Govt gives nod to sale of 2 rational FDC drugs

These FDC drugs, which combine two or more drugs in fixed doses, were deemed rational by an expert committee.

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Approval approved
Picture: Pixabay

Last Updated on December 31, 2023 by The Health Master

Rational Fixed Dose Combination

The Indian government has granted approval for the manufacture and marketing of two Fixed-Dose Combination (FDC) drugs, namely:

  • Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate (used for cough relief).
  • Imipramine + Diazepam (used to treat depression).

These FDC drugs, which combine two or more drugs in fixed doses, were deemed rational by an expert committee.

Approval and Post-Market Surveillance:

Out of the 19 FDCs reviewed by the expert committee, three others were also found to be rational. However, these three FDCs require additional data generation.

Despite this, the government has permitted their manufacture and marketing, subject to post-market surveillance and reporting on the data regarding their medicinal value.

Ban on Irrational FDCs:

A government notification has announced the prohibition of 14 FDCs that were deemed “irrational” for manufacture and marketing.

Among these banned combinations are Nimesulide and Paracetamol, used for pain relief, and Chlopheniramine Maleate and Codeine syrup, utilized for treating dry cough.

Related news: Govt prohibits 14 FDC Drugs, Citing Safety Concerns

Additional Banned FDCs:

The list of prohibited FDC drugs includes the combinations:

  • Pholcodine + Promethazine,
  • Amoxicillin + Bromhexine,
  • Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol,
  • Paracetamol + Bromhexine Phenylephrine + Chlorpheniramine + Guaiphenesin,
  • and Salbutamol + Bromhexine.

The union health ministry issued a notification regarding this ban on Friday.

Understanding Fixed-Dose Combination (FDC):

FDC refers to the combination of two or more drugs in fixed ratios to create a single dosage form.

In a 2016 editorial published in the Indian Journal of Pharmacology, Dr. Y. K. Gupta, former head of the pharmacology division at AIIMS, and Dr. Suganthi S. Ramachandra classified the available FDCs in India into three categories: The Good, the Bad, and the Ugly FDCs.

Categorizing FDCs:

Good FDCs: The “Good” FDCs are those with strong justifications, such as:

  • Carbidopa + levodopa,
  • Sulfonamides + trimethoprim,
  • Antitubercular drugs,
  • Antiretroviral drugs,
  • Some antihypertensives,
  • Certain antidiabetic medications.

Bad FDCs: On the other hand, the “BadFDCs are primarily formulated for marketing purposes and provide little therapeutic value, raising debates about their justification. Examples of “Bad” FDCs include:

  • Combinations of dual nonsteroidal anti-inflammatory drugs (NSAIDs),
  • NSAIDs with muscle relaxants,
  • NSAIDs with H2 blockers.

Ugly FDCs: Lastly, the “UglyFDCs lack both evidence and theoretical justifications, such as formulations containing:

  • Cough syrups with multiple antihistamines,
  • Decongestants,
  • Bronchodilators,
  • Cough suppressants,
  • Expectorants,
  • Combinations of antifungal,
  • Antibiotic,
  • Steroid,
  • Topical local anesthetics.

Challenges and Ubiquity of FDCs:

The editorial attributed the prevalence of FDCs to the challenges faced in developing new chemical entities, with pharmaceutical companies finding it easier to develop FDCs.

India’s generic drug market, driven by intense competition among multiple manufacturers after patent expirations, often leads to the creation of FDCs claiming multiple advantages without scientific validation.

As of 2016, it was estimated that India had over 6,000 FDCs available.

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