Centre Expands QR Code Tracking for Critical Medicines

The amendment requires manufacturers of these medicines to print or affix a Bar Code or Quick Response (QR) Code on the primary packaging of the product.

The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, expanding the scope of Schedule H2 to bring more categories of medicines under a QR Code-based track and trace system. The move is aimed at strengthening the integrity of India's pharmaceutical supply chain, improving the ability to authenticate medicines and reducing the circulation of counterfeit and substandard drugs.

Under the revised rules, all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 will now fall under Schedule H2. The expanded framework significantly increases the number of medicines that must carry digital identification, extending a system that was previously limited to the country's top 300 pharmaceutical brands.

The amendment requires manufacturers of these medicines to print or affix a Bar Code or Quick Response (QR) Code on the primary packaging of the product. In cases where there is not enough space on the primary pack, the QR Code may be placed on the secondary packaging. The digital code will allow healthcare professionals, regulators, distributors and other authorised users to verify the authenticity of medicines throughout the supply chain using software applications.

Each QR Code will contain important information about the product, including a unique product identification code, the generic and brand names of the medicine, the manufacturer's name and address, the batch number, manufacturing and expiry dates, the manufacturing licence number and details of excipients wherever applicable. By making this information readily accessible, the government aims to improve transparency and enable quicker verification of pharmaceutical products at different stages of distribution.

Officials said the expanded traceability framework will strengthen regulatory oversight by making it easier to identify genuine products and detect counterfeit or substandard medicines before they reach patients. Improved tracking throughout the supply chain is also expected to help regulators investigate irregularities more efficiently while increasing accountability among manufacturers and distributors.

The measure is expected to play an important role in India's efforts to combat Anti-Microbial Resistance (AMR). Counterfeit and poor-quality antimicrobial medicines contribute to ineffective treatment and can accelerate the development of drug-resistant infections. By improving the identification and monitoring of antimicrobial products, the QR Code system is expected to support better quality control and strengthen public health safeguards.

The revised framework will also enhance monitoring of narcotic and psychotropic medicines regulated under the NDPS Act, 1985. Authorities believe the ability to trace these medicines throughout the supply chain will strengthen efforts to prevent diversion and misuse while supporting the government's "Nasha Mukt Bharat" initiative aimed at reducing drug abuse across the country.

Recognising that manufacturers and other stakeholders will require time to adopt the new requirements, the Ministry has introduced the changes in phases. The provisions covering vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into effect from July 1, 2027. The requirement for antimicrobial medicines will become mandatory from July 1, 2028, giving the pharmaceutical industry additional time to upgrade packaging systems and implement the necessary technology.

The latest amendments represent another step in the government's broader effort to modernise pharmaceutical regulation through digital technologies. By expanding QR Code-based identification to a wider range of critical medicines, the Ministry aims to strengthen patient safety, improve confidence in the medicine supply chain and reinforce India's position as a producer of high-quality pharmaceutical products while ensuring greater transparency and accountability across the healthcare sector.