Centre Notifies Removal of Syrup Exemption From Schedule K of Drugs Rules

The Ministry of Health and Family Welfare announces a small change to the Drugs Rules, 1945. Earlier, the government had proposed amendments to the Drugs Rules and published a draft notification on 29 December 2025.

The draft was made public on December 30, 2025 inviting objections and suggestions from the public within 30 days. After considering the feedback received, the Central Government decided to go ahead with the amendment.

The government has framed the Drugs (Fifth Amendment) Rules, 2026 in exercise of the powers conferred under the Drugs and Cosmetics Act, 1940 and after obtaining the recommendations of the Drugs Technical Advisory Board. These rules shall come into force on the date of their publication in the Official Gazette.

The amendment makes a specific change in Schedule K of the Drugs Rules, 1945. Under the category “Class of Drugs“, against Serial Number 13, Item Number (7), the word “Syrups” has been removed.