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Tantangan Kebijakan Pengawasan Obat dan Makanan dalam Mendukung Peningkatan Daya Saing, Ekonomi dan Bisnis di Indonesia: Sebuah Studi Analisis Perdhana Ari Sudewo
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

In line with Indonesia's target to become a developed country by 2045, structural reforms in the industrial sector in Indonesia will continue to be carried out with a target in 2030 to be able to contribute 30% to Indonesia's Gross Domestic Product (GDP). In structural reforms, the Drug and Food Industry is a priority industry. It requires a Drug and Food Control policy issued by the Indonesian Food and Drug Authority (Indonesian FDA) to support increasing competitiveness by creating a business ecosystem that supports Indonesia's economic growth. This study aims to analyze the challenges of Drug and Food Control policies in increasing the competitiveness of the Drug and Food Industry to support economic growth, expand employment, and create a good business ecosystem in Indonesia. The study was conducted using secondary data through literature studies from books, journals, reports, study results, articles, and internal Indonesian FDA documents. The results of the study show that the Indonesian FDA must be ready and adaptive to face various supervisions, including challenges that have never been faced by the Indonesian FDA before, the impact of government demands, the digitization of the Industrial sector, and the development of Food and Drug Science. The Indonesian FDA must formulate appropriate policies and prepare adequate resources to be able to face these challenges. This study is expected to provide benefits for policymakers and employees at the Indonesian FDA and relevant stakeholders in preparing, compiling, and establishing appropriate policies to support competitiveness, economy, and business in Indonesia.

Dampak Dualisme Peraturan Sabun Cuci Tangan Iin Febrianti Sende; Anita Kembaren; Warmanto Firmansyah; Zein Fadhlurrahman
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

During the Covid-19 pandemic, people’s need for hand soap has increased which on the other hand is used by business actors to produce and selling more than before. Currently, there is a dualism of hand soap regulations in Indonesia, hand soap can be registered as Household Health Supplies (PKRT) which is supervised by the Ministry of Health, and as Cosmetics which is supervised by Indonesian FDA. The research aims to determine the trend of hand soap distribution and the potential impact of the dualistic condition of hand soap regulations, as a form of early detection to prevent or reduce crime in the cosmetic sector, especially for hand soap products. The research was conducted by collecting registration data and distribution data through direct field research and online mapping in e-commerce. The results showed that hand soap registered as cosmetics is more than as PKRT, and there was an increase in the number of registration data for hand soap as PKRT and Cosmetics during 2020. Based on the results of monitoring distribution in online and offline media, it is known that there are hand soaps registered as Cosmetics, PKRT, PKRT and cosmetics (double distribution permits), and illegal (do not have distribution permits). The dualism of hand soap regulation can confuse supervisory and enforcement officers in handling illegal hand soap, as well as potentially be exploited by criminals who produce and distribute illegal hand soap. This also has an impact on the existence of hand soap that has a double distribution permit (PKRT and Cosmetics) which is considered inefficient and can harm business actors. Indonesian FDA must take strategic steps to resolve the dualism of hand soap regulations, by coordinating with the Ministry of Health and intensifying the supervision of hand soap distribution in the market.

Desain Primer dan Analisis in Silico untuk Amplifikasi Gen mt-Co1 pada Tikus got (Rattus norvegicus) Maria A E D Sihotang; Yola Eka Erwinda; Eniek Suwarni; Erita Lusianti
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Brown rat or commonly called sewer rat (Rattus norvegicus) meat is one of ingredients that is usually used to counterfeit beef meatballs to reduce the production prices. These issues can be very detrimental to consumers, in terms of health and halal reasons. Thus, this condition has prompted the development of test methods to detect sewer rat meat in processed foods. Several method developments in detecting the content of sewer rat meat in processed food have been carried out. One of the simplest and fastest methods to identify sewer rat meat is Polymerase Chain Reaction (PCR). Most method developments for detecting sewer rat meat have used endpoint PCR, but this method still has several shortcomings in terms of specificity and promptness in obtaining results. Therefore, developing a sewer rat meat detection method using real-time PCR and combined with a more sensitive and specific TaqMan probe can be an alternative for detecting sewer rat meat in processed foods. Primer and probe design is the first and crucial step in the development of detection methods with real-time PCR. This study aims to design primers and probes for the detection of the mt-CoI gene in sewer rats. The mt-CoI gene sequence of Rattus norvegicus (NC_001665.2) was obtained from the National Center of Biotechnology Information (NCBI) database. Primer was designed using Primer3Plus software. Then, several candidates of primers and probes were analyzed in silico for specificity of the mt-CoI gene using software, including Primer-BLAST and Nucleotide-BLAST. The result of this study is primers and probes which are specific to the mt-CoI gene in sewer rats (Rattus norvegicus), with the sequence of forward primer (5’-ATGAGCAAAAGCCC ACTTTG-3’), reverse primer (5’-CGGCCGTAAGTGAGATGAAT-3’), and probe (5’-GCAGGGATACCTCGTCGTTA-3’). The result can be used to develop methods for detecting sewer rat meat in meatballs or other processed foods using real-time PCR and TaqMan probes.

A Status Kelayakan Fortifikasi Vitamin A Minyak Goreng Sawit Tahun 2016 - 2020 di Wilayah Stunting Yayu Sulistia; Dinalia Dinalia; Agustina Wanty Sumule; Annisa Dyah Lestari
Eruditio : Indonesia Journal of Food and Drug Safety Vol 3 No 1 (2022): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Stunting still becomes a health problem that must be taken into serious consideration in Indonesia because it affects the quality of Human Resources in the future. Several attempts were made to meet the needs of micronutrients to overcome stunting. One of the Government's steps to decrease the stunting rate is adding more nutrients to foods often consumed by the public (fortification), one of which is palm cooking oil. Fortification of Vitamin A in palm cooking oil is a government program to decrease the rate of children lacking Vitamin A. This study aims to determine the feasibility status of vitamin A fortification in palm cooking oil that spreads within stunting areas in Central Sulawesi, South Sulawesi, North Sulawesi, and South Kalimantan. This research used a descriptive research method with a qualitative approach by using data collection from sipt.pom.go.id in the year 2016-2020. Samples were taken in districts where the stunting prevalence was located. Determining vitamin A levels using the Chromatography method based on SNI 7709:2019 with the standard vitamin A in cooking oil that spread in distribution channels was 20 IU/g. The status of Vitamin A fortification in palm cooking oil that spread in Central Sulawesi, South Sulawesi, North Sulawesi, and South Kalimantan was still below the standard, and if it was being averaged, for over the last five years, it has only reached 36.12%. Hence, it is suggested that the Government establish a specific regulation that regulates the use of safer palm cooking oil to maintain its quality, as well as the importance of education about the food stock storage for the public in the distribution area to maintain people's food stability

Penetapan Limit of Detection (LOD) dan Sensitivitas Metode Deteksi Pseudomonas aeruginosa dalam Berbagai Matriks Sediaan Obat Nur Aini; Maria Purba; Sitoresmi Triwibowo; Nenden Sholihatul; Ratna Wulandari
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Contamination of certain microorganisms in pharmaceutical products can potentially reduce or even inactivate therapeutic activity and harm patient health. Pharmacopoeia monograph determine the microbiological quality in medicinal products. One of them is P. aeruginosa parameters which should not be present in pharmaceutical preparations. Pharmacopoeia states that microbial detection methods must be able to detect microorganisms, including P.aeruginosa not more than 100 colonies, but the actual detection limit has never been set quantitatively and many variables can affect the microorganism recovery. This study aims to determine the range of Limit of Detection (LOD) values and the sensitivity of the P. aeruginosa method on pharmaceutical products. Detection method of P. aeruginosa refers to the specific microbial test of the Indonesian Pharmacopoeia VI (2020) is culture media methods. Experiments used eight pharmaceutical products representing five dosage forms contaminated with P. aeruginosa ATCC 9027 with three levels of concentration. The results determined LOD range and sensitivity of P. aeruginosa detection method in pharmaceutical products, and analyzed descriptively. This study shows that pharmacopeia method of P. aeruginosa testing can detect P. aeruginosa in various drug preparation matrices with a detection limit of 1-10 colonies and a sensitivity of 100%. Results of this study can be used as reference for LOD value in the verification of the P. aeruginosa detection in medicinal product.

Profil Peredaran Obat Disfungsi Ereksi Ilegal Fauqi Elfarabi; Fuji Handayani; Yovia Rizki Arrahman; Ari Andriano Santoso
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Indonesian FDA's data of supervision and law enforcement from 2008 - 2018 show that the trend of finding illegal drugs circulating in Indonesia continued to increase. Erectile dysfunction therapy class drugs dominate the trend of findings, also strengthened by the Indonesian FDA's Public Warning data and the Post Market Alert System report from 2015 - 2017, were widely found traditional medicines containing erectile dysfunction drugs. A study about Profile of Illegal Erectile Dysfunction Drug Circulation is arranged based on data and findings above, in implementing the function of preventing drug and food crime as one of the Indonesian FDA's responsibilities for the availability of efficacious, safe, and qualified medicines. The study aims to identify circulation (including users), the potential value of the circulation of illegal erectile dysfunction drugs in Indonesia, and the potential diversion in the distribution of raw materials for erectile dysfunction drugs using qualitative and quantitative methods. Qualitative methods are carried out through field observations to obtain distribution descriptions, internet surveys, and investigations by undercover, surveillance, and controlled delivery. Quantitative methods are carried out through market surveys using purposive and non-random sampling techniques in 8 (eight) regions in Indonesia, i.e., Jabodetabek, Serang, Padang, Bandung, Semarang, Surabaya, Bali, and Samarinda. The results showed that the distribution of erectile dysfunction drugs offline through permanent kiosks/stalls/carts in Indonesia is still widely found. The online circulation of erectile dysfunction drugs has also increased with the expansion of the market through websites, social media, and e-commerce. The profile of erectile dysfunction drug users is in the productive age group (30-45 years) with income levels between IDR 2,000,000 to IDR 4,000,000, per month and the most consumed brand is Viagra. Potential diversion of the circulation of raw materials for erectile dysfunction drugs occurs in importing raw materials and distributing them from each PBF/importer to the pharmaceutical industry.

Analisis Hasil Pengawasan Iklan/Promosi Suplemen Kesehatan Sebelum dan Selama Masa Pandemi COVID-19 Angelia Puspita Nugraheni; Sarmauli Purba; Devi Riani; Wahyuri; Nurizati
Eruditio : Indonesia Journal of Food and Drug Safety Vol 1 No 2 (2021): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

For entrepreneurs, advertising/promotion is a means to introduce a product. For the public, it is a means to get information about a product, so that people become very dependent on advertising/promotion. Data from BPS shows a sharp spike in online sales during the Corona Virus Disease-19 (COVID-19) pandemic, which was influenced, among other things, by government policies to limit activities outside the home. As a result, the need for health supplements has increased during the COVID-19 pandemic; several times, there have been stock shortages due to panic buying. Business actors can use this momentum for advertising/promote products that do not comply with the provisions to increase product sales, thus possibly resulting in a significantly different level of advertising/promotional violations from before the COVID-19 pandemic. This study aims to analyze the results of supervision of health supplement promotion/advertising before the COVID-19 pandemic (2018-2019) and during the COVID-19 pandemic (2020-July 2021) to determine the significance level of differences in advertising/promotional violations before and during the pandemic, the types of media that were reported to have the most violations during the COVID-19 pandemic, the types of advertising/promotional violations and the fifth regions in Indonesia that reported the highest levels of offenses. The data analyzed is secondary data from the supervision of advertisements/promotions throughout Indonesia, collected from 2018 to September 5, 2021, obtained from the Directorate of Traditional Medicines and Health Supplements Control. The data was processed descriptively and using the chi-square method to see the significance, with the results that there were significant differences in advertising/promotion violations before and during the COVID-19 pandemic, the media that committed the most violations was internet media, with the highest type of violation being advertising/promoting products with exaggerated claims. The two regions in Indonesia that included the ten most extensive offenses before and during the COVID-19 pandemic were Jakarta and Makassar.

Profil Tindak Lanjut Hasil Pengawasan Sarana Produksi Distribusi Obat dan Makanan dan Upaya Perbaikaannya Bidan Tringani Damanik
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 2 (2022): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

The inspection of production and distribution facilities carried out by the Balai POM in Ambon is said to be successful if the follow-up recommendations of the inspection results are followed up on time and in accordance with suggestions for improvement. The recommendations realization achievement for the results of inspections followed up by stakeholders in 2020 was 27.78% of the target of 55.00%. The average achievement in the last 3 (three) years is 37.80% of the average target of 51.67%. The trend of achieving follow-up recommendations for inspection results in the previous 3 (three) years tends to decrease. The follow-up profile review of recommendations for inspection results was prepared using descriptive analysis of secondary data compared to standards through systematic literature studies to provide information on alternative improvement strategies in the future. Increasing the follow-up of recommendations on the results of an inspection by stakeholders can be carried out through strategies to improve internal and external factors. Improvement of internal factors such as the timing of publishing and submitting recommendations for inspection results, communication patterns with stakeholders, planning inspection targets, and monitoring and evaluation. External factors improvements, including stakeholder understanding of the follow-up of recommendations on production and distribution facilities inspection results and its benefits for the regions. Monitoring, evaluating, and reviewing the cooperation agreements formed with the regency/city government in Maluku province. Refreshment of regulations on the effectiveness and follow-up of the results of drug and food control; and forming cooperation agreements with district/city governments that still need to have a cooperation agreement. Another improvement strategy is communication, information, and education to the public, who will be the end consumers of drug and food circulation. Sufficient and up-to-date knowledge and understanding are one of the capitals to becoming smart consumers to be more agile and selective in choosing and consuming the drugs and food needed.

Dampak COVID-19 Terhadap Tren Permohonan Layanan Informasi dan Pengaduan Konsumen Secara Elektronik pada ULPK Loka POM di Kabupaten Banyumas Tahun 2019-2020 Ana Yulia; Rahmat Hidayat; Siska Indriarsih; Eka Wahyuni
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

The Consumer Complaints Service Unit (ULPK) Loka POM in Banyumas Regency is tasked with providing information, accommodating and informing the results of follow-up complaints submitted by the community. COVID-19 or better known as the Corona Virus has become a public concern and has changed the mechanism of public services at all institutions and agencies in Indonesia, including the ULPK Loka POM in Banyumas Regency. The existence of social distancing policies resulted in a change in the trend of requests for information services and consumer complaints electronically, where direct consultation facilities which in 2019 became the most popular choice of consumers (57.87%) turned into online consultations via WhatsApp as much as 52.27% in 2020. The increase in the number of WhatsApp media usage in 2020 by 13.18%. On the other hand, there was a decrease in the number of applicants in the first semester of 2021 by 22%. Through this research, it is also known that the most professions of applicants for information services and consumer complaints in 2019 were the general public (40.53%), turning into professions of business actors as much as 45.34% (2020) and 56% (Semester I of 2021). . This research was conducted using a descriptive method by analyzing data from ULPK Loka POM in Banyumas Regency which was obtained from the application of the Consumer Complaints Service Reporting System (Simpel LPK). From this study, several recommendations were obtained, namely: (1) It is necessary to carry out public service innovations for the community, (2) It is necessary to measure the Community Satisfaction Index (IKM) on a regular basis, and (3) It is necessary to determine the target focus of Communication, Information, and Education activities. (KIE) for business actors.

Review: Uji Sterilitas dan Regionalisasi Laboratorium Sterilitas Badan POM: Review: Uji Sterilitas dan Regionalisasi Laboratorium Sterilitas Badan POM Henny Setiawati; Bertha Lolo Lukita
Eruditio : Indonesia Journal of Food and Drug Safety Vol 2 No 1 (2021): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Sterile products are preparations that meet the physical, chemical requirements and free from microorganisms, both bacteria and fungi. The sterility test is used as one of the parameters for products released from a manufacturer, even though it is not to guarantee entire of the batch meets the sterile requirements. Sterile preparations are manufactured in a facility that has strict environmental characteristics to minimize the risk of microbial contamination. Sterility testing facilities also requires certain facilities to avoid false-positive results, because sterility testing is only be repeated if there is an error in laboratory testing. Sterility test results that give non-sterile results need to be reviewed whether the results obtained are from the product or due to laboratory errors. Sterility testing facilities require large costs. Expensive testing facilities causes the testing are not conducted by all Provincial Laboratory. The regionalized laboratory at Badan POM is a concept to conduct sterility testing that meets national/international guidelines and reduces large costs. This review is based on a literature study covering sterility testing based on national and international guidelines, sterility testing facilities, limitations of sterility testing and investigation of sterility test failure. Additionally, this review will also describe the concept of regionalization of sterility test laboratories at the Indonesian Food and Drug Authority (Indonesian FDA)

Home Page

OAI Link

Editorial Team

Contact

Reviewer

Google Scholar

Contact Name
Listia Ningsih

Contact Email
listia.n@pom.go.id

Phone
+6281395105898

Journal Mail Official
eruditi@pom.go.id

Editorial Address
Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location
Kota adm. jakarta pusat,

Dki jakarta

INDONESIA

Abstract

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Abstract

Home Page

OAI Link

Editorial Team

Contact

Reviewer

Google Scholar

Contact Name Listia Ningsih

Contact Email listia.n@pom.go.id

Phone +6281395105898

Journal Mail Official eruditi@pom.go.id

Editorial Address Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location Kota adm. jakarta pusat, Dki jakarta INDONESIA

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Abstract

Contact Name
Listia Ningsih

Contact Email
listia.n@pom.go.id

Phone
+6281395105898

Journal Mail Official
eruditi@pom.go.id

Editorial Address
Gedung Batik Lt.5 - Badan POM Jl. Percetakan Negara No. 23 Kel. Johar Baru, Kec. Johar Baru, Jakarta Pusat 10560

Location
Kota adm. jakarta pusat,

Dki jakarta

INDONESIA