09
May
[Blog] Pharmaceutical Serialization in Pakistan: What You Need to Know Ahead of the 2025 Deadline
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Pharmaceutical Serialization in Pakistan: What You Need to Know Ahead of the 2025 Deadline
As the pharmaceutical industry in Pakistan prepares for the full implementation of serialization regulations, August 2025 marks a significant compliance milestone. The Drug Regulatory Authority of Pakistan (DRAP) has set a clear roadmap that will soon make serialization mandatory for all registered pharmaceutical drugs. If your organization is operating in or exporting to Pakistan, it’s time to get ready.
Overview of Pakistan’s Serialization Timelin
The current regulatory framework is outlined in SRO 962(I)/2019, published on August 27, 2019, which introduced a phased approach:
- February 2020:
- GTIN (Global Trade Item Number) required for all registered drugs.
- 2D Data Matrix barcodes to be printed on at least one packaging line by all manufacturers and importers.
- August 2021:
- Mandatory printing of 2D Data Matrix codes on all registered pharmaceutical drugs.
- August 2025:
- Full serialization required for complete track and trace compliance.
What Is Required?
According to the regulation, GS1 standards must be followed, and the following elements are to be included in the 2D Data Matrix code:
- Global Trade Item Number (GTIN)
- Expiry Date
- Batch/Lot Number
- Serial Number (SN)
These same data points must also appear in human-readable format on the packaging.
Currently, aggregation is not yet mandatory, but it is planned to be part of the 2025 rollout, with GS1-128 Linear 1D barcodes expected to be used for packaging hierarchy management.
Additionally, data submission is required through the DRAP portal, ensuring that medicine traceability is centralized and monitored by the national authority.
How to Prepare
With the serialization deadline fast approaching, pharmaceutical companies should take the following steps:
- Evaluate your current packaging lines for compatibility with GS1 2D Data Matrix implementation.
- Ensure GTIN assignment for all registered products.
- Implement or upgrade serialization and aggregation software to support compliant data structure.
- Plan your integration with the DRAP portal for timely data submission.
- Start aggregation pilots early to be ready for possible enforcement in 2025.
How SoftGroup Supports Compliance in Pakistan
At SoftGroup, we provide end-to-end serialization and aggregation solutions that comply with GS1 standards and the latest DRAP requirements. Our technology enables:
- High-speed printing and verification of serialized barcodes
- Seamless data exchange with regulatory portals
- Real-time batch tracking and reporting
- Aggregation setup with GS1-128 support
- Scalable software to cover all levels – from packaging lines to enterprise-level compliance
With over 130 customers in 32 countries and experience supporting track-and-trace systems on five continents, SoftGroup is prepared to help pharma companies in Pakistan meet upcoming regulatory demands.
Stay Ahead of Compliance.
Contact SoftGroup today to assess your readiness for the August 2025 deadline and explore solutions tailored for the Pakistani market.