GS1 QR and DataMatrix Compliance for Regulated Industries

RxTrace enables GS1 aligned identification and traceability for pharmaceutical, food, and dairy companies. It is built for audit readiness and privacy safe compliance.

GS1 QR and DataMatrix only
Unit to Box to Carton to Pallet (SSCC)
No consumer or patient data capture

Regulatory Requirements Coverage

RxTrace supports GS1 aligned workflows that help organizations meet global and Indian regulatory traceability expectations.

European Union – Falsified Medicines Directive (EU FMD)

The EU Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161 mandate that prescription medicines carry a unique identifier consisting of GTIN, serial number, batch number, and expiry date. This information is encoded in a GS1 DataMatrix barcode and verified through the European Medicines Verification System.

United States – Drug Supply Chain Security Act (DSCSA)

The DSCSA requires an interoperable electronic tracing system for prescription drugs. The product identifier includes product code, serial number, lot number, and expiration date. When GS1 standards are used, this is encoded as a serialized GTIN in a GS1 DataMatrix barcode.

India – Drugs and Cosmetics Rules (Indian FDA)

As per GSR 823(E) dated 17 November 2022, the Drugs Rules 1945 were amended to mandate barcodes or QR codes on primary and secondary packaging of the top 300 drug formulations. Required data includes product identification, batch number, manufacturing date, expiry date, and manufacturing licence number.

Central Drugs Standard Control Organisation (CDSCO)

CDSCO supports GS1 based identification and traceability practices aligned with global serialization and aggregation standards for pharmaceutical manufacturing and exports.

RxTrace supports GS1 aligned compliance workflows. Final regulatory compliance depends on customer implementation and applicable local regulations.

GS1 Payload Logic

RxTrace uses a GS1 compliant, code only payload model where compliance information is embedded directly into the barcode or QR code without capturing consumer or patient data.

(01) GTIN – Product Identification

Globally unique product identification as per GS1 standards
Ensures product authenticity across supply chain
Used by RxTrace to link SKU and product master
Compatible with EU, US, and Indian regulations

(17) Expiry Date

Mandatory for regulated pharmaceutical products
Enables expiry validation during scanning
Prevents circulation of expired medicines
Read and validated directly by RxTrace scanner

(11) Manufacturing Date

Supports Indian FDA and CDSCO requirements
Used for batch age and shelf life calculations
Displayed clearly during verification scans
Embedded directly in GS1 payload

(10) Batch or Lot Number

Critical for recalls and quality investigations
Links units to manufacturing batch
Validated by RxTrace without backend data capture
Supports regulator and auditor traceability needs

(21) Unique Serial Number

Legally required for EU FMD and US DSCSA
Uniquely identifies every saleable unit
Generated and validated by RxTrace engine
Prevents duplication and counterfeiting

(00) SSCC – Logistic Units

Used for cartons and pallets aggregation
Links unit to box, carton, and pallet hierarchy
Required for warehouse and distributor operations
Fully supported by RxTrace packaging rules

RxTrace follows a code centric compliance model where trust is embedded in the GS1 payload itself, ensuring privacy safe, audit ready, and regulator friendly traceability.

Scanner App Support

RxTrace scanner applications are designed for verification purposes only and not for surveillance.

Reads GS1 QR and DataMatrix from any compliant source

Supports unit, box, carton, and pallet scans

Offline capable verification

No login required for unit level scan

Token based access for higher level scans

No data capture during scanning

Downloadable Audit Reports

Generate regulator ready reports without exposing personal, patient, or consumer data.