INDIA · WORLD & POLITICS

India mandates blue-strip labels for antimicrobials

Economic Times Economic Times 21 Feb · 3:58 PM
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India’s central government issued a notification requiring all antimicrobial drugs and preparations to carry a conspicuous blue vertical strip on packaging labels.
India mandates blue-strip labels for antimicrobials
Why it matters
The notification creates an additional, standardized packaging identifier for antimicrobials, forcing label redesign and print/packaging changeovers across affected SKUs. Pharma associations are contesting the measure, increasing uncertainty over whether the mandate is sustained or modified, but the binding instrument cited is the issued notification. Because antimicrobials already carry Schedule H/H1 warnings and often use QR/barcodes and traceability systems, the change introduces parallel labelling requirements that can complicate packaging inventory management and regulatory sign-offs. The operational impact concentrates in packaging procurement, line clearance, and coordination with contract packers and printers. The policy intent is to curb misuse, but the immediate decision pressure is compliance execution versus potential revision if the notification is withdrawn.
Implications
  • Packaging redesign and re-approval cycles for antimicrobial SKUs
  • Higher packaging changeover complexity across plants and CMOs
  • Risk of non-compliant inventory if old strips remain in circulation
  • Added compliance layer alongside Schedule H/H1 and traceability labels
Who is affected
  • Antimicrobial drug manufacturers and marketing authorization holders
  • Contract manufacturing and packaging organizations (CMOs/CPOs)
  • Packaging material suppliers and label/strip printers
  • Hospital and retail pharmacy supply chains handling antimicrobial inventory
Source

Read original → Economic Times

Topics

World & Politics Policy & Regulation Law & Public Safety Compliance Health & Medicine Pharma & Biotech

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