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The Union Health Ministry has recently banned 156 “irrational” fixed dose combinations (FDC) medicines which includes antibiotics, painkillers, and multivitamins.
Many banned FDCs were approved by state authorities but lacked adequate research or trials to confirm their safety and efficacy.
The ban aims to protect public health by preventing potential risks from these combinations and curbing misuse and resistance issues.
Fixed Dose Combinations (FDC) medicines
As per Rule 122-E of Drugs & Cosmetics Rule 1945, FDCs are medicines that have two or more active ingredients in a single pill, capsule or shot.
These are intended to treat multiple symptoms or conditions at once.
An FDC is a new drug when it meets two conditions
It combines two or more drugs already approved for individual use in a fixed ratio.
It alters the ratio of drugs in an already approved FDC, along with making changes to its claims
Mostly FDCs are in combinations of cough, cold, and fever preparations; antimicrobials; vitamins and minerals etc.
Rationale for Usage of FDCs
Enhanced efficacy
Cost-effectiveness
Reduced pill burden
Improved adherence
Improved patient convenience
Issues associated with FDCs
Lack of individual dose flexibility
Unapproved and Banned FDCs
Increased risk of Anti-microbial Resistance (AMR)
Reduced transparency and affordability concerns
Ethical concern
Limited choice for patients
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