The Union Health Ministry has notified amendments to the Drugs Rules, 1945, significantly expanding the scope of QR code-based tracking requirements. According to the latest official statement, the new provisions bring all antimicrobials, vaccines, anti-cancer medicines, and narcotic and psychotropic drugs under Schedule H2, which mandates the use of bar codes or Quick Response (QR) codes for product identification and verification. The Ministry of Health and Family Welfare (MoHFW) has amended the existing track-and-trace framework to include these categories, marking a major expansion of drug safety measures. With the latest amendment, coverage has been significantly expanded to include all vaccines, antimicrobials, anti-cancer drugs, and narcotic and psychotropic medicines regulated under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. The move comes against the backdrop of increasing concerns over fake medicines entering the market, posing serious risks to patient safety and public health, and is expected to strengthen regulatory oversight and ensure greater transparency, safety and accountability in India's pharmaceutical supply chain.
Under the amended provisions, manufacturers will be required to print or affix a barcode or QR code on the primary packaging label of drug formulations, or on secondary packaging where space constraints exist. As reported by the government, the QR code will contain comprehensive product information including unique product identification code, generic and brand names, manufacturer's name and address, batch number, manufacturing and expiry dates, manufacturing licence number, and details of excipients. The requirement was previously applicable only to the top 300 pharmaceutical brands in the country, but has now been expanded to cover all drugs in the specified categories. The code will enable authentication and verification of medicines through software applications across the supply chain, allowing consumers, pharmacists, distributors, and regulators to verify the authenticity of medicines at various points in the supply chain. According to Business Standard, officials stated that "The present amendment significantly expands its coverage to include all vaccines, antimicrobials, anti-cancer medicines and narcotic and psychotropic drugs, thereby broadening the scope of traceability and strengthening safeguards against the circulation of counterfeit and substandard medicines."
The enhanced traceability framework is designed to strengthen safeguards against counterfeit and substandard medicines by enabling authentication and verification of products at various stages of the supply chain. According to the government, the QR code requirement for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will take effect from July 1, 2027, while antimicrobials will be brought under the framework from July 1, 2028. Health officials stated that "The enhanced traceability mechanism aims to facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products." The inclusion of antimicrobials is also expected to support efforts to tackle antimicrobial resistance (AMR), a growing public health challenge, by facilitating better identification and monitoring of counterfeit and substandard antimicrobial products. The move marks one of the most significant expansions of India's pharmaceutical authentication framework and is expected to strengthen consumer confidence while enhancing the integrity of the country's drug supply chain.
To provide adequate time for implementation, the government has prescribed phased timelines for compliance with the new requirements. As reported by the government, provisions relating to vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into force from July 1, 2027, while those relating to antimicrobials will become effective from July 1, 2028. The notification indicates this staggered approach allows pharmaceutical companies adequate preparation time for the expanded tracking requirements, with the move aimed at strengthening the integrity of India's pharmaceutical supply chain and ensuring greater safety and accountability for patients and healthcare providers. The staggered rollout is specifically aimed at curbing counterfeit drugs, improving verification and strengthening patient safety across the pharmaceutical sector, while the decision is expected to support efforts to curb the distribution of spurious medicines and contribute to the fight against Anti-Microbial Resistance (AMR) by helping identify and monitor counterfeit and substandard antimicrobial products.
