Cough Syrup Labels Should Have Child Safety Warning: DCC

Cough syrup labels should not carry pictures of infants, toddlers, toys or other child-friendly images, and should prominently warn that the medicines “shall not be used in children below 4 years of age”, the Drugs Consultative Committee (DCC) has recommended.

The twin recommendations are aimed at preventing parents from mistaking cough syrups as child-friendly medicines, amid continuing concerns over their use in young children and reports of serious adverse events, including deaths, linked to contaminated or substandard cough syrups in India and abroad.

The DCC, which advises the Centre and states on uniform implementation of drug regulations, has agreed in principle that the warning should be displayed prominently in red and in an appropriately increased font size to ensure it is clearly visible on the label.

The recommendations were made at the DCC’s 70th meeting held on September 18, 2026, where the committee discussed concerns over the continued use of cough syrups in young children despite earlier health advisories.

The committee also recommended initiating necessary amendments to the Drugs Rules, 1945, to give the warning statutory backing.

The proposed labelling change is significant because packaging is often the first source of information for consumers. Pictures of babies, toddlers or toys can inadvertently suggest that a medicine is suitable for children, particularly when parents are seeking quick relief for cough or cold.

The move is part of a series of regulatory measures being taken to tighten the sale and use of cough syrups, especially in the paediatric population.

In June this year, the Union Health Ministry had notified a final amendment to the Drugs Rules, 1945, removing cough syrups from Schedule K. This effectively ends the earlier exemption that allowed certain cough syrups to be sold in villages with populations below 1,000 without complying with some retail sale licensing requirements.

With the removal of “syrup” from the relevant Schedule K entry, cough syrups will have to be sold and dispensed through duly licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

In December last year, the Ministry had issued a draft amendment proposing the change.

The tightening of regulation follows concerns over the safety of paediatric cough preparations. The issue gained particular attention after reports in 2025 alleged that more than 20 children in India died after consuming contaminated cough syrup. Similar incidents involving contaminated cough syrups have also been reported in other countries.

The Ministry had, while responding to child deaths reported in Madhya Pradesh in October last year, advised doctors that cough and cold medicines should not be prescribed to children below two years of age and are not recommended for children below five years. For older children, any such use should follow clinical evaluation, appropriate dosing and close supervision.

The latest DCC recommendation sets a specific labelling warning for children below four years, while the broader clinical guidance remains relevant when doctors assess whether such medicines should be used in children.

Another concern relates to the ingredients used in oral liquid medicines.

The DCC had previously discussed reports of problems involving propylene glycol and related impurities such as diethylene glycol (DEG) and ethylene glycol (EG) in syrups intended for paediatric use.

Many oral liquid formulations use solvents such as propylene glycol. If these ingredients or the manufacturing process are not adequately controlled, there is a risk of contamination with DEG or EG, which can cause serious toxicity.

The committee also discussed the possibility of using alternative excipients and formulations to reduce such risks.