Diethylene Glycol: The Hidden Killer in Medicines

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A Silent Threat

Diethylene glycol (DEG) is a clear, sweet‑tasting liquid most commonly used as an industrial solvent, antifreeze agent, and in resins or plastics. It is not intended for human consumption. Yet, tragically, DEG has repeatedly found its way into medicines — especially liquid syrups — with devastating consequences.

Why It Slips In?

  • Cost factor: DEG is cheaper than pharmaceutical‑grade glycerin or propylene glycol, which are used as solvents in syrups.
  • Similar appearance: To the naked eye, DEG looks and behaves like safe excipients, making substitution or contamination hard to detect without proper testing.
  • Weak oversight: Inadequate raw material testing and reliance on supplier certificates of analysis have allowed DEG to enter drug supply chains.

How It Harms?

Once ingested, DEG is metabolized into toxic compounds that damage the kidneys, liver, and nervous system.

  • Early symptoms: nausea, vomiting, abdominal pain.
  • Progression: inability to urinate, neurological impairment.
  • Outcome: acute kidney failure, often fatal in children.

The World Health Organization estimates that at least 300 child deaths worldwide since 2022 have been linked to DEG/EG‑contaminated medicines.

A History of Tragedies….

  • 1937, USA: The infamous Elixir Sulfanilamide disaster killed over 100 people, leading to the creation of the modern FDA.
  • 1998, India: 33 children died in Delhi from DEG‑tainted cough syrup.
  • 2019, Jammu (India): 12 child deaths linked to DEG contamination.
  • 2022–23, The Gambia & Uzbekistan: Over 80 children died after consuming Indian‑made syrups contaminated with DEG/EG.
  • 2025, India: Coldrif cough syrup (Sresan Pharma) tested with nearly 49% DEG, causing at least 24 child deaths.

Preventing the Next Disaster….

  • Mandatory testing: Regulators like the FDA and WHO now require identity testing for DEG/EG in every batch of high‑risk excipients such as glycerin and propylene glycol.
  • Global vigilance: WHO has issued multiple Medical Product Alerts since 2022 to warn countries of contaminated syrups.
  • Industry responsibility: Manufacturers must move beyond supplier certificates and perform in‑house analytical testing (e.g., gas chromatography, HPLC).

Key Takeaway

Diethylene glycol is a cheap industrial chemical that has repeatedly infiltrated medicines due to weak testing and oversight. Its presence in cough syrups has caused mass child deaths across decades. Only rigorous testing, strict regulation, and global cooperation can prevent history from repeating itself. Quality assurance is not optional; it is life‑saving. For guidance on quality compliance and regulatory assurance, contact us at Saanvi Pharma Consulting UG (hb.).

1.  World Health Organization (2023). Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination – analytical methods developed for testing paediatric medicines. Retrieved from: WHO: DEG/EG contamination – analytical methods (2023)

2.  U.S. Food and Drug Administration (2023). Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High‑Risk Drug Components for Diethylene Glycol and Ethylene Glycol. Retrieved from: https://www.fda.gov/media/167974/download

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