With the aim of strengthening the quality and safety of India’s pharmaceutical supply chain, the Union Health Ministry has brought additional categories of drugs under the QR code-based track-and-trace framework.
The ministry has notified amendments to the Drugs Rules, 1945, to expand the ambit of Schedule H2. The primary objective of Schedule H2 is to prevent counterfeiting and enhance the traceability, quality and safety of medicines.
Under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945.
With this amendment, manufacturers of these drug formulations will be required to print or affix a bar code or Quick Response (QR) code on the primary packaging label of the product or, where space is inadequate, on the secondary packaging label. The QR code will store information that can be accessed through software applications to facilitate authentication and verification of the product throughout the supply chain.
The QR code will contain key product information, including the unique product identification code, generic and brand names, name and address of the manufacturer, batch number, manufacturing and expiry dates, manufacturing licence number, and details of excipients, wherever applicable.
In 2022, the Central Drugs Standard Control Organisation (CDSCO), India’s central drug regulatory agency, notified Schedule H2 drugs and amended Rule 96 of the Drugs and Cosmetics Act, which deals with the labelling of drugs in India. The amendment to Rule 96 mandates that manufacturers of Schedule H2 drugs print or affix a bar code or QR code on the label.
The requirement for QR code-based identification was previously applicable to the country’s top 300 pharmaceutical brands. The latest 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 enhanced traceability mechanism will facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products. The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market. It will also contribute to the national fight against Anti-Microbial Resistance (AMR) by enabling better identification and monitoring of counterfeit and substandard antimicrobial products," the health ministry said in a statement.
