Strengthening Supply Chain Integrity: Pakistan's Comprehensive Track and Trace Framework

Pakistan's Comprehensive Track and Trace Framework

Pakistan has established a robust regulatory framework for track and trace systems, spearheaded by the Drug Regulatory Authority of Pakistan (DRAP) and the Federal Board of Revenue (FBR). These comprehensive regulations, particularly SRO 470(I)/2017 for pharmaceuticals and the broader FBR Track and Trace System, represent Pakistan's commitment to combating counterfeit products, enhancing tax compliance, and ensuring supply chain transparency across critical sectors including pharmaceuticals, tobacco, cement, sugar, and fertilizers.

Key Features of Pakistan's Track and Trace Regulations

Mandatory GS1 Data Matrix Serialization

Pakistan requires all regulated pharmaceutical products to bear unique GS1 Data Matrix barcodes containing essential product information including serial numbers, batch/lot numbers, expiry dates, and manufacturer details. This machine-readable identification system enables precise tracking from production through distribution to end consumers. The serialization extends across all packaging levels—primary, secondary, and tertiary—ensuring comprehensive traceability throughout the supply chain network.

Comprehensive Product Information Encoding

The regulations mandate that specific product data be encoded within the barcode system, including product name and description, strength and dosage form, batch numbers, expiry dates in YYMMDD format, manufacturer registration numbers, pricing information, and unique serial numbers for each sellable unit. This detailed information encoding creates a complete digital fingerprint for each product, enabling authorities to verify authenticity and track movement with unprecedented precision.

Multi-Sector Implementation Approach

Beyond pharmaceuticals, Pakistan's track and trace system encompasses high-risk sectors including tobacco, cement, sugar, fertilizers, beverages, petroleum products, and steel industries. The FBR's integrated system uses unique identification markings, specialized tax stamps, and real-time data exchange capabilities to monitor these sectors comprehensively. This multi-sector approach demonstrates Pakistan's holistic commitment to supply chain security and revenue protection.

Phased Compliance Timeline with Strategic Flexibility

The regulatory framework incorporates a thoughtful implementation timeline, allowing a six-month adaptation period for pharmaceutical manufacturers and importers, with a two-year optional period for certain barcode labeling requirements. After three years, full serialization becomes mandatory across all packaging levels. The Registration Board maintains authority to grant conditional relaxations for specific products facing practical implementation challenges, ensuring regulatory compliance while accommodating industry realities.

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

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How LSPedia Can Support Your Pakistan Compliance Journey

Achieving compliance with Pakistan's multi-layered track and trace requirements demands specialized expertise and strategic implementation planning. LSPedia's comprehensive software solutions are specifically designed to address the unique challenges of SRO 470(I)/2017 and FBR Track and Trace System requirements. Our platform seamlessly integrates GS1 Data Matrix generation, real-time data exchange capabilities, and multi-sector compliance monitoring, ensuring your organization meets all regulatory obligations while optimizing operational efficiency. From initial serialization setup to ongoing compliance maintenance, LSPedia provides the technological infrastructure and expert guidance necessary to navigate Pakistan's evolving regulatory environment successfully.

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We invite you to learn more about how LSPedia can support your compliance and supply chain needs. For more information about our solutions, partnership opportunities, or to speak with one of our experts.

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