India’s alarming ‘Fix Dose Combination’ problem

India’s alarming ‘Fix Dose Combination’ problem

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

What are FDCs?
• Fixed-dose combination (FDC) medications are a blend of two or more active pharmaceuticals administered in a single dose. They are common in the treatment of various diseases such as hypertension, diabetes, HIV, HCV, pain, and respiratory disease.
• An example of a fixed-dose combination (FDC) HIV drug is Atripla, a combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate.

Key Findings of study:
• 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.
• Unregulated FDCs contribute to Antibacterial Microbial Resistance (AMR), posing a significant health risk amid rising prevalence in India.
• FDCs improve patient compliance, especially for diseases like AIDS, enhancing treatment outcomes through combined formulations.
• Crafting FDCs, despite known drug safety, poses challenges due to potential side effects and interactions, necessitating a rigorous approval process.
• Indian pharmaceutical firms exploit FDCs to avoid price control laws, introducing a plethora of medically unjustifiable combinations for profit and Lack of standards for testing FDC quality benefits manufacturers, allowing self-provided standards.

What is the role of regulators?
• Regulatory shortcomings allow unchecked proliferation of dubious FDCs. Manufacturers exploit loopholes in the absence of set standards.
• Doctors, often presuming regulatory diligence, contribute to the issue by prescribing FDCs.

Way Forward
• Experts suggest need for the Ministry of Health to intervene and address the incompetence of the drug regulatory framework in India.