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Regulation of the Minister of Health of the Republik of Indonesia Numer 007 of 2012
About Traditional Drug Registration and Regulation of the Head of the Drug and Food
Supervisory Agency Republik of Indonesia Numer HK.00.05.41.1384 of 2005 concerning
Criteria and Procedure Like the Registration of Traditional Medicines, Standardized Herbal
Medicines, and Fitofamarka mention that every traditional medicine circulating in the
territory of Indonesia must have marketing authorization issued by the head of the agency5.

Law No. 36 of 2009 concerning Health and Regulation Minister of Health of the
Republic of Indonesia Number 007 of 2012 concerning Drug Registration Traditional and
Regulation of the Head of the Republic of indonesia Drug and Food Control Agency
Indonesia Number HK.00.05.41.1384 of 2005 concerning Criteria and Procedures
registration of Traditional Medicines, Standardized Herbal Medicines, and Fitofamarka. That
regulation stated that any traditional medicine circulating in the territory of indonesia is not
having marketing authorization from the head of the agency can be given administrative
sanctions. Sanction others in the form of orders for withdrawal from circulation and / or
destruction of traditional medicines who do not meet the standards and or requirements6.

The following are the results of research in the field obtained by the authors including
to the Department of industry and Trade (DISPERINDAG) Samarinda City Results interview
with what was done by the author to Heny’s mother as the field head domestic trade from the
Departement og Industry and Trade (DISPERINDAG) Samarinda City regarding the
procedure for permitting traditional medicines to enter, he said “that the procedure fot
cosmetic medicine for other medical devices is not the authority of the trade service, the
authority of the trade service is to non-medicinal goods or medical devices as stipulated in the
Act – Trade Law Number 7 of 2014 concerning Trade in Article 32 Paragraph 1 Letter A
reads, registrations of Goods is only done for products other than food, beverages, medicine,
cosmetics, household health supplies (PKRT), tools health, and goods subject to excise
because registration of the item has been arranged based on other statutory provisions”.
Therefore Heny’s mother mentioned that “the domain of traditional medicine is not the
authority of the Service Trade7.

Second interview from Samarinda City Health Office (DINKES) Results interview
conducted by the author to Mrs. Dra. Tiyur, Apt as the kasi field Pharmacy and medical
Devices East Kalimantan Provincial Health Office explained “That the Health office server
the fields of administration of facilities and infrastructure. It was also stated in Law Number
006 of 2012 concerning the Dan Industry Traditional drug bussiness in Article 6 reads, every
industry and business in the field of medicine traditional must have permission from the
Minister”.

He mentioned “companies that have registered themselves later audit and

completeness of traditional drug companies that have been carried out register himself as for
the Laboratory or health personnel, if already meets the requirements of the administration
process of the traditional medicine industry given permission, then for registration medicine
industry given permission, then for registration of the drug product he mentioned that the
BBPOM because the Provincial Health Office and the Ministry of Health are only as an
administrative process from industry or company8.

The results of the third interview with business actors. A. Ana’s Drug Store. In the
interview the author asked a number of things, namely regarding the regulations related and
also how the process of obtaining traditional medicine brand “Pi Kang Shuang” In this case,
the mother is the owner of a drug store located on Jalan Cendana never knew about
regulations or laws which regulates the validity of traditional medicines and how to find out
the validity of these traditional medicines.

He explained “then at the stage of the process of the existence of traditional medicine
The speaker said that the traditional medicine was given by a salesperson offer from the
existence of the needs of the community the source buys traditional medicine said, the
resource person said that ordinary people are looking for these traditional medicines so my
business just know how to trade it”.9

The fourth interview is the Sandalwood Drug store in the interview the author also
asked about the relevant regulations and the reasons for the drug the traditional brand “Pi
Kang Shuang” is still traded even though it’s not have marketing authorization, the informant
“told the author that they did not know that the drug is illegal or does not have a distribution
permit because of it explain the BPOM number which turns out the BPOM number is invalid
or fake, the informant said that they only got goods from sales, writers asking for sales is
from which company or office where but the resource person doesn’t know because the
salesman just came offer goods that are usually purchased by the public and sold by the
source”.
 Interview of the four City Central Drug and Food Control Offices (BBPOM)
Samarinda. Results of interviews with those conducted by the author to Mrs. Wulan as the
Division of Head of Sartification from the Center for Drug and Food Control (BBPOM) said
“the traditional Pi Kang Shuang brand of medicinal products is distributed has been revoked
or in other words it is not registeres at BBPOM”.

He conducted a data survey when the author interviewed about medicinal products
brand Pi Kang Shuang, as for the procedure for licensing traditional medicine for explanation
he who entered the city said “the inclusion of traditional medicine through several stages
namely pre-market and post market.10 Pre-market supervision, meaning food products and
medicines before being circulated must be supervised first through pre-market evaluation”.

The production must be evaluated first whether it is qualified for quality and product
safety, also monitoring what production facilities fulfill CPOB requirements (how to make
good drugs). The means of product produced must also be evaluated through a test laboratory
if the test results meet the requirements, distribution permits will be given.

The distribution permit number code depends on whether the product is domestic or
foreign if the traditional medicine in the country is TR code if it is traditional medicine
abroad IT code. Post-market supervision, after products that already have circulating permits
the POM Center conducts sampling by purchasing distribution equipment such as stalls, shop,
pharmacies, and even suggested production to be re-tested, if not fulfilling the requirements
of the initial administration, withdrawal will be carried out.

From traditional medicinal products produced by the producers, not a few do not has
validity or distribution permit to be traded and very easy found or obtained in drug stores,
pharmacies or traditional markets, even though traditional medicine that has no validity to
circulate.

In interview with traders who still sell traditional medicines brand Pi Kang Shuang in
the trade of traditional medicine traders never knew concerning regulations or laws governing
validity traditional medicine and how to know the validity of these traditional medicines then
at the stage of the process of the existence of the traditional medicine the speaker said that the
traditional medicine is given by the sales offering from the presence community needs traders
buy traditional medicine.
 Factors Causing the Distribution of Traditional Medicine, Pi Kang Shuang, which is
not Having marketing licenses in Samarinda City. Traditional medicine is currently one of the
factors in supporting community needs, especially in matters health. At present the need for
traditional medicine is arguably increasing towards the demand for the number of users of
traditional medicine itself, the importance will be health is done by many people to maintain
their health use drugs or traditional medicines to dry or remove pain.