Subject: Science & Technology

Rapid advancements in pharmaceutical research have led to the development of innovative drug delivery systems, among which Fixed-Dose Drug Combinations (FDCs) have emerged as a significant therapeutic approach, combining two or more active pharmaceutical ingredients in a single dosage form.

Understanding Fixed-Dose Drug Combinations (FDCs)

• FDCs are pharmaceutical products that contain fixed doses of two or more active drugs combined in a single dosage form, designed to simplify drug administration and improve treatment outcomes.
• They are widely used in treating various conditions like tuberculosis, diabetes, and malaria through programs like National Tuberculosis Elimination Program (NTEP).
• According to recent studies, 57% of non-DOTS tuberculosis prescriptions in central India utilized FDCs, demonstrating their widespread adoption.

Merits of FDCs

• Enhanced Patient Compliance:

  • Reduces pill burden and simplifies dosing schedule.
  • Improves adherence to treatment regimens, particularly in chronic diseases.

• Better Treatment Outcomes:

  • The artesunate-mefloquine (ASMQ) FDC registered in India has shown high efficacy in malaria treatment.
  • A 2025 study demonstrated that dapagliflozin-saxagliptin FDC effectively improved glycemic control in type 2 diabetes patients.

• Cost-Effectiveness:

  • Reduces packaging, distribution, and storage costs.
  • Makes treatment more affordable for patients.

Demerits and Challenges

• Safety Concerns:

  • Between 2023-2025, India banned 205 FDCs due to safety concerns and lack of therapeutic justification.
  • 14 FDCs were banned in 2023 alone due to potential health risks.

• Regulatory Issues:

  • 35 FDCs were withdrawn as they were approved without mandatory safety evaluations.
  • Difficulty in adjusting individual drug doses within the combination.

• Drug Resistance Risk:

  • Inappropriate use may contribute to antimicrobial resistance.
  • Limited flexibility in dose modification based on individual patient needs.

The future of pharmaceutical care lies in balancing the benefits and risks of FDCs through robust regulatory frameworks like the Central Drugs Standard Control Organization (CDSCO) guidelines and evidence-based medicine practices to ensure patient safety and therapeutic efficacy.