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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| Active Pharmaceutical Ingredient (API) is the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended therapeutic effects. |
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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Drugs and Cosmetics Act, 1940
- It regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licenses and permits.
- Its main objective is to ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards.
- The associated Drugs and Cosmetics Rules, 1945 (formulated in association with the 1940 Act), provide provisions for classifying medications into schedules and instructions for the storage, sale, presentation, and prescription of each schedule.
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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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August 28, 2024
