Published Oct 04, 2026 | 4:41 PM ⚊ Updated Oct 04, 2026 | 4:54 PM
The intent is to ensure that the product packaging does not create an impression that it is intended for use in infants.
Synopsis: CDSCO’s Drugs Consultative Committee (DCC) has recommended a prominent red warning on cough syrup labels stating they should not be used in children below four years. It also recommended banning pictures of infants, toddlers, toys or similar imagery that could suggest use in young children, with amendments to the Drugs Rules proposed.
Cough syrup labels may soon have to carry a prominent warning against their use in children below four years of age, while manufacturers may also be barred from using pictures of babies, toddlers or toys on the packaging, following recommendations by the CDSCO’s Drugs Consultative Committee (DCC).
The recommendations were made during the DCC meeting held on 29 September, where the committee discussed concerns over the continued prescribing and use of cough syrups in young children despite an advisory issued by the Directorate General of Health Services (DGHS).
The DCC was specifically apprised of concerns over the “rampant prescribing of cough syrups to infants” and deliberated on a proposal to introduce a statutory warning under Rule 96 of the Drugs Rules, 1945.
The committee agreed in principle that cough syrup labels should prominently carry a warning in red stating: “WARNING: Cough syrup shall not be used in children below 4 years of age.”
The recommendation will need approval from the Drug Technical Advisory Board (DTAB) of the CDSCO at its next meeting, followed by a draft notification and the prescribed final Gazette notification process before it becomes legally enforceable. The entire process is expected to take about a year or more.
The DCC also raised concerns about the way cough syrups are presented on their packaging.
The committee recommended that “pictures of infants, toddlers, toys or similar depictions which may suggest use in small children should not appear on such labels to avoid any confusion.”
It further recommended that the warning be displayed “prominently in an appropriately increased font size.”
The intent, according to the minutes, is to ensure that the product packaging does not create an impression that the medicine is intended for use in infants or young children, while making the age restriction immediately visible to consumers.
The DCC said that “necessary action for amendment of the Drugs Rules, 1945 may be initiated accordingly.”
This means the recommendation will still have to go through the regulatory process before it becomes a legally enforceable labelling requirement.
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The proposed warning comes months after the Centre tightened the rules governing the sale of syrup formulations.
In June, the Union Health Ministry amended the Drugs Rules, 1945, by removing the word “Syrups” from Schedule K. The change removed the exemption that had allowed syrup formulations to be sold without a prescription under that schedule.
The amendment followed a draft proposal issued by the government in December 2025 seeking public comments. The final notification said the objections and suggestions received from the public had been considered before the amendment was issued.
(Edited by Dese Gowda)
