Notification/Circular No.: G.S.R. 299(E) dated April 21, 2026
Applicable Act/Rule: Drugs Rules, 1945
Applicable Section/Rule: Rule 89
Central Government has published draft rules to amend the Drugs Rules, 1945, after consultation with the Drugs Technical Advisory Board. The draft rules have been issued for public information, and objections or suggestions may be submitted within thirty days from the date of availability of the Gazette notification.
The draft amendment proposes substitution of specified forms under Rule 89. The amendment expands the list of forms applicable under the rule. The provisions apply to entities governed under the Drugs Rules, 1945.
“1.(i) These rules may be called the Drugs (…… Amendment) Rules, 2026.
(ii) They shall come into force after the 3 months of publication of the final rules in the Official Gazette.
2. In the Drugs Rules, 1945, under rule 89, the words “Form 25 or Form 28” shall be substituted with the words “Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or Form 28F”.”
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