The Ministry of Health & Family Welfare has issued draft rules (G.S.R. 927(E), dated December 29, 2025) proposing to omit the word “Syrup” from Entry 7, Serial No. 13 under “Class of Drugs” in Schedule K of the Drugs Rules, 1945. Stakeholders have 30 days from public availability of the Gazette to submit objections or suggestions to the Under Secretary (Drugs) or via email.
The Government of India has published draft rules G.S.R. 927(E) to amend the Drugs Rules, 1945. The proposal, issued under Sections 12(1) and 33(1) of the Drugs and Cosmetics Act, 1940 after consultation with the Drugs Technical Advisory Board (DTAB), seeks to remove “Syrup” from Schedule K, specifically Serial No. 13, Entry 7 under the column “Class of Drugs.” This change would alter the list of items enjoying Schedule K facilitation/exemptions.
The notification invites objections and suggestions within 30 days from the date copies of the Gazette containing these draft rules are made available to the public. Submissions may be addressed to the Under Secretary (Drugs), Ministry of Health & Family Welfare, Kartavya Bhawan‑1, New Delhi, or emailed to drugsdiv-mohfw@gov.in. The rules will come into force on publication in the Official Gazette following due consideration.