The Centre has said cough syrups linked to child deaths in Madhya Pradesh and Rajasthan showed no DEG or EG contamination, but Tamil Nadu detected diethylene glycol in one Coldrif batch and halted production, highlighting gaps in drug safety oversight.
The News
The Union Health Ministry on Friday said laboratory tests had ruled out contamination in cough syrups linked to the deaths of children in Madhya Pradesh and Rajasthan, stating that none of the samples contained diethylene glycol (DEG) or ethylene glycol (EG) — toxic chemicals known to cause acute kidney injury and death.
However, in a conflicting finding, the Tamil Nadu Drugs Control Department said a government laboratory analysis of Coldrif syrup had detected diethylene glycol adulteration in one batch and ordered an immediate halt to production.
“The batch SR-13 (May 2025–April 2027), manufactured by Sresan Pharmaceuticals in Kancheepuram district, was found adulterated with DEG and declared not of standard quality,” said S. Gurubharathi, Deputy Director, Drugs Control, Tamil Nadu.
The State also issued a show-cause notice to the manufacturer and launched a wider quality review of other formulations produced at the facility.
Background of the Incident
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In Madhya Pradesh, nine children died after consuming Coldrif syrup; in Rajasthan, two deaths were linked to a dextromethorphan-based syrup.
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Central and state drug regulators, along with experts from the National Institute of Virology (NIV) and National Centre for Disease Control (NCDC), collected syrup and patient samples.
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Tests found no DEG or EG in the samples from Madhya Pradesh or Rajasthan. One child in MP tested positive for leptospirosis, suggesting an unrelated cause.
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The Rajasthan government clarified that the syrup was not prescribed by government doctors, and children had consumed it without medical advice.
Centre’s Advisory
The Health Ministry issued an advisory urging that cough syrups for children be used only under medical prescription.
“Cough in children is often self-limiting; over-the-counter syrups can be harmful, particularly for those under two years,” the advisory stated.
The Tamil Nadu Finding
While national agencies ruled out contamination, Tamil Nadu’s Government Drugs Testing Laboratory found DEG in the same Coldrif batch.
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Production has been suspended pending further tests.
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The State regulator has informed the Central Drugs Standard Control Organisation (CDSCO) and asked for a recall of affected batches across India.
Officials said the discrepancy between central and state findings may arise from sample variation or laboratory methodology, and confirmatory re-testing is under way.
Scientific Focus: Diethylene Glycol and Ethylene Glycol
What Are DEG and EG?
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Diethylene glycol (DEG) and Ethylene glycol (EG) are industrial solvents used in manufacturing antifreeze, resins, and plasticisers.
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Both are colorless, odorless, sweet-tasting liquids — which makes accidental ingestion more likely when substituted for pharmaceutical-grade solvents like propylene glycol or glycerin.
Toxicity and Health Impact
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DEG and EG are highly nephrotoxic (kidney-damaging) substances.
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Once ingested, they metabolize to glycolic acid and oxalic acid, which damage the renal tubules and central nervous system.
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Symptoms include nausea, vomiting, lethargy, seizures, and acute kidney failure, often leading to death.
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Even small quantities can be lethal in children.
Why Contamination Happens
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In drug manufacturing, propylene glycol or glycerin is used as a solvent in syrups.
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Contamination occurs when non-pharmaceutical-grade DEG/EG is substituted or adulterated into raw materials to cut costs or due to inadequate quality testing.
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The absence of stringent input testing and supplier audits has caused recurring tragedies globally.
Past Incidents
| Year | Country | Deaths | Cause |
|---|---|---|---|
| 1937 | U.S. | 105 | Elixir Sulfanilamide contaminated with DEG |
| 1990 | Nigeria | 47 children | Paracetamol syrup with DEG |
| 2020 | India (Jammu) | 12 children | Contaminated ColdBest syrup |
| 2022 | Gambia | 70 children | Indian-made cough syrups found with DEG |
| 2023 | Uzbekistan | 19 children | Contaminated Indian syrups with EG |
Each tragedy led to renewed scrutiny of India’s pharmaceutical exports and calls for stronger regulation and testing of excipients (inactive ingredients).
Regulatory Implications
The conflicting results between the Centre and Tamil Nadu underline the fragmented oversight of India’s pharmaceutical quality control.
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CDSCO (Central Drugs Standard Control Organisation) is responsible for nationwide coordination, but States license and inspect most drug manufacturers.
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Variations in testing infrastructure, capacity, and enforcement create loopholes.
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India’s export-oriented pharmaceutical industry, valued at $50 billion, faces reputational risks whenever domestic lapses emerge.
Experts recommend:
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Mandatory pre-dispatch solvent testing for all syrup manufacturers.
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Unified national recall system for defective batches.
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Batch-level traceability using digital barcoding and AI tracking.
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Public disclosure of test results to rebuild confidence.
The Broader Lesson
While the Centre’s findings suggest no systemic contamination, Tamil Nadu’s detection shows how even isolated lapses can have fatal outcomes.
The tragedy highlights the need for:
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Rigorous raw material verification,
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State-centre coordination, and
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A single-window national database for drug quality reports.
Above all, it reiterates a simple but vital message — paediatric cough syrups should never be administered without prescription, as misuse can obscure diagnosis and compound risk.
Conclusion
India’s pharmaceutical sector, a global supplier of affordable medicines, continues to face questions over quality control and regulatory coherence.
The Coldrif episode — where the Centre and State reached divergent conclusions — underscores the urgency for a uniform national quality surveillance system.
