On 25 June 2026 the Union Health Ministry amended the Drugs Rules, 1945 to mandate QR codes on vaccines, antimicrobials, anti-cancer medicines and narcotic and psychotropic substances.
Scope of the mandate
- Covered categories: Vaccines; antimicrobials; anti-cancer medicines; narcotic and psychotropic drugs.
- Legal change: Amendments to the Drugs Rules, 1945 brought these categories under Schedule H2.
- Previous coverage: QR-based identification earlier applied only to the top 300 pharmaceutical brands in India.
Packaging and data requirements
- Placement: QR code or barcode must be printed/affixed on primary packaging or on secondary packaging if primary lacks space.
- Mandatory data elements: Unique product identification code; generic and brand names; manufacturer’s name and address; batch number; manufacturing and expiry dates; manufacturing licence number; excipients where applicable.
Compliance timeline
- Deadlines: 1 July 2027 — vaccines, anti-cancer, narcotic and psychotropic drugs; 1 July 2028 — antimicrobials.
Operational intent
- Traceability framework: Inclusion in Schedule H2 expands the existing track-and-trace regime for pharmaceuticals.
- Public-health aims: Measures target counterfeit and substandard medicines and support actions against antimicrobial resistance (AMR).
IASPOINT Booster Facts
- Statute: Drugs Rules, 1945 govern manufacture, labelling and distribution of drugs; Schedule H2 is a regulatory classification within these rules.
- Machine-readable ID: QR/barcode links products to a unique product identification code for automated verification.
- Packaging unit: Primary pack is the unit for consumer-level authentication under the mandate.