The Drugs Consultative Committee (DCC) has proposed a prominent statutory warning on cough syrup labels restricting their use in children below four years of age, amid concerns over the widespread prescribing of cough syrups to young children.
The proposal was discussed during the 70th Meeting of the Drugs Consultative Committee (DCC), held in hybrid mode on 18 September 2026 at CDSCO Headquarters, FDA Bhawan, Kotla Road, New Delhi.
During the meeting, the DCC was apprised of concerns regarding the use of cough syrups in young children despite an earlier advisory issued by the Directorate General of Health Services (DGHS).
The Committee deliberated on a proposal to prescribe a statutory warning under Rule 96 of the Drugs Rules, 1945. The DCC agreed in principle that cough syrup labels should prominently display the following warning in red colour:
“WARNING: Cough syrup shall not be used in children below 4 years of age.”
The proposed warning is intended to make the age restriction clearly visible to healthcare professionals, caregivers and consumers.
The DCC also recommended that cough syrup labels should not contain pictures of infants, toddlers, toys or similar illustrations that could suggest that the product is intended for use in very young children. According to the Committee, such depictions could create confusion regarding the appropriate age group for the medicine.
The DCC further recommended that the warning should be displayed prominently and in an appropriately increased font size so that it is easily noticeable on the product label.
Following the deliberations, the Committee recommended that necessary action be initiated for amendment of the Drugs Rules, 1945 to incorporate the proposed statutory warning. The recommendation represents a proposed regulatory change at this stage. Any mandatory labelling requirement would follow the prescribed regulatory process for amendment of the Drugs Rules.
The matter was considered as part of the proceedings of the 70th DCC meeting held on 18 September 2026.
