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).
Highlights of the Report:
- 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.
- 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
- It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act
- CDSCO is controlled and governed by Directorate General of Health Services which comes under Ministry of Health and Family Welfare, Government of India
- 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