Herbs have more value in terms of health and medical treatment. The varieties in herbs contain certain substances, which function as medicine and supplement that a human body needs. The production of medicine made out of herbs, otherwise known as Herbal Medicine, does not go through chemical processes. However, the herbal medicine produced is not inferior in quality to the drugs sold in the pharmacy.
Based on the statement of Director General of Chemical, Pharmaceutical and Textiles of the Ministry of Industry to Bisnis.com, in 2019, the Herbal Medicine industry grows more than 6%, which is above Indonesia’s national economic growth. With more than 30,000 varieties of herbs in Indonesia, the Herbal Medicine industry is poised to continue growing, and it becomes important to understand what permits are required to sell Herbal Medicine in Indonesia.
Distribution Permit is Necessary for Selling and Distributing Herbal Medicine
Anyone can produce Herbal Medicine as long as they know how to do it. There is no written recipe or laboratory test result about Indonesian Herbal Medicine because commonly the use of Herbal Medicine based on prior experience. Recently, Herbal Medicines are being tested, and the result shows its ability to cure any disease.
Nowadays, not only does Herbal Medicine is used for personal consumption, more and more people sell and distribute them to make money. However, there is no standard of Herbal Medicine production process, making it very susceptible to health risks. The circulation of Herbal Medicine in public is dangerous if it is not strictly regulated.
In Indonesia, the Minister of Health set forth mandatory Distribution Permit for those who would like to sell, circulate and/or distribute Herbal Medicine in Indonesia. The full terms and conditions of such is regulated under the Minister of Health Regulation No. 007 of 2012 concerning Registration of Traditional Medicine. In general, the function is to ensure traditional medicines are sold and distributed in Indonesia under Distribution Permit, to avoid any fatal health risks to the public.
Herbal Medicines that can Obtain Distribution Permit
Based on the Minister of Health Regulation No. 007 of 2012, for a Herbal Medicine to obtain the Distribution Permit, they must fulfill the following criterias:
- They are made using materials that fulfills the security and quality requirements;
- They are made by applying How To Make Better Traditional Medicine (Cara Pembuatan Obat Tradisional Yang Baik or CPOTB) procedure;
- They fulfill the requirements of Farmakope Herbal Indonesia or other requirements that are acknowledged;
- They are proven to be nutritious, whether by empirical, hereditary, and/or scientific manner;
- Their marking contains objective, complete, and not misleading information.
Herbal Medicine are not allowed to contain:
- Ethyl alcohol is more than 1%, except in tincture dosage form those whose use is dilution;
- Chemical drugs that are the result of isolation or synthetic nutritious medicine;
- Narcotics or psychotropic substances; and/or
- Other materials based on health and/or considerations based on research endangering health.
However, the following Herbal Medicine is exempted from the requirement to obtain Distribution Permit:
- traditional medicine made by jamu racikan and jamu gendong businesses;
- simplicia and galenic preparations for industrial purposes and the need for traditional medical services;
- traditional medicine used for research, samples for limited number of registrations and exhibitions traded.
Imported Herbal Medicines
Based on the Minister of Health Regulation No. 007 of 2012, only the following parties are allowed to import Herbal Medicine:
- Traditional Medicine manufacturers;
- Traditional Medicine small businesses; or
- Traditional Medicine importers;
All of them must have obtained agency appointment and authorization to conduct registration from the Herbal Medicine manufacturer in the country of origin.
Legal Consequences of Selling Herbal Medicines without Distribution Permit
Based on the Law No 36 of 2009 of Health, any person who intentionally produces or circulates pharmaceutical preparations and /or medical devices that do not have a marketing authorization as referred to in Article 106 paragraph (1) shall be liable to a maximum imprisonment of 15 (fifteen) years and a maximum fine of Rp1,500,000,000 , 00 (one billion five hundred million rupiah).
Therefore, it is very clear that for anyone who dares to sell Herbal Medicines without a Distribution Permit, they may be charged with imprisonment and/or fines. Therefore it is a very important obligation for manufacturers and distributors alike to ensure that the Herbal Medicine they are selling has a Distribution Permit.
We can assist you in resolving your problems regarding to Distribution Permit in Indonesia by first checking the facts and documents. You can contact us via e-mail firstname.lastname@example.org or +62821 1000 4741
Author : Chrissie Margaretha/ Sekar Ayu
Editor : Hasyry Agustin