Enhancing Indonesian FDA Supervision to Combat Antimicrobial Resistance: Regulatory Gaps and Multifaceted Solutions

Introduction. Antimicrobial resistance (AMR) is a mounting public health threat in Indonesia, fueled by widespread non-prescription antibiotic sales and limited regulatory effectiveness.

The purpose of the study. The purpose of this study was to assess prescription adherence, patterns of antibiotic supply, and regulatory violations by analyzing 2023 data from the Indonesian Food and Drug Authority’s Jakarta Regional Office.

Materials and methods. This study analyzes 2023 inspection data from 105 Jakarta pharmacies, randomly and purposively sampled from 2,735 registered facilities, to assess prescription compliance, supply patterns, and regulatory breaches. Using a cross-sectional approach, we examined antibiotic dispensing against prescription records, documented stock levels, identified frequently supplied antibiotics, and explored the reasoning for non-prescription sales.

Results. Results revealed that 37% of antibiotics were provided without prescriptions, highlighting pervasive self-medication. Amoxicillin dominated supplies (63%), followed by Cefixime and Metronidazole, heightening resistance risks. Regulatory tools, mainly administrative reprimands, proved inadequate; notably, 20% of non-prescription antibiotics were distributed to unregulated midwives, underscoring oversight weaknesses. Fragmented education among health providers and the public further limits efforts to curb AMR.

Research limitation. The study is limited by its reliance on inspection data from a single year and region, which may not capture trends elsewhere in Indonesia or ongoing changes in pharmacy practice.

Conclusions. To address these systemic issues, we recommend stronger penalties, enhanced oversight — especially regarding midwife practices — real-time sales monitoring, integrated public education campaigns aligned with WHO guidance, and coordinated efforts across agencies to control online antibiotic sales.

Compliance with ethical standards. The study does not require submission of the opinion of the biomedical ethics committee or other documents.

Funding. The study had no sponsorship.

Conflict of interest. The authors declare no conflict of interest.

Received: June 23, 2025 / Revised: November 25, 2025 / Accepted: December 17, 2025 / Published: March 4, 2026