The move is aimed at bringing syrup-based formulations, including cough syrups, under stricter regulatory oversight, official sources said.
The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, published in the official gazette. The amendment came into force with immediate effect from the date of its publication.
According to the notification issued by the Ministry of Health and Family Welfare, the word “syrups” has been omitted from item 7 in the “Class of Drugs” column of Schedule K of the Drugs Rules, 1945.
Schedule K specifies categories of drugs that are exempt from certain provisions relating to manufacture, sale and distribution under the Drugs and Cosmetics Act and Rules, subject to prescribed conditions.
The move follows a draft notification issued by the government in December last year seeking objections and suggestions from stakeholders.
The ministry said the comments received from the public had been considered before finalising the amendment after consultation with the Drugs Technical Advisory Board (DTAB), the country’s highest statutory body on technical matters related to drugs.
The decision comes against the backdrop of increased regulatory scrutiny of cough syrups and other liquid oral formulations in recent years following reports of contamination-linked deaths of children in several countries.
According to sources, the latest amendment is expected to enhance traceability and regulatory supervision of syrup-based medicines by ensuring that manufacturers and sellers comply with stricter licensing and quality-control requirements.
