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Health ministry to mandate tracking mechanism for vaccines, antimicrobials, cancer and N&P drugs
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Gireesh Babu, New Delhi
October 22 , 2025
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The Union ministry of health and family welfare has proposed an amendment to the Drugs Rules, 1945, to mandate labels of all vaccines, antimicrobials, narcotic and psychotropic drugs listed under the Narcotic and Psychotropic Drugs Act (NPDA), 1985, and all anti cancer drugs carry quick response (QR) code.
The move is to prevent counterfeiting and enhance the traceability, quality and safety of medications. A draft has been released in line with the recommendations of the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB) in its previous meetings.
The Ministry has said that the draft rules shall be taken into consideration on or after the expiry of a period of 30 days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. It also said that objections and suggestions received from any person within the period will be considered by the Centre.
It proposes to title the existing list of 300 brands in the Schedule H2, the category of medicines which are mandated to carry a barcode or QR code on their label, under the Drugs Rules as Table I and to insert a Table 2 to include all vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer drugs under the Schedule.
DCC, in its meeting held on June 17, 2025, greed to the proposal for amendment of the Drugs Rules, to fix QR code on the labels of these products.
The DTAB, in its meeting held on August 14, 2024, recommended to include all anticancer medicines under the Schedule H2, identifying that unscrupulous criminals in collusion with hospital pharmacies were found refilling empty vials of expensive anti-cancer medicines with counterfeit drugs.
"These anti-cancer drugs must be issued under strict directives to implement mandatory QR codes and rigorous track and trace mechanisms on every vial and strip of medication that are marketed in India," it said.
In another meeting, the DTAB has recommended affixing bar code or QR code on all vaccine products, as part of obtaining the benchmarking maturity levels required under the upcoming World Health Organisation (WHO) Global Benchmarking of vaccines. It also recommended that the tracking mechanism be extended to all antimicrobials, and narcotic and psychotropic substances in a phased manner.
The DCC meeting in June, this year, while suggesting QR codes on these drugs, also recommended the pharma industry to raise public awareness regarding the use of quick-response code, while dismissing concerns raised by some stakeholders that the usage of QR codes for scanning by the public is dismal, as not substantial in public interest.
The concern of some of the stakeholders that the usage of QR codes are negligible as against the investment made on affixing the code was raised during a stakeholder consultation was conducted in the matter on May 16, 2025. The consultation was arranged to look into a draft notification prepared after the DTAB's approval for the proposal for affixing bar code or QR code on the label of all vaccines, antimicrobials, anti cancer and NDPS drugs mentioned under the NDPS Act.
"...during the meeting two of the stakeholders have raised concerns that the usages in terms of scanning is dismal (0.3%) and capital investment is appreciable. Further industry also does not benefit in brand equity after spending additional in crores," noted the DCC in its latest meeting.
The DCC, after considering the suggestions opined, "that the manufacturers should raise public awareness regarding the use of QR code and the concerns raised by the stakeholders do not appear to be substantial in public interest and accordingly agreed with the proposal to appropriately amend the Drugs Rules, 1945".
It may be noted that the government has already mandated affixing QR code on labels of 300 brands of different products through a notification in November, 2022 and it was implemented from August 1, 2023.
"The manufacturers of drug formulation products as specified in Schedule H2 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, on the secondary package label that store data or information legible with software application to facilitate authentication," said the notification.
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