Drugs Technical Advisory Board (DTAB) instructed the Drugs Controller General of India (DCGI) to pursue product license withdrawal for irrational fixed-dose combination (FDC) antibiotics with State Licensing Authorities (SLAs). The move follows persistent non-submission of data by SLAs and increased concerns regarding unapproved and inappropriately used antibiotics in India.

Key Highlights:

Regulatory action against unapproved FDC antibiotics

• DTAB, during its 92nd meeting on April 24, 2025, observed non-compliance by SLAs in spite of several reminders to DCGI for submission of lists of licensed antibiotic combinations.

• Board suggested that the DCGI take action for revocation of licenses of irrational FDCs under current drug regulations.

Absence of information from state regulators

• SLAs were previously requested to furnish the list of licensed antibiotic combinations and indicate unapproved FDCs in the market.

• The order, which was originally made in May 2024, was predicated on suggestions by a sub-committee constituted by DTAB.

Mounting concern on antibiotic abuse

• The problem stems from an April 2023 expert meeting of ICMR, which reported the prevalent irrational use of antibiotic combinations and sought immediate regulatory action.

• A second meeting, under the chairmanship of DGHS, in October 2023 charged CDSCO with carrying out bi-annual review of antibiotic FDCs.

Sub-committee review and composition

• A sub-committee of DTAB was formed in January 2024 under Dr. D.S. Arya of AIIMS, and comprises a pharmacologist, medicine specialist, and microbiologist.

• The committee is tasked with assessing marketed antibiotic FDCs and suggesting bans or regulatory actions.

Precedent set on unapproved drug bans

• DCGI in March 2025 directed cancellation of licenses for meropenem and disodium EDTA for injection on the basis of their classification as new drugs subject to central approval.

• The CDSCO has reaffirmed its vigilance on manufacturers selling medicines without central authorization.

The DTAB's request for the withdrawal of licenses of irrational combinations of antibiotics is a major step forward in India's efforts to fight antimicrobial resistance and implement rational use of drugs. With regulatory pressure mounting, manufacturers and SLAs are likely to ensure greater compliance to safeguard public health and maintain drug quality standards.