Pharma Packaging Levels Explained: What Barcode Goes on Primary, Secondary and Tertiary Packs

Ask a packaging development team where the barcode goes on a new pharma SKU and the honest answer is usually "wherever artwork left space." That works until the strip, the carton, and the shipper each need a different code, carrying different data, read by a different person, under a different rule. Pharma packaging in India runs on three levels — primary, secondary, and tertiary — and the barcode decision is different at every one of them.

Getting it right matters more in 2026 than it did two years ago. The Schedule H2 QR requirement, which started with 300 named brands in August 2023, now extends to every vaccine, antimicrobial, anticancer and NDPS drug from July 2027 onwards. A lot more SKUs are about to need a code on the pack, and the cheapest time to plan where it goes is before the artwork is locked.

Primary first

The Schedule H2 rule puts the Bar Code or QR Code on the primary pack label. The secondary pack is the fallback only where the primary label genuinely doesn't have enough space — so primary-pack real estate is now a regulatory decision, not just a design one.

The Three Levels, and What Each One Is For

Each packaging level has a different job in the supply chain, and the barcode on it should serve that job. A code that's perfect for a warehouse scanner is useless to a patient, and a code built for a patient's phone camera is the wrong tool for a pallet.

Level 1 · In contact with the product

Primary Packaging

The blister, strip, vial, ampoule, bottle or tube that actually touches the medicine. This is the pack a patient may end up holding after the carton is thrown away, which is exactly why regulators want the code here. It's also the hardest surface to print on: aluminium foil reflects light, vials and bottles curve, and a 10-tablet strip leaves very little free area once the mandatory text is in place. A compact 2D symbol — usually a GS1 DataMatrix or a small QR code — is the only practical option on most primary packs.

Level 2 · The saleable unit

Secondary Packaging

The monocarton or outer box that holds one or more primary packs and is usually what changes hands at the pharmacy counter. Cartons give you a flat, printable board surface and the most room, so this is where GTIN, batch, expiry and any variable code are easiest to print well. When a strip simply can't hold a legible code, the Schedule H2 FAQ allows the code to move here instead. Products sold through modern retail may also carry an EAN-13 for point-of-sale scanning.

Level 3 · Logistics

Tertiary Packaging

The shipper, case or pallet that moves stock from plant to depot to distributor. Nobody outside the supply chain ever sees it. The standard code here is a GS1-128 logistics label carrying an SSCC (Serial Shipping Container Code, application identifier 00), which uniquely identifies that physical case or pallet. Tertiary codes are read by fixed or handheld scanners at goods receipt and dispatch, not by consumers.

What Barcode Goes Where: A Quick Reference

Level	Typical examples	Usual data carrier	Typical data	Who scans it
Primary	Blister, strip, vial, bottle label	GS1 DataMatrix or QR code	Schedule H2 data set: product code, names, manufacturer, batch, dates, licence number	Patient, pharmacist, field auditor
Secondary	Monocarton, outer box	GS1 DataMatrix / QR; EAN-13 for retail POS	GTIN, batch, expiry; H2 data set if primary has no space	Pharmacist, retailer, stockist
Tertiary	Shipper, case, pallet	GS1-128 logistics label	SSCC, plus optional GTIN, batch and quantity of contents	Warehouse, depot, distributor

Where Packaging Teams Run Into Trouble

The primary pack was designed before the code was

Most strip and blister artwork in India was designed years before any QR requirement existed. Adding a code later usually means shrinking it until it fits — and a 2D code shrunk below the size the printer and the foil can reliably reproduce will look fine to the eye and fail when scanned. If the code can't be printed at a size that reads consistently, it is better to use the secondary-pack fallback than to put an unreadable code on the strip.

Codes placed over folds, seams, and perforations

A code printed across a carton crease, a blister perforation, a glue flap or a heavily varnished patch will distort or crack. Reserve a flat, unvarnished code panel at the artwork stage, with a clear margin — the quiet zone — on all sides.

Treating the static and variable parts as one job

The GTIN and the fixed text never change, so they can be printed with the artwork. Batch, manufacturing date, expiry and any unit-level serial change constantly and must be printed on the packaging line. Teams that don't separate these two early end up with the variable code squeezed into whatever space the static design left over.

Aggregation decided too late

Aggregation is the parent-child link between levels: which strips are in which carton, which cartons in which shipper, which shippers on which pallet. The DGFT withdrew its export track-and-trace provisions in January 2025, handing authentication of exported formulations to the Health Ministry under the Drugs Rules — so aggregation is no longer a DGFT filing requirement. It is still how a brand knows what is inside a sealed case without opening it, and it is very hard to add once a line is running. Decide early whether you want it.

The barcode question is really a packaging-hierarchy question. Decide what each level needs to prove, and to whom, before anyone opens the artwork file. — Ratifye Supply Chain Desk

Don't Forget the API Rule

Finished formulations aren't the only packs with a code requirement. Since 1 January 2023, Active Pharmaceutical Ingredients manufactured or imported in India must carry a QR code on their labels at each level of packaging, under G.S.R. 20(E). For companies that make both APIs and formulations, it makes sense to run both on the same coding standard and the same data system rather than two separate setups.

A Packaging Checklist for New and Re-Designed SKUs

Map every SKU to its rule. Is it a Schedule H2 Table 1 brand, does it fall into a Table 2 category from 2027, or is the code voluntary?
Choose the code level. Primary pack wherever a legible code fits; secondary only where it genuinely doesn't.
Standardise on GS1 identifiers. GTIN for the product and SSCC for logistics units, so trading partners and export markets can read the same data.
Reserve a code panel in the artwork. Flat, unvarnished, away from folds and seams, with the quiet zone protected.
Split static and variable print. Artwork carries the fixed elements; the line prints batch, dates and serials.
Decide on aggregation now. Even where it isn't legally required, it is far cheaper to design in than to retrofit.
Verify, don't just scan. A phone reading the code once is not the same as a graded print-quality check.

Where Ratifye Fits

Ratifye generates GS1-compliant codes for each packaging level from a single platform — the patient-facing QR on the strip or carton, and the logistics identifiers above it — and links them, so a scan at any level resolves to the same product record. Because it works with the coders and printers already on your lines, adding it doesn't require new hardware, and most teams go live in about two weeks. Each code can also carry cryptographic authentication, so the code on the pack doesn't just identify the product — it proves the pack is genuine.

Take Action

Planning codes for a new SKU or a 2027 category?

Ratifye's team can review your packaging hierarchy and show where each code should sit — strip, carton and shipper — before the artwork goes to print. Start with 500 free authentications.

Talk to our team

Sources: CDSCO notification G.S.R. 823(E) dated 17 November 2022 and CDSCO FAQs on Bar Code / QR Code implementation for Schedule H2 brands (July 2023); G.S.R. 506(E) dated 22 June 2026 (Drugs (Seventh Amendment) Rules, 2026) inserting Table 2 in Schedule H2; G.S.R. 20(E) on QR codes for Active Pharmaceutical Ingredients; DGFT public notice of January 2025 withdrawing the track-and-trace provisions for pharmaceutical exports; GS1 General Specifications for SSCC and GS1-128. Consult the primary regulatory texts and your regulatory team for decisions specific to your products.