Over a year before the deaths of at least two dozen children were linked to contaminated cough syrups, India’s top drug regulator had already sounded the alarm about the same formulation.
India Today has accessed a December 2023 letter from the Central Drugs Standard Control Organisation (CDSCO) that explicitly warned pharmaceutical companies against prescribing a particular fixed-dose combination (FDC) — Chlorpheniramine Maleate IP 2mg + Phenylephrine Hydrochloride IP 5mg — to children below four years of age.
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