India’s alarming ‘fixed dose combination’ problem
- December 9, 2023
- Posted by: OptimizeIAS Team
- Category: DPN Topics
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India’s alarming ‘fixed dose combination’ problem
Subject: Science and Tech
Section: Health
Concept:
- Antimicrobial resistance is at risk due to the study’s shocking findings on the frequency of antibiotics’ unapproved and illegal Fixed Dose Combinations (FDCs) in India.
- Public health requires immediate action in response to the pharmaceutical industry’s use of FDCs as a means of circumventing legislation and regulatory inefficiencies.
Historical Aspect:
- Tracing the issue back to 1978 and subsequent regulatory amendments provides context to the ongoing challenges.
Key Highlights:
- Alarming Prevalence: In 2020, 60.5% of antibiotics in India were unapproved FDCs, with an additional 9.9% banned, raising concerns about antimicrobial resistance.
- Patient Compliance vs. Risks: FDCs, aimed at improving patient adherence, pose risks due to potential interactions between combined drugs, necessitating a stringent approval process.
- Pharmaceutical Industry’s Strategy: Exploitation of FDCs allows the industry to evade drug price regulations, contributing to the proliferation of irrational combinations.
Key Terms:
- Fixed Dose Combination (FDC): Combinations of multiple drugs in a single dosage form, potentially affecting drug interactions and therapeutic efficacy.
- Antimicrobial Resistance (AMR): The ability of microorganisms to resist the effects of medications, posing a global health threat.
Key Challenges:
Continued sale of unapproved FDCs highlights regulatory inefficiency, allowing non-compliance despite existing legal provisions.
Reliance on Section 26A orders reveals a reactive rather than proactive regulatory approach, indicating systemic challenges.
Key Issues:
- Pharmaceutical Industry’s Exploitation: The strategic use of FDCs to avoid regulatory scrutiny undermines the integrity of drug pricing and quality.
- Ineffectiveness of Regulatory Measures: Despite legal provisions, the regulatory system relies on reactive prohibitions rather than proactive prevention.