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India Regulatory

India Drug Barcoding Requirements

Regulatory Agency Ministry of Health (India)
Regulation Name Rules on Barcode or QR Code for the Top 300 Brands
Compliance Dates The amended rules Effective from the 1st March 2026.
Applies to It introduced the mandatory inclusion of Quick Response (QR) codes on the primary level and secondary level packaging labels for the top 300 brands .

Primary Packaging

Barcode Symbology QR Codes
Barcode Contents
  • 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 license number
  • qualitative details of excipients
Serial Number Randomization No
Serial Number Reuse Not Specified
Human Readable Expiry Date Format YYMMDD
Barcode Data Encoding GS1 Standards
Product Code Notes QR Code shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label.
Free Samples must be marked? Not Specified

Secondary Packaging

Barcode Symbology QR Codes
Barcode Contents
  • 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 license number
  • Qualitative details of excipients
Serial Number Randomization No
Serial Number Reuse Not Specified
Human Readable Expiry Date Format YYMMDD
Barcode Data Encoding GS1 Standards
Free Samples must be marked? Not Specified

Aggregation Data Capture

Parent-Child Mapping Aggregation Capture?
 Not Required

Data Exchange

Send Unit Data to Government Repository? Not Specified
Send Unit Data to Third-Party Repository? As Applicable
Send Unit Data to Trading Partner? As Applicable
Send Aggregation Data to Government Repository? Not Specified
Send Aggregation Data to Third-Party Repository? Not Specified
Send Aggregation Data to Trading Partner? As Applicable

Authentication

Who Offers Data Repository for Authentication? No
Manufacturers Must Register Shipments in Repository? Yes (Exports)
Downstream Trading Partners Must Authenticate on Receipt? No (Future)
Downstream Trading Partners Must Authenticate on Shipment? No

Government Reporting

Manufacturer Activity Reported? Yes
Downstream Trading Partner Activity Reported? No
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

About Kevision Systems

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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