The government has banned 156 fixed-dose combination (FDC) drugs, including popular medicines such as Cheston Cold and Foracet, used for cold and fever and pain respectively.

Key highlights On Fixed Combination Drugs

• The ban is the most sweeping crackdown on FDCs since 2018, when 328 such drugs were banned.
  • A total of 499 FDCs have been banned since 2014.
• The ban was issued under section 26 A of the Drugs and Cosmetics Act, 1940 stating that there is “no therapeutic justification” for these medicines and they may involve “risk” to people.

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About Fixed Dose Combination

• Definition: Fixed Dose Combination (FDC) refers to a pharmaceutical product that contains two or more active ingredients combined in a fixed ratio in a single dosage to improve compliance.
• Usage: FDCs are commonly used in the treatment of infectious diseases, cardiovascular disorders, diabetes, and asthma. Eg Nimesulide, Paracetamol dispersible tablets etc.

Advantages of FDC Drugs 

• Complementary Mechanisms of Action: FDC formulations have unique advantages such as complementary mechanisms of action, synergistic effects, better tolerability, elongated product life-cycle management, and cost savings.

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• Optimal Therapeutic Benefits: Use of FDCs is a rational approach for achieving optimal therapeutic benefits while minimizing pill-burden.
• Improved Tolerability: The combined formulation can reduce side effects and improve patient adherence.
• Extended Product Life-Cycle: FDCs help in managing drug formulations over a longer period.
• Cost Savings: FDCs generally offer economic benefits by reducing overall treatment costs.
• Reduced Pill-Burden: FDCs minimize the number of pills a patient needs to take, simplifying treatment.

Risks associated with FDC

• Drug Interactions: Combining drugs can lead to interactions where active ingredients or excipients might alter each drug’s performance.
• Potential Toxicity: The drugs may interact with each other to create a more toxic element, often called metabolites.

Reasons for Banning Fixed Dose Combination (FDC) Drugs

• Ineffectiveness and Redundancy: Many FDCs were banned because they contained ingredients that did not work well together or included unnecessary components for patients, leading to ineffective or redundant treatment.
• Antibiotic Resistance: The ban targets combinations of antibiotics to prevent unnecessary use, which contributes to antibiotic resistance. Increased resistance necessitates stronger doses or new antibiotics for treating even simple infections.
• Increased Market Proportion: Despite bans, FDCs made up a growing proportion of antibiotic sales in India, indicating persistent issues with irrational combinations.
• Pricing Control Evasion: Companies often create FDCs to bypass pricing controls on essential medicines, manipulating costs to avoid regulatory pricing caps.
• Regulatory Failures: Initial approvals for FDCs were granted without adequate trials for the combinations, leading to the circulation of irrational drug mixes.
• Compliance with New Regulations: The government’s recent actions align with updated regulations requiring central approval for FDCs as new drugs, aiming to eliminate irrational combinations from the market.
• Historical Oversight: A 2012 parliamentary panel identified issues with irrational drug combinations. A 2014 committee reviewed 3,450 FDCs and found 963 to be irrational. Of these, 499 have been banned, highlighting ongoing efforts to address the problem.

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