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The Health | june-july, 2020
| Probe |
A global
crime network
By Khirtini K Kumaran
While once we may need to
worry about buying counterfeit
medication from street vendors or
sundry shops, the fakes have now
infiltrated legitimate supply chains and
pharmaceutical businesses.
The production, manufacturing
and distribution process of legitimate
medicines are quite complex. As such,
counterfeiters are taking advantage of
the loopholes of this complex process
to introduce counterfeit medications
into licensed pharmaceutical markets.
According to the United Nations
Interregional Crime and Justice
Research Institute (UNICRI),
repackaging is one such example of
a loophole. The problem arises when
original pharmaceutical products cross
the borders of various countries, and
numerous importers, retailers and
distributors are involved.
The repackaging process that takes
place throughout the distribution and
shipment procedure offers extensive
possibilities of introducing counterfeit
medicines to the legal supply channels.
In a case that shocked Vietnam,
six former executives of a private
pharmaceutical company there were
found guilty of forging paperwork to
distribute fake cancer drugs in 2017.
They claimed the medicines were
manufactured by a Canadian company,
which investigators found to be nonexistent.
UNICRI states that there are
overwhelming numbers of rogue
pharmacies selling uncontrolled
medicines that may not comply with
legal standards and regulations.
Without any prescription requirement
and review, or any origin and quality
guarantee of the product purchased,
patients are defenceless.
What makes worse is that these
counterfeiters can successfully conceal
their identity behind a well-designed
website, which makes it hard for the
authorities to track them.
The counterfeiting business is
a lucrative business with low risks,
especially where regulations and
enforcement are weak, and penalties
are mild. Counterfeiters are enticed
as the profits far outweigh the cost of
repercussions.
The UNICRI states that
counterfeiting is nothing but one more
“feed-gear” for organised criminal
groups to receive more “funds”.
The prevalence of counterfeit
medicine is growing, and it is
detrimental to global health and
socioeconomic development.
Dr N Ganabaskaran.
Datin Dr Faridah Aryani.
Zeff Tan.
The need for stringent
countermeasures
Strong legislation, regulatory and
enforcement framework is paramount
in the efforts to combat the prevalence of
counterfeit and substandard medicines in
Malaysia.
“All medicinal products in Malaysia
must be registered with the MoH first
before being marketed to consumers,
including products made overseas.
Registered products are guaranteed in
terms of Safety, Quality and Efficacy,”
warned Dr N Ganabaskaran, president of
Malaysian Medical Association (MMA).
“The registered product has a MAL
registration number and a hologram safety
label on its packaging. If a drug product
does not have both of these features, it is
unlikely to be registered with MoH.”
The public can verify the number on
the National Pharmaceutical Regulatory
Agency (NPRA) website. Since January
2005, in addition to the MAL registration
number, the safety label, hologram
Meditag, is used to authenticate and verify
that products sold are registered.
“At times, they (counterfeits) may
look similar, and the prices can be lower
compared to the drugs registered with
MoH. The public can check this with the
NPRA's website. Check the source of the
drug if it came from a certified health
facility that can prescribe and dispense
drugs,” he said.
He added private clinics in Malaysia
were highly-regulated with more than
53 laws, and there are a few laws that
explicitly regulate the purchase and sale of
drugs with deterrent sentences.
Duopharma, on its part, has invested
heavily to introduce the “Track and Trace”
system which uses a unique identifier
barcode in the form of QR code printed on
The PED, however, works together
with the KPDNHEP to combat the
sales of counterfeit medicines
through facilitating detection of
counterfeit medicines and their
removal from the market during
inspections, raids and other
enforcement activities.”
– Dr Faridah Aryani
the packaging, up to the unit of sales or
unit of doses. This QR code can be used to
trace its manufacturing information and
be located throughout various stages of the
supply chain.
“Another initiative which we are
exploring, albeit from a halal perspective,
is to undertake a study to understand
how blockchain technology can help us to
trace each product down to individual raw
materials to approved suppliers,” Leonard
shared.
This, he said, maybe applicable in the
context of identifying fake or counterfeit
products as each unit of an SKU would be
traceable within their system.
He added: “Should there be any doubts;
consumers can verify the authenticity of
the purchase with our representatives.
We have and will continue to work
closely with the regulatory authorities to
perform routine market surveillance for
reports or complaints from consumers,
and it includes concerns on counterfeit
medicines.”
The PED is the primary enforcement
body authority responsible for tackling
unregistered and adulterated medicines,
while counterfeit products are under the
purview of the Ministry of Domestic Trade
and Consumer Affairs (KPDNHEP).
“The PED, however, works together
with the KPDNHEP to combat the sales of
counterfeit medicines through facilitating
detection of counterfeit medicines and
their removal from the market during
inspections, raids and other enforcement
activities,” stated Dr Faridah Aryani.
There has also been close collaboration
between PED with other agencies at
the national and global level. Since
2012, the PED, teaming up with the
Royal Malaysian Customs Department
(RMCD), Cybersecurity Malaysia (CSM)
and the Malaysian Communications and
Multimedia Commission (MCMC), have
collaborations with Interpol with the
Pangea and STORM Operations. Globally,
the operations, which involves over 100
countries, resulted in arrests and the
seizure of millions of units and packages.
Websites were also shut down.
Apart from strict regulations and
enforcement, consumer awareness of the
quality of medicine use is fundamental.
Those who lack knowledge regarding the
existence of counterfeits medicines and
its dire health side effect are bound to
purchase without the doubt or suspicion.
“Consumer education is needed to create
awareness of the dangers of counterfeit
drugs and medicines and most importantly
on how to identify genuine and fake
medicines,” said Paul Selvaraj.
Dr Faridah Aryani acknowledges the
importance of awareness and states that
the PED continuously educates the public
on the danger of taking unregistered or
counterfeit or fake medicines through
talks, campaigns, exhibitions broadcasts
on radio and national TV, publications in
newspapers and social media.
Counterfeit medicines are detrimental
to the health of the public and the
reputation of the healthcare system
and profession. Constant and deterrent
cooperation among all stakeholders to
combat this issue is required.
With more stringent enforcement from
authorities and higher awareness among
consumers, the eradication of counterfeit
and substandard medicines is possible if all
parties work together.
An international and local collaboration
between enforcement and legal
departments is also crucial to track and
put an end to this growing menace. — The
Health