India Pharma Outlook Team | Wednesday, 22 October 2025
The Union Ministry of Health and Family Welfare has suggested a significant modification of the Drugs Rules 1945, which would require Quick Response codes (QR)on labels of all medicines - vaccines, antimicrobials, anticancer, narcotic and psychotropic drugs.
The purpose is to combat counterfeit medicines as well as ensuring traceability, safety, and quality throughout the pharmaceutical supply chain.
Per the draft notification in respect of recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), there will be an opportunity for one month of public objections and suggestions, from the date of publication in the Gazette of India.
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The amendment plans to rename the current list of 300 brands in Schedule H2 to be Table 1, as well as introduce a new Table 2 which will include all vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer medicines. This proposal was accepted by the DCC in their June 2025 meeting, while DTAB expressed concerns regarding alarming issues of counterfeit anticancer drugs being sold in some collusion with hospital pharmacies.
The DTAB also connected it to the forthcoming World Health Organization's (WHO) Global Benchmarking for vaccine traceability, underscoring the necessity for a track and trace mechanism. Despite some concerns in the industry about too many drugs leading to high costs and not enough people scanning publically available QR codes (estimated at 0.3%), the committees determined this proposal was in the public interest for patient safety purposes.
India had QR codes implemented for 300 different drug brands as of August, 2023, and this expansion indicates the beginning of a larger shift towards digital drug traceability within the pharma manufacturing and distribution process.
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