Notification/Circular No. – G.S.R. 554(E) August 18, 2025
Applicable Act/Rule – Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940
Applicable Section/Rule – Rule 96
Effective Date – March 1, 2026
The Central Government had earlier proposed amendments to the Drugs Rules, 1945 through a draft notification issued on July 12, 2024. This draft was published to gather inputs from stakeholders such as manufacturers, distributors, and healthcare professionals. After reviewing the objections and suggestions received, and with the advice of the Drugs Technical Advisory Board, the Government finalised the Drugs (2nd Amendment) Rules, 2025. The notification was issued on August 18, 2025, with the changes set to apply from March 1, 2026.
Key amendments –
1.In rule 96, in sub-rule (7), —
(a) In clause (vii), for the words “date of expiry; and”, the word “date of expiry” shall be substituted;
(b) After clause (viii), the following clause shall be inserted, namely:-
“(ix) qualitative details of excipients.”
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