Serialization, Track and Trace, and Evolving Packaging Compliance in the Pharmaceutical Industry
As counterfeit medicines become increasingly widespread and pose a growing threat to public health, track-and-trace systems have become indispensable. Regulatory authorities in Türkiye and around the world are now implementing stronger measures to improve pharmaceutical safety.
The issue of counterfeit—or “substandard and falsified”—medicines is not limited to a single country. It has become a major global public health crisis. Until the beginning of 2026, counterfeiting was particularly prevalent in the vitamins and performance-enhancing supplements market. However, as of 2026, counterfeit activity has increasingly shifted towards medicines used in potentially life-saving treatments, including antibiotics, insulin, and the rapidly growing category of GLP-1 weight-loss medications.
The following statistics illustrate the scale and seriousness of the problem:
• Market value: The annual value of the global counterfeit pharmaceutical market is estimated to be as high as USD 432 billion.
• Prevalence: The World Health Organization estimates that one in every ten medical products in low- and middle-income countries is either substandard or falsified.
• Regional burden: Africa carries the heaviest burden, with an estimated prevalence rate of approximately 18.7%. This is almost twice the global average reported for developing countries.
• “East-to-West” flow: Approximately 79% of dangerous counterfeit products seized at international borders originate from China and Hong Kong, with the United States and European Union countries being among their main destinations.
These developments demonstrate that serialization has evolved far beyond simply printing a unique barcode on each secondary package. They once again highlight the importance of creating a clear, complete, and verifiable data trail for every pharmaceutical product, from production to the end user.
The Evolution of Global Pharmaceutical Packaging Compliance Requirements
Serialization has transformed packaging compliance in the pharmaceutical industry. In the past, compliance primarily focused on accurate labelling and the use of tamper-evident seals. Today, compliance requires each individual product unit to be tracked from the manufacturing facility to the pharmacy shelf, creating a dynamic and continuous monitoring process.
This has created a complex global regulatory environment for pharmaceutical packaging. Different countries and regions have introduced their own serialization and traceability standards.
For example, the European Union’s Falsified Medicines Directive requires the use of two-dimensional barcodes and anti-tampering devices. In the United States, the Drug Supply Chain Security Act requires electronic, interoperable traceability at the package level.
In Türkiye, the Pharmaceutical Track and Trace System, known as İTS, is used as a central registration and monitoring platform. The system requires human medicinal products to be uniquely identified using Data Matrix codes. It tracks, in real time, all supply-chain movements and related cancellations reported at each stage through which a product passes. These activities include production, import, export, purchasing, sales, transfers, consumption, loss, and reimbursement. The system also enables essential operations such as product recalls and blocking.
When pharmaceutical products cross international borders, packaging systems must be capable of adapting, printing, and verifying different data sets according to the regulatory requirements of the country or region in which the medicine will be sold.
Track and Trace in Pharmaceutical Packaging: Turning Regulatory Compliance into a Competitive Advantage
Leading companies in the smart packaging industry view track-and-trace requirements not merely as a regulatory burden, but as an opportunity to create a competitive advantage.
With robust serialization technology, pharmaceutical companies can gain greater visibility and control over their supply chains. This makes it possible to identify bottlenecks more quickly, manage inventory more effectively, and carry out accurate and targeted product recalls when necessary.
Compliance with regulatory requirements also demonstrates a company’s commitment to safety and quality. As a result, it can strengthen trust among healthcare authorities, business partners, healthcare professionals, and patients.
Important Note
The online sale of prescription medicines is prohibited in Türkiye. Only certain product categories, including food supplements, vitamins, dermocosmetic products, and medical devices such as blood pressure monitors, may be purchased online through the websites of licensed pharmacies.
To minimise the risk of purchasing counterfeit products, consumers should use only official and reputable websites operated by licensed businesses with established physical pharmacies.
