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9th December 2023 (9 Topics)

India’s alarming ‘fixed dose combination’ problem


A recent study exposes rampant sale of unapproved and banned antibiotic FDCs in India, fueling antibacterial resistance; regulatory and market challenges persist.

Alarming Proliferation of Unapproved Antibiotic FDCs

  • Concerning Study Findings: Academics reveal in the Journal of Pharmaceutical Policy and Practice that 60.5% of antibiotic Fixed Dose Combinations (FDCs) were unapproved, and 9.9% were banned in India in 2020.
  • AMR Threat: Unregulated FDCs contribute to Antibacterial Microbial Resistance (AMR), posing a significant health risk amid rising prevalence in India.
  • Medical Rationale for FDCs: FDCs improve patient compliance, especially for diseases like AIDS, enhancing treatment outcomes through combined formulations.

Challenges and Misuse in FDC Production

  • Complex Formulation Process: Crafting FDCs, despite known drug safety, poses challenges due to potential side effects and interactions, necessitating a rigorous approval process.
  • Industry Exploitation: Indian pharmaceutical firms exploit FDCs to avoid price control laws, introducing a plethora of medically unjustifiable combinations for profit.
  • Quality Standards and Price Manipulation: Lack of standards for testing FDC quality benefits manufacturers, allowing self-provided standards; FDCs offer companies a pretext for charging higher prices.

Role of Regulators, Doctors, and Market Dynamics

  • Regulatory Gaps: Regulatory shortcomings allow unchecked proliferation of dubious FDCs; manufacturers exploit loopholes in the absence of set standards.
  • Market-driven Pseudo-Innovation: FDC strategy incentivizes companies to create pseudo-innovations, enabling higher pricing until market competition catches up.
  • Doctor's Role: Doctors, often presuming regulatory diligence, contribute to the issue by prescribing FDCs; a complex interplay of market dynamics demands urgent regulatory intervention.
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