E-leaflet and e-label: what India requires on medicine packs
7 min read
E-leaflet and e-label are two phrases that come up together in pharmaceutical packaging, usually in the same sentence as QR code, and usually with the question of whether the printed leaflet is on its way out. This post explains what each term means, what Indian law currently requires, and what all of it means for the leaflet, carton and label that still have to be printed.
One caution before anything else: this is a printer explaining the packaging consequences, not legal advice. The rules change by notification, and the only authority is the current text on the CDSCO website. Confirm the position with your regulatory team before an artwork is signed off.
What an e-leaflet is
An e-leaflet, also called an electronic package insert or ePI, is the content of the patient information leaflet served digitally rather than only on paper. In practice the patient or pharmacist scans a QR code on the pack, or types a short URL, and reads the leaflet on a phone. The digital version can be longer than the paper one, can be offered in several languages, can be read aloud by a screen reader, and can be corrected without recalling stock.
The idea is not new and it is not Indian in origin. The European Union has been piloting ePI for some years, and several markets have allowed an electronic leaflet for hospital-only products where a pharmacist rather than a patient is the reader. The pattern everywhere so far has been the same: the electronic version is added alongside the printed one, and the printed one is withdrawn only for specific product classes, if at all.
What an e-label is
An e-label is the same idea applied to the label and carton rather than the leaflet. The identifying data on the pack, such as the product name, manufacturer, batch number and expiry date, is encoded so that a scanner can read it and a system can verify it. Where an e-leaflet is for the person taking the medicine, an e-label is mostly for the supply chain: the wholesaler, the pharmacy and the regulator checking that a pack is genuine and in date.
The two overlap because they usually share one QR code. A single code on the carton can carry the pack data in machine-readable form and also resolve to a page holding the leaflet. That is why the two phrases are searched together, and why a packaging artwork brief now tends to specify both.
What India currently requires
The rule that matters is Rule 96 of the Drugs Rules, 1945, as amended by notification G.S.R. 823(E) dated 17 November 2022. It requires a QR code or barcode on the primary or secondary packaging of the 300 formulation brands listed in Schedule H2, and it took effect on 1 August 2023. Active pharmaceutical ingredient packs have carried a QR code since 1 January 2023 under a separate requirement.
The code has to be machine-readable and has to carry a specific set of data. The government has said it intends to extend the requirement beyond the first 300 brands, and CDSCO consulted during 2024 and 2025 on braille labelling and voice-assisted QR codes so that visually impaired patients can reach the leaflet content. Treat any date for those extensions as unconfirmed until it appears in a notification.
What the rule does not do, as of this writing, is remove anything. The printed leaflet, the printed carton and the printed label remain required under the existing labelling rules. The QR code is in addition to them, not instead of them.
- Unique product identification code, in practice the GTIN
- Proper and generic name of the drug
- Brand name
- Name and address of the manufacturer
- Batch number
- Date of manufacturing
- Date of expiry
- Manufacturing licence number
What this means for the printed leaflet
The leaflet still has to be printed, still has to carry the full approved text, and still has to fold down to fit the carton. A common mistake when a QR code is added is to assume the paper leaflet can now be shorter. It cannot, unless the approved text itself has been shortened through the regulatory process. What the QR code allows is a better digital version alongside the paper one, not a thinner paper one.
Leaflets are printed on thin paper, typically forty to sixty GSM, at small type sizes, and are folded many times. Legibility at that size is a safety matter rather than a design preference. Keep the body type no smaller than the approved artwork, keep the fold marks off the text, and proof the folded piece against the carton it must fit inside before a run is approved.
What this means for the carton and label
The QR code is the new element and it is the one most often printed badly. A code that will not scan is a compliance failure that looks, on the artwork, like a compliance success. Three things decide whether it scans.
Size and quiet zone first. A code carrying the eight data fields above is denser than a code holding a web address, so it needs more physical space to print each module cleanly. Leave a clear margin around it on all four sides. Contrast second: dark modules on a light, matte background scan reliably; a code printed over a metallic foil, a holographic panel or a busy image frequently does not. Placement third: put it on a flat panel, not across a fold, a crease or a glue flap.
Batch number, manufacturing date and expiry date are variable data. They change with every batch, so they are almost never part of the printed artwork. They are added afterwards by inkjet or laser coding on the packing line, and if the QR code has to carry them, the code itself is generated and applied at that stage too. The printed artwork therefore needs a clean, unprinted panel of the right size, in the right place, on a surface the coder can mark. Agree that panel with the packing line before the carton is printed, not after.
- Print the code at the size the data density needs, with a clear margin all round
- Dark on light, matte finish, never over foil or a holographic panel
- On a flat panel, away from folds, creases and glue flaps
- Leave a clear panel for the batch, dates and any line-applied code
- Test-scan a physical proof with more than one phone before approving the run
What to send your printer
Send the approved artwork as a PDF with fonts embedded and at least three millimetres of bleed on the carton and label. Send the QR code as a vector or as a high-resolution black-and-white image, not a screenshot. Tell the printer which panel is reserved for line coding so it is left clean. If the leaflet has been approved at a particular size and fold, say so, because a printer will otherwise choose the most economical fold and that may not be the approved one.
A test scan of the printed proof, with the actual phone models your patients are likely to use, takes two minutes and is the single most useful check in the whole process.
Common questions
Does the QR code replace the printed leaflet in India?
Not as of this writing. Rule 96 as amended adds a QR code or barcode requirement for the Schedule H2 brands; the printed leaflet, carton and label remain required under the existing labelling rules. Confirm with the current CDSCO notification before changing any artwork.
Does the requirement apply to every medicine?
The August 2023 requirement applies to the 300 formulation brands in Schedule H2, and API packs have needed a code since January 2023. The government has said it intends to extend it further; treat any wider date as unconfirmed until notified.
Why does a QR code print fine on screen but fail to scan on the pack?
Usually one of three things: it was printed too small for the amount of data it carries, it sits over a foil or holographic finish that defeats the contrast, or it crosses a fold. A physical proof scanned with a phone finds all three before the run.
Can the batch number and expiry date be part of the printed artwork?
They can, but almost nobody does it that way because they change with every batch. They are normally applied on the packing line by inkjet or laser coding, so the artwork should leave a clean panel for them.