Removal of Syrup Exemption from Schedule K under Drugs (Fifth Amendment) Rules, 2026

Notification/Circular No.: G.S.R. 477(E) dated June 9, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940 (23 of 1940) | Drugs Rules, 1945
Applicable Section/Rule: Schedule K, Column — Class of Drugs, Serial Number 13, Item Number (7)
Effective Date: June 15, 2026

Draft of these rules was published vide G.S.R. 927(E) dated December 29, 2025 in the Gazette of India, Extraordinary, inviting objections and suggestions from persons likely to be affected, within thirty days from the date the copies were made available to the public. Copies were made available on December 30, 2025. Objections and suggestions received from the public were considered by the Central Government. The rules are made after consultation with the Drugs Technical Advisory Board.

In the Drugs Rules, 1945, in Schedule K, in the column under the heading “Class of Drugs,” against serial number 13, in item number (7), the word “Syrups,” shall be omitted.

“In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word “Syrups,” shall be omitted.”

The effect of this amendment is the removal of “Syrups” from the list of drugs exempted under Schedule K at the specified entry. The Drugs Rules, 1945 were last amended vide G.S.R. 444(E) dated June 1, 2026.

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