Pakistan’s 2D barcode rules: what pharma packaging buyers need to know

Guidance, not legal advice

This post is guidance written for packaging and procurement staff. It is not legal advice, and it is not a substitute for the regulations themselves. Regulatory responsibility for label content, including the barcode and what it encodes, rests with the marketing authorisation holder. We print to the artwork you approve. The rules summarised here are current to the review date shown at the top of the page and cited at the bottom; the amendments are still draft at the time of writing, and you should verify their status with DRAP before relying on anything time-sensitive.

The framework, in order

Four instruments matter, and they stack.

The Drugs Act, 1976 is the basis for registering drug products. The Drugs (Labelling and Packing) Rules, 1986 are the operative labelling rules — what must appear on the pack. The DRAP Act, 2012 established the Drug Regulatory Authority of Pakistan. And SRO 470(I)/2017, dated 15 June 2017, amended the labelling rules to introduce mandatory barcoding for identification, tracking and verification in the supply chain.

Sitting on top of those is DRAP’s Guidelines on Labeling and Packing of Pharmaceutical and Biological Drugs, document PE&R/GL/GR/007, first edition, effective 18 March 2024 — the current guidance document, and the primary source for our DRAP labelling guide. It cites WHO Technical Report Series 902, Annex 9 as its international basis.

What SRO 470(I)/2017 actually requires

The SRO made a barcode mandatory on pharmaceutical packaging for identification, tracking and verification. The requirements are built on GS1 standards: the product is identified by a GTIN — a Global Trade Item Number, fourteen characters as encoded — and the machine-readable code carries, alongside it, the expiry date, the batch number and a serial number. The code is applied to primary and secondary packaging: the container that touches the product, and the carton it goes in.

“Machine-readable 2D code” in practice means a GS1 DataMatrix — the small square code you will have seen on medicine cartons in most regulated markets. It is chosen because it holds those four data elements in a very small footprint and reads reliably at speed, provided it has been printed well. That proviso is the subject of the second half of this post.

The four data elements

The first element is fixed for a product. The second and third change per batch. The fourth changes per pack — and that is the one that changes how the code has to be produced. A GTIN, batch and expiry can be printed once for a whole run. A unique serial per carton cannot be printed by an offset plate, because the plate is the plate: it needs variable-data printing, applied either inline at the printer or on the packaging line at the manufacturer.

Primary, secondary and tertiary: where the code goes

The SRO requires the code on primary and secondary packaging. In practice that means the blister, bottle or vial label, and the carton.

The 2025 draft amendments to the 1986 Rules — published by DRAP for stakeholder feedback and circulated through the industry association during 2025 — move the framework further toward full serialisation: a serialised GS1 DataMatrix on secondary packaging, and logistics identifiers on tertiary packaging, meaning the shipper case. The direction of travel is toward every carton being uniquely identified and every shipper being scannable as an aggregation of the cartons inside it. These are draft at the time of writing. Whether, and when, they apply to your product category is something to confirm with DRAP or your regulatory adviser rather than assume from a blog post — including this one.

The part nobody explains: a code has to grade, not just print

Here is the angle that matters to a packaging buyer and that no printer in this market writes about. A DataMatrix is not compliant because it is on the carton. It is compliant if it can be read — at line speed on the packaging line, again at the distributor, again at the pharmacy. Readability is measured by verification grading, and the grade depends on how the code was printed at least as much as on what it encodes.

Four print variables decide it.

Contrast. A scanner reads the difference between the dark modules and the light background. Low ink density, a tinted background, a dark board or a code printed in a colour other than black all reduce contrast, and a code with poor contrast grades down or fails.

Quiet zone. The code needs a clear margin around it on every side, free of print, creases, glue and the edge of the panel. A quiet zone that is encroached on by artwork — a border, a line of type, a crease — stops the scanner locating the symbol.

Substrate. Ink behaves differently on coated and uncoated board. On an absorbent surface the modules spread and the fine gaps between them fill in; on a very glossy surface the scanner can catch glare. The board under the code is a specification, not an accident.

Varnish and lamination. A coating over the code area can reduce contrast, add glare, and — where the code is applied by the manufacturer’s own coder after printing — stop the ink keying to the surface at all. Whether the code area is left uncoated has to be decided in the artwork, before the finishing is specified.

Every one of those is a decision made at the press or before it. Which is why we say, without exaggeration, that on a pharmaceutical carton print quality is a compliance issue. A code that grades poorly is a quality event on the packaging line, and it is recorded against the manufacturer, not the printer.

What we do about it, and what we do not claim

We produce cartons and leaflets with dedicated clear zones and the substrate specified for your DataMatrix or serialisation vendor, and we check print contrast on every run. Concretely, that means the code area is designed into the artwork rather than left over: positioned on a flat panel clear of creases and glue, sized with its quiet zone, kept free of varnish or laminate where that matters, with the board chosen so the modules stay crisp — and then the contrast is checked through the run against the approved sample.

Where the serialised code itself is applied on your packaging line by your own coder, the pack we hand you is one your codes will grade on. Where a job calls for the unique codes to be printed by us, we will tell you plainly what we can produce for that specific job and how it will be verified before you commit to anything — rather than list a capability on a website and hope it survives your supplier audit.

And the boundary, stated as plainly: we print to the artwork you approve. What the code encodes, whether the GTIN is correctly allocated, whether the batch and expiry are right, and whether your product falls under the current or the draft rules are all matters for the marketing authorisation holder. We do not certify, we do not approve, and no printer can take that responsibility on your behalf.

A checklist for the artwork stage

If you are specifying a pharmaceutical carton, these are the questions to settle with your printer before the dieline is signed off, because after the die is cut they become expensive.

• Which panel carries the DataMatrix, and is it flat, clear of creases and glue, and inside the safety margin?
• How large is the code, and is the quiet zone drawn on the artwork around it?
• Is the code printed by the printer, or applied on your line? If on your line, what does your coder need — an uncoated window, a particular surface?
• What board is under the code, and has a sample been scanned and graded on it?
• Is the code area excluded from varnish and lamination in the finishing specification?
• Where do the human-readable batch, expiry and serial sit, and are their overprint areas sized for the character set your coder produces?
• Is the mock-up going into your regulatory review? DRAP’s guideline expects pack design to be considered at the review of mock-ups, and the sampling stage produces exactly that artefact.

The pharmaceutical packaging pages set out how each of those is handled on a job, and the DRAP labelling guide covers the mandatory particulars that sit alongside the code.