1. Before go live (pre-Aug 2023 for new products; now for new launches)

• Identify whether any SKUs fall under Schedule H2.

• Define GTINs and QR / barcode design.

• Update artwork to include machine-readable code with all required data.

2. During packaging

• Print QR / barcodes on primary or secondary packs as per space.

• Validate that data fields are correctly populated and encoded.

• Run print quality checks (grade, contrast, readability).

3. Post-production and distribution

• Maintain master data and batch records aligned with QR content.

• Provide customers / patients with a clear way to scan and verify packs (company app, web page, or third-party solution).

• Retain batch-mapping so that recalls and complaints can be investigated using QR data.

Reporting Hub

• This is a labelling and authentication requirement, not a full national movement-reporting hub like Tatmeen or DTTS.

• Oversight is by Ministry of Health and Family Welfare (MoHFW) and CDSCO.

• Manufacturers must ensure QR/barcode content is accurate and supports downstream authentication (e.g. via mobile or web tools built by the company or third-party providers).

There is no central EUFMD-style track and trace portal for the 300 Drugs QR; DAVA and iVEDA/iTTS exports portals are no longer active for this scope, and this requirement applies to domestic brands listed in Schedule H2.

• The 300 Drugs QR rule does not impose aggregation or SSCC reporting.

• Many manufacturers still:

• Use SSCC barcodes on shipper cartons and pallets for internal WMS/ERP logistics and exports.

• Maintain internal mapping between sales packs, shippers and batches to support recalls and investigations.

For your global templates, you can treat India 300 Drugs QR as:

• Pack-level QR / barcode only,

• No mandatory case/pallet aggregation requirement.

• Printing QR / barcodes only on secondary packs where primary packs have space.

• Missing one or more mandatory data elements (for example, licence number or manufacturing date).

• Mismatch between text on the label and encoded data (e.g. wrong batch or expiry).

• Poor print quality leading to failed scans at pharmacy or hospital level.

• Treating 300 Drugs QR as a full serialization system and mixing it with export DAVA/iVEDA expectations instead of focusing on on-pack authentication for domestic Schedule H2 brands.