Recent reports from India have alarmed families and healthcare providers alike. Several children and adults, and even some medical professionals, fell seriously ill, and in tragic cases, died, after consuming certain cough syrups. Initial investigations point to the brand ColdRif, primarily in Madhya Pradesh and Rajasthan, as linked to clusters of acute kidney failure and other life-threatening conditions. In response, multiple states have banned these syrups, and the Centre has issued urgent advisories on safe usage, while nationwide testing is underway.
It is crucial to understand the facts, the underlying science, and safety measures to prevent panic from overshadowing reason.
What Are Ethylene Glycol (EG) and Diethylene Glycol (DEG) and Why They Pose Severe Health Risks
Ethylene glycol (EG) and diethylene glycol (DEG) are industrial chemicals, commonly found in antifreeze, brake fluids, and certain plastics. They are never intended for medicinal use, as even small doses can cause severe harm, particularly to children.
As per reports, when ingested, these compounds are broken down into toxic byproducts, such as glycolic acid, oxalic acid, and diglycolic acid, which attack the kidneys and other organs. The main consequence of acute poisoning is nephrotoxicity, leading to acute tubular injury, metabolic imbalances, and potentially acute kidney failure. Other effects may include neurological damage and multi-organ failure.
Past global incidents illustrate the risk: in 2022, contaminated Indian cough syrups led to nearly 70 child deaths in The Gambia, and in Uzbekistan in 2023, dozens of children perished after ingesting DEG-contaminated medicines.
How Cough Syrup Can Become Contaminated with Industrial Solvents
Cough syrups are composed of several key elements:
- Active Pharmaceutical Ingredients (API): The main drugs that treat cough, cold, or congestion (e.g., dextromethorphan, ambroxol).
- Vehicle (solvents or diluents): Typically water, glycerine, propylene glycol, or other approved pharmaceutical-grade solvents.
- Preservatives, stabilisers, and sweeteners: To maintain consistency, prevent microbial growth, and make the medicine palatable.
- Other additives: Colouring agents, buffers, and viscosity modifiers.
Contamination can occur due to:
- Substitution of industrial-grade solvents like DEG or EG for cheaper glycerine or propylene glycol.
- Poor quality control or compromised supply chains, allowing cross-contamination.
- Invisible chemical similarity: DEG and EG are colourless, odourless, and viscous, making them difficult to detect without precise testing such as gas chromatography.
Regulatory Standards and Safety Measures for Detecting Toxic Solvents in Medicines
Worldwide, strict regulations limit DEG and EG in pharmaceuticals to extremely low levels (=0.1%). The WHO regularly issues alerts about these chemicals in paediatric medicines. National quality control labs often use screening methods like thin-layer chromatography (TLC) and confirmatory tests such as gas chromatography to ensure safety.Preventive strategies include:
- Auditing suppliers and certifying pharmaceutical-grade components.
- Rigorous batch testing and laboratory oversight.
- Swift recall mechanisms in case of contamination detection.
Current Indian Scenario: What ColdRif Investigations Reveal
Investigations show that a batch of ColdRif syrup manufactured by Sresan Pharma, Tamil Nadu, tested positive for extremely high levels of DEG (48.6%) at the manufacturing site. This triggered bans in Tamil Nadu, Madhya Pradesh, and other states.
Interestingly, several other samples collected from pharmacies in Madhya Pradesh and Rajasthan did not show DEG or EG contamination, suggesting that only specific batches may be affected.
Steps Taken by Indian Health Authorities to Safeguard Public Health
The Ministry of Health and Family Welfare, alongside state authorities, has acted swiftly:
- Banned and recalled affected batches, suspending their sale.
- Launched widespread testing of cough syrup samples across states.
- Issued advisories to avoid cough/cold syrups in children under 2 years, and exercise caution up to 5 years.
- Formed expert committees to investigate root causes, regulatory gaps, and recommend systemic improvements.
Safe Cough Syrup Practices for Families and Caregivers
While authorities continue investigations, families can take practical precautions:
- Follow prescriptions strictly: Dosage and duration should be age- and weight-appropriate.
- Prefer single-agent syrups rather than combination formulations to minimise risk.
- Avoid expired medicines or syrups from dubious sources.
- Seek medical advice if symptoms persist or worsen, instead of self-adjusting doses.
- Store syrups correctly, following label instructions for temperature and humidity.
Separating Fact from Fear: Not All Cough Syrups Are Dangerous
Although the ColdRif controversy has sparked widespread alarm, it is important to remember:
- Not all cough syrups are unsafe. Most undergo stringent quality control and adhere to regulatory standards.
- The current tragedy appears batch-specific, rather than a universal problem across all syrup brands.
- Informed caution, medical supervision, and awareness of recalls are the best strategies to protect children and adults alike.
Inputs from agencies
