UPSC Mains 2013 GS Paper 3 Q14: model answer
What do you understand by Fixed Dose Drug Combinations (FDCs)? Discuss their merits and demerits.
What the question wants
Explain what fixed dose drug combinations are and discuss their merits and demerits.
How to structure it
Meaning, merits, demerits, regulation.
- Definition
- Merits
- Demerits
- India's regulatory story
How to think it through
FDC: two or more active ingredients in a fixed ratio in one dose form. Rational FDCs: TB (rifampicin + isoniazid), HIV ART, malaria ACT, hypertension polypill. Merits: compliance, lower pill burden, cost, synergy, less resistance. Demerits: irrational combinations, dose inflexibility, side effects, AMR, approved by states without central approval. Kokate Committee 2016; ban on 344 FDCs March 2016; SC 2017 sent back to DTAB; 328 banned 2018; 156 banned August 2024.
Model answer
In India, a person with a cough can buy a single tablet with an antibiotic, a painkiller and an antihistamine mixed together. Many such pills have no scientific basis. Fixed dose combinations can be life-saving or simply irrational.
What FDCs are
- Two or more active drugs combined in a fixed ratio in one tablet, capsule or syrup.
- Rational examples: TB drugs (rifampicin with isoniazid), HIV antiretrovirals, artemisinin combination therapy for malaria.
Merits
- Better compliance: fewer pills, so patients complete treatment.
- Synergy: drugs act together, sometimes at lower doses.
- Less resistance in TB, HIV and malaria when drugs are always taken together.
- Lower cost and simpler logistics for public programmes.
- WHO Essential Medicines List includes several rational FDCs.
- Polypill for heart disease in older patients.
Demerits
- Irrational combinations with no added benefit.
- No dose flexibility: one drug may be overdosed to get the other right.
- Hidden ingredients: patients do not know what they are taking.
- More side effects and drug interactions.
- Antibiotic misuse, driving AMR.
- Many were licensed by state regulators without central approval.
The Indian story
- The Kokate Committee reviewed FDCs; 344 were banned in 2016.
- After the Supreme Court sent the matter to the DTAB, 328 were banned in 2018.
- Another 156 FDCs were banned in August 2024.
Combinations are good medicine when science chooses them and bad business when marketing does.
Draw: Two pills side by side: a rational TB FDC and an irrational cough syrup mix.
Keywords, cases and data to drop in
FDC, rational vs irrational, ACT, TB FDC, ART, polypill, compliance, AMR, Kokate Committee, 344 banned 2016, DTAB, 328 banned 2018, 156 banned 2024, CDSCO.
Where most answers lose marks
- Writing only demerits. The question asks for merits too.
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Question text as printed in the official UPSC Civil Services (Main) question paper. The model answer is original Battle IAS work; use it to learn structure, not to memorise.
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