Traditional Medicines and OTC Products
Key legal info on traditional medicines and OTC products in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative drugs and devices?
Traditional drugs are mainly regulated under MOH Regulation No. 006 of 2016 on Traditional Drugs Industries and Business (“MOH Regulation 006”) and MOH Regulation No. 007 of 2012 on Traditional Drugs Registration (“MOH Reg. 007”).
Traditional drugs may only be manufactured by any limited liability company (perseroan terbatas) or cooperation (koperasi) that engages in the field of traditional drugs industry (industri obtat traditional – “IOT”) and natural material extract industry (industri ekstrak bahan alam – “IEBA”), which has obtained a license granted by the MOH through DGPHD.
Traditional drugs that are marketed in Indonesia must obtain an MA issued by the Head of BPOM, with an exception for some types of jamu (Indonesian traditional herbal drugs). The MA is valid for 5 years. Certain types of jamu (Indonesian traditional herbal drugs) are exempted from the mandatory MA requirement/
Traditional drugs are prohibited to be manufactured or marketed in the forms of: intravaginal, eye drops, parenteral and suppositories (except for hemorrhoids).
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
No, they cannot. Traditional drugs may only be advertised only after the content of the advertisement has been reviewed and approved by BPOM.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
There are some limitations of claims that can be advertised for traditional drugs, including:
- Claims must conform with the efficacy as stated in the MA of the advertised product;
- Claims which are not related to the quality, safety and efficacy of the products must be supported by valid data;
- Efficacy for diseases which required diagnosis or treatment from physicians must not be advertised, such as cancer, diabetes, hypertension, hepatitis and other chronic diseases;
- The advertisement must not make claims for the functions of each ingredient as the product contains various ingredients;
- The advertisements must be adjusted if there is a change to the safety, efficacy and quality of the product.
Further, the claims must not use superlative, such as “the only”, “number one”, “most”, “top”, etc.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The regulatory requirements for OTC products generally refer to the requirements for medicines in general as elaborated in Chapter 3.
Please see our response to Question 22 of Chapter 3 on the authorization for marketing OTC products, and our response to question 30 of Chapter 3 on the manufacturing requirements for OTC products.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Please see our response to question 39 of Chapter 3. Sales of OTC products to end consumers are only allowed to be done by pharmaceutical services facility, which includes pharmacy, hospital pharmacy, health center (puskesmas), clinic, or drug store.
6. What health, advertising, and marketing claims may be made for OTC products?
Please see our response to question 38 of Chapter 3. Generally, the claim to be made for medicines (including OTC) should be objective, complete, and not misleading. This means that the claim must be made in accordance with the real condition of the product and not deviate from the nature of benefit and safety of the product. In addition to the information on efficacy, the claim should also provide information on the matters that need attention, such as contraindications and side effects of the product. Furthermore, the claim must be true, accurate, responsible and not take advantage of community concerns about health issues or lead the community to excessive use of the product.
7. Can OTC products be marketed or advertised directly to the public?
OTC products are allowed to be marketed and advertised directly to the public, provided that they have obtained valid MAs and their advertisements’ content have been approved by the BPOM.
Under BPOM Regulation 8/2017, OTC products may be advertised on the following media:
- Printed media
newspapers, magazines, tabloids, bulletins, calendars, posters or brochures, leaflets, stickers, booklets, pamphlets, and yellow pages.
- Electronic media
television (including running text) and radio.
- Outdoor media
billboard, neon box, name board, air balloon, car spare tire cover, printed ads that are pasted/hung outdoors, banner, transit ad, videotron, gimmick, and backdrop.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
There is no explicit procedure on the conversion from a prescription-only product to become an OTC product. However, a holder of MA for prescription-only products may submit a major variation registration application to the BPOM in the event that based on review by the MOH, the drugs shall be re-classified as free drugs (OTC products).
In addition, under BPOM Regulation 24/2017, drugs with MAs may be re-assessed if based on monitoring on efficacy, safety, and quality of the drugs carried out by the holder of the MAs, the information on efficacy, safety, and quality of the relevant drugs submitted to the BPOM must be updated.
Based on the monitoring data supplied by the holder of the MAs, the BPOM will decide on whether a re-assessment on certain drugs is required. If so, the holder of the MAs must submit updated and authentic data and information on such drugs to be re-assessed within 6 months as of the date of the notification by the BPOM.
The BPOM will deliver a written decision to the holder of the MAs on the result of the re-assessment, which may be in the form of amendment to the classification of the drugs (including prescription-only product to OTC product).
9. What are the requirements for the importation of either traditional drugs or OTC products?
Under Head of BPOM Regulation No. 4 of 2017 on Importation of Drugs and Food into the Territory of the Republic of Indonesia (“BPOM Reg 4”), drugs (including traditional medicines and OTC products) that are allowed to be imported into the territory of the Republic of Indonesia are those that have obtained MAs, complied with the prevailing laws on importation, and obtained Import Approval (which must be obtained for each importation). Compliance with the prevailing laws on importation includes obtaining Importer’s identification number (locally known as Angka Pengenal Importir – “API”).
Following the launching of the OSS system, the Indonesian Government introduced new types of licenses, including the Single Identity Number (locally referred to as Nomor Induk Berusaha or “NIB”).
The NIB is a new type of license that did not exist prior to the introduction of the OSS system. The NIB is a single identity number that covers the following general licenses:
(i) Business Registration Certificate (TDP);
(ii) API; and
(iii) Customs access (for companies conducting importation and/or exportation – locally known as Hak Akses Kepabeanan).
Under BPOM Reg 4, importation of drugs and food may only be carried out by the holder of MAs or its attorney. A pharmaceutical industry holding an MA may appoint another pharmaceutical industry or pharmaceutical wholesaler/distributor to conduct the importation. However, the holder of the MA is still responsible for the quality of the drugs.
The qualified applicant will be able to register for the Import Approval via the BPOM online system by submitting electronic documents such as MA, analysis certificate, invoice, and evidence of payment of non-tax state revenue (registration fee).
Further, there is an obligation for the MA holder of imported drugs to engage in local manufacturing of the drugs imported by them, within 5 years of the MA being issued.