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🇵🇰 DRAP announce draft Track and trace guidelines in Pakistan

🇵🇰 DRAP announce draft Track and trace guidelines in Pakistan

#DRAP (Drug Regulatory Authority of Pakistan)

Administrator · Global Track & Trace Hub June 30, 2026 2 min read 6 views

On 29 June 2026, #DRAP (Drug Regulatory Authority of Pakistan) released the #Draft Track & Trace Guidelines, providing greater clarity on the country's upcoming pharmaceutical serialization and traceability framework.


Here are some of the key highlights:

🔹 Primary Packaging

• Currently exempt from serialization requirements (subject to future revision).


🔹 Secondary Packaging

Each pack must carry a GS1 DataMatrix containing:

• (01) GTIN

• (17) Expiry Date

• (10) Batch/Lot Number

• (21) Unique Serial Number


🔹 Tertiary (Shipper/Carton) Packaging

Homogeneous cartons:

• GS1 DataMatrix with GTIN, Expiry Date, and Batch/Lot Number

• GS1-128 barcode with SSCC


Heterogeneous cartons:

• GS1-128 barcode with SSCC only


🔹 System Architecture

• Platform-independent CSV/XML data exchange

• Secure, scalable, and industry-neutral aggregation and traceability framework


🔹 Manufacturer & Importer Requirements

• GS1 registration (GTIN, GLN, GCP)

• DRAP system registration

• GAMP and 21 CFR Part 11 compliant printing systems (where applicable)

• Master data and transaction XML/CSV submission

• Unique serialization, barcode quality verification, and compliance with DRAP requirements


🔹 Distributors, Wholesalers & Retailers

• DRAP registration

• GLN acquisition

• AIDC scanning capability

• Reporting of suspect or anomalous products


📅 Implementation

DRAP proposes a phased rollout, beginning with secondary packaging serialization, followed by tertiary-level serialization and full data submission. Manufacturers are advised to prepare for a transition period of up to six years for full tertiary serialization, subject to DRAP's final implementation timelines.


🌍 Want to explore the complete draft guidelines and follow #Pakistan's Track & Trace journey?


Visit the Pakistan page on the #TraceHub Country Tracker to access detailed regulatory updates and stay informed as the framework continues to evolve.

https://tracehub.1dts.com/RegulationHub/Country?code=PK