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Fixed-Dose Combination : Banned

Fixed-Dose Combination : Banned

The Indian government has recently banned 156 Fixed-Dose Combination (FDC) drugs.

  • Fixed-dose combination (FDC) drugs are medications that combine two or more Active Pharmaceutical Ingredients (APIs) in a single dosage form, such as a pill, capsule, or injection.
  • These drugs are often prescribed for conditions requiring multiple medications, such as tuberculosis, diabetes, and hypertension, to enhance patient compliance by reducing the number of pills taken daily.
  • The rationale for the Ban: The banned FDCs were deemed “irrational” by the central government, as they do not provide any additional therapeutic benefits.
  • The combinations in these FDCs may involve ingredients that either do not work synergistically or include unnecessary components that do not require simultaneous administration.
  • FDCs can improve patient compliance, especially for chronic diseases where multiple medications are required.
  • Some FDCs may include unnecessary components, leading to patients consuming drugs they don’t need.
  • For example, Cheston Cold includes paracetamol, cetirizine, and phenylephrine, which are not necessary for treating bacterial infections but are used for managing cold symptoms.
  • Banned FDCs: The recent ban includes various drug combinations:
    • Gastrointestinal treatments: Enzyme combinations for digestive issues.
    • Anti-allergy treatments: Combinations of levocetirizine with nasal decongestants, and cough syrups with mucus-breaking properties.
    • Skin treatments: FDCs like menthol with aloe vera, and silver sulfadiazine with antiseptics.
    • Migraine and menstrual pain: Combinations for treating migraines and menstrual cramps.
    • Erectile dysfunction: Combinations involving sildenafil (Viagra) with other drugs affecting blood vessels and muscles.