2 more looses battle to death, toll reaches to 23 due to toxic cough syrup

Nagpur/Chhindwara, October 2025 – A tragic wave of pediatric deaths linked to contaminated cough syrup has raised urgent concerns about pharmaceutical safety and regulation in India. In a matter of just 45 days, the death toll from Coldrif cough syrup—a product manufactured by Tamil Nadu-based Sresan Pharmaceuticals—has escalated to 23, with children from Madhya Pradesh succumbing to acute kidney failure and severe brain damage, sparking outrage among families, healthcare professionals, and public health authorities.​

The Outbreak: What Happened?

Between mid-August and early October 2025, clusters of unexplained pediatric illnesses and deaths emerged in Madhya Pradesh, concentrated particularly in Chhindwara district. Most victims were under five years of age and reportedly presented with symptoms of vomiting, abdominal pain, lethargy, and quickly progressing renal failure. On investigation, the common factor was administration of Coldrif cough syrup, prescribed by local physicians and dispensed at district pharmacies.visionias​

Subsequent laboratory testing revealed a hazardous level of diethylene glycol (DEG)—an industrial chemical commonly used in brake fluids and antifreeze—present at 48.6%, nearly 500 times the permissible limit of 0.1% in oral medicinal preparations. DEG has no role in human medicine and is highly toxic; ingestion can cause kidney failure, neurologic complications, and rapid death, especially in children.timesofindia.indiatimes+3​

Regulatory and Criminal Response

Authorities wasted no time initiating public health alerts and criminal investigations. The Madhya Pradesh Chief Minister Mohan Yadav met grieving families and healthcare staff at government hospitals in Nagpur and AIIMS, promising to “bring to justice the accused who killed the kids.” Efforts included:

• Immediate ban and recall of Coldrif syrup across multiple states, with police seizing hundreds of bottles from affected districts.​

• Arrest of Sresan Pharma’s owner and the doctor who prescribed the syrup, facing charges including homicide, drug adulteration, and violations of the Drugs and Cosmetics Act.​

• Permanent revocation of Sresan Pharma’s manufacturing license following further inspections and safety lapses.​

• Suspension and disciplinary action against local drug controllers cited for negligence .

The World Health Organization (WHO) has requested clarification from the Indian government on whether contaminated batches were exported and is assessing the need for a Global Medical Products Alert.​

Mechanism of DEG Toxicity: Why Is It So Dangerous?

Diethylene glycol, when ingested, is metabolized in the liver to toxic compounds such as oxalic acid. These compounds form sharp crystals that deposit in kidney tubules, causing acute and irreversible kidney failure. Other organs, particularly the brain and peripheral nerves, can also be affected, leading to coma, seizures, and multiorgan dysfunction.​

Symptoms may be delayed, making early recognition and intervention challenging. In Coldrif’s case, children fell rapidly ill and required advanced therapies such as continuous renal replacement therapy (CRRT), which is expensive and not widely available .

Statistical and Contextual Perspective

The Coldrif tragedy is not an isolated event. Contaminated cough syrups recurrently cause child fatalities in India. In 2022–2023, similar incidents across Kerala, MP, and Tamil Nadu claimed the lives of 66 children; internationally, over 300 children died from DEG and ethylene glycol poisoning in The Gambia, Uzbekistan, and Indonesia, prompting WHO global alerts.​

Key statistics:

• 23 deaths in 45 days (Coldrif, Madhya Pradesh 2025).​

• Laboratory confirmation: 48.6% DEG detected (safe limit < 0.1%).​

• Over 1,500 bottles seized in affected districts .

Expert Perspectives

Dr. Manish Tiwari, Head of Pediatrics at GMCH Nagpur, stated, “We tried our best but couldn’t save them. The aggressiveness of kidney and neurological damage caused by DEG is devastating—even prompt renal replacement may not reverse the process in young children”.​

Peer-reviewed literature highlights that DEG and ethylene glycol have no safe therapeutic application in humans, and their substitution or contamination in medicinal products often follows cost-cutting or regulatory failure. Propylene glycol, a pharmaceutical-grade solvent, is the recommended safe alternative in cough syrups.​

Independent toxicology experts not involved in the current investigation emphasize the “urgent necessity of trace analysis and independent batch testing for excipients—especially glycerin and propylene glycol—used in all pediatric syrups”.​

Implications for Public Health

The crisis underscores major flaws in India’s drug safety regulatory system:

• Fragmented oversight allows small manufacturers to substitute industrial-grade chemicals for pharmaceutical excipients to cut costs, often escaping detection until mass casualties occur.​

• Licensing and inspection protocols must become more stringent, with central coordination and frequent random batch testing.​

• Pharmacies, physicians, and parents must remain vigilant and report any adverse drug reactions swiftly.

For the general public:

• Always verify batch numbers and manufacturer safety alerts; never purchase or administer medicines with unclear labeling or origin.​

• Consult healthcare professionals and rely on brands with transparent supply chains and established reputations.

• Recognize early symptoms of suspected drug poisoning (vomiting, abdominal pain, lethargy, decreased urine output) and seek immediate medical help.

Limitations and Counterarguments

While the investigation implicates Sresan Pharmaceuticals and local regulatory lapses, systemic factors—such as poverty, limited health literacy, and poor access to high-quality healthcare—exacerbate community vulnerability. Counterviews caution against blanket condemnation of the entire pharmaceutical sector, emphasizing that most Indian drug producers follow international standards and supply safe, cost-effective medicines worldwide.​

However, recent events make clear that regulatory reform and robust pharmacovigilance are critical to prevent future tragedies.​

Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.

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