New regulations aim to strengthen medicine authentication, combat counterfeiting, and improve supply chain monitoring
New Delhi: India is set to significantly strengthen its pharmaceutical safety framework with the expansion of QR code-based tracking for several critical categories of medicines. The move is designed to improve product verification, enhance patient safety, and create a more transparent and accountable drug distribution system across the country.
The initiative follows recent amendments to the Drugs Rules, 1945, by the Ministry of Health and Family Welfare. Under the revised regulations, vaccines, antimicrobial medicines, anti-cancer drugs, and narcotic and psychotropic substances regulated under the NDPS Act have been brought under Schedule H2, making digital identification mandatory for these products.
Manufacturers will be required to print or affix a barcode or QR code on the primary packaging of these medicines. Where space constraints exist, the code may be placed on secondary packaging. The QR code will serve as a digital identity for each medicine pack, enabling regulators, healthcare providers, distributors, and authorized stakeholders to verify product information instantly.
The digital code will contain key details such as the product’s unique identification number, generic and brand names, manufacturer information, batch number, manufacturing and expiry dates, licence details, and other relevant product data.
The expanded requirement goes beyond the earlier system, which covered only the country’s top 300 pharmaceutical brands. Authorities believe the broader rollout will help curb counterfeit and substandard medicines, improve regulatory oversight, and boost public confidence in healthcare products.
The phased implementation will begin on July 1, 2027, for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs. Antimicrobial medicines will follow from July 1, 2028, allowing manufacturers time to adapt to the new packaging and compliance requirements.
Officials also expect the enhanced traceability system to support efforts against antimicrobial resistance and improve monitoring of controlled medicines, helping prevent misuse and illegal diversion while ensuring safer access to essential drugs for patients nationwide.
