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Health Care Policy Summary

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Executive Summary: WHO defines fixed dose combination (FDC) as ‘a combination of two or more actives in a fixed ratio of doses’. In other words, FDC includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses. WHO has made it clear that, fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance. Accordingly, 19th WHO Model List of Essential Medicines, contains only 27 FDCs out of 414 total medicines. On the contrary, Indian pharmaceutical market is flooded with unnecessary, expensive, hazardous, irrational FDCs. Recent ban by MoHFW on 344 FDCs has again brought attention to these irrational formulations in market. The need of a drug policy guiding the rational use of FDC drugs is stressed more than ever. The following policy brief will address the possible actionable policy options for rational use of FDC drugs. These will include legal, regulatory and promotional measures, which will reinforce and expand the efforts of the Government to ensure that, the irrational FDCs are not manufactured, prescribed, sold or used. Context: Ministry of Health and Family Welfare, Government of India banned production, sale and marketing of 344 FDC drugs, with an immediate effect, through

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