Health Ministry expands QR Code-based track and trace framework for medicines

New Delhi (Raghwendra Pratap Singh) : The Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, to expand the ambit of Schedule H2 and bring additional categories of drugs under the QR Code-based track and trace framework.

The Ministry said that under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs are covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. It said that all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945.

The Ministry noted that manufacturers of these drug formulations will be required to print or affix a barcode or Quick Response (QR) Code on the primary packaging label of the product or, where there is inadequate space, on the secondary packaging label. The requirement for QR Code-based identification was earlier applicable to the top 300 pharmaceutical brands in the country.

The present amendment significantly expands its coverage to include all vaccines, antimicrobials, anti-cancer medicines and narcotic and psychotropic drugs, thereby broadening the scope of traceability and strengthening safeguards against the circulation of counterfeit and substandard medicines. The provisions relating to vaccines, narcotic and psychotropic drugs, and anti-cancer medicines shall come into force from 1st July next year, while the provisions relating to antimicrobials shall become effective from 1st July 2028.