Union Health Ministry to Amend Drugs Rules for Inclusion of Excipients in QR Codes

The proposal to include excipient details on drug labels arose from grievances that parabens, used as preservatives in pharmaceuticals, cause allergies in many individuals.

The Union Health Ministry has initiated amending the Drugs Rules to mandate the inclusion of details of excipients in the data stored on drug formulation product labels as bar codes or Quick Response (QR) Codes.

This move aims to address issues faced by people allergic to certain excipients, allowing them to identify these components in drug formulations before use.

The Ministry has issued a draft notification to amend sub-rule (7) of Rule 96 of the Drugs Rules, 1945. This amendment will include "details of excipients" as the ninth particular in the stored data on the drug formulation label, following the manufacturing license number.

Currently, barcodes or QR codes on drug labels store information such as the unique product identification code, proper and generic drug names, brand name, manufacturer's name and address, batch number, manufacturing date, and expiry date.

Background to The Present Development

The Ministry had previously mandated that manufacturers of drug formulation products specified in Schedule H2 print or affix barcodes or QR codes on the primary packaging label or the secondary package label if there is inadequate space on the primary label.

These codes store data that is readable by software applications to facilitate authentication.

The inclusion of excipient data is expected to be considered thirty days after the draft rules are published. The Ministry further stated that the central government will consider any objections or suggestions received within this period.

The proposal to include excipient details on drug labels was considered following grievances that parabens, used as preservatives in pharmaceutical products, cause allergies in many individuals.

Currently, the strips of medicines available in retail medical shops do not clearly indicate the excipient composition, making it difficult for patients to identify paraben-free antihypertensive medication and other drugs.

The suggestion was to include details of excipients or INS codes on every strip of medicines.

Consultative Committees' Recommendations

The 61st Drugs Consultative Committee (DCC) meeting discussed the inclusion of excipient details in medicine package inserts. It noted that there is no current mandate for manufacturers to provide package inserts with drugs marketed in the country.

The committee recommended issuing an advisory for mentioning excipient details on drug formulations on a voluntary basis.

However, in its 62nd meeting held in September 2023, the DCC reviewed the Action Taken Report of the 61st meeting and acknowledged the practical challenges of mentioning all excipients on product labels.

The committee suggested capturing this information through QR codes or in the package insert. It recommended amending the November 17, 2022, notification mandating barcodes or QR codes for the top 300 brands to include excipient information, at least for these brands initially.

The Drugs Technical Advisory Board (DTAB) discussed the matter in its January 25, 2024 meeting. It recognized the difficulty of including details of all excipients on every strip of medicines and suggested preparing a list of excipients causing hypersensitivity for mention on the label.

However, DTAB agreed with the proposed amendment to capture excipient information in QR codes for the top 300 brands.