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These were banned due to the concerns about their irrationality and potential risks to human health with safer alternatives available.
- Previously, 344 combination drugs in 2016 and 14 FDCs in 2023 were also banned.
About FDC
- These are the combination of two or more Active Pharmaceutical Ingredients (APIs) in fixed ratios and also known as 'cocktail drugs'.
- APIs are the biologically active component of a drug product that produces the intended effects.
Benefits of the FDC
- Targeting multiple disease pathways: Leading to improved response rates and rapid actions.
- Minimises pill burden: Fewer pills ensures greater adherence and better outcomes. Eg, a single pill for fever, cough, and pain can foster better compliance.
- Beneficial for treating chronic illness: Like TB, diabetes, etc.
- It has a pharmacokinetic advantage.
- Pharmacokinetics is defined as the study of absorption, distribution, metabolism, and excretion of drugs by the body.
Concerns with FDC
- Physiological or Chemical reaction: Opposing/Antagonistic combination can lead to enhanced toxicity, reduced efficacy, etc.
- Decreased Shelf life: In case of chemical incompatibility between the two drugs.
- Growing antibiotic resistance: Sale of unapproved or banned FDCs containing antibiotics.
Rules Governing FDC in India
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