Amid drug quality and patient safety concerns, the Union Health ministry has amended rules to prohibit sale of syrups, including cough syrups, without a doctor's prescription. The government has also notified an amendment to the Drugs Rules, 1945, saying that the exemption given for the sale of cough syrups in small villages has been withdrawn
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. 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.
Meanwhile. the government has notified an amendment to the Drugs Rules, 1945, saying that the exemption given for the sale of cough syrups in small villages has been withdrawn. The Ministry added that with the omission of the word “Syrup”, this exemption will no longer be available for cough syrups. Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed under it.
Earlier, the sale of cough syrups in villages with a population of less than one thousand without requiring compliance with certain retail sale licensing provisions was permitted. It added that the measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.
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