KBLI 2020 · Kode 5-digit

21021Raw Materials Industry for Traditional Medicine (for Humans)

Diperbarui terakhir · Bersumber dari OSS Indonesia

This group includes businesses that process various extracts and simplicia, galenic preparations, additives or other materials, both active and inactive, that are altered or unaltered, used in the processing of traditional medicine, even if not all of these materials are present in the final product.

For foreign investors

Key facts for KBLI 21021

The essentials a foreign investor needs to know before reading the rest of this page.

  • Closed to foreign equity — Indonesian capital must be 100% under Pres. Reg. 10/2021. Foreign investors typically work via commercial / IP / off-take agreements with an Indonesian-owned licensee instead.

  • No foreign capital permitted — entities operating under KBLI 21021 must be 100% Indonesian-owned. The standard PT PMA route is unavailable.

  • High-risk activity — requires NIB + full Operating License (Izin) to operate commercially. NIB alone enables only the preparation stage; an Operating License must be obtained before invoicing or production starts.

  • Statutory licensing turnaround: 7 days once we submit the application — on top of the 2–3 weeks for PT PMA incorporation. We coordinate the full sequence end-to-end.

  • Issuing authority for PMA: Menteri/Kepala Badan — specific to foreign-owned entities under this KBLI.

  • BPOM registration mandatory: a separate Indonesian FDA marketing authorization (NIE) is required before any product is marketed. Facility must be CPOB-certified.

  • Ongoing reporting: quarterly LKPM (Investment Activity Report) to BKPM plus 10 sector-specific obligations. We file these on your behalf as part of monthly compliance — you stay out of the OSS portal entirely.

At a glance
For Large-scale (PMA) operation
Foreign investment
Domestic capital only
Foreign investors cannot own shares in this activity
0%
foreign capital
Direct PMA path
Not available
See below for alternatives
Recommended structure
Commercial framework
Indonesian operator + commercial agreement
Next step
Book a call
Tailored structure for your plan
§ 01

Status investasi (lokal)

Regulasi BUPM (Bidang Usaha Penanaman Modal) Indonesia menempatkan kode ini dalam salah satu dari lima kategori. Untuk perusahaan dengan pemegang saham WNI, batasan investasi asing dan ketentuan khusus PMA tidak berlaku — aturan di bawah mencakup yang relevan untuk operator lokal.

Status · Terbuka untuk modal lokal

Dicadangkan untuk modal Indonesia — sepenuhnya terbuka untuk Anda

KBLI 21021 dibatasi pada kepemilikan Indonesia 100% menurut Perpres 10/2021. Sebagai investor lokal (pemegang saham WNI atau perusahaan 100% lokal) ini menguntungkan Anda: kegiatan ini tertutup untuk modal asing, mengurangi lapis kompetisi. Pendirian PT lokal mudah dijalankan.

Aturan sub-kegiatan

Sub-kegiatan dengan ketentuan sektor

1
  • Industri bahan baku obat tradisional untuk manusia
    Modal dalam negeri 100%
Tersedia untuk perusahaan 100% milik Indonesia (PT lokal). Tidak ada batasan kepemilikan asing yang berlaku, tidak ada kewajiban pelaporan LKPM, dan aturan modal disetor IDR 2,5 miliar untuk PMA tidak berlaku — modal disetor ditentukan oleh para pendiri di akta. Aturan khusus sektor di atas tetap berlaku jika relevan.
§ 02

What this means for foreign investors

An honest read of the situation, plus the structures that work in practice. We've handled all of these — book a call to walk through your specific plan.

You can't hold equity in this activity directly.

This KBLI is reserved to 100% Indonesian capital under Pres. Reg. 10/2021. Foreign investors cannot own shares in an entity registered for this code. The honest paths forward are: (1) operate a different but related KBLI that's open to PMA, (2) partner with a fully Indonesian-owned licensee under a commercial / IP / supply agreement (not equity), or (3) explore a Special Economic Zone where the rule may be relaxed.

Pathways that work

  • Move to a different value-chain step

    The cleanest path: operate a related but open KBLI. For example, foreign investors blocked from primary commodity production frequently succeed with the processing, distribution, branding, or export-trade codes upstream or downstream of the restricted activity.

  • Special Economic Zone (KEK) or Free Trade Zone (Batam)

    Several restricted codes have higher or full PMA caps inside designated KEK zones (Sanur Health, Lido, Mandalika) or the Batam Free Trade Zone — manufacturing, logistics, and IT services especially. The IUK regime under BP Batam relaxes ownership rules selectively in exchange for export orientation. We assess whether your operation can benefit. See the BP Batam IUK guide for the requirements.

  • Indonesian-owned operating company + commercial agreement

    A 100% Indonesian-owned operating entity can hold the restricted licence while you contract with it commercially. We structure these arrangements deliberately — without nominee shareholding, which is unenforceable and increasingly scrutinised.

PMA-viable codes in the same area

These siblings are usable by a foreign-owned PT PMA — they have a Large-scale licensing matrix and aren't on a restricted list. Each has its own context badge so you can pick by trade-off.

Restricted KBLIs need a tailored structure. Book a call and we'll map the right entity, partner, and licensing path for your specific business.
Talk to a corporate-services specialist
§ 03

Apa itu KBLI 21021?

Penjelasan sederhana tentang klasifikasi ini dan jenis usaha yang termasuk di dalamnya.

KBLI 21021 adalah kode Klasifikasi Baku Lapangan Usaha Indonesia 5-digit untuk raw materials industry for traditional medicine (for humans). Termasuk dalam kategori Manufacturing Industry di bawah subgolongan Traditional Medicine Industry (golongan pokok 21) dalam taksonomi resmi KBLI 2020 yang dikelola Badan Pusat Statistik (BPS).

This group includes businesses that process various extracts and simplicia, galenic preparations, additives or other materials, both active and inactive, that are altered or unaltered, used in the processing of traditional medicine, even if not all of these materials are present in the final product.

Siapa yang membutuhkan KBLI 21021?

Setiap entitas, baik milik Indonesia maupun asing, yang berniat beroperasi di bidang raw materials industry for traditional medicine (for humans) sebagai kegiatan usaha utama atau sekunder wajib memilih kode ini pada NIB (Nomor Induk Berusaha). Kode yang dipilih menentukan instrumen perizinan yang dibutuhkan, otoritas penerbit, dan kewajiban kepatuhan berkelanjutan.

Mengapa kode ini penting?

Pendekatan Berbasis Risiko OSS Indonesia menggunakan kode KBLI untuk menentukan tiga hal: (1) apakah investasi asing diizinkan dan dengan batas berapa, (2) instrumen perizinan berbasis risiko yang dibutuhkan, dan (3) otoritas yang menerbitkan setiap instrumen. Memilih kode yang salah dapat menunda atau membatalkan izin Anda.

§ 04

Panduan khusus Farmasi

Konteks sektor yang berlaku untuk KBLI 21021 di luar proses OSS umum. Konfirmasi dengan kementerian terkait sebelum komitmen modal.

Regulator utama
Kementerian Kesehatan (Kemenkes) / BPOM
  • ·Sertifikasi CPOB wajib untuk semua fasilitas produksi.
  • ·Izin Edar BPOM (NIE) dibutuhkan untuk setiap SKU produk.
  • ·Modal asing di farmasi bermerek terbuka hingga 100%; obat generik mungkin memiliki persyaratan mitra lokal.
  • ·Manufaktur vaksin dilindungi strategis; partisipasi asing sering via JV dengan Bio Farma.
§ 05

Halal certification

Indonesia requires BPJPH Halal certification for an expanding range of consumer-product categories. This KBLI's activities fall in scope — see what's required and when.

BPJPH certification required

Halal certification is rolling in for pharmaceuticals.

OTC pharma mandatory by October 2029

OTC pharmaceuticals must hold Halal certification by October 2029; prescription drugs follow by 2034. The bar for pharma is high — every excipient, gelatin source, and processing aid must trace back to Halal-certified suppliers. Plan an 8-12 month certification project. We coordinate BPJPH alongside the BPOM marketing authorisation that any pharma product needs anyway.

  • 01

    Audit & gap analysis

    Review your formulation, supply chain, and facility against BPJPH criteria. Identify ingredients or processes that need swapping.

  • 02

    LPH inspection

    An accredited Halal Inspection Body (LPPOM-MUI is the largest) audits the facility and reviews documentation.

  • 03

    BPJPH issuance

    The Halal certificate is issued under the BPJPH register and the Halal label can be applied to packaging.

Halal certification is a core Emerhub service. We've handled BPJPH projects for foreign-brand food, cosmetics, and pharma operators across Indonesia — including supply-chain re-sourcing where needed. Bundle it with your PT PMA setup and we coordinate both timelines.
Talk to a Halal advisor
§ 05

Dalam KBLI 2025 mendatang

BPS Indonesia menerbitkan taksonomi KBLI 2025 baru pada awal 2025. OSS, BKPM, dan kementerian operasional belum mengadopsinya — KBLI 2020 tetap menjadi standar aktif untuk pendaftaran usaha. Berikut apa yang akan datang untuk kode spesifik ini.

Dilanjutkan ke KBLI 2025

KBLI 21021 mempertahankan nomor kode dan ruang lingkup yang sama dalam taksonomi baru. Deskripsi kegiatan, hierarki, dan tujuan penggunaan kode tetap dipertahankan.

  • ·Lanjutkan menggunakan 21021 untuk pendaftaran saat ini di KBLI 2020.
  • ·Ketika OSS mengadopsi KBLI 2025 (waktu belum diumumkan), tidak diperlukan migrasi untuk kode ini.
  • ·Tingkat risiko, izin, dan rutinitas otoritas yang ditampilkan di atas tetap berlaku di kedua taksonomi.

Ketika OSS mengadopsi KBLI 2025, kami akan memigrasi entitas yang ada ke kode pengganti yang sesuai sebagai bagian dari layanan kepatuhan berkelanjutan — tidak diperlukan tindakan dari pihak Anda sekarang.

Bicara dengan spesialis
§ 06

Reference data: how this KBLI is regulated

The data below is the official OSS regulatory profile for this code. It applies to qualifying Indonesian operators (or to your operating partner). Foreign investors won't file these directly, but it's useful context when structuring a partnership or commercial arrangement.

Foreign investors: the licensing matrix below is for context only — direct PMA registration isn't possible for this code. See pathways above for what actually works.

§ 02

Tingkat risiko per skala usaha

Indonesia's OSS Risk-Based Approach assigns a separate risk level for each of the four business scales. The licensing instruments required (NIB, Standard Certificate, Operating License) are determined by the risk level. Foreign-owned entities (PT PMA) must register at the Large scale, so the rightmost column applies to most foreign investors.

01

Micro

Usaha Mikro
≤ IDR 2 B turnover
High risk
NIB + full Operating License (Izin) before invoicing.
02

Small

Usaha Kecil
IDR 2 – 15 B
High risk
NIB + full Operating License (Izin) before invoicing.
03

Medium

Usaha Menengah
IDR 15 – 50 B
High risk
NIB + full Operating License (Izin) before invoicing.
04

Large

PMA scale
Usaha Besar
IDR > 50 B
High risk
NIB + full Operating License (Izin) before invoicing.
What does each risk level require to operate? ›
Low. NIB alone is sufficient for both preparation and commercial operation. Issued instantly via OSS.
Medium-Low. NIB enables preparation only. Commercial operation requires a self-declared Sertifikat Standar (Standard Certificate). Operating with NIB alone is not legally compliant.
Medium-High. NIB enables preparation only. Commercial operation requires a Sertifikat Standar verified by the competent ministry — typically with a site or document inspection.
High. NIB enables preparation only. Commercial operation requires a full Operating License (Izin) issued by the competent ministry after substantive review.
Beyond OSS, sector-specific permits commonly apply on top — e.g. SBU for construction, BPOM for food/cosmetics/medicines, OJK for financial services, IUP for mining, PSE for digital services. See the industry-specific guidance below for what applies to this KBLI.
Yang dibutuhkan untuk beroperasi
NIB
Preparation only — additional permit needed below
Operating License (Izin)
Important: NIB is issued for the preparation stage. Commercial operation requires a full Operating License (Izin) issued by the competent ministry after a substantive review of the operator's capability, facility, and compliance. Operating with NIB alone exposes the entity to penalties, blacklisting, and contract invalidation.
Processing time
7Days
Statutory turnaround

Persyaratan permohonan

5

Dokumen dan kapabilitas yang harus dipenuhi pada saat pendaftaran

  • 01Memiliki dokumen rencana penggunaan jenis, spesifikasi, jumlah, dan asal dari bahan baku, serta sumber dan jumlah/ besaran dari energi dan air baku, yang dibutuhkan untuk menjalankan kegiatan usaha industri dalam 1 (satu) siklus produksi atau selama lamanya 6 (enam) bulan ke depan
  • 02Memiliki dokumen berupa: a. Spesifikasi mesin dan/atau daftar peralatan b. Foto mesin/ peralatan c. Perjanjian jual beli/sewa yang membukti-kan: 1) Penguasaan (kepemilikan/ sewa) mesin untuk menghasilkan produk farmasi serta peralatan pengujian kualitas produk 2) Kesesuaian kapasitas produksi terpasang pada data usaha
  • 03Memiliki dokumen struktur organisasi SDM minimal terdiri dari: a. Pimpinan perusahaan b. Bagian produksi dan/atau quality control c. Bagian pemasaran
  • 04Memiliki dokumen bagan alur: a. Pengadaan, penerimaan, penyimpanan bahan baku b. Proses produksi c. Proses quality control d. Pengemasan, penyimpanan, pengangkutan dan distribusi hasil produksi
  • 05$47

Kewajiban berkelanjutan

11

Kewajiban kepatuhan dan pelaporan selama operasional

  • 01Memiliki bukti penyampaian wajib Data Industri tervalidasi setiap 6 (enam) bulan sekali sesuai peraturan perundang undangan di bidang perindustrian
  • 02Menjamin keamanan dan keselamatan alat, proses, hasil produksi, penyimpanan, serta pengangkutan, sesuai peraturan perundang undangan
  • 03Memiliki layanan keluhan pelanggan/ produk terhadap: a. Kejadian tidak diinginkan (adverse event) b. Kualitas produk (product quality) yang membuktikan komitmen pelayanan minimal kepada pelanggan
  • 04Memiliki dokumen hasil kalibrasi peralatan quality control secara periodik atau hasil uji laboratorium independen atas produk yang dihasilkan secara periodik
  • 05Memiliki dokumen berupa SOP evakuasi bencana, termasuk penataan rambu keselamatan kerja
  • 06Memiliki sertifikat Sistem Manajemen Mutu (ISO 9001)
  • 07Memiliki SOP keamanan dan keselamatan atas: a. Penyimpanan bahan baku berupa bahan kimia b. Penggunaan mesin/ peralatan c. Proses produksi
  • 08Penggunaan bahan baku memperhatikan Farmakope Herbal Indonesia atau standar lain yang ditentukan
  • 09Memiliki dokumen Surat Keterangan Apoteker Penanggung Jawab Industri Ekstrak Bahan Alam
  • 10Memiliki paling sedikit 1 (satu) orang Apoteker Penanggung Jawab Industri Industri Ekstrak Bahan Alam
  • 11Menyampaikan laporan penyaluran produk setiap 6 (enam) bulan sesuai ketentuan perundang undangan di bidang kesehatan

Otoritas penerbit

Otoritas yang menerbitkan izin tergantung pada situasi Anda.

OtoritasBerlaku saat
Menteri/Kepala BadanSeluruhnya
Menteri/Kepala BadanPMA
§ 04

Basic requirements (KKPR)

Class-level prerequisites that apply to every operator under this KBLI, independent of business scale. These commonly include minimum capital rules for PMA entities and spatial-planning (KKPR) conformance.

Mandatory before any license can be issued
  1. 01Seluruh Bidang Usaha dalam Ruang Lingkup Kegiatan KBLI ini, hanya terbuka untuk modal dalam negeri 100%, sebagaimana diatur di dalam Peraturan Presiden No. 49 Tahun 2021 tentang Perubahan Atas Peraturan Presiden No. 10 Tahun 2021 tentang Bidang Usaha Penanaman Modal.
§ 05

Auxiliary permits (PB UMKU)

This KBLI commonly carries 1 additional permits attached to specific operational activities. PB UMKU permits are issued separately from the main business license — apply only for the ones relevant to your operation.

Emerhub advisor
Bicara dengan Emerhub

KBLI 21021 butuh struktur khusus. Mari kita rancang.

KBLI yang dibatasi butuh struktur yang dirancang seputar pembatasan tersebut — kemitraan, kode alternatif, KEK, atau pengaturan komersial. Kami sudah menangani semuanya. Satu percakapan akan memberi tahu Anda apa yang cocok untuk rencana Anda.
Diskusikan struktur Anda