In September 2025, in Chhindwara, a district in central Madhya Pradesh, children with ordinary colds — the kind every parent recognises, a runny nose, a mild fever, a cough that keeps a toddler up at night — were given a few millilitres of a cough syrup called Coldrif. Within days, some of those same children stopped producing urine. Their kidneys had shut down.
By the time the pattern was recognised, traced, and stopped, at least 20 to 24 children under the age of five were dead. The medicine given to soothe a cold had been contaminated with diethylene glycol — an industrial solvent used in brake fluid and antifreeze, present in the implicated batch at a concentration close to 500 times the internationally accepted safety limit.
This is not a freak, one-off accident. It is the latest entry in a pattern of diethylene glycol poisoning that has repeated across the world for almost a century, driven by the same economic incentive every time: industrial-grade solvent is far cheaper than the pharmaceutical-grade version, and in places where testing is thin, nobody catches the substitution until children start dying.
What actually happened in Chhindwara
Coldrif was an ordinary-looking children's cold formulation — a combination of paracetamol, chlorpheniramine maleate, phenylephrine hydrochloride, and sodium citrate, manufactured by Sresan Pharmaceuticals, a small unit operating out of Kancheepuram district in Tamil Nadu. It was the kind of low-cost, widely stocked syrup that gets handed across a pharmacy counter or a government clinic desk without a second thought.
The problem was not the active ingredients. It was the liquid they were dissolved in. Every oral liquid medicine needs a solvent to carry the active drug — normally pharmaceutical-grade propylene glycol or glycerin, both safe when properly sourced and tested. In batch SR-13 of Coldrif, manufactured in May 2025, that solvent had been substituted, in whole or in part, with diethylene glycol — a chemical with no legitimate place in a medicine meant for a two-year-old.
The outbreak was not isolated to one product. Around the same time, the WHO alert also flagged two Gujarat-manufactured oral liquids — Respifresh TR from Rednex Pharmaceuticals and ReLife from Shape Pharma — that tested positive for diethylene glycol, though both were recalled before any confirmed deaths were linked to them. A separate, unrelated cluster of three child deaths in Rajasthan's Sikar and Bharatpur districts involved a different, dextromethorphan-based syrup from Kayson Pharma that did not test positive for diethylene glycol at all — a reminder that not every pediatric syrup death in this period had the same cause, even though public alarm treated them as one story.
A joint team from the National Centre for Disease Control, the National Institute of Virology, and the CDSCO initially tested ten retail samples of Coldrif from Chhindwara pharmacies and found diethylene glycol in only one. That led to an early, incorrect public statement that Coldrif was clean — directly contradicting state-level lab results. More thorough testing later confirmed uniform contamination across batch SR-13, but the contradictory early findings delayed a unified clinical warning by days that likely mattered.
How diethylene glycol actually kills
Diethylene glycol itself is not especially dangerous on its own — it is only moderately toxic in its original form. The lethality comes entirely from what the liver does to it after it is swallowed.
Once ingested, diethylene glycol is absorbed quickly and travels through the bloodstream to the liver, where an enzyme called alcohol dehydrogenase begins breaking it down. The first breakdown product is further oxidised into a compound called 2-hydroxyethoxyacetic acid, which itself is converted into the molecule that actually does the damage: diglycolic acid.
Diglycolic acid is the villain of this entire story. Structurally, it closely resembles succinate, a molecule the body's cells normally use as fuel inside their mitochondria — the tiny structures that generate a cell's energy. Because of this resemblance, the kidneys' proximal tubule cells actively transport diglycolic acid inside, mistaking it for something useful. Once inside, it does the opposite of what succinate would do: it jams a key enzyme in the mitochondrial energy chain, and the cell's ability to produce energy collapses.
Diglycolic acid does not poison the kidney the way a caustic chemical burns tissue. It tricks the kidney's own cells into absorbing it, then shuts down their power supply from the inside. That is why kidney failure from diethylene glycol develops over days rather than hours — it takes time for the toxic metabolite to build up and starve enough cells of energy to matter.
With their energy supply gone, kidney tubule cells flood with reactive oxygen species, their membranes break down, and they die in large numbers. The clinical result is severe, diffuse damage to the kidney's filtering tubules — acute kidney injury that, in a young child with little physiological reserve, can progress to complete kidney failure within days.
Why children pay a disproportionate price
Diethylene glycol poisoning is dangerous for anyone, but it is dramatically more lethal in young children, and the reason comes down to how immature their metabolism still is.
A newborn's liver expresses only a fraction of the alcohol dehydrogenase activity an adult's does, and this enzyme system does not fully mature until later childhood. Slower metabolism should, in theory, mean slower conversion into the toxic metabolite. But it works the other way around in practice: because a child's kidneys also filter and excrete the parent diethylene glycol far less efficiently than an adult's, the compound stays in circulation for longer, giving the body's secondary metabolic pathways more time to keep converting it into diglycolic acid.
The net effect is that children convert a substantially higher proportion of an ingested dose into the toxic metabolite than adults do. Combined with a lower physiological buffering capacity and a much higher risk of rapid dehydration, this is why the same weight-adjusted dose of contaminated syrup that might cause moderate illness in an adult can be fatal in a toddler within days.
The three-phase unraveling
Diethylene glycol poisoning follows a fairly predictable clinical pattern, and understanding it explains why so many cases in Chhindwara were caught too late.
Phase one — the phase that looks like nothing (0 to 24 hours)
In the first day, symptoms are non-specific: nausea, vomiting, abdominal pain, sometimes mild drowsiness or an unsteady gait, caused by diethylene glycol's ethanol-like effect on the nervous system. These symptoms are nearly indistinguishable from ordinary viral gastroenteritis — precisely the kind of illness a parent expects a cold-and-fever syrup to help with. This is the phase where the poisoning is most treatable, and it is also the phase almost nobody recognises as an emergency.
Phase two — the kidneys fail (24 to 96 hours)
As diglycolic acid accumulates, the child develops severe metabolic acidosis, rapid and laboured breathing as the body tries to compensate, and a steep decline in urine output that can progress to complete anuria — no urine production at all — within 72 hours. Dangerous electrolyte imbalances, including life-threatening high potassium levels, often follow.
Phase three — delayed neurological damage (beyond 96 hours)
In children who survive the acute kidney failure, a third phase can emerge roughly four days in: nerve damage causing facial paralysis or eye-movement problems, progressing in severe cases to seizures, worsening weakness, and coma. Children who survive this phase often carry lasting neurological and kidney damage for life.
The window where treatment works best — phase one — is exactly the window where the illness looks the least serious. By the time a child's symptoms are unambiguous enough to alarm a parent or a rural clinic, the kidneys are often already failing.
This has happened before — many times
Diethylene glycol poisoning from contaminated medicine is not a new phenomenon. It is closer to a century-old, recurring failure mode of the global pharmaceutical supply chain, and India has been at the centre of it more than once.
The first recorded incident was the 1937 Elixir Sulfanilamide disaster in the United States, which killed over a hundred people and directly led to the US Food, Drug, and Cosmetic Act of 1938 — the law that first required drugs to be proven safe before sale. Since then, near-identical outbreaks have struck Bombay in 1986, Nigeria in 1990, Bangladesh in 1990 to 1992, Haiti in 1995, Gurgaon in India again in 1998, Panama in 2006, and Nigeria again in 2008 to 2009 with a contaminated teething syrup. More recently, in 2022, diethylene glycol-contaminated cough syrups traced to Haryana-based Maiden Pharmaceuticals killed dozens of children in the Gambia, and syrups traced to Noida-based Marion Biotech killed children in Uzbekistan the same year.
The pattern across every one of these outbreaks is identical: when the price of pharmaceutical-grade solvent rises or supply gets disrupted, some manufacturer, somewhere, substitutes a cheaper industrial-grade equivalent — and in a regulatory system without the lab capacity to test every incoming drum of raw material, the substitution goes undetected until children start dying.
The doctor, the commission, and the family network
What makes the Chhindwara chapter of this story different from a straightforward manufacturing failure is what investigators found once they started asking who had been prescribing Coldrif, and why.
Dr. Praveen Soni, a senior government pediatrician at the Civil Hospital in Chhindwara's Parasia sub-division, was arrested on October 4, 2025, and charged with culpable homicide not amounting to murder. Investigators alleged he had been receiving a financial commission — reportedly around ₹2.50 per bottle — directly from Sresan Pharmaceuticals for prescribing Coldrif to patients at his private clinic.
The arrangement went further than a simple kickback. His relative reportedly served as the district's primary wholesale stockist for Coldrif. The retail pharmacy attached to his private hospital — the one that actually dispensed the contaminated syrup to families — was owned and run by his wife, Jyoti Soni, who was arrested a month later, on November 3, as a co-conspirator. A regional medical representative from Sresan Pharmaceuticals was detained around the same time.
A closed loop — the prescriber, the stockist, and the pharmacy — all sat inside one family, all financially tied to the same manufacturer whose product turned out to be lethal. That is not a manufacturing accident anymore. That is a commercial incentive structure that made a contaminated product harder to catch.
What happened to the company that made it
At the manufacturing end, regulatory and law enforcement action moved fast once the contamination was confirmed. On October 9, 2025, G. Ranganathan, the proprietor of Sresan Pharmaceuticals, was arrested at his residence in Chennai by a joint team from the Madhya Pradesh Special Investigation Team and local police, then transported to Madhya Pradesh to face prosecution.
Tamil Nadu's Directorate of Drugs Control sealed Sresan's manufacturing facility in Kancheepuram, shut its registered offices, and revoked its manufacturing licenses entirely. On October 13, the Enforcement Directorate conducted coordinated raids across seven locations tied to the company's financial network, and by December 3, it had formally attached ₹2.04 crore in Chennai-based assets belonging to Ranganathan under anti-money-laundering law — treating the profits from a contaminated batch as the proceeds of crime.
The treatment that could have saved them — and why it wasn't there
Diethylene glycol poisoning is, in principle, a treatable condition if it is caught early enough. The problem in Chhindwara was that "in principle" and "in a rural Madhya Pradesh clinic" turned out to be very different things.
The gold-standard antidote is fomepizole, a drug that binds to the same liver enzyme, alcohol dehydrogenase, roughly a thousand times more strongly than diethylene glycol does. Given early enough, it essentially blocks the entire toxic pathway — the parent compound never gets converted into diglycolic acid at all, and the body simply excretes it safely. Where fomepizole is unavailable, controlled intravenous ethanol can work the same way, though it is far harder to manage safely in small children. For diglycolic acid that has already formed, hemodialysis can clear it directly from the blood.
Confirming diethylene glycol poisoning requires gas chromatography-mass spectrometry — equipment that fewer than one in five district-level laboratories in high-risk regions actually have. Fomepizole itself is manufactured in India and is not especially expensive by global standards, but as an orphan antidote it is rarely stocked outside select tertiary hospitals. When Coldrif poisoning struck Chhindwara, local clinics had neither the diagnostic equipment nor the antidote nor ready access to pediatric dialysis — forcing doctors to fall back on oral ethanol and slow referrals to distant hospitals. Case fatality in settings without early fomepizole and dialysis has run above 70 percent, against under 30 percent where both are available within the first day.
Why India's drug regulation let this happen — again
The recurrence of diethylene glycol poisoning inside India is not really a story about one bad manufacturer. It is a story about a regulatory structure that keeps producing this exact failure.
Under the Drugs and Cosmetics Act of 1940, India runs a split-governance system. The Central Drugs Standard Control Organisation sets national standards, approves new drugs, and regulates imports — but the power to actually issue manufacturing licenses, inspect factories, and enforce Good Manufacturing Practice sits entirely with the individual drug control authorities of 28 states and 9 union territories. This is the same structural gap that the revised Schedule M was designed to close on the manufacturing-standards side — but licensing and enforcement authority itself remains fragmented.
That fragmentation creates enormous variation in enforcement quality from one state to another, and it opens the door to what regulators call license shopping — a manufacturer seeking approval in whichever state has the lightest oversight. It is compounded by a staffing crisis that rarely makes headlines: as of late 2024, more than 300 of the CDSCO's 504 sanctioned drug inspector posts — roughly 60 percent — sat vacant. A recruitment drive announced in September 2025 filled only 49 of them. With that few inspectors, meaningful proactive inspection of manufacturing plants is close to impossible; enforcement becomes reactive, arriving only after a contamination has already killed someone.
What reform would actually require
India's upcoming Drugs, Medical Devices and Cosmetics Act, 2025 is being positioned as an opportunity to centralise licensing authority and toughen penalties for manufacturing violations — but the specific gaps this case exposed are narrower and more fixable than a full legislative overhaul.
Mandatory gas chromatography-mass spectrometry testing for diethylene glycol on every incoming drum of excipient, rather than reliance on a paper certificate of analysis from a supplier, would have caught batch SR-13 before it ever reached a bottling line. QR-code or blockchain-based batch traceability would make it possible to pull a contaminated product from shelves in hours rather than weeks. And joint liability provisions — making a brand owner criminally responsible for what a contract manufacturer actually produces — would close the accountability gap that lets a company disappear into a loan-licensing arrangement when something goes wrong.
The Coldrif tragedy did not happen because the chemistry of diethylene glycol poisoning was a mystery — it has been documented since 1937. It happened because a cheap solvent substitution went untested, a prescriber had a financial reason not to ask questions, and a state regulatory system too understaffed to inspect proactively only found out after children were already dying. Excipient testing is not a bureaucratic formality — it is the only thing standing between a bottle of cough syrup and a bottle of poison. Every reform proposed after this case is really one idea repeated in different forms: verify what actually goes into the bottle, before it reaches a child.
What this means for you
If you are heading into quality assurance, regulatory affairs, or manufacturing, the Coldrif case is the clearest possible argument for why excipient verification is not a paperwork exercise — it is the single control point that stood between a bottle of cough syrup and a bottle of poison. A certificate of analysis from a supplier is a claim, not proof; the only way to know what is actually in a drum of solvent is to test it.
It is also worth sitting with the commercial layer of this story, not just the chemistry. A prescriber, a stockist, and a pharmacy sitting inside one family, all financially aligned with a single manufacturer, is exactly the kind of quiet conflict of interest that UCPMP 2024 was designed to prevent in the field-force relationship between reps and doctors — and it shows what happens when that kind of alignment goes unchecked at the local level instead.
And if you go into regulatory affairs or public health policy, understand that this exact failure — cheap solvent substitution, thin testing capacity, fragmented state-versus-central enforcement — has now repeated in India alone across 1937, 1986, 1998, and 2025, and internationally many more times beyond that. The chemistry of the problem was solved decades ago. What keeps failing is verification. That is the part of the system a career in this industry can actually change.
Quick answers
What is the Coldrif cough syrup tragedy?
In late 2025, a batch of Coldrif, a children's cough syrup manufactured by Sresan Pharmaceuticals in Tamil Nadu, was found contaminated with diethylene glycol, an industrial solvent toxic to the kidneys. Children in Chhindwara district, Madhya Pradesh, who took the syrup for ordinary colds developed acute kidney failure within days. More than 20 children under the age of five died.
How many children died from Coldrif cough syrup?
Official figures confirmed at least 20 to 24 child deaths in Madhya Pradesh linked to contaminated Coldrif syrup, almost all under the age of five. A separate but parallel incident in Rajasthan involving a different, dextromethorphan-based syrup from Kayson Pharma killed three more children, though that product did not test positive for diethylene glycol.
What caused the Coldrif cough syrup contamination?
Laboratory testing of batch SR-13 of Coldrif found diethylene glycol at a concentration nearly 500 times the internationally accepted safety limit. Diethylene glycol is a cheap industrial solvent that is sometimes substituted for pharmaceutical-grade propylene glycol or glycerin during manufacturing, usually to cut raw material costs.
Why is diethylene glycol dangerous in medicines?
Diethylene glycol itself is only moderately toxic, but the liver converts it into diglycolic acid, a metabolite that mimics a molecule the body's cells normally use for energy production. Diglycolic acid concentrates in kidney tubule cells and shuts down their mitochondria, causing the cells to die and the kidneys to fail. Children convert a higher proportion of the dose into this toxic metabolite than adults do, which is why pediatric mortality is so high.
Who was responsible for the Coldrif cough syrup deaths?
Sresan Pharmaceuticals manufactured the contaminated batch; its owner, G. Ranganathan, was arrested and the company's licenses were revoked. Separately, a government pediatrician in Chhindwara, Dr. Praveen Soni, was arrested for allegedly taking a per-bottle commission from Sresan to prescribe Coldrif, while his wife's pharmacy dispensed it and a relative acted as the local stockist.
Has diethylene glycol poisoning happened before?
Yes, repeatedly, going back to the 1937 Elixir Sulfanilamide disaster in the United States. Similar outbreaks have struck Bangladesh, Haiti, Nigeria, Panama, India itself in 1998, and, more recently, Gambia and Uzbekistan in 2022, both traced to Indian manufacturers. The pattern repeats because industrial-grade diethylene glycol is far cheaper than pharmaceutical-grade solvents, and testing gaps in lower-resource regulatory systems let contaminated batches through.
- Mora Vyshnavi. (2026). The Coldrif Cough Syrup Tragedy: A Review of Diethylene Glycol Contamination and Pediatric Safety Failures in India. World Journal of Pharmaceutical Sciences, 14(01).
- Manikandan, V., Aswini, B., Jalakandeswari, K., Mitha, P. M., Monika, G., & Uvasri, D. (2026). The Deadly Consequences of Contaminated Medicine: A Look into the Killer Cough Syrup Case. World, 5(1).
- Thakur, S., Mandha, M., & Sharma, S. Diethylene Glycol Toxicity in Children: Clinical Features, Mechanisms, and Global Outbreaks.
If this was useful, the next piece worth reading is on Ranbaxy and the FDA — a different kind of Indian pharma manufacturing failure, where the falsified data was in the lab rather than the raw material, but the same regulatory understaffing let it run for years.