NEW DELHI, June 16: The Union Health Ministry has amended drug rules to prohibit the sale of syrups, including cough syrups, without a doctor’s prescription, in a move aimed at strengthening drug quality standards and patient safety.
The amendment, notified through the Drugs (Fifth Amendment) Rules, 2026, came into effect immediately upon its publication in the official gazette. Officials said the decision brings syrup-based formulations under stricter regulatory oversight.
According to the notification issued by the Ministry of Health and Family Welfare, the word “syrups” has been omitted from Item 7 under the “Class of Drugs” column in Schedule K of the Drugs Rules, 1945. Schedule K lists categories of drugs exempt from certain provisions governing manufacture, sale and distribution under the Drugs and Cosmetics Act.
The amendment follows a draft notification issued in December last year inviting objections and suggestions from stakeholders. The ministry said public feedback was examined before finalising the rules in consultation with the Drugs Technical Advisory Board (DTAB), the country’s highest statutory body on technical drug-related matters.
The move comes amid heightened scrutiny of cough syrups and other liquid oral medicines following reports of contamination-linked child deaths in several countries in recent years.
Officials said the revised regulations are expected to improve traceability, strengthen quality control and ensure greater compliance by manufacturers and sellers dealing in syrup-based medicines. (Agencies)
