‘Many combination drugs not approved by regulator’

‘Many combination drugs not approved by regulator’


According to the study published in Tropical Medicine & International Health, many Fixed Dose Combinations (FDCs) do not have approval from the Central Drugs Standard Control Organization (CDSCO).

Important Facts:

Highlights of the Report:

  1. Out of 110 anti-TB FDCs available in India, only 32, (<30%), had approval. In the case of malaria FDCs, only eight out of 20 (40%), were approved by CDSCO.
  2. According to the author, a least transparent regulatory framework and ambiguity over licensing powers have contributed to the problem

Note: An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form.


These unapproved FDCs, including those dispensed for diseases like TB and malaria, raises safety and efficacy concerns. In the absence of a robust pharmacovigilance mechanism in India, there is no track on the adverse effects of these FDCs


  1. It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act
  2. CDSCO is controlled and governed by Directorate General of Health Services which comes under Ministry of Health and Family Welfare, Government of India
  3. Functions:
  • Laying down standards of drugs, cosmetics, diagnostics and devices.
  • To regulate market authorization of new drugs.
  • To regulate clinical research in India.
  • To approve licenses to manufacture certain categories of drugs as Central Licence approving Authority e.g. for Blood Banks
  • To regulate the standards of imported drugs.
  • Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC).
  • Testing of drugs by Central Drugs Labs
Categories : Test 1 (5004)
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