Government Bans 14 Combination Drugs

• 06 Jun 2023

Why in News?

The Central Government of India has issued a gazette notification banning 14 fixed-dose combination (FDC) medicines commonly used to treat cough, fever, and infections.

• The ban, which takes immediate effect, follows recommendations from an expert committee appointed to assess the efficacy of these drug combinations.

What are FDC Medicines?

• Definition:
  • According to the Central Drugs Standard Control Organisation (CDSCO), FDCs refer to products containing one or more active ingredients used for a particular indication(s).
• Reason for the Ban:
  • The ban follows the recommendations of the expert committee and the Drugs Technical Advisory Board.
  • The committee concluded that the banned FDCs lack therapeutic relevance and may pose risks to human beings.

What are the Challenges of FDC?

• Increased Risk of Side Effects:
  • Combining multiple active ingredients in FDC drugs can lead to a higher risk of adverse drug interactions and increased susceptibility to side effects.
  • Some patients may experience heightened sensitivity or allergic reactions to one or more components of the FDC drug, which may be difficult to identify and manage due to the fixed combination.
  • For example, A combination of Paracetamol, Bromhexine, Phenylephrine, Chlorpheniramine, and Guaiphenesin in a single FDC drug may increase the risk of side effects such as drowsiness, dizziness, and elevated blood pressure.
• Regulatory Challenges:
  • Regulating FDC drugs can be challenging due to the complexities associated with evaluating the safety and efficacy of multiple active ingredients in a single formulation.
  • Ensuring quality control and standardization of FDC drugs becomes more demanding as compared to single-component medications.
• Overuse and Misuse:
  • FDC drugs can contribute to overuse and misuse of medications. Patients may unknowingly consume multiple active ingredients unnecessarily or in inappropriate combinations, leading to potential health risks.
• Lack of Evidence-based Clinical Data:
  • Some FDC drugs may have been approved based on limited or insufficient clinical evidence supporting their efficacy and safety profiles.
  • The absence of robust scientific data can raise concerns about the appropriateness and reliability of FDC drugs for specific medical conditions.

What is the Central Drugs Standard Control Organisation (CDSCO)?

• The CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act 1940.
• Major Functions:
  • Regulatory control over the import of drugs, approval of new drugs and clinical trials.
  • Approval of certain licences as Central Licence Approving Authority
• Drug Controller General of India (DCGI)
  • DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
  • It comes under the Ministry of Health & Family Welfare.

Source: TH