Why in News?

• The Union Health Ministry has published a gazette notification banning 14 Fixed Dose Combination (FDC) drugs citing lack of therapeutic justification and an expert committee’s recommendation for their prohibition.

What’s in Today’s Article?

• About FDC Drugs (Meaning, Utility, Benefits, Challenges, etc.)
• News Summary

About Fixed Dose Combination (FDC) Drugs:

• Combination products, also known as fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form.
• The Food and Drug Administration, USA defines a combination product as ‘a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product’.
• It is widely accepted that most drugs should be formulated as single compounds.
• Fixed ratio combination products are acceptable only when –
  • The dosage of each ingredient meets the requirement of a defined population group and
  • The combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance.
• FDCs are highly popular in the Indian pharmaceutical market and have been particularly flourishing in the last few years.
• Advantages of FDC Drugs –
  • FDC formulations have unique advantages such as complementary mechanism of action, synergistic effects, better tolerability, elongated product life-cycle management, and cost savings.
  • Use of FDCs is a rational approach for achieving optimal therapeutic benefits while minimizing pill-burden.

Challenges/Demerits of FDC Drugs:

• There are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.
• Unfortunately, many FDCs being introduced in India are usually irrational.
  • The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions.
• Irrational FDCs also impose unnecessary financial burden on consumers.
  • Medical practitioners who patronize such combinations could be the centre of controversy when subjected to litigation in consumer forums.
  • This is due to the fact that these combinations do not find mention in standard text or reference books and reputed medical journals.
• Pharmaceutical manufacturers, however, continue to reap the benefits of huge sales, and therefore continue to promote combinations with vigour.

News Summary:

• The Central government has banned 14 Fixed Dose Combination (FDC) drugs which lacked therapeutic relevance.
• The banned combinations include medicines used for cough, fever and infections, and are sold over the counter.
• The ban, which comes into effect immediately, follows recommendations of an expert committee formed to examine the efficacy of these drug combinations.