The Union Health Ministry has expanded the QR code-based track-and-trace framework to include additional categories of drugs, such as all vaccines, antimicrobials, narcotic and psychotropic substances under the NDPS Act, 1985, and all anti-cancer drugs. This move aims to strengthen the quality and safety of India's pharmaceutical supply chain.
Amendments to Drugs Rules, 1945
The ministry notified amendments to the Drugs Rules, 1945, expanding the ambit of Schedule H2. The primary objective of Schedule H2 is to prevent counterfeiting and enhance traceability, quality, and safety of medicines. Under the amended provisions, manufacturers of these drug formulations must print or affix a bar code or Quick Response (QR) code on the primary packaging label, or on the secondary packaging label if space is inadequate.
QR Code Content and Purpose
The QR code will store key product information accessible via software applications for authentication and verification throughout the supply chain. This includes the unique product identification code, generic and brand names, manufacturer name and address, batch number, manufacturing and expiry dates, manufacturing licence number, and details of excipients, wherever applicable.
In 2022, the Central Drugs Standard Control Organisation (CDSCO) initially notified Schedule H2 drugs and amended Rule 96 of the Drugs and Cosmetics Act, which mandates QR codes on labels. That requirement applied only to the top 300 pharmaceutical brands. The latest amendment significantly broadens coverage to include all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs.
Impact on Supply Chain and Public Health
The enhanced traceability mechanism will facilitate authentication at various supply chain stages, enabling improved tracking and verification of drug products. The health ministry stated, "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."
