Pakistan Serialization and Traceability Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Pharmaceutical serialization and barcode requirements in Pakistan are regulated by the Drug Regulatory Authority of Pakistan (DRAP). Pakistan has established a regulatory framework requiring barcode identification on pharmaceutical packaging and is progressing toward the implementation of serialization for medicines.

The regulatory foundation is defined under S.R.O. 470(I)/2017 – Drugs Labelling and Packing Rules, which introduced mandatory barcode labeling for pharmaceutical products to support identification, tracking, and verification within the supply chain.

Pakistan is currently transitioning from basic barcode identification to GS1 DataMatrix based serialization. Regulatory updates issued by DRAP indicate that the authority is moving toward the implementation of 2D barcodes with serialized identifiers on pharmaceutical packaging.

At present, Pakistan’s framework focuses primarily on product identification through barcodes and serialization readiness, and a fully operational national end to end track and trace reporting platform has not yet been publicly implemented.

Labelling Requirements 

Pharmaceutical products manufactured or imported for distribution in Pakistan must include machine readable barcodes on the packaging in accordance with DRAP labeling rules.

Under the current regulatory framework and draft amendments, the following barcode formats are specified:

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Secondary Packaging

Secondary packaging is expected to include a GS1 DataMatrix barcode containing:

  • GTIN
  • Serial Number
  • Batch or Lot Number
  • Expiry Date

These identifiers allow each medicine package to be uniquely identified and support verification across the pharmaceutical supply chain.

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Tertiary Packaging

Tertiary packaging may include GS1-128 barcodes. Where applicable, logistics units may include Serial Shipping Container Codes (SSCC) to support supply chain handling and distribution.

Human readable information printed on the packaging must match the encoded barcode data.

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Regulatory Timeline 

2017
DRAP issued S.R.O. 470(I)/2017 – Drugs Labelling and Packing Rules, introducing mandatory barcode labeling requirements for pharmaceutical products.

2025
DRAP published draft amendments expanding the barcode framework to include GS1 DataMatrix barcodes with serialization on secondary packaging and logistics identifiers on tertiary packaging.

Current Status
Pakistan has implemented barcode identification requirements and is actively progressing toward broader serialization implementation across the pharmaceutical sector.

Reporting Requirements 

The current DRAP regulations focus primarily on barcode labeling and serialization readiness rather than mandatory electronic reporting of supply chain events.

Operation
Requirement
Secondary Pack Identification
GS1 DataMatrix barcode containing GTIN, Serial Number, Batch/Lot, Expiry Date
Tertiary Pack Identification
GS1-128 barcode with logistics identifiers such as SSCC where applicable
Serialization
Random serial numbers encoded within GS1 DataMatrix on secondary packaging
Import Compliance
Imported medicines must comply with barcode requirements before distribution

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Operational Timelines for Industry 

  • Ensure pharmaceutical packaging complies with DRAP barcode labeling rules.
  • Configure packaging systems to generate GS1 DataMatrix barcodes on secondary packaging.
  • Prepare serialization capabilities aligned with DRAP implementation initiatives.
  • Apply GS1-128 barcodes on tertiary packaging where required.
  • Monitor regulatory updates related to serialization rollout and future traceability infrastructure.

Reporting Hub

Pakistan does not currently operate a national pharmaceutical serialization reporting platform that captures supply chain transaction events such as commissioning, shipment, receiving, or dispensing.

The current regulatory framework focuses on barcode identification and serialization implementation, while broader traceability infrastructure continues to be developed.

Supply chain traceability is currently supported through company systems, packaging identification, and regulatory documentation rather than through a centralized government reporting platform.

Aggregation Requirements 

Pakistan’s regulatory framework includes provisions for tertiary packaging identification using GS1-128 barcodes and SSCC codes.

However, aggregation at case and pallet level is not yet fully mandatory across the pharmaceutical supply chain, and implementation timelines are phased under regulatory updates.

Manufacturers and distributors may implement aggregation internally to support logistics operations and supply chain management.

Common Errors to Avoid 

  • Assuming Pakistan operates a fully implemented national pharmaceutical track and trace system.
  • Using linear barcodes where GS1 DataMatrix is required for serialization readiness.
  • Mismatch between barcode data and human readable packaging information.
  • Failure to implement barcode labeling before product distribution.
  • Ignoring phased implementation requirements for tertiary packaging identifiers.

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