Question 1

What is pharmaceutical traceability?

Accepted Answer

Pharmaceutical traceability is the ability to track and verify the identity, location, and status of a drug product at every point in the supply chain — from manufacturing through distribution to the point of dispensing. It encompasses serialisation (assigning unique identifiers to each saleable unit), aggregation (linking individual units to cases and pallets), and verification (confirming authenticity and supply chain integrity at dispensing or border control). Traceability is mandated by regulations including the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD).

Question 2

What is pharmaceutical serialisation?

Accepted Answer

Pharmaceutical serialisation is the process of assigning a globally unique identifier — typically a 2D barcode conforming to GS1 standards — to each individual saleable unit of a drug product. The identifier encodes product GTIN, batch number, expiry date, and serial number. Serialisation enables product verification at the point of dispensing, supports market withdrawal and recall at the unit level, and is a regulatory requirement in major markets including the US (DSCSA), EU (FMD), and markets across Asia-Pacific and the Middle East.

Question 3

What regulations govern pharmaceutical traceability?

Accepted Answer

Key traceability regulations include: US Drug Supply Chain Security Act (DSCSA) — requires unit-level serialisation and electronic interoperability across the supply chain; EU Falsified Medicines Directive (FMD/Directive 2011/62/EU) — mandates unique identifiers and anti-tampering devices with verification at point of dispensing; and national regulations in markets including India (Schedule M), Brazil (ANVISA), Saudi Arabia (SFDA), China (NMPA), and others. Each market has specific requirements for serialisation format, aggregation, verification, and reporting.

Question 4

What is the difference between track and trace vs. serialisation?

Accepted Answer

Serialisation is the foundation — assigning unique identifiers to individual drug units. Track and trace is the broader system that uses those identifiers to record and verify the movement of products through each custody transfer in the supply chain. A fully integrated track and trace system captures events at manufacture, packaging, export, import, distribution, and dispensing — creating an auditable record of the product's entire journey that can be queried for verification, investigations, and regulatory reporting.

Question 5

How does traceability help prevent pharmaceutical counterfeiting?

Accepted Answer

Traceability prevents counterfeiting by enabling verification of product authenticity at any point in the supply chain. When a pharmacist scans a unit at the point of dispensing, the system verifies the serial number against the national or global product repository. Counterfeit products either carry duplicate serials (detectable through verification) or no valid serial — triggering alerts that prevent dispensing. Serialisation also enables rapid, targeted recalls when product integrity is compromised, reducing patient risk.

Question 6

What is GS1 and why does it matter for pharma traceability?

Accepted Answer

GS1 is the global standards organisation that defines the identification, barcoding, and data exchange standards used in pharmaceutical traceability. GS1 standards include the GTIN (Global Trade Item Number) for product identification, the SSCC (Serial Shipping Container Code) for logistics units, GS1-128 and DataMatrix barcode formats, and EPCIS (Electronic Product Code Information Services) for supply chain event exchange. Regulatory frameworks including DSCSA, FMD, and many national regulations explicitly reference or mandate GS1 standards.

Question 7

How do companies manage traceability across multiple markets?

Accepted Answer

Multi-market traceability requires coordinating different serialisation requirements, label formats, verification network connections, and reporting obligations across jurisdictions. A centralised traceability platform manages market-specific compliance configurations while maintaining a single data layer for global visibility. It handles jurisdiction-specific barcode formats and data elements, connects to national verification systems (such as NMVS in Europe or DSCSA repositories in the US), and provides consolidated dashboards for global supply chain visibility and exception management.

See every product. From factory to patient.

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From production line to pharmacy shelf.

Identity starts at the production line

Compliance first. Intelligence layered on top.

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India's largest pharma track-and-trace provider.

A top-10 pharma company needed end-to-end product traceability across multiple manufacturing sites and distribution tiers — but existing solutions only covered compliance, not operational intelligence.

Everything we can deploy for Traceability & Supply Chain.

End-to-End Serialisation

Authentication & Anti-Counterfeiting

Regulatory Compliance Reporting

Last-Mile Tracking

Supply Chain Analytics

Government Portal Integration

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