What are Fixed Dose Combination Drugs (FDCs)? Enumerate the concerns associated and despite all the harms why they are so popular in India?

Published: June 7, 2019

A fixed drug combination is combination of two or more Active Pharmaceutical Ingredient (API) combined in a single dosage form. Fixed dose combinations (FDCs) were declared irrational by a Health Ministry expert committee set up in 2014.
Concerns associated:

  • FDCs are ineffective, hazardous or simply inappropriate
  • The drugs lacked the therapeutic value
  • Some drugs are unsafe and promoted antibiotic resistance
  • 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
  • Unapproved FDCs mainly affects those who get treated in the private sector
  • If there is an adverse reaction from an FDC, it may be difficult to identify the ingredient responsible for causing the reaction
  • Pharmaceutical companies may also try to evergreen their patents by obtaining exclusive rights to sell an FDC, even though the patent for individual components have expired

Reasons for Popularity of FDCs:

  • Increased efficacy
  • Better compliance
  • Reduced cost
  • Useful in the treatment of infectious diseases like HIV, malaria and tuberculosis
  • Useful for chronic conditions especially, when multiple disorders co-exist
  • Reduce the pill burden by reducing the number of pills to be taken by the patients

India has a double challenge- to phase out irrational antibiotic FDCs in the private sector that are contributing to resistance generation, and to phase in the WHO-recommended daily FDC regimen for drug-sensitive TB to the national TB programme.

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