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

Area of Science:

• Public Health
• Pharmaceutical Policy
• Paediatric Medicine

Background:

• Recurrent paediatric deaths linked to diethylene glycol (DEG)-contaminated cough syrups in India reveal critical regulatory and medicine use failures.
• Children remain exposed to hazardous, non-essential multiple-drug combinations despite global and domestic warnings.
• The commentary addresses the ethical concerns of using over-the-counter (OTC) cough syrups for viral illnesses in young children.

Purpose of the Study:

• To analyze the intersection of clinical irrationality and regulatory gaps in paediatric pharmaceutical governance in India.
• To review recent incidents (2022-2025) of DEG contamination and evaluate policy responses.
• To propose a roadmap for improved pharmaceutical stewardship and rational medicine use.

Main Methods:

• Analysis of regulatory failures and clinical practices related to paediatric cough syrups.
• Review of recent incidents of diethylene glycol (DEG) contamination and associated policy responses.
• Development of a four-pillar stewardship roadmap for pharmaceutical governance.

Main Results:

• Persistent weaknesses identified in supply-chain oversight and excipient testing.
• Continued reliance on OTC cough syrups for self-limiting viral illnesses in children under five is prevalent.
• Policy responses have not fully addressed the systemic issues leading to contamination and irrational use.

Conclusions:

• Aligning India's paediatric pharmaceutical governance with WHO rational use principles is crucial.
• A four-pillar stewardship roadmap (clinical restraint, quality assurance, market surveillance, public communication) is proposed.
• Urgent action is needed to prevent avoidable mortality and rebuild public trust in the healthcare system.