NEW DELHI: The Centre has expanded QR code-based tracking to include vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs to strengthen the quality, safety and traceability of pharmaceutical products.
The move follows amendments to the Drugs Rules, 1945, notified by the Union Health and Family Welfare Ministry.
Under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945.
Manufacturers of these drug formulations will now be required to print or affix a Bar Code or Quick Response (QR) Code on the primary packaging label of the product or, where space is insufficient, on the secondary packaging label.
The QR Code will store information that can be accessed through software applications for authentication and verification of the product throughout the supply chain.
It will contain details such as the 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, wherever applicable.
Earlier, the QR code requirement was applicable only to the top 300 pharmaceutical brands in the country. Officials said the amendment significantly expands coverage to include all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs.
The enhanced traceability mechanism is expected to improve tracking and verification of medicines, strengthen regulatory oversight and help curb the circulation of counterfeit and substandard drugs. Officials said it will also support efforts to combat Antimicrobial Resistance (AMR) by enabling better identification of counterfeit and substandard antimicrobial products.
The Ministry has prescribed phased timelines for implementation. The provisions relating to vaccines, narcotic and psychotropic drugs, and anti-cancer medicines will come into force from July 1, 2027, while those relating to antimicrobials will take effect from July 1, 2028.
The measure is also expected to help track and authenticate the supply chain of NDPS drugs as part of efforts towards a “Nasha Mukt Bharat.”
