New Delhi: The Union Health Ministry has expanded the scope of QR Code-based drug tracking by bringing all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs under Schedule H2 of the Drugs Rules, 1945.
The move aims to strengthen the quality, safety, and integrity of India’s pharmaceutical supply chain by improving traceability and authentication of medicines, according to an official statement.
Under the amended rules, manufacturers will be required to print or affix a Bar Code or Quick Response (QR) Code on the primary packaging label of these medicines. In cases where there is insufficient space, the code can be placed on the secondary packaging.
The QR Code will store key product details that can be accessed through software applications. Information embedded in the code will include the unique product identification code, generic and brand names, manufacturer details, batch number, manufacturing and expiry dates, manufacturing licence number, and excipient information where applicable.
The QR Code-based identification system was previously limited to the country’s top 300 pharmaceutical brands. The latest amendment significantly widens coverage to include all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances Act, 1985.
According to the ministry, the enhanced track-and-trace mechanism will enable authentication of medicines at different stages of the supply chain and improve monitoring of drug movement. The measure is expected to strengthen regulatory oversight and help curb the circulation of counterfeit and substandard medicines.
The initiative is also expected to support efforts to combat Anti-Microbial Resistance by improving the identification and monitoring of fake or poor-quality antimicrobial products.
To allow adequate preparation time for manufacturers and stakeholders, the ministry has introduced phased implementation timelines. The provisions for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into effect from July 1, 2027. The provisions relating to antimicrobials will be implemented from July 1, 2028.
