Govt mandates QR codes for vaccines, antimicrobials, cancer drugs to curb counterfeit medicines
The Health Ministry has amended the Drugs Rules, 1945, mandating QR codes for all vaccines, cancer drugs, and antimicrobials under Schedule H2. The phased rollout starting July 2027 aims to eliminate counterfeit medications from India's supply chain
New Delhi: The government has expanded the ambit of QR code-based tracking to include vaccines, antimicrobials, anti-cancer medicines and narcotic and psychotropic drugs to strengthen the quality, safety and integrity of India’s pharmaceutical supply chain, according to an official statement on Thursday.
The Ministry of Health and Family Welfare (MoHFW) has notified amendments to the Drugs Rules, 1945, bringing these categories of medicines under Schedule H2 and expanding the scope of the existing track-and-trace framework.
Under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer medicines will be required to carry a barcode or quick response (QR) code on their packaging.
Now, manufacturers will have to print or affix the QR code on the primary packaging label of the product or where space is insufficient on the secondary packaging label.
The QR code will store key information that can be accessed through software applications to facilitate authentication and verification of medicines across the supply chain.
According to the government, the code will contain details such as 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 information on excipients, wherever applicable.
The QR code-based identification requirement was earlier applicable only to the top 300 pharmaceutical brands in the country.
The enhanced traceability mechanism will enable authentication of medicines at various stages of the supply chain and improve tracking and verification of drug products, according to the government.
It further noted that the decision is expected to support efforts to curb the distribution of spurious medicines and contribute to the fight against Anti-Microbial Resistance (AMR) by helping identify and monitor counterfeit and substandard antimicrobial products.
Moreover, to provide adequate time for implementation, the government has prescribed phased compliance timelines.
The provisions relating to vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into force from July 1, 2027, while the provisions relating to antimicrobials will become effective from July 1, 2028.
The measure is aimed at strengthening regulatory oversight and ensuring greater transparency, safety and accountability in the country’s pharmaceutical supply chain, the government said.