Fixed Dose Combinations and their Ban Issues of Concern

S. Srinivasan

Abstract


Debates about health-care policy are central to the understanding of the welfare state. One of the mandates of the state is to ensure the sale of safe medicines as also the need for withdrawing harmful drugs the moment it is known to be harmful. Out of the more than one lakh crore rupee sales in the country, almost 45 per cent are FDCs of which 50 per cent are irrational. That is around R 25,000 crore and a lot of which is outright waste of money of the patient on unnecessary ingredients in these irrational FDCs. These irrational FDCs may, in addition, cost the patient much more by way of serious adverse effects and even death. The large FDC market that includes irrational antibiotic combinations also contribute largely to antimicrobial resistance so that routine antibiotics do not work when they ought to. This article highlights how the government of India was forced, due to the scathing reports submitted by the Standing Committee examining Central Drugs Standard Control Organisation, to take steps to ban irrational FDCs. It also critically evaluates the verdict given by Delhi High Court that quashed the government of India’s attempt to ban irrational FDCs.


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