Excipient Details to Be Included in Drug QR Codes Says Union, proposing to amend Drug Rules, 1945

Excipient Details to Be Included in Drug QR Codes Says Union, proposing to amend Drug Rules, 1945

Qualitative details of excipients in QR Code 

Union Health Ministry has officially introduced an amendment to the Drugs Rules, 1945, mandating the inclusion of qualitative details of excipients in the barcodes or Quick Response (QR) codes on drug formulation labels. The new rule, issued as the Drugs (2nd Amendment) Rules, 2025, will come into effect from March 1, 2026.

This regulatory update enhances an earlier proposal, which had only suggested including basic details of excipients. Now, drug manufacturers will be required to provide qualitative information about excipients, substances used alongside the active ingredient in medications-within the QR codes. The move is aimed at aiding patients, particularly those with allergies to certain excipients like parabens, to make safer choices.

 Additions to Rule 96(7)

Under Rule 96(7) of the Drugs Rules, QR codes on packaging must already include details such as product ID, brand and generic names, manufacturer details, batch number, manufacturing and expiry dates, and license number. The newly added requirement brings the total to nine key data points, with qualitative excipient details now becoming a mandatory addition.

This amendment is brought after  a series of discussion and consultation  beginning with public feedback on a draft rule issued in July 2024, and extensive discussions by the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB). While there were issues regarding the practicality of listing all excipients on physical packaging, consensus was eventually reached to embed this data digitally, starting with the top 300 drug brands.

Click here to Access the official guidance document

Tags: Excipient Details, QR Code, Drug Rules, 1945