Government Mandates Doctor Prescription for Cough Syrups Removing OTC Status
PICTURE FOR REPRESENTATION PURPOSE ONLY
NEW DELHI, June 16, 2026 — The Ministry of Health and Family Welfare has issued a crucial notification making cough syrups and other syrup formulations unavailable over the counter at chemist shops without a doctor prescription.
According to the official gazette notification G.S.R. 477(E) issued by the Department of Health and Family Welfare, all medical syrups will no longer fall under the OTC category, meaning consumers can no longer purchase them directly without medical authorization.
The new regulations, officially titled the Drugs (Fifth Amendment) Rules, 2026, come into immediate effect from the date of their publication in the Official Gazette. As detailed in the attached document 1001688020.jpg, the Central Government exercised its powers under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, to amend the existing Drugs Rules, 1945.
The change was finalized after extensive consultation with the Drugs Technical Advisory Board and careful consideration of public objections and suggestions received following a draft notification issued on December 29, 2025.The structural regulatory change strictly alters Schedule K of the Drugs Rules, 1945.
Under the specific column heading Class of Drugs, against serial number 13, in item number (7), the word “Syrups,” has been officially omitted. Signed by Joint Secretary Harsh Mangla under file number F. No. X.11014/11/2025-DR, this amendment aims to regulate the sale of liquid oral formulations to curb misuse and ensure safer consumption patterns across the country.