The Coldrif Cough Syrup Tragedy: A Review of Diethylene Glycol Contamination and Pediatric Safety Failures in India

Abstract

In October 2025, India experienced a tragic outbreak of paediatric deaths linked to consumption of the cough-and-cold liquid formulation Coldrif Syrup, manufactured by Sresan Pharmaceuticals. The present review examines the event in the wider context of paediatric cough-syrup usage, regulatory vulnerabilities, formulation factors and pharmacology, adverse toxicology, public-health response and future prevention. The review first outlines the history of paediatric cough syrups and regulatory frameworks in India, then analyses the composition of Coldrif, its pharmacological rationale, and evidence of usage in children aged 2-8 years. Next, we summarise clinical and epidemiological evidence of efficacy and safety, followed by detailed discussion of the toxic contamination event: detection of diethylene glycol (DEG) in the batch, mechanisms of DEG toxicity, mortality outcomes (at least 20–24 children under five died), and key lapses in manufacturing and oversight. We then review regulatory and public-health responses: immediate product recalls, manufacturing shutdowns, arrests, revision of testing norms (incorporation of DEG/EG testing in monograph), and advisory-against use in very young children. The article closes with recommendations for clinicians, pharmacists and caregivers around rational prescribing of cough-cold syrups in children, safer alternative strategies, and calls for strengthened pharmacovigilance, manufacturing oversight and supply-chain traceability. Although cough and cold remain common in children, this calamity emphasises that benefit-risk balance demands rigorous manufacturing quality and regulatory vigilance. Keywords: paediatric cough syrup, Coldrif, diethylene glycol, contamination, drug safety, India.