The Coldrif Syrup Tragedy (2025): A Case of Pediatric Deaths in India

The Coldrif Syrup Tragedy (2025): A Case of Pediatric Deaths in India

The Coldrif tragedy of 2025 shook India when a common cough syrup turned deadly, taking the lives of several innocent children. This presentation raises awareness about the consequences of poor drug manufacturing standards, the importance of regulatory oversight, and the need to protect public health from preventable pharmaceutical disasters.

1. “Sweet Taste, Bitter Truth: The Story Of The Coldrif Tragedy” Presented by Ms. Sharwari Sonawane Mr. Vitthal Kundgir Divine College Of Pharmacy, Satana 1

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3. What Happened…..? Several childrens in Madhya Pradesh and Rajasthan developed acute kidney failure and died . The deaths are being linked to a pediatric cough syrup branded “ Coldrif ” manufactured by Sresan Pharmaceuticals in Kanchipuram, Tamil Nadu. Laboratory tests revealed that a batch (Batch No . SR-13 , manufactured May 2025, expiring April 2027) of the syrup contained diethylene glycol (DEG) at extremely high concentrations far above permissible safety limits. Diethylene glycol is a toxic industrial solvent (used e.g. in antifreeze, plastics, etc.), not meant for ingestion. When ingested, it can cause severe kidney injury, neurological damage, and death. 3

4. In Madhya Pradesh, around 433 bottles of this syrup were seized. Authorities traced that 222 bottles had already been sold. A doctor who prescribed the syrup Dr. Praveen Soni, has been arrested and regulatory action is being taken against the manufacturer State governments ( Madhya Pradesh, Maharashtra, Kerala ) have banned the sale and distribution of the implicated syrup. The central Health Ministry has confirmed that samples of the syrup tested positive for per DEG beyond missible limits and ordered inspections of drug manufacturing units across multiple states. 4

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6. The contents of the bottles shown in the image, identified as "COLDRIF" cough syrup, are primarily stated on the label as: Paracetamol Phenylephrine hydrochloride Chlorpheniramine maleate syrup Recent reports indicate that some batches of coldrif cough syrup have been found to contain (DEG), a toxic industrial solvent, which led to a ban of the syrup in several states in India.  Laboratory tests revealed a high concentration of diethylene glycol in certain samples, rendering the syrup "not of standard quality".  6

7. Diethylene Glycol ….. Formula: C₄H₁₀O₃ Diethylene Glycol (DEG) is a colorless, sweet-tasting industrial solvent. Mention that it’s sometimes mistakenly or illegally substituted for glycerine or propylene glycol in syrups. Even small contamination can cause acute renal failure and death. Uses: Antifreeze, brake fluids, plasticizers. Not for human consumption. Toxic dose: As little as 0.1 mL/kg can be fatal in children 7

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9. Mechanism of Toxicity DEG is metabolized to 2-hydroxyethoxyacetic acid which causes metabolic acidosis and renal tubular necrosis . Target organs: Kidneys, CNS, Liver . Symptoms: Nausea, Vomiting, Headache ,Renal failure ,Coma ,Death 9

10. DEG - Safety limit in pharmaceutical Preparations As per IP and WHO guidelines According to the Indian pharmacopoeia (IP 2022, volume III, appendix 2.3.1 Maximum permissible limit of diethylene glycol (DEG) or ethylene glycol in glycerol, propylene glycol, and polyethylene glycol used in pharmaceutical preparations is not more than 0.10% (v/v). Any raw material or syrup containing DEG more than 0.10% (v/v) is considered unsafe and non-compliant with IP standards. In pediatric formulations, even trace contamination (>0.05%) can be toxic because of smaller body weight and immature metabolism. 10

11. Sequence of key events in the COLDRIF cough syrup incident Date Events May 2025 Batch SR-13 manufactured Sept 2025 Children develop renal failure in MP Oct 1–5, 2025 Deaths reported, samples collected Oct 4, 2025 DEG confirmed in lab tests Oct 5–6, 2025 State wide ban and FIR filed 11

12. Role of Pharmacist Before tragedy Verify manufacturer and batch quality Check CDSCO alerts or recalls Ensure proper labeling and licensing During tragedy Stop dispensing suspected batch Report ADRs to PVPI Inform doctors and authorities 12

13. After tragedy Support recall and public awareness Return contaminated stock Educate patients on safe medicine use Long-term role GMP compliance Strengthen pharmacovigilance Promote ethical pharmacy practice 13

14. Reference Indian Pharmacopoeia Commission (IPC), Indian Pharmacopoeia 2022, Vol. III, Appendix 2.3.1 WHO Alert: Substandard (contaminated) liquid dosage forms containing DEG and EG (Jan 2023) CDSCO Drug Safety Circular (2023): Permissible limit of DEG ≤ 0.10% v/v Times of india (oct 2025) Economic times (oct 2025) NDTV health report (oct 2025) 14

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