India’s Drugs Regulatory Authority Implements Ban on Anti-Cold Drug for Children Below Four Years

India’s drug regulatory body has taken a decisive step in safeguarding children’s health by imposing a ban on the use of an anti-cold drug combination for those under four years old. The move follows a series of unfortunate incidents globally, where at least 141 child deaths have been linked to similar cough syrups.

The regulatory authority, responding to concerns regarding the promotion of an unapproved anti-cold drug formulation for infants, has mandated that drug manufacturers label their products with a warning against usage in children below the age of four. This fixed-drug combination (FDC) comprises chlorpheniramine maleate and phenylephrine, commonly utilized in syrups or tablets to alleviate common cold symptoms.

This directive, disclosed on December 18, aims to ensure the safety of young children and underscores the country’s commitment to stringent pharmaceutical quality control measures. India continues to rigorously test and monitor drug exports to maintain global health standards.