Pharma track and trace solution for India and global markets
OCX Labs gives pharmaceutical manufacturers unit-level traceability and AI-driven supply chain workflows, so every pack can be identified, followed and verified from your line to the patient's pharmacy.
One product identity. Different market requirements.
India
CDSCO Schedule H2. A barcode or QR code on the primary pack label, or the secondary label if space is short.
United States
DSCSA. Interoperable, electronic tracing of prescription drugs at package level.
European Union
FMD and Delegated Regulation 2016/161. A unique identifier in a 2D barcode plus an anti-tamper device on prescription packs.
Serialization is the beginning. Traceability is the record around it.
Follow each saleable pack from packing to distribution instead of relying on batch records. Link units to cases and pallets so one scan at dispatch accounts for everything inside.
Connect the pack to the case, the case to the pallet.
Aggregation links units to cases and pallets, creating parent-child relationships that make distribution records easier to follow and investigate.
Trace upstream, not only downstream.
Extend the record upstream to the materials that go into each batch. Keep batch-to-ingredient records in a form you can query.
Built around real pharmaceutical supply chains.
and contract manufacturers
US, EU or Gulf markets
preparing for upstream traceability
reliable product data from suppliers
Questions, answered clearly.
A pharma track and trace system records the identity and movement of each medicine pack through manufacturing, packing, distribution and dispensing. Its purpose is to prove a product is genuine and to find affected units fast if something goes wrong.
Schedule H2 of the Drugs Rules requires manufacturers of listed medicines to put a barcode or QR code on the primary pack label, or on the secondary label if space is short. It first covered the top 300 brands and was extended in June 2026 to vaccines, antimicrobials, narcotic drugs and anti-cancer medicines.
The 2026 notification lists nine elements: a unique product identification code, generic and brand names, manufacturer name and address, batch number, manufacturing and expiry dates, manufacturing licence number, and excipient details where applicable.
DSCSA applies to trading partners in the US supply chain: manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. If your medicine is sold in the US, your US partners will expect serialized product data from you.
Most prescription medicines in the EU must carry a unique identifier in a 2D barcode and an anti-tamper device. The identifier holds a product code, a serial number, the batch number and the expiry date. Pharmacies verify the pack and mark it as dispensed.
Serialization gives each pack a unique serial number. Aggregation links packs to the cases and pallets that hold them. Track and trace records every step those packs take through the supply chain and lets partners verify them.
India has already introduced QR code labelling for active pharmaceutical ingredients, and industry commentary expects traceability to move further upstream. Check current CDSCO notifications for your materials, and keep batch-to-ingredient records in a form you can query.
For exports, yes. The DGFT's track and trace notice requires barcodes that follow GS1 standards, with a GTIN, batch, expiry and serial number, and GS1 India prescribes the standard. For the domestic Schedule H2 rules, the notification asks for a barcode or QR code without naming GS1, but using GS1 identifiers keeps your data consistent across India, the US and the EU.
We provide unit-level traceability and AI-driven workflows on a single platform, so your records stay consistent across markets. Ask for a walkthrough and we will show it on your own product.
Ready to see how this works on your product?
We will walk you through a short demo on your own product, tailored to your distribution.