Drug Controller Bans Anti-cold Medicines For Children Below Four Years
New Delhi, December 21 (TNA) India's drug regulator has banned the use of anti-cold drug combinations for children under four years of age. Along with this, it has been ordered that labeling of medicines should be done accordingly. The prescribed drug combination includes chlorpheniramine maleate and phenylephrine.
It is often used in syrup or tablets to treat common cold symptoms. The decision to ban this has been taken in view of the death of 141 children worldwide.
The regulator's order on anti-cold drug combinations, also known as fixed-drug combinations (FDCs), was issued on December 18 and made public on Wednesday. The Drug Controller General of India (DCGI) said drug manufacturers need to label their products with a warning that FDCs should not be used in children under four years of age.
The regulator said that complaints are being received regarding anti-cold drug combination in children. That's why we have taken this decision.