Amid drug quality and patient safety concerns, the Union Health Ministry has amended rules that earlier gave exemptions to cough syrups from manufacturing, distribution, and retail licensing regulations.
The rule mandates that cough syrup would no longer be available at establishments that do not process a drug retailing licence.
The move is aimed at bringing syrup-based formulations under stricter regulatory oversight and comes amid heightened scrutiny of liquid oral medicines following reports of contamination-linked child deaths in several countries.
The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, and came into force immediately upon publication in the official gazette on June 15.
Under the amendment, the word "syrups" has been omitted from Item 7 in the "Class of Drugs" column of Schedule K of the Drugs Rules, 1945.
Consumers could often purchase cough syrups from non-pharmaceutical retail outlets without going through standard pharmacy channels.
With the latest amendment, cough syrups and other syrup-based formulations have been removed from the exemption list.
Consequently, their sale and dispensing will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act.
