risk of medicines-counterfeit drugs.pdf

International Journal of Risk & Safety in Medicine 16 (2004) 181–190 181IOS Press

Risk of medicines: Counterfeit drugs

Dora Nkem Akunyili a and Ijeoma P.C. Nnani b,∗

a Director General, National Agency for Food and Drug Administration and Control (NAFDAC),Nigeriab Deputy Director, NAFDAC, Nigeria

Abstract. Living in general is a risky endeavour. Certain risks are taken without much thought because of the apparent over-whelming benefits. This is often the case for many consumers of medicines who assume medicines to be wholly safe and healthcare providers infallible. Patients rely on healthcare providers for information, risk assessment, and protection from risks dueto medical interventions.

Some common risks due to medical interventions include medication errors, exposure to radiation, over/under dosing, adverseevents/reactions, hospital acquired infections, counterfeit drugs, etc. Unfortunately, risk factors such as counterfeit medicines(though occurring for a long time) are just becoming apparent in the last three decades, first to only a few countries while othersstill seem unaware or choose to dwell in denial of their existence.

There has been an astronomical increase in the detection of counterfeit medicines worldwide. The magnitude of this increaseand consequent death toll demands greater attention in the consideration of the safety of medicines. Counterfeit medicinesconstitute a risk to the pharmaceutical industry, healthcare providers, the healthcare system as a whole and ultimately to thepatient. The risks to the patient include, lack of effect, toxicity, adverse drug reactions (ADRs), loss of economic and otherresources and ultimately death.

Due to dearth of information and research and lack of a globally coordinated approach to anti-counterfeiting, global estimatesof deaths due to counterfeit medicines can only be guessed. Indications from both published data and anecdotal evidenceindicate that millions of lives may be saved annually if there are no counterfeit antibiotics, antiretrovirals, anti-malarial, anti-tubercular drugs, vaccines and other life saving medicines.

This paper identifies these risks and proposes a concerted global action towards reducing the production and circulation ofcounterfeit pharmaceuticals on the world market. It also suggests a possible role for pharmacovigilance in anti-counterfeiting.

Keywords: Counterfeit medicines, safety of medicines, pharmacovigilance, global anti-counterfeiting organ

1. What are counterfeit drugs (medicines)?

A counterfeit medicine is one, which is deliberately and fraudulently mislabelled with respect to iden-tity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit prod-ucts may include products with the correct ingredients or with the wrong ingredients, without activeingredients, with insufficient active ingredients or with fake packaging [17].

Definitions for counterfeit medicines vary from country to country, based on perception of the prob-lem. Various countries’ definitions are rather unwieldy, perhaps, in an attempt to capture the complexnature of counterfeit medicines as well as the act of counterfeiting itself. (See various definitions inBox 1.)

*Address for correspondence: Ijeoma P.C. Nnani, Corporate Headquarters, National Agency for Food and DrugAdministration and Control (NAFDAC), Plot 2032 Olusegun Obasanjo Way, Wuse Zone 7, Abuja, Nigeria. Tel.: +00 923409 6702823; Fax: +00 9234 09 5241108; E-mail: [email protected].

0924-6479/04/$17.00 2004 – IOS Press and the authors. All rights reserved

182 D.N. Akunyili and I.P.C. Nnani / Risk of medicines: Counterfeit drugs

Box 1

Definitions of fake drugs used in various countries

Nigerian definition for instance combines the provisions of two decrees1,2 and gives the definitions as follows,“fake drug” is:

Any drug or drug product which is not what it purports to be; or

Any drug or drug product which is so coloured, coated, powdered or polished that the damage is concealed orwhich is made to appear to be better or of greater therapeutic value than it really is, which is not labelled in theprescribed manner or which label or container or anything accompanying the drug bears any statement, designor device which makes a false claim for the drug or which is fake or misleading; or

Any drug or drug product whose container is so made, formed or filled as to be misleading, or

Any drug or drug product whose label does not bear adequate directions for use and such adequate warningagainst use in those pathological conditions or by children where its use may be dangerous to health or againstunsafe dosage or methods or duration of use; or any drug or drug product, which is not registered by the Agencyin accordance with the provisions of the Food, Drugs and Related Products (Registration, etc.) Decree 1993, asamended;

According to the Pakistan manual of drug laws3, a counterfeit drug is “a drug the label or outer packing ofwhich is an imitation of, resembles or so resembles as to be calculated to deceive, the label or outer packing ofa drug manufacturer”.

The Republic Act No. 8203 of the Philippines defines counterfeit drugs medicines as4:

Medicinal products with correct ingredients but not in the amounts as provided there under, wrong ingredients,without active ingredients, with insufficient quantity of active ingredients, which results in the reduction of thedrug’s safety, efficacy, quality, strength or purity. It is a drug, which is deliberately and prudently mislabeledwith respect to identity and/or source or with fake packing, and can apply to both branded and generic products.It also refers to:

The drug itself, or the container or labeling thereof or any part of such drug, container or labeling bearingwithout authorization the trademark, trade name, or identification mark or imprint or any likeness to that whichis owned or registered in the Bureau of Patent Trademark and Terminology Transfer (BPTTT) in the name ofanother natural or juridical person;

A drug product refilled in container by unauthorized persons if the legitimate labels or marks are used;

An unregistered imported drug product, except drugs brought into the country for personal use as confirmedand justified by accompanying medical records; and

A drug which contains no amount of, or a different active ingredient, or less than eighty percent (80%) of theactive ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss ofefficacy due to expiration.

1Supplement to official Gazette Extraordinary. No 29 Lagos, 11th May 1999, vol. 86, pg. A1105.2Supplement to official Gazette Extraordinary. No. 2, vol. 80, 20th February, 1993, Part A, pg. A221.3Pakistan Manual of Drug Laws: Lahore Times Publication, 1987.4Congress of Philippines, Republic of Philippines, Republic Act No. 8203, July 1996.

Some countries do not have any definition or legislation against counterfeit medicines while in others,counterfeiting of medicines is treated under the broad umbrella of commercial offences rather than ahealth related offence.

Counterfeit medicines are fundamentally substandard, therefore unsafe by virtue of the fact that theyare produced outside of any form of regulation and control. However, all substandard medicines are

D.N. Akunyili and I.P.C. Nnani / Risk of medicines: Counterfeit drugs 183

not necessarily counterfeits. While the two are potentially unsafe, the difference is that counterfeits areproducts of deliberate fraud while some substandard medicines may result from error (not deliberate) dueto process, personnel and/or raw materials in the course of medicine production, distribution, storage, etc.

Any potentially beneficial pharmaceutical product is a target for counterfeiting. The truism is that ifyou can make it, they can fake it [7].

The World Health Organization (WHO) began to collate reports of counterfeit pharmaceuticals from1982. There were 771 reports from 1982 to 1999. From 1999 to 2000, further 46 reports were received.Of the reports 60% came from developing countries even though there is gross under-reporting. Distrib-ution of the reported cases of counterfeit medicines, from 1999 to 2002, categorized therapeutically wasas follows [20]:

Antibiotics 26%Hormones and steroids 18%Anti-asthmatics and anti-allergy 8%Anti-malarials 7%Analgesics and antipyretics 6%Others (14 therapeutic categories) 33%

Reports from developed countries indicate that the most frequently counterfeited medicines are newand thus expensive lifestyle medicines, like antihistamines, hormones and steroids. Developing countrieson the other hand report mostly counterfeits of medicines used in life-threatening conditions such asmalaria, tuberculosis and HIV/AIDS [19].

In countries where drug distribution systems are not effectively regulated and controlled and whererational use of drugs is not common practice, highly counterfeited drugs include, antibiotics, anti-inflammatory drugs, vitamin supplements and medicines that are often scarce, banned or restricted foruse.

The indication from Nigeria is that, antihypertensives, analgesics, multivitamin/mineral preparations,antidiabetics and non-steroidal anti-inflammatory drugs (NSAIDs), including banned butazolidine, arecommonly counterfeited.

In Nigeria some specific forms of counterfeit medicines that were identified include [1]:

– Drugs with no active ingredient(s), e.g., lactose or even chalk in capsules, tablets, etc.– Drugs with insufficient active ingredient(s), e.g., chloroquine tablets containing 41 mg of chloro-

quine instead of 200 mg, 50 mg Ampicillin as against 250 mg.– Drugs with different ingredient(s) from what is stated on the package, e.g., olive oil in Supradyn

(multivitamin preparation) Capsules.– Drugs without the full name and address of the manufacturer.– Clones of registered drugs, e.g., Nixoderm labelled “Made in Nigeria”.– Expired and relabeled drugs with the intention of extending the shelf life.

Statutorily, drugs not registered by the National Drug Regulatory Authority, NAFDAC (i.e. withoutmarketing authorization) are considered as counterfeits in Nigeria.

2. Counterfeit medicines, a reality

Many professionals are unaware of counterfeit medicines even in countries where the problem isgrave. Consumers are less aware since a code of silence seems to prevail over counterfeit medicines. The


Box 2

Various types of counterfeiting

Fraudulently mislabelled

Dermovate Cream

Often counterfeited as a skin lightening cosmetic cream. On analysis, counterfeits often contain no actives.Counterfeiters also extend the range to soaps and lipsticks which the genuine product manufacturer does notproduce.

Correct Ingredients

Imuran Tablets (China) – Counterfeits was found to contain correct amount of active ingredient, Azothioprine,but labeling was incorrect, “Azathiopring”. Counterfeit product failed to disintegrate after 4 hours in water at37 degrees whereas genuine tablets disintegrated in 45 minutes.

Wrong Ingredients

Zinecef Tablets (China) – Counterfeit contained Cefuroxime Sodium (Injectable form which is poorly absorbedorally) instead of Cefuroxime Axetil, the correct oral active ingredient.

Without Active Ingredients

3TC (Hong Kong) – Antiviral for preventive use against the onset of AIDS in people living with HIV. Counter-feits had exact replica of packages and literature inserts and attempt to reproduce the covert anti-counterfeitingfeatures. Analysis revealed that counterfeits contained no actives.

Engerix-B vaccine (Pakistan) – Perfect copy of labels but contained no trace of vaccine and content was notsterile.

Adulteration or reuse of components

Fortum injection (Vietnam) – Labels and cartons of products showed stains, rubber plugs showed puncturemarks comfirming previous use. On analysis, content was found to be Streptomycine instead of Ceftazidime.

failure of the WHO to make the issue of counterfeit pharmaceuticals prominent on the agenda duringhealth talks at the World Summit on Sustainable Development in 2002 underscores this unwritten codewhich stems more from low awareness of the magnitude of this risk than from negligence.

A presentation from Glaxo SmithKline (GSK) at the SMI anticounterfeiting conference in the UKin 2003 illustrated the company’s experience with all the categories of counterfeits as contained in theWHO definition earlier stated. This does not imply by any means that the company fares worse thanothers in the Pharmaceutical industry. Rather it demonstrates the kind of alertness and openness expectedfrom the industry to tackle this problem. See Box 2 for examples [14].

A review of some actual reports/seizures of counterfeit medicines from around the world will verymuch bring home the reality of counterfeit medicines.

2.1. North and South America

– Report by the US FDA of 3 lots of counterfeit Combivir and 3 lots of Lipitor preparations. About200,000 bottles of Lipitor were recalled (2003).

– Counterfeit alert from Solvay Pharmaceuticals, Inc. in response to the discovery of counterfeitANADROL R© Tablets. On analysis, the counterfeited Anadrol did not contain oxymethalone theactive ingredient. Rather, it contained Androstenedione (December 2003).

– Counterfeit Serostim (Serono), Epogen, Gamimune (Bayer), Zyprexa (Eli Lily) reported in the USA(2002).


– Suspect bottles supposedly containing 60 tablets of Combivir (Lamivudine plus Zidovudine) whichin reality contained Ziagen (Abacavir Sulfate) (USA, 2002).

– Detection of counterfeit Voltaren, Tegretol, Hidergine and Reliveran (Novartis products) in Ar-gentina (1998). Novartis directed investigations which resulted in seizure of hundreds of US$ worthof counterfeit and adulterated medicines, printing and packaging materials (both Novartis and otherproducts) in Argentina.

– 6 Million ampoules of counterfeit Voltaren seized in Colombia (2000).

2.2. Europe

– 240,000 packs of counterfeit medicines and 2 tonnes of raw materials worth 1 million US$ seizedin Italy (2000).

– The Medical Control Agency (MCA) of the United Kingdom reported detection of many samplesof counterfeit Viagra (Sildenafil Citrate), and other unapproved Sildenafil products (content varybetween 40–100% of active ingredient) [2]. The government medicines safety agency seized £2.3million worth of illegal and fake Viagra in 2003 and mounted numerous prosecutions. A report fromRussia showed that 12% of drugs in circulation are counterfeit [15]. In some countries of the formerUSSR, counterfeits account for up to 30% of drugs in circulation while in Ukraine this figure goesup to 40%, and in the case of certain pharmaceuticals it can be up to 80% [13].

2.3. Africa

– Counterfeit Ampicillin containing no active ingredient in Tanzania (2000).– Fake Adrenaline reported to have contributed to the death of two children during open-heart surgery

in Nigeria in 2003. Further investigations by NAFDAC revealed that the suxametonium used inthe surgical procedure was substandard and the infusion was not sterile. It was reported that thedoctors/pharmacists arbitrarily increased the dose of the counterfeit suxametonium by three timesto get a muscle relaxant effect.

– Counterfeit products (drugs, food, cosmetics, medical devices, chemicals, and water including alldrinks but mostly pharmaceuticals), valued at an equivalence of over 43 million US$ were seizedand destroyed in Nigeria by the National Agency for Food and Drug Administration and Control(NAFDAC) between April 2001 and December 2003. Estimates from various studies of the extentof counterfeit medicines in circulation in Nigeria range from 25% to 80%.

– 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 Macrodantin 50 mg(urinary tract antiseptic) on their market (2003).

– Report of counterfeit antiretroviral Ginovir 3D (zidovudine 200 mg, lamivudine 150 mg, indinavir40 mg) capsules, in Cote d’Ivoire. On analysis, the capsules were found to contain, Zidovudine201 mg, Stavudine 40 mg and some other unidentified substance (2003).

2.4. Asia

– The state Drug Administration of China seized counterfeit drugs valued at US$ 57 million. Theyalso closed 1,300 illegal factories (2002) [18].


– The State Drug Administration of China in a nationwide survey of the quality of medicines, carriedout in the last quarter of 1998, found that 13.1% of the 20000 batches tested were either counterfeitor fell below minimal pharmaceutical standards.

– 660 kg of fake drugs, 1000 kg of raw materials and boxes bearing the logo of another companywere found in a counterfeiting factory in India (2001) [9].

– A total of 5,012,617 capsules of assorted counterfeit medicines including amoxicillin, ampicillin.cloxacillin, ampiclox and other products were seized in December 2003 in Myanmar. The seizedcounterfeits were smuggled in from India and China by unregistered and notorious counterfeitingcompanies [10].

According to the WHO, counterfeit and substandard medicines that have failed quality testing circulat-ing in some Asian countries are as follows: about 8.5% and 8% of medicines on the market in Thailand,and Vietnam, respectively; 16% in Myanmar. Some of the highest drug failure rates of these tests in-cluded the tuberculosis drug rifampicin, with 26 percent failure rate, and the antibiotic cotrimoxazole,with a 24 percent failure rate.

A five country survey of Southeast Asia (Cambodia, Thailand, Myanmar, Vietnam, and Laos) in 2001revealed that 38% of 104 samples of artesunate on sale in pharmacies and shops were counterfeits [11].

These reports are indicative of the global nature of the menace of counterfeiting but some countriesare more affected, and to say that Nigeria is one of the most affected is not an exaggeration

3. Scope of problem

There is much uncertainty about the extent of global counterfeiting, due to low global awareness,dearth of research and information on the subject and lack of cohesive global approach to solving theproblem. “Information on the problem is inadequate and there are no global studies conducted” [3].

Counterfeit medicines are estimated at about 5% of global trade (WHO/IFPMA) [4].The US Food and Drug Administration estimates that counterfeits make up more than 10% of the

global medicines market in both developed and developing countries. This translates to over US$ 32billion annually [19]. Mr. Benjamin England, a 17-year veteran of the US-FDA described counterfeitingas “a problem larger than FDA”. Another estimate from the US department of trade puts pharmaceuticalcounterfeiting at 18% of world trade. This translates to a reduction in annual profits of about EURO292 million for the pharmaceutical industry. The Pharmaceutical Security Institute (PSI) estimates thatabout 5.8% of revenue in Pharmaceuticals is lost to counterfeiting in the EU countries (PSI study, 2002).In developed countries, the unregulated sale of drugs through the Internet fuels the proliferation ofcounterfeit medicines and counterfeit Viagra presents a classical case.

Developing countries present a bleaker prognosis on counterfeiting. This is driven by the existence ofnone or weak drug regulation, control and enforcement, scarcity and/or erratic supply of basic medicines,chaotic drug distribution systems, corruption and unaffordable prices of essential medicines. Estimatesfrom developing countries vary from below 10% of medicines in circulation to over 50%. Despite theWHO pre qualification of HIV/AIDS, malaria and tuberculosis medicines, counterfeits still abound.

There is therefore no doubt as to whether counterfeit medicines constitute a global reality and menace.


4. Risk of counterfeit medicines

The risk of counterfeit medicines is multidimensional. There are economic, socio-security, environ-mental and health related aspects of this risk. Counterfeit medicines present diverse problems to thenation, industry, regulatory authority, healthcare providers/systems and ultimately the patient. This pa-per however shall dwell mainly on the health related risks of counterfeit medicines to the patient.

The health related risks of counterfeit medicines arise because they are inherently defective. They maybe placebos, contain toxic materials or be contaminated due to the fact that they are produced under poorGMP and outside of any form of regulation whatsoever.

Use of counterfeit medicines may result in treatment failure consequent to lack of effect, which inturn could result in worsening of disease condition, deformity and death. Counterfeit medicines couldintroduce new ADRs, dangerous interactions or intensify already known ones.

Between 1995 and 1996, over 50,000 people were unknowingly inoculated with fake vaccine during ameningitis epidemic in Niger. This donated vaccine resulted in over 2,500 deaths [8]. The case of coun-terfeit bulk erythromycin active ingredient used in production in the US resulted in an unprecedentedescalation of ADRs from the finished product. About 1,974 ADRs including 49 deaths were reported inrelation to the use of Gentamicin from 1989 to 1994 and further 254 ADRs including 17 deaths fromMay 1999 and January 2000 were traced to batches produced using bulk actives manufactured by LongMarch Pharmaceuticals of Sichuan China.

The consumption of paracetamol/cough syrup prepared with toxic diethylene glycol instead of propy-lene glycol led to death of 109 children in Nigeria (1990), 59 deaths in Haiti (1995), 30 infant deaths inIndia (1998) and similar incidents in other parts of the world. The WHO estimates over 500 deaths ofmainly infants from all over the world due to unknown or fraudulent contamination of pediatric dosageforms with diethylene glycol [3]. Used as antifreeze in refrigerators, lacquer, in cosmetics and as lubri-cant, on ingestion diethylene glycol causes CNS depression, and severe renal injury which may lead todeath from uremia. Like ethylene glycol, victims of diethylene glycol poisoning experience acute renalfailure caused by pronounced renal disease including destruction of epithelial cells, interstitial edema,focal hemorrhagic necrosis in the cortex, extensive hydropic degeneration, numerous oxalate casts andcrystals in the convoluted tubules [6]. The diethylene glycol may be responsible for the initial CNSdepression experienced on ingestion while the oxalate and other intermediaries are responsible for thenephrotoxicity.

Detection of counterfeit antiretrovirals in various parts of the world including the US should be mostdisturbing to all proponents of drug safety. The safety implications of the fraudulently labeled Combivir(lamivudine plus zidovudine) that actually contained, Ziagen (abacavir sulfate), found in the US in 2002is far reaching on the global efforts in antiretroviral therapy. Ordinarily, the tendency of HIV reversetranscriptase mutations favours the development of resistant strains and this has shaped the focus ofresearch and development of more effective antiretrovirals. This also underscores the need for theirrational use if drug resistance is to be minimized.

The three drug antiretroviral regime of abacavir, zidovudine and lamivudine is effective in both adultand pediatric treatment of HIV infection. The most obvious risk of the use of the Ziagen (abacavir)relabeled as Combivir (lamivudine + zidovudine) is that the patient is taking an overdose of abacavirand none of the other two drugs. The use of this counterfeit Combivir in various combination regimeswith proven efficacy may therefore result in lack of effect, increased toxicity, ADRs, interactions andother complications. Abacavir is known for a distinctive and fatal hypersensitivity reaction which occursin 2% to 5% of users [5]. Symptoms include fever, malaise, rash, nausea and vomiting. Initial symptoms


appear within six weeks and abet with dechallenge while rechallenge may progress to severe hypotensionand death.

The use of the counterfeit Combivir like other counterfeit medicines challenges drug safety and safetypractitioners because while looking out for expected responses from Combivir, one is actually dealingwith a double dose of Abacavir.

Malaria causes the death of over two million people per annum mostly in the endemic regions ofSoutheast Asia and tropical Africa. Antimalarials rank among the therapeutic groups that have devel-oped resistance in very quick succession. From quinine, chloroquine, sulphadoxine-pyrimethamine, pri-maquin, mefloquin to halofantrine strains of the plasmodium parasite resistant to these agents have beenreported resulting in continuous change of antimalaria policy, treatment guidelines, ways to tackle newside effects, adverse reactions and of course lots of other changes for the industry as well. The wide andintense counterfeiting of antimalarials might have contributed considerably to resistance to antimalarialmedicines and subsequent treatment failures. Quite often, these antimalarials are not analyzed to ascer-tain their quality prior to use. It is therefore difficult to ascertain if perceived resistance is due to theorganism or to substandard products such as counterfeits.

Artemisinin derivatives offer much hope in the face of massive drug resistance to malaria but withreports of massive faking in Asia, this may not last long. In a study carried out in five South East Asiancountries, 29% of samples of artesunate tested contained no artesunate while 38% of those purchasedfrom pharmacies were counterfeits [12]. The dangers of counterfeit antimalarials to public health de-pends on whether they just contain a placebo, they are substituted with a cheaper and less effectiveantimalarial/other drugs, or that they are outright toxic substances. For example, detected counterfeitantimalarials analysed in Nigeria present a vast array, from placebo containing halofantrin, purportedchloroquine preparations containing Aspirin laced with chloroquine to impact bitter taste for a full proofdisguise, and other contaminated and adulterated forms containing highly toxic materials. The case ofcounterfeit chloroquine containing Aspirin obviously has potential risks of interactions, contraindica-tions, as well as toxicity. When used in children, the dangers from this counterfeit chloroquine chal-lenges pharmacovigilance activities in view of the safety implications of using Aspirin in under agedpersons.

– At least 30 deaths were reported in Cambodia following the use of counterfeit antimalarials preparedwith sulphadoxine-pyrimethamine which were labelled and sold as artesunate. The cause of deathin this situation could either be from lack of pharmacological effect, presence of contaminants andother toxic material or ADR to Sulphonamides in unsuspecting predisposed individuals.

– Counterfeits of various antibiotics have been detected in Nigeria and from around the world. Thecase of counterfeit Ampicillin labeled as 250 mg which contained only 50 mg of actives obviouslypresent the risk of under dosing, lack of effect and subsequent treatment failure. This form of coun-terfeiting also causes loss of confidence in diagnosis, result of laboratory analysis and therapeuticintervention. It created suspicion regarding patient’s compliance. Coupled with irrational use of an-tibiotics in the society, counterfeits are a viable recipe for the precipitation of drug resistance andincreased cost of treatment.

5. Pharmacovigilance and counterfeit medicines

The presumption in pharmacovigilance (PV) is that drug quality and efficacy are assured so safetyconcerns in ADR reporting do not take into consideration risk factors such as those from counterfeiting.


Many countries may not enjoy the liberty of such presumption as the increasing reality of the dangers ofcounterfeit medicines stare them in the face. Product quality, safety and efficacy could be compromisedat several points, from the sourcing of raw actives and excipients to manufacture, packaging, distribu-tion, storage, etc. of medicines. There is fortunately a growing awareness that the scope of PV shouldbe expanded beyond signal detection to other safety concerns [16]. Counterfeit medicines constituteone of those yet to be integrated safety issues. Pharmacovigilance must be on the alert for counterfeitmedicines because with counterfeits, one may not even be dealing with the medicine one presumes tobe monitoring.

6. Conclusion

Presently, national centres collaborating in ADR monitoring are concerned mainly with signal detec-tion of ADRs. WHO has instituted a number of actions towards addressing counterfeit drugs. Theseinclude support to strengthen the regulatory framework and facilitate information exchange. The overallgoal of this support is to promote the regular availability and accessibility of affordable essential medi-cines of good quality. WHO also works with countries to ensure that quality assurance is built into theentire drug supply chain and is intensifying work in anti-counterfeiting among others [16].

The WHO product Certification Scheme was hoped to help assure quality of pharmaceuticals movingin international commerce. The main snag with the WHO certification is that it is not legally bind-ing therefore it enjoys little commitment from several countries. WHO is also saddled with very manyresponsibilities such that it requires a dedicated organ to provide the kind of focus required for anti-counterfeiting.

The year 2003 witnessed the highest activities in anti-counterfeiting efforts in various countries andby the global community since 1982 when the problem first popped up during a workshop in Nairobi onrational use of drugs. All these activities are in the right direction but the astronomical increase in detec-tion of counterfeit medicines in both developed and developing countries questions the effectiveness ofthe current interventions and their capability to dismantle the international cartel behind pharmaceuticalcounterfeiting. The present anti-counterfeiting efforts lack proper coordination, so, a lot of energy andother resources are dissipated by individual countries to protect their geographical boundaries. Unfortu-nately, risk factors such as drug resistance sometimes defy such boundaries. No country can fight andwin this war alone.

The most feasible way to prevent the reoccurrence of the gruesome tragedies caused by counterfeitmedicines is through a concerted global policy backed with action on anti-counterfeiting.

The news of a proposed death penalty for counterfeiting offences in some countries in Asia depictsmuch seriousness but cannot provide the desired teeth which a concerted global policy, backed by legisla-tion and a well funded implementing organ can provide. At the Global forum on anticounterfeiting organ-ised in 2002 by Reconnaissance international, the establishment of, “an international convention againstfaking/counterfeiting of pharmaceuticals just like what obtains for narcotics” was recommended [1].The adoption of this recommendation as part of the recommendations of the Pre-ICDRA Conference inFebruary 2004 in Madrid, Spain, is a landmark decision in anticounterfeiting and demands the concertedsupport of the entire global community. We hope that this recommendation will eventually be adoptedby the World Health Assembly.

All hands must be on deck to successfully dismantle the criminal network that perpetrates counterfeit-ing of pharmaceuticals.


Anti-counterfeiting calls for a great rethink on where to begin to report in pharmacovigilance. Shouldit remain at the amber light of signal detection or should we begin from the red light of counterfeitmedicines which presents the possibility of compromised quality, safety and efficacy.

To promote safety, minimize cost and successfully eliminate counterfeiting of medicines in a sustain-able manner, we further recommend as follows,

– Exporting countries should regulate pharmaceutical products meant for export as effectively asthose for local consumption.

– Better global awareness must be created on the problem of pharmaceutical counterfeiting.– Global commitment to anti-counterfeiting of medicines should have the same vigor, legal backing,

commitment and impetus given to global control of Narcotics.

Drug safety monitoring should be alert to the reality of counterfeit medicines and the extra facet itputs to the risk of medicines.

References

[1] D.N. Akunyili, Understanding the problem: The African perspective with special emphasis on Nigeria, The Global Forumon Pharmaceutical Anticounterfeiting, September 22–25, 2002.

[2] S. Clarke, Investigation of counterfeit medicinal products in the United Kingdom, The Global Forum on PharmaceuticalAnticounterfeiting, September 22–25, 2002.

[3] Counterfeit Drugs. Guidelines for the Development of Measures to Combat Counterfeit Drugs, WHO, 1999.[4] General Policy Topics, WHO Drug Information 6(2) (1992).[5] A.G. Gilman, J.G. Hardman and L.E. Limbert, Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 10th

edn, McGraw-Hill, New York, 2001, p. 1359.[6] R.E. Gosselin, R.P. Smith and H. Hodge, Clinical Toxicology of Commercial Products, 5th edn, Williams and Wilkins,

Baltimore, 1984.[7] D.M. Hopkins, L.T. Kontnik and M.T. Turnage, Counterfeiting Exposed. Protecting Your Brand and Customers, Wiley,

2000.[8] http://www.who.int/meidacentre/factsheets/2003/fs2.[9] T. Mura, Mission Report: Socialist Republic of Vietnam WHO Regional Office for the Western Pacific, 1992.

[10] Myanmar Information Committee, Yangon Information sheet No. C-2891 (I), 2004.[11] P. Newton, Murder by fake drugs in SE Asia – Prevalence and prevention, The Global Forum on Pharmaceutical Anti-

counterfeiting, September 22–25, 2002.[12] P.N. Newton, S. Proux, M. Green, F. Smithuis, J. Rosendaal, S. Prakonpan, K. Chetivanich, M. Mayax, S. Ooareesuwan,

J. Farrar, F. Nosten and N.J. White, Fake artesunate in South East Asia, Lancet 357 (2001), 1948–1950.[13] A. Pakharenko-Anderson, Building legislation and regulatory implementation environment: the Ukraine experience, The

Global Forum on Pharmaceutical Anticounterfeiting, September 22–25, 2002.[14] G. Power, Combating Pharmaceutical Counterfeiting. GSK: A Case Study. SMI Conference Document 6th to 7th October

2003, the Hatton, London.[15] R. Rosen, Fighting counterfeit drugs in Russia: A Case Study, The Global Forum on Pharmaceutical Anticounterfeiting,

September 22–25, 2002.[16] The Importance of Pharmacovigilance. Safety Monitoring of Medical Products. WHO, 2002.[17] WHO Expert Committee on Specifications for Pharmaceutical Preparations, Technical Reports Series 863, WHO, Geneva,

1996.[18] WHO Fact sheet N◦275, November 11, 2003.[19] WHO Media Center, Fact Sheet no 275, November 2003.[20] E. Wondemagegnehu, Combating Pharmaceutical Fraud & Counterfeiting. SMI Conference Document 6th to 7th October

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