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.