ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has announced that compliance with the 2D barcoding and serialization, or track-and-trace, system will be mandatory for all locally manufactured and imported pharmaceutical products with effect from October 9, 2026.
According to an official communique, with reference to previous notifications and directives issued on the subject cited above, the DRAP is digitizing the national pharmaceutical landscape as part of its overarching regulatory reforms and as part of its strategic plan of National Regulatory System 2026-30, to modernize the regulatory ecosystem, the authority has developed and launched pharmaceutical track and trace system.
The document said that in alignment with its statutory mandate under the DRAP Act, 2012, and the amended Drugs (Labelling & Packaging) Rules, 1978 (S.R.O.963(I)/2026 dated 9th June, 2026), this system is being rolled out in a phased manner. Phase I covers all locally manufactured and imported pharmaceutical products and its scope requires a unique 2D Data Matrix barcode and serialization with effect from 9th October, 2026.
This intervention will help to curb spurious, falsified, counterfeit and unregistered medicines, integrated product recalls, and ensures real-time supply chain transparency/ integrity across Pakistan.
In order to materialize this regulatory initiative through an inclusive and enabling approach, DRAP conducted extensive policy dialogues with key industry bodies, including the Pakistan Pharmaceutical Manufactur-ers’ Association (PPMA), the Pharma Bureau, importers, etc. Moreover, to support seamless industry on boarding and capacity building, DRAP executed nationwide technical sessions, workshops, and nationwide hands-on training roadshows providing guidance on 2-D Data Matrix standards, serial generation logic, vendor readiness, and e-Services portal integration.
Furthermore, DRAP published the comprehensive Guidelines on GSI Data Matrix Barcode and Serialization of Pharmaceutical Products, supplemented by step-by-step video tutorials and user assistance modules, to ensure regulatory clarity, optimize portal navigation, and accelerate system adaptability across the pharmaceutical sector (https://www.dra.gov.pk/news updates/regulatory updates/general/guidelines-on-gsl-datamatrixbarcode-and-serialization-of-pharmaceutical-products).
Subsequent to previous notifications and correspondence on the subject matter, and following the completion of foundational regulatory measures, portal deployment, and nationwide capacity building, DRAP hereby reiterates that all registered drug products manufactured locally or imported into Pakistan on or after 9th October 2026, implement 2-D barcode and serial numbers as per S.R.O.963(I)/2026 dated 9th July, 2026.
Further it is clarified that batches manufactured locally or imported with manufacturing date prior to 9th October, 2026 are exempted from this requirement and shall remain permitted for import, distribution, and sale.
All manufacturers and importers shall adhere strictly to the technical parameters defined in above mentioned rules. In case of non-compliance, legal action under relevant legislation will be initiated.
Copyright Business Recorder, 2026