Fixed-Dose Combinations (FDCs)

Source- This post on Fixed-Dose Combinations (FDCs) has been created based on the article “What are combination drugs; why have 156 of them been banned?” published in “Indian Express” on 28th August 2024.

Why in News?

The government has banned 156 fixed-dose combination (FDC) drugs, including popular medicines like Cheston Cold, used for colds and fever, and Foracet, used for pain relief.

About Fixed-Dose Combinations (FDCs)

1. Definition: Fixed-Dose Combinations (FDCs) are medications that combine two or more active ingredients into one form, such as a pill, capsule, or injection.

2. Purpose: FDCs help patients who need multiple medications, like those with tuberculosis or diabetes, by reducing the number of pills they need to take daily. This can improve their adherence to treatment.

3. Examples of Banned FDCs:

Anti-Allergy Combinations: Such as Levocetirizine with a nasal decongestant and syrups that break down mucus, combined with paracetamol.

Skin Treatments: Combinations like menthol with aloe vera, and aloe vera with vitamin E in medicated soaps; silver sulfadiazine (for burns) with an antiseptic, aloe extract, and vitamin.

Migraine Medication: Combined with another drug to prevent nausea.

Pain Relief for Menstrual Cramps: Mefenamic acid combined with anti-fibrotic medicine tranexamic acid.

Reasons for the Recent Ban on 156 FDCs:

1. Lack of Therapeutic Benefits: The banned FDCs were considered “irrational” because they offered no significant health benefits. The ingredients did not work well together or included unnecessary components.

2. Increased Antibiotic Resistance: Unnecessary combinations, especially involving antibiotics, contribute to resistance, making infections harder to treat and requiring stronger antibiotics.

3. Regulatory Changes: New rules since 2019 classify FDCs as new drugs, requiring approval by the central drug regulator, which has reduced the number of irrational combinations in the market.

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