DRAP makes 2D barcodes mandatory on new medicines from October 9

The Drug Regulatory Authority of Pakistan (DRAP) has made two-dimensional (2D) barcodes and serial numbers mandatory for pharmaceutical products manufactured locally or imported into Pakistan from October 9, 2026, under its new track and trace system.

In a circular issued on October 8, DRAP said the requirement applies to all registered drug products manufactured locally or imported on or after October 9. Batches manufactured locally or imported before that date are exempt and can continue to be imported, distributed and sold.

The new system requires pharmaceutical products to carry a unique 2D Data Matrix barcode and serialization in line with the amended Drugs (Labelling & Packaging) Rules, 1978, introduced through S.R.O.963(I)/2026.

DRAP said the initiative aims to curb spurious, falsified, counterfeit and unregistered medicines, improve product recall procedures and strengthen transparency across the pharmaceutical supply chain.

The authority has introduced the Pharmaceutical Track & Trace System as part of its broader regulatory reforms and the Strategic Plan of the National Regulatory System for 2026-30.

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

The authority also conducted technical sessions, workshops and training programmes nationwide to help manufacturers and importers comply with barcode standards, serial number generation requirements and integration with its e-Services portal.

DRAP has published guidelines on GS1 Data Matrix barcodes and serialization, along with video tutorials and user assistance materials, to support implementation.

The authority warned that manufacturers and importers failing to comply with the applicable technical requirements could face legal action under the relevant legislation.