BPOM Tightens Online Drug and Food Regulations: What Businesses Need to Know

With the rapid growth of e-commerce, online drug and food distribution has become a major part of Indonesia’s market. However, the ease of purchasing healthcare products online brings potential risks to consumers, particularly regarding safety, quality, and regulatory compliance. To address these concerns, BPOM issued Regulation No. 14 of 2024, tightening the supervision of online drug and food distribution.

This new regulation outlines strict licensing requirements, monitoring responsibilities, and penalties for violations, ensuring businesses operate transparently and within legal frameworks. Understanding and adhering to these regulations is crucial for companies in the pharmaceutical and food industries to maintain compliance and avoid sanctions.

Key Takeaways

1. BPOM Regulation No. 14/2024 strengthens supervision of online drug and food distribution to ensure consumer safety.
2. Businesses and e-commerce platforms must comply with licensing, verification, and reporting obligations.
3. Certain drugs and cosmetics are restricted or prohibited from online sales to prevent public health risks.
4. Failure to comply can result in warnings, product bans, website access termination, or business license revocation.

Key Obligations for Online Businesses and Platforms

To comply with BPOM Regulation No. 14/2024, businesses engaged in online drug and food distribution must meet the following requirements:

1. Obtain the Proper Business Licenses.
   Electronic Pharmacy System Providers (PSEF) must have a valid business license.
2. Display Mandatory Product Information.
   Businesses must provide clear and transparent product details, including:
   • Business Name & Address
   • Product Details (including distribution permit numbers & issuance dates)
   • Licensed Pharmaceutical Personnel as responsible parties
3. Implement a Product Verification System:
   • Ensure all listed products meet BPOM standards.
   • Use a validation system to verify product legality before selling.
4. Responsibilities of Online Platforms (PSEF & PPMSE)
   Online marketplaces and trading platforms must:
   • Monitor & evaluate transactions to detect violations.
   • Block or remove unlicensed sellers.
   • Grant BPOM access for regulatory oversight.
   • Submit monthly reports on business activities & transactions.

BPOM’s Supervision and Enforcement

BPOM actively monitors and enforces regulations through the following measures:

1. Online Monitoring
   Uses automated web crawlers to scan:
   • E-commerce platforms
   • Advertisements & promotions
   • Social media listings
2. On-Site Inspections
   Physical audits of businesses suspected of violating regulations.
3. Guidance & Training
   BPOM offers licensing assistance and compliance education to help businesses meet requirements.
4. Penalties for Non-Compliance
   • Written Warning – For minor infractions.
   • Product Suspension – Temporary removal of non-compliant products.
   • Access Termination – Permanent platform bans for repeat violations.
   • Business License Revocation – For severe or repeated offenses.

2. Streamlining 21 Core Business Processes

CTAS is more than just a system upgrade—it represents a fundamental transformation of 21 tax administration processes, including:

• Taxpayer Registration & Compliance Monitoring
• Tax Collection & Payment Processing
• Data Integration & Risk Management
• Audit, Investigation, & Appeals Handling

Restricted and Prohibited Products for Online Sales

Prohibited Drugs:

• Narcotics and psychotropic substances.
• Injectable drugs (except insulin for personal use).
• Contraceptive implants.

Prohibited Cosmetics:

• Products with more than 10% Alpha Hydroxy Acid (AHA).
• Teeth whiteners with over 6% hydrogen peroxide.
• Refillable cosmetics that pose contamination risks.

Restricted Drugs:

• Pharmaceutical precursors for self-medication (limited to three-day doses).
• Prescription-only medications require electronic prescriptions.
• Erectile dysfunction medications are only available via doctor-issued e-prescriptions sent directly to healthcare providers.

How Businesses Can Ensure Compliance

The new BPOM regulations require businesses to navigate licensing procedures, reporting obligations, and risk management strategies. Ensuring full compliance can be challenging—this is where professional business advisory services become essential.

With extensive experience in business licensing and regulatory compliance, Permitindo’s Business Licenses Advisory Services can assist businesses in:

• Obtaining and maintaining the necessary business permits (PSEF, PPMSE, and distribution licenses).
• Ensuring compliance with BPOM’s product transparency and reporting requirements.
• Navigating regulatory changes efficiently to avoid penalties.

By partnering with Permitindo, businesses can ensure smooth operations while meeting all BPOM regulations, allowing them to focus on growth while staying compliant.

Conclusion

BPOM Regulation No. 14 of 2024 marks a significant step in enhancing consumer protection in online drug and food distribution. By implementing strict licensing, monitoring, and compliance requirements, the government aims to create a safer and more transparent digital marketplace.

For businesses in the pharmaceutical and food industries, understanding these regulations and ensuring full compliance is essential to maintaining consumer trust and avoiding legal repercussions. As regulations continue to evolve, seeking expert guidance in business licensing and compliance can help businesses operate confidently and responsibly in Indonesia’s dynamic digital economy.