Union health ministry adds all vaccines, cancer drugs to schedule H2 for strict tracking & QR codes

Published 25 June 2026 · local

New Delhi: The Union health ministry expanded mandatory track-and-trace requirements to cover all vaccines, antibiotics, cancer drugs and narcotic and psychotropic substances, widening an anti-counterfeiting system that previously applied only to India’s 300 top-selling drug brands. The rules, issued under Schedule H2 of the Drugs Rules, 1945, require manufacturers to print QR codes or barcodes, unique to each product, on packaging, allowing regulators and consumers to verify a product's authenticity, batch details, and manufacturing history with a scan. The government expanded this system to ensure that fake products do not reach patients. Also Read | India orders nationwide crackdown on smuggled, unapproved medicines The implementation will follow two distinct deadlines to give companies time to adapt.

Provisions covering vaccines, narcotics, psychotropic drugs, and anti-cancer medicines take effect from 1 July 2027, while companies making antimicrobial drugs have until 1 July 2028 to comply, the ministry said in a gazette notification. The expansion aims to curb the circulation of spurious and substandard medicines and support India's fight against antimicrobial resistance by improving tracking of counterfeit or low-quality antibiotic products across the supply chain. “The present amendment significantly expands its coverage to include all vaccines, antimicrobials, anti-cancer medicines and narcotic and psychotropic drugs, thereby broadening the scope of traceability and strengthening safeguards against the circulation of counterfeit and substandard medicines,” the health ministry said.

Allowing authentication The health ministry stated that the tracking mechanism will allow authentication of medicines at various stages of the supply chain to track and verify drug products. “The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market,” the health ministry said. Under the rules, manufacturers must place the Bar Code or QR Code on the primary packaging label or, if there is insufficient space, on the secondary packaging label. This code must contain detailed manufacturing data that software applications can read. Also Read | India overhauls food safety licencing, scraps permit renewal norm “The QR Code will contain key product information including 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 details of excipients, wherever applicable,” the health ministry said.