When institutional reliability matters: the story of di-ethylene glycol Premium

Explore India's struggle with di-ethylene glycol (DEG) contamination and the urgent need for reliable public health institutions.

The government of Tamil Nadu’s Directorate of Drug Control recently issued a public notice against a specific batch of Almond Kit syrup, after laboratory tests detected adulteration with ethylene glycol. This finding emerged during routine surveillance. It comes barely five months after India lost over 20 children in Madhya Pradesh last year due to contaminated cough syrups. Together, these episodes underline the fact that India faces a long battle against adulterations to protect patients from avoidable deaths, bringing to the fore, the inability of the public to rely on governmental institutions meant to protect them.

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.

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.

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.