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DRAP Makes 2D Data Matrix Codes and Serialization Mandatory on Medicines

The regulator says the change will strengthen supply‑chain transparency and let it trace and recall products through a new digital track‑and‑trace system.

Overview

  • DRAP has implemented a phased pharmaceutical track‑and‑trace system that requires unique 2D Data Matrix codes and serial numbers on registered drugs produced or brought into Pakistan under its amended labelling rules.
  • The rule is part of DRAP’s National Regulatory System 2026–30 reforms and links serialization to the authority’s e‑Services portal for serial generation and verification.
  • Manufacturers and importers were given technical guidance, nationwide workshops and video tutorials to help onboard to the system, and DRAP published detailed Data Matrix and serialization guidelines.
  • DRAP clarified that batches already produced or imported before the rollout remain permitted for sale, and warned that failure to meet the prescribed technical parameters could result in legal action.
  • The measure is designed to reduce counterfeit and unregistered medicines, enable faster integrated product recalls, and may force packaging and IT changes that raise short‑term costs for makers and distributors.