Three Different Jobs
| OCR / OCV print verification | Serialization | Aggregation | |
|---|---|---|---|
| Question it answers | Is the printed batch, date and expiry present, legible and correct for this run? | Does every saleable unit carry a unique, recorded identity? | Which units are inside which bundle, case and pallet? |
| Code type | Human-readable text, often alongside a 1D or 2D code | Typically a GS1 DataMatrix with product code, serial, batch and expiry | Serialized units plus case and pallet labels (e.g. SSCC) |
| Unique per pack? | No: the same string for the whole batch | Yes | Yes, plus the parent–child links |
| Data system | Local: expected string, results, reject images | Line, site and enterprise serial-number management; reporting to authorities or trading partners where required | Same as serialization, plus the packing hierarchy |
| Line hardware | Camera at the coder or labeller, plus a reject | Printer, camera or verifier, reject, line controller | Scanning at each packing level, often manual or semi-automatic stations |
| Main driver | GMP: correct printing (e.g. revised Schedule M 18.5.5) | Market regulations (e.g. US DSCSA, EU FMD) and customer requirements | Market and customer requirements; supply-chain efficiency |
OCR vs OCV in One Minute
OCR (optical character recognition) reads the characters and returns text, which the system compares with the expected value. OCV (optical character verification) checks the printed characters against a known expected string and print quality. It answers “is this exactly what should be here, and is it legible?” Both use the same camera hardware, and most lines use a combination. The expected value should come from the batch recipe or line PLC, not be typed in by hand. Revised Schedule M clause 20.6 expects a second check on manual entry of critical data. More detail is in barcode, batch code and OCR verification.
What the Rules Say, Market by Market
Summary only. Regulations and timelines change. Confirm current requirements for your products and destination markets with regulatory affairs before scoping a project.
India: barcodes on Schedule H2 brands
The Drugs (Eighth Amendment) Rules, 2022 (G.S.R. 823(E), 17 November 2022) added a requirement under Rule 96 for the drug formulation brands listed in Schedule H2 (300 brands) to print a barcode or QR code on the primary packaging label. The secondary label may be used if the primary doesn't have enough space. The code must hold the unique product identification code, proper and generic name, brand name, manufacturer name and address, batch number, manufacturing date, expiry date and manufacturing licence number. It applies to batches manufactured on or after 1 August 2023. This is a product-level code requirement, not a unit-level serialization and aggregation mandate.
India: export track and trace (withdrawn)
DGFT's export track-and-trace system for drug formulations had required barcoding and data uploads at secondary and tertiary packaging levels, with the primary level repeatedly deferred. It was withdrawn by Public Notice 44/2024-25 dated 31 January 2025. Exporters now follow the rules of each destination market.
United States: DSCSA
The Drug Supply Chain Security Act requires product identifiers on prescription drug packages and interoperable, electronic, package-level tracing. Enhanced requirements took effect on 27 November 2023, followed by an FDA stabilization period to 27 November 2024 and then staggered exemptions. For manufacturers, the exemption period ended on 27 May 2025. Indian manufacturers exporting prescription drugs to the US are typically asked by their US partners to serialize saleable units and cases.
European Union: Falsified Medicines Directive
Under Delegated Regulation (EU) 2016/161, most prescription medicines placed on the EU market have carried a unique identifier in a 2D DataMatrix and an anti-tampering device since 9 February 2019. Packs are verified against a central repository system.
Which One Does Your Line Need?
| Scenario | Typically needed |
|---|---|
| Domestic generics, not on Schedule H2 | Print verification of batch, MFD and expiry (GMP). Label and barcode inspection to prevent mix-ups |
| Domestic brand listed in Schedule H2 | As above, plus a compliant barcode or QR code printed with the required data and verified on the line |
| US prescription exports | Unit and case serialization through a serialization system, usually with aggregation as required by partners, plus print verification |
| EU exports | Unique identifier and anti-tampering device per FMD, through a serialization system, plus print verification |
| FMCG, food, nutraceuticals | Batch, date and price print verification. Barcode grading for retail if customers require it |
A Note on Barcode Grading
Reading a code is not the same as grading its print quality. ISO/IEC 15416 (linear barcodes) and ISO/IEC 15415 (2D symbols) define print-quality grades. Some customers and markets specify a minimum grade. If you need graded verification with a formal report, say so in your URS, because it affects the camera, lighting and calibration requirements.
What Optomech Supplies, and What We Don't
We supply: OCR/OCV print verification of batch, lot, manufacturing date and expiry, for inkjet, thermal transfer and laser codes, as a capability of our LIS label inspection platform. That includes label presence, position and wrong-label checks, barcode checks, and automatic rejection.
We don't supply: serialization or aggregation software, serial-number management, or regulatory reporting. If you need those, use a dedicated serialization vendor. Our stations can work on the same line.
Not sure which project you're scoping? Start with our pharma packaging compliance hub or the revised Schedule M checklist.