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.