2026.06.09 G.S.R. 477(E)_Notification for Removal of Syrup exemption under schedule K in the Drugs Rules,1945

On 9 June 2026, the Ministry of Health and Family Welfare issued Notification G.S.R. 477(E), formally enacting the Drugs (Fifth Amendment) Rules, 2026. This amendment follows the draft rules published on 29 December 2025 under G.S.R. 927(E), which invited objections and suggestions from stakeholders within thirty days of the Gazette’s release.   After reviewing public feedback and consulting the Drugs Technical Advisory Board, the Central Government finalized the amendment. The rules, effective from the date of publication in the Official Gazette, introduce a specific change to Schedule K of the Drugs Rules, 1945.   Under the column “Class of Drugs,” against serial number 13, item number (7), the word “Syrups” has been omitted. This modification reflects regulatory intent to streamline exemptions and ensure clarity in classification under Schedule K.   The notification underscores the government’s commitment to transparent rule‑making, incorporating stakeholder input while reinforcing compliance with the Drugs and Cosmetics Act, 1940.