Ministry Of Health and Family Welfare on 8th August, 2019, amended the Drugs and Cosmetics Rules, 1945 and thereby released Drugs and Cosmetics (Amendment) Rules, 2019. The draft of these Rules has also been released to mandate that a Quick Response Code to be affixed on drug label.
According to the amendment made in the principal Rules, a Quick Response code or information readable with software application to facilitate tracking and tracing of the product is to be borne on the label of every pharmaceutical ingredient (bulk drug) manufactured or imported in India.
The stored data or information shall include the following:
- 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, (viii) Date of expiry or retesting,
- Serial shipping container code,
- Manufacturing licence no. or import licence no.
- Special storage conditions required (if any).
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Click here to read other recent amendments in the Drugs and Cosmetics Rules.
