The Union Health Ministry has barred the sale of syrups, including cough syrups, without a doctor’s prescription.
The amendment removes “syrups” from Schedule K exemptions under the Drugs Rules, 1945.
The move aims to improve traceability, licensing compliance and quality control for syrup-based medicines.
The Union Health Ministry has prohibited the sale of syrups, including cough syrups, without a doctor’s prescription, amid concerns over drug quality and patient safety, according to PTI.
The move is intended to bring syrup-based formulations under stricter regulatory oversight and ensure closer monitoring of their manufacture, sale and distribution, PTI reported, citing official sources.
The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, published in the official gazette. It 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, PTI reported.
The ministry said the comments received from the public had been considered before finalising the amendment after consultation with the Drugs Technical Advisory Board, 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.
(WIth inputs from PTI)
