India's Drug Amendment Rules

On January 18, 2022, the Drugs (Amendment) Rules, 2022 were amended by the Indian Ministry of Health and Family Welfare. The amendment mandates QR codes on every active medicinal component beginning on January 1, 2023. Every active pharmaceutical ingredient (API) imported or manufactured in India is required to have a QR (Quick Response) code on the label and at every packaging level, per the notification's new drug modifications rule.

THE STORED QR CODE DATA MUST CONTAIN THE FOLLOWING INFORMATION:

  • Unique product identification code
  • Name of the API
  • Brand name (if any)
  • Name and address of the manufacturer
  • Batch no.
  • Batch size
  • Date of manufacturing
  • Date of expiry or retesting
  • Serial shipping container code (SSCC)
  • Manufacturing licence no. or import licence no.
  • Special storage conditions required (if any)

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