DCGI Told to Act Against Unapproved Antibiotic FDCs
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New Delhi: The Drugs Technical Advisory Board (DTAB), India's apex drug advisory body, has taken a firm stance on curbing the irrational use of antibiotic fixed dose combinations (FDCs) by directing the Drugs Controller General of India (DCGI) to initiate license withdrawal procedures for unapproved formulations. This move comes in response to continued non-submission of critical data by State Licensing Authorities (SLAs), despite repeated reminders.
The matter was discussed during DTAB’s 92nd meeting held on April 24, 2025, under Agenda No. 15, which reviewed the status report on proposals to regulate FDC antibiotics. According to the official meeting minutes:
“The non-submission of the desired information by the SLAs is not justified. DTAB opined that the DCG(I) may take up the matter with SLAs for withdrawal of the product license of such FDCs for appropriate action as per the provisions.”
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