The global pharmaceutical supply chain is at growing risk from counterfeit drugs, costing companies billions and putting the health of patients in danger. Secure packaging is an important factor in combating fake products. This has resulted in the enforcement of stringent legislation to make sure that pharmaceutical packaging cannot be easily imitated. Through the use of new anti-counterfeiting technology pharmaceutical packaging manufacturers can easily produce secure packaging and fulfill government policies. This article discusses counterfeit drugs, current regulations and the latest packaging technologies.
The World Health Organization (WHO) currently estimates the global trade in counterfeit drugs to be worth £75 billion and will continue to grow at a staggering rate of 13% a year. WHO has also suggested that 1% of prescribed drugs in the developed world and 30% in parts of the developing world may be fake. The threat is even bigger on the internet, 50% of drugs bought on illegal online pharmacies are thought to be counterfeits. As the counterfeit trade grows and becomes more profitable the criminals are becoming increasingly sophisticated and capable in the way they package their products.
In addition to manufacturing fake drugs, counterfeiters are seeking to infiltrate the legitimate supply chain. This allows them to steal authentic shipments and redirect them to other markets, reselling them to their own profit. Another emerging threat to the security of the pharmaceutical supply chain is ‘third shift’ packaging production. This involves contractors or their staff carrying out extra, hidden production runs and selling the resulting genuine packaging to counterfeiters.
As a result, global regulatory bodies have introduced strict legislation to ensure maximum security of pharmaceutical packaging.
Regulatory Outlook
The WHO Expert Committee on Specifications for Pharmaceutical Preparations has stressed the importance of implementing a quality assurance program. In the relevant report, the committee focuses on the role of packaging in relation to the stability of pharmaceuticals and the potential for counterfeiting. It is specified that the design of the packaging must contribute to preventing tampering with, or the counterfeiting of, the enclosed medicinal products. Packaging must also carry the correct information and identification of the product.
The US Food and Drug Administration (FDA) enforces rule 21 CFR Part 211, which specifies current good manufacturing practice for finished pharmaceuticals. Within this framework, the rule mandates that tamper-evident packaging should be used for over-the-counter (OTC) human drug products. According to the regulation, a tamper-evident package has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred. It should not be able to duplicate the packaging using commonly available materials or processes.
In 2003, in response to the increasing number of counterfeiting incidents, the US FDA formed a Counterfeit Drug Task Force. The force aims to create a comprehensive system of modern protective measures against counterfeit drugs. One of the measures is to ensure the security of packaging by using tamper-resistant tapes, holograms and color-shifting inks and dyes.
New secure packaging technologies have been developed to facilitate easy regulatory compliance.
Secure Packaging as an Anti-Counterfeiting Measure
Defeating the counterfeiters demands a multi-level approach, an element of which is secure packaging. However, in order to ensure optimal security of pharmaceutical packaging, both overt and covert technologies need to be used.
Latest technological advancements have seen the introduction of a multi-level range of solutions with which to ensure the security of pharmaceutical packaging in order to safeguard the supply chain and authenticate products within the global pharmaceutical market. The solutions incorporate sophisticated covert technology for use by customs agencies, authorized distributors and other parties with access to high tech readers or secure databases. They also feature advanced overt identification capabilities for users who have to rely on the evidence of their own eyes.
The new technologies offer the flexibility to be adjusted to the specific security issues and needs of each company. On that basis, they can incorporate a blend of features, from overt counterfeiting deterrents such as holograms and security seals, to invisible markers that can be placed anywhere on the package. These countermeasures can be fully integrated into wider solutions, such as electronic readers and secure database systems used by manufacturers, distributors or government agencies. The result is a suite of solutions that is effective at all stages of the supply chain, virtually anywhere in the world.
Overt Technologies
Overt features enable instant authentication of packaging through visual inspection by the user without requiring expert knowledge. Optically variable features such as holographic devices within the design and color shift inks are the most common and effective overt security features, enabling packaging to be validated both quickly and easily.
Holography
Easily identifiable holograms, showing the pharmaceutical manufacturer’s logo for example, are primarily used as first level identification devices and are designed to enable successful authentication at point of inspection. Additional features, such as nanotext and hidden images, can be used as second and third level techniques for trained and equipped specialists.
High security holograms cannot be reproduced by using conventional printing methods available on the market. In addition, tiny holographic markers can be printed in a predetermined position on the packaging. These markers are clearly visible when viewed with a magnifier, but invisible to the naked eye.
