In a move aimed to strengthen the pharmaceutical supply chain, the Union Health Ministry has expanded the ambit of its QR code-based drug traceability framework to include vaccines, antimicrobial, anti-cancer medicines, and narcotic and psychotropic substances.
The decision is expected to enhance patient safety, improve regulatory oversight and help tackle the growing challenge of counterfeit and substandard medicines.
The Ministry has notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2. As a result, manufacturers will be required to print or affix a barcode or Quick Response (QR) code on the primary packaging of these products. Where space constraints make this impractical, the code may be placed on the secondary packaging, as per the notification.
The QR code will carry essential product information, including a unique product identification code, generic and brand names, name and address of the manufacturer, batch number, manufacturing and expiry dates, manufacturing licence number and details of excipients wherever applicable.
The information can be accessed through software applications, enabling verification of the product throughout the supply chain.
The move marks a substantial expansion of India's existing track-and-trace mechanism, which was previously applicable to the country's top 300 pharmaceutical brands. By extending the requirement to entire categories of critical medicines, the government hopes to create a more robust system for monitoring drug movement from manufacturing units to healthcare facilities and pharmacies.
A senior official from the Ministry said, the measure is designed to improve transparency and make it easier to authenticate medicines at different points in the distribution chain. The ability to verify product details through a simple scan could help healthcare professionals, distributors and regulators identify counterfeit or suspicious products before they reach patients.
The decision comes amid growing global concerns over falsified and substandard medicines, which continue to pose a serious threat to public health. Counterfeit drugs may contain incorrect ingredients, inadequate amounts of active pharmaceutical substances or, in some cases, no therapeutic ingredients at all. Such products can lead to treatment failure, disease progression and avoidable deaths.
The inclusion of vaccines is particularly significant given their central role in disease prevention and public health programmes. Vaccines often pass through complex supply chains before reaching beneficiaries. Enhanced traceability is expected to strengthen confidence in immunisation programmes by ensuring that only genuine and properly regulated products reach healthcare institutions.
The expansion also covers all anti-cancer medicines, a category where treatment outcomes depend heavily on the quality and consistency of drugs. Cancer therapies are among the most expensive and specialised medicines available, making them vulnerable to counterfeiting and unauthorised distribution. Improved tracking mechanisms could help safeguard patients undergoing life-saving treatment.
Equally important is the inclusion of antimicrobials, a category that lies at the heart of the global battle against antimicrobial resistance (AMR). Public health experts have repeatedly warned that poor-quality and counterfeit antibiotics can contribute to the emergence of drug-resistant microbes by exposing pathogens to insufficient drug concentrations. This allows microorganisms to survive and develop resistance, making infections increasingly difficult to treat.
The official said that improved traceability of antimicrobial medicines will support national efforts to address AMR by facilitating better identification and monitoring of products moving through the market.
It could also assist regulators in detecting substandard medicines that may undermine treatment effectiveness.
The decision to bring narcotic and psychotropic drugs under the QR code framework is expected to strengthen monitoring of medicines that carry a risk of diversion, misuse and illegal trafficking. These drugs, regulated under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, require stringent oversight because of their potential for abuse. Digital traceability could help authorities monitor movement more effectively and identify irregularities in distribution channels.
Recognising the scale of changes required by manufacturers and distributors, the government has provided a phased implementation timeline. The provisions relating to vaccines, anti-cancer medicines and narcotic and psychotropic drugs will come into effect from July 1, 2027. The requirements for antimicrobials will become mandatory a year later, from July 1, 2028.
The staggered timeline is intended to give pharmaceutical companies adequate time to modify packaging systems, integrate digital tracking technologies and establish compliance mechanisms, said the official.
