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Adulterated cough syrup caused acute kidney failure deaths in children: lessons have still not been learnt
Devaraj Ezhilarasan1, Munusamy Karthick1
1Department of Pharmacology, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Chennai, Tamil Nadu, 600 077, India.
Abstract:
In 2025, 24 children in India died after consuming COLDRIF, a paediatric cough syrup, due to acute kidney failure. Batch SR-13 from Sresan Pharmaceuticals in Tamil Nadu, India,was contaminated with 46.28 % diethylene glycol (DEG), a toxic solvent used in place of pharmaceutical-grade excipients. Kidney biopsies from children confirmed acute tubular necrosis. DEG toxicity, via its metabolites 2-hydroxyethoxyacetic acid and diglycolic acid, causes metabolic acidosis and nephrotoxicity. Global incidents highlight repeated risks of DEG adulteration in children medicines. Regulatory lapses and poor-quality control remain major contributors. Strict adherence to Good Manufacturing Practices and vigilant regulatory oversight are essential to prevent such fatal outbreaks.
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