India expands QR code mandate to vaccine, cancer drug packaging

INDIA – India’s health ministry has extended its pharmaceutical track-and-trace framework to vaccines, antimicrobials, anti-cancer medicines and narcotic drugs, mandating barcodes or QR codes on packaging labels for these critical therapies.

The Ministry of Health and Family Welfare notified amendments to the Drugs Rules, 1945, placing these categories under Schedule H2 and widening a labelling regime previously confined to the country’s top 300 pharmaceutical brands. 

Under the revised rules, manufacturers must print or affix a barcode or Quick Response code on the primary packaging label of each product. 

Where space constraints arise, the code may instead appear on the secondary packaging label. 

The labelling requirement marks a substantial shift for packaging operations, since every unit must now carry machine-readable identification rather than batch-level markings alone.

Encoded Data Elevates Label Complexity

The QR code must store nine discrete data elements: a unique product identification code, generic and brand names, manufacturer details, batch number, manufacturing and expiry dates, manufacturing licence number, and information on excipients where applicable. 

This information becomes accessible through software applications, enabling authentication and verification at multiple points along the supply chain. 

For label converters and packaging printers, the mandate introduces new demands around variable data printing, inline verification and serialisation-ready substrates. 

Unit-level serialisation is considerably harder to replicate than conventional batch numbers, which counterfeiters can duplicate with relative ease.

Phased Timelines Allow Packaging Lines to Adapt

The government has prescribed staggered compliance dates to give packaging operations adequate preparation time. 

Provisions covering vaccines, anti-cancer medicines, and narcotic and psychotropic drugs take effect from July 1, 2027. 

Requirements for antimicrobials follow from July 1, 2028. Manufacturers have been encouraged to pursue voluntary early adoption ahead of the notified deadlines, allowing packaging lines to test and refine their labelling systems before enforcement begins.

Counterfeit Control and AMR Shape Regulatory Direction

The expansion responds to persistent concerns over spurious medicines entering supply chains. 

Enhanced traceability is expected to strengthen regulatory oversight, curb spurious medicines, and support the fight against antimicrobial resistance by improving identification of counterfeit and substandard antimicrobial products. 

The measure also aligns with the government’s “Nasha Mukt Bharat” initiative. India’s pharmaceutical packaging market was valued at US$5.14 billion in 2025 and is projected to reach US$8.18 billion by 2031, growing at 8.05% annually. 

The mandate adds pressure on converters to invest in serialisation-ready printing and vision inspection capabilities, particularly as export-oriented manufacturers must simultaneously satisfy FDA and EU serialisation requirements.

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