What are Fixed-Dose Combination (FDC) Drugs?

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What are Fixed-Dose Combination (FDC) Drugs? Blog Image


Fourteen fixed-dose combination (FDC) medicines found to lack therapeutic relevance have been banned by the Central Government through a gazette notification issued recently.

About Fixed-Dose Combination (FDC) Drugs:

  • A FDC drug includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.
  • They have been shown to appreciably reduce the risk of medication non-adherence, which is particularly important in patients with chronic diseases.
  • However, their rationality for use should be based on sound medical principles as there have been concerns with their irrationality and utility in several countries.
  • Common examples: Cough syrups Phensedyl and Corex, Vicks Action 500.
  • Advantages of FDCs:
    • Burden of keeping track of several medications, understanding their various instructions, etc. is reduced which improves patient compliance and therefore improves treatment outcomes.
    • The FDCs are more economic than single ingredient drugs.
    • The manufacturing cost is quite low as compared to the cost of producing separate products
    • Then there is Simpler logistics of distribution.
  • Disadvantages of FDCs:
    • If an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction.
    • If the drugs combination is not appropriate, then it can lead to some patients getting too much of an ingredient and others getting too little. FDCs "limit clinicians' ability to customize dosing regimens."


Q1) What are active pharmaceutical ingredients (APIs)?

Active ingredients are the substances in drugs that are responsible for the beneficial health effects experienced by consumers. The active ingredient in a pharmaceutical drug is called an active pharmaceutical ingredient (API). An example of an API is the acetaminophen contained in a pain relief tablet.

Source: Government bans 14 combination drugs used to treat common ailments