QR Code-based Drug Traceability Expansion: Strengthening Safeguards Against Counterfeit Medicines

Key facts

• The Union Ministry of Health (Health Ministry) notified amendments to the Drugs Rules, 1945, to expand the QR code-based track-and-trace framework under Schedule H2.
• Schedule H2 now includes all vaccines, antimicrobials, anti-cancer drugs, and narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985.
• QR codes on packaging must store the unique product identification code, generic and brand names, manufacturer name and address, batch number, manufacturing and expiry dates, manufacturing licence number, and excipients.
• Compliance timelines are set for July 1, 2027, for vaccines, narcotic and psychotropic drugs, and anti-cancer medicines, and July 1, 2028, for antimicrobials.
• The Health Ministry notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, on June 22, 2026, pursuant to the Jan Vishwas (Amendment of Provisions) Act, 2026.