Resource · Pharmaceutical
What must appear on a pharmaceutical carton in Pakistan
A working guide to the labelling particulars required by the Drugs (Labelling and Packing) Rules, 1986 and DRAP’s current labelling guideline — written for packaging development and artwork teams rather than for lawyers.
This is guidance, not legal advice
Regulatory responsibility for label content rests with the marketing authorisation holder. We are a printer and converter: we reproduce the artwork you approve, and we do not approve, certify or verify regulatory content. Always work from the current official text and your own regulatory affairs function.
- Primary source
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Guidelines on Labeling and Packing of Pharmaceutical and Biological Drugs
Drug Regulatory Authority of Pakistan (DRAP) · Document PE&R/GL/GR/007 · 1st Edition · effective 18 March 2024 - Also referenced
- Drugs Act 1976 (s.7) · Drugs (Labelling and Packing) Rules, 1986 · DRAP Act 2012 · SRO 470(I)/2017 · WHO TRS 902, Annex 9
- Last reviewed
- — regulations change; check dra.gov.pk for the current text before relying on this page.
Guideline §6.1
The nine mandatory particulars
Under §6.1, “Manner of Labeling”, these particulars must appear either in print or in writing in inedible ink in a conspicuous manner on the label of the innermost container and on the container in which it is packed.
That last point is the one that catches artwork teams out: it is not a choice between the blister and the carton. Both carry the particulars, subject to the relaxations below.
- The registered name of the drug
- The international non-proprietary name (INN) Required immediately after the registered name where that name is proprietary. Where there is no INN, the pharmacopoeial name or another name approved by the Registration Board, shown conspicuously.
- Each active ingredient, with its weight By INN, pharmacopoeial, generic or chemical name.
- Name and principal place of business of the manufacturer
- The drug manufacturing licence number
- The drug registration number
- The date of expiry
- Urdu version of the drug name, the dosage and the instructions Three separate items, all in Urdu. This is the particular most often under-allowed for at artwork stage, because the Urdu text needs real space and cannot simply be set smaller to fit.
- Batch number, date of manufacture and maximum retail price
The relaxation for small packs
For drugs packed in a strip, blister or foil, ampoules of 2 ml or less, ampoules containing sterile suture or ligature, and printed collapsible tubes — where these are placed in an outer package, it is sufficient to give the information on the outer packing. The Registration Board may also relax any of the conditions above.
Guideline §6.2 – §6.12
Additional requirements by category
These sit on top of the nine particulars, not instead of them. Each adds text that has to be allowed for in the artwork — which is why the category is worth establishing before a layout is drawn rather than after.
| § | Category | What must additionally appear |
|---|---|---|
| 6.2 | Drugs for internal use | If a scheduled substance: “to be sold on prescription of a registered medical practitioner only”. If 3% or more alcohol by volume: a statement of alcohol content as average % v/v of absolute alcohol. |
| 6.3 | Parenteral preparations | Route of administration. If unpreserved: “Single use. Discard unused portion”. If preserved: “multiple use” plus duration, conditions of use and storage after first puncture. Dilution directions where required. |
| 6.4 | Preparations for external use | “For external use only” — ointments, creams, liniments, lotions and antiseptics. |
| 6.5 | Physician’s samples | “Physician sample not for Sale”, overprinted or stamped. For strip, blister or foil packs, ampoules of 3 ml or less and collapsible tubes, on the outer packing only. |
| 6.6 | Government supply | “Government supply”, or the mark required by the supplying agency. |
| 6.7 | Veterinary drugs | “For veterinary use only”. |
| 6.8 | Pressurised containers and flammable products | Cautionary statements, hazard symbols and signal words. For manual pump sprays with flammable ingredients, for example “Do not use near an open flame”. |
| 6.9 | Special containers | Containers too small for a full inner label may carry abbreviated labelling, provided an outer label meets all the requirements. Covers multiple-dose packs (blisters, strips, push-through cards, ampoules and vials on a plastic strip) and single-dose packs (sachets, pouches, individual dose vials, pre-packaged syringes). |
| 6.10 | Outer transparent wrapper | A transport cover, wrapper or case used solely for packing, transport or delivery does not itself require labelling. |
| 6.11 | Pharmacopoeial letters | “P.P”, “Ph.I”, “Eur.P”, “B.P”, “B.P.C” or “U.S.N.F” printed in indelible ink to indicate the specification standard followed. |
| 6.12 | Packing of finished drugs | Finished drugs ready for use are packed in containers intended for retail sale to a hospital dispensary, clinic or similar institution. |
Guideline §6.13
Exporting? The rules are different
This is the provision most worth knowing if you produce for export, and the one least often explained. Drugs registered for export only are exempt from the 1986 Rules, and may be labelled according to the requirements of the importing country instead.
That exemption is not unconditional. The innermost container must still bear, conspicuously:
- the name of the drug
- the name and principal place of business of the manufacturer
- the batch number, the date of manufacture and the date of expiry
For strips, foils and blisters, ampoules of 2 ml or less and printed collapsible tubes, these may appear on the outer packing — except for the expiry date, which stays on the innermost container.
In practice this means an export pack can be built to the destination market’s rules — its language, its required statements, its layout conventions — while still carrying that irreducible set of identifiers. It is worth confirming both regimes in writing before artwork is drawn, because the two sets of requirements frequently want the same space on the same panel.
Brand names are assessed too
Under §7, DRAP assesses proposed brand names for confusion risk against indication, patient population, dosage form, route, strength and prescribing setting. Names must not be misleading, promotional, comparative, superlative, spiritual, wholly acronyms, or contain punctuation.
§7(h) is the part that touches printing directly: labelling and pack design are to be considered as contributing factors for safe use, and discussed at the time of the review of mock-ups.
That is a useful alignment rather than an extra burden: the physical cut-and-creased sample produced for print approval is the same artefact that review expects to see.
SRO 470(I)/2017
Barcodes, GS1 DataMatrix and what it means for print
SRO 470(I)/2017, dated 15 June 2017, introduced mandatory barcode labelling for identification, tracking and verification through the supply chain. The requirements are built on GS1 standards, using the GTIN as the product identification code.
What the 2D code has to carry
- Expiry date
- Batch number
- Product identification — drug name, dose, pack size
- Serial number
To be printed on primary and secondary packaging. Pakistan is transitioning from basic barcode identification toward GS1 DataMatrix-based serialisation; draft amendments circulated through 2025 extend the framework to serialised DataMatrix on secondary packaging and logistics identifiers on tertiary packaging. Verify the current status before relying on this — it is the part of this page most likely to have moved.
The part nobody tells packaging buyers
A DataMatrix does not merely need to be printed. It needs to grade — to be readable by a scanner at line speed and to pass verification. Four print variables decide whether it does:
- Contrast between the code and its background
- An unobstructed quiet zone around the code
- Substrate — how absorbent the board is, and how much the ink spreads
- Any varnish or laminate sitting over the code area
Which makes print quality a compliance issue rather than an aesthetic one — and makes the code area something to specify in the artwork, not to leave to the finishing decision.
Before artwork is drawn
Six things to settle first
None of these is a printing decision, and all six change the layout. Settling them before a designer starts is the cheapest hour anyone spends on a pharmaceutical pack.
- Which category the product falls into Internal, parenteral, external, veterinary or a physician’s sample — each adds text.
- Whether the pack is domestic, export-only, or both Export-only changes the regime entirely under §6.13. Dual-market packs need both.
- How much space the Urdu text genuinely needs Name, dosage and instructions, all in Urdu. It cannot simply be set smaller to fit.
- Where the 2D code sits, and what applies it A flat panel clear of creases and glue, with a quiet zone and no varnish over it.
- Which particulars sit on the innermost container And which the outer pack carries, if a relaxation under §6.9 or §6.13 applies.
- Who signs the artwork off, and against what Version control and written proof approval are what make the rest defensible.
We print to the artwork you approve
If you produce pharmaceutical packaging in Pakistan and want a printer who already works this way — version-controlled artwork, pre-production mock-ups for your review, clear zones specified for your codes and documented checks on every run — that is what our pharmaceutical work is built around.
This guide summarises publicly available regulatory documents as an aid to packaging teams. It is not legal advice and it is not a substitute for the official text. Responsibility for label content rests with the marketing authorisation holder. Last reviewed .