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Govt. Bans 14 Fixed Dose Combination (FDC)


The Union Health Ministry has published a gazette notification banning 14 Fixed Dose Combination (FDC) drugs citing lack of therapeutic justification and an expert committee’s recommendation for their prohibition.


GS II: Government policies and Interventions

Dimensions of the Article:

  1. About Fixed Dose Combination (FDC) Drugs
  2. Advantages of FDC Drugs
  3. Challenges of FDC Drugs

About Fixed Dose Combination (FDC) Drugs:

  • Combination products or fixed dose drug combinations (FDCs) consist of two or more active drugs in a single dosage form.
  • The Food and Drug Administration (FDA) in the USA defines a combination product as a product composed of a drug and a device, a biological product and a device, a drug and a biological product, or a drug, device, and a biological product.
  • It is widely accepted that most drugs should be formulated as single compounds.
Acceptability of Fixed Ratio Combination Products
  • Fixed ratio combination products are acceptable only under specific conditions:
    • The dosage of each ingredient meets the requirement of a defined population group.
    • The combination demonstrates a proven advantage over single compounds administered separately in terms of therapeutic effect, safety, or compliance.
Popularity in the Indian Pharmaceutical Market
  • FDCs are highly popular in the Indian pharmaceutical market.
  • They have experienced significant growth in recent years.

Advantages of FDC Drugs:

  • Complementary Mechanism of Action: FDC formulations combine drugs with complementary mechanisms of action, which can enhance the therapeutic effectiveness of the treatment. The combined action of multiple drugs in a single dosage form can target different aspects of a disease or provide a more comprehensive treatment approach.
  • Synergistic Effects: FDCs can exhibit synergistic effects, where the combined action of the drugs produces a greater therapeutic effect compared to individual drugs used alone. This can result in improved efficacy and better treatment outcomes for patients.
  • Better Tolerability: In some cases, combining drugs in an FDC can help reduce side effects or improve tolerability. The interaction between the drugs can minimize adverse reactions, making the treatment more manageable for patients.
  • Elongated Product Life-Cycle Management: FDC formulations can extend the life cycle of a product by combining drugs that have already been individually approved. This allows pharmaceutical companies to innovate and offer new treatment options without going through the lengthy process of developing and gaining approval for completely new drugs.
  • Cost Savings: FDCs can lead to cost savings for both patients and healthcare systems. By combining multiple drugs into a single formulation, the overall cost of treatment may be reduced. This can make the medication more affordable and accessible, particularly in resource-constrained settings.
  • Minimized Pill-Burden: Using FDCs reduces the number of pills a patient needs to take. This can simplify treatment regimens and improve patient adherence to medication schedules, especially for individuals who need to take multiple drugs regularly.

Challenges of FDC Drugs:

  • Increased Chances of Adverse Drug Effects and Interactions: FDC drugs have a higher likelihood of causing adverse drug effects and drug interactions compared to individual drugs given separately.
  • Irrational FDCs: Unfortunately, in many cases, FDCs introduced in India and possibly in other regions are deemed irrational. This means that the combinations may lack scientific justification or evidence of their efficacy and safety. The use of such irrational FDCs can pose significant risks to patients.
  • Risk of Adverse Drug Reactions: The use of irrational FDCs exposes patients to unnecessary risks of adverse drug reactions. Since the combinations may not have undergone rigorous testing or may lack sufficient clinical data, patients may be subjected to potential harm without clear benefits.
  • Financial Burden: Irrational FDCs impose an unnecessary financial burden on consumers. Patients may end up paying for combination products that provide no additional therapeutic value compared to individual drugs. This can lead to increased healthcare costs and limited access to essential medications.
  • Legal Controversy: Medical practitioners who prescribe or endorse irrational FDCs may face controversy and legal challenges, particularly when patients experience adverse effects or unsatisfactory outcomes. In consumer forums and litigation, the use of such combinations may be questioned due to their absence from standard references and reputable medical journals.
  • Promotional Practices: Pharmaceutical manufacturers may continue to promote and market FDCs, regardless of their rationality, to benefit from high sales. This can perpetuate the use of unnecessary combinations and hinder the adoption of evidence-based treatment approaches.

-Source: The Hindu

December 2023