In the sweltering heat of central India, a parent’s worst nightmare has unfolded with alarming speed. What began as routine prescriptions for toddlers’ coughs has spiralled into a national health scandal, as cough syrup consumption has been linked to a surge of acute kidney injuries and child deaths across Madhya Pradesh and neighbouring states. By 6 October 2025, official reports confirmed 14 fatalities in Madhya Pradesh and 2 in Rajasthan, with dozens more children affected. In response, several states have imposed emergency bans and conducted drug seizures while investigators work to trace the source of contamination. At the centre of the crisis lies Coldrif, a paediatric syrup manufactured by Sresan Pharma (Tamil Nadu), with the implicated batch SR-13 (May 2025) found by state laboratories to contain dangerously high levels of Diethylene Glycol (DEG) — a toxic solvent with a deadly history in Indian pharmaceuticals.
A Wave of Unexplained Losses
In Madhya Pradesh, previously healthy infants and toddlers began presenting with vomiting, lethargy, reduced urine output and acute kidney injury (AKI). Within weeks, clusters of similarly afflicted children – often siblings or neighbours who had consumed the same syrup – were admitted to hospitals. By early October, 14 children had died and many others remained hospitalised. Rajasthan suspended the distribution of Kayson Pharma-supplied medicines and took action against its drug controller, after 2-4 deaths reported in Jodhpur.
The Union Health Ministry convened an emergency meeting, mobilising drug controllers and state agencies. A Special Investigation Team (SIT) and criminal inquiries were launched. Among those detained was Dr Praveen Soni, a government physician in Chhindwara, accused of prescribing lapses. The medical fraternity, however, decried this as misdirected accountability. As Dr Abrar, a paediatrician from Alwar, noted: “A doctor can only prescribe medicine in correct doses according to the patient’s illness. Whether a medicine is genuine or not depends on the manufacturer and the licensing authority. How can a doctor be responsible for the contents inside a bottle or tablet? Doctors neither make these formulations nor issue licences. While the death of children is tragic and irreparable, arresting a doctor seems unjust – he appears to be a scapegoat.”
The tragedy highlights not only the human cost of regulatory failure but the systemic tendency to shift blame downward rather than tackle malpractice at source.
Post-mortem and biopsy findings pointed to toxic kidney injury: shrunken kidneys and oxalate-type crystals in several cases. Samples from the Coldrif batch SR-13 were sent to drug analysis labs in Tamil Nadu and Chennai. Initial results showed 48.6% DEG, a lethal concentration, while confirmatory tests are ongoing. Variations in early results prompt authorities to treat findings as provisional pending forensic and judicial review.
Marketed Remedy, Hidden Poison
Coldrif was marketed as a paediatric cough syrup for relieving upper respiratory symptoms. According to its label, its active ingredients include Chlorpheniramine Maleate (1 mg), Paracetamol (125 mg), Phenylephrine (5 mg), and Sodium Citrate. Normally, such syrups use propylene glycol as a safe solvent; in batch SR-13, authorities found 48.6% diethylene glycol (DEG), which is wholly incompatible with human use.
DEG’s danger lies in its being colourless, odourless, and miscible with pharmaceutical ingredients. Substituted for propylene glycol (often for cost-cutting), it can bypass routine sensory checks yet cause fatal poisoning. In children, DEG metabolises into oxalic acid, which crystallises in the kidneys as calcium oxalate, causing severe oxalate nephropathy, tubular necrosis and acute kidney failure – precisely the mechanism clinicians found in these cases.
Sresan Pharmaceutical Under Siege
In probes and press reports, Sresan Pharmaceuticals (Kanchipuram area) is named as the manufacturer of Coldrif batch SR-13 (manufactured May 2025, expiry April 2027). Tamil Nadu’s drug control wing inspected the facility and lifted multiple samples for urgency. Both state and central regulators – including the Central Drugs Standard Control Organisation (CDSCO) – have launched risk-based inspections across several states and coordinated laboratory assessment. Several states (Madhya Pradesh, Maharashtra, Kerala, Uttar Pradesh and others) have banned or suspended the sale of Coldrif, ordered seizures, and detained stocks. National consumer and human rights bodies have issued notices to authorities demanding an explanation and remedial action.
Early FIRs and criminal filings name the manufacturer and its directors under provisions of the Drugs & Cosmetics Act and penal statutes. Press reports suggest company directors have been summoned, records placed under scrutiny, and licence-level action is under consideration, though details of formal arrests and charges remain under investigation.
Prescription Practices, Supply Chains and The Role of Clinics
The route by which the syrup reached children is now a sombre pattern: a trusted local clinician prescribed and dispensed it for coughs or fevers, and parents administered it at home. Official accounts suggest that in Chhindwara, a single physician repeatedly supplied Coldrif to multiple children in a short span; he has since been detained for alleged negligent prescribing. Meanwhile, investigators trace the batch’s passage through wholesalers, distributors, private chemists and some government supply lines – exposing distributor oversight gaps and flawed procurement checks.
Supply-chain lapses and over-the-counter availability of paediatric syrups have long been red flags. The present episode has triggered directives to pharmacists to suspend sales of these syrups without valid prescriptions and surrender suspect stocks. Several state controllers have begun door-to-door inspections of pharmacies.
Clinical Picture and Prognosis
Clinically, DEG poisoning presents initially with gastrointestinal symptoms – nausea, vomiting, abdominal pain – easily mistaken for viral illness. Within 48-72 hours, progressive kidney failure and central nervous system signs (lethargy, seizures, encephalopathy) emerge. Histology typically shows oxalate nephropathy with tubular necrosis. Mortality is extremely high in settings without timely dialysis; aggressive supportive care, including haemodialysis, can improve survival, although that is often logistically challenging in rural areas.
Historical and Global Context
This is not an isolated tragedy. WHO and other agencies have documented multiple episodes of DEG or diethylene glycol contamination in paediatric medicines, causing fatal outbreaks – notably The Gambia (2022, about 70 deaths), Indonesia, and others in 2022-23 – as well as earlier incidents across decades. WHO has issued medical product alerts and urgent calls to strengthen the detection of substandard/falsified medicines. The 2022-23 wave alone caused hundreds of child deaths globally, intensifying scrutiny of excipient sourcing and audits.
Historically, the 1937 Elixir Sulfanilamide disaster (over 100 deaths) led to the 1938 Food, Drug, and Cosmetic Act in the U.S., which formalised pre-market safety oversight. Together, these episodes underscore that India’s present crisis is part of a recurring, preventable pattern – catastrophes occur when quality control and regulatory vigilance collapse.
Policy Responses Under Way
Authorities have begun urgent action. The Madhya Pradesh government has announced ₹4 lakh ex-gratia assistance to bereaved families, while state drug controllers have banned the implicated batch and ordered stock seizures. The Central Drugs Standard Control Organisation (CDSCO) has launched nationwide inspections and called for expedited testing of both drug samples and victims’ biological specimens. The National Human Rights Commission has issued notices to state and central agencies seeking explanations and remedial steps.
Several states have restricted paediatric cough syrup sales to prescription-only, and pharmacy associations have been advised to avoid certain combination medicines for young children until further clarity. Internationally, the WHO has reiterated that cough and cold medicines offer little or no benefit to children under five and can be harmful, urging tighter global surveillance of substandard and falsified products.
The Regulatory Gap
Preliminary investigations point to systemic failure: substitution of excipients (cheaper DEG replacing propylene glycol), weak in-house quality control, falsified laboratory records, poor distributor supervision, limited market surveillance, and underfunded testing labs. Experts also emphasise irrational prescribing of combination syrups for mild viral illnesses and a retail culture in which medicines are dispensed with minimal professional oversight.
Public-health experts call for comprehensive reform: mandatory random batch testing for excipient purity; stronger oversight of excipient supply chains; risk-based factory inspections; rapid forensic testing protocols; clearer prescribing guidelines; restrictions or bans for children under two; and greater investment in rural critical-care capacity, including paediatric dialysis. The CDSCO has pledged intensification of inspections and coordinated action with state regulators to strengthen surveillance and accountability.
Banning Paediatric Cough Syrups for The Very Young
Medical evidence shows most over-the-counter cough and cold syrups yield little or no benefit in children under two, while carrying risks of sedation or overdose even when not adulterated. Both WHO and national regulators advise against routine use of antitussives or combination cold remedies in infants and toddlers, favouring supportive care – hydration, nasal saline, fever control, and medical review.
Given repeated contamination episodes and limited therapeutic value in young infants, clinicians and child-health advocates are urging stricter restrictions – even a ban on certain paediatric formulations for under-twos. They stress that any such policy must be coupled with public education and better access to safe, evidence-based alternatives.
Families’ Grief and the Demand for Accountability
The human cost is irreparable. In Chhindwara, parents recount the same unbearable trajectory: a mild cough, a trusted prescription, and a precipitous slide into acute kidney failure and death. Meagre state compensation – however welcome – cannot substitute a child lost. Families are pursuing civil and criminal actions, even as investigations progress. Civil society groups, paediatricians and rights organisations demand rapid publication of forensic findings, full disclosure of distribution chains, prosecution of culpable parties, and fair compensation for both bereaved families and survivors needing long-term care.
Will This Scandal Catalyse Lasting Change?
India produces a substantial share of the world’s generics and hosts many reputable manufacturers. Yet the recurrence of DEG contamination episodes – from earlier domestic tragedies to the 2022-23 global export-linked wave – shows that scale alone cannot guarantee safety. This crisis lays bare persistent weaknesses in excipient sourcing, manufacturing oversight and market surveillance. Immediate responses – bans, seizures, inspections, arrests, compensations – are necessary. But without deeper systemic reform, this may recur as yet another avoidable tragedy, rather than a turning point.
Our children deserve medicines that heal, not harm. The current investigations must be swift, precise and transparent; regulators must publish dated lab reports, audit logs, and enforcement actions. Clinical services must be adequately resourced for survivors. Only disciplined institutional learning, backed by political will, can prevent such grief from repeating.