The World Health Organisation (WHO) closely monitors the health situation in India. This follows reports of pediatric illnesses and deaths in Madhya Pradesh and Rajasthan, with a suspected link to contaminated cough syrup use. These tragic events highlight an ongoing public health concern. The Central Drugs Standard Control Organisation of India (CDSCO) confirmed no contaminated cough syrups responsible for these deaths were exported. This provides some reassurance regarding international spread.
Investigation into Contaminated Cough Syrup
Reports emerged during the week of September 29. They describe symptoms consistent with acute renal failure and acute encephalitis syndrome. On October 8, the WHO received confirmation from the CDSCO. Investigators detected Diethylene Glycol (DEG) in at least three oral syrup medicines. Children in the reported cases consumed these medicines. The CDSCO identified the contaminated products as Coldrif, Respifresh TR, and ReLife. These contained 48.6 per cent DEG, 1.342 per cent DEG, and 0.616 per cent DEG, respectively.
Consequently, the CDSCO informed WHO that authorities have recalled the affected products. Additionally, authorities ordered the identified manufacturers to cease production of all medical products. While these actions are crucial, the WHO has yet to receive official information regarding the source of the DEG contamination. Furthermore, it remains unclear if authorities identified or removed contaminated pharmaceutical material from circulation.
Understanding Diethylene Glycol (DEG) and Ethylene Glycol (EG)
Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic substances. Manufacturers typically use these compounds as industrial solvents and antifreeze agents. Even small amounts can be fatal, particularly for children. The recent deaths of 20 children underscore this severe danger. These children were primarily from Chhindwara, Betul, and Pandhurna districts in Madhya Pradesh. They died after consuming Coldrif cough syrup. A Tamil Nadu-based pharmaceuticals company manufactured this specific syrup.
Global Context and Regulatory Gaps
Since 2002, numerous outbreaks of DEG and EG contamination in oral syrup medicines have occurred worldwide. Indeed, these incidents have claimed many lives and severely affected countless patients, predominantly children. Consequently, the UN’s agency has issued seven Medical Product Alerts since October 2022. Manufacturers marketed many of these for paediatric use. Furthermore, they widely exported them to low- and middle-income countries (LMIC). Two additional alerts addressed falsified bulk chemicals posing as pharmaceutical-quality excipients.
The WHO has expressed deep concern over these developments. It emphasizes the potential risk of contaminated products reaching other countries, especially through unregulated channels. It has flagged a significant regulatory gap in DEG/EG screening for domestically marketed medicines in India. Identifying the contamination source and removing any contaminated pharmaceutical material in circulation are top priorities. The WHO remains committed to supporting India in safeguarding public health and ensuring the safety of medical products.
Collaborative Efforts and Future Outlook
The South-East Asia Regulatory Network is facilitating ongoing discussions with the Indian Pharmacopoeia Commission (IPC). The IPC has offered to support regional capacity building for EG/DEG testing. Moreover, in July 2025, the WHO and UNODC released a joint report on contaminated medicines. This report specifically highlighted the ongoing public health crisis caused by the contamination of medicines with industrial-grade toxic chemicals, notably DEG/EG.
Frequently Asked Questions
Q1: What are the specific contaminated products identified in India?
The CDSCO identified Coldrif, Respifresh TR, and ReLife oral syrup medicines as containing Diethylene Glycol (DEG).
Q2: Why are Diethylene Glycol (DEG) and Ethylene Glycol (EG) dangerous?
DEG and EG are toxic industrial solvents and antifreeze agents. They can cause acute renal failure and acute encephalitis syndrome, leading to fatalities, even in small amounts, especially for children. Understanding the toxicology of these substances is crucial for healthcare professionals, particularly those in paediatrics and intensive care medicine.
Q3: What actions have Indian authorities taken in response to these contaminations?
The CDSCO has recalled the contaminated products and ordered the identified manufacturers to stop production of all medical products. They also confirmed that these specific contaminated batches were not exported.
References
- WHO monitoring situation amid deaths of children from cough syrup in MP – ETHealthworld
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