Last Updated on May 28, 2025 by The Health Master
Antibiotic
The Drugs Technical Advisory Board (DTAB) advocates action that makes an irrational revocation of antibiotic fixed-dose combinations (FDCs) across India even more likely.
Recently, the DTAB acknowledged that many states have not responded to its communication about whether they’ve suspended/revoked these drug combinations, and therefore, informed consent from the state drug controllers was lacking.
Thus, the DTAB has recommended that CDSCO generate a plea for revocation of product approval for irrational antibiotics due to the failure of state coverage.
This is a positive step in the right direction to battle antibiotic resistance and effectively use drugs across India.
92nd DTAB meeting
The 92nd DTAB meeting took place on April 24, 2025, where the board reviewed the outcomes of their efforts and the policy decision regarding irrational use of FDC antibiotics.
The second meeting, thus held on 01.06.2024, confirmed the DTAB’s decision to rescind approvals for antibiotic FDCs, citing probable safety issues sans effective treatment, while also opening a regulatory avenue for the market.
In this case, for this to open a regulatory avenue in the market, the subcommittee reviewed and then decided on two means of market regulation—ensuring no irrational use of antibiotic FDCs within the Indian drug market by getting them approved and assessing local production.
Why Is There a New Regulation?
The new regulation is the result of an experts meeting at ICMR on April 25, 2023.
Thereafter, a subsequent meeting took place on October 16, 2023, intending to deliberate on the same under the Chair of Dr. Atul Goel, Director General of Health Services (DGHS).
90th DTAB meeting
The issue was presented to DTAB in its 90th meeting on 25th January 2024.
Because of the issue’s complexity, DTAB has opted to form a subcommittee led by Dr. D. S. Arya, from the Department of Pharmacology at AIIMS, which will assess the situation and recommend a way forward.
DTAB’s recent actions imply that a positive trend is emerging with Indian regulatory bodies paying attention to the unheard-of usages of antibiotics.
Q. What are fixed-dose combinations (FDCs)?
A. FDCs are those drugs that have two or more active pharmaceutical ingredients (APIs) in one dosage form.
Q. Why is irrational use of antibiotics an issue?
A. Antibiotic resistance is when bacteria develop the ability to defeat the effects of those drugs that formerly could treat them effectively. This complicates disease treatment—and exposes patients to inappropriate medications and their side effects.
Q. What are State Licensing Authorities (SLAs)?
A. SLAs are state-based regulatory bodies that grant drug manufacturing licenses to manufacture drugs for sale.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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