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.
In this article
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 a 2D Data Matrix holds
A Data Matrix is a small square code made of black and white cells. Unlike a traditional barcode, it can hold several pieces of information in very little space and can still be read if partly damaged. On medicine packs it usually follows the GS1 standard, which encodes each item of information with a short identifier:
| Data | GS1 identifier |
|---|---|
| Product code (GTIN) | (01) |
| Expiry date | (17) |
| Batch or lot number | (10) |
| Unique serial number | (21) |
The serial number is what makes each pack unique. When it is recorded in a central system, anyone along the supply chain — and eventually a pharmacist or patient — can check whether a code is genuine, has already been used or belongs to a recalled batch.
How other countries did it
Pakistan is following a path already taken elsewhere. The European Union has required unique identifiers and tamper-evident packaging on most prescription medicines since February 2019 under its Falsified Medicines Directive, and the United States has been phasing in serialised, electronic traceability under its Drug Supply Chain Security Act since 2013. Their experience shows that systems are usually introduced in phases — first coding the packs, then recording and verifying codes, and later tracing products through each step of distribution.
A practical checklist
- Obtain product codes (GTINs) for each pack type and register product data as DRAP requires.
- Choose a printing method — thermal inkjet, laser or pre-printed labels — that suits your line speed and packaging material.
- Add camera inspection to verify that every code is readable and correct, and reject faulty packs.
- Install serialisation software to generate, manage and report serial numbers to the DRAP portal.
- Validate the system, train operators and update procedures.
- Agree data exchange with contract manufacturers, importers and distributors.
Common pitfalls
Experience elsewhere shows where serialisation projects tend to slip: codes printed too small or with poor contrast to be read reliably; line speeds reduced because the printer or camera cannot keep up; master data — product codes and pack details — entered inconsistently; and contract manufacturers or importers left out of the planning. Testing codes with real scanners, involving packaging suppliers early and running a pilot product before rolling out across a plant all reduce those risks.
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.
