Drugs (Fifth Amendment) Rules, 2026 mandates doctor's prescription for all syrups

Key facts

• The Union Ministry of Health and Family Welfare issued a notification under the Drugs (Fifth Amendment) Rules, 2026, making all syrups, including cough syrups, available only on a doctor's prescription.
• The amendment omits the word "Syrups" from Schedule K of the Drugs Rules, 1945, removing their exemption from certain sale and distribution provisions.
• The rules came into force on the date of their publication in the Official Gazette, as stated in the notification.
• A draft of the proposed rules was published in December 2025, and public objections and suggestions were considered before finalisation.
• The Central Government framed the rules after consultation with the Drugs Technical Advisory Board, in exercise of powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.