THE DEADLY CONSEQUENCES OF CONTAMINATED MEDICINE: A LOOK INTO THE KILLER COUGH SYRUP CASE
Authors/Creators
- 1. Department of Pharmaceutical Chemistry, Adhiparasakthi College of Pharmacy, Melmaruvathur, 603319.
- 2. Department of Pharmacology, Adhiparasakthi College of Pharmacy, Melmaruvathur, 603319.
Description
In 2025, India faced a major public health crisis following the deaths of several children who consumed a cough syrup contaminated with diethylene glycol (DEG), a highly toxic industrial chemical prohibited in pharmaceutical formulations. The affected product, intended for pediatric use, contained DEG due to the substitution of pharmaceutical-grade excipients with industrial-grade solvents, reflecting severe lapses in Good Manufacturing Practices (GMP) and quality control. DEG toxicity primarily targets the kidneys, leading to acute renal failure, metabolic acidosis, neurological complications, and multi-organ dysfunction, particularly in children due to their physiological vulnerability. The incident prompted immediate regulatory actions, including product bans, recalls, seizures, suspension of manufacturing licenses, and legal proceedings against the responsible manufacturer. The World Health Organization (WHO) issued a Medical Product Alert, highlighting the global risk posed by contaminated liquid medicines and urging heightened international vigilance.[31] This tragedy underscores the critical importance of strict excipient quality assurance, robust regulatory oversight, and strengthened pharmacovigilance systems to ensure the safety of pediatric medicines and prevent similar incidents in the future.
Files
30 WJPSR 1956.pdf
Additional details
References
- 1. WHO Medical Product Alert — The World Health Organization issued an alert confirming the presence of diethylene glycol (DEG) in oral liquid medicines reported from India that were linked with acute illness and child fatalities; WHO warned these are unsafe and potentially fatal, especially in children. World Health Organization.
- 2. Reuters Reporting on Toxic Cough Syrups & Child Deaths — India declared three cough syrups (including Coldrif) toxic after multiple child deaths from kidney failure. The syrups were found to contain DEG far above permissible limits and were banned. Reuters.
- 3. NDTV News Desk. (2025, October 7). Cough syrup deaths rise in Madhya Pradesh, opposition makes "bulldozer" demand. NDTV. - https://www.ndtv.com/india-news/coldrif-cough-syrup-deaths-rise-in-madhya-pradesh-opposition-makes-bulldozer-demand-9412234.
- 4. Times of India. Sresan licence revoked, unit shut down. Chennai: The Times of India; Oct 14, 2025.
- 5. NDTV. Cough syrup deaths in India: Children die after consuming contaminated Coldrif syrup. NDTV; 2025. - https://www.ndtv.com.
- 6. Food & Drugs Administration (Drugs Wing), Punjab. (2025, January 6). Office order declaring Coldrif syrup as not of standard quality due to diethylene glycol contamination (Order No. Drugs (3) Pb. 2025). Government of Punjab.
- 7. Metabolite-Driven Toxicity: Inhibition of Metabolism of Diethylene Glycol Prevents Target Organ Toxicity in Rats. Toxicological Sciences, 2010 — Shows that the toxic effects of DEG arise from its metabolites HEAA and DGA, and blocking metabolism prevents toxicity. OUP Academic.
- 8. Multi-Organ Involvement: While kidneys are the primary target, DEG metabolites also cause metabolic acidosis (due to acid accumulation), hepatic stress, and neurologic dysfunction, which may contribute to multi-organ failure if not treated promptly. PubMed.
- 9. Neurological Effects Linked to DEG: Neurotoxic effects of nephrotoxic compound diethylene glycol — Animal evidence of neurotoxicity and its association with kidney injury due to metabolite accumulation. PubMed.
- 10. Acute Kidney Injury and Metabolite Accumulation: Renal toxicity caused by diethylene glycol: an overview — Summarizes renal tubular damage, metabolic acidosis, and neurologic involvement seen in DEG poisoning. PubMed.
- 11. Chemistry World. (2025, Oct). 23 Indian children's deaths linked to contaminated cough syrup.
- 12. People. (2025). At least 20 children, all under the age of 5, dead after consuming contaminated cough syrup: Reports.
- 13. NDTV. Cough syrup deaths in India: Children die after consuming contaminated Coldrif syrup. NDTV; 2025. Available from: https://www.ndtv.com.
- 14. Health Policy Watch. (2025). Toxic cough syrup, weak oversight: India's unending drug safety crisis.
- 15. The Federal / WHO report. (2025). WHO asks India if Coldrif cough syrup was exported as death toll rises.
- 16. The Straits Times. (2025). Repeated deadly cough syrup scandals pose hard questions for India's drug regulators.
- 17. The Central Drugs Standard Control Organisation (CDSCO) launched risk-based inspections of manufacturing facilities and worked with state regulators to sample and analyse other syrups and medications to identify potential quality failures. ETPharma.com.
- 18. World Health Organization (WHO). (2025). Contaminated medicines affecting children: Questions and Answers. World Health Organization. - https://www.who.int
- 19. World Health Organization (WHO). (2025, October). WHO warns against use of contaminated cough syrups link ed to child deaths. World Health Organization. - https://www.who.int
- 20. Economic Times. (2025, October). WHO issues alert on contaminated Indian cough syrups linked to child deaths. - https://economictimes.indiatimes.com
- 21. State Government Action in Uttar Pradesh — The UP government banned the sale of cough syrup linked to child deaths in Madhya Pradesh after finding toxic adulteration with DEG, and ordered seizure and testing of syrups. The Indian Express.
- 22. Public Alerts in Haryana — A public health alert was issued in Haryana after detection of toxic DEG impurity in a cough syrup formulation, underscoring regulatory vigilance. Business Standard.
- 23. Tamil Nadu and Kerala also initiated bans and stock seizures to prevent further exposure. These steps aimed to remove the dangerous products from circulation and prevent additional pediatric harm. India Today.
- 24. The Gambia (2022) — DEG & EG-Contaminated Cough Syrups World Health Organization+1.
- 25. Indonesia (2022) — Toxic Syrups with DEG/EG World Health Organization+1.
- 26. Uzbekistan (2022–2023) — Dok-1 Max & Ambronol Syrups World Health Organization+1.
- 27. Cameroon (2023) — NATURCOLD Cough Syrup World Health Organization.
- 28. Marshall Islands & Micronesia (2023) — Guaifenesin TG Syrup World Health Organization.
- 29. World Health Organization. (2025, October 13). Medical product alert N°5/2025: Substandard (contaminated) oral liquid medicines. - https://www.who.int/news/item/13-10-2025-medical-product-alert-n-5-2025-substandard-contaminated-oral-liquid-medicines.
- 30. World Health Organization.(2014). https://www.who.int/publications/i/item/9789241547559.
- 31. World Health Organization. (2002). The importance of pharmacovigilance: Safety monitoring of medicinal products. World Health Organization. https://apps.who.int/iris/handle/10665/42493.
- 32. Government Test Report on DEG Contamination — A government laboratory found high levels of DEG (≈46.28%) in a cough syrup sample, confirming industrial chemical adulteration in a product linked to child fatalities, prompting quality checks and regulatory action. The Economic Times.