Ketergantungan Indonesia terhadap bahan baku obat (BBO) impor masih menjadi tantangan utama dalam penguatan ketahanan farmasi nasional. Pemerintah telah mendorong penggunaan BBO lokal melalui kebijakan Tingkat Komponen Dalam Negeri (TKDN), prioritas penggunaan produk dalam negeri, dan mekanisme pengadaan melalui e-Katalog. Namun, implementasi penggunaan BBO lokal di tingkat industri masih menghadapi berbagai tantangan, baik dari aspek teknis, ekonomi, maupun kebijakan. Penelitian ini bertujuan untuk menganalisis penggunaan BBO lokal pada produksi obat HIV di salah satu industri farmasi nasional dengan meninjau faktor input, proses, dan output berupa kinerja penjualan produk. Penelitian ini menggunakan desain observasional dengan metode kualitatif melalui wawancara mendalam, yang dilengkapi dengan analisis kuantitatif deskriptif untuk menjelaskan kinerja penjualan produk. Data diperoleh melalui wawancara mendalam terhadap delapan informan dari fungsi Research and Development (R&D), Quality Assurance, produksi, keuangan/costing, dan komersial, serta melalui telaah dokumen perusahaan, data pasar IQVIA, dan regulasi terkait. Hasil penelitian menunjukkan bahwa penggunaan BBO lokal memiliki nilai strategis dalam meningkatkan TKDN dan memperkuat posisi produk pada pasar pengadaan pemerintah. Namun, penggunaan BBO lokal belum sepenuhnya memberikan efisiensi biaya bagi industri farmasi karena sebagian besar harga BBO lokal masih lebih tinggi dibandingkan BBO impor, sehingga berdampak pada peningkatan harga pokok produksi. Meskipun demikian, seluruh produk yang dianalisis masih menghasilkan gross margin positif dengan tingkat margin yang bervariasi antarproduk. Dari sisi proses, penggunaan BBO lokal memerlukan kesiapan R&D, evaluasi karakteristik bahan baku, validasi proses, pengendalian mutu, serta optimasi produksi. Keberhasilan penggunaan BBO lokal sangat bergantung pada konsistensi mutu, kontinuitas pasokan, harga yang kompetitif, kesiapan teknis industri, dan dukungan kebijakan pengadaan yang selaras dengan agenda ketahanan farmasi nasional.

Indonesia’s dependence on imported active pharmaceutical ingredients (APIs) remains a major challenge in strengthening national pharmaceutical resilience. The government has promoted the use of local APIs through the Domestic Component Level (TKDN) policy, the prioritization of domestic products, and procurement mechanisms through the e-Catalogue system. However, the implementation of local API utilization at the industry level continues to face various challenges, including technical, economic, and policy-related aspects. This study aims to analyze the use of local APIs in the production of HIV drugs or antiretrovirals in one national pharmaceutical industry by examining input, process, and output factors, with the output represented by product sales performance. This study used an observational design with a qualitative method through in-depth interviews, supported by descriptive quantitative analysis to explain product sales performance. Data were obtained through in-depth interviews with eight informants from the Research and Development (R&D), Quality Assurance, production, finance/costing, and commercial functions, as well as through reviews of company documents, IQVIA market data, and relevant regulations. The results showed that the use of local APIs has strategic value in increasing TKDN and strengthening product positioning in the government market. However, local API utilization has not fully provided cost efficiency for the pharmaceutical industry, as most local APIs remain more expensive than imported APIs, thereby increasing the cost of goods manufactured. Nevertheless, all analyzed products still generated positive gross margins, with margin levels varying across products. From the process perspective, the use of local APIs requires R&D readiness, evaluation of raw material characteristics, process validation, quality control, and production optimization. The successful utilization of local APIs depends on quality consistency, supply continuity, competitive pricing, industry technical readiness, and procurement policy support aligned with the national pharmaceutical resilience agenda.

Sebagai Upaya mendorong pelaku usaha untuk meningkatkan kepatuhan terhadap regulasi dan standar dalam rangka menjamin keamanan, mutu dan khasiat obat serta peningkatan daya saing industri farmasi, Badan POM memiliki program penilaian maturitas industri farmasi. Namun, proses penilaian masih dilakukan secara manual sehingga kurang efisien dan berpotensi menimbulkan kesalahan. Penelitian ini bertujuan mengembangkan prototipe otomasi dan integrasi Sistem Informasi Penilaian Maturitas Industri Farmasi dengan System Development Life Cycle (SDLC) menggunakan metode prototipe. Analisis kebutuhan dilakukan menggunakan kerangka PIECES, sedangkan pengujian sistem menggunakan blackbox testing meliputi System Integration Test (SIT) dan User Acceptance Test (UAT) dengan lingkup uji simulasi persepsi terhadap pengguna dan perhitungan skor. Hasil penelitian menunjukkan bahwa sistem berhasil mengotomasi proses penilaian maturitas, terintegrasi dengan e-Sertifikasi CPOB dan Sistem Informasi Pengawasan Terpadu (SIPT), serta otomasi skor dan level maturitas. Sistem meningkatkan efisiensi, akurasi, dan ketertelusuran data, serta mendukung transformasi digital BPOM untuk efektivitas pengawasan produksi obat berbasis data dan risiko.

The Indonesian Food and Drug Authority (BPOM) has established the Pharmaceutical Industry Maturity Assessment Program to encourage pharmaceutical industry to comply with regulatory requirements and quality standards, thereby ensuring the safety, quality, and efficacy of drugs, as well as strengthening the competitiveness of the pharmaceutical industry. However, the maturity assessment process is currently conducted manually, resulting in inefficiencies, fragmented data management, and an increased risk of calculation errors. This study aimed to develop a prototype of an automated and integrated Pharmaceutical Industry Maturity Assessment Information System using the System Development Life Cycle (SDLC) with a Prototype development approach. System requirements were identified using the PIECES framework, while system performance was evaluated through black-box testing, including System Integration Testing (SIT) and User Acceptance Testing (UAT), as well as simulation-based validation of user and maturity score calculations. The developed system successfully automated the end-to-end maturity assessment process, integrated data from e-certification and SIPT, and automated maturity score calculation and level maturity determination. The prototype demonstrated improved operational efficiency, calculation accuracy, and data traceability while providing real time information to support evidence based and risk-based inspection. These findings indicate that the proposed system has the potential to strengthen BPOM's digital transformation in pharmaceutical manufacturing oversight.