Ban on 35 FDC Drugs: India’s CDSCO banned 35 fixed-dose combination drugs due to safety violations.
Reason for the Ban: The drugs were approved without the required safety and efficacy evaluations under the NDCT Rules, 2019. State drug regulators approved them without central oversight.
combine two or more active pharmaceutical ingredients in a single dosage form.
Regulatory Oversight: New FDCs classified as “New Drugs” require central approval from CDSCO, not State Licensing Authorities (SLAs), as per NDCT Rules, 2019.
Advantages of FDCs: Can improve patient compliance, provide synergistic action, potentially reduce treatment costs, and prevent microbial resistance (in cases like TB/HIV).
Concerns and Risks: Some FDCs have irrational combinations lacking scientific validation and can contribute to antimicrobial resistance. They increase the risk of adverse effects, lack individualized dosage options, and utilize regulatory loopholes.
