BPOM Prepares New Regulation on Product Recall and Destruction

The Food and Drug Authority (Badan Pengawas Obat dan Makanan – “BPOM”) is preparing a new regulation to streamline the rules governing the recall and destruction of products in the categories of traditional medicines, quasi-drugs, health supplements, and cosmetics. The proposed regulation is intended to consolidate the various existing regulations into a single, more uniform framework to ensure that products circulating in the market comply with the required standards of safety, quality, and efficacy.

Muhammad Kasuri, Deputy for the Supervision of Traditional Medicines, Health Supplements, and Cosmetics at BPOM, emphasized that transparency will be a key element of the new regulation. According to him, every stage of the product recall and destruction process must be governed by a clear mechanism so that it can serve as an effective supervisory tool for both regulators and business actors. 

"To ensure transparency as a form of oversight, both we as the regulator and the business actors we supervise must have clear procedures governing how products are recalled and destroyed, so that the process complies with the applicable requirements and does not cause environmental pollution," he said.

The proposed regulation expands the scope of items subject to destruction so that it is no longer limited to finished products. It will also cover packaging materials, labeling, advertisements, and raw materials that fail to meet the applicable requirements, have expired, or are associated with criminal offences. The regulation further stipulates that destruction must be carried out in a manner that does not pollute the environment or endanger public health. In addition, distribution license holders will be required to attach photographic or video documentation to the official destruction report as evidence that the destruction has been carried out, thereby enhancing the transparency and accountability of the oversight process.