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India has expanded its QR code-based drug traceability system to cover all antimicrobial medicines, vaccines, cancer drugs, and narcotic and psychotropic medicines.
The amended Schedule H2 framework will make QR codes mandatory for these medicine categories in phases, with antimicrobials covered from July 1, 2028.
The system will allow medicines to carry key product details, including batch number, expiry date, manufacturer information and excipient details.
Better traceability can help regulators identify substandard, spurious or falsified antimicrobials, supporting India’s fight against antimicrobial resistance.
The Union Ministry of Health and Family Welfare has expanded India’s QR code-based drug traceability system to cover all vaccines, antimicrobial medicines, cancer drugs, and narcotic and psychotropic medicines.
Under a new government notification issued on June 22, 2026, these medicines have been brought under Schedule H2 of the Drugs Rules, 1945, making QR code-based traceability mandatory for critical medicines.
India introduced its first domestic QR code-based drug traceability framework in November 2022 by creating Schedule H2 under the Drugs Rules, 1945.
Schedule H2 specifies drug formulations that are required to carry a barcode or QR code on their packaging for digital authentication and traceability. From 1 August 2023, manufacturers of the country’s top 300 pharmaceutical brands were required to print or affix a barcode or QR code on medicine packs to enable digital authentication and traceability across the pharmaceutical supply chain.
However, the framework covered only selected top-selling brands. While it included several widely used antibiotics, such as amoxicillin-clavulanic acid, azithromycin, cefixime, cefpodoxime proxetil and cefuroxime axetil, many other antimicrobial medicines marketed in India remained outside the traceability system.
The 2026 amendment addresses this gap by extending QR code-based traceability to all antimicrobial medicines, along with other critical medicines. The expanded framework marks an important shift from a system based on top-selling brands to one that covers entire categories of high-priority medicines.
Every pack of these medicines will now carry a unique digital identity, strengthening supply-chain monitoring and improving medicine authentication.
Before Schedule H2 was introduced in 2022, medicines in India were identified through mandatory label information under Rule 96 and tracked mainly through batch processing, packaging and distribution records maintained under Schedule M, which covers good manufacturing practices. These records allowed manufacturers and regulators to investigate quality complaints and recall affected batches.
Under the amended rules, manufacturers must print or affix a QR code on the primary packaging of every vaccine, antimicrobial medicine, anti-cancer drug, and narcotic or psychotropic medicine. Where there is insufficient space, the QR code may be placed on the secondary packaging.
The QR code will provide the following essential product information:
unique product identification code
proper and generic name of the drug
brand name
name and address of the manufacturer
batch number
manufacturing date
expiry date
manufacturing licence number
details of excipients
The original 2022 framework required eight product data fields. Information on pharmaceutical excipients was added later following regulatory concerns about adulteration. These details include information on inactive ingredients used to deliver, stabilise, preserve or otherwise support the performance of the active pharmaceutical ingredient.
To give manufacturers sufficient time to comply, the ministry has adopted a phased implementation schedule. The QR code requirement will become mandatory for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs from 1 July 2027, and for antimicrobial medicines from July 1, 2028.
Manufacturers have also been encouraged to adopt the system voluntarily before the mandatory deadlines to accelerate improvements in medicine authentication and supply-chain transparency.
The move is particularly important in the fight against antimicrobial resistance (AMR), a major global public health challenge in which microorganisms become resistant to medicines, making infections harder to treat.
It also aligns India’s pharmaceutical regulation with the priorities of its national action plan against AMR.
The amendment advances a key commitment under India’s National Action Plan on Antimicrobial Resistance 2.0 to strengthen the track-and-trace system for antimicrobials. Under Strategic Objective 4, the action plan aims to promote the responsible use of antimicrobial medicines in humans, animals and food, while strengthening regulatory systems to ensure access to quality-assured antimicrobials.
As part of this, it proposes expanding the QR code-based drug traceability framework beyond the initial list of 300 pharmaceutical brands to cover all antimicrobial medicines.
AMR is driven not only by the misuse and overuse of antimicrobial medicines, but also by the circulation of substandard, spurious, falsely labelled and falsified medicines.
Poor-quality antimicrobials may contain insufficient active ingredients or fail to meet quality standards, leading to treatment failure and allowing resistant microorganisms to survive and spread. Substandard antimicrobials are also difficult to identify once they enter the supply chain.
A digital traceability system can help regulators authenticate medicines, trace their movement and rapidly recall defective batches.
The expanded QR code framework can strengthen India’s pharmaceutical supply chain and support the country’s efforts to combat antimicrobial resistance. However, its success will ultimately depend on effective implementation.
