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India Expands Drug Traceability with QR Codes
26 Jun
Summary
- QR codes now mandatory for vaccines, antimicrobials, and cancer drugs.
- New rules aim to curb counterfeit medicines and bolster supply chain security.
- Compliance deadlines are phased, starting from July 2027.
India's Union Health Ministry has updated the Drugs Rules, 1945, expanding the QR code-based track-and-trace system. This enhancement now includes all vaccines, antimicrobials, narcotic and psychotropic drugs, and anti-cancer medicines under Schedule H2.
Manufacturers will be required to affix QR codes on primary or secondary packaging. These codes will store essential product information for authentication and verification across the supply chain, aiming to prevent counterfeit and substandard medicines. This represents a significant increase in coverage from the previous top 300 brands.
The new traceability mechanism is expected to bolster regulatory oversight and aid in combating antimicrobial resistance by enabling better monitoring of drug products. The Ministry has established phased implementation timelines to allow industry adaptation.
Compliance for vaccines, narcotic/psychotropic drugs, and anti-cancer medicines is mandated from July 1, 2027. Antimicrobials will follow with a July 1, 2028 deadline. Additionally, amendments to the Clinical Establishments Act aim to streamline processes and reduce compliance burdens.
