The government has broadened QR code-based tracking to include vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs. This move aims to enhance the quality, safety, and integrity of India’s pharmaceutical supply chain. The Ministry of Health and Family Welfare has revised the Drugs Rules, 1945, to incorporate these medications under Schedule H2, expanding the existing track-and-trace framework.
Manufacturers will now be mandated to incorporate a barcode or QR code on the packaging of vaccines, antimicrobials, narcotic and psychotropic drugs, and anti-cancer medicines. The QR code will contain essential information accessible through software applications for authentication and verification purposes. Key details stored in the code include the unique product identification code, generic and brand names, manufacturing details, and batch information.
The updated regulations require the QR code to be displayed on the primary packaging label of the product. In cases where space is limited, it can be placed on the secondary packaging label. Previously, this QR code identification was limited to the top 300 pharmaceutical brands in the country. This enhanced traceability mechanism is designed to authenticate medicines at different supply chain stages, enhancing tracking and verification of drug products.
The government anticipates that this measure will help combat the distribution of counterfeit medicines and address Anti-Microbial Resistance (AMR) concerns. By identifying and monitoring counterfeit and substandard antimicrobial products, the initiative aims to contribute to the fight against AMR. To allow for implementation, the government has set phased compliance deadlines. Starting from July 1, 2027, vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will need to comply, while antimicrobials must adhere to the regulations from July 1, 2028.
This step is intended to bolster regulatory oversight, ensuring increased transparency, safety, and accountability within India’s pharmaceutical supply chain.
