New Delhi, June 25: In a move aimed at strengthening the integrity of India’s pharmaceutical supply chain and curbing the circulation of counterfeit medicines, the Centre has expanded the scope of QR code-based drug tracking to include vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic substances.
The Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2 and widening the existing track-and-trace mechanism used for pharmaceutical products.
Under the revised regulations, manufacturers will be required to print or affix a barcode or Quick Response (QR) code on the packaging of all vaccines, anti-cancer medicines, antimicrobials, and narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances Act, 1985.
The government stated that the QR code must be placed on the primary packaging label wherever possible. In cases where space constraints exist, manufacturers may place the code on the secondary packaging label.
The digital code will store critical product information that can be accessed through software applications to enable authentication and verification throughout the supply chain. According to the notified provisions, the information embedded in the QR code will include a unique product identification code, generic and brand names, manufacturer details, batch number, manufacturing and expiry dates, manufacturing licence number, and information relating to excipients wherever applicable.
The move significantly expands the existing system, which was previously limited to the country’s top 300 pharmaceutical brands.
According to the government, the enhanced traceability framework will improve monitoring of medicines at multiple stages of distribution and facilitate easier verification of drug products by stakeholders across the supply chain.
The government also said the measure is expected to strengthen efforts against the distribution of spurious medicines. In the case of antimicrobials, improved tracking and verification mechanisms are expected to support efforts to address Anti-Microbial Resistance (AMR) by helping identify counterfeit and substandard products circulating in the market.
To allow adequate time for implementation, the government has introduced phased compliance deadlines. QR code requirements for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into effect from July 1, 2027.
The provisions relating to antimicrobials will become operational from July 1, 2028.
The Ministry said the expanded framework is intended to improve transparency, accountability and regulatory oversight while enhancing patient safety and confidence in the country’s pharmaceutical distribution network.
