The Tamil Nadu Narcotics Management Bureau authorities just lately issued a public notification banning sure batches of Almondkit syrup after laboratory exams detected ethylene glycol contamination. This discovering got here to gentle throughout routine monitoring. It comes simply 5 months after India misplaced greater than 20 youngsters final 12 months to contaminated cough syrup in Madhya Pradesh state. These episodes spotlight the truth that India faces an extended battle towards adulteration to guard sufferers from avoidable deaths, and spotlight the lack of the general public to depend on authorities establishments which might be supposed to guard sufferers.
The story behind the delivery of the FDA
The rise of the US Meals and Drug Administration (FDA), the world’s most influential drug regulator, is linked to diethylene glycol (DEG), the identical chemical that precipitated deaths final 12 months, and its origin story is one among tragedy.
In 1937, sulfanilamide was a marvel drug. It was one of many first antibiotics created and has saved numerous lives from lethal bacterial infections. Nonetheless, in actuality, there was an issue that it was troublesome to dissolve in water. In liquid pharmaceutical merchandise resembling syrups, solvents play a central position in making the drug simple to make use of and dependable. Many lively drug substances are insoluble in plain water and, within the absence of an acceptable solvent, precipitate inconsistently, making spoonful dosing imprecise. Acceptable solvents disperse the drug evenly, enhance stability throughout storage, and guarantee predictable absorption of the drug into the physique. Solvents additionally affect style, texture, and shelf life, making them important elements within the design of secure and efficient liquid formulations.
American pharmaceutical firms determined to resolve this drawback by dissolving DEG in a seemingly innocent solvent.Inside weeks, greater than 100 individuals had died throughout the nation, lots of them youngsters. The perpetrator was not medication however solvents. On the time, the corporate was not breaking any legal guidelines. There was no authorized obligation to check medicines for security earlier than promoting them. This tragedy shocked the nation and caused historic modifications. In 1938, america handed the Federal Meals, Drug, and Beauty Act, which required premarket security testing of medication. This remodeled the FDA from a humble paperwork to a scientific regulatory authority with the ability to examine, take a look at, approve, and recall medication.
perceive you
DEG is a straightforward natural chemical belonging to the glycol household with the formulation (HOCH2CH2)2O. It’s a colorless, odorless, barely candy, barely viscous liquid. It mixes simply with water and alcohol, doesn’t evaporate shortly, is steady over a large temperature vary, and is cheap to supply. These properties make it a superb industrial solvent. DEG mimics safer pharmaceutical solvents resembling glycerin and propylene glycol. From an unscrupulous producer’s perspective, DEG is less expensive than glycerin or propylene glycol, that are extra pricey, require higher sourcing, and require high quality management. In much less regulated environments, DEGs symbolize a helpful different that may cut back manufacturing prices with out appreciably altering the ultimate product.
Mechanism of toxicity
The precise mechanism of DEG toxicity stays unclear. When ingested, it’s absorbed from the intestines and metabolized by enzymes resembling alcohol dehydrogenase within the liver. It’s transformed to poisonous acidic metabolites, particularly diglycolic acid, which is the principle substance liable for organ injury. Diglycolic acid is instantly poisonous to the proximal tubules of the kidney. These tubules are liable for filtering and reabsorbing important substances from the blood. When the kidneys are broken, they out of the blue cease working. This causes acute kidney harm, accumulation of poisons within the blood, electrolyte disturbances, and extreme metabolic acidosis. Clinically, this describes the everyday sample seen in DEG poisoning. That’s, preliminary nausea and vomiting, adopted by a misleading interval of obvious enchancment adopted by fast deterioration, renal failure, decreased urine output, confusion, seizures, and in extreme circumstances, dying.
reputable use
There are a lot of reputable makes use of for DEGs, and they’re important, so that they can’t be fully banned. Utilized in antifreeze and brake fluids to forestall freezing and guarantee mechanical reliability. It performs a task within the manufacturing of resins, plasticizers, inks, adhesives, and dyes. Within the textile trade, it’s helpful within the manufacturing of polyester fibers. Pure fuel processing includes eradicating moisture from pipelines. In all these functions, DEG works effectively and safely. Chemical substances will not be the dangerous guys. It is a shift to prescription drugs.
Traces of world habit
DEGs have been linked to mortality in a number of international locations for almost a century, beginning in 1937 in america. In Spain in 1985, 5 individuals died from contaminated topical preparations. In Nigeria, contaminated paracetamol syrup killed 47 youngsters in 1990, adopted by one other outbreak in 2008 that killed 84 youngsters. In Bangladesh, DEGs in paracetamol syrup had been linked to greater than 300 little one deaths between 1990 and 1992. In Argentina in 1992, 29 individuals died from contaminated propolis syrup. In 1996, roughly 88 youngsters died in Haiti from contaminated acetaminophen syrup. In Panama in 2006, DEGs in medicines had been linked to 365 deaths. Cough syrup was linked to 70 little one deaths in The Gambia in 2022, adopted by Uzbekistan and Indonesia in the identical 12 months, the place contaminated syrup was linked to about 20 and 100 little one deaths, respectively.
lengthy battle of india
India has encountered DEG a number of instances within the final 4 a long time. In 1986, a DEG-contaminated batch of glycerin utilized in a Mumbai hospital precipitated at the very least 21 sufferers to die from acute kidney failure. Not too long ago, in 2022 and 2023, Indian-manufactured cough syrups containing DEG had been discovered to be linked to little one deaths in a number of abroad international locations.
The lesson for India right here from the US is to emulate its institutional braveness. The FDA wasn’t created as a result of America preferred regulation. It was constructed as a result of America discovered the arduous manner {that a} nation can’t prosper with out robust establishments. If India actually desires to change into self-reliant, it wants its establishments to be robust, dependable, and defend public well being. With out this, we find yourself merely reacting to tragedy reasonably than avoiding it.
(Dr. C. Aravinda is a tutorial and public well being doctor. Views expressed are private. aravindaaiimsjr10@hotmail.com)
issued – February 8, 2026 8:04 AM IST
