About Fixed Dose Combination (FDC) Drugs

What’s in today’s article?

• Why in News?
• About Fixed Dose Combination (FDC) Drugs
• Challenges/Demerits of FDC Drugs
• News Summary

 

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.

 

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 ost 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, as 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.

 

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Q1) What is Red Line Campaign by Union Health Ministry?

MoHFW launched Red Line awareness campaign on Antimicrobials Resistance, urging people not to use medicines marked with a red vertical line, including antibiotics, without a doctor's prescription.

 

Q2) What is Jan Aushadhi Kendra?

Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) is a campaign launched by the Department of Pharmaceuticals to provide quality medicines at affordable prices to the masses.

 

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