Medicine as Poison”: Discovery of Contaminants in Cough Syrup Linked to Child Deaths

“Medicine as Poison”: Discovery of Contaminants in Cough Syrup Linked to Child Deaths

Introduction

In a shocking and tragic development, authorities in India have discovered that a popular cough syrup—Coldrif, produced by Sresan Pharmaceuticals—was contaminated with diethylene glycol (DEG), a toxic industrial solvent. The contamination has been linked to the acute kidney failure and subsequent deaths of children in Madhya Pradesh and Rajasthan. The incident raises serious questions about pharmaceutical oversight, regulatory enforcement, and the safety of pediatric medications.

The Emergence of a Crisis

Over recent weeks, hospitals in Madhya Pradesh’s Chhindwara district began admitting children with symptoms including vomiting, reduced urine output, and signs of acute kidney injury. Despite treatment, a number of children succumbed to renal collapse. News reports point to at least 14 child deaths in Madhya Pradesh alone as of early October 2025. The Times of India+3The Times of India+3The Times of India+3

The common thread among many of the cases was that the children had been treated for common illness symptoms—cough, cold, fever—and had been given Coldrif cough syrup. The scale and pattern of the deaths prompted investigations by local and central authorities.

Discovery of the Contaminant

After intense scrutiny, a laboratory test conducted by the Tamil Nadu Food and Drugs Administration (TN FDA) revealed that a sample of Coldrif syrup (batch SR‑13, manufactured May 2025, expiry April 2027) contained diethylene glycol (DEG) at levels well beyond permissible limits. ETPharma.com+4Business Standard+4mint+4

In one of the test reports, the DEG content was alarmingly high—48.6% w/v—leading to a declaration that the sample was “adulterated and injurious to health.” The Times of India A corroborating analysis from the Bhopal Drug Testing Laboratory found DEG at 46.28% in the same batch. The Times of India

DEG is a clear, colorless chemical commonly used in industrial applications (such as antifreeze, solvents, and brake fluid). Its ingestion can cause severe kidney, liver, and neurological damage—especially dangerous in children. 

Conflicting Claims & Ongoing Investigations

While the discovery of DEG in the TN FDA–tested sample seems conclusive, the picture is still murky. Some authorities, including the Union Health Ministry and the Central Drugs Standard Control Organisation (CDSCO), initially stated that multiple other samples they tested did not detect DEG or ethylene glycol (EG). ETPharma.com+5India Today+5The Financial Express+5

The government maintains that only one sample so far has been confirmed to contain the contaminant, while many others remain within acceptable quality standards. ETPharma.com+3Business Standard+3ETPharma.com+3

In response, the CDSCO has launched risk‑based inspections of pharmaceutical manufacturing facilities across six states, focusing on 19 drug samples (including Coldrif) to detect process failures or lapses in quality control. ETPharma.com+2ETPharma.com+2 An expert multi-disciplinary team—comprising officials from the Indian Council of Medical Research (ICMR), National Institute of Virology (NIV), AIIMS, and other institutions—has been tasked with evaluating all possible causative factors, including environmental sources, water contamination, and other toxins. 

The Toll: Children as Victims

The victims of this tragedy have been infants and toddlers—typically under the age of five—who were given the syrup during what were otherwise common respiratory illnesses. After initial mild symptoms like fever and cough, many children progressed rapidly to serious conditions marked by low urine output, elevated blood urea and creatinine levels, and fatal renal failure. 

Families recounted horror stories: children started vomiting, then stopped passing urine, and despite being transferred to larger hospitals (often across state lines), many could not be saved. www.ndtv.com+1 In one case, a kidney biopsy from a child revealed acute tubular injury and presence of DEG in renal tissue. The Times of India

Authorities have already arrested those involved in prescribing or distributing the tainted syrup. A government doctor was arrested in Madhya Pradesh, and a Special Investigation Team (SIT) has been formed to identify culpable parties within the manufacturing, regulatory, and distributing chain. 

Regulatory Lapses and Systemic Failures

This tragedy is not isolated. Globally, there have been previous episodes where cough syrups contaminated with DEG or EG have led to mass poisonings and child deaths—most notably in The Gambia, Uzbekistan, and Indonesia. Al Jazeera+2mint+2 In fact, the World Health Organization has repeatedly flagged the dangers of DEG in pharmaceutical products. Al Jazeera

India’s pharmaceutical industry, despite being among the world’s largest, has often faced criticism for erratic enforcement of quality standards and the prevalence of small-scale manufacturers with limited oversight. mint+3ETPharma.com+3Business Standard+3 In this instance:

• Substandard raw materials or substitution of propylene glycol with DEG may have occurred. mint+2Business Standard+2
• Internal process controls and validation steps may have been bypassed or inadequately monitored.
• Post‑market surveillance and batch recall mechanisms appear delayed or insufficient.
• Coordination between central and state drug regulatory bodies has been disjointed, leading to delays and contradictory statements. India Today+1

One recent commentary argued that the system tends to scapegoat local doctors while shielding regulatory agencies and manufacturers from accountability—a pattern that may repeat here unless higher accountability is enforced. 

Immediate Response: Bans, Testing, and Advisories

Reacting swiftly, multiple states have banned the sale, distribution, and use of Coldrif syrup, especially the implicated batch(s). Maharashtra, Madhya Pradesh, Tamil Nadu, and Kerala have all issued bans or withdrawals in their jurisdictions. The Times of India+4The Times of India+4The Times of India+4 The Uttar Pradesh Food Safety & Drug Administration (FSDA) has also called for statewide collection and testing of cough syrups, with orders to seize contaminated stock. The Times of India

The Health Ministry has confirmed the presence of DEG in samples beyond permissible limits and called for rational use of cough syrups in children (particularly under age two). The Times of India+5The Economic Times+5The Times of India+5 Some states have also prohibited sale of cough syrup without prescription and issued stricter guidelines for pharmacists. The Times of India

The CDSCO’s inspections aim to uncover process lapses across manufacturing units in six states. ETPharma.com+1 At the same time, a central advisory has emphasized that many coughs in children are self-limiting and do not require pharmacological treatment. 

Broader Implications & Lessons

This case lays bare deep vulnerabilities in drug safety frameworks:

1. Raw material sourcing and validation — ensuring pharmaceutical‑grade components, not cheaper industrial substitutes.
2. Process oversight and batch testing — especially in small-scale facilities where cost pressures may tempt cutting corners.
3. Strong post-market surveillance and rapid recall protocols — critical when medicines are used on vulnerable populations like children.
4. Inter-agency coordination and transparency — conflicting statements between central and state regulators undermine public trust and delay action.
5. Legal accountability and deterrence — punishing negligent actors along the chain, not only frontline prescribers.

The tragedy underscores that medicines meant to heal can kill when safety is compromised—but the cost is borne by the most innocent and defenseless. Strong regulatory reform, rigorous enforcement, and systemic vigilance are now non-negotiable.