11-December-2023-Editorial

INDIA’S ALARMING ‘FIXED DOSE COMBINATION’ PROBLEM

A recent study has exposed a concerning reality in India’s pharmaceutical landscape, revealing that a significant portion of fixed-dose combination (FDC) antibiotics sold in the country is either unapproved or banned. FDCs involve combining multiple drugs into a single dosage form, aiming to enhance patient compliance and treatment outcomes. However, their unregulated proliferation raises serious issues, impacting drug efficacy, legal accountability, and contributing to antimicrobial resistance (AMR).

Issues with Fixed Dose Combinations (FDCs):

Reduced Drug Efficacy: Interaction of active or inactive ingredients in FDCs may compromise drug effectiveness or generate toxic byproducts.

Legal Loopholes: FDCs escape price control regulations, providing manufacturers a way to circumvent legal scrutiny under the Drugs (Prices Control) Order.

Unwarranted Combinations: Many FDCs lack medical justification, combining unrelated drugs, such as anti-inflammatories with vitamins.

Lack of Quality Standards: Regulatory bodies lack established quality standards for FDCs, leading to challenges in holding manufacturers accountable for substandard products.

Higher Costs: Manufacturers exploit FDCs’ unique product status to charge higher prices, impacting healthcare costs.

Weak Licensing Norms: State drug controllers often issue licenses for unapproved FDCs, overlooking regulatory requirements.

Legal Complexities: Prohibition orders from the Ministry of Health face legal challenges, resulting in inconsistent decisions and continued manufacturing of problematic FDCs.

Contributing to AMR: Unregulated FDCs contribute to antimicrobial resistance, a grave public health concern.

Antimicrobial Resistance (AMR):

AMR occurs when microbes evolve to resist the effects of antimicrobial treatments, rendering medications ineffective against them. Superbugs, resilient strains of microorganisms, emerge as a consequence, posing severe challenges to public health.

Types of Antimicrobial Resistance:

Natural Resistance: Microbes possess inherent structural characteristics that confer resistance without exposure to antimicrobials.

Acquired Resistance: Genetic changes in microbes make them resistant to previously effective antimicrobials.

Cross Resistance: Resistance against drugs with similar mechanisms or structures, whether related or unrelated.

Multi-drug Resistance and Pan-resistance: Bacteria become resistant to multiple antibiotics, limiting treatment options.

Conclusion:

The prevalence of unapproved and banned FDC antibiotics in India is a critical issue that demands urgent attention. The adverse consequences, ranging from compromised drug efficacy to contributing to AMR, highlight the need for a robust regulatory framework. Scientifically designed approval processes are essential to ensure the safety and effectiveness of FDCs, thereby safeguarding public health and mitigating the growing threat of antimicrobial resistance.