Hindu Editorial Analysis : 5-June-2023

The Central Government has recently taken a significant step towards ensuring the efficacy and safety of medicines by banning fourteen fixed-dose combination (FDC) medicines through a gazette notification. The ban, which is effective immediately, comes after recommendations from an Expert Committee and the Drugs Technical Advisory Board. This essay explores the justification for the ban, provides a list of the banned combinations, and discusses the concept of FDCs, their advantages, and disadvantages.

Justification for the Ban

The ban on these FDCs stems from the Expert Committee’s findings, which concluded that there is no therapeutic justification for these combinations and that they may pose risks to human health. This decision reflects the government’s commitment to prioritize public health and ensure that medications provide the intended benefits without undue risks.

Banned Combinations

The banned FDCs encompass medicines used for common ailments such as cough, fever, and infections, which are often available over the counter. The list of banned combinations includes:

  1. Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
  2. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
  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
Understanding FDCs

Fixed-Dose Combinations (FDCs) are products that contain one or more active ingredients used for specific indications. FDCs can be categorized into four groups:

  1. FDCs with New Active Ingredients: These combinations involve at least one new drug. Approval for marketing such FDCs requires data submission similar to that of any new drug, including clinical trials.
  2. FDCs with Already Approved Ingredients: These combinations involve active ingredients that are already individually approved and marketed. The ingredients are combined for the first time to address specific claims, and there may be significant pharmacodynamic or pharmacokinetic interactions.
  3. Modified FDCs: This group comprises marketed combinations where changes in the ratio of active ingredients or new therapeutic claims are proposed. Approval for marketing such FDCs requires appropriate rationale and supporting published reports.
  4. Established Combinations: These FDCs consist of active ingredients widely used individually in the same indication(s) for an extended period. They are combined for convenience purposes without making additional claims.
Why In News

The Central Government has taken a significant step to ensure public safety by banning fourteen fixed-dose combination (FDC) medicines that were found to lack therapeutic relevance. This proactive measure, conveyed through a recently issued gazette notification, aims to safeguard the well-being of individuals by removing ineffective drug combinations from the market.

MCQs about Banning Ineffective FDC Medicines

  1. What is the primary reason behind the Central Government’s ban on fourteen fixed-dose combination (FDC) medicines?
    A. Lack of availability in the market
    B. High cost of FDC medicines
    C. Therapeutic irrelevance and potential risks
    D. Limited production capacity
    Correct Answer: C. Therapeutic irrelevance and potential risks
    Explanation: The government banned these FDC medicines because the Expert Committee found no therapeutic justification for them and highlighted potential risks to human health.
  2. FDCs can be divided into different groups based on:
    A. Availability in over-the-counter pharmacies
    B. Level of government regulation
    C. Number of active ingredients used
    D. Cost-effectiveness for patients
    Correct Answer: C. Number of active ingredients used
    Explanation: FDCs can be classified into groups based on factors such as whether the active ingredients are new drugs, already approved and combined for the first time, undergoing modifications, or established combinations.
  3. What is one advantage of using FDC medicines?
    A. Customized dosing regimens for patients
    B. Greater identification of active ingredient responsible for adverse reactions
    C. Improved medication compliance and reduced pill burden
    D. Enhanced solubility and dissolution properties
    Correct Answer: C. Improved medication compliance and reduced pill burden
    Explanation: FDC medicines simplify the medication regimen for patients, leading to better compliance by reducing the number of pills they need to take.
  4. What is one disadvantage associated with FDC medicines?
    A. Increased availability of appropriate drugs and strengths
    B. Clear identification of active ingredients in case of adverse reactions
    C. Compatibility issues among active ingredients during development
    D. Limited review and regulation by governing authorities
    Correct Answer: C. Compatibility issues among active ingredients during development
    Explanation: Scientists face challenges in developing FDC formulations due to compatibility issues among the active ingredients and excipients, affecting factors such as solubility and dissolution.

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