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W hile consumers may not care if the handbag or pair of trainers they buy is fake, a medicine that is not what it claims to be is no laughing matter. At best, a fake medicine will do nothing to relieve a patient's condition: at worst, a fake medicine containing toxins such as arsenic or anti-freeze can kill. Yet fake medicines are a booming glob-al trade. Producers of fake medicines are evolving from basement operations to manufacturing on an industrial scale. A diverse range of players are involved in their manufacture and distribution, including medical professionals such as pharmacists and physicians, criminal groups, rogue local pharmaceutical companies, organised crime syndi-cates, corrupt government officials and terrorist organisations 1 . An increasing Producers of fake medicines are evolving from basement operations to manufacturing on an industrial scale.
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www.emhn.org Fake Medicines in Asia
FEB
2013
1
EMHN BRIEFING No.1
Fake medicines in Asia
Philip Stevens & Dr. Helmy Haja Mydin
While consumers may not care if
the handbag or pair of trainers
they buy is fake, a medicine that is
not what it claims to be is no laughing
matter. At best, a fake medicine will do
nothing to relieve a patient’s condition:
at worst, a fake medicine containing
toxins such as arsenic or anti-freeze
can kill.
Yet fake medicines are a booming glob-
al trade. Producers of fake medicines
are evolving from basement operations
to manufacturing on an industrial scale.
A diverse range of players are involved
in their manufacture and distribution,
including medical professionals such
as pharmacists and physicians, criminal
groups, rogue local pharmaceutical
companies, organised crime syndi-
cates, corrupt government ocials and
terrorist organisations1. An increasing
Producers of
fake medicines
are evolving
from basement
operations to
manufacturing
on an industrial
scale.
Summary
Fake medicines - which are either criminally motivated or the result of
lax manufacturing standards - are a worsening problem, particularly in
Asia. In some of poorer parts of the continent, up to a quarter of medi-
cines fail quality tests.
Evidence shows that cheap generic drugs are the most faked medi-
cines in Asia, although there appears to be a particular problem with
anti-malarial drugs in places such as Laos and Cambodia. China and
India appear to be production hotspots.
Producers and purveyors of fake medicines are exploiting the increas-
ing globalisation of the pharmaceutical supply chain, poorly defined and
enforced civil and criminal laws, and a lack of an international definition
of what legally constitutes a fake medicine.
International eorts to combat fake medicines have been hampered by
the inability of countries to agree on a legal definition for fake medicines.
Legal scholars and health experts are now pushing for a global treaty to
correct this problem and allow for greater cooperation between nation-
al authorities, but this will be many years o.
At any rate, a treaty will only be as eective as the legal and regulatory
enforcement capacity in the worst aected countries. In many coun-
tries, general weakness of the rule of law is at the heart of the problem
of fake medicines, so it is unclear how adding more and stricter laws
and regulations will address this very basic shortcoming.
Technology can help legitimate manufacturers protect their brands,
and this is discussed in the next EMHN briefing paper.
www.emhn.org Fake Medicines in Asia
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EMHN BRIEFING No.1
February 2013
body of evidence suggests that much
of the supply of fake medicines orig-
inates in Asian countries including
China and India.
Despite the seriousness of this global
issue, the international community
has yet to agree on the best path of
action. An international treaty is being
discussed, and most stakeholders call
for greater regulation and harsher crim-
inal sanctions. But are such measures
necessarily the best way of tackling this
complex problem?
This is the first of a two-part briefing
which examines the scope and causes
of the fake medicines industry, and
assesses some of the international
initiatives that are being implemented
to tackle the problem. The second part
will look at some potential solutions.
What are fake medicines?
Broadly, fake medicines fall into two
main categories: drugs with intention-
ally falsified ingredients, and those
whose content is unintentionally sub-
standard due to poor manufacturing
practices.
Medicines with intentionally falsi-
fied ingredients are usually made
with criminal motives and often mas-
querade behind the brand or trade-
marks of legitimate manufacturers.
The consumer has no guarantee
as to the content of such products,
which may contain therapeutically
insucient levels of active ingre-
dient, inactive substances such as
chalk, or even toxins. Such products
are a major public health threat.
Substandard medicines, which are
legitimately manufactured but are
sold to the consumer after undergo-
ing one or more regulatory failures
such as manufacturing error, degra-
dation in transit or storage, or expi-
ration. These medicines are likely
to be therapeutically substandard,
and therefore must be considered a
public health threat.
In practice, overlaps between deliber-
ately falsified and negligently substan-
dard medicines are inevitable. Studies
in locations suering from poor quality
drugs typically discover both. It can be
extremely dicult to dierentiate be-
tween the two, as it is not always clear
whether the actions leading to faulty
drugs were deliberate. Furthermore,
the dierence is of little concern to a
patient harmed by bad medicine.
As it is dicult to distinguish between
falsified and substandard medicines,
and because they both pose a con-
siderable threat to health, for simplicity
this briefing paper refers to all such
medicines as “fakes”.
How big is the problem
globally?
The problem of fake medicines is clear-
ly worsening, although the diculty of
identifying fake products makes it im-
possible to gauge its true extent. Until
recently, the World Health Organisation
(WHO) suggested that 10-30% of medi-
cines circulating in lower and middle-in-
Asia
Latin America
Europe
Eurasia
N. America
Near East
Africa
954
40%
381
16%
351
15%
257
11%
237
10%
128
5%
64
3%
Figure 1:
Pharmaceutical crime incidents by region, 2011
Source: Pharmaceutical Security Institute 2011
The most widely faked medicines in Asia are
cheap o-patent drugs.
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EMHN BRIEFING No.1
February 2013
come countries were fakes; however it
no longer cites a particular figure.
Some figures cited by international or-
ganisations give some indication of the
extent of the problem:
Between 10 and 30% of medicines
in developing countries are fake, ac-
cording to the International Medical
Products Counterfeiting Taskforce 2
In 2011, 1,986 pharmaceutical crime
incidents were documented glob-
ally (including counterfeiting, theft,
and illegal diversion), with nearly
half of seizures made by enforce-
ment ocials being of ‘commercial
size’3.
According to WHO, 50% of medi-
cines purchased over the Internet
(from illegal sites that conceal their
physical mailing address) were
found to be counterfeit4.
How big is the problem in
Asia?
According to the Pharmaceutical Se-
curity Institute, Asia suered from the
highest numbers of incidents of phar-
maceutical crimes in 2011 (although
this may understate the extent of the
problem in Africa, which generally suf-
ferers from poor enforcement capacity)
(Figure 1).
Fake anti-malarial drugs appear to be
a particular problem in mainland South
East Asia. A recent study found 38%
to 53% of samples purchased from
pharmacies and shops to be fake, with
many packages bearing falsified secu-
rity holograms5.
Malaysia, a wealthier country with a rel-
atively well developed regulatory and
legal environment, has a fake medicine
prevalence of roughly 3-5% of all med-
icines in circulation. By contrast, poorer
countries tend to suer from higher
rates (Figure 2). For instance, the Inter-
national Pharmaceutical Manufacturers
Group (IPMG) in Indonesia has estimat-
ed that fake drugs constitute 25% of In-
donesia’s US$2 billion pharmaceutical
market6.
Why is there an increase in
fake drugs?
Fake drugs in recent decades have
surged largely because the rewards of
Prevalence of fake medicines in
Malaysia
Prevalence of fake medicines in a sample of
lower-income Asian countries
According to MoH studies, 5.2% of medicines
sold over the counter are fake.
In 2006, Pfizer (Malaysia) found that 4.8% of its
proprietary drugs (Viagra, Norvasc and Lipitor)
were fake.
Malaysian pharmacy enforcement ocers found
362 fake medicines batches amongst 11,934
seized (3.03%).
In 2005, a study by the Pharmaceutical Associa-
tion of Malaysia found 5% of prescription med-
icines were fake, including eye drops, inhalers,
and medication for erectile dysfunction (where
incidence was 8.5%).
In 2007, fake medicines totaling a value of
US$10.6m were seized in Malaysia, an increase
of 40% since 2004
A 2008 report by Espicom found that “coun-
terfeiting…makes up an estimated 5 %” of the
pharmaceutical market in Malaysia
In 2006 a study throughout Laos, Myanmar,
Vietnam, Cambodia found that 68% of artesuna-
te (anti-malaria) drugs did not contain the correct
amount of active ingredient (Alter Hall, 2006).
27% of anti-malarial drugs tested in Cambodia
in 2006 were found to have incorrect levels of
active ingredient (Lon, 2006).
22% of sampled antibiotics and anti-malarial
drugs sampled in Laos in 2004 had incorrect
levels of active ingredient.
7% of a sample of anti-malarial, TB and antibiotic
drugs tested in major Indian cities failed quality
testing (Bate, 2012).
The Federation of Indian Chambers of Commerce
claim that 15-20% of medicines on sale in India
are fake7, although the government claims the
rate is 0.04% based on its own research.
Figure 2
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EMHN BRIEFING No.1
February 2013
common and inexpensive medicines
that have long seen their patents ex-
pire (Figure 3).
This suggests that counterfeiters tar-
geting Asian countries prefer to exploit
therapeutic classes for which there is
a large potential market, rather than
exploiting the higher price dierentials
that could be derived by faking on-pat-
ent medicines (which tend to have
smaller markets).
Although Malaysia has relatively low
rates of fake medicines compared to
certain ASEAN neighbours, there are
some concerns about the quality and
integrity of the many traditional medi-
cines that are widely sold in the country.
A study published in 2005 found
that 14% of tested Smilax Luzon-
ensis (more commonly known as
Akarbanar) contained 0.51–1.23ppm
mercury, thereby contravening
quality requirements for traditional
medicines in Malaysia9.
faking medicines far outweigh the risks.
Manufacturers and purveyors of fake
medicines can make large profits while
running minimal risks of detection. The
chance of a successful criminal prose-
cution or civil action is even less likely.
Faking medicines has become a rel-
atively low-risk activity as a result of
some major deficiencies in the legal
systems of the worst aected countries:
Weak or absent rule of law, wherein
fake medicine producers may be
able to bribe law-enforcement o-
cials to turn a blind eye, or where the
drug regulation agency becomes
corrupted.
Inability of brand owners to protect
their trademarks due to inadequate,
unenforceable or absent legislation .
Lack of adequate civil liability laws,
which would allow consumers
harmed by fake products to sue the
perpetrator for damages – thereby
discouraging such activity.
A lack of a global consensus as
to what legally constitutes a fake
medicine, making it easier to exploit
global supply chains, parts of which
may pass through locations where
legislation is weak and /or poorly
enforced.
Dierent kinds of products
Fake medicines can include both
on-patent branded medicines, and
common and cheap generic medicines,
such as analgesics, anti-infectives and
even vitamin pills.
Generic medicines are particularly pop-
ular targets in poorer Asian countries:
the top five most faked medicines in
Indonesia and the Philippines are all
Rank Indonesia Philippines
Drug Class Drug Class
1Ponstan
500mg
Painkiller Adalat Gits
30mg tablet
Anti-hyperten-
sive
2Fansidar tablet Anti-malarial Ventolin
Expectorant
syrup
Anti-asthma
3Dextamine
tablet
Antihistamine Ponstan
500mg
Painkiller
4Glibenclamide
tablet
Anti-diabetic Diatabs
reformulated
Anti-diarrhoeal
5Ponstan
250mg capsule
Painkiller Propan syrup Vitamins
Figure 3: Top five faked medicines in Indonesia and Philippines
The globalisation of pharmaceutical supply
chains has created new opportunities for the
fake medicines trade
Source: Cockburn et al, 2005; National Agency of food and Drug Control, Indonesia, 20078
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EMHN BRIEFING No.1
February 2013
In 2012, the Health Director General
in Malaysia advised the public to
stop buying the traditional product
Mymen Plus after it was found to
contain a scheduled poison10.
Where do fake medicines
originate?
Given the complexity of global pharma-
ceutical supply chains and the increas-
ing technical skill of counterfeiters, it is
dicult for researchers and authorities
to determine the exact origins of a fake
product. There is an increasing body of
evidence to suggest that the two main
fake medicine producing countries are
India and China. India, home to up to
16,000 small drug producers, appears
in particular to be a major production
area:
According to 2005 TAXUD statistics
released by the European Commis-
sion, 75% of global cases of coun-
terfeiting originate from India, 7%
from Egypt and 5% from China11.
A 2004 survey of medicines on sale
at a large bazaar in New Delhi found
that only 7.5% were genuine. A re-
port in an Indian newspaper said
that fakes are freely sold to “export-
ers who sell them to unsuspecting
health administrators in Sub-Saha-
ran Africa, who receive some of the
millions in aid money”12.
In 2008 the Nigerian government
banned imports from 22 Indian
pharmaceutical firms13 and even set
up an oce for their regulator (NAF-
DAC) in India in order to improve the
quality of the drug supply.
China is also implicated as a major pro-
duction source for fake medicines:
Negative impacts of fake medicines
Increased mortality and morbidity as sick people are not treated
correctly or actively harmed by toxic products.
Development of drug resistance, particularly for anti-malarials,
anti-infectives and anti-retrovirals.
Adverse eects from incorrect active ingredients.
Loss of confidence in health systems and health workers.
Economic loss for patients and health systems.
Undermining of drug research and development as innovator drugs
compete with fake versions.
Crowding out of legitimate drug manufacturers, who have made
costly investments in bringing their plants up to Good Manufactur-
ing Practice
A general erosion of confidence in health systems and the medi-
cines supply, making it less likely that the sick will come forward for
treatment
There is an
increasing
body of
evidence
to suggest
that the
two main
fake medicine
producing
countries are
India and China.
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EMHN BRIEFING No.1
February 2013
In 2008, concerns about the qual-
ity of China’s drug manufacturing
industry and its potential impact
on US patients led the US Federal
Drug Administration to establish its
first overseas oce in Beijing.14
In 2009, Nigeria’s NAFDAC stated
that that a large consignment of
fake generic anti-malarial pharma-
ceuticals labelled “Made in India”
were, in fact, found to have been
produced in China.15
A 2008 investigation into the prov-
enance of a range of fake anti-ma-
larial products circulating in South
East Asia found definitive proof
that many samples originated from
the China/SE Asia border. This was
determined after forensic analysis
found pollen samples from plants
that grow only this region.16
There is also evidence that counterfeit-
ers are taking advantage of the minimal
customs bureaucracy of free trade
zones such as Dubai, Mauritius, Panama
and Hong Kong to penetrate legitimate
pharmaceutical supply chains. Accord-
ing to an investigation by the New York
Times, nearly a third of all counterfeit
drugs confiscated in Europe in 2006
transited via the United Arab Emirates17.
The costs of fake medicines
The main risk of fake medicines is to
individual health. At their most danger-
ous, fake medicines can contain toxic
materials that are actively harmful to
health. For example, 80 patients died
in the US in 2008 after taking Chinese
manufactured Heparin (an anti-coagu-
lant) that had been contaminated with
over-sulphated chondroitin sulphate.
Other examples of toxic contaminants
found in fake medicines include heavy
metals such as lead or arsenic, rat poi-
son, road paint, anti-freeze and floor
wax.18
There are also wider public health risks
to fake medicines. Drug resistance can
occur when a patient suering from a
disease caused by a micro-organism or
parasite, such as malaria or tuberculo-
sis) takes a fake with a sub-therapeutic
amount of active ingredient. The dose
will not be enough to kill the micro-or-
ganism, which will then learn how to
outwit the drug, resulting in drug-resis-
tant strains of disease.
This is currently an acute problem with
tuberculosis in sub Saharan Africa, and
is a worsening problem in South East
Asia.19
Drug resistant forms of malarial para-
site have also rendered all classes of
anti-malarials next to useless in treating
the disease in many parts of the world,
with the exception of newer artemisi-
nin-based treatments. There are now
concerns that these too will be outwit-
ted by malaria parasites as a result of
the high prevalence of fakes circulating
in South East Asia. In 2012 a team of re-
searchers wrote a report in The Lancet,
showing evidence of drug resistance to
artemesinin therapies on the border of
Thailand and Myanmar, increasing con-
cern that resistance could soon spread
to India, and subsequently Africa20.
What is being done at the
international level?
It is clear that fake medicines are not
only a growing menace in the poorer
Asian countries, but that they are pen-
etrating the supply chain even in rela-
tively tightly regulated markets such as
Malaysia.
Given that fake medicines have thrived
Toxic
contaminants
found in fake
medicines
include
heavy metals
such as lead or
arsenic,
rat poison,
road paint,
anti-freeze and
floor wax.
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EMHN BRIEFING No.1
February 2013
on the globalisation of pharmaceutical
supply chains, many have looked to
the UN’s specialist health agency, the
World Health Organization, to provide
the appropriate global regulatory and
legal framework to member states, in
particular an internationally recognised
legal definition for fake medicines. This
is a vital precondition of concerted in-
ternational action to combat a problem
that involves perpetrators moving fake
goods across multiple borders and op-
erating in multiple jurisdictions.
However, it has so far been impossi-
ble for the international community to
agree on a definition for fake medicines.
The WHO’s attempt at its International
Medical Products Anti-Counterfeiting
Taskforce (IMPACT) was ultimately de-
railed at a meeting of the World Health
Assembly in 2010 by India, on the
back of ill-founded fears that an overly
restrictive definition would be used to
hinder its powerful generics industry
– even though the future profitability of
the Indian generics industry is entirely
dependent on maintaining a reputation
for producing safe, high quality medi-
cines.
In 2010 the Council of Europe ratified
the MEDICRIME convention, to which
EU member states and a number of for-
mer Soviet states are signatories. While
this treaty provides signatories with
useful clarity over what legally consti-
tutes a fake medicine, it is unlikely that
a European-led convention will attract
signatories from Asia and other emerg-
ing markets where the main locus of
the problem lies.
There are few regional Asian initiatives
of note, with the exception of Interpol
activities and ASEAN attempts to
harmonise medical systems in order
to promote greater trade in health ser-
vices between members. But ASEAN’s
eorts have been hampered by high
rates of counterfeit medical products,
particularly in countries like Thailand
and Cambodia.21
Increasing numbers of health policy ex-
perts and legal scholars are now push-
ing for an international treaty in order
to coordinate global action against the
scourge of fake medicines. According
to its proponents, “the lack of a treaty
means there is generally no agreement
on which medicines are wrongful or
criminal; no requirement for police to
cooperate across borders in carrying
out international investigations; and no
requirement for prosecutors to share
evidence or to respond to extradition
requests to bring perpetrators to jus-
tice.”22 As an example, Indonesia does
not identify medical counterfeiting as
a specific crime, which hampers the
ability of enforcement ocials to seize
fake products and proceed against
perpetrators.
An international treaty would correct
such problems by providing to signa-
tory countries an agreed international
definition for the various kinds of fake
medicines; define new public health
crimes in international law regard-
ing fake medicine manufacture and
trade; and provide new resources for
strengthening regulatory capacity in
countries where regulation is weakest.
A treaty would provide an important
framework to begin addressing the
problem of fake medicines, but it is
clearly many years o given the diver-
gent industrial interests of emerging
and developed economies. Further, it
will only be as eective as the ability
of signatory countries to enforce reg-
ulations, minimise ocial corruption
and uphold the rule of law – an ability
that is lacking in many Asian countries
(particularly India, Pakistan, Cambodia,
Indonesia does
not identify
medical
counterfeiting
as a specific
crime,
which hampers
the ability of
enforcement
ocials to seize
fake products
and proceed
against
perpetrators.
www.emhn.org Fake Medicines in Asia
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EMHN BRIEFING No.1
February 2013
Vietnam, Philippines and Thailand).23
There is also the risk that a treaty might
add further layers of bureaucracy to the
process of drug approval, potentially
delaying market access to innovative
therapies.
The limits of regulation
Most academic and NGO commen-
tators on the problem of fake medi-
cines typically prescribe a mixture of
stronger regulation, harsher criminal
penalties, and an increase of enforce-
ment activities against individual per-
petrators. Many countries in Asia are
indeed increasing regulatory capacity
and redrafting penal codes to further
criminalise the fake medicines trade –
even introducing the death penalty, in
the case of China, India and the United
Arab Emirates. Governments are also
stepping up enforcement, with China
arresting 1,900 people in August 2012,
for instance.24
In countries where the rule of law is
weak, the creation of new regulatory
layers and tougher criminal sanctions
may be counterproductive, as new
powers for regulators create opportu-
nities for bribery and corruption. Major
corruption scandals within drug regula-
tory bodies occurred in Nigeria in 2000
and Italy in 2008, while in 2012 the
Indian Central Drugs Standard Control
Organisation was found to be colluding
with both local and multinational phar-
maceutical companies over the approv-
al of drugs in the country.25
To be eective, stier criminal pen-
alties depend on an ecient and fair
rule of law, something which does
not exist in many Asian countries,
particularly the poorer ones which
have the greatest problem.
the creation of
new regulatory
layers and
tougher criminal
sanctions may
be counterpro-
ductive, as
new powers
for regulators
create
opportunities
for bribery and
corruption.
About the Authors
Philip Stevens is Executive Director
of Emerging Markets Health Network
Dr Helmy Haja Mydin is a Fellow
at the Institute for Democracy and
Economic Aairs (IDEAS) Malaysia.
Both can be contacted at
info@emhn.org
Stronger criminal penalties will
likely drive activities further into the
hands of organised criminal cells
and will also likely result in further
corruption, as the criminal cells
seek to infiltrate law-enforcement
agencies. The fake medicines trade
is already showing worrying signs of
mafiaisation, with organised crime
groups such as Chinese triads and
Mexican drug gangs all becoming
implicated in the trade over the past
decade. Increasing evidence also
implicates the involvement of Hez-
bollah and al Qaeda.
The increase in seizures by Interpol
and others in recent years is more a
symptom of - rather than a solution
to - the problem. They do nothing
to address the more deep-seated
origins of the problem, as has been
amply demonstrated by the failure
of similar strategies over the last 50
years with illegal narcotics.
More eective solutions must
address its fundamental cause,
which revolve around the inability of
legitimate manufacturers to protect the
integrity of their brands. Legal reforms
can go some way towards addressing
these problems, as can innovative uses
of technology. These are discussed in
the second of this two part briefing
paper.
www.emhn.org Fake Medicines in Asia
9
EMHN BRIEFING No.1
February 2013
EMHN is a project of Malaysia’s Institute for Democracy and Economic Aairs (IDEAS) that aims to help
emerging markets address their health challenges by exploring the potential of markets and the private
sector. EMHN works with its network of scholars, think tanks and thought leaders to ensure this perspective
is heard in policy debates in Asia, Latin America and Africa. Examples of EMHN activities include:
Coordinating the writing and dissemination of policy papers, monographs and opinion editorials
Conducting public seminars and events
Providing commentary to the media on topical health policy issues
References
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... In 2013, Malaysia reported a prevalence of 3-5% of UMPs in the local market [12]. However, this provided little insight to authorities and policy makers on the actual prevalence of UMPs among MMRs, as the source of UMPs or methods of identification were not recorded, and this was limited to specific types of medicine [12]. ...
... In 2013, Malaysia reported a prevalence of 3-5% of UMPs in the local market [12]. However, this provided little insight to authorities and policy makers on the actual prevalence of UMPs among MMRs, as the source of UMPs or methods of identification were not recorded, and this was limited to specific types of medicine [12]. It was deemed that a similar study covering MMRs in Malaysia, regardless of types and brand of MPs and using a reproducible methodology, was warranted. ...
... In 2005, the Pharmaceutical Association of Malaysia reported that 5% of prescription medicines comprising eye drops, inhalers and medicines for erectile dysfunction, were fake [12,19,20]. In 2006, the pharmaceutical company Pfizer conducted a market survey on its innovator drugs (Viagra, Norvasc and Lipitor) in Malaysia, which revealed that 4.8% were counterfeited products [12,19]. ...
Article
Background Globally, substandard and falsified medical products (SFMPs) have been a major public health concern, and can be devastating to patients’ safety. In Malaysia, the detection of unregistered medical products (UMPs) by the Pharmacy Enforcement Division (PED) officers among mainstream medicines’ retailers (MMR), aims to curb the distribution of SFMP to the public. Objective This study explored the UMP detected by PED officers during routine inspections among the MMR that were sampled for the screening of UMP. The MMR include private medical clinics (PMCs), retail pharmacies (RPs) and non-pharmacy drug stores (NPDS). Methods This was a retrospective cross-sectional study that gathered the relevant information using a data collection form, from the routine inspection reports (RIRs) of the MMR in Sarawak throughout the year 2016. Of the 361 PMCs, 242 RPs and 894 NPDS that underwent routine inspection during the study period, a total of 20 PMC, 23 RP and 43 NPDS were selected by the senior PED officer in charge of the inspection unit to undergo screening of UMPs and were included for the purpose of this study. The top 10–12 MP, which were commonly used and had high turnover, based on the sales record of every premises, were sampled. The methods used to detect UMP were through the searching of online product registration database “QUEST 3”, the vetting of the Meditag™ Hologram (MH) using its decoder and the vetting of the MH serial numbers through Meditag Online Ordering System. Data analyses were conducted with SPSS V20.0. Results From the 86 premises selected for screening of UMPs, a total of 888 MPs were sampled and recorded into RIR. It was found that 4 out of 888 (0.45%) samples were UMP. Each the UMPs were found in NPDS. In term of types of the UMP found, two were traditional medicines, one was a controlled medicine and one was an over-the-counter medicine. Conclusion The findings of this study provide preliminary information to relevant authorities on the UMPs detected by PED officers during routine inspections among selected MMRs.
... Consumers in developing countries are used to purchasing traditional and complementary medications, sometimes without proper labelling and maybe sometimes indifferent when receiving their medications without proper labelling. [12,21] The public needs to be adequately informed about the risks of unregistered medicinal products [22,23] and learn to lodge a report to relevant authorities when necessary. Strong correlations between knowledge of the need for medication registration in Malaysia and the attitude of opposing unregistered drug use, as demonstrated by the current research, underpin the value of awareness. ...
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Objective Unregistered medications which are lacking regulation in terms of safety, efficacy and quality may cause unpredictable adverse drug reactions (ADRs) in consumers. Therefore, this study aimed to assess the public knowledge, attitude and practice of consuming and purchasing unregistered health products in Malaysia. Methods A cross‐sectional study involving members of the Malaysian public was carried out using the convenience sampling method. Descriptive statistics were used to summarise the socio‐demographic characteristics of the respondents. Associations between knowledge items/scores and other items were assessed using Spearman’s rank correlations and Cramer’s V. Regression analyses were carried out to determine whether the socio‐demographic characteristics of the respondents influenced knowledge and practice relating to unregistered medications. Key findings A total of 649 respondents completed the questionnaire with the majority being female (66.1%), unmarried (66.5%), Malay (52.5%) and possessing a bachelor’s degree (53.5%). The knowledge of the public surveyed regarding unregistered (unlicensed) medications was lacking, especially in being able to identify a registered health product in Malaysia and formally complaining if necessary. The respondents agreed that currently, there are insufficient laws and educational programmes to tackle the issue. The respondents exhibited good practice habits by purchasing their medications from healthcare professionals. Mean knowledge score was positively correlated to practice scores at rs = 0.423 (P‐value < 0.001). Ethnicity and education level were significant predictors of knowledge scores, while ethnicity, age and income group influenced practice‐related items. Conclusion While respondents generally had good medication purchasing practices, their knowledge about and attitude to unregistered medications indicated the need for more educational awareness of the issues.
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Article
For the past several decades, global health research and policy have raised the alarm about the growing threat of counterfeit and low-quality drugs (henceforth ‘fakes’). These high-profile and regularly-repeated claims about ‘fake drugs’ pepper scholarly publications, grey literature, and popular writing. We reviewed much of this work and found that it shares two characteristics that sit awkwardly alongside one another. First, it asserts that fake drugs constitute an urgent threat to lives. Second, it reports trouble with ‘gaps’ in the evidence on which their claims are based; that data is weaker and less conclusive than anticipated. Given the ubiquity of and urgency with these claims are made, we found this juxtaposition perplexing. To understand this juxtaposition better, we undertook a close reading of the strategies authors employed to negotiate and overcome data and evidence ‘gaps’ and asked questions about the cultures of scholarly publishing in global health research. We argue that a scholarly commitment to studying fakes despite--rather than because of—the evidence functions to support the continuation of similar research. It also works against asking different questions—for instance regarding the lack of easy access to pharmacological data that might make it possible to know fakes differently.
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Article
Substandard and falsified medicines kill patients, yet progress on the twin challenges of safeguarding the quality of genuine medicine and criminalising falsified ones has been held back by controversy over intellectual property rights and confusion over terms. Amir Attaran and colleagues propose a global treaty to overcome the problems.
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Article
Since 1998 the serious public health problem in South East Asia of counterfeit artesunate, containing no or subtherapeutic amounts of the active antimalarial ingredient, has led to deaths from untreated malaria, reduced confidence in this vital drug, large economic losses for the legitimate manufacturers, and concerns that artemisinin resistance might be engendered. With evidence of a deteriorating situation, a group of police, criminal analysts, chemists, palynologists, and health workers collaborated to determine the source of these counterfeits under the auspices of the International Criminal Police Organization (INTERPOL) and the Western Pacific World Health Organization Regional Office. A total of 391 samples of genuine and counterfeit artesunate collected in Vietnam (75), Cambodia (48), Lao PDR (115), Myanmar (Burma) (137) and the Thai/Myanmar border (16), were available for analysis. Sixteen different fake hologram types were identified. High-performance liquid chromatography and/or mass spectrometry confirmed that all specimens thought to be counterfeit (195/391, 49.9%) on the basis of packaging contained no or small quantities of artesunate (up to 12 mg per tablet as opposed to approximately 50 mg per genuine tablet). Chemical analysis demonstrated a wide diversity of wrong active ingredients, including banned pharmaceuticals, such as metamizole, and safrole, a carcinogen, and raw material for manufacture of methylenedioxymethamphetamine ('ecstasy'). Evidence from chemical, mineralogical, biological, and packaging analysis suggested that at least some of the counterfeits were manufactured in southeast People's Republic of China. This evidence prompted the Chinese Government to act quickly against the criminal traders with arrests and seizures. An international multi-disciplinary group obtained evidence that some of the counterfeit artesunate was manufactured in China, and this prompted a criminal investigation. International cross-disciplinary collaborations may be appropriate in the investigation of other serious counterfeit medicine public health problems elsewhere, but strengthening of international collaborations and forensic and drug regulatory authority capacity will be required.
Article
Artemisinin-resistant falciparum malaria has arisen in western Cambodia. A concerted international effort is underway to contain artemisinin-resistant Plasmodium falciparum, but containment strategies are dependent on whether resistance has emerged elsewhere. We aimed to establish whether artemisinin resistance has spread or emerged on the Thailand-Myanmar (Burma) border. In malaria clinics located along the northwestern border of Thailand, we measured six hourly parasite counts in patients with uncomplicated hyperparasitaemic falciparum malaria (≥4% infected red blood cells) who had been given various oral artesunate-containing regimens since 2001. Parasite clearance half-lives were estimated and parasites were genotyped for 93 single nucleotide polymorphisms. 3202 patients were studied between 2001 and 2010. Parasite clearance half-lives lengthened from a geometric mean of 2·6 h (95% CI 2·5-2·7) in 2001, to 3·7 h (3·6-3·8) in 2010, compared with a mean of 5·5 h (5·2-5·9) in 119 patients in western Cambodia measured between 2007 and 2010. The proportion of slow-clearing infections (half-life ≥6·2 h) increased from 0·6% in 2001, to 20% in 2010, compared with 42% in western Cambodia between 2007 and 2010. Of 1583 infections genotyped, 148 multilocus parasite genotypes were identified, each of which infected between two and 13 patients. The proportion of variation in parasite clearance attributable to parasite genetics increased from 30% between 2001 and 2004, to 66% between 2007 and 2010. Genetically determined artemisinin resistance in P falciparum emerged along the Thailand-Myanmar border at least 8 years ago and has since increased substantially. At this rate of increase, resistance will reach rates reported in western Cambodia in 2-6 years. The Wellcome Trust and National Institutes of Health.