BPOM Regulation Number 7 of 2026 Introduces New Obligations on Drug Promotion and Advertising, Prohibits Bonuses

Introduction

On 29 April 2026, the Food and Drug Supervisory Agency (“BPOM”) issued Regulation of the Food and Drug Supervisory Agency Number 7 of 2026 on Drug Promotion and Advertising (“BPOM Regulation 7/2026”), which took effect since that date. This regulation establishes guidelines for drug promotion and advertising activities, covering content criteria, media channels, approval mechanisms, obligations and prohibitions for businesses, as well as supervision systems and administrative sanctions.

In addition, BPOM enacted this regulation to align the supervision of drug advertising with developments in health law, risk-based business licensing in the pharmaceutical subsector, and trends in electronic marketing media. Furthermore, the government aims to protect the public from the proliferation of information that is not objective, incomplete, and potentially misleading in the practice of drug promotion and advertising. BPOM Regulation 7/2026 implements the mandate of Article 425 paragraph (2) of Government Regulation Number 28 of 2024 on Health, which requires the issuance of technical rules on drug promotion.

 

Comparison

BPOM Regulation 7/2026 revokes and replaces Regulation of the Food and Drug Supervisory Agency Number 2 of 2021 on Guidelines for the Supervision of Drug Advertising (“BPOM Regulation 2/2021”). The following table presents a comparison between BPOM Regulation 7/2026 and BPOM Regulation 2/2021:

 

Key Provisions

Classification of Drugs and Promotional Media

According to Article 4, BPOM classifies drugs that businesses may promote into prescription drugs and non-prescription drugs. Article 5 provides that businesses may only advertise and promote prescription drugs through scientific media specifically targeting medical and health professionals. Conversely, businesses may advertise and promote non-prescription drugs broadly to the general public. Article 7 provides an exception whereby pharmaceutical industries may publish prescription drugs on their official websites as company profiles, limited to displaying product packaging images, trade names, composition, and/or drug strength.

Criteria and Risk Management in Promotional Activities

Article 8 paragraph (1) requires promotion organizers to present information that is objective, complete, and not misleading. Furthermore, Article 8 paragraphs (3) and (4) require pharmaceutical industries, PBF, pharmaceutical service facilities, and electronic pharmaceutical system operators to develop and implement promotional risk management to prevent misuse and/or deviation in drug distribution within the community. This risk management requires businesses to control aspects including:

1. Stock management, including demand estimation and disease prevalence; 
2. Drug shelf life; 
3. Supply chain integrity; and/or 
4. Return or outright purchase policies. 

Qualification Requirements for Promotion Organizers

Articles 10 and 11 require pharmaceutical industries and PBF to assign promotion organizers who meet adequate qualification standards. Article 10 specifies promotion organizers as:

1. Medical representatives, product specialists, or similar marketing personnel; 
2. Sales personnel from pharmaceutical industries and/or PBF; and 
3. Other parties formally assigned by pharmaceutical industries, PBF, pharmaceutical service facilities, electronic pharmaceutical system operators, and/or other facilities, including various levels of marketing management. 

Promotion organizers must report any complaints or drug safety information from the public to their respective institutions. Article 11 paragraph (3) requires healthcare facilities and pharmaceutical industries to ensure that promotion personnel possess knowledge of:

1. The promoted product; 
2. Communication; 
3. Marketing; 
4. Promotion ethics; 
5. Pharmacovigilance; and/or 
6. Applicable laws and regulations. 

Advertising Content and Service Contact Obligations

Under Article 13 in conjunction with Annex I, advertisers must ensure that advertising materials are free from excessive claims, including prohibiting the use of terms such as “safe,” “harmless,” and/or “free/no side effects.” Businesses must not display advertisements claiming instant therapeutic effects, using superstition, or utilizing testimonial endorsements from celebrities, medical professionals, or public officials. Article 17 requires businesses to include public information service contact details in all visual media advertisements, except those with a duration of less than 6 seconds.

Specific Information Requirements for Certain Drugs

Article 15 introduces specific obligations for certain drugs to include particular information in their advertisements. These drugs consist of 15 categories:

1. Cough or flu medicine; 
2. Anti-allergy drugs (new category compared to BPOM Regulation 2/2021); 
3. Asthma drugs; 
4. Ulcer medication; 
5. Anthelmintic drugs; 
6. Topical antifungal drugs; 
7. Eye drops; 
8. Mouthwash; 
9. Throat medication; 
10. Bruise medication; 
11. Laxatives; 
12. Motion sickness drugs; 
13. Malaria drugs; 
14. Anti-diarrheal drugs; and/or 
15. Other drugs determined by the Head of the Agency. 

These specific information provisions are further regulated in Annex II and do not apply to prescription drugs, narcotics, and psychotropics advertised to medical/health professionals. In addition to adding anti-allergy drugs, BPOM Regulation 7/2026 removes the “Anemia Drug” category from the list (previously regulated under BPOM Regulation 2/2021). Annex II requires manufacturers to include the following information:

1. Flu/cough medicine: “May cause drowsiness” (for antihistamine-containing drugs) and/or “Observe Warnings and Contraindications, Do Not Exceed the Recommended Dose” (for nasal decongestants); 
2. Anti-allergy drugs: “May cause drowsiness” (if containing sedating antihistamines); 
3. Asthma drugs: symptom certainty and dosage warnings; for theophylline ≥120 mg, must include a warning on heart palpitations; 
4. Ulcer medication: recommendation for regular meals; for simethicone ≥50 mg, may include the claim “Relieves bloating”; 
5. Anthelmintics: diagnostic certainty and hygiene recommendations; 
6. Topical antifungals: personal hygiene information and minimum 2-week use; 
7. Eye drops: prohibition of use with contact lenses (for benzalkonium chloride content); 
8. Mouthwash: recommendation for regular tooth brushing; 
9. Throat medication: recommendation to consult a doctor if symptoms persist for more than 3 days; 
10. Bruise medication: prohibition of application on mucous membranes or open wounds; 
11. Laxatives: warning for short-term use only and recommendation for fiber intake; 
12. Motion sickness drugs: “May cause drowsiness”; 
13. Malaria drugs: must comply with Ministry of Health Malaria Treatment Guidelines and include worsening symptom warnings; and 
14. Anti-diarrheal drugs: recommendation for oral rehydration solution and warning against use in children under 5 years. 

Prohibitions in Promotional Practices

Article 35 prohibits pharmaceutical industries, PBF, pharmaceutical service facilities, electronic pharmaceutical system operators, and other facilities from directly or indirectly providing bonuses/gifts in the form of money and/or goods to the public, health professionals, and/or medical personnel, including their families and affiliates, in relation to product sales to increase sales turnover. Article 36 prohibits various potentially unhealthy promotional practices, including:

1. Cooperation in drug prescribing with healthcare facilities or professionals to increase sales; 
2. Establishing special groups, including multi-level marketing schemes; 
3. Conducting prize-based promotions through packaging returns or quizzes; 
4. Conducting disguised promotions through clinical trials, epidemiological studies, marketing studies, or other research; 
5. Providing drug samples to the public for promotional purposes; 
6. Providing bonuses in the form of drugs or pharmaceutical preparations; 
7. Providing excessive discounts below market prices that may lead to unfair competition; and/or 
8. Providing discounts through commission mechanisms. 

Article 38 prohibits the use of interactive communication features on social media as a direct transaction platform for drug sales. Article 39 paragraph (1) prohibits individuals from conducting drug promotion and/or advertising unless they act as formally appointed advertisement actors by the pharmaceutical industry.

 

Sanctions

Article 42 provides that violations of various provisions, including obligations for objective and complete promotion (Articles 3 and 8), advertisement approval obligations (Article 18), prohibition of bonuses (Article 35), prohibition of multi-level marketing and disguised promotions (Article 36), prohibition of prescription drug promotion by pharmaceutical facilities (Article 37), and prohibition on individual promotion (Article 39), are subject to administrative sanctions in the form of:

1. Warning; 
2. Severe warning; 
3. Temporary suspension of activities; 
4. Revocation of marketing authorization; and/or 
5. Revocation of Good Distribution Practice (CDOB) certification. 

Sanctions are imposed by the Head of the Agency, and the procedures for issuance follow BPOM regulations governing follow-up actions on drug and drug material supervision.

 

Transitional Provisions

According to Article 44, applications for advertisement approval submitted before 29 April 2026 will continue to be processed under BPOM Regulation 2/2021. Advertisement approvals issued under BPOM Regulation 2/2021 remain valid as long as they do not conflict with BPOM Regulation 7/2026. However, approvals that do not comply with the new provisions must be adjusted no later than 29 April 2027.

 

Closing

BPOM Regulation 7/2026 updates the rules on drug promotion and advertising in Indonesia to protect the public from misleading information and to align with digital marketing trends. This regulation strengthens supervision by limiting prescription drug advertising to scientific media for medical professionals, requiring qualification standards for promotion organizers, and mandating the implementation of risk management in drug distribution. In addition to setting strict advertising content standards and requiring specific warning information for 15 categories of drugs, this regulation also prohibits bonuses, disguised promotions, direct sales transactions through social media, and promotions by individuals. For any violations, BPOM may impose administrative sanctions up to the revocation of marketing authorization and CDOB certification, while providing a transitional period for businesses to adjust existing advertising materials no later than 29 April 2027.