Health Ministry Proposes Barcoding Rule for All Vaccines, Antimicrobials, Anticancer, and Narcotic Drugs

New Delhi: In a major regulatory move, the Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Drugs Rules, 1945, to include all vaccines, all antimicrobials, all narcotic and psychotropic drugs under the Narcotic and Psychotropic Drugs Act, 1985, and all anticancer drugs under Schedule H2.

Under the proposed changes, manufacturers of these medicines will now be required to print or affix a barcode or QR code on product labels, strengthening traceability, safety, and regulatory compliance.

These drafts of certain rules that the Central Government proposes to make came in exercise of the powers conferred by subsection (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board.

The MoHFW has invited public objections and suggestions within 30 days of the notification’s publication. The notice further added, "Objections and suggestions that may be received from any person within the period specified above will be considered by the Central Government."

Submissions can be sent to the Director (Drugs Regulation), MoHFW, Room No. 407, A-Wing, Nirman Bhavan, New Delhi–110011, or emailed to drugsdiv-mohfw@gov.in.

The Ministry of Health and Family Welfare had notified the Drugs (Eighth Amendment) Rules, 2022 (“Amendment Rules”) on November 17, 2022, which amended the Drugs and Cosmetics Rules, 1945 to insert a new labeling requirement for drug formulation products specified under Schedule H2 of the DnC Rules. The Amendment Rules came into force on August 01, 2023.

Schedule H2 contains a list of 300 drugs that are required to be in compliance with the Amendment Rules.

The manufacturers of drug formulation products as specified in Schedule H2 have to print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space on the primary package label, on the secondary package label that store data or information legible with a software application to facilitate authentication.

This enables storage of data or information regarding the product, readable with a software application to facilitate tracking and tracing of the product. The stored data associated with the QR code include certain minimum particulars prescribed, which include proper and generic name of the drugs, unique product identification code, brand name, batch number, date of manufacturing, date of expiry, name and address of the manufacturer, etc.

Earlier, the Medical Dialogues Team had reported that the Drug Technical Advisory Board (DTAB) in its 91st meeting on August 14, 2024, had considered and approved the proposal for a track and trace mechanism for oncology products by providing quick response and bar codes.

Now, in continuation, through the gazette notification, the Ministry of Health and Family Welfare has proposed:

"1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.

(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.

2. (i) In the Drugs Rules, 1945, under Schedule H2, below the title [see sub-rules (6) and (7) of rule 96] the words “Table 1” shall be inserted.

(ii) In Drugs Rules, 1945, under Schedule H2, after the Table 1, a Table shall be inserted namely: -

Table 2

To view the official gazette notification, click the link below: