2013 · GS Paper 3 · Q14 · 10 marks
What do you understand by Fixed Dose Drug Combinations (FDCs) ? Discuss their merits and demerits.
In short
A Fixed Dose Combination puts two or more drugs in a fixed ratio into one dosage form, improving adherence and slowing resistance in TB, HIV and malaria but causing dose rigidity and hidden toxicity when irrational. India banned 344 FDCs in 2016, 328 in 2018 and 156 in 2024.
Model answer
Ghissu Editorial · Verified 4 Oct 2026 · 304 words
Better adherence
Fewer pills help patients finish long courses, so India's TB programme adopted daily four-drug FDC tablets in 2017.
Curbing resistance
Drugs taken together cannot be taken alone, the logic of WHO's artemisinin combinations for malaria.
Synergy
Clavulanic acid protects amoxicillin, and the tenofovir-lamivudine-dolutegravir pill simplifies HIV care.
Lower cost
One product is cheaper to make, stock and distribute, the logic behind the Indian Polycap Study (2009) of a single heart-disease pill.
Dose rigidity
One ingredient cannot be adjusted alone, risking wrong doses in children, the elderly and kidney patients.
Hidden toxicity
An adverse reaction is hard to trace to one ingredient, and patients take drugs they do not need.
Regulatory loophole
State licences without central approval let unapproved FDC antibiotics flood the market, as a British Journal of Clinical Pharmacology study found, feeding antimicrobial resistance.
Repeated bans
After the Kokate Committee's review, 344 FDCs were banned in 2016 and 328 in 2018 on the Drugs Technical Advisory Board's advice.
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