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3 min read
Despite being one of the most regulated industries in the world, the prevalence of counterfeit drugs is a sad reality in the emerging markets of the pharmaceutical industry. With increasing globalization of pharmaceutical supply chains and rapid market expansion in emerging economies, the risks associated with drug counterfeiting, falsified medicines, and parallel trade continue to rise. According to a report by the Authentication Solution Provider’s Association (ASPA), the number of counterfeit incidents in India increased by an average of 20% on a year-to-year growth between 2018 to 2020 and 17% between 2019 to 2020. Furthermore, a study by the European Union Agency for Law Enforcement Cooperation (Europol) noted some changes in the origin of the counterfeits seized in 2020. In 2019, they came from China and Singapore. In 2020, the majority were from China and Turkey, with minor contributions from Vietnam. Counterfeiting drugs, also known as brand theft, directly affects patients' health and morbidity. From a regulatory standpoint, counterfeit medicines pose significant risks to patient safety, pharmacovigilance, and compliance. Hence, protecting the brand against illegal alterations and duplication is crucial.
Challenges of Drug Counterfeiting
There are two (02) significant challenges of counterfeiting drugs. They are as follows:
1. Identification of Counterfeit Drugs
It is becoming increasingly difficult for companies and their supply chain partners to distinguish between counterfeit products and genuine medicines. The growing complexity of global pharmaceutical distribution networks and outsourcing models further amplifies this challenge. With an increasing demand for medicinal products, there is a risk of third-party vendors, which has led to an increase in adulterations. Identifying unauthorized alterations in the medicinal product is crucial in reducing it.
Solution: The usage of specific covert (invisible) features that are not visible to the naked eye. Incorporating such identification features in the secondary packaging helps the end user or supply chain partners detect any product mishandling or duplication. These advanced anti-counterfeiting technologies also support regulatory compliance and serialization mandates across global markets.
Covert features such as the following can be considered:
- Radiofrequency Identification (RFID) Tags: RFID is known for its ability to identify each item uniquely. The authenticity of the product can be verified by scanning the RFID serial number of a particular drug package and confirming its authenticity directly with the manufacturer. RFID-enabled packaging supports track-and-trace systems, supply chain visibility, and compliance with global serialization regulations. It helps pharmaceutical companies combat counterfeits and illegal adulteration of drugs before they reach the end user.
- Thermochromic Inks: This feature is another colossal development to curb counterfeits. The inks react to any change in temperature. They print temperature indicators on the packaging of the medicinal product. Since these indicators are permanent, stakeholders are informed about any product damage or changes that may have occurred during transit. This technology is especially relevant for cold-chain pharmaceutical products and biologics.
- Quick Response (QR) Codes: This is another anti-counterfeiting feature embedded in the drug package. Every package has a unique QR code, which allows transparent communication with the external stakeholders and the product. When integrated with digital authentication platforms, QR codes enable patient engagement, real-time verification, and regulatory reporting. The scanner can identify any duplicity of such codes, thus protecting the drug and customers.
2. Prevention of Counterfeiting
After identifying counterfeit drugs, the next challenge for pharmaceutical organizations is preventing them.
Solution: If certain features are introduced into the secondary packaging of medicinal products, they can help prevent the fake drug market. These are overt or visible features. Any wear and tear of these elements translates to misuse. Since these are visible to the naked eye, they prevent the drug's illegal usage, alterations, and duplication. Overt security features also enhance consumer confidence and brand integrity in highly competitive emerging markets.
Overt features include the following:
- Holographic Labels: Holography allows three-dimensional images in the primary packaging. Holographic figures are challenging to capture with conventional photography and can be reconstructed under white light. Pharmaceutical organizations use holograms in their logos to authenticate the products. Any depreciation of the hologram indicates rough handling of the product. Holographic artwork elements are widely recognized by regulators and consumers as trusted anti-counterfeiting measures.
- Sealing Tapes: Manufacturers also use single-use polypropylene tapes to seal the primary packaging of the medicinal product. Any breakage in the tape can be linked with tampering by the end user. Tamper-evident packaging solutions are now a regulatory expectation in many emerging and regulated markets.
- 3D Effects: Manufacturers also use color-shift inks in the product package, which gives the observer a 3D effect when shifted to different angles. Any wear and tear on the 3D pattern indicates improper storage/handling of the drug. Such visual security features also strengthen pharmaceutical brand protection strategies.
The effect of not securing the drugs through packaging is counterfeiting, which affects not only the end users but the organization as well. It can lead to regulatory non-compliance, product recalls, loss of market authorization, and reputational damage. Hence, pharmaceutical organizations and their supply chain partners should start incorporating specific overt and covert features in the primary and secondary packaging to secure medicinal products and overcome the challenges. A 360-degree packaging security approach—combining regulatory artwork, serialization, anti-counterfeiting technologies, and compliance-driven design—protects a pharmaceutical brand by making its products authentic and accountable.
Our experts at Freyr can help your organization design and implement end-to-end regulatory artwork and packaging security strategies aligned with global health authority expectations. Get in touch to know more.
