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21 June 2026

Ban on 16 fixed dose combination drugs

The ban on fixed dose combination drugs is a significant regulatory action by the Ministry of Health and Welfare concerning public health policy and the oversight of pharmaceutical standards, which is a recurring theme in GS2 governance and regulatory body questions.

1 min read 2 questions 2 prelims

Notes

  • The Union Ministry of Health and Family Welfare has banned 16 Fixed Dose Combination (FDC) drugs in public interest.
  • An FDC is defined as a medicine containing two or more active drugs combined in a fixed ratio in a single dosage form.
  • The ban targets formulations deemed irrational or unsafe, citing a lack of therapeutic justification and potential risks to patients.
  • The banned list includes dermatological preparations, analgesic and antispasmodic medicines, and various antibiotic-based formulations.
  • Specific examples of prohibited combinations include: acetyl salicylic acid with ethoheptazine; dicyclomine, paracetamol and clidinium bromide; gliclazide with chromium picolinate; and various amoxicillin-based combinations with serratiopeptidase.
  • Combinations of aloe vera or aloe extract with ingredients like Vitamin E, jojoba oil, and tea tree oil are also included in the ban.
  • While some FDCs are beneficial for treatment compliance and effectiveness, irrational combinations can be ineffective or harmful.

Questions

  1. What are Fixed Dose Combination (FDC) drugs? Discuss the rationale behind the government's recent move to ban certain irrational FDC formulations in the interest of public health. 150 words
    Attempt this — 150 words in 8 min
    0 / 150 words 8:00
  2. The regulation of pharmaceutical products is critical for ensuring patient safety and therapeutic efficacy in India. In the context of the recent ban on 16 FDC drugs, analyze the challenges associated with the proliferation of irrational drug combinations and the role of the Union Ministry of Health and Family Welfare in regulating the drug market. 250 words
    Attempt this — 250 words in 11 min
    0 / 250 words 11:00

Prelims

  1. What is the primary definition of a Fixed Dose Combination (FDC) drug?

  2. Which of the following categories of drugs was NOT mentioned as part of the recent ban on 16 FDCs?