which
they purport to be or are represented to possess (Swaminath, 2008). AMs purport to
be or are represented as medicines whose names are recognized in an official
compendium, but have strength differing from the standard set forth in such
 compendium. In addition, they have quality or purity that fall below the standard set
forth in such compendium. AMs consist in whole or in part any filthy, putrid or
decomposed substance, or any medicine that has been prepared, packaged or stored
under unsanitary conditions where it may have been contaminated with filth thereby
rendering it injurious to health. An AM is also any medicine that is packed in a
container which is composed in whole or in part of any injurious or deleterious
substance which may render the content injurious to health. Any medicine which
bears or contains for the purposes of colouring, any colour other than one which is
prescribed, or contains any harmful or toxic substance which may render it injurious
to health, or has been mixed with some other substance so as to reduce its quality or
strength is also AM (Swaminath, 2008).
Thus, CMs include products with correct ingredients, wrong ingredients, no active
pharmaceutical ingredient (API) or fake packaging and labeling, substandard and
adulterated products with correct labeling. These can be illustrated “mathematically”
as shown below:
❖ Fake packing and/or labeling + correct quantity of correct ingredient =
counterfeit medicine.
❖ Fake packing and/or labeling + incorrect quantity of correct ingredient =
counterfeit medicine.
❖ Fake packing and/or labeling + no active ingredient = counterfeit medicine.
❖ Fake packing and/or labeling + wrong ingredient = counterfeit medicine.
❖ Genuine packing and/or labeling + incorrect quantity of correct ingredient
(deliberate) = counterfeit medicine.
❖ Genuine packing and/or labeling + no active ingredient (deliberate) = counterfeit
medicine.
❖ Genuine packing and/or labeling + wrong ingredient (deliberate) = counterfeit
medicine.
❖ Genuine packing and/or labeling + incorrect quantity of correct ingredient (not
deliberate) = substandard medicine.
❖ Genuine packing and/or labeling + unsanitary processing (Bad Manufacturing
Practice) = adulterated medicine.
❖ Genuine packing and/or labeling + unsanitary facility for processing (Bad
Manufacturing Practice) = adulterated medicine.
❖ Unsanitary packing and/or labeling + unsanitary facility and processing (Bad
Manufacturing Practice) = adulterated medicine.
❖ Genuine packing and/or labeling + correct quantity of correct ingredient +
sanitary facility and processing (cGMP ) = genuine medicine.

3.2 Magnitude of the Burden

Menace of counterfeit medicines is recognized internationally. It exists in developed and
developing countries. However, the true extent of the problem is not known due to lack of
global studies. Appearance of CMs in International commerce was first mentioned as
problem at WHO Conference of Experts on rational Drug Use in Nairobi, Kenya 1985
(WHO, 2003a). It has assumed greater importance due to globalization. Globally, it is one of
the fastest growing grey economies after prostitution, narcotics, terrorism and arm trade
(Swaminath, 2008). According to WHO estimates, CMs are up to 10% of pharmaceutical
trade of which 25% is consumed in developing countries. Also, the US based Centre for
Medicines in the Public Interest predicted that, counterfeit drug sales will reach USS 75
billion globally in 2010, which is a 90% increase from 2005 (WHO, 2006b).
 Reports of 771 cases of substandard medicines were entered into the WHO
database on counterfeits in April 1999, of which, 77% were from developing
countries. Analysis of the data showed that 60% of the 325 cases had no an active
ingredient in the product (WHO, 2003b). Another study in The Lancet concluded that
up to 40% of artesunate products (anti-malarial medicines) contain no active
ingredients which result in no therapeutic benefits (WHO, 2003b). Also,
GlaxoSmithKline in the United States discovered counterfeiting of medicines used for
HIV/AIDS treatment in 2002 in which bottles containing Ziagen® (abacavir sulphate)
were mislabeled Combivir® (WHO, 2003b). Since both medicines are part of
combination therapies for HIV/AIDS, there is potential life threatening adverse drug
reactions and toxicity.
There were 46 confidential reports relating to counterfeit medicines from 20
countries that were received by WHO between January 1990-Oct 2000 of which
about 60 % are from developing countries while 40 % from industrialized countries
(WHO, 2003b). However, Chakravarty et al (as cited in Gautam et al, 2009) stated
that vast majority of CMs are thought to be produced in China, India and Russia,
though significant numbers of illegal factories have been reported in Nigeria and
Philippines. Fake medicines are estimated to represent 13-30 % of pharmaceutical
market in India and about 75 % cases of CMs originate from India being a major
exporter of CMs to developing countries including ARVs (Chakravarty et al as cited
in Gautam et al, 2009).
In 2006, Peru’s counterfeit drug sales have risen from an estimate of US$ 40
million in 2002 to US$ 66 million while Russia’s Federal Service for Health Sphere
Supervision reported that 10 % of all drugs on the Russian market were counterfeit
(WHO, 2006b). According to WHO report of CMs for 2005, 50 % of the pharmacies
in Dominican Republic operated illegally while 10% of the medicines that arrived in
the country were fake and the commercialization of counterfeit medicines generated
economic losses of around $40 million to the pharmaceutical industry of El Salvador.
In addition, counterfeit pharmaceutical products account for approximately $130
million annual sales in Kenya while pirated drugs constituted 25 % of Indonesia’s $2
billion pharmaceutical market (WHO, 2006b). The WHO reports of CMs for 2004
shows that approximately 70 % of medicines used by the Angolan population were
forgeries; an estimate of US$60 million or 5 % of the total annual market of
medicines sold in Colombia were contraband, counterfeit or adulterated; 35 % of
pharmaceuticals available in the Lebanese market were counterfeit while illegal
products represented about 10 % of the pharmaceutical market in Mexico (WHO,
2006b). WHO reports of CMs for 2003 showed that 30 % of drug store outlets visited
by food and drug deregulation officers carry and sell counterfeit drugs. Also, WHO
reports of CMs for 2002 revealed that 13 % of the drugs on Cambodia domestic
market were counterfeit or substandard; an estimation of about 8 % of over-the-
counter drugs sold in China are counterfeit; an estimated illegal drugs growth in India
was estimated to be from 10 % to 20 % of the total market while the countries’
pharmaceutical companies claimed a loss in revenue of between 4 % and 5 %
annually.
In Nigeria, the era 1985 to 2000 heralded the regime of counterfeiting of products
medicines inclusive (Akinyandenu, 2013; Erhun et al, 2001). Furthermore, an
estimate of 70 % of drugs in circulation in Nigeria was either fake or adulterated in
2002 while 48 % of goods and drugs imported into the country in 2004 were
substandard or counterfeit (WHO, 2006b).
 Internet-based sales of pharmaceuticals are a major source of counterfeit
medicines (WHO, 2006b). Pre-requisite for legally operated Internet pharmacies
include government licensed facilities and dispensing of medication on presentation
of a valid patient prescription. However, WHO reports showed that illegal Internet
pharmacies are operated internationally, sell products that have an unknown or vague
origin and sell medications without prescriptions (WHO, 2006b).
The death casualties due to CMs are enormous. In Nigeria, 109 children died
after the use of paracetamol syrup in 1990 (Bonati, 2009) while 14 children died after
the administration of chloroquine phosphate injection in 1994 (Aluko, 1994). Also,
Nigerian supply of 88,000 Pasteur Merieux and SmithKline Beecham meningitis
vaccines to Niger in 1995 resulted in about 2,500 deaths after vaccination
(Akinandenu, 2013) while 84 children were reported dead between late 2008 and
early 2009 due to diethylene glycol-contaminated My Pikin Baby Teething Mixture
(Bate et al, 2009). Also, there were cases of counterfeit artesunate-amodiaquine
(Ehianeta et al, 2012). The battle against counterfeit medicines in Nigeria led to the
promulgation of the Counterfeit and Fake Drugs and Unwholesome Processed Foods
(Miscellaneous Provisions) Act No.25 of 1999 which makes provision for the
prohibition of sale and distribution of counterfeit, adulterated, banned, fake,
substandard or expired drugs (PCN, 2009b). In addition, the promulgation of
National Agency for Food and Drug Administration and Control (NAFDAC) Decree
No. 15 of 1993 led to the establishment of NAFDAC with the mandate: to regulate
and control quality standards for foods, drugs, cosmetics, Medical devices, chemicals,
detergents and packed water imported, manufactured locally and distributed in
Nigeria. The Federal task force on Counterfeit and Fake Drugs and Unwholesome
Processed Foods (Miscellaneous Provisions) Act operates within NAFDAC
Other CMs casualties include 89 people died in Haiti after using cough syrup
containing di-ethylene glycol 1995 (WHO, 2006b) and 30 people died in Cambodia
after taking counterfeit antimalarial medicine in 1999 (WHO, 2006b). Furthermore,
38% of 104 antimalarial drugs for sale in pharmacies in Southeast Asia did not
contain any active ingredients, causing a number of preventable deaths from the
disease according to a study in 2001 (WHO, 2006b). In 2004, a trail of death was
caused by fake medicine (WHO, 2006b).
All kinds of medicines have been counterfeited which include antibiotics,
hormones, analgesics, steroids, and antihistamines. These drugs form almost 60 % of
the products reported. In terms of types of counterfeits and their magnitude, the
products reported can be grouped into six categories (WHO, 2003a):
• Products without active ingredients, 32.1 %;
• Products with incorrect quantities of active ingredients, 20.2 %;
• Products with wrong ingredients, 21.4 %,
• Products with correct quantities of active ingredients but with fake packaging, 15.6
%;
• Copies of an original product, 1 %; and
• Products with high levels of impurities and contaminants, 8.5 %.
Specific examples of counterfeiting showing country of origin, the year and the type of
counterfeiting are as shown in the table below (WHO, 2012):
SFFC medicine Country/Year Report
1. Avastin (for cancer United States of Affected 19 medical practices in the USA.
treatment) America, 2012 The drug lacked active ingredient
2. Viagra and Cialis (for United Kingdom, Smuggled into the UK. Contained undeclared
 SFFC medicine Country/Year Report
erectile dysfunction) 2012 active ingredients with possible serious health
risks to the consumer
3.Truvada and Viread (for United Kingdom, Seized before reaching patients. Diverted
HIV/AIDS) 2011 authentic product in falsified packaging
4. Zidolam-N (for Nearly 3 000 patients affected by falsified
Kenya, 2011
HIV/AIDS) batch of their antiretroviral therapy
Smuggled into the USA. Contained
5. Alli (weight-loss United States of
undeclared active ingredients with possible
medicines) America, 2010
serious health risks to the consumer
6. Anti-diabetic traditional Contained six times the normal dose of
medicine (used to lower China, 2009 glibenclamide. Two people died, nine people
blood sugar) were hospitalized
United Republic of Discovered in 40 pharmacies. The drug
7. Metakelfin (antimalarial)
Tanzania, 2009 lacked sufficient active ingredient

4.0 Summery
In this unit, you have learnt that a counterfeit medicine (CM) is one which is deliberately and
fraudulently mislabeled with respect to identity and/or source. Pakistan Manual of Drug Laws
defines CM as а drug, the label or outer packing of which is an imitation of, resembles or so
resembles as to be calculated to deceive, the label or outer packing of а drug manufacture as
well as the magnitude of the effects of counterfeit medicine.

5.0 Self-Assessment
I. Define Drug
II. Give 3 definitions of counterfeit medicine
III. Give brief description of the magnitude of counterfeit medicine

6.0 Tutor Marked

I. Give global description of counterfeit drug
II. Give Specific examples of counterfeit drug, showing country of origin, the year and
the type of counterfeiting

7.0 References
Akinyandenu, O. (2013). Counterfeit drugs in Nigeria: A threat to public
health. African Journal of Pharmacy and Pharmacology, 7(36), 2571-2576.
Alubo, S. O. (1994). Death for sale: a study of drug poisoning and deaths in
Nigeria. Social Science & Medicine, 38(1), 97-103.
Bansal, D., Malla, S., Gudala, K., & Tiwari, P. (2013). Anti-counterfeit
technologies: a pharmaceutical industry perspective. Scientia Pharmaceutica, 81 (1),
1-13.
Bate, R., Ayodele, T., Tren, R., Hess, K., & Sotola, O. (2009). Drug use in
Nigeria. Retrieved from
http://www.ippanigeria.org/nigeria_drug_project_august2009.pdf.
Accessed 5/5/2014.
Bonati, M. (2009). Once again, the children are the main victims of fake
drugs. Archives of Disease in Childhood, 94(6), 468.
 Burci, G. L. (2013). Public health and counterfeit medicines: the role of the
World Health Organization. Insights, 17(2).
Dukes, M. N. G., Quick, J. D. (1997).Managing Drug Supply: Toward Sustainable
Supply and Rational use of Drugs. In Quick, J. A., Rankin, J. R., Laing R. O,
O’connor, R.W., Hogerzeil, H. V., Dukes, M. N. G., & Garnett, A. (Eds.). Managing
Drug Supply (2nd ed., pp.3-16). United States of America:Kumarin Press.
Ehianeta, T., Williams, B., Sukurak, J., Mohammed, N. Anyankora, C. (2012).
Quality survey of some brands of artesunate-amodiaquine in Lagos drug market.
African Journal of Pharmacy and Pharmacology, 6(9), 636-642.
Erhun, W. O., Babalola, O. O., & Erhun, M. O. (2001). Drug Regulation and
Control in Nigeria: The challenge of Counterfeit Drugs. Journal of Health &
Population in Developing Countries, 4(2), 23-34.
Finlay, B.D. (2011). Counterfeit drugs and national security. Retrieved from
Gautam, C. S., Utreja, A., & Singal, G. L. (2009). Spurious and counterfeit drugs: a
growing industry in the developing world. Postgraduate Medical Journal 85, 251-
256.
http://www.stimson.org/images/uploads/research-pdfs/Full Counterfeit_Drugs_a
nd_Nationa l_ Security.pdf. Accessed on 5/5/2014.
International Pharmaceutical Federation. (2011). Counterfeit medicines. Retrieved
from
http://www.whpa.org/Counterfeit_Medicines_IPJ_Vol27_No2_CONGRESS.pdf.
Accessed on 1/5/2014.
Pharmacists Council of Nigeria. (2009a). The 4-Part Compendium of the
Minimum Standard of the Assurance of Pharmaceutical Care in Nigeria (2nd ed.).
Ibadan: ARK Ventures.
Pharmacists Council of Nigeria. (2009b). Ta A compilation of Pharmacy Laws,
Drugs and Related Laws and Rules in Nigeria, 1935-2000 (2nd ed.). Abuja:Clear
Impression Limited.
Sharma, Y. (2011, March 30). Fighting fake drugs with high-tech solution.
Science and Development Network. Retrieved form
http://www.scidev.net/en/health/detecting-counterfeit-drugs/features/fighting-fake-
drugs-with-high-tech-solutions-1.html. Accessed on4/4 2011.
Swaminath, G. (2008). Faking it – I The Menace of Counterfeit Drugs. Indian
Journal of Psychiatry, 50, 238-240.
West, D. (2009). Purchasing and inventory management. In M. Weitz & K. J.
Davis (Eds.), Pharmacy management: essentials for all practice settings (2nd ed., pp.
383-399). United States of America: The McGraw-Hill Companies Inc.
United States Code. (2010). Adulterated drugs and devices. Retrieved from
http://www.law.cornell.edu/uscode/text/21/351. Accessed on 3/5/2014.
World Health Organization. (2002). The selection and use of essential medicines.
Retrieved from http://apps.who.int/medicinedocs/pdf/s4875e/s4875e.pdf. Accessed on
3/2/2014.
World Health Organization. (2003a). General information on counterfeit.
Retrieved from
http://www.who.int/medicines/services/counterfeit/overview/en/index1.html.
Accessed on 5/5/2014.
World Health Organization. (2003b). Substandard and counterfeit medicines.
Retrieved from http://www.who.int/mediacentre/factsheets/2003/fs275/en/. Accessed
on 5/5/2014
 World Health Organization. (2006a). What are sub-standard medicines?
Retrieved from http://www.who.int/medicines/services/counterfeit/faqs/06/en/.
Accessed on 6/5/2014.
World Health Organization. (2006b). Counterfeit medicines. Retrieved from
http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/index1.html.
Accessed on 6/5/2014.
World Health Organization. (2012). Medicines: spurious/falsely-
labeled/falsified/counterfeit (SFFC) medicines. Retrieved from
http://www.who.int/mediacentre/factsheets/fs275/en/. Accessed on 5/5/2014.
Unit 2: Implications of Counterfeit Drugs and Anti-Counterfeit Measures
Contents
1.0 Introduction
2.0 Learning Outcomes
3.0 Main Contents
3.1 Factors Encouraging Counterfeiting Of Medicines
3.2 Implications of Counterfeit Medicines
3.3 Anti-Counterfeit Measures In Pharmaceutical Industry
3.4 Authentication of a Pharmaceutical Product using Analytical Methods
3.5 Recommendations for Combating Counterfeit Medicines
4.0 Summary
5.0 Self-Assessment Questions
6.0 Tutor Marked Assessment
7.0 Further Reading

1.0 Introduction
Counterfeit Medicine is a drug with containers or labeling of which, without authorization,
bears the trademark, trade name, or other identifying mark, imprint, or any likeness thereof,
of a drug manufacturer, processor, packer, or distributor other than the person or persons who
in fact manufactured, processed, packed, or distributed such drugs, thereby, falsely purports
or is represented to be the product of, or to have been packed or distributed by, such other
drug manufacturer, processor, packer, or distributor. This you focus on the implications of
these counterfeit drugs and the measures that can be taken against them

2.0 Learning Outcomes

At the end of this module, you should be to:
i. list factors that encourage counterfeiting of medicines;
ii. discuss the implications of counterfeit medicines; and
iii. list and explain anti-counterfeit measures in the Pharmaceutical industries

3.0 Main Content

3.1 Factors Encouraging Counterfeiting of Medicines
There are different factors encouraging counterfeit medicines in our environment. Some of
these factors are:
1 Lack of or weak enforcement of existing laws on the quality, safety and efficacy of
both imported and locally manufactured medicines encourage counterfeiting.
Offenders are not afraid of arrest and prosecution (WHO, 2003a)
2. Weak penal actions encourage medicine counterfeiting since there is no fear of being
apprehended and prosecuted. This is especially so when there are more severe
penalties for counterfeiting non-medicinal products (WHO, 2003a).
3. Absence of or weak drug regulation encourages counterfeiting of medicines. The
unique role of medicines require that they be safe, effective and of good quality in
order to produce the desired therapeutic effect. To ensure these properties, it is
necessary to create a competent national drug regulatory authority with the necessary
human and other resources so that the manufacture, importation, distribution and sale
of medicines can be adequately regulated (WHO, 2003a).
4. Corruption and conflict of interest adversely affect enforcement of laws prohibiting
counterfeiting of medicines (WHO, 2003a).
 5. High remunerative trade also encourages counterfeiting of medicine. Low cost of
manufacture of counterfeit medicines coupled with high demand for medicines result
in significantly high profits (WHO, 2006b).
6. Lack of cooperation between stakeholders results in counterfeiters escaping detection,
arrest, prosecution, and conviction. Also, failure of pharmaceutical manufacturers,
wholesalers, retailers and the public to report to national drug regulatory authorities
contribute to the flourishing of the menace (WHO, 2003a).
7. Lack of control by exporting countries and within free trade zones results in
flourishing of counterfeit medicines. Many exporting countries do not regulate export
pharmaceutical products to the same standard as those for domestic use.
Pharmaceutical products are sometimes exported through free trade zones where drug
regulation is lax, giving room for repacking and relabeling (WHO 2012).
8. Availability/accessibility of advanced technology encourage counterfeiting. A study
in The Lancet showed that counterfeiters' ability to reproduce holograms and other
sophisticated printing techniques had dramatically improved between 2001 and 2005,
making detection even more difficult (WHO 2006b).
9. Poverty sustains counterfeiting. Paying for medicines constitute major recurrent
public health expenditures (second to salaries) and also account for over half of all
private health expenditures (Dukes, 1997). Some people seek medicines that are sold
more cheaply. These are often available from non-regulated outlets, where the
incidence of counterfeit medicines is likely to be higher.
10. Low-availability of testing facilities makes detection of counterfeit medicines
difficult. Thus, offenders are emboldened to perpetuate counterfeiting.

3.2 Implications of Counterfeit Medicines

The followings are the implications of counterfeit medicines:
1. Public Health Crisis
Counterfeit medicines pose a serious public health threat. This is because their content
could be dangerous due to contamination, inadequate or no active ingredient resulting
in treatment failure. Ineffective treatment can lead to a complex series of woes
(WHO, 2012) such as:
I. drug resistance
II. obsolescence of cheap effective drugs as in the case of anti-malarial medicines
III. adverse drug reactions
IV. increased morbidity (illness)
V. mortality (death),
VI. decline in confidence in public health care systems and healthcare
professionals
VII. Loss of confidence of health care practitioners in the medications.
There are also cases of toxicity associated with counterfeit medicines which also leads to the
complex series of woes as above.
The complexity of the health crisis due to counterfeit medicines can be best imagined and
appreciated with a consideration of the following counterfeit medicine case:
“After his first in-center dialysis in January 2008, Randy Hubley of Toledo, Ohio suffered
severe abdominal pain, diarrhea, and shortness of breath. Two days later, Randy collapsed
and did not regain consciousness. Investigations attributed his death to heparin, an
anticoagulant that treats blood clotting during kidney dialysis. According to reports, the
heparin used before his treatment was counterfeit—the drug was contaminated with
oversulfated chrondroitin sulfate, a compound that is structurally similar to heparin, rendering
detection of the false substance extremely difficult. Counterfeit heparin induces severe
allergic reactions; in 2008, the FDA documented 81 deaths and about 600 allergic reactions
linked to the tainted drug. Its origin was traced back to a production plant in Changzhou,
China, which also exports pharmaceuticals to Germany, Canada, France, Italy, and other
countries” (Finlay, 2011).
2. Threat to National and International Security
According to Finlay (2011), counterfeiting of medicines poses a threat to national and
international security. The profits accrued from this sinister crime are increasingly being co-
opted by an array of organized criminal and terrorist entities to fund their despicable
operation’s globally (Finlay, 2011).

3. Negative Economic Impact

Poor therapeutic outcomes also have economic implications. Huge finances are wasted as
result of microbial resistance, increased morbidity, hospital admission and long hospital stay,
poor quality life, loss of income/low productivity. The economic impact on part of the
consumer can be summarized by the slogan “Health is Wealth”. Huge wastage of resources
(money, man, minutes, material and information) of pharmaceutical manufacturers,
wholesalers and retailers due to product obsolescence (as a result of microbial resistance)
and product expiration (due to low/no product turnover) (West, 2009). Nationally, there is
loss of revenue since counterfeiters evade legitimate taxation (Finlay 2011).
4. Intellectual Property Rights
Counterfeiting of medicines also violates Intellectual Property (IP) Rights as a result of
unlawfully bearing a registered trademark in which case the victims of counterfeiting are the
trademark owners (Burci, 2013). The breach of IP may include patency and industrial design.

3.3 Anti-Counterfeit Measures in Pharmaceutical Industry

The common and familiar anti-counterfeit measures currently in use in Nigeria include:
1. Tamper-evident/tamper-resistant packing,
The product packing has an indicator or entry barrier which provides visible or audible
evidence to the consumers that the product has been tempered with, if breached or missing.
Examples include blister packs, tape seals, shrinkable seals, film wrappers and breakable caps
(Bansal et al, 2013).
2. Holograms:
There could be combination of three layered security features (Bansal et al, 2013):
a. Overt features,
b. Covert features such as micro-text, scrambled images UV-sensitive or
specialized.
c. This requires trained examiners and appropriate decoding equipment.
d. Serialization of hologram. Authentication is combined with traceability.
3. mPedigree:
This is a type of track and trace system. An offshore data centre tracks the codes which are
randomly generated by the pharmaceutical manufacturer. The medicine pack has a distinctive
panel that reveals a ten-digit code when scratched. This code is sent to a sent to a central
number through a short message service (SMS) and a response to the SMS is received. The
response indicates whether the medicine is genuine or counterfeit (Sharma, 2011).
In Nigeria, mPedigree has been incorporated into the national quality assurance standards for
pharmaceuticals by the Nigeria Government (Sharma, 2011). The practical steps involved in
the use of mPedigree in Nigeria are:
a. Scratch the distinctive panel (card) to reveal the PIN
b. Text PIN to 38353.
c. Wait for a response.
 Note: Text PIN only ONCE.

3.4 Authentication of a Pharmaceutical Product using Analytical Methods

Analytical methods such as chromatography (High Performance Liquid Chromatography
(HPLC), Gas Chromatography (GC) coupled with optical, electrochemical or mass detectors,
Thin-Layer Chromatography (TLC), Colorimetry, optical spectroscopy, and isotopic
characterization, Near Infra-Red (NIR) and Raman spectroscopies are used to authenticate
pharmaceutical products. Raman spectroscopy is an analytical technique which uses the
interaction between light and molecular bonds to characterize individual chemicals such that
each compound creates a unique fingerprint.
Currently in Nigeria, TruScan Handheld Raman Spectrometer is used by NAFDAC to detect
counterfeit medicines. TruScan identifies the slightest difference in the medicine formulation.
The user is alerted with a clear “pass” or “fail” reading within seconds of use.

3.5 Recommendations for Combating Counterfeit Medicines

1. There should be development of appropriate medicines policy options, legislation, and
enforcement strategies by each country at а national level. The policies should involve all
stakeholders.
2. The governments of each country should demonstrate political will/commitment for
evolving and implementing programs for combating counterfeit medicines.
Political will and commitment should be demonstrated by:
a. Enacting new drug laws or updating existing drug laws that prohibit
counterfeit medicines.
b. Establishing institutions for the regulation of medicines and clearly setting out
in the drug laws, the power, duties and responsibilities of the institution(s)
c. Training of personnel, including enforcement officers, for national drug
control.
d. Making available necessary financial and other resources.
e. Ensuring that the drug laws are enforced.
f. Continuous investment in technologies and strategies that detect counterfeit
medicines.
g. Fostering international cooperation in the control of pharmaceutical.
h. Entering into bilateral and multilateral agreements with other governments
and with international organizations such as World Health Organization
(WHO), Interpol and the World Customs Organization (WCO).
3. Judicial procedures and policies should reflect the seriousness of the problem and the
offence. There should speedy disposal of cases involving counterfeit medicines. Also severe
penal sanctions on convicted offenders should be imposed. Confiscation/forfeiture and
destruction of counterfeit medicines should be ordered by the courts.
4. Combating counterfeiting of medicines is а shared responsibility of all persons. Non-
Governmental Organizations (NGOs) and Community Based Organizations (CBOs) should
be provided with information and methods for counterfeit medicines detection, in order to
report cases to the national drug regulatory agencies.
5. Education and information campaigns about the menace of counterfeit medicines,
legitimate sources of genuine medicines and the need of patients to inform their prescriber
about treatment failure and ADRs should be directed at the general public.
6. Demonstration of greater cooperation between countries at sub-regional, regional and
international levels so that privatization and liberalization of the world economy and
extensive opening of borders to trade do not contribute to proliferation of counterfeit
medicines
 7. Internet pharmacy practice should also be regulated through licensure
8. International convention to control trade in counterfeit medicines should be organized
by WHO Member States.

4.0 Summary
CMs cause serious public health crisis and constitute major threat to National and
International Security. They create negative economic impact and violate Intellectual
Property Rights. It is a must to take positive actions today to combat CMs. We must not
forget: No action today, no solution tomorrow!

5.0 Self-Assessment Questions

i. List 4 factors that encourage counterfeiting of medicines
ii. Explain the effects of counterfeit medicines
iii. List and explain 5 anti-counterfeit measures in the Pharmaceutical industries

6.0 Tutor Marked Questions

I. List 5 political will and commitment that should be demonstrated by government
against drug counterfeit
II. Discuss the authentication of a pharmaceutical product using analytical Methods

7.0 Further Readings

Akinyandenu, O. (2013). Counterfeit drugs in Nigeria: A threat to public
health. African Journal of Pharmacy and Pharmacology, 7(36), 2571-2576.
Alubo, S. O. (1994). Death for sale: a study of drug poisoning and deaths in
Nigeria. Social Science & Medicine, 38(1), 97-103.
Bansal, D., Malla, S., Gudala, K., & Tiwari, P. (2013). Anti-counterfeit
technologies: a pharmaceutical industry perspective. Scientia Pharmaceutica, 81 (1),
1-13.
Bate, R., Ayodele, T., Tren, R., Hess, K., & Sotola, O. (2009). Drug use in
Nigeria. Retrieved from
http://www.ippanigeria.org/nigeria_drug_project_august2009.pdf.
Accessed 5/5/2014.
Bonati, M. (2009). Once again, the children are the main victims of fake
drugs. Archives of Disease in Childhood, 94(6), 468.
Burci, G. L. (2013). Public health and counterfeit medicines: the role of the
World Health Organization. Insights, 17(2).
Dukes, M. N. G., Quick, J. D. (1997).Managing Drug Supply: Toward Sustainable
Supply and Rational use of Drugs. In Quick, J. A., Rankin, J. R., Laing R. O,
O’connor, R.W., Hogerzeil, H. V., Dukes, M. N. G., & Garnett, A. (Eds.). Managing
Drug Supply (2nd ed., pp.3-16). United States of America:Kumarin Press.
Ehianeta, T., Williams, B., Sukurak, J., Mohammed, N. Anyankora, C. (2012).
Quality survey of some brands of artesunate-amodiaquine in Lagos drug market.
African Journal of Pharmacy and Pharmacology, 6(9), 636-642.
Erhun, W. O., Babalola, O. O., & Erhun, M. O. (2001). Drug Regulation and
Control in Nigeria: The challenge of Counterfeit Drugs. Journal of Health &
Population in Developing Countries, 4(2), 23-34.
Finlay, B.D. (2011). Counterfeit drugs and national security. Retrieved from
Gautam, C. S., Utreja, A., & Singal, G. L. (2009). Spurious and counterfeit drugs: a
growing industry in the developing world. Postgraduate Medical Journal 85, 251-
256.
http://www.stimson.org/images/uploads/research-pdfs/Full Counterfeit_Drugs_a
nd_Nationa l_ Security.pdf. Accessed on 5/5/2014.
International Pharmaceutical Federation. (2011). Counterfeit medicines. Retrieved
from
http://www.whpa.org/Counterfeit_Medicines_IPJ_Vol27_No2_CONGRESS.pdf.
Accessed on 1/5/2014.
Pharmacists Council of Nigeria. (2009a). The 4-Part Compendium of the
Minimum Standard of the Assurance of Pharmaceutical Care in Nigeria (2nd ed.).
Ibadan: ARK Ventures.
Pharmacists Council of Nigeria. (2009b). Ta A compilation of Pharmacy Laws,
Drugs and Related Laws and Rules in Nigeria, 1935-2000 (2nd ed.). Abuja:Clear
Impression Limited.
Sharma, Y. (2011, March 30). Fighting fake drugs with high-tech solution.
Science and Development Network. Retrieved form
http://www.scidev.net/en/health/detecting-counterfeit-drugs/features/fighting-fake-
drugs-with-high-tech-solutions-1.html. Accessed on4/4 2011.
Swaminath, G. (2008). Faking it – I The Menace of Counterfeit Drugs. Indian
Journal of Psychiatry, 50, 238-240.
West, D. (2009). Purchasing and inventory management. In M. Weitz & K. J.
Davis (Eds.), Pharmacy management: essentials for all practice settings (2nd ed., pp.
383-399). United States of America: The McGraw-Hill Companies Inc.
United States Code. (2010). Adulterated drugs and devices. Retrieved from
http://www.law.cornell.edu/uscode/text/21/351. Accessed on 3/5/2014.
World Health Organization. (2002). The selection and use of essential medicines.
Retrieved from http://apps.who.int/medicinedocs/pdf/s4875e/s4875e.pdf. Accessed on
3/2/2014.
World Health Organization. (2003a). General information on counterfeit.
Retrieved from
http://www.who.int/medicines/services/counterfeit/overview/en/index1.html.
Accessed on 5/5/2014.
World Health Organization. (2003b). Substandard and counterfeit medicines.
Retrieved from http://www.who.int/mediacentre/factsheets/2003/fs275/en/. Accessed
on 5/5/2014
World Health Organization. (2006a). What are sub-standard medicines?
Retrieved from http://www.who.int/medicines/services/counterfeit/faqs/06/en/.
Accessed on 6/5/2014.
World Health Organization. (2006b). Counterfeit medicines. Retrieved from
http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/index1.html.
Accessed on 6/5/2014.
World Health Organization. (2012). Medicines: spurious/falsely-
labeled/falsified/counterfeit (SFFC) medicines. Retrieved from
http://www.who.int/mediacentre/factsheets/fs275/en/. Accessed on 5/5/2014.