Note4Students

From UPSC perspective, the following things are important :

Prelims level: Fixed dose combination (FDC) Drug

Mains level: Not Much

fdc drug ban

Central Idea: Exploring the recent ban on 14 fixed dose combination drugs in India and its rationale.

What are FDC Drugs?

Definition: FDC drugs are combinations of active ingredients in a fixed ratio, commonly used in a single pill or syrup.
Benefits offered: FDCs can reduce pill burden, improve adherence to therapy, and lower costs.
Risks associated: Certain combinations can be pharmacologically incompatible, have abuse potential, and contribute to antibiotic resistance.

Issue of Irrational FDCs

Licensed FDCs: FDCs introduced for the first time require prior approval, while many older FDCs were licensed without proper scrutiny.
Lack of safety: Lack of evidence on safety and efficacy led to the categorization of many licensed FDCs as irrational.
Legal challenges: A ban on 344 FDCs in 2016 was stayed by the Delhi High Court, prompting further review and subsequent ban on 329 FDCs in 2018.

Referral to Drugs Technical Advisory Board: The Supreme Court entrusted the review of FDC drugs to the government’s expert body.
Ban on 14 Pre-1988 FDCs: An expert committee recommended banning certain FDCs licensed before 1988.
Balancing Prior Approvals and Inquiry: The Supreme Court excluded 15 FDCs licensed prior to 1988 from the ban but allowed for an inquiry.

Impact on Drug Availability: The ban affects approximately 40-50 brands used for cough, fever, pain, and common infections.
Support from Pediatricians: Many pediatricians welcome the ban, citing harmful combinations in FDC drugs.
Call for Additional Scrutiny: Calls to consider banning Nimesulide for single-dose use due to liver risks.

Conflicting Effects of Ingredients: Experts highlight how ingredients in cough syrups may work against each other, reducing their efficacy.
Limited Evidence on Cough Syrups: Weak evidence suggests cough syrups may not significantly reduce cough duration.
Caution for Cough Suppressants: Prescription-only use is advised, particularly for individuals with underlying lung conditions.

Economic Savings and Improved Quality of Life: The ban may lead to cost savings and enhanced well-being for individuals.
Importance of Safe Drinking Water: Access to clean drinking water is crucial for public health and overall quality of life.
Evidence-Based Decision-Making: Ensuring the safety and effectiveness of medical treatments through research and evaluation.
Addressing Emerging Health Challenges: Continuous monitoring and research are necessary to tackle evolving health risks.
Optimizing Healthcare Practices: Ongoing efforts to improve healthcare systems and practices for better patient outcomes.

Conclusion

The recent ban on 14 fixed dose combination (FDC) drugs in India highlights the government’s commitment to ensuring the safety and efficacy of pharmaceutical products.