Pakistan makes 2D barcodes mandatory to curb counterfeit medicines

October 12, 2026 (MLN): Pakistan has made two-dimensional (2D) barcodes and serialization mandatory for all locally manufactured and imported pharmaceutical products manufactured or imported on or after Oct. 9, as the government seeks to curb counterfeit medicines and improve transparency in the drug supply chain.

The Drug Regulatory Authority of Pakistan (DRAP) said in a notification that manufacturers and importers must comply with the new requirements under the amended Drugs (Labelling and Packaging) Rules, 1978, introduced through S.R.O. 963(I)/2026.

The authority said the requirements apply to all registered drug products manufactured locally or imported into Pakistan from Oct. 9, 2026, under the first phase of its Pharmaceutical Track and Trace System.

However, medicine batches manufactured locally or imported before Oct. 9 are exempt from the requirement and will remain permitted for import, distribution and sale, DRAP said.

The system requires a unique 2D Data Matrix barcode and serial numbers on pharmaceutical products, enabling improved tracking across the supply chain.

DRAP said the initiative aims to prevent the circulation of spurious, falsified, counterfeit and unregistered medicines, facilitate product recalls and strengthen real-time supply chain transparency.

DRAP said it had held consultations with industry bodies, including the Pakistan Pharmaceutical Manufacturers' Association and Pharma Bureau, as well as importers, to support implementation.

The authority also conducted technical sessions, workshops and nationwide training roadshows to familiarise industry participants with barcode standards, serial number generation, vendor readiness and integration with its e-Services portal.

It has published guidelines on Data Matrix barcodes and serialization, along with video tutorials and user assistance materials, to help pharmaceutical companies comply with the requirements.

DRAP said manufacturers and importers must strictly follow the technical parameters specified in the relevant rules. Noncompliance could result in legal action under applicable legislation.

The rollout forms part of DRAP's Strategic Plan for the National Regulatory System 2026-30, which aims to modernise pharmaceutical regulation and digitise the country's drug regulatory framework.

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