Fixed Dosage combinations

• 14 fixed-dose combination (FDC) medicines found to lack therapeutic relevance have been banned by the Ministry of Health and Family Welfare
• The banned FDCs are part of 344 fixed-dose combinations prohibited for sale by the Union Health Ministry in 2016 but the makers of 15 such drugs challenged the decision in Delhi High Court.
• The ban, under Drugs and Cosmetics Act, 1940, comes after an expert committee recommended that there is no therapeutic justification for these FDCs and FDC may involve risk to human beings.
• The banned combinations include medicines used for cough, fever and infections, and are sold over the counter.

ABOUT FIXED-DOSE COMBINATION (FDC) DRUGS

• FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
• It may be administered as single entity products given concurrently or as a finished pharmaceutical product.
• Benefits
  • Patients benefit from added effects of two medicinal products given together.
  • They have been shown to appreciably reduce the risk of medication non-adherence, which is particularly important in patients with chronic diseases.
  • The FDCs are more economic than single ingredient
  • The manufacturing cost is quite low as compared to the cost of producing separate products.
• ISSUES RELATED TO FDCS-
  • Dosage alteration of one drug as per an individual patient’s need, is not possible.
  • The FDCs formulated without due diligence can pose problems namely pharmacodynamic mismatche. one drug having additive/antagonistic effect leading to reduced efficacy or enhanced toxicity.
  • FDCs do harm by encouraging irrational and indiscriminate use by people.

Irrational use of FDCs of antibiotics is among the major causes of antibiotic resistance in India.