The effects of fake and expired drugs on Health
By
Dr. K. D. S. Bamitale
Department of Physiology and Pharmacology
Obafemi Awolowo University
Ile-Ife, Nigeria.
Introduction
Drugs are chemical substances with diverse pharmacological actions. They bring about
different changes when they interact with biological systems. They may cause contraction
of muscles, alterations of hormonal levels, and secretions from glands, modulation of
nervous activity and a host of other physiological changes in the body. Drug is the
generic name for any substance used for the prevention, diagnosis and treatment of
diagnosed diseases and also for the relieve of symptoms.
The word medicine is usually preferred for the therapeutic drugs to distinguish them from
the addictive drugs which are used illegally.
Over-the-counter medicine are drugs for alleviating unpleasant symptoms of self-limiting
illnesses, any remedy which does not require a medical prescription.
Drug problems in the Third world Countries:
Third world countries spend high percentage of their meagre foreign exchange earnings
on drugs usually imported from industrialized Western countries. Long term plans for the
prevention of so called tropical diseases are frequently frustrated by political instability,
natural disasters,mismanagement, illiteracy and underdeveloped economies. Most third
world countries are short of foreign exchange to buy drugs, so the quantity of drugs
imported is highly restricted. Consequently, a very high demand by rapidly expanding
populations put the price of most drugs beyond the reach of all but a rich few. The
whole issue of modern drugs in the third world countries can be considered as problems
of (1) quality assurance and drug availability, and (2) stability of drugs in the tropics. The
two problems are closely related. For if an unstable pharmaceutical preparation loses its
potency in hash tropical environment, the material is virtually unavailable, if not actually
harmful.
It is an arduous task to guarantee the quality of drugs being imported because of the lack
of requisite skill and expertise and even with quality drugs that has been standardised in
temperate zones to be stored at 25ºC still present problems with preservation in the
tropics due to unfavourable environmental temperature. This unfavourable temperature
conditions affect the shelve lives of these drugs thereby making them lose potency or
even make more toxic as they quickly expire. The quality assurance and good
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manufacturing practice in industrialized societies are designed for products to be used
mostly in temperate environments. Shelve lives are caliberated with maximum room
temperature of 25ºC in view. So even with high standards of manufacture, the quality of a
product cannot be guaranteed once it has been subjected to tropical conditions.
Stability of Drugs in Tropics:
One important aspect of drug problems in the tropics is the effect of weather on drugs.
Heat, light and high humidity cause drugs to deteroriate, so that unless proper storage
facilities are provided, many drugs may rapidly lose potency.
Expiry dates (shelve life) is that time period as determined by the manufacturer, during
which the product remains within its defined specifications. The expiry date is
determined after testing the drug potency under conditions which reflect those under
which the drug would be stored in patients home, hospital store,pharmacy store or shop
shelf. For imported drugs,these conditions are often vastly different in the country of
origin from those in the tropics. Few European and North American pharmacceutical
firms would ensure drug stability under conditions of light, temperature, humidity and
microbial contaminations encountered in tropics. The conditions are responsible for the
rapid deteroriation of drugs and toxicity.
When drugs deteroriate under the impact of harsh tropical conditions , not only do they
become worthless therapeutically, but also the products are also often toxic. It is thus
imperative in a tropical region to devote resources to the provision of facilities for proper
storage of drugs under conditions which minimize contamination and deteroriation in
order to enhance shelf-life, guarantee efficacy and prevent waste of resources and human
morbidity and mortality due to consumption of expired drugs. This can be ensured by the
help of government agensies like the Federal Ministry of Health and Human Services.
FAKE OR COUNTERFEIT DRUGS
A counterfeit drug or a counterfeit medicine is a medication which is produced and sold
with the intent to deceptively represent its origin, authenticity or effectiveness. The word
counterfeit connotes fake or things that are not genuine or original in nature. The
common street term for counterfeit drug in some society is "beat bag". A counterfeit
drug may be one which does not contain active ingredients, contains an insufficient
quantity of active ingredients, or contains entirely incorrect active ingredients (which
may or may not be harmful), and which is typically sold with inaccurate, incorrect, or
fake packaging. Fake medicines and generic drugs which are deliberately mislabeled in
order to deceive consumers are therefore counterfeit, while a drug which has not received
regulatory approval is not necessarily so.
Counterfeit medicines are part of the broader phenomenon of substandard
pharmaceuticals – medicines manufactured below established standards of quality and
therefore dangerous to patients’ health and ineffective for the treatment of diseases. The
difference is that counterfeits are deliberately and fraudulently mislabeled with respect to
identity or source. Counterfeiting occurs both with branded and generic products and
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counterfeit medicines may include products with the correct ingredients but fake
packaging, with the wrong ingredients, without active ingredients or with insufficient
active ingredients.
Counterfeit drugs as a global public health challenge
Counterfeit medicines represent an enormous public health challenge. Anyone, anywhere
in the world, can come across medicines seemingly packaged in the right way, in the
form of tablets or capsules that look right, but which do not contain the correct
ingredients and, in the worst case scenario, may be filled with highly toxic substances. In
some countries, this is a rare occurrence, in others like Nigeria, it is an everyday reality.
Counterfeit medicines range from random mixtures of harmful toxic substances to
inactive, useless preparations. Occasionally, there can be “high quality” fakes that do
contain the declared active ingredient. In all cases, contents of counterfeits are unreliable
because their source is unknown or vague and always illegal. Fake drugs can cause harm
to patients and sometimes lead to death.
Any kind of product can be and has been counterfeited: expensive lifestyle and anticancer medicines, antibiotics, medicines for hypertension and cholesterol lowering drugs,
hormones, steroids and inexpensive generic versions of simple pain killers and
antihistamines. In developing countries the most disturbing issue is the common
availability of counterfeited medicines for the treatment of life-threatening conditions
such as malaria, tuberculosis and HIV/AIDS.
Reports of counterfeit drugs world-wide
Trade in fake medicines is more prevalent in countries with weak drug regulation and
enforcement, scarcity or erratic supply of basic medicines, unregulated markets and
unaffordable prices. But as counterfeiting becomes more sophisticated, these products are
increasingly present even in better controlled markets.
In January 2006, the United States Food and Drug Administration (FDA) issued an alert about
fraudulent flu remedies, including counterfeit prescription oseltamivir (Tamiflu) medication. The
Dutch Healthcare Inspectorate warned consumers in early 2006 not to buy Tamiflu through the
Internet, after counterfeit capsules were found in the Netherlands containing lactose and vitamin C,
and no active substance. In the United Kingdom, officials seized 5 000 packets of counterfeit Tamiflu
in early 2006, estimated to be worth £500 000. A recent study in The Lancet concluded that up to 40%
of products labeled as containing artesunate (anti-malarial) contain no active ingredients and therefore
have no therapeutic benefits. That study showed that counterfeiters’ ability to reproduce holograms
and other sophisticated printing techniques had dramatically improved between 2001 and 2005,
making detection even more difficult. In Peru the sale of counterfeit drugs has risen from an estimated
US$ 40 million in 2002 to a current US$ 66 million, according to Peru’s Association of
Pharmaceutical Laboratories (ALAFARPE). These figures include medicines that entered the country
as contraband, expired, counterfeit, adulterated, with altered or missing labels and those stolen from
the warehouses of the Ministry of Health, the armed forces, and the police. In Lima alone the number
of illegal pharmacies devoted to counterfeit medicines has increased from an estimated 200 in 2002 to
a current number of 1 800 stores. The General Directorate of Medicines, Supplies and Drugs
(DIGEMID) of the Department of Health (MINSA) seized around 460 000 adulterated and expired
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medicines in 2005 alone. In 2006, Russia’s Federal Service for Health Sphere Supervision (FSHSS)
reported that 10% of all drugs on the Russian market were counterfeit. However, other sources
estimate that the real figure could be much higher.
In 2005
The Dominican Republic’s Public Health Department reported that 50% of the countries
pharmacies operated illegally and 10% of the medicines that arrived in the country were fake. For
example, some of the medicines found had expired over 10 years before. El Salvador’s
Association of Pharmaceutical Companies (INQUIFAR) reports that there is a widespread
availability of counterfeit drugs on the domestic market. According to the local manufacturer
Gamma Laboratorios, the commercialization of counterfeit medicines generated economic losses
of around $40 million to the country’s pharmaceutical industry that year. Indonesia’s International
Pharmaceutical Manufacturers Group (IPMG) estimated that pirated drugs constituted 25% of
Indonesia’s $2 billion pharmaceutical market. According to IPMG, the fake drugs hit foreign
pharmaceutical companies’ bottom lines and posed a potential serious public health threat. In
Kenya, a random survey by the National Quality Control Laboratories (NQCL) and the Pharmacy
and Poisons Board found that almost 30% of the drugs in Kenya were counterfeit. Some of the
drugs were no more than just chalk or water marketed as legitimate pharmaceutical products.
According to figures from the Kenyan Association of Pharmaceutical Industry, counterfeit
pharmaceutical products account for approximately $130 million annually in sales in the country.
In 2004
In Angola, according to the National Department of Intellectual Copyright Crime of the Economic
Police, approximately 70% of medicines used by the Angolan population were forgeries. In Colombia,
the Association of Colombian Pharmaceutical Industries (ASINFAR) estimated that US$ 60 million or
5% of the total annual market of medicines sold were contraband, counterfeit or adulterated.
Lebanon’s National Health Commission (NHC) reported in 2004 that 35% of pharmaceuticals
available in the Lebanese market were counterfeit. In Mexico, federal agents seized approximately 60
tons of stolen, expired and counterfeit pharmaceuticals in Sahuayo, Michoacán, and Guadalajara,
Jalisco. Reports indicated that in Mexico alone, illegal products represented about 10% of the
pharmaceutical market. In Nigeria, the Ebonyi State Task Force on Counterfeit and Fake Drugs
reported that approximately 48% of goods and drugs imported into the country were substandard or
counterfeit.
In The 2003
Philippine’s Bureau of Food and Drug (BFAD) reported that 30% of drug store outlets visited by food
and drug deregulation officers carry and sell counterfeit drugs.
In 2002
In Cambodia, a Health Ministry survey conducted in 2002 revealed that 13% of drugs on
the domestic market were counterfeit or substandard, including anti-malaria drugs and
antibiotics. China’s Research and Development-based Pharmaceutical Association
estimated that about 8% of over-the-counter drugs sold in China are counterfeit. India’s
pharmaceutical companies suggested that in India’s major cities, one in five medicines
sold was a fake. They claimed a loss in revenue of between 4% and 5% annually. The
industry also estimated that illegal drugs had grown from 10% to 20% of the total market.
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Nigerian health officials estimated that 70% of drugs in circulation in the country are
either fake or adulterated.
Chinese counterfeit drugs
Many counterfeit drugs sold in the Third World or on the Internet originate in China. The
State Food and Drug Administration is not responsible for regulating pharmaceutical
ingredients manufactured and exported by chemical companies. This regulatory hole,
which has resulted in considerable international news coverage unfavorable to China, has
been known for a decade, but failure of Chinese regulatory agencies to cooperate has
prevented effective regulation.
On May 6,2005, the Chinese press agency Xinhua reported that the World Health
Organization had established Rapid Alert System (RAS), the world’s first web-based
system for tracking the activities of drug cheats, in light of the increasing severity of the
problem of counterfeit drugs.
Counterfeit drugs in India
According to latest figures released by the Organization for Economic Cooperation and
Development (OECD), contrary to popular notions, India emerges as the biggest culprit
in fake drug manufacture. According to this report 75 per cent of fake drugs supplied
world over have their origins in India, followed by 7 per cent from Egypt and 6 per cent
from China.
The BBC, along with many other news outlets, reported on the activity of the DirectorGeneral of NAFDAC Prof Dora Akunyili, who has been appointed to deal with the
problem of fake drugs in Nigeria. According to these reports, many of the fake drugs
came from the same countries that make normal drugs, especially China and India. In the
case of India, while it is against the law to make fake drugs for domestic use, it is not
against the law to make fake drugs for export.
An individual who applies a counterfeit medication may experience a number of
dangerous consequences to their health, such as unexpected side effects, allergic
reactions, or a worsening of their medical condition. A number of counterfeits do not
contain any active ingredients, and instead contain inert substances, which do not provide
the patient any treatment benefits. Counterfeit medications may also contain incorrect
ingredients, improper dosages of the correct ingredients, or they may contain hazardous
ingredients. Fake antibiotics with a low concentration of the active ingredients can do
damage world wide. Courses of antibiotics that aren’t seen through to completion allow
bacteria to regroup and develop resistance.
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The extent of the problem of counterfeit drugs is unknown. Counterfeiting is difficult to
detect, investigate, and quantify. So, it is hard to know or even estimate the true extent of
the problem. What is known is that they occur worldwide and are more prevalent in
developing countries. It is estimated that upwards of 10% of drugs worldwide are
counterfeit, and in some countries more than 50% of the drug supply is made up of
counterfeit drugs. Furthermore, the World Health Organization estimates that the annual
earnings of counterfeit drugs are over US$ 32 billion.
Three counterfeit prescription drugs have reached the shelves of American pharmacies
and in some cases have been given to patients. Some vials contained cheap generic
versions of the drugs named on the packaging; others contained liquids with no active
ingredients.
The drugs involved, all three of which are injectable, are filgrastim (Neupogen), an
anticancer drug sold by Amgen; and two versions of the human growth hormone
somatropin, Serostim, made by Serono, and Nutropin, which is sold by Genentech.
Genentech issued a warning to patients, physicians, pharmacies, and wholesalers that the
counterfeit drug may pose a serious health risk to patients. It also showed how closely the
packaging of counterfeited Nutropin AQ resembled the genuine version.
All three drugs are expensive, which could be why the counterfeiters selected them. A 12
week course of Serostim, for example, which is used to treat wasting associated with
AIDS, costs $21 000 (£15 000). In the case of Serostim, some patients complained of a
slight swelling or a skin rash after injections.
All three companies immediately informed the US Food and Drug Administration (FDA),
who launched its own investigation in May.
Officials of the US Customs Service said that their seizures of counterfeit and other
prescription drugs had risen sharply in recent years. The service seized 9725 parcels of
prescription drugs in 1999 compared with 2145 the year before. Most of the seizures
were of drugs purchased by Americans from websites operating in foreign countries, but
some of the seizures were commercial shipments that were intended for resale. Even a
small percentage of counterfeit drugs in the drug supply can pose significant health risks
to the populace. In recent years, FDA has encountered a range of counterfeit drugs that
illustrate the public health threats posed by counterfeiters’ drugs.
AFRICA
In a survey of 519 drugs in 3 African countries between 1991 and1993, 77 drugs (18%)
were found to be substandard. In Tanzania, counterfeit Ampicillin containing no active
ingredient was found in 2000. In 2003, the Medicines Control Council (MCC) Of South
Africa appealed to all members of the public, and health professionals not to sell or
purchase counterfeits of the medicine Macrodantin50mg (urinary tract antiseptic) on their
market. In 2003, there were reports of counterfeit antiretroviral Ginovir3D
(Zidovudine200mg, Lamivudine150mg, Indinavir40mg) capsules, in Cote d’Ivoire. On
analysis, the capsules were found to contain, Zidovudine 201mg, Stavudine 40mg and
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some other unidentified substance. In the Republic of Benin, for instance, this interboundary trade is known as the “parallel market”. A report quotes the Benin’s National
office of Health Protection as estimating patronage of this parallel market to be around
85% of the population. These counterfeit and often under-strength drugs generally come
from Gabon, Nigeria, and certain Asian, European and North American countries. This
market is often controlled by traveling sales persons who have no training and lack all
necessary skills to dispense drugs. In view of this flow of trade on pharmaceutical
products between Nigeria and other neighbouring countries, the situation in Nigeria
naturally reflects that of the West African sub region except for one or two countries.
Even though faking/counterfeiting of pharmaceutical products is a global phenomenon,
some countries are more affected, and to say that Nigeria is one of the most affected is
not an exaggeration. Most West African countries are also badly affected, but the
problem may not be highlighted in some of these countries, as they are in Nigeria,
because of weak or non-existent drug regulatory authorities. Currently, there is no
reliable statistics on the level of incidence of fake drugs in Nigeria. Estimates of the
extent of counterfeit medicines in circulation in Nigeria ranged from 25% to 80% from
various studies before 2001. A study by Poole in Nigeria in 1989 indicated that 25% of
samples studied were fake, 25% genuine and 50% inconclusive. In 1990, Adeoye Lambo,
a former WHO Deputy Director reported that 54% of drugs in every major pharmacy in
Lagos were fake, and that the figure had risen to 80% in the subsequent year. Taylor et al
reported that 48% of drugs tested were fake and substandard. Antimalarials, antibiotics,
and vitamins are among the most used drugs in Nigeria. Out of the three, antimalarials as
a group had the least proportion of products with standard active ingredients.
Characteristics of fake or adulterated drugs and effects on health
The regular use of substandard or counterfeit medicines can lead to therapeutic failure or
drug resistance. In some cases, it can lead to death. Some of these characteristics and
untoward effects are described briefly below:
Toxic Effects: Some fake drugs contain ingredients that, if ingested or injected, can
cause health problems. For example, the recently counterfeited Procrit, an important drug
for cancer and AIDS patients, contained nonsterile tap water, which can cause an
infection in the bloodstream.
Unintended Effects: Some counterfeits substitute one drug for another. For example,
insulin has been substituted for a more expensive injectable drug. And there was a report
that counterfeiters emptied bottles of Zyprexa, a drug used for schizophrenia and acute
bipolar mania, and replaced them with white tablets imprinted with the word “aspirin.”
Ineffective Treatments: Some fake drugs contain some active ingredient, but are sub
potent. Others attempt to accurately copy the real drug, but still pose safety risks because
they are not formulated in a way that achieves the right therapeutic levels in the patient’s
blood.
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No active ingredients: some counterfeit drugs have any active ingredients. For example,
a counterfeit version of Serostim, a growth hormone used in AIDS patients, was found to
have no active ingredients hence leads to therapeutic failure and further deterioration of
health.
Labels that look real: Over the past several years, counterfeiters have gained access to
sophisticated technologies that enable them to very closely duplicate the packaging and
labeling of legitimate prescription drugs. In fact, labeling for a product can be so exactly
duplicated that it may require extremely close inspection by experts in order to identify
subtle differences from the legitimate product.
In all of these cases, at a minimum, patients face the risk of therapeutic failures or
worsening of the health problem that the drug was intended to treat. Sometimes, toxicities
can be potentially much worse. While no fatalities have been causally linked to specific
counterfeit drugs in the last decade, criminals who engage in such counterfeiting
practices clearly have disregard for the well-being of ill patients and the safe practices of
legitimate companies and individuals involved in the distribution of prescription drugs.
A number of cases of fatalities associated have been reported in many countries a typical
one from Argentina was documented by WHO. Veronica Diaz was a healthy 22 year old
woman, living in Viedma, Argentina, who had mild anaemia caused by insufficient iron
in her blood and required her to receive iron injections. In December of 2004, she became
very sick and died of liver failure after receiving the 7th of a 10 injection treatment. The
medicines authority of Argentina, ANMAT, determined that she had been given a highly
toxic counterfeit. Authorities were unable to determine the source of the counterfeit
product due to falsified paper work. While most of the counterfeit production throughout
Argentina was recovered and four persons were prosecuted, the highly fragmented
distribution system prevented the recall from being 100% successful. In May of 2005
another woman died and a 22 year old pregnant woman was injected with the same
counterfeit. She survived but gave birth to a 26 week premature baby. To date,
Argentinean law does not consider counterfeiting medicines a crime.
Documented cases fake/expired drug fatalities:
In Niger Republic, the use of fake meningitis vaccine resulted in the death of about 2,500
persons. In 1989, poorly compounded Chloroquine syrup killed several children in U.N.T.H,
Enugu in the early ‘80s of which there is no statistics, partly because many of the deaths were not
even reported. In 1990, the “Paracetamol syrup disaster”occurred when 109 children died in
Ibadan and Jos, after taking paracetamol/ cough syrup produced with the toxic ethylene glycol
solvent instead of propylene glycol. This tragedy occurred more than fifty years after that of the
U.S.A. In 2002, 3 patients reacted adversely to infusions manufactured by a Nigerian company.
Some of the adverse reactions exhibited by the patients were severe rigor, vomiting, sweating,
restlessness, seizure, impaired level of consciousness, etc. The reactions stopped immediately
after the administration of the infusions were discontinued. Investigations by NAFDAC on the
offensive infusions collected from the hospital revealed that three (3) batches were heavily
contaminated. Fake Adrenaline reported to have contributed to the death of three children
during open-heart surgery in Nigeria in 2003. Further investigations by NAFDAC
revealed that the suxamethonium used in the surgical procedure were also substandard. In
2004 three Nigerian hospitals reported cases of adverse reactions from the use of
contaminated infusions produced by four Nigerian companies. Consequently we sampled
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infusions and water for injection from all over the country. Our results confirmed that
some batches of infusions produced by the indicted companies were heavily
contaminated with microorganisms. 147 of the 149 brands of water for injection screened
were also not sterile. Counterfeit products, (drugs, food, cosmetics, medical devices,
chemicals, and water including all drinks but mostly pharmaceuticals) valued at over
N8.0b (US$60 million) were seized and destroyed in Nigeria by the National Agency for
Food and Drug Administration and Control (NAFDAC) between April 2001 and
December 2004. During a meningitis epidemic in Niger in 1995, more than 50 000 people were
inoculated with fake vaccines resulting in 2 500 deaths. The vaccines were received as a gift from
a country which thought they were safe. 89 children died in Haiti in 1995 and 30 infants died in
India in 1998 due to the consumption of paracetamol syrup prepared with diethylene glycol (a
toxic chemical used in antifreeze). In 2001, in South-East Asia, a Wellcome Trust study revealed
that 38% of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients.
In Cambodia, in 1999, at least 30 people died after taking counterfeit anti-malarials prepared with
sulphadoxine-pyrimethamine (an older, less effective anti-malarial) which were sold as
artesunate.
IMPLICATIONS OF COUNTERFEIT DRUGS:
According to NAFDAC, counterfeiting of medicines is the greatest evil of our time and the
highest weapon of terrorism against public health, as well as an act of economic sabotage. It is an
ill wind that blows nobody good. The evil of fake drugs is worse than the combined scourge
of malaria, HIV/AIDS and armed robbery put together. This is because malaria can be
prevented, HIV/AIDS can be avoided and armed robbery may kill a few at a time, but
counterfeit/fake drugs kill en mass. The social problem posed by hard drugs, cocaine,
heroine etc. cannot also be compared with the damage done by fake drugs, because illicit
drugs are taken out of choice, and by those that can afford them, but fake drugs are taken
by all and anybody can be a victim. Fake drugs have embarrassed our healthcare providers and
eroded the confidence of the public on our healthcare delivery system. This development has led
to treatment failures, organ dysfunction/damage, worsening of chronic disease conditions and the
death of many Nigerians. The situation became so bad that even when patients were treated with
genuine antibiotics, they no longer respond positively due to resistance induced by previous
intake of fake/counterfeit antibiotics. Most of our local pharmaceutical industries that are
producing genuine drugs, employing labour and boosting our economy, could not break even
because of unfair competition with drug fakers, who are only paying for packaging and probably
freighting without spending on active ingredients, which are the most expensive components of
any drug.
Because counterfeiting is difficult to detect, investigate, and quantify, it is hard to know
the true extent of the problem. Counterfeiting is greatest in those regions where the
regulatory and legal oversight is weakest. Most industrialized countries with effective
regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New
Zealand) have a low proportion, i.e. less than 1% of market value. Many countries in Africa and
parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be
counterfeit, while other developing markets have less than 10%; overall, a reasonable range is
between 10% and 30% Many of the former Soviet republics have a proportion of counterfeit
medicines which is above 20% of market value — this falls into the developing country range.
Medicines purchased over the Internet from sites that conceal their physical address are
counterfeit in over 50% of cases.
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Due to inadequate regulation and enforcement, the quality, safety and efficacy of both
imported and locally manufactured medicines in many developing countries cannot be
guaranteed. Smuggling and illegal importation of drugs are rife. Counterfeit drugs are not
only sold in countries with ineffective drug regulation but they are also exported or reexported.
Counterfeiters and their allies aggressively seek to avoid detection. They engage in
elaborate conspiracies to disguise their activities. They establish fictitious businesses and
front companies. They exploit weaknesses in border control whenever governments try to
promote world commerce by reducing border inspections. They use false documents to
obtain essential active pharmaceutical ingredients, as well as manufacturing equipment to
replicate genuine products.
Some policy-makers have argued that drug regulation represents an unnecessary barrier
to trade and should be reduced to a minimum. Pharmaceuticals, however, are not a
standard commodity, since consumers and prescribers are unable independently to assess
their quality, safety and efficacy and the consequences of ineffective regulatory oversight
can be deadly to patients.
Reasons for proliferation of counterfeiting medicines world-wide:
The production of counterfeit drugs need not occur in large infrastructures or facilities.
The majority of the counterfeiters apprehended so far carried out their activities in
ordinary households, small cottage industries, or in backyards.
Counterfeiting of medicines is a hugely lucrative business due to the continued high
demand for medicines and low production costs. The absence of deterrent legislation in
many countries also encourages counterfeiters since there is no fear of being apprehended
and prosecuted.
When prices of medicines are high and price differentials between identical products
exist there is a greater incentive for the consumer to seek medicines outside the normal
supply system. In many countries the official supply chain fails to reach many
communities, especially in rural areas. Poverty, and the lack of an official supply chain,
are major factors in creating markets for counterfeit products. In Africa, the distribution
systems of drugs are quite inappropriate as drugs are sold by road side market
men/women like other goods and chemist shops run by uneducated people.
In 1988, the Prescription Drug Marketing Act (PDMA) was enacted as an effort to ensure
that prescription drug products in the U.S. would be safe and effective and to avoid an
unacceptable risk that counterfeit, adulterated, misbranded, subpotent or expired drugs
were being sold to the American public. The PDMA sought to introduce safeguards into
the drug distribution system to provide assurances through paper records of the true
source and distribution history (“pedigree”) of a prescription drug. While the PDMA
provided some protections, it has important limitations which include:
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1. Some of its provisions have made it possible for determined counterfeiters to skirt
its intent.
2 .Its reliance on paper records can be quite costly, especially for small- and mediumsized wholesalers. Also, paper records can be easily forged.
3 .PDMA does not envision the use of modern technologies that can assist with
tracking or verifying the authenticity of legitimate prescription drugs.
In the 15 years since PDMA was enacted, there have been many changes in the industry
and in anti-counterfeiting technologies, as well the introduction of electronic ordering,
inventory control, and record-keeping used by the pharmacies—which may provide more
effective mechanisms to achieve PDMA’s goals.
Counterfeiters use state of the art technologies, such as desktop publishing, to produce
labels that are indistinguishable from the original labels. These labels put false "new"
expiration dates on expired products and make adulterated or ineffective drugs look like
the real thing. Counterfeiters have the ability to make and stamp tablets with company
logos and even to package them in blister packs.
Counterfeiting is prevalent outside the United States and is growing at an alarming pace.
A joint workshop of the World Health Organization and the International Federation of
Pharmaceutical Manufacturers Associations concluded in 1992 that in some countries as
much as 60% of all drugs may be counterfeit.
The WHO has estimated that between 5% and 8% of the worldwide trade in
pharmaceuticals is in counterfeits, and that the problem is worse in developing nations
than in developed nations such as the United States. The 5-8% range is only an estimate
since no one has conducted a systematic study of the worldwide problem of counterfeit
medicines.
Factories in China and India are the source of most of the bulk active ingredients used in
counterfeit pharmaceuticals worldwide. It is believed that some products are sourced in
India, fraudulently labelled in the area around San Diego, California, and then shipped
into Mexico for sale to unsuspecting Americans. A 1997 seizure by US customs officials
of more than $60m worth of misbranded and counterfeit pharmaceuticals that were
destined for drugstores in Tijuana supports this theory. The active ingredients seemed to
have originated from India.
The US Customs Service, the Postal Service, and the FDA are struggling to cope with the
growing flood of counterfeit drugs that threatens the health of Americans and the
integrity of their pharmaceutical companies.
The FDA has recommended that US customs agents at mail inspection sites be required
to send back all small foreign drug shipments they find, the only exception being those
for "compassionate use," so that seriously ill patients could order drugs from overseas
that are unavailable in the United States.
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Globally, national laws are often inadequate, and international shipments are not searched
or verified in free trade zones. There is also a lack of dedicated enforcement personnel
and resources, no specific treaty or set of uniform international obligations, and no staff
dedicated to monitoring compliance
Steps advocated by WHO to combat counterfeit medicines
In order to mobilize awareness and action in the fight against fake drugs, in February
2006, WHO created the first global partnership known as the International Medicinal
Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT is comprised of all 193
WHO Member States on a voluntary basis and includes international organizations,
enforcement agencies, national drug regulatory authorities, customs and police
organizations, non-governmental organizations, associations representing pharmaceutical
manufacturers and wholesalers, health professionals and patients’ groups. These groups
have joined to improve coordination and harmonization across and between countries so
that eventually the production, trading and selling of fake medicines will cease. To
accomplish this mandate, IMPACT will focus on the following five key areas:
Legislative and regulatory infrastructure
Legal systems are often not equipped to deal with the extremely serious consequences of
counterfeit medicines and penalties for counterfeiters are too light to act as deterrents.
Stronger legislation will help empower those who have to deal with counterfeits and
counterfeiters in the course of their work; namely, the police, customs officials and the
judiciary. IMPACT will look at existing laws in countries; present effective models
countries can replicate and adapt to meet their own needs. IMPACT will focus on
developing a set of principles for the establishment of appropriate legislation and penal
sanctions including a clear legal definition of counterfeit medicines.
Regulatory implementation
IMPACT will identify the means by which regulators may take action and implement
legislative measures taken on counterfeit medicines, including revised approaches to
ensure that standards for quality, safety and efficacy are implemented and distribution
chains effectively controlled. In many countries regulatory oversight of pharmaceuticals
is ineffective, especially of distribution channels. Coordinated action at the local level is
essential between health authorities, police, customs, and judiciary institutions to ensure
proper regulation, control, investigation and prosecution. IMPACT will help countries
with weak regulatory systems to strengthen them by improving collaboration and
drawing from the experience, capacity and resources of all IMAPCT stakeholders.
Enforcement
IMPACT will help to identify and coordinate action between customs, police and the
judiciary of different countries to monitor borders, track counterfeit goods and apprehend
counterfeiters. By working with the World Customs Agency, INTERPOL, and informal
networks of enforcement officers, IMPACT will facilitate communication between
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enforcement and health authorities improve international collaboration and develop
appropriate mechanisms that will enable importing countries, especially in the developing
world, to trigger investigation and identification of the actual source of counterfeit
medicines plaguing their markets.
Technology
By utilizing the broad partnership from health agencies to pharmaceutical manufacturers
and distributors, IMPACT aims to help develop innovative solutions. Given disparities
between the level of technological access in industrialized and developing countries,
IMPACT will help facilitate the transfer of technology across both developed and
developing countries. Technology can contribute creative tools and in some cases
leapfrog lengthy legal and administrative processes to provide faster solutions. For underresourced countries, means to technology transfer and adapt it to the local situation
should be explored.
Risk communication
IMPACT will identify and create the most coordinated and effective mechanisms
required to both respond and alert key audiences, stakeholders and the general public
about counterfeits in communities and across countries. International information
networks will be created or strengthened to monitor the traffic of goods, exchange
information, issue alerts from country to country and region to region. Increased public
information is essential for patients, dispensers, and doctors who have a right to know if
there are suspect goods on the market but must also contribute to detecting counterfeits
by reporting and helping to investigate suspicious cases. Special initiatives will be
launched to make internet users aware of the risks they run when purchasing medicines
from unknown sources and to address consumers in extremely poor and rural areas where
patients may be unable to make informed choices and may not be aware of their rights.
In conclusion, counterfeiting of drugs and stocking of expired drugs are evils of our time
the need to be put in check by all stake holders in order to safe guard health and preserve
lives as no one is immuned to the outcome of this devilish acts.
Reference:
1. WHO (2006). Counterfeit medicine. Fact Sheet N0 275 November 2006.
2. Erhun W.O, Babalola O.O and Erhun M.O (2001).Drug Regulation and Control in
Nigeria: The Challenge of Counterfeit Drugs. Journal of Health & Population in
Developing Countries; 2001, 4(2):23-34
3. US Food and Drug Administration initiative to curb Counterfeit Drugs 2008.
http//:www.fda.gov/
4. Dora Akunyili (2005). Counterfeit drugs and Pharmacovigilance. www.nafdacnigeria
.org
5. Okpako D.T (2003) Principles of Pharmacology: A tropical Approach. 2nd Edition.
Cambridge University Press, UK
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