DCGI Told to Act Against Unapproved Antibiotic FDCs
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.”
The DTAB’s position follows a series of communications sent by the DCGI since 2024, urging state regulators to submit comprehensive lists of antibiotic combinations licensed by them and to flag any unapproved products currently circulating in their jurisdictions. These requests were rooted in growing concern over the widespread and unchecked availability of irrational antibiotic combinations, which contribute to antimicrobial resistance (AMR).
The push to regulate antibiotic FDCs gained momentum after a key meeting at the Indian Council of Medical Research (ICMR) on April 25, 2023, where experts recommended immediate steps to ban inappropriate combinations already in the market and to prevent new irrational combinations from entering the system.
Further, during a meeting chaired by Dr. Atul Goel, Director General of Health Services (DGHS) on October 16, 2023, it was agreed that the Central Drugs Standard Control Organisation (CDSCO) would conduct six-monthly reviews of antibiotic FDCs approved and marketed across different states.
To operationalize this, DTAB in its 90th meeting on January 25, 2024, constituted a sub-committee under the chairmanship of Dr. D.S. Arya, Professor of Pharmacology at AIIMS, to thoroughly examine the issue and recommend action. The Board also decided that the sub-committee would include experts such as a pharmacologist, a medical specialist, and a microbiologist for a well-rounded evaluation.
Read Also: CDSCO Asks SLAs To Provide List Of Antibiotic Combinations Licensed For Manufacturing And Marketing
Despite these institutional efforts, the lack of response from state regulators has prompted the DTAB to recommend immediate administrative intervention. The Board has now formally empowered the DCGI to coordinate with SLAs to revoke licenses for antibiotic FDCs that are found to be irrational or lacking approval under central regulations.
