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India's Cough Syrup Tragedy Shows Huge Drug Safety Gaps

Three syrups from Indian manufacturers contained diethylene glycol levels far above safe limits, prompting recalls and production halts after child deaths in Madhya Pradesh.

  • The World Health Organization issued a medical alert on September 30 after child deaths in Madhya Pradesh linked to contaminated syrups with diethylene glycol, CDSCO reported on October 8.
  • Since October 2022, World Health Organization has flagged repeated diethylene glycol contamination in liquid medicines, noting only 0.1 per cent is permissible and assisting regulators with testing.
  • Lab tests found Sresen Pharmaceutical's Coldrif contained 48.6 per cent DEG, while Rednex Pharmaceutical's Respifresh and Shape Pharma's ReLife had 1.3 per cent and 0.6 per cent respectively, and WHO said the products were not meant for export.
  • We have initiated risk-based inspections at 19 drug manufacturing units across six states to identify quality lapses, CDSCO official D R Gahane said, while the owner of Sresen Pharmaceuticals was arrested and sales banned.
  • Experts say India supplies at least 20% of generics yet 20–25% may fall short; Nakul Pasricha urged better traceability, asking, `Are the current penalties a sufficient deterrent?` while Dinesh Thakur called state procurement a `patronage scheme.
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The World Health Organization has issued a global warning regarding three cough and cold syrups manufactured in India. According to the WHO, these syrups have been found to contain a toxic compound called Diethylene Glycol (DEG), which has caused severe illness and death in children.

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Times of India broke the news in India on Monday, October 13, 2025.
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