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The Indonesian Food and Drug Administration or Badan Pengawas Obat dan Makanan (BPOM) plays a crucial role in ensuring the safety and quality of drugs sold in the country.
To achieve this goal, the BPOM has established strict labeling and packaging requirements that all drug product labels must adhere to.
With this detailed blog, drug manufacturers and importers operating in Indonesia will understand BPOM, its drug labeling requirements, and how you can comply with any regulations effortlessly.
What is BPOM?
The National Agency of Drug and Food Control (NADFC), also known as Badan Pengawas Obat dan Makanan (BPOM), is Indonesia's Food and Drug Administration. It is responsible for Indonesian pharmaceutical regulations including drugs, medical devices, and traditional medicines. The BPOM ensures that these products are safe, effective, and of good quality for consumers.
Drug labeling requirements by BPOM
Regulations set by BPOM require accurate labeling for natural medicines, quasi-medicines, and health supplements manufactured and distributed in Indonesia. This practice ensures consumer safety and prevents product recalls. Here’s the list of general labeling requirements you need to follow:
1. Product name and dosage form
The product name can be a common general or trade name. It must meet the following criteria:
- It should be clearly labeled and presented.
- The product name does not conflict with the provisions of laws and regulations, morality, culture, or public order.
- It should not include promotional or misleading language, codes, symbols or images.
- Do not use a name that is substantially or completely similar, including writing and pronunciation, to the name of a product that already has a Marketing Permit.
- You must not use the name of a disease that requires a clinical diagnosis from a doctor.
- Additional information included in the product name must be the information included to show the differences between the content, strength of the preparation or efficacy/benefits of the product.
As for dosage form, it must correspond with the product being manufactured and distributed according to the BPOM distribution permit.
Note that the labels must be printed in Bahasa Indonesia with Arabic numerals and Latin text.
2. Name and address of the industry and/or Business Actor
The label must include the name and address of the importer, who has been appointed by the producer in the country of origin. Additionally, it should also include the name and address of the producer in that country.
3. Composition/List of ingredients
List the active ingredients of natural medicines, quasi medicines, and health supplements. The list of active ingredients is preceded by either “Composition,” “Materials used,” or “Ingredients”.
(i) Active ingredients must be included qualitatively and quantitatively if they are a main supporting composition for efficacy. If not, it should only be labeled qualitatively.(ii) If the active ingredient contains more than one type of active ingredient, the quantitative composition is included cumulatively according to the total weight.(iii) Active ingredients originating from animals, animal extracts or plants must be listed in accordance with their scientific name.
4. Net content, net weight, or quantity
Net content and net weight are the information regarding the contents or weight of natural medicines, quasi medicines, and health supplements contained in one unit of packaging or container which is stated and written in metric units. The metrics include:
- Milligrams (mg), grams (g), or kilograms (kg) for weight measurements.
- Milliliter (mL), or liter (L) units for volume.
This section must be labeled in a part of the packaging where it is the easiest to read for consumers.
5. Efficacy/benefit-related claims
The business actors must include the claims of efficacy/benefits with the approval issued by the Head of the Agency.
6. Method of use
The usage instructions for the drugs must:
- Clearly label them and write in a language that is easy to understand.
- Include pictures of how to use the product.
This information must comply with the serving instructions approved by BPOM.
7. Contraindications, side effects, interactions, warnings and/or precautions
Just like every other label, the drug labels also come with warnings, cautions, and/or contraindications. These warnings should align with the registration evaluation results by the BPOM. Here’s an example to understand how it is issued:
8. Distribution Permit number
The Distribution Permit Number on the Labeling must begin with the words "POM" followed by 2 letters and 9 digits.
9. Production code
The production code is a marking consisting of numbers or letters or a combination of both. It is also referred to as a batch identifier to track the manufacturing history of the batch from production to distribution. It may be listed separately from the other information on the Labeling.
10. Expiration dates
The expiration date must show the:
- Date, month, and year
- or month and year
The expiry date information may be stated separately from the label attached to the packaging, accompanied by instructions on where to state the expiry date, which may be:
- “expired, see the bottom of the bottle”
- "expired, look at the bottle cap".
The inclusion of the expired date is based on the risk assessment.
11. Storage instructions
Storage condition information must align with the quality of documents submitted during registration. In case the medicines or supplements are being used more than once, you may include information on storage conditions after the Packaging has been opened.
12. 2D barcode
2D Barcode is a graphic representation of digital data in a two-dimensional format with high decoding capacity that can be read by optical devices used for identification, tracking, and tracing. The requirement to include 2D Barcode is not so old and the procedures for including 2D Barcodes in your labels are implemented in accordance with the provisions of statutory regulations.
The 2D barcode application must be implemented by 7 December 2025 for all prescription drugs, including biological products.
Other labeling requirements
You can include additional information necessary for mandatory labeling, such as halal certification, alcohol content, and specific material ingredients. Few other information on the natural medicines, quasi medicines, and health supplements labels include:
- Nutritional content
- Quality Assurance documents
- Consumer service information
- Information about gluten-free and no additives
- Information about clinically tested or clinically proven
- Description of marketing awards
What happens if you don’t comply with BPOM?
Failure to comply with BPOM drug labeling and packaging requirements can result in serious consequences. The BPOM may take a variety of actions against non-compliant products and companies, including:
(i) Warning
(ii) Withdrawal of the product
(iii) Destruction
(iv) Temporary suspension of activities
(v) Revocation of certificate such as Good Manufacturing Practice for Natural Medicines
(vi) Cancellation/revocation of distribution permit number
(vii) Or, announcement to the public
Comply easily with Artwork Flow
It can be challenging to stay on top of all the regulations and implement them on all the labels of the drug products you own. To accelerate your product's market entry while adhering to BPOM regulations, a smart label compliance solution like Artwork Flow’s ComplyAI can sort you and your team out.
Using ComplyAI, you can send out error-free labels (and yes, hundreds of them!) by letting the AI engine:
- Detect errors in the language.
- Identify mislabeling of active ingredients,
- Spot missing allergens in your labels.
- Scan your barcode for accurate information and more.
To streamline and automate your drug label compliance activities, book a demo with us and learn how you can achieve impressive results such as faster turnaround time, reduced label review hours, and improved team efficiency.
Terms to understand Indonesian drug labeling
- Natural medicines: These are medicines derived from natural sources such as plants, animals, or minerals. They can be traditional remedies or modern pharmaceuticals extracted from natural substances.
- Quasi drugs: They often contain active ingredients that have mild therapeutic effects.
- Health supplements: These are products created to supplement the diet by providing nutrients or other substances that are not normally consumed in sufficient quantities.
- Primary packaging: This is the immediate packaging that comes into direct contact with the product. It can be a bottle, blister pack, or other container.
- Secondary packaging: This is the packaging that contains the primary packaging. It is often used for shipping and display purposes.
- Distribution permit: It is a permit issued by the BPOM that allows a company to distribute drugs or other regulated products in Indonesia.
- Business actors: These are individuals or organizations involved in carrying out the drug trade, including manufacturers, importers, distributors, and retailers within the jurisdiction of the Unitary State of the Republic of Indonesia.
- Generic name: A generic name is a name used for products in the form of a generic name or a name based on an empirical history of efficacy, the name of the main active ingredient, or a name determined in the national health program.
- Main Supporting Composition Efficacy: It is the main active ingredient that supports the indication claim in natural medicinal products.
- Adequate Nutritional Intake (AKG): AKG describes the nutritional adequacy for all people regardless of their age, gender, body size, or physical activity.
