Illegal Drug Sales are Increasingly Widespread, How is the Drug Distribution License?

Corporate Secretary Service Indonesia – The circulation of illegal drugs in Indonesia continues to increase, raising concerns about the impact on public health and safety. In 2023 alone, a report by mediaindonesia.com (29/03/24) stated that the Food and Drug Monitoring Agency (BPOM) found 347 thousand cases of illegal drug and food circulation in e-commerce.

Drugs without an official distribution permit from BPOM have the potential to contain hazardous materials that endanger consumers. In addition, BPOM has regulated that every drug circulation must have a distribution permit granted by BPOM. So, how exactly is the provision of drug distribution permitted in Indonesia? Check out the following explanation!

The Importance of a Circulation Permit to Avoid Illegal Drug Sales

Before discussing the provisions of the drug distribution permit, it is necessary to know first why the distribution permit is important. The tragedy of 204 children dying from toxic syrup containing ethylene glycol and diethylene glycol compounds, which caused atypical progressive acute kidney disorder (GGAPA) at the end of last year, is strong evidence of the importance of drug distribution permits.

Ironically, these drugs already had distribution licenses but proved to be dangerous after distribution. If even licensed drugs can be risky, imagine the dangers posed by unlicensed medications. Meanwhile, drug and food supervision is regulated in Presidential Regulation No. 80/2017 on BPOM (Perpres 80/2017), which places BPOM as the responsible party.

Article 4 of PR 80/2017 confirms that BPOM is authorized to issue distribution permits and product certificates based on safety, efficacy, and quality standards and conduct testing per applicable regulations.

Issuance of Drug Distribution License by BPOM

Medicines include materials, including biological products such as vaccines, hormones, and blood products, that are used to affect or check body systems and health conditions, as well as for diagnosis, prevention, cure, and health improvement. A distribution license is an approval required for a medicine to be sold in Indonesia. With the issuance of Law No. 17/2023 on Health (Law 17/2023), drugs are now included in the category of Pharmaceutical Preparations, which also includes Medicinal Materials, Natural Medicines, cosmetics, health supplements, and quasi-medicines.

Read Also: Cosmetics Business Legality: Intellectual Property to Protect!

Every person who produces or distributes pharmaceutical preparations must obtain a license from the central or regional government (Article 143 of Law 17/2023). The distribution permit, issued by BPOM, is one of the required permits. The process of obtaining this distribution license is regulated in BPOM Regulation No. 24/2017 on Criteria and Procedures for Drug Registration (BPOM Regulation 24/2017) as last amended by BPOM Regulation 13/2021.

Requirements and Documents for Applying for a Drug Distribution Permit

For pharmaceutical industry players who want to register a drug distribution permit, the registration process is divided into three categories: categories for new drugs and biological products, categories for generic drugs and branded generic drugs, and categories for medicines with special technology.

The main requirements that must be met are as follows:

1. Drug Name: Drugs can be given a generic or trade name. The trade name must be clear, not misleading, and distinct from other drugs. The trade name must not be similar to a drug already registered or whose distribution license has been revoked.
2. Registration Documents: Domestically produced drugs must have a pharmaceutical industry license and a Certificate of Good Manufacturing Practice (GMP). If the company is established after 2021, the required license is the Business Identification Number (NIB) obtained through the OSS system concerning the KBLI.

Four main sections must be prepared completely and systematically in preparing drug registration documents so that the registered drug can obtain a distribution license from BPOM, according to Appendix IV of BPOM Regulation 24/2017.

1. The first section is Administrative Documents and Product Information, which includes a table of contents, administrative documents, and product and label information.
2. The second section is Quality Documents, which consists of a summary of quality documents (RDM), documents describing drug quality, and a bibliography. These documents prove that the product meets the set quality standards.
3. Next is the Non-Clinical Document, which contains the non-clinical study review and summary, non-clinical study matrix, non-clinical study report (if required), and bibliography. This section describes the results of laboratory studies or trials conducted on animals or outside the human body to assess the drug’s safety before it is tested on humans.
4. Finally, the Clinical Document includes the clinical study review and summary, clinical study matrix, clinical study report, and bibliography. This section contains the results of human clinical trials to confirm the safety and effectiveness of the drug.

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