Cough Syrup Deaths in India
Cough Syrup Deaths in India: A Growing Public Health Crisis
Cough Syrup Deaths in India:
The tragic deaths of children linked to contaminated cough syrups have emerged as a serious public health crisis in India, exposing critical gaps in pharmaceutical regulation and quality control. This ongoing issue has not only claimed numerous young lives domestically but has also severely damaged India’s reputation as the “pharmacy of the world.”
Recent Domestic Incidents
In October 2025, India faced another devastating outbreak when at least 14 children died after consuming contaminated cough syrups in Madhya Pradesh and Rajasthan. The primary culprit was identified as Coldrif cough syrup, manufactured by Sresan Pharma in Tamil Nadu, which contained diethylene glycol (DEG) levels of 46.28% – far exceeding the permissible limit of 0.1%. Nine children died in Chhindwara district, Madhya Pradesh, with symptoms including kidney failure, reduced urination, and acute renal complications.
In Rajasthan, three additional deaths were reported, with children developing symptoms of vomiting, drowsiness, anxiety, and unconsciousness after consuming dextromethorphan-based cough syrups distributed under the state’s free medicine scheme. The state subsequently banned all 19 medicines supplied by Kaysans Pharma and halted distribution of cough syrups containing dextromethorphan as a precautionary measure.
Global Impact and International Scandals
India’s contaminated cough syrups have caused international tragedies that have severely damaged the country’s pharmaceutical reputation. The most devastating incident occurred in The Gambia in 2022, where approximately 70 children under five years old died from acute kidney injuries after consuming four cough syrups manufactured by Maiden Pharmaceuticals. The WHO investigation revealed “unacceptable levels” of diethylene glycol and ethylene glycol in products including Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
In Uzbekistan, 18 children died in December 2022 after consuming Dok-1 Max cough syrup manufactured by Marion Biotech. Preliminary tests showed the syrup contained ethylene glycol, another toxic industrial solvent. Similarly, contaminated cough syrups from Indian manufacturers have been linked to child deaths in Cameroon and Indonesia.
The Toxic Chemicals Behind the Deaths
The primary culprits in these tragedies are diethylene glycol (DEG) and ethylene glycol (EG) – industrial solvents used in antifreeze, paints, brake fluids, and plastics. These chemicals are never meant for pharmaceutical use but are sometimes illegally substituted for legitimate pharmaceutical-grade ingredients like glycerin and propylene glycol because they are significantly cheaper.
When ingested, DEG and EG are metabolized into highly toxic compounds that cause severe kidney, liver, and nervous system damage. Children are especially vulnerable because even tiny amounts relative to their body weight can be fatal. Symptoms typically begin with nausea, abdominal pain, and reduced urination, rapidly progressing to acute kidney failure, seizures, and death.
Regulatory Failures and Systemic Issues
The recurring cough syrup deaths highlight multiple systemic failures in India’s pharmaceutical regulatory framework:
Weak Manufacturing Oversight
Many pharmaceutical companies have cut corners in quality control, using cheaper industrial-grade chemicals instead of pharmaceutical-grade ingredients. The pressure to produce cost-effective medications quickly has led to shortcuts in quality assurance protocols.
Inadequate Regulatory Enforcement
The Central Drugs Standard Control Organisation (CDSCO) and State Drug Regulatory Authorities (SDRAs) face challenges in effectively monitoring over 10,500 pharmaceutical manufacturing units across India. According to the health ministry’s drug survey conducted between 2014-2016, more than 3% of drugs sold in retail outlets were substandard or spurious.
Export vs. Domestic Standards Disparity
Many medicines exported from India are not subject to the same regulatory scrutiny as those for domestic use. Following the international scandals, India mandated that all cough syrups destined for export be tested at government laboratories before dispatch – a protection notably absent for cough syrups in the domestic market.
Supply Chain Vulnerabilities
The complex global supply chain of pharmaceutical ingredients creates multiple opportunities for contamination. Companies often rely heavily on supplier certificates of analysis without conducting comprehensive independent testing, and the origin and chain of custody of ingredients is frequently unclear.
Government Response and Regulatory Actions
Following the recent deaths and international pressure, Indian authorities have initiated several measures:
Immediate Actions
Criminal charges have been filed against Sresan Pharma and a doctor who prescribed the contaminated syrup
The company’s manufacturing license has been recommended for cancellation by CDSCO
Risk-based inspections have been ordered at 19 pharmaceutical manufacturing units across six states
Policy Changes
The Centre issued an advisory against prescribing cough and cold medications to children under 2 years old
Mandatory Good Manufacturing Practices (GMP) implementation was required for all pharmaceutical manufacturers, with deadlines of six months for large firms and 12 months for small and medium enterprises
Over 100 pharmaceutical companies have had their licenses cancelled or suspended, and more than 50 laboratories have been found lacking and told to shut down
Enhanced Testing Requirements
Post-scandal, India made batch-wise testing mandatory for cough syrups before export, particularly to African and other developing countries. However, this enhanced scrutiny applies only to exports, leaving domestic consumers potentially vulnerable.
The Broader Quality Control Crisis
The cough syrup deaths are part of a larger quality control crisis in Indian pharmaceuticals. In September 2024, CDSCO flagged 53 drugs as “Not of Standard Quality,” including widely-used medications such as calcium and vitamin D3 supplements, diabetes medications, and blood pressure medicines manufactured by major companies like Sun Pharma, Glenmark Pharmaceuticals, and Alkem Laboratories.
Impact on India’s Global Reputation
These incidents have severely damaged India’s reputation as a reliable pharmaceutical supplier. India provides 40% of generic medications consumed in the United States, 25% in the United Kingdom, and over 90% in numerous African nations. Several countries have begun demanding independent testing of Indian pharmaceutical products or have imposed bans on selected exports.
The Way Forward
To prevent future tragedies and restore confidence in Indian pharmaceuticals, experts recommend:
Strengthened Regulatory Framework
Enhanced enforcement of Good Manufacturing Practices with regular, unannounced inspections
Standardized penalties and clear definitions of violations to ensure consistent enforcement across states
Mandatory comprehensive testing of all high-risk ingredients, particularly glycerin and propylene glycol, for DEG and EG contamination
Supply Chain Transparency
Complete traceability of pharmaceutical ingredients from manufacture to final product
Mandatory disclosure of supplier information and chain of custody documentation
Independent verification of supplier certificates of analysis rather than reliance on provided documentation
Equal Standards for Domestic and Export Markets
Uniform quality standards and testing requirements for both domestic consumption and export products
Mandatory batch testing for all cough syrups and high-risk medications, not just exports
Enhanced International Cooperation
Harmonized safety standards between regulatory bodies globally
Rapid information sharing mechanisms for contamination incidents
Joint inspections and mutual recognition agreements with international regulatory agencies