Govt. Bans 14 Combination Drugs Used to Treat Common Ailments

Subject : Science and technology

Section: Health

Concept :

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 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.