India 300 Drugs QR Compliance

Schedule H2 Top 300 Brands – QR / Barcode Requirement

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

Summary

India has introduced QR / barcode-based authentication for the top 300 drug brands sold in the domestic market, listed under Schedule H2 of the Drugs Rules, 1945. Under this rule, every pack of these brands must carry a readable code (QR or barcode) that stores key product and manufacturing details. The goal is to help patients, pharmacists and regulators verify the authenticity of high-volume, high-risk medicines and curb counterfeiting.

The requirement is notified through G.S.R. 823(E) dated 17 November 2022 and is in force from 2023 August 1.

Labelling Requirements 

For all formulations listed in Schedule H2 (top 300 brands):

  • Each pack must have a Bar Code or Quick Response (QR) Code on: ‍
    • Primary pack, or ‍
    • Secondary pack if there is not enough space on the primary.

The code must store at least the following data:

  • Unique product identification code
  • 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

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Human readable text on the label must be consistent with the data encoded in the QR / barcode.

Aggregation (SSCC) is not mandated under this rule, but companies often use SSCC barcodes on shipping cartons for internal logistics and export purposes.

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Regulatory Timeline 

  • 2022 June 14 – MoHFW issues draft notification proposing QR / barcode on top 300 drug brands
  • 2022 November 17 – Final notification G.S.R. 823(E) amends Drugs Rules, 1945 and inserts Schedule H2 listing the top 300 brands
  • 2023 August 1 – Rule comes into force; QR / barcode printing becomes mandatory on these 300 brands
  • 2024 – 2025 – Government and CDSCO indicate plans to expand QR / barcode requirements beyond the top 300 brands, including APIs and other categories

Reporting Requirements 

Since this is QR on-pack rather than event reporting, the focus is on data encoded in the code:

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Item in Code
Purpose
Unique product ID code
Distinguish each brand / SKU and support lookups
Proper and generic name
Clinical identification of the medicine
Brand name
Market name known to prescribers and patients
Manufacturer name and address
Source transparency and recall support
Batch number
Traceability for recalls and quality issues
Manufacturing date
Shelf-life calculation and GMP checks
Expiry date
Validation at dispensing and use
Manufacturing licence number
Regulatory accountability and quick verification

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Manufacturers may optionally make the QR “dynamic” and web-linked to allow real time authentication services, but the core rule focuses on the minimum data set above.

Operational Timelines for Industry 

  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.

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  1. 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).

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  1. 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.

Aggregation Requirements 

  • 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.

Common Errors to Avoid 

  • 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.

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