Pharm'Up 
During its 70th meeting held on September 18, 2026, at CDSCO Headquarters in New Delhi, the Drugs Consultative Committee (DCC) proposed a prominent statutory warning on cough syrup product labels restricting their use in children under four years of age. This regulatory move addresses ongoing concerns regarding the widespread prescription and use of cough syrups among young children, despite previous advisories.
Key Proposals and Labeling Requirements
- Statutory Warning Text: The DCC agreed in principle to mandate a clear warning under Rule 96 of the Drugs Rules, 1945, to be printed in red color stating:“WARNING: Cough syrup shall not be used in children below 4 years of age.”
- Removal of Misleading Imagery: The committee recommended that cough syrup labels should not feature pictures of infants, toddlers, toys, or similar illustrations that could imply the product is intended for very young children.
- Prominence and Visibility: The statutory warning must be displayed prominently with an appropriately increased font size so it is easily noticeable by consumers, caregivers, and healthcare professionals.
Regulatory Process and Next Steps
The committee’s recommendation represents a proposed regulatory step toward amending the Drugs Rules, 1945. Implementing any mandatory labeling requirement will follow the prescribed legal process for rule amendments.
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