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WHO Issues Global Alert on Indian Cough Syrups After 22 Child Deaths

Tests confirmed extreme diethylene glycol contamination that can cause acute kidney failure.

Overview

  • At least 22 children under five in Madhya Pradesh’s Chhindwara district died after consuming the syrups, with additional cases treated in Nagpur, according to India’s drug regulator.
  • The WHO alert names three products—Coldrif, Respifresh TR, and ReLife—with measured diethylene glycol levels of 48.6%, 1.3%, and 0.6% respectively, far above the 0.1% limit for oral medicines.
  • Indian authorities ordered production halts, suspended product authorizations, and launched recalls, while Tamil Nadu revoked Sresan Pharmaceuticals’ licence, shut the facility, and saw owner G. Ranganathan arrested.
  • CDSCO and the US FDA reported no evidence that the implicated batches were exported, and officials say the syrups were not shipped to the United States.
  • Regulators began risk-based inspections at 19 manufacturing units across six states, and the episode follows multiple WHO alerts since 2022 that highlighted recurring gaps in drug-safety oversight and excipient quality.