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Fixed Dose Combinations (FDCs)

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  • According to a study, of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator.
  • As of April, the CDSCO had approved 1,288 FDCs. This is disproportionately high compared with the availability in a tightly regulated market like USFDA, which has only a few hundred approved FDCs.

Combination medicines (or fixed-dose combination [FDC] medicines) are:

  • medicines containing two or more active components in fixed proportions in a single dosage form
  • Several medications in fixed combination to be taken together, presented in composite packaging (co-pack).


  • India is one of the world’s largest markets for fixed dose combination drugs that make up almost half the market share but medical experts say most of them are irrational, that is they haven’t been approved by the national regulator. Many of them slip through India’s labyrinthine regulation process with agencies at the central and state level, which often don’t coordinate.
  • The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. Such combinations of drugs are being used in the treatment of a wide range of conditions and are particularly useful in the management of HIV/AIDS, malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.
  • FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio of doses has been shown to be safe and effective and when all of the actives contribute to the overall therapeutic effect. In addition there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects, but such claims should be supported by evidence.
  • Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution, improved patient adherence and reduced development of resistance in the case of antimicrobials.


Vishal Thakur By - Vishal Thakur
Posted On - 12/10/2018 12:00:00 AM

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