The Drugs (Eighth Amendment) Rules, 2022.


The Ministry of Health and Family Welfare on 17th November 2022, has published the Drugs (Eighth Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.

The amendment is brought under rule 96  which deals with manner of labelling of drugs in which the following sub rule 6 and 7 has been notified has follows:

(6) The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.

(7) The stored data or information referred above shall include the following particulars, namely:—

  • unique product identification code;
  • proper and generic name of the drug
  • brand name
  • name and address of the manufacturer;
  • batch number;
  • date of manufacturing;
  • date of expiry; and
  • manufacturing licence number.

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