Farah Choirun Nisa (22/492279/FA/13381)

Dorinda Zita Wjunior (22/496075/FA/13459) (Group 3)

PT Herbal Sejahtera has long marketed “Herba Angin” in liquid sachet form as an herbal medicine. With high market competition, the company wants to innovate products in dosage forms, health claims, and new target consumers, and plans to increase product categories.

New Product Category Options: Health Supplements

Dosage Innovation: Effervescent

Target Consumer: Active workers

Proposed Claim: Helps relieve fatigue

Does the company need to upgrade its license qualification? No, it remains as an IOT

Athiya Nometri Zahra (22/497897/FA/13501)

Haiva Kezia (22/497947/FA/13504)

1. New Product Category: Jamu

Rationale:

- Easier and faster regulatory approval compared to OHT or Phytopharmaceuticals.

- Cost-effective (no need for clinical trials).

- Keeps traditional identity while modernizing the format.

2. Dosage Form Innovation: Softgel Capsules

Rationale:

- Masks strong herbal taste, increasing comfort.

- Modern, practical, and easy to swallow.

- Suitable for all ages and gives a premium image.

- Better stability and shelf life for liquid ingredients.

3. Target Consumers: All Age Groups, Especially Those Sensitive to Taste

Rationale:

- Offers a solution for consumers who previously avoided the product due to its strong taste or aroma.

- Expands market reach, including young adults who prefer modern and tasteless formats, elderly individuals who may have trouble swallowing tablets or dislike bitter tastes, busy professionals and travelers who need a health supplement that’s easy to carry and consume anytime.

4. Proposed Health Claims:

- Helps relieve symptoms of nausea and colds

- Supports immune function during fatigue

- Promotes digestive comfort while traveling

5. License Qualification: IOT (Industri Obat Tradisional)

Rationale:

- Already sufficient for jamu in softgel form.

- No need to upgrade to pharmaceutical license.

Evana Clarissa K.S. (22/496172/FA/13466)

Nadeeya Kayika Aisvarya (22/496186/FA/13467)

Product Category: Fitofarmaka

Formulation Innovation: Lozenges

Target Consumers: Travelers

Proposed Claims: Helps relieve mild diarrhea, alleviates symptoms of digestive disorders, prevents infections

Need to Improve Qualifications: According to BPOM Regulation No. 17 of 2022, IOT companies are not eligible to produce Phytopharmaceuticals. Therefore, collaboration with a licensed pharmaceutical industry partner is necessary. This can be achieved by licensing the formula to a CDMO or licensed pharmaceutical partner, who would then produce and register the product on their behalf.

Nadya Ainun Nissa 22/496143/FA/13463

Khairunnisa Desy P. 22/496144/FA/13464

Choice of New Product Category: Standardized Herbal Medicine (OHT)
The OHT category allows for more specific and scientific claims, supported by:

• Standardization of active herbal extract ingredients.

• Preclinical tests that prove efficacy and safety.
  Unlike traditional jamu, OHT can target more critical market segments that require scientific evidence.
  It does not require clinical trials like phytopharmaceuticals, making it more realistic in terms of budget and time.

Dosage Form Innovation: Lozenges

• Practical and portable, suitable for mild “masuk angin” (common cold-like symptoms) often experienced during travel, intense activity, or at the workplace.

• Lozenges enable direct contact in the mouth and throat cavity, making them suitable for mild complaints such as nausea, throat discomfort, bitter taste in the mouth, or light dizziness.

• Flavor development potential (mint, ginger, honey) makes the product more user-friendly, and may even attract the children and teenage segments.

• Solid dosage form is more stable than liquid preparations and more economical in terms of packaging.

  
  

Target Consumers: Adults (e.g., Active Workers and Travellers)

• “Masuk angin” symptoms are very common in people with high mobility, such as those working overtime, frequently in air-conditioned rooms, fatigued, or often traveling (by land, sea, or air).

• Lightweight, easy to carry, and spill-proof.

• Provides a calming effect or helps relieve early symptoms of “masuk angin.”

  
  

Proposed Claim after Becoming OHT: “Helps relieve symptoms of ‘masuk angin’ such as nausea, bloating, light dizziness, general discomfort, and throat irritation.”

The claim remains in accordance with OHT regulations because it is:

• Symptomatic/mild in nature

• Based on documented traditional use

• Supported by preclinical studies on active ingredients (e.g., ginger, mint leaves, turmeric rhizome, or cinnamon).
  The claim is not exaggerated and stays within BPOM’s regulatory framework for OHT.

Does the Company Need to Upgrade Its Licensing Qualification? No —continue using IOT license

• To produce OHT, the company only needs to hold an IOT license.

• A Pharmaceutical Industry license is only required if the company intends to move up to the phytopharmaceutical level (which requires clinical trials and pharmaceutical-grade facilities).

• However, the company must comply with CPOTB applicable to OHT products.

1. Fawnia Dewi Audina Salsabillah (22/492282/FA/13382)

2. Nayya Humaira Putri (22/492301/FA/13383)

3. Hasna Salma Sabita (22/492329/FA/13384)

Our group proposes a new product category as a health supplement, since gummies are generally categorized as health supplements that are easy to consume and widely favored, especially by children and adults seeking a practical alternative to liquid herbal products. The innovative dosage form we suggest is a gummy (chewable candy), which has been proven to attract consumer interest, especially children, due to its chewy texture and more pleasant taste compared to traditional herbal drinks. Safe gel-forming agents such as carrageenan from seaweed can be used to maintain the product’s texture and stability.

The target consumers are children and active workers. Children often find it difficult to consume liquid herbal products, so gummies offer a more appealing and convenient alternative. Additionally, busy working adults in need of quick solutions to support their health and reduce fatigue are also a promising market segment.

We propose the following health claims for the product: boosting immunity, reducing fatigue, and supporting digestive health. These claims align with the traditional benefits of “Herba Angin”, which is commonly used to relieve colds, tiredness, and maintain overall wellness. All claims must be supported by appropriate active ingredients and comply with BPOM regulations to avoid misleading claims. 

Given the shift from a traditional liquid jamu to a gummy form classified as a health supplement, we believe the company should collaborate with a licensed pharmaceutical manufacturer or upgrade its license to a pharmaceutical industry. If the company currently holds only and IOT (Industry Obat Tradisional) license, producing gummies with health claims requires meeting stricter standards for safety, quality, and product registration, which are best achieved through regulatory collaboration or license enhancement. 

References 

Citra Dewi, M. (2019). PERLINDUNGAN KONSUMEN TERHADAP PRODUK BERSKALA RUMAH TANGGA TANPA IZIN EDAR (STUDI KASUS PRODUK NUGGET). Jurnal Panji Keadilan : Jurnal Ilmiah Nasional Mahasiswa Hukum.

Paundryakarna, R., Adila Syahid, N., Puspitasari, L., Febrianto, Y., Nabilla Azzahroh, L., Ridwan Malik Batubara, M., Ayu Oktaviana, K., Ulfa, M., Putri, R.P., & Hadiyati Nur Hafida, S. (2024). Sosialisasi Pencegahan Stunting dengan Inovasi Gummy Bayam sebagai Alternatif Kreatif untuk Penuhi Gizi Anak. Prosiding Webinar Pengabdian Masyarakat.

Rochmawati, N., & Ermawati, D.E. (2021). Pengaruh Konsentrasi Karagenan pada Sifat Fisika dan Kimia Sediaan Gummy Jamu Kunyit Asam. Majalah Farmaseutik.

Setyaningrum, D., & Maghfiroh, A.M. (2020). Pendampingan Pengurusan Izin Edar BPOM Produk Jamu Gendong Desa Ngablak, Kecamatan Dander, Kabupaten Bojonegoro. Jurnal ABDINUS : Jurnal Pengabdian Nusantara.

Wahyuningrum, R., Hartanti, D., & Charisma, S.L. (2025). EDUKASI CEK "KLIK” UNTUK MEMASTIKAN KEAMANAN JAMU DAN PRODUK PANGAN KEPADA ANGGOTA PKK KELURAHAN TANJUNG KABUPATEN BANYUMAS. Jurnal Pengabdian Masyarakat Multidisiplin.