The government has expanded its QR code-based drug tracking system to cover vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic substances in a move aimed at strengthening the safety, quality and integrity of India’s pharmaceutical supply chain, according to an official statement issued on Thursday.
The Ministry of Health and Family Welfare (MoHFW) has notified amendments to the Drugs Rules, 1945, bringing these categories under Schedule H2 and widening the scope of the existing track-and-trace framework.
Under the revised rules, all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, will be required to carry a barcode or Quick Response (QR) code on their packaging.
Manufacturers will be required to print or affix the QR code on the primary packaging label of the product. Where space constraints exist, the code may be placed on the secondary packaging label.
According to the government, the QR code will store key information that can be accessed through software applications for authentication and verification throughout the supply chain.
The encoded information will include a unique product identification code, generic and brand names, manufacturer details, batch number, manufacturing and expiry dates, manufacturing licence number, and information on excipients, wherever applicable.
The QR code-based identification requirement was previously limited to the country’s top 300 pharmaceutical brands. The latest amendment significantly expands its coverage across critical drug categories.
The government said the enhanced traceability mechanism will facilitate authentication and verification of medicines at multiple stages of the supply chain, improving the ability to track and monitor drug products.
The move is also expected to strengthen efforts to curb the circulation of spurious medicines and support the fight against antimicrobial resistance (AMR) by helping authorities identify counterfeit and substandard antimicrobial products.
To allow adequate time for implementation, the government has introduced phased compliance timelines. The provisions relating to vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into effect from July 1, 2027, while the requirements for antimicrobials will be implemented from July 1, 2028.
According to the government, the measure is intended to enhance regulatory oversight and promote greater transparency, safety and accountability across the pharmaceutical supply chain.
(With IANS inputs)
