Toxic Cough Syrup Deaths Trigger FDA Response And India Crackdown
WASHINGTON, DC – The US Food and Drug Administration confirmed on October 10 that toxic cough syrups linked to the deaths of children in India had not been exported to the United States. The agency said it was aware of reports detailing contamination of children’s cough and cold medicines in India with diethylene glycol and ethylene glycol — industrial chemicals that can cause kidney failure and death if ingested.
The confirmation followed growing alarm in India after a series of child deaths tied to contaminated syrups. On October 8, Indian authorities warned the public to avoid two additional cough syrup brands following the deaths of 17 children under the age of five. Laboratory tests revealed that the syrups contained dangerously high levels of diethylene glycol — nearly 500 times above the permissible limit.
The World Health Organization (WHO) has since pointed to what it called a “regulatory gap” in India’s oversight of domestically sold syrup medicines. India’s Central Drugs Standard Control Organization informed the US FDA that the contaminated products were not exported and were distributed only within India.
The crisis deepened this week with a nationwide crackdown. On October 13, India’s Enforcement Directorate (ED) raided seven locations across Chennai, including the residence of Sresan Pharmaceuticals owner S. Ranganathan and offices of senior Tamil Nadu Drug Control Department officials, as part of a money-laundering probe linked to the deaths.
The raids came shortly after a major breakthrough in the case. On October 9, Sresan Pharmaceuticals’ 75-year-old owner, G. Ranganathan, who had been absconding since the deaths were reported, was arrested in Chennai during a late-night operation coordinated between Madhya Pradesh and Tamil Nadu police. His arrest followed the discovery that at least 22 children in Madhya Pradesh’s Chhindwara district had died after consuming the company’s Coldrif cough syrup.
Investigators later searched the company’s Kancheepuram manufacturing facility, uncovering over 300 safety and regulatory violations. Officials said the plant used non-pharmaceutical-grade chemicals, and tests confirmed that the Coldrif syrup contained 48.6 percent diethylene glycol — an industrial solvent banned in medicinal products.
Authorities suspect that the toxic contamination resulted from the deliberate use of substandard ingredients to cut production costs. The investigation, which now involves both state and federal agencies, is expected to expand amid concerns about broader lapses in India’s pharmaceutical safety regime. (IANS)
