The Ministry of Health and Family Welfare has issued a notification called the Drugs (2nd Amendment) Rules, 2025. These new rules amend the Drugs Rules, 1945, to mandate the inclusion of qualitative details of excipients on drug labels. This amendment was issued on August 18, 2025 and will come into effect from March 1, 2026.
The amendment was finalized after a public consultation process following the publication of draft rules on July 12, 2024. The Central Government, after consulting with the Drugs Technical Advisory Board, considered all objections and suggestions before issuing this final notification.
Specifically, the amendment modifies Rule 96, sub-rule (7) of the Drugs Rules, 1945. The change involves:
- Deletion of the word “and” at the end of clause (vii).
- Insertion of a new clause (ix) after clause (viii), which states that the label on a drug container or package must include “qualitative details of excipients”.
This change is a significant step towards increasing transparency for consumers and healthcare professionals by providing more information about the components of a drug.
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