New Delhi: In a move aimed at strengthening safeguards against counterfeit and substandard medicines, the Union government has expanded the ambit of the QR code-based track-and-trace mechanism to cover all antimicrobials, vaccines, anti-cancer medicines, and narcotic and psychotropic drugs, according to a notification issued by the Union Health Ministry Thursday.
The provisions covering vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will take effect from July 1, 2027, while the same for antimicrobials will come into force from July 1, 2028, the notification said.
The ministry notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2, which mandates the use of bar codes or Quick Response (QR) codes for product identification and verification.
Under the amended provisions, manufacturers will be required to print or affix a bar code or QR code on the primary packaging label of the drug formulation, or on the secondary packaging where space constraints exist, the ministry said.
The code will enable authentication and verification of medicines through software applications across the supply chain.
According to the ministry, the QR code will contain key product information such as 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 requirement was previously applicable only to the top 300 pharmaceutical brands in the country.
With the latest amendment, its coverage has been significantly expanded to include 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 strengthen safeguards against counterfeit and substandard medicines by enabling authentication and verification of products at various stages of the supply chain, it said.
The ministry noted the measure would also support efforts to curb the distribution of spurious medicines and contribute to India’s fight against antimicrobial resistance (AMR) by facilitating better identification and monitoring of counterfeit and substandard antimicrobial products.
To provide adequate time for implementation, the government has prescribed phased timelines for compliance.
The provisions relating to vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into force from July 1, 2027 while those relating to antimicrobials will become effective from July 1, 2028, the notification said.
