The Indian government has recently banned 156 Fixed-Dose Combination (FDC) drugs.
What are Fixed-Dose Combination (FDC) drugs?
Fixed-dose combination (FDC) drugs are medications that combine two or more Active Pharmaceutical Ingredients (APIs) in a single dosage form, such as a pill, capsule, or injection.
These drugs are often prescribed for conditions requiring multiple medications, such as tuberculosis, diabetes, and hypertension, to enhance patient compliance by reducing the number of pills taken daily.
The rationale for the Ban: The banned FDCs were deemed "irrational" by the central government, as they do not provide any additional therapeutic benefits.
The combinations in these FDCs may involve ingredients that either do not work synergistically or include unnecessary components that do not require simultaneous administration.
Benefits: FDCs can improve patient compliance, especially for chronic diseases where multiple medications are required.
Risks: Some FDCs may include unnecessary components, leading to patients consuming drugs they don't need.
For example, Cheston Cold includes paracetamol, cetirizine, and phenylephrine, which are not necessary for treating bacterial infections but are used for managing cold symptoms.
Banned FDCs: The recent ban includes various drug combinations:
Gastrointestinal treatments: Enzyme combinations for digestive issues.
Anti-allergy treatments: Combinations of levocetirizine with nasal decongestants, and cough syrups with mucus-breaking properties.
Skin treatments: FDCs like menthol with aloe vera, and silver sulfadiazine with antiseptics.
Migraine and menstrual pain: Combinations for treating migraines and menstrual cramps.
Erectile dysfunction: Combinations involving sildenafil (Viagra) with other drugs affecting blood vessels and muscles.
Concerns with FDCs:
Overuse of antibiotics: Some FDCs include combinations of antibiotics, leading to their overuse and contributing to the growing issue of antibiotic resistance. This occurs when bacteria become resistant to commonly used antibiotics, necessitating stronger or higher doses for treatment.
Lack of therapeutic justification: Many FDCs combine drugs that do not require co-administration, potentially exposing patients to unnecessary medications, which could result in adverse effects.
Avoidance of pricing control: Some pharmaceutical companies create FDCs to circumvent government-imposed price controls on essential medicines. By introducing new combinations, they can set higher prices, undermining efforts to make essential drugs affordable.
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