QR codes made mandatory on vaccines, antimicrobials, cancer and narcotic drugs to curb counterfeits

The government has expanded its QR code-based track-and-trace system to include all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs, in a major step aimed at strengthening safeguards against counterfeit and substandard pharmaceuticals.

The Union Health Ministry has amended the Drugs Rules, 1945, bringing these categories under Schedule H2, which mandates the use of barcodes or QR codes on medicine packaging for identification and verification across the supply chain.

Under the new rules, manufacturers will be required to print or affix QR codes on primary packaging or secondary packaging where space is limited. The digital code will allow verification of medicines using software applications at various stages of distribution.

The QR code will contain detailed product information, including a unique product identification number, brand and generic names, manufacturer details, batch number, manufacturing and expiry dates, licence number, and other relevant data.

Earlier, this requirement was limited to the top 300 pharmaceutical brands in the country. With the latest expansion, the system now covers a significantly wider range of essential and high-risk medicines.

Officials said the move is expected to enhance traceability, reduce circulation of spurious drugs, and improve patient safety by enabling faster authentication of medicines in the market.

The ministry also said the measure will support efforts to combat antimicrobial resistance (AMR) by improving monitoring and identification of substandard antimicrobial products.

The implementation will be phased. QR code requirements for vaccines, cancer drugs, and narcotic and psychotropic medicines will come into effect from July 1 this year, while antimicrobials will be brought under the system from July 1, 2028.