2D barcodes are now mandatory on medicines: what manufacturers and importers need to know
DRAP’s SRO 963(I)/2026 requires Data Matrix codes and serial numbers on medicines made or imported from 9 October 2026.
Pakistan’s pharmaceutical track and trace system has entered its first phase. The Drug Regulatory Authority of Pakistan (DRAP) has issued S.R.O. 963(I)/2026 under the amended Drugs (Labelling and Packaging) Rules, 1978, APP reported on 12 October 2026.
What the rule requires
- All registered drug products — made in Pakistan or imported — must carry a unique 2D Data Matrix barcode and serial number.
- It applies to products manufactured or imported on or after 9 October 2026.
- Batches made or imported before that date are exempt and may still be imported, distributed and sold.
- DRAP has published guidelines on Data Matrix barcodes and serialisation, and the system links to its e-Services portal.
- DRAP warned that non-compliance could lead to legal action.
Why it is happening
The aim is to stop spurious, falsified, counterfeit and unregistered medicines reaching patients, to make recalls easier and to make distribution more transparent. The step is part of DRAP’s Strategic Plan for the National Regulatory System 2026–30. DRAP consulted the Pakistan Pharmaceutical Manufacturers’ Association, the Pharma Bureau and importers, and ran workshops and nationwide training roadshows on barcode standards, serial number generation, vendor readiness and portal integration.
What it means on the factory floor
For manufacturers and importers, the practical work sits on the packaging line and in IT: printing and verifying codes, generating serial numbers and connecting data to the portal. That makes serialisation equipment, label printing, vision inspection and software suppliers newly relevant to every plant.
Suppliers in these areas exhibit at Pharma Asia 2026, where track and trace was also on the convention agenda last year.
