Pakistan has made two-dimensional (2D) barcodes and serialisation mandatory for pharmaceutical products manufactured locally or imported into the country from October 9, 2026. The Drug Regulatory Authority of Pakistan (DRAP) introduced the requirement under amendments to the Drugs (Labelling and Packaging) Rules, 1978, through S.R.O. 963(I)/2026. The measure forms the first phase of the national Pharmaceutical Track and Trace System, designed to improve medicine verification and increase transparency across the pharmaceutical supply chain. The requirement applies to registered drug products manufactured domestically or imported on or after the effective date, while batches manufactured or imported before October 9 remain exempt and may continue to be imported, distributed and sold.
Under the new rules, pharmaceutical manufacturers and importers must place a unique 2D Data Matrix barcode and serial number on applicable medicine packaging. These identifiers are intended to help trace products through the supply chain, making it easier to monitor their movement and identify suspicious or unregistered medicines. The system is also expected to support product recalls by helping authorities identify affected batches when a quality or safety issue emerges. By introducing product-level identification, DRAP aims to improve oversight and reduce opportunities for counterfeit, falsified and unregistered medicines to enter the market. The wider track-and-trace framework is intended to modernise pharmaceutical regulation through digital monitoring rather than relying solely on conventional inspection and recordkeeping.
DRAP has consulted pharmaceutical industry organisations, including the Pakistan Pharmaceutical Manufacturers’ Association and Pharma Bureau, as well as medicine importers, to support implementation. The authority has also arranged technical sessions, workshops and training roadshows to explain barcode standards, serial number generation, vendor readiness and integration with its e-Services portal. Guidance documents and video tutorials have been made available to help companies understand the technical requirements and prepare their systems. Manufacturers and importers must follow the specifications set out in the relevant regulations, and DRAP has warned that non-compliance may lead to legal action under applicable legislation.
The rollout is part of DRAP’s Strategic Plan for the National Regulatory System 2026–2030, which includes modernising pharmaceutical oversight and digitising regulatory processes. The federal government approved the nationwide track-and-trace framework earlier in 2026, with the stated objective of improving medicine authenticity, public safety and supply-chain accountability. The system is also expected to support access to reliable product information and make it easier for regulators to investigate suspected counterfeit medicines. However, implementation will depend on pharmaceutical companies meeting the technical requirements and integrating serialisation into their production and import processes. For consumers, the new rules represent a shift towards digitally traceable medicines, although the practical availability and method of public barcode verification will depend on the system’s implementation.
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