ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has made two-dimensional (2D) barcoding and serialization mandatory for all locally manufactured and imported pharmaceutical products, as part of efforts to eliminate counterfeit, substandard and unregistered medicines.
Under the new requirement, pharmaceutical products manufactured locally or imported into Pakistan on or after October 9 must carry a unique 2D Data Matrix barcode and serial number under the Pharmaceutical Track and Trace System.
DRAP said the system was being introduced in phases to modernise the country’s pharmaceutical regulatory framework and improve transparency across the medicine supply chain.
In the first phase, the requirement will cover all locally manufactured and imported pharmaceutical products. The system will also apply to human and veterinary medicines, according to the authority.
However, batches manufactured locally or imported before October 9, 2026, are exempt from the requirement and will remain permitted for import, distribution and sale.
The authority has directed pharmaceutical manufacturers and importers to comply with the technical requirements specified under the relevant rules, warning that legal action would be initiated against those found violating the regulations.
DRAP said the Track and Trace System would help curb the circulation of spurious, falsified, counterfeit and unregistered medicines, facilitate product recalls and ensure greater transparency and integrity throughout the supply chain.
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The authority has also held consultations with key industry stakeholders, including the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), Pharma Bureau and medicine importers, to facilitate implementation of the system.
DRAP said the 2D barcode would enable consumers to verify the authenticity of medicines by scanning the code printed on the packaging, strengthening public confidence in the pharmaceutical supply chain.