The story begins with a child with a fever, a cough that would not go away, and a parent's simple, human hope: a bottle of syrup that would soothe, not harm. It is a sequence so ordinary that it happens millions of times daily across small towns and big cities in India. Yet, at the end of the line of that ordinary act there can be a catastrophe so swift and bewildering that it leaves whole families bereft, clinicians scrambling for answers, and regulators asking the same two terrible questions, how could this happen, and who will take responsibility? Over the last few years the world has watched, in fits and starts and with growing alarm, as pockets of such catastrophes were traced to the same hidden cause: paediatric cough syrups that contained industrial glycols - diethylene glycol and ethylene glycol poisons masquerading as innocuous excipients. In October 2025, another such horror unfolded in India, centred in Madhya Pradesh and rippling outward to reveal the old and uncomfortable truths about manufacturing gaps, supply-chain opacity, regulatory lapses, and a marketplace that can be cruel to the least powerful among us, children.
The immediate, heartbreaking facts must be stated plainly. From late August through early October 2025, clusters of acute kidney injury and unexplained paediatric deaths were reported in districts of Madhya Pradesh and some neighbouring states. Clinical and forensic investigations pointed to a common thread: children who had taken over-the-counter cough syrups and shortly after developed the rapid renal deterioration typical of toxic glycol poisoning. Samples taken from at least one implicated batch were reported to contain very high proportions of diethylene glycol, the same industrial solvent that has wrecked lives elsewhere in the world. Indian police opened criminal manslaughter investigations and federal regulators initiated risk-based inspections at manufacturing plants across several states as they attempted to trace distribution channels and remove suspect stock from shelves. Within days, the name of one product recurred in reports and hospital records: Coldrif, produced for the market by a manufacturer whose details drew investigators to a specific facility. The news coverage and preliminary official actions in the first weeks made unmistakably clear that this was not merely a medical puzzle but a legal and moral emergency.
To understand how this tragedy in 2025 fits into a larger, distressing pattern, one must go back through the most recent few years. The World Health Organisation issued urgent alerts in late 2022 and again in early 2023 after several countries, The Gambia, Uzbekistan, and Indonesia among them, reported clusters of acute kidney injury and child deaths linked to paediatric syrups that tested positive for ethylene glycol and diethylene glycol. Those alerts were not mere alarmism. They were the culmination of laboratory findings, hospital case series, and international inquiries that together painted a pattern: medicines intended for infants and young children sometimes contained impure glycerin or substitute solvents that were contaminated with toxic industrial glycols. These compounds are inexpensive, watery liquids used in industrial processes and as antifreeze; they are absolutely unsafe in medicines. The WHO’s call in January 2023 for “immediate and concerted action” was an attempt to close a fast-moving breach in the global medicine supply chain—an appeal to regulators, manufacturers, procurement agencies, and clinicians to treat paediatric syrups as an axis of vulnerability requiring urgent, coordinated attention.
When an explainable chain of causation exists between a medicine and child deaths, the public instinct is to ask who made it and why the market allowed it to reach a child’s hands. The Gambia episode in 2022 linked multiple deaths to a set of cough and cold syrup products sourced from an Indian manufacturer. The WHO, after laboratory confirmations in affected countries, issued product alerts naming specific products that should be removed from circulation. In those cases, Indian authorities responded with a mixture of inspections, suspensions, and court actions; yet controversy followed. There were allegations of sample tampering during testing, accusations about regulatory capture, and a longer story about how products made in one country could travel through trade channels to end up killing children in another. That tragedy forced a reckoning about the quality of excipients, the integrity of supply chains, and the effectiveness of surveillance systems designed to safeguard global medicine markets.
A different but related episode unfolded in Uzbekistan, which reported dozens of child deaths were linked to syrup products manufactured by another Indian company. The Uzbek courts, after their own investigations, convicted and sentenced several individuals for offences connected to the distribution and sale of substandard medicines. Indian authorities also launched probes, inspected manufacturing sites, and at times suspended production. But the legal, administrative, and scientific threads did not always move in lockstep; where foreign investigators found toxic contaminants, some domestic tests initially reported inconsistent results, and questions were raised about the integrity of laboratory sampling and the adequacy of local inspections. The episodic nature of enforcement sites closed and later permitted to resume operations under judicial orders exposed an awkward friction between the need for rapid public-protection action and the protections that due process affords to firms. The result, all too often, was uncertainty for grieving families and reputational damage to an industry that supplies essential medicines to much of the world.
Why do these poisons show up in medicines at all? The immediate chemical answer is blunt: diethylene glycol and ethylene glycol have properties that allow them to serve as inexpensive, water-miscible solvents. Glycerin and propylene glycol are the excipients typically used to give syrups their viscosity and palatable mouthfeel, but the global market for pharmaceutical-grade glycerin and propylene glycol is complex and fragmented, and cheaper substitutes or contaminated batches can enter supply chains. When quality control fails, either because a manufacturer buys substandard excipients, because adulterated raw materials are intentionally substituted, or because testing is inadequate or circumvented, he resulting medicine can contain lethal contaminants. The physiological mechanism by which these glycols destroy a child’s organs is well known: they are metabolised into acids and oxalates that devastate the kidneys, provoke metabolic acidosis, and cause multi-organ collapse. Children are particularly vulnerable because of their smaller body mass and developing organs; what might be a non-fatal dose for an adult can be catastrophic for an infant. Scientific reviews and clinical case series have laid out these toxicopathological pathways clearly, and yet the reality of contaminated batches appearing in diverse markets persists.
The specifics of factory inspections and what investigators have found differ by case, but a recurring motif emerges: evidence of deviations from good manufacturing practices, poor documentation, inadequate raw material controls, and unhygienic conditions. In past episodes, regulatory teams from central and state authorities visited offending sites and reported “serious breaches” that ranged from lax environmental controls to inconsistent analytical records. Some facilities were ordered to halt production while corrective actions were sought; in other instances, courts reinstated licences, either because the administrative process had been procedurally flawed or because the evidence presented did not meet the legal threshold the court required. Those judicial reversals created a difficult public narrative: the same firm that stood accused in one context could, months later, be allowed to resume manufacture because of statutory safeguards and legal process. That tension between the speed of public protection and the slowness of legal adjudication has been one of the grimmest features of these scandals, because it leaves regulators with uncomfortable trade-offs and families with little sense of closure.
Beyond the chemistry and the factory floor, there is the human economy that enables adulteration. Syrups are cheap to make, widely used, and, for manufacturers, they are high-turnover items. Profit margins are squeezed across generic pharmaceutical production, and in some market segments, the pressures to cut costs are real. Excipients that meet pharmaceutical-grade standards cost more; buying from opaque supply chains or intermediaries may appear to yield short-term savings. If a firm’s internal quality assurance is weak, if regulatory inspections are infrequent or perfunctory, and if distribution routes move products quickly across state and national borders with limited traceability, a dangerous product can travel far before anyone realises what has happened. Corruption and human failings complicate this picture: allegations in previous episodes that laboratory sample chains had been interfered with, or that officials might have been bribed to look the other way, have haunted parts of the public record. Whether the causation is deliberate substitution, inadvertent contamination, or supply-chain negligence, the result is the same—children exposed to lethal chemicals in medicines meant to heal them.
The government response in India to such tragedies has been a mixture of rapid emergency measures, longer-term investigations, and an occasionally halting regulatory reform process. When cases are first reported, health ministries and state drug controllers have issued advisories, ordered the seizure of suspect batches, instructed door-to-door surveys to find distributed stock, and sometimes suspended or cancelled licences. Central agencies have launched risk-based inspections, and the police have filed criminal cases. Yet critics point to patterns of delay, inconsistent testing results, and the limited deterrent effect of penalties when they are applied. In some cases, regulators have been accused of reacting only after foreign authorities issued warnings or after foreign courts reached findings, rather than pre-emptively enforcing the same standards domestically. This is a pointed and painful critique: India is a leading global supplier of generic medicines, and yet the enforcement that protects external markets is at times stronger than the one that protects its own children. The disparity between export standards and domestic enforcement, where samples destined for foreign buyers are stringently tested while large segments of the local market continue to operate under laxer scrutiny, has been repeatedly cited by public-health advocates. The consequence is a moral paradox: the medicines that travel abroad are often subject to the high bar buyers demand, while the medicines sold at home can, in practice, face lower barriers. That must change if the state’s primary duty is to protect its citizens, especially its most vulnerable.
Why, then, has the government not simply banned these syrups and punished the culprits with more decisiveness? The answer is complicated by practical, legal, and political limitations. A blanket ban on classes of medicines can create shortages and encourage black-market substitutes that may be even less safe. A punitive approach that is not accompanied by systemic reforms, clearer traceability, stronger supply-chain oversight, routine independent testing of excipients, well-resourced laboratory capacity, and transparent recall mechanisms may stall at the point of implementation. Moreover, administrative actions can be reviewed and overturned in courts if due process is not observed. The pharmaceutical industry is also a large employer and an economically significant sector; regulatory policy must balance public protection with the need to avoid unintentionally crippling legitimate manufacturers. All of this has been used, sometimes rightly and sometimes as an excuse, to justify a slower, case-by-case approach rather than radical prohibitions. But critics rightly note that incrementalism without real enforcement and effective penalties is inadequate where children have died. It is one thing to close a facility temporarily pending inspection; it is another to ensure that supply chains are re-engineered and that the criminal law is used where deliberate wrongdoing is proven.
The mystery behind illegal production and its stubborn persistence in the market is more social and systemic than mystical. Illicit or negligent practices flourish where incentives align for short-term gain and where the probability of detection and punishment is low. The ingredients that are most vulnerable to substitution excipients such as glycerin, move through multiple tiers of distribution and may be sourced internationally from chemical suppliers whose records are difficult to audit. A manufacturer seeking to reduce costs might buy through intermediaries rather than direct accredited suppliers. If a company’s in-house quality control is not robust, or if its analytical laboratories lack independence, contaminated batches can slip through. If regulators conduct inspections but these are limited in number, unpredictable, or focused on paperwork rather than thorough chemical verification, the detection function is blunted. Finally, if the post-market surveillance system's adverse event reporting by clinicians and cross-border information-sharing between regulatory authorities are weak, clusters of toxicity may not be identified until multiple tragedies have already occurred.
There is also the problem of market invisibility: many cough syrups are sold over the counter in small quantities through neighbourhood chemists, travel across informal trade routes, and are consumed in semi-urban and rural settings where clinical documentation is thin. When a child falls ill with acute kidney injury in a village, the clinical team may be too small to launch an epidemiological probe, and toxicology laboratories may not be equipped to test for glycols. Each delay compounds the tragedy. In other words, the structural conditions of demand, business incentives, weak surveillance, and fragmented regulatory enforcement create an environment in which contaminated products can be produced, distributed, and sold with alarming consequences.
Techniques to remedy this are known and feasible. They include tighter control of excipient supply chains, mandatory testing of batches of syrups for solvent contaminants before release to the market, random independent audits of manufacturing laboratories, and the enforcement of stronger penalties for willful negligence or fraud. Effective recall procedures need to be codified and rehearsed. The distribution chain must be more transparent, with batch-level traceability available to regulators. Independent external laboratories must be funded and made available as a check on in-house quality control. Importantly, regulatory laboratories must be beyond the reach of undue influence, with clear chains of custody for samples and a culture of professional independence that makes bribery or tampering harder. The WHO has urged such measures and provided technical guidance; nations that export and import pharmaceuticals alike have a stake in enforcing them.
But policy and regulation are only part of the story. There is a moral and human dimension that cannot be legislated away. A drugmaker, at its most humane, must accept that a product destined for a child carries an extra burden of responsibility. The rhetoric of corporate social responsibility cannot replace the scrupulous day-to-day practices of laboratory validation, supplier vetting, and ethical leadership. Families whose children died in past clusters have sued and sought accountability through courts and tribunals, and those legal battles are long, wrenching, and expensive. They cannot, by themselves, restore life. What they can do is produce public records that pin down responsibility and set precedents for stronger oversight. The state must use both the stick of criminal sanction and the carrot of capacity-building for smaller manufacturers who genuinely wish to comply but lack resources for sophisticated quality systems.
The international angle complicates responsibility but also offers pathways to improvement. The global medicine supply chain is porous; raw materials and finished products cross borders with considerable speed. The WHO’s product alerts function as a necessary early-warning system because a regulatory failure in one jurisdiction can have fatal consequences in another. But the WHO is an advisory body; effective prevention requires national regulators that are proactive and adequately resourced. Countries that import medicines must also exercise due diligence; procurement agencies should demand documentation of excipient provenance and independent batch testing for paediatric formulations. Buyers, especially those working in aid and humanitarian contexts, must be vigilant because contaminated syrups have a history of disproportionately affecting the most resource-poor health systems.
It also helps to consider the epidemiology of the tragedies. Contamination with diethylene glycol produces a fairly characteristic pattern. A child consumes a syrup and initially presents with non-specific gastrointestinal symptoms: vomiting, fever, and lethargy. Within a short period, urine output declines, and laboratory markers show metabolic acidosis and rising creatinine—signs of acute kidney injury. Unless the attending clinicians and public-health authorities link contaminated medicine quickly, an epidemic of such cases may be mislabelled as viral or environmental. This is one reason why clinician education about the possibility of chemical toxins in paediatric medicines is so important. In several past episodes, clinicians on the ground were the ones who first noticed the clustering and sounded the alarm; empowering them to report and enabling their reports to be rapidly investigated is an essential public-health function.
Part of the blame for these tragedies must also be laid at the feet of complacency. For decades, antibiotics, antipyretics, and cough syrups have been produced at massive scales and sold cheaply across India and abroad. The combination of scale and the globalisation of raw material sourcing means that a single contaminated drum of an excipient can contaminate many thousands of finished bottles. When regulators do not insist on batch-wise analytical confirmation from accredited laboratories, or when suppliers are allowed to self-certify without external checks, the safety net is compromised. There are strong economic arguments to be made for investing in robust quality infrastructure, not only because it prevents death and disability but because reputational costs of scandal can cause long-term damage to firms and national industries. Yet the up-front costs of building that infrastructure deter some manufacturers, and the business models of others remain predatory.
There is also a more delicate question about the cultural framing of medicines and risk. In many parts of India, medicines are not treated as the domain of regulated transactions between prescribers and state-licensed pharmacies; they are commodities sold informally in small shops, passed around as home remedies, or administered by well-meaning relatives. The impulse to give a child a syrup for a cough is often immediate and comforting. Changing those deeply embedded health behaviours requires patient, community-level education: not panic, but a better-informed public that understands when to seek medical help and when to question the provenance of a medicine. Public advisories that simply tell parents to stop giving syrups without explaining alternatives or without ensuring that safe products are available risk unintended harm. A single-policy approach, ban or warn, will fail unless it is accompanied by efforts to improve access to safe alternatives and to retrain the healthcare workforce in recognising toxin syndromes.
There are also practical, current steps that can be taken immediately to reduce risk. Regulators can implement mandatory independent testing of every batch of paediatric syrup before release, especially where the product is destined for paediatric use. This testing should be done by labs that are accredited and external to the manufacturer. Regulators can enforce traceability systems so that any suspect batch can be rapidly located in warehouses and retail shops. Enforcement should be prompt and transparent: when a batch fails, the recall and communication must be rapid and visible. Penalties must be substantial enough to create deterrence. Inspections should include unannounced visits and a focus on the quality of raw materials and of in-house laboratories. The chain of custody for samples taken for testing must be documented and protected against tampering, with CCTV, independent witnesses, and digital logging of sample movements. In short, regulators must make it harder to hide dangerous practices and easier to find and punish them.
This may sound technocratic, and indeed, much of the problem is technical. But there is an ethical substrate to the solutions: those who manufacture medicines for children must be held to a higher standard, and the state must be unequivocal about protecting minors. A regulatory culture that treats children’s medicines as a second-class problem because they are often cheap, rather than as an urgent public good, is a moral failure. Parents and clinicians must be able to assume that a medicine labelled for infants meets the highest standards for purity and safety. If a child dies from a contaminated syrup, that is a preventable death, and prevention is the obligation of both industry and the state.
Looking back at the most recent episodes - Gambia, Uzbekistan, Indonesia, and now the 2025 clusters in Madhya Pradesh, one sees a common refrain: these tragedies are not inexplicable anomalies. They are the outcome of identifiable failures, many of which are fixable. What remains stubbornly difficult is the combination of legal, economic, and governance incentives that have allowed substandard products to persist. Where judicial review is robust and civil liberties are protected, firms may successfully contest administrative actions; where global supply chains are opaque, contaminated inputs can slip through. The technical fixes, stronger testing, better laboratories, batch traceability, and tougher penalties are necessary but insufficient unless the political will exists to implement them rapidly and transparently. That will, in turn, depend on public pressure, media scrutiny, and an independent civil society that refuses to let such tragedies fade into the background.
The victims of these episodes are not statistics. They are infants whose lives were short, and families are left with the incomprehensible calculus of grief. Their stories, mothers who dressed a child for a routine clinic visit, fathers who bought an over-the-counter syrup at a trusted store, must remain central to the policy discourse. A paternalistic approach that argues the solution is only technical will be incomplete; the outrage of citizens is a necessary engine for change. Communities must demand clear, enforceable standards and the rapid recall of suspect medicines. They must insist on transparent reporting of inspection findings and on public disclosure of supply-chain provenance for products intended for children.
There are signs of change. International organisations have sharpened their alerts and technical recommendations; national agencies have, in response to scandals, expanded inspection regimes and risk-based sampling. Judicial systems in affected countries have pursued culpability in select cases, and some manufacturers have been suspended, fined, or compelled to improve practices. But the progress is incremental, and the stakes are high. The fundamental question is whether a major pharmaceutical-producing nation will decide that the same standards applied to exported medicines must, without exception, be applied to products sold domestically to Indian children. Until that choice is made and enforced, the possibility of repetition will remain.
The last image to leave the mind is small and unmistakable: a child’s hand wrapped around a medicine bottle, a caregiver watching for improvement, an implicit trust placed in the entire machinery of production and public protection. That trust must be honoured. Scientific vigilance, uncompromising regulatory enforcement, and a moral commitment to place the welfare of children above the vagaries of market calculus are not optional luxuries; they are essential obligations. If anything good is to come from the sorrow and anger these tragedies cause, it must be a more resilient system, one that makes it harder to poison a child and easier to punish those who would put profit before life. The time for such a system is now, because every day of delay is another day a child is at risk.
The road ahead requires concrete action on many fronts at once. Public-health authorities must expand active surveillance for acute kidney injury in children and improve the speed and scope of toxicological investigations. Regulatory agencies must mandate independent, accredited testing of excipients and finished paediatric syrups, strengthen documentation of supply chains, and publish inspection reports so the public can see whether enforcement is substantive or symbolic. Courts and prosecutors must be prepared to pursue cases of willful wrongdoing, with penalties that reflect the gravity of the harm. Industry must accept and finance the upgrades needed to make manufacturing and analytical systems robust. Civil society and the media must maintain scrutiny and refuse to let the story be consigned to the archive of tragedy. Above all, clinicians must be trained to suspect contaminated medicines early and to report clusters without fear. Only a combination of technical reform, legal accountability, economic incentives for compliance, and public outrage will create the conditions in which a parent can once again hand a syrup bottle to a coughing child and trust that it is medicine in the truest sense: a means to mend.
The history of contaminated cough syrups is a cautionary tale about globalisation, governance, and moral responsibility. It tells us that when regulatory attention is scattered and enforcement is uneven, vulnerable populations pay the price. It also tells us that the knowledge to stop these tragedies exists. Chemistry, epidemiology, law, and supply-chain management together can close the doors that allow industrial glycols to enter medicines. The remaining ingredient is the political will to do so. Until that will is marshalled and acted upon decisively, a small child in a little town may continue to be the last person to trust—in a bottle that promises comfort but contains danger.
If there is a single, stubborn lesson to be drawn from the long and painful sequence of events spanning multiple countries and years, it is this: medicines bought for children demand the highest standards of proof of safety. Anything less is a risk no society can ethically accept.