Pharmaceutical packaging and carton printing

The Drugs (Labelling and Packing) Rules, 1986 and the current DRAP labelling guideline require the particulars to appear on the innermost container and on the pack it goes into: the registered name of the drug, the international non-proprietary or pharmacopoeial name, each active ingredient with its weight, the manufacturer’s name and principal place of business, the manufacturing licence number, the registration number, the date of expiry, an Urdu version of the drug name, dosage and instructions, and the batch number, date of manufacture and maximum retail price. Category-specific statements are added on top of that. We have written the detail up for packaging staff in our DRAP labelling guide. Responsibility for what the label says rests with the marketing authorisation holder — our job is to reproduce the artwork you approve, accurately.

“Leaflet” is the general term for the printed patient information sheet. An insert is a folded leaflet placed inside the carton next to the blister or bottle. An outsert is a much more compact multi-panel block affixed to the outside of the pack, used where there is no room inside. They are folded differently, on different equipment, at different costs — the outsert is the harder product by a distance. Full detail on our leaflets, inserts and outserts page.

Braille on a carton is embossed with a dedicated strip-die after printing — it is a separate tooling and finishing operation, not a print effect, and the EU and several other export markets require it. Tell us the destination market and the pack size with your enquiry and we will confirm in writing what we can produce for your job before you commit to anything.

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. Contrast, quiet zone, substrate and any varnish over the code area all change whether a code grades — so the code area is designed in rather than left over, and the pack we hand you is one your codes will grade on.

Board and ink are specified per job rather than fixed, because the carton, the leaflet and the label each need something different: a carton needs stiffness and a surface a code will grade on, a leaflet needs very light stock that still takes small type without set-off. Send us the pack, the fill line and the code requirement and we will specify the substrate against them and confirm it with your quote.

Yes, and we recommend it. The mock-up is cut and creased in the production board on your actual dieline, so it is a physical pack rather than a PDF. DRAP’s labelling guideline expects labelling and pack design to be considered at the review of mock-ups, which means the same artefact serves your regulatory review and our print approval. What you do with it in your submission is your decision — we produce it to your approved artwork.

Artwork is version-controlled and released to plate only against your written proof approval. Each revision is logged against the job number, the approved proof is held on file, and the press runs against the sample you signed rather than against the last file that arrived by email. That is deliberately the slowest part of the process.

Yes. Drugs registered for export only are exempt from the 1986 Rules and may be labelled to the importing country’s requirements under DRAP Guideline §6.13, while the innermost container still carries the drug name, the manufacturer’s name and principal place of business, the batch number, and the dates of manufacture and expiry. Send us the destination market’s specification with your approved artwork and we will produce to it.

Both depend on the construction, the board and whether a new die is needed. Offset carries a fixed plate and make-ready cost, so the unit price falls as the run lengthens; digital has no plates and suits short runs and versioned artwork. Lead time runs from approved artwork and a signed sample, not from your enquiry. Send the pack size, quantity and code requirement and we will confirm both with the quote.

Batch counts are verified at packing and reconciled before dispatch, and the approved proof is held on file against the job number so any later query is answered against what you actually signed. Tell us what retention period your quality agreement requires and we will confirm what we can commit to in writing.