From The Economic Times · Teena Thacker · · 1m 10s
India to add red warning labels to cough syrup bottles
New rules would ban use in children under four and require pictorial labels showing older kids.
In brief
New rules would ban use in children under four and require pictorial labels showing older kids. India's drug regulator is proposing mandatory red warning labels on cough syrups to prevent their use in children under four years old. Originally reported by The Economic Times.
Red warning labels proposed
India's drug regulator wants mandatory red labels on cough syrups warning against use in children below four years of age.
Picture labels for clarity
The proposal includes pictorial depictions of school-age children on bottles to show the medicine is for older kids, not infants or toddlers.
Advisory already issued last year
A health services advisory in October 2025 already warned against prescribing cough and cold medicines to children below two years of age.
Doctors still prescribing to infants
Despite the advisory, complaints show doctors continue prescribing cough syrups to infants below two years old.
“The practice has continued even after the DGHS issued specific directions against it in October 2025”
Committee reviewing the issue
A technical committee discussed the matter in April 2026 and recommended stakeholder consultation on labelling changes.
Widespread use drives concern
Cough syrups are among the most commonly prescribed and over-the-counter medicines in India, raising long-standing safety concerns for young children.
The key point
India's drug regulator is proposing mandatory red warning labels on cough syrups to prevent their use in children under four years old.
