On January 18, 2022, the Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. The amendment makes QR codes mandatory on every active pharmaceutical ingredients. The Amendment Rules will come into force from January 01, 2023.

Key Amendments

  • In Rule 96 relating to manner of labelling, the following sub-rule shall be inserted:

“(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely:—

(i) Unique product identification code,

(ii) Name of the API,

(iii) Brand name (if any),

(iv) Name and address of the manufacturer,

(v) Batch no.,

(vi) Batch size,

(vii) Date of manufacturing,

(viii) Date of expiry or retesting,

(ix) Serial shipping container code,

(x) Manufacturing licence no. or import licence no.

(xi) Special storage conditions required (if any).”.

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