9th December 2023 (8 Topics)
1
Dec
2
Dec
4
Dec
5
Dec
6
Dec
7
Dec
8
Dec
9
Dec
11
Dec
12
Dec
13
Dec
14
Dec
15
Dec
16
Dec
18
Dec
19
Dec
20
Dec
21
Dec
22
Dec
23
Dec
25
Dec
26
Dec
27
Dec
28
Dec
29
Dec
30
Dec
India’s alarming ‘fixed dose combination’ problem
Context:
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.
You must be logged in to get greater insights. click here to login
More Articles
Courses
Study
Notes
Home
Resources
More
