HomeStoryIndia's drugs regulator bans anti-cold drug for kids aged under 4

India’s drugs regulator bans anti-cold drug for kids aged under 4

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FDA Investigating Common Cold Meds With Phenylephrine
  1. India’s drugs regulator has banned an anti-cold drug combination for children under four due to concerns about its safety.
  2. At least 141 deaths, globally linked to toxic cough syrups, triggered this restriction, including 12 fatalities in India in 2019.
  3. The directive requires drugmakers to label products with warnings against usage in children below 4 years old.
  4. The banned combination includes chlorpheniramine maleate and phenylephrine, often used for cold symptoms.
  5. India has intensified scrutiny and mandated testing for cough syrup exports, aiming to ensure drug safety.

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