Pharmaceutical Serialization Explained: Combating Counterfeit Drugs at the Source

Pharmaceutical serialization refers to assigning a unique identifier, such as a DataMatrix code or QR code, to each saleable unit of medicine. This identifier typically encodes details like product code, serial number, batch (lot) number, and expiration date. When scanned, it enables verification of a product’s authenticity and facilitates end-to-end tracking throughout the supply chain, from manufacturing to dispensing.

Why Is It Crucial?

Counterfeit medicines are fraudulent drugs that may contain incorrect or harmful ingredients or lack active ingredients altogether. According to the World Health Organization (WHO), at least 1 in 10 medical products in low- and middle-income countries are either substandard or falsified. The U.S. Food and Drug Administration (FDA) warns that counterfeit medicines may contain the wrong ingredients, incorrect dosages, or harmful substances.

Signs of Counterfeit Medicines

Serialization is a cornerstone in combating counterfeit drugs:

• The World Health Organization estimates that 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
• Physical Appearance: Differences in colour, size, or shape compared to previous purchases.
• Counterfeit medicines can carry incorrect active pharmaceutical ingredients (APIs), harmful contaminants, or variable potency, potentially leading to serious health risks.
• Serialization enhances patient safety, enables precise recalls, protects public health, deters diversion and theft, and reinforces brand integrity and trust.

Global Regulatory Landscape: Track & Trace

Global health authorities mandate serialization and related track-and-trace solutions to safeguard pharmaceutical supply chains:

European Union (Falsified Medicines Directive – FMD)

• Requires a 2D DataMatrix code on each saleable package encoding product code, serial number, batch number, and expiry date, plus a tamper-evident feature.
• At dispensing, the code is scanned and decommissioned, preventing reuse.

United States (Drug Supply Chain Security Act – DSCSA)

• Envisions unit-level serialization and electronic, interoperable transaction data exchange across manufacturers, wholesalers, and dispenser
• Full enforcement began in late 2023, with compliance deadlines in 2025 for manufacturers (by May), wholesalers (by August), and remaining partners.

Other Regions

• India, China, Brazil, and others are introducing similar serialization mandates, often involving 2D codes and centralized reporting systems

How Serialization and Track-and-Trace Work Together

Serialization uniquely identifies each product, while track-and-trace records every custody and location change across the supply chain—enhancing transparency, enabling authentication at each step, and supporting recall efficiency.

Technologies deployed include:

• 2D barcodes, such as DataMatrix or QR codes
• RFID tagging
• Cloud-based platforms for centralized data exchange and verification

Challenges & Strategic Opportunity

Implementing serialization isn’t without hurdles:

• Regulatory diversity: Differing regional requirements complicate global manufacturers’ compliance strategies.
• Cross-functional complexity: Requires coordination among IT, production, packaging, regulatory, and quality teams.
• Cost and technical barriers: Upgrading systems, training staff, and integrating with partners can be resource-intensive.

However, serialization also provides strategic advantages:

• Enhanced supply chain resilience—visibility helps identify bottlenecks and enables quick adaptation.
• When combined with analytics, serialized data can enable predictive insights, optimize inventory, support recall actions, and foster consumer engagement via QR-scan-based communication.

Scan Plus: Supporting Pharma Compliance with Smart Serialization

Scan Plus supports pharmaceutical manufacturers and CMOs with compliance-ready serialization, medicine verification, and track-and-trace solutions—a vital tool in today’s regulatory landscape.

Key strengths include:

• Prevent Counterfeiting: Through robust serialization processes, Scan Plus helps safeguard distribution channels and block counterfeit medicines.
• Global Regulatory Compliance: Fully aligned with major standards—including the EU FMD, U.S. mandates, and GCC regional rules.
• Efficiency & Collaboration: Enhances coordination between Marketing Authorization Holders (MAHs) and CMOs with streamlined serialization workflows.
• Tailored for CMOs: Provides intuitive interfaces for managing serial numbers, batch and product data, supporting diverse file formats (e.g., Direct Access, shipment, end-of-batch).
• Seamless EU integration: Compatible with EU serialization systems like Topia EU-Serialization.

Scan Plus thus delivers end-to-end serialization management with compliance, flexibility, and operational clarity—especially valuable for MAHs and CMOs seeking to meet global tracking and verification standards.

Summary Table

References

• World WHO: On substandard and falsified medical products
• European Falsified Medicines Directive (EU FMD)
• US Drug Supply Chain Security Act (DSCSA) enforcement updates.
• Global regulatory trends and serialization standards (GS1, ISO, etc.)
• Fundamentals of serialization & track-and-trace in pharma