Be Careful, Make Sure Your Supplements Product Have a Distribution Permit!

Corporate Secretary Service Indonesia – Recently, the Food and Drug Monitoring Agency or Badan Pengawas Obat dan Makanan (BPOM) reported that many dietary supplement containing medicinal chemicals or Bahan Kimia Obat (BKO) without a distribution permit are circulating freely. Especially in various online stores or e-commerce.

Reporting from cnnindonesia.com back in 2022, BPOM Deputy for Supervision of Traditional Medicines, Health Supplements, and Cosmetics Reri Indriani stated that they found more than 658,205 traditional medicines and health supplements that were illegal and/or contained BKO. Meanwhile, the total economic value is IDR 27.8 billion.

In fact, health supplements that do not have a distribution permit, aka illegal, have the potential to be dangerous because they are not checked first by BPOM. This is regulated in Law Number 36 of 2009 concerning Health (Law 36/2009) and Law Number 11 of 2020 concerning Job Creation (Law 11/2020).

In fact, many people like to consume health supplements to maintain their health. Of course, this is a big crime and harms the community. Both business actors who produce and the public who consume health supplements, both must know about the distribution permit for health supplements. Check out the discussion in the following article.

Criteria that must be met for a distribution permit

Health supplements that are allowed to circulate and have a permit must meet the following criteria (BPOM Regulation 11/2020):

1. Safety, benefits, and quality.
2. Marking.

One important element in fulfilling the above criteria is the implementation of Good Manufacturing Practice (GMP), which includes (BPOM Regulation 11/2020):

1. Good Manufacturing Practice (GMP);
2. Good Traditional Medicine Manufacturing Practices (CPOTB); and/or
3. Good Processed Food Production Method (CPPOB).

Application for Registration of Circulation Permit

Pharmaceutical businesses must apply for registration online, called e-Registration.

There are three types of registration applications, including (BPOM Regulation 11/2020):

1. New registration
2. Variation registration
3. Re-registration

Read Also: Why is the BPOM License for Products Important?

The registration application applies to a wide range of dietary supplement, which are categorized into:

1. Domestic health supplements, including:
   • Health supplements manufactured in the country
   • Health supplements made under contract
   • Health supplements made under license
   • Health supplements made under patent
2. Export-only health supplements
3. Imported health supplements

This article will further discuss domestically manufactured health supplements and the new registration application process.

Requirements for Business Actors of Domestically-Made Health Supplements

Some of the requirements that must be met by business actors of domestically made health supplements include (BPOM Regulation 11/2020):

1. Have a pharmaceutical industry, traditional medicine industry, traditional medicine small business, or food industry license. It can also be a Business Identification Number (NIB).
2. Have implemented Good Manufacturing Practices (CPOB, CPOTB, and/or CPPOB) as evidenced by a certificate.

Category of New Registration Application

There are two categories of health supplements in the new registration process, which include (BPOM Regulation 11/2020):

1. Category 1: single or combination of active ingredients that have known safety and benefit profiles

2. Category 2:

• A new single active ingredient or combination
• New posology
• New claim
• New dosage form
• Safety and benefit profile unknown

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