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.