FIXED DOSE COMBINATION

UPSC GS MAINS IMPORTANT QUESTIONS

What do you understand by fixed dose drug combination(FDC'S). Discuss their merits and demerits.


Fixed Dose Combination(FDC) drugs are drugs having two or more active ingredients in a single dosage. They are widely used  to improve patience compliance as it is easier for them to take one drug than several. They are acceptable only if the drugs so combined have therapeutic advantage. Eg: Ibuprofen.




India is one of the world's largest markets for FDC drug that make up almost half of the market share.  

Central drug regulator of India(CDSCO)came out with the policy guideline for the approval of FDC's in 2013. DCG directed the manufacturers to prove the safety and efficiency of FDC's licensed prior to 1 Oct 2012, failing which production will be banned. 


Advantage of FDC's:


1. They provide benefits in terms of potentiating therapeutic efficiency.
2. They decrease the incidence of adverse effects of drugs.
3. They have pharmacokinetic advantages. 
4. They are cheaper than individual drugs due to reduced cost of packaging to distribution.
5. It lowers manufacturing and logistics cost.


Disadvantages of FDC's:


1. It could be unsafe for consumption as it has potential health risks associated with it.
2. These risks may not originally exist in the individual ingredient, but it increases its risk seriousness.
3. When side effect occurs, it is difficult to recognize which ingredient caused it.
4. Rampant use of FDC's enables anti-biotic resistance to grow at a significant rate. Eg. Ciprofloxacin resistant have made typhoid treatment very difficult.
5. FDCs are famous, not because of therapeutic effect but because of its low manufacturing cost and high demand.


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