Daijiworld Media Network - New Delhi
New Delhi, Jun 25: The government has expanded the QR code-based track-and-trace system to cover all antimicrobials, vaccines, anti-cancer medicines, and narcotic and psychotropic drugs in a move aimed at strengthening safeguards against counterfeit and substandard medicines.
The Union Health Ministry has notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2. The revised rules mandate the use of bar codes or Quick Response (QR) codes for identification and verification of medicines.
As per the amended provisions, drug manufacturers will have to print or affix a barcode or QR code on the primary packaging label of formulations. In cases where space is limited, the code can be placed on the secondary packaging, the ministry said.
The QR code will allow authentication and verification of medicines through software applications across the entire supply chain.
According to the ministry, the QR code will carry essential details including a 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.
The ministry said the QR code requirement was earlier applicable only to the top 300 pharmaceutical brands in the country. With the latest amendment, the system has now been extended to all vaccines, antimicrobials, anti-cancer drugs, and narcotic and psychotropic medicines regulated under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985.
The enhanced traceability framework is expected to help authorities and consumers verify medicines at different stages of the supply chain and strengthen measures against spurious and poor-quality drugs.
The ministry said the move would also support India’s efforts to tackle antimicrobial resistance (AMR) by enabling better identification and monitoring of counterfeit and substandard antimicrobial products.
To ensure smooth implementation, the government has introduced a phased compliance timeline. The QR code requirement for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into effect from July 1 this year, while the provisions for antimicrobials will be implemented from July 1, 2028.