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.
FDC Definition: Fixed-dose combination (FDC) drugs 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.
