Health Sector – UHC, National Health Policy, Family Planning, Health Insurance, etc.

The story behind the Ban on 14 FDC Drugs


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.

Government Action and Expert Review

  • 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.

Implications of the Ban

  • 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.

Cautions Regarding Cough Syrups

  • 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.

Socioeconomic impact of the Ban

  • 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.


  • 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.

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