The Ministry of Health and Family Welfare on 18th January 2022 has Published the Drugs (Amendment) Rules, 2022 which shall come into force from 1st January 2023.
As per the amendment under rule 96(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:—
- 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,
- Manufacturing licence no. or import licence no.
- Special storage conditions required (if any).
