Rational use and regulatory stewardship for paediatric cough syrups in India: A public health imperative.

Abstract

Recurrent paediatric deaths from diethylene glycol (DEG)-contaminated cough syrups in India highlight critical failures in regulatory stewardship and rational medicine use. Despite global alerts and domestic advisories, children continue to be exposed to hazardous, non-essential multiple-drug combinations. This commentary analyses the intersection of clinical irrationality and regulatory gaps, arguing that persistent reliance on over-the-counter (OTC) cough syrups for self-limiting viral illnesses in children under five is ethically indefensible. We review recent incidents (2022-2025) and policy responses, identifying persistent weaknesses in supply-chain oversight and excipient testing. We propose a four-pillar stewardship roadmap: clinical restraint to curb unnecessary prescribing; rigorous quality assurance, including universal batch testing; intensified market surveillance; and public communication to counter misconceptions. Aligning India's paediatric pharmaceutical governance with WHO rational use principles is urgently needed to prevent further avoidable mortality and restore trust in the public health system.