THE DEADLY CONSEQUENCES OF CONTAMINATED MEDICINE: A LOOK INTO THE KILLER COUGH SYRUP CASE

V. Manikandan*, B. Aswini, K. Jalakandeswari, P. Madhu Mitha, G. Monika, D. Uvasri

In 2025, India faced a major public health crisis following the deaths of several children who consumed a cough syrup contaminated with diethylene glycol (DEG), a highly toxic industrial chemical prohibited in pharmaceutical formulations. The affected product, intended for pediatric use, contained DEG due to the substitution of pharmaceutical-grade excipients with industrial-grade solvents, reflecting severe lapses in Good Manufacturing Practices (GMP) and quality control. DEG toxicity primarily targets the kidneys, leading to acute renal failure, metabolic acidosis, neurological complications, and multi-organ dysfunction, particularly in children due to their physiological vulnerability. The incident prompted immediate regulatory actions, including product bans, recalls, seizures, suspension of manufacturing licenses, and legal proceedings against the responsible manufacturer. The World Health Organization (WHO) issued a Medical Product Alert, highlighting the global risk posed by contaminated liquid medicines and urging heightened international vigilance.[31] This tragedy underscores the critical importance of strict excipient quality assurance, robust regulatory oversight, and strengthened pharmacovigilance systems to ensure the safety of pediatric medicines and prevent similar incidents in the future.