In a significant move to strengthen the quality, safety and integrity of India’s pharmaceutical supply chain, the Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, expanding the scope of Schedule H2 and bringing additional categories of medicines under the QR code-based track-and-trace framework.
Under the revised provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, as well as all anti-cancer medicines, have now been included under Schedule H2.
This means 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. Where there is inadequate space, the code may be placed on the secondary packaging label. The QR Code will enable product authentication and verification across the supply chain.
The ministry highlighted that the 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.
Until now, QR code-based identification requirements applied only to the top 300 pharmaceutical brands in the country. The latest amendment significantly expands its coverage to include all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs, strengthening safeguards against the circulation of counterfeit and substandard medicines.
The enhanced traceability mechanism is expected to improve authentication, tracking and verification of medicines at different stages of the supply chain, thereby strengthening regulatory oversight and supporting efforts to curb the distribution of spurious medicines in the market.
The move is also expected to contribute to India’s fight against antimicrobial resistance (AMR) by enabling better identification and monitoring of counterfeit and substandard antimicrobial products.
Additionally, the ministry said the initiative will help strengthen tracking and authentication of the NDPS drug supply chain and support the nation’s fight for “Nasha Mukt Bharat.”
To allow adequate preparation time for industry stakeholders, the Ministry has introduced a phased implementation timeline. Provisions related to vaccines, narcotic and psychotropic drugs, and anti-cancer medicines will take effect from July 1, 2027, while compliance requirements for antimicrobials will come into force from July 1, 2028.
