Amendment to the Provisions on Online Drug Supervision under Food and Drug Authority (BPOM) Regulation Number 30 of 2025
Summary
Regulation of the Food and Drug Authority (BPOM) Number 30 of 2025 regarding the Amendment to Regulation of the Food and Drug Authority Number 14 of 2024 regarding Supervision of Drugs and Food Circulated Online (“BPOM Regulation 30/2025”) was issued on October 22, 2025, and took effect on its date of promulgation, November 3, 2025.
The main objective of this regulation's issuance is to update the legal framework for online drug and food supervision to better align with current legal needs, while strengthening public protection from products that do not meet standards.
Background and Context
This regulation seeks to protect the public from the online circulation of drugs and food that do not meet safety, efficacy/benefit, quality, and nutritional standards. Over time, BPOM Regulation Number 14 of 2024 on the Supervision of Drugs and Food Circulated Online (“BPOM Regulation 14/2024”) was deemed no longer adequate to address existing regulatory needs. Therefore, this amendment was necessary to ensure that supervisory provisions remain relevant and effective in addressing the challenges posed by online product circulation.
Comparison with the Previous Regulation
The following is a comparison between BPOM Regulation 30/2025 and BPOM Regulation 14/2024:
| Aspect | BPOM Regulation 14/2024 | BPOM Regulation 30/2025 |
| Online Circulation Exemption (Article 3) | The online circulation of Drugs, Natural Ingredient Drugs, Quasi Drugs, or Health Supplements is exempted for Submissions made through an Electronic System directly and limited to internal use to meet healthcare needs at the relevant Health Service Facility. | The online circulation of Drugs, Natural Ingredient Drugs, Quasi Drugs, Health Supplements, or Processed Food is exempted for the Submission of Drugs, Natural Ingredient Drugs, Quasi Drugs, Health Supplements, or PKMK (Special Medical Purpose Processed Food) made through an Electronic System directly and limited to internal use to meet healthcare needs at the relevant Health Service Facility. |
| Online Circulation Obligations (Article 5) | Drugs and food circulated online must have a Distribution Permit in accordance with the provisions of laws and regulations. |
Drugs and food circulated online must:
|
Key Provisions
| Regulatory Aspect | Description | Article |
| Expansion of Supervisory Exemption | This provision revises the scope of the exemption. First, Article 3 now explicitly mentions "Processed Food" [Pangan Olahan] as a product whose online circulation is regulated. Second, the list of products exempted from supervision (specifically for internal submission at Health Service Facilities) is expanded by adding "PKMK" (Special Medical Purpose Processed Food) [Pangan Olahan untuk Keperluan Medis Khusus]. Previously, the exemption only covered Drugs, Natural Ingredient Drugs, Quasi Drugs, and Health Supplements. | Article I point 1 (amending Article 3) |
| Addition of Mandatory Online Circulation Requirements |
This article reinforces the obligations for business actors. If previously it only required a "Distribution Permit", the obligation is now split into two cumulative points:
The addition of point 1 provides a stronger legal basis for BPOM to take action against the circulation of misleading products even if they already have a Distribution Permit. |
Article I point 2 (amending Article 5) |
| Affirmation of Criminal Sanctions (Non-Absolution Clause) | This article affirms that the imposition of administrative sanctions (such as warnings, freezing of permits, fines, etc.) regulated in this BPOM Regulation does not eliminate or nullify the application of criminal sanction provisions found in other laws and regulations. This clause provides legal certainty and strengthens BPOM's position to apply cumulative sanctions (administrative and criminal) to violators. | Article I point 3 (inserting Article 28A) |
Conclusion
The enactment of BPOM Regulation 30/2025 reinforces and clarifies the supervisory framework for the online circulation of drugs and food.
Three key takeaways:
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Affirmation that all products circulated online must hold a valid Distribution Permit and comply with quality, labeling, and advertising standards;
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Clarification of the supervisory exemption, now explicitly including PKMK (Special Medical Purpose Processed Food) for internal use by health service facilities; and
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Confirmation that administrative sanctions do not preclude criminal prosecution, thus strengthening enforcement.
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