FIXED-DOSE COMBINATION (FDCs): DEBATE

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    News

    • Fourteen fixed-dose combination (FDCs) medicines found to lack therapeutic relevance have been banned by the Central Government through a gazette notification issued over the weekend.

    Justification for Ban

    • The ban, which comes into effect immediately, follows recommendations of the Expert Committee formed to examine the efficacy of these drug combinations and the Drugs Technical Advisory Board.
    • The expert committee recommended that “there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings”.

    Banned Combinations Include

    • The banned combinations include medicines used for cough, fever and infections, and are sold over the counter.
    • The banned FDCs are part of 344 fixed-dose combinations prohibited for sale by the Union Health Ministry in 2016 but the makers of 15 such drugs challenged the decision in Delhi High Court.

    List

    1.       Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine

    2.       Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5 ml

    3.       Phenytoin + Phenobarbitone Sodium

    4.       Chlorpheniramine + Codeine Phosphate + Menthol Syrup

    5.       Salbutamol + Bromhexine

    6.       Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin

    7.       Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride

    8.       Nimesulide + Paracetamol dispersible tablets

    9.       Amoxicillin + Bromhexine

    10.   Pholcodine + Promethazine

    11.   Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol

    12.   Chlorpheniramine Maleate + Codeine Syrup

    13.   Ammonium Chloride + Bromhexine + Dextromethorphan

    14.   Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol

    What are FDCs?

    • According to the Central Drugs Standard Control Organisation (CDSCO), Fixed-Dose Combination (FDCs) refer to products containing one or more active ingredients used for a particular indication(s).

    FDCs can be divided into the following groups

    • The first group of FDCs includes those in which one or more of the active ingredients is a new drug. For such FDCs to be approved for marketing data to be submitted will be similar to data required for any new drug (including clinical trials).
    • The second group FDCs includes those in which active ingredients already approved/marketed individually are combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.
    • The third group of FDCs includes those which are already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim. For such FDCs, the appropriate rationale including published reports (if any) should be submitted to obtain marketing permission. Permission will be granted depending upon the nature of the claim and data submitted.
    • The fourth group of FDCs includes those whose individual active ingredients (or drugs from the same class) have been widely used in a particular indication(s) for years, their concomitant use is often necessary and no claim is proposed to be made other than convenience.

    Advantages of FDCs

    • Improved medication compliance by reducing the pill burden of patients. Pill burden is not only the number of pills needing to be taken, but also the associated burdens such as keeping track of several medications, understanding their various instructions, etc.
    • FDC formulations have unique advantages such as complementary mechanism of action, synergistic effects, better tolerability, elongated product life-cycle management, and cost savings. 
    • Since FDCs are reviewed by regulating agencies, the active ingredients used in the FDCs are unlikely to exhibit adverse drug interactions with each other.

    Disadvantages of FDCs

    • There may not be an FDC available with the appropriate drugs and/or in the most appropriate respective strength(s) for a given patient, which can lead to some patients getting too much of an ingredient and others getting too little. Thus FDCs “limit clinicians’ ability to customize dosing regimens.”
    • If an adverse drug reaction occurs from using an FDC, it becomes difficult to identify the active ingredient responsible for causing the reaction.
    • Scientists face challenges in the development stages of multi-drug formulations such as compatibility issues among active ingredients and excipients affecting solubility and dissolution.

    If one drug is contraindicated for a patient, whole FDC cannot be prescribed.

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