A tragic event unfolded in Madhya Pradesh state. Fourteen children, most of them under five years old, lost their lives to kidney failure. This happened after they took Coldrif Syrup, a cough medicine. Tests showed the syrup held 46.28% diethylene glycol. That level dwarfs the safe limit of 0.1%. These young victims suffered quick harm from the poison. Parents sought help for common coughs, only to face heartbreak. Such cases raise deep worries about child safety in everyday health care.
Police moved fast on legal steps. They filed a criminal case against Sresan Pharma, the maker of the syrup. Officers also arrested the doctor who wrote the prescriptions. The charges hit hard. They include culpable homicide, which means causing death through neglect but not full murder. Drug adulteration ranks high too, as the syrup mixed in a deadly toxin. Violations of the Drugs and Cosmetics Act add to the list. This act sets rules for safe drug making in India. The arrests signal a push for justice. Yet questions linger: how did this batch escape checks? Families demand answers to prevent more pain.
This case fits a larger pattern of danger. Diethylene glycol in cough syrups from India has struck before. Since 2022, it claimed at least 141 children’s lives in Gambia, Uzbekistan, and Cameroon. Back in 2019, twelve kids in India died from a similar tainted product. These events span borders and years. They point to flaws in how syrups get made and sold. Health experts track these outbreaks. One report from the World Health Organization warns of repeated risks in low-cost medicines. Why do these toxins keep slipping through? It often ties to cost-cutting in production.
Diethylene glycol serves many uses outside drugs. Factories put it in antifreeze to stop liquids from freezing. It shows up in cosmetics for smooth texture. Lubricants rely on it for better flow. But in medicines, even tiny amounts can kill. The poison builds up in the body. First signs hit hard: vomiting shakes the stomach. Abdominal pain twists like a knife. Then comes acute kidney injury, where organs fail fast. Death follows if not treated quick. Kids face worse odds because their small bodies can’t fight it. Doctors explain it as a sweet-tasting deceiver. It mimics safe ingredients like glycerin, fooling taste tests.
India’s rules show a clear weak spot. The bad batch stayed inside the country. It skipped the 2023 export testing mandate. That year, leaders required checks for syrups sent abroad. Tests hunt for toxins like diethylene glycol before ships leave ports. But local sales face no such guard. Products for Indian buyers often dodge full scans. This setup creates a double standard. Medicines for export get stricter eyes, while home ones risk less oversight. Why the split? Experts say it stems from trade pressures. Global buyers pushed for safer exports after deaths abroad. Local rules lag behind. This gap leaves kids at home exposed. Calls grow for equal tests everywhere. Until then, trust in basic syrups frays.
The recent deaths of 14 children in Madhya Pradesh, India, from contaminated cough syrup represent not an isolated tragedy but a recurring pattern that threatens both India’s pharmaceutical reputation and public health across multiple continents. This analysis examines the systemic failures, regulatory gaps, and potential implications for Singapore and the broader Asian region.
The Madhya Pradesh Tragedy: What Happened
In October 2025, 14 children, predominantly under the age of five, died in Madhya Pradesh state after consuming Coldrif Syrup, a cough medication manufactured by Sresan Pharma. Laboratory testing revealed catastrophic contamination: the syrup contained 46.28% diethylene glycol (DEG), a level 462 times higher than the permitted 0.1% threshold.
The victims presented with a consistent and devastating clinical pattern: initial symptoms of common cold or flu, followed by prescription of Coldrif Syrup, leading to urine retention, acute kidney disorder, and ultimately kidney failure. The speed and severity of these outcomes underscore the extreme toxicity of the contamination level.
Understanding Diethylene Glycol: The Silent Killer
Diethylene glycol is an industrial chemical with legitimate uses in antifreeze, cosmetics, and lubricants. However, when ingested, it becomes a potent nephrotoxin (kidney poison). The World Health Organization identifies its symptoms as ranging from:
- Vomiting and abdominal pain
- Neurological symptoms
- Acute kidney injury
- Death in severe cases
The particularly insidious nature of DEG poisoning is that initial symptoms mimic common illnesses, delaying recognition and treatment until irreversible kidney damage has occurred. Children are especially vulnerable due to their smaller body mass and developing organ systems.
A Pattern of Contamination: Not the First Time
The Madhya Pradesh incident is part of a disturbing pattern that has damaged India’s pharmaceutical credibility:
International Deaths (2022-Present)
- Gambia: Indian-made cough syrups killed children
- Uzbekistan: Similar contamination incidents
- Cameroon: Additional child fatalities
- Total international deaths: At least 141 children since 2022
Previous Indian Incidents
- 2019: 12 children died in India from contaminated cough syrup
This represents a cumulative death toll of at least 167 children over six years, with the actual number potentially higher due to underreporting or misdiagnosis.
The Root Cause: Industrial-Grade Substitution
The contamination stems from a cost-cutting practice that substitutes pharmaceutical-grade propylene glycol with industrial-grade alternatives:
Pharmaceutical-Grade Propylene Glycol
- Intended for human consumption
- Rigorous purity standards
- Higher cost
- Safe for use in medicines
Industrial-Grade Propylene Glycol
- Never intended for human consumption
- May contain significant toxin levels
- Used in detergents, antifreeze, paints
- 30-50% cheaper than pharmaceutical grade
- Often contaminated with diethylene glycol or ethylene glycol
The economic incentive is clear: India’s manufacturing costs are already 35% lower than the US and Europe. Substituting industrial-grade solvents creates additional margin but at catastrophic human cost.
Regulatory Failures and Double Standards
The most troubling aspect of this crisis is the regulatory asymmetry between exported and domestically consumed medicines:
For Exported Medicines (Since 2023)
- Mandatory testing at government-approved laboratories
- Testing specifically for diethylene glycol and ethylene glycol
- Products must meet strict purity standards before export
- Implemented after international deaths damaged India’s reputation
For Domestically Sold Medicines
- No equivalent mandatory testing requirement
- The Coldrif Syrup batch was distributed only within India
- Falls outside the scope of the 2023 export testing rules
- Essentially a two-tier safety system
This creates an unconscionable situation where Indian children receive medicines with lower safety guarantees than those exported abroad. The message is clear: foreign markets merit protection that domestic consumers do not receive.
Legal and Regulatory Response
Criminal Proceedings
Sresan Pharma faces serious charges:
- Culpable homicide not amounting to murder
- Adulteration of drugs
- Violations of the Drugs and Cosmetics Act
- Potential penalties: substantial fines and life imprisonment
The prescribing doctor has been arrested, though this raises questions about whether individual physicians can reasonably be expected to detect pharmaceutical manufacturing fraud.
Administrative Action
- Manufacturing license cancellation recommended by the Central Drugs Standard Control Organisation
- Regulatory action taken against a company unit
- Neighboring states (Uttar Pradesh, Rajasthan) have banned the syrup
- Health Ministry advisory on “rational use” of cough syrups for children
The Broader Context: India’s Pharmaceutical Industry
India’s pharmaceutical sector is a global powerhouse:
- Size: $50 billion industry, third-largest globally by volume
- Export dependence: Over 50% of industry value comes from exports
- Market dominance:
- 40% of generic medicines used in the United States
- 25% of all medicines used in Britain
- Over 90% of medicines in many African nations
This market position means contamination incidents have far-reaching implications. Countries dependent on Indian pharmaceuticals face a difficult calculus: the medicines are affordable and often the only available option, but safety concerns are mounting.
Singapore Impact and Implications
Direct Risk Assessment
Singapore’s pharmaceutical supply chain has several protective factors:
- Regulatory Rigor: The Health Sciences Authority (HSA) maintains strict import controls and testing requirements
- Multiple Suppliers: Singapore sources pharmaceuticals from multiple countries, reducing single-source dependency
- Local Manufacturing: Singapore has domestic pharmaceutical production capabilities
- Wealth Factor: Higher purchasing power enables access to premium pharmaceutical-grade products
Indirect Concerns
However, several factors warrant attention:
Regional Supply Chain Exposure: Singapore serves as a pharmaceutical hub for Southeast Asia. Contaminated products entering regional supply chains could affect:
- Medical tourism patients treated in Singapore
- Re-exported pharmaceuticals to neighboring countries
- Generic medications in Singapore’s healthcare system
Import Verification Challenges: Even with robust testing, not every batch of every imported medicine undergoes comprehensive testing. Random sampling means some contaminated batches could theoretically enter the market.
Indian Pharmaceutical Presence: Indian pharmaceutical companies have significant market share in Singapore’s generic drug market. While major companies generally maintain higher standards, the systemic issues in India’s pharmaceutical sector create background risk.
Singapore’s Regulatory Advantage
Singapore’s approach differs fundamentally from India’s problematic dual standard:
- Unified Standards: HSA applies identical safety standards to imported and locally produced medicines
- Mandatory Registration: All therapeutic products must be registered with HSA before sale
- Good Manufacturing Practice (GMP): Manufacturers must meet GMP standards
- Post-Market Surveillance: Ongoing monitoring of medicines in the market
- Adverse Event Reporting: Robust pharmacovigilance system
Risk to Regional Medical Hub Status
Singapore’s position as a trusted medical hub for the region depends on pharmaceutical safety assurance. High-profile contamination incidents, even if originating elsewhere, can erode confidence in regional healthcare systems.
Why Cough Syrup? A Product Category Analysis
Cough and cold medications are disproportionately represented in contamination incidents for several reasons:
High Volume, Low Margin
These are commodity products with thin profit margins, creating pressure to cut costs through ingredient substitution.
Liquid Formulation
Syrups require solvents (propylene glycol) as a base. This creates the opportunity for substitution that doesn’t exist with solid oral dosage forms.
Pediatric Formulations
Children’s medicines are often liquid for ease of administration, concentrating risk in the most vulnerable population.
Limited Therapeutic Value
The Health Ministry’s statement is revealing: “Cough medications have minimal proven benefit in children but carry significant risks.” This raises questions about whether these products should be widely available at all.
Weak Oversight
Over-the-counter or easily prescribed medications may receive less regulatory scrutiny than controlled substances or specialized therapeutics.
Systemic Issues in India’s Pharmaceutical Regulation
The recurring contamination incidents reveal deep structural problems:
Fragmented Regulatory Authority
Pharmaceutical regulation in India is divided among:
- Central Drugs Standard Control Organisation (national level)
- State drug controllers (state level)
- This creates coordination challenges and regulatory gaps
Resource Constraints
With thousands of pharmaceutical manufacturers, regulators lack the resources for comprehensive oversight. Testing capacity is limited, enabling bad actors to operate.
Enforcement Gaps
Even when violations are detected, enforcement is often slow and inconsistent. The fact that Sresan Pharma was able to distribute contaminated product suggests pre-market testing was inadequate.
Export Prioritization
The 2023 rule requiring testing for exports but not domestic products reveals where priorities lie: protecting India’s international reputation and export revenue rather than protecting Indian children.
Weak Supply Chain Verification
Manufacturers’ sourcing of raw materials appears inadequately verified. The ability to substitute industrial-grade chemicals for pharmaceutical-grade suggests either:
- Deliberate fraud that evaded detection
- Inadequate testing of incoming raw materials
- Corrupt oversight at some level
Public Health Implications
Immediate Concerns
Beyond the 14 confirmed deaths, several questions remain unanswered:
- How many children consumed the contaminated syrup but survived with kidney damage?
- What is the long-term health outlook for survivors?
- How many batches of contaminated product were produced?
- Are other Sresan Pharma products contaminated?
Broader Impact on Medication Adherence
High-profile contamination incidents erode trust in medicines generally. Parents may avoid giving children necessary medications, potentially leading to:
- Delayed treatment of serious conditions
- Resistance to vaccination programs
- Increased use of unregulated traditional remedies
Economic Impact on Affected Families
In India, medical expenses are often catastrophic for families:
- Cost of emergency treatment
- Ongoing dialysis or kidney transplant costs
- Lost parental income during treatment
- Funeral expenses for deceased children
Most affected families lack adequate health insurance, creating long-term economic devastation.
International Ramifications
Damage to India’s Pharmaceutical Brand
Each contamination incident undermines confidence in Indian pharmaceuticals:
- Import restrictions from affected countries
- Increased testing requirements increasing costs
- Preference for pharmaceuticals from other sources
- Potential loss of market share worth billions
Implications for Global Drug Supply
Many countries, particularly in Africa and parts of Asia, depend heavily on affordable Indian generics. If confidence erodes significantly:
- Treatment costs could rise as countries source from more expensive suppliers
- Some patients may lose access to essential medicines entirely
- Public health outcomes could deteriorate in developing countries
WHO and International Regulatory Response
The World Health Organization and international regulators face challenges:
- How to maintain access to affordable medicines while ensuring safety
- Whether to require universal testing of Indian pharmaceutical imports
- How to support India in strengthening its regulatory framework
Lessons for Singapore and Regional Policymakers
Maintain Regulatory Vigilance
Singapore should not become complacent despite its strong regulatory framework:
- Continue comprehensive testing of imported pharmaceuticals
- Increase random sampling frequency for high-risk product categories
- Enhance supply chain verification for pharmaceutical ingredients
Regional Regulatory Cooperation
ASEAN countries should strengthen pharmaceutical regulatory cooperation:
- Share information about contamination incidents rapidly
- Harmonize minimum safety standards
- Coordinate testing to avoid duplication while ensuring coverage
- Develop regional pharmaceutical quality assurance mechanisms
Supply Chain Diversification
Over-reliance on any single source creates vulnerability:
- Singapore should maintain diverse pharmaceutical sourcing
- Support development of regional manufacturing capacity
- Consider strategic stockpiles of essential medicines
Public Education
Consumers should be informed about:
- How to verify legitimate pharmaceuticals
- The importance of purchasing from licensed sources
- Adverse event reporting mechanisms
Support for India’s Regulatory Modernization
As a major pharmaceutical consumer, Singapore has an interest in helping strengthen India’s regulatory system:
- Technical assistance programs
- Regulatory training exchanges
- Support for laboratory capacity building
The Path Forward: Recommendations
For India
Immediate Actions:
- Extend mandatory testing requirements to domestically sold medicines
- Strengthen raw material sourcing verification
- Increase random testing of products already in the market
- Fast-track prosecution of Sresan Pharma case to demonstrate accountability
Medium-Term Reforms:
- Consolidate regulatory authority to reduce fragmentation
- Increase funding for drug testing laboratories
- Implement pharmaceutical supply chain traceability systems
- Strengthen penalties for contamination to ensure deterrence
- Require pharmaceutical-grade certification for all medical product ingredients
Long-Term Systemic Change:
- Build a culture of quality in pharmaceutical manufacturing
- Professionalize regulatory workforce
- Implement risk-based inspection systems
- Develop early warning systems for contamination detection
For Singapore
Regulatory Measures:
- Review current testing protocols for liquid oral medications from high-risk sources
- Enhance post-market surveillance
- Consider country-specific risk profiles in import decisions
- Strengthen adverse event monitoring systems
Regional Leadership:
- Advocate for ASEAN pharmaceutical safety standards
- Share HSA expertise with regional regulators
- Support capacity building in neighboring countries
- Promote regional pharmaceutical manufacturing to reduce single-source dependency
Public Health Communication:
- Maintain transparency about pharmaceutical safety measures
- Educate healthcare providers about contamination risks
- Ensure public awareness of reporting mechanisms for adverse events
For International Community
- Support India’s regulatory modernization financially and technically
- Maintain pressure for universal safety standards (no domestic/export double standards)
- Develop rapid response mechanisms for contamination incidents
- Balance access concerns with safety imperatives
Conclusion: A Preventable Tragedy
The deaths of 14 children in Madhya Pradesh were entirely preventable. The contamination level of 46.28% diethylene glycol represents not a minor quality control lapse but either catastrophic negligence or deliberate fraud. The recurring pattern of similar incidents suggests systemic failures rather than isolated problems.
For Singapore, the incident serves as a reminder that global pharmaceutical supply chains are only as strong as their weakest link. While Singapore’s robust regulatory framework provides substantial protection, the integration of global pharmaceutical markets means that problems elsewhere can have ripple effects.
The fundamental lesson is clear: pharmaceutical safety cannot be compromised for cost savings, and regulatory standards cannot differ based on whether products are consumed domestically or exported. Every child, regardless of nationality or economic status, deserves medicines that meet the highest safety standards.
India’s pharmaceutical industry has the technical capability, manufacturing capacity, and talent to be a global leader in quality as well as volume. Realizing this potential requires matching its manufacturing scale with regulatory rigor that protects all consumers equally. Until that happens, tragedies like the Madhya Pradesh incident will continue to claim innocent lives and erode confidence in an industry vital to global health.
The 14 children who died deserved better. So do the millions of children who will take medicines tomorrow. Their safety must be the pharmaceutical industry’s first priority, not an afterthought.