A spoonful of cough syrup that was meant to relieve symptoms may become a deadly poison. This isn't a fictional scenario but a real tragedy caused by diethylene glycol (DEG) contamination. On October 13,2025, the WHO issued an emergency alert, revealing that cough syrups produced in India were contaminated with DEG, including batches of Coldrif, Respifresh TR, and ReLife. According to Indian media reports, at least 20 children in Madhya Pradesh state have died. This inexpensive industrial raw material, resembling pharmaceutical excipients in properties, has been frequently misused by unscrupulous manufacturers in drug production, leading to multiple global public health disasters.

What is ethylene glycol? How toxic is it?

Diethylene glycol (DEG), a colorless, transparent, viscous liquid, is widely used in automotive antifreeze, industrial solvents, and plasticizers. With a production cost approximately half that of propylene glycol—a standard pharmaceutical excipient—its natural mild sweetness and chemical similarity to pharmaceutical ingredients have made it a prime substitute for counterfeiters.

However, the toxicity of diethylene glycol (DEG) cannot be overlooked. Once ingested, it metabolizes into toxic substances like oxalic acid, directly damaging kidney tubules and causing irreversible kidney failure. It also suppresses the central nervous system. Data shows the lethal dose of oral DEG is approximately 1 mL/kg. For a 10kg infant, even two or three tablespoons of high-concentration DEG syrup could be fatal. More alarmingly, this toxicity manifests subtly with early symptoms resembling common colds, often leading to delayed treatment.

A tragedy spanning nearly a century

Diethylene glycol contamination is nothing new. In the past 100 years, it has caused dozens of tragedies around the world, each of which has exposed a gap in the drug safety chain.

1. The 1937 sulfadiazine酏ate incident in the United States

This stands as a landmark tragedy in the history of pharmaceutical regulation. When a U.S. company substituted glycerol with diethylene glycol to produce sulfonamide elixir, it caused 107 deaths within two months, with most victims being children. This incident directly prompted the enactment of the Federal Food, Drug, and Cosmetic Act, which for the first time required pre-market safety certification for pharmaceuticals, and laid the foundation for the modern Food and Drug Administration (FDA).

2. The 2006 China Qi Er Pharmaceutical incident

Doctors at Guangdong Zhongshan Third Hospital discovered that multiple patients developed sudden kidney failure after receiving injections of Liangjunjia Injection, resulting in nine fatalities. Investigations revealed that the pharmaceutical manufacturer had purchased counterfeit propylene glycol from unlicensed vendors, which was actually industrial-grade diethylene glycol. More shockingly, the company's quality control inspector, lacking proper certification despite having only a junior high school education, issued false compliance reports, allowing toxic raw materials to enter the production process.

3. The 2006 Panama sugar syrup incident

A cough syrup produced by a Panamanian government-owned pharmaceutical company has caused 34 deaths, prompting nearly 50,000 emergency blood tests. U.S. Centers for Disease Control and Prevention (CDC) tests revealed the diethylene glycol in the syrup originated from expired glycerin with altered expiration dates. Suppliers falsified 2004 expired raw materials as 2007 expiration products, which were smuggled into the factory through shell companies.

4. Repeated incidents: India's' toxic syrup' serial cases

In 2022, nearly 100 children died in India after consuming cough syrup containing diethylene glycol (DEG) exported to the Gambia. In 2023, Cold Out syrup from India caused six more child deaths in the Gambia, with DEG levels reaching 1.2% – far exceeding the WHO's safety threshold of 0.25%. By October 2025, at least 20 children in Madhya Pradesh died from Coldrif cough syrup containing 48.6% DEG, nearly 500 times higher than India's national standard. The scandal reached its peak when the company was found guilty of over 350 regulatory violations, with toxic ingredients sourced from paint industry suppliers.

[How do countries defend?]

The painful lessons have promoted the continuous upgrading of the global drug regulatory system, and different countries and regions have formed their own prevention and control strategies:

[Multiple parties work together to build a drug safety line]

The treatment of diethylene glycol pollution requires the multi-dimensional cooperation of enterprise self-discipline, regulatory efforts, technical support and public vigilance, which is indispensable.

1. Enterprises: Guard the first gate at the source

Pharmaceutical manufacturers must implement a rigorous supplier audit system, sourcing raw materials exclusively from qualified and compliant suppliers while strictly prohibiting procurement from non-pharmaceutical channels such as chemical traders or paint distributors. They must also strictly adhere to GMP standards, conducting comprehensive DEG testing on every batch of raw materials. Testing personnel must hold legally required qualifications, and issuing false reports is strictly prohibited.

2. Regulation: From "post-incident accountability" to "pre-incident prevention"

Regulators should classify excipients such as propylene glycol and glycerin as high-risk materials and enforce mandatory batch-by-batch testing. Drawing on the EU's experience, they should incorporate DEG testing into pharmacopoeial standards and establish a cross-border drug traceability system, implementing a "whitelist" management system for exported pharmaceuticals. Penalties for non-compliant enterprises must be intensified, including criminal prosecution and market bans, to create a deterrent effect.

3. Technology: Promote rapid detection technology

The implementation of precision detection methods such as gas chromatography-mass spectrometry (GC-MS) has been promoted, with portable screening devices deployed at customs, pharmaceutical factories, and pharmacies to enable real-time testing during raw material warehousing, product release, and cross-border distribution. The WHO-recommended two-stage detection method—thin-layer chromatography screening combined with gas chromatography confirmation—effectively addresses the capacity limitations of grassroots laboratories.

4. The public: Learning to recognize risk signals

Parents should verify whether medications have a National Medical Products Administration (NMPA) import registration certificate before administering them to children, avoiding overseas purchases from unregulated channels. Be cautious of products labeled as "quick cough relief" or "herbal secret formulas" without disclosing ingredients. If the medication tastes abnormally sweet, discontinue use immediately. Should symptoms like reduced urination, vomiting, or lethargy occur after consumption, seek medical attention promptly and report to the drug regulatory authorities.

From 1937 to 2025, nearly a century of painful lessons has repeatedly shown: drug safety is no trivial matter – any lapse in the chain of responsibility could lead to catastrophe. While contamination by diethylene glycol (DEG) isn't insurmountable, the solution lies in corporate responsibility, rigorous oversight, timely technological advancements, and public vigilance. This century-old "sweet trap" will ultimately be eradicated. May we never again face such a toxic threat!

Disclaimer: This article is intended solely for knowledge exchange, sharing, and popular science purposes. It does not constitute commercial promotion or serve as medical guidance or medication advice. If any content infringes on your rights, please contact us for removal.

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