The full version of this counterfeiting feature can be read in the July issue of our digital magazine: http://www.pharmtech.com/ptedigital0710
To date, the pharmaceutical industry's primary defence to counterfeiting is to create more sophisticated packaging that makes
imitation more difficult, such as packaging involving barcoding and RFID. However, counterfeiters are becoming increasingly
sophisticated and this approach ultimately only secures the packaging rather than the product itself. Also, implementing an
RFID strategy can be very costly from an operational standpoint because it requires additional manpower and also introduces
some technology hurdles that must be overcome before it can be more broadly applied. For example, each individual pallet or
package requires an individual RFID chip, which despite decreasing prices, still costs about 7–15 cents. In the case of the
Viagra implementation in 2006, Pfizer ultimately spent $5 million on just the pilot phase of their RFID tagging initiatives.1 Additionally, there are also unsettled questions about whether the RF energy used to read the tags may impact sensitive
One analytical technique that has gained significant traction in the fight against counterfeits is Raman spectroscopy, which
was originally created for use in condensed matter physics and chemistry where it was used to study vibration, rotational
and other low-frequency modes in a system. The biggest difference between Raman spectroscopy and RFID is that the former tests
the actual drug and/or raw materials, which is important for markets where the product is sold without its original packaging.
Raman spectroscopy also accurately identifies chemicals through sealed glass, plastic bottles, plastic bags and blister packs,
which means that the operator does not come into direct contact with the substance. This avoids potential contamination and
preserves the integrity of any evidence that can be used against counterfeiters.
In recent years, Raman spectroscopy has become available as a lightweight, handheld instrument that can identify even slight
differences in drug formulations. This type of instrument can be deployed to authenticate the raw materials and/or finished
products on the spot at points throughout the supply chain, including:
- Ports of inspection — to allow enforcement to execute random sample testing of raw materials and finished products before
they enter the supply chain, thereby eliminating the risk to consumer health.
- Distributors — by making handheld analytical instruments available at massive distribution centers, businesses can catch counterfeit
materials and/or drugs before they are sent to the various worldwide locations, after which they can be very difficult to
track and recall should a problem be identified at a later point in time.
- Point of sale — conducting field inspections at the point of sale is the critical place where these instruments should be
deployed to ensure counterfeit drugs are not ending up in the hands of patients. Additionally, these inspections send a clear
message to counterfeiters because they are done publicly at pharmacies and open markets.
The problems in developing countries
The World Health Organisation (WHO) estimates that counterfeit pharmaceutical levels range from less than 1% in the developed
world to more than 30% in less developed regions. In less developed countries, there are gaps throughout the supply chain
because standards are not as strict as they are in more developed regions. Open markets, where the unauthorised re-sale of
medicines often takes place, are also very prevalent in these regions.
Bringing technologies to less developed countries should be a top priority, and these technologies should ideally be portable
and easy to use with minimal training, which handheld Raman instruments may be able to offer.
Some countries already have an anti-counterfeiting strategy in place. For instance, Nigeria's National Agency for Food and
Drug Administration and Control (NAFDAC) has launched a text messaging service called the Mobile Authentication Service (MAS)
that allows anyone in Nigeria to check the authenticity of their medicines. More than 80% of the population in Africa have
mobile phones, which makes systems such as these highly accessible to the general public.
In combination with its MAS system, Nigeria is also using our handheld Raman instruments to identify even the slightest difference
in drug formulation. After just two weeks of deployments, the instruments had helped authorities seize more than 60000 counterfeit
drugs.3 The technology was also used to help NAFDAC intercept a consignment of counterfeit Lonart DS anti-malarial tablets worth
10 million naira.3 Arrests were made in connection with the incident, which sends a clear message to counterfeiters that there will be consequences.
Nigeria's aggressive anti-counterfeiting campaign is now being emulated in other developing countries. For instance, Indonesia's
national agency for food and drug control (BPOM) is now using TruScan and others are also evaluating the technology.