Securing Every Medicine

Pakistan’s pharmaceutical sector is entering an important phase in its journey towards greater transparency, accountability and patient safety. The implementation of a pharmaceutical Track and Trace system, including 2-D Data Matrix barcodes and serialisation, is more than a technological upgrade. In my view, it represents a fundamental shift in how medicines can be identified, monitored and traced from the manufacturing floor to the patient.

I recently attended PPMA North training conducted in collaboration with the Drug Regulatory Authority of Pakistan (DRAP) on the Online Pharmaceutical Track and Trace System. The discussions demonstrated that successful implementation requires much more than installing a barcode printer on a packaging line. It demands coordination among Quality Assurance, Production, Engineering, IT, Regulatory Affairs, Warehousing and Distribution. The challenge is as much organisational as it is technical.

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At the heart of the system is serialisation, which assigns a unique identity to individual saleable packs. Traditionally, medicines have been identified through product names, batch numbers and expiry dates. With serialisation, two packs from the same batch can carry different serial numbers. The GTIN identifies the product, while the serial number identifies the individual pack. Together with batch and expiry information, these elements create a more detailed digital identity.

The GS1 Data Matrix, a compact two-dimensional barcode, can carry this information. However, barcode implementation must be treated as a controlled manufacturing process, not merely a printing activity. A serialised packaging line may combine printers, cameras, verification software and automatic rejection mechanisms to ensure that each code is accurate, readable and associated with the correct product and batch. Packs failing verification must be rejected and accounted for.

This creates new responsibilities for Quality Assurance. In a batch of 100,000 packs, several hundred codes might be rejected. The manufacturer must reconcile the codes generated, printed, rejected, reworked, destroyed and ultimately accepted. Electronic records must correspond with physical production records. The system must explain discrepancies rather than simply record them. Data integrity is therefore essential. User access, record changes and system activities require controls, including audit trails and principles associated with 21 CFR Part 11 where applicable.

The objective is not another complicated database but a reliable system in which information is accurate, attributable, secure and retrievable. Aggregation adds another dimension: individual serialised packs can be linked to cartons and cartons to pallets. These relationships could help companies trace products during distribution and recalls without relying entirely on manual records. EPCIS, or Electronic Product Code Information Services, extends identification into event-based traceability, recording what happened to a product, when, where and during which business process.

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Yet technology alone cannot guarantee success. The industry needs trained personnel, validated computerised systems, reliable infrastructure, effective SOPs and strong change control. Packaging equipment requires qualification and maintenance; deviations require investigation and recurrent problems effective corrective and preventive action. Regulatory Affairs must maintain accurate product information, Production must execute serialisation correctly, and IT must ensure security, backups and system availability. Warehouses and distributors also have responsibilities beyond the manufacturing site.

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For QA, reconciliation may be the greatest challenge. Every physical movement should have an appropriate electronic counterpart, and important electronic events must be explainable through controlled records. There is also a wider public-health imperative. Counterfeit and falsified medicines can harm patients, while stronger traceability gives regulators and legitimate manufacturers tools to investigate suspicious products and strengthen oversight of the supply chain. This matters when medicines are recalled.

Implementation must nevertheless remain practical and proportionate. Smaller manufacturers face substantial costs for printers, cameras, software, servers, integration and training. Clear regulatory guidance, standardised technical requirements and adequate implementation support are essential. Success should be measured not by the number of barcodes printed, but by how reliably medicines can be connected to their verified identities and movements through the legitimate supply chain.

Pakistan’s pharmaceutical industry has an opportunity to turn serialisation from a regulatory obligation into a genuine quality-management tool. The humble 2-D barcode can become a digital link between manufacturer, regulator, distributor, pharmacist and patient. The future of pharmaceutical quality depends not only on what medicine is made, but on whether its origin, batch, individual identity and movements can be trusted. That is the real promise of Track and Trace: a more transparent, accountable healthcare system.

Dr Zeeshan KhanThe writer is a pharmacist, LUMS alum, and a financial literacy expert. He tweets at: @DrZeeshanKhanA1

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