When institutional reliability matters: the story of di-ethylene glycol
FDA’s origin story
The rise of the world’s most influential drug regulator, the United States’ Food and Drug Administration (FDA), is linked to the same chemical, Di-Ethylene Glycol (DEG) that caused the deaths last year, and its origin story is one of tragedy.
In 1937, sulfanilamide was a wonder drug. It was one of the first antibiotics to be made, and had saved countless lives from deadly bacterial infections. Yet, it posed a practical challenge: it did not dissolve easily in water. In liquid medicines such as syrups, a solvent plays a central role in making the drug usable and reliable. Many active drug substances do not dissolve in plain water, and without a suitable solvent, they would settle unevenly, leading to inaccurate dosing with each spoonful. A proper solvent keeps the drug uniformly distributed, improves stability during storage, and allows the medicine to be absorbed predictably in the body. Solvents also influence taste, texture, and shelf life, making them essential components in the design of safe and effective liquid formulations.
A pharmaceutical company in the USA decided to solve this by dissolving it in a seemingly harmless solvent, DEG.Within weeks, more than 100 people died across the country, many of them children. The solvent was the killer, not the drug. At the time, the company had broken no law. There was no legal requirement to test drugs for safety before marketing. The tragedy shocked the nation and led to a historic shift. In 1938, the United States passed the Federal Food, Drug, and Cosmetic Act, mandating pre-market safety testing for medicines. This transformed the FDA from a modest office into a scientific regulatory authority with the power to inspect, test, approve, and recall drugs.
Understanding DEG
DEG is a simple organic chemical belonging to the glycol family, with the formula (HOCH2CH2)2O. It is a colourless, odourless, slightly viscous liquid with a faintly sweet taste. It mixes easily with water and alcohol, does not evaporate quickly, remains stable over a wide temperature range, and is inexpensive to manufacture. These properties make it an excellent industrial solvent. DEG mimics safer pharmaceutical solvents such as glycerine or propylene glycol. From an unscrupulous manufacturer’s perspective, DEG is far cheaper than glycerine or propylene glycol, which costs more, requires better sourcing, and demands quality control. In poorly- regulated environments, DEG becomes a convenient substitute that reduces production costs without visibly altering the final product.
Toxicity mechanism
The exact mechanism of DEG toxicity remains unclear. Once ingested, it is absorbed from the gut and metabolised in the liver by enzymes such as alcohol dehydrogenase. It is converted into toxic acidic metabolites, particularly diglycolic acid, which is the principal agent responsible for organ damage. Diglycolic acid has a direct toxic effect on the proximal renal tubules of the kidneys. These tubules are responsible for filtering and reabsorbing essential substances from the blood. When they are damaged, the kidneys abruptly fail. This leads to acute kidney injury, accumulation of toxins in the blood, electrolyte disturbances, and severe metabolic acidosis. Clinically, this explains the typical pattern seen in DEG poisoning: early nausea and vomiting, followed after a deceptive period of apparent improvement followed by rapid deterioration, kidney failure, reduced urine output, confusion, seizures, and, in severe cases, death.
Legitimate uses
DEG cannot be banned altogether, as its legitimate uses are numerous and essential. It is used in antifreeze and brake fluids, where it prevents freezing and ensures mechanical reliability. It plays a role in the manufacture of resins, plasticisers, inks, adhesives, and dyes. In the textile industry, it helps produce polyester fibres. In natural gas processing, it removes moisture from pipelines. In all these applications, DEG performs efficiently and safely. The chemical is not the villain. Its migration into medicines is.
Watch: Cough syrup deaths, Nobel Prize and antimicrobial resistance
Global trail of poisoning
DEG has been linked to deaths across multiple countries for nearly a century, since 1937 in the USA. In Spain in 1985, contaminated topical preparations caused five deaths. In Nigeria in 1990, contaminated paracetamol syrup caused 47 child deaths, followed by another outbreak in 2008 that resulted in 84 child deaths. In Bangladesh between 1990 and 1992, DEG in paracetamol syrups was associated with the deaths of more than 300 children. In Argentina in 1992, contaminated propolis syrup caused 29 deaths. In Haiti in 1996, contaminated acetaminophen syrups led to around 88 child deaths. In Panama in 2006, DEG in medicines were linked to 365 deaths. In The Gambia in 2022, cough syrups were associated with 70 child deaths, followed by Uzbekistan and Indonesia in the same year, where contaminated syrups were linked to about 20 and nearly 100 child deaths, respectively.
India’s long battle
India’s encounter with DEG has occurred at multiple points over the past four decades. In 1986, a glycerin batch contaminated with DEG used in hospitals in Mumbai led to the deaths of at least 21 patients due to acute kidney failure. More recently, in 2022 and 2023, Indian-manufactured cough syrups containing DEG were linked to child deaths in several countries abroad.
The lesson for India from the United States here, is in replicating its institutional courage. The FDA was not built because America loved regulation; it was built because America learnt, painfully, that without strong institutions, the nation can’t prosper. If India truly wants to become self reliant, then it must ensure its institutions are strong, reliable and safeguard public health. Without this, we will simply be reacting to tragedy, not averting it.
(Dr. C. Aravinda is an academic and public health physician. The views expressed are personal. aravindaaiimsjr10@hotmail.com)
Published – February 08, 2026 08:04 am IST
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