Herbal Medicine Pak Efizal tgl Nov 2024

Herbal Medicine: Regulation of Natural Substance Drugs

Overview

  • Institution: Universitas Sanata Dharma

  • Course: Regulatory Aspects of Herbal Medicinal Products

  • Instructor: Efizal, SSi., Apt., MSi.

  • Year: 2024

Course Materials

  • Topics Covered:

    • Scope of regulation for herbal medicines (OBA).

    • Safety and quality requirements for herbal medicines.

    • Claims regarding the benefits and labeling of herbal medicines.

    • Regulations related to advertising and licensing of herbal medicine practices.

Regulations for Herbal Medicines (OBA)

Labeling Standards

  • Accurate Labeling:

    • Must contain objective, complete, and non-misleading information.

Efficacy Requirements

  • Proven Efficacy:

    • Must be substantiated through empirical (traditional use) evidence or scientific studies.

Manufacturing Standards

  • Good Manufacturing Practices (GMP):

    • Requires adherence to good manufacturing practices for herbal medicines.

Compliance with Standards

  • Standardization:

    • Must meet the Indonesian Herbal Pharmacopoeia standards or other recognized scientific references.

  • Quality and Safety:

    • Must utilize materials that comply with safety and quality standards.

Issues and Problems in Herbal Medicines (OBA)

  • Common Claims:

    • Various herbal products claim to aid conditions such as hypertension, diabetes, or cancer.

    • Specific claims include alleviating symptoms like dizziness, high blood pressure, or improving circulation.

Definition of Herbal Medicines (OBA)

  • Herbal Medicines:

    • Comprises materials or products derived from natural resources (plants, animals, minerals) that have been traditionally used or scientifically validated for health maintenance, disease prevention, or treatment.

Classification of Herbal Medicines

  • Categories:

    1. Jamu (traditional herbal medicine).

    2. Standardized herbal medicine.

    3. Phytopharmaceuticals (scientifically validated herbal products).

    4. Other herbal products based on innovations.

Regulations Concerning Claims of Herbal Medicines

  • Regulatory Framework:

    • Governed by various regulations set forth by BPOM regarding efficacy, safety, and clinical testing for herbal medicines.

Principles for Establishing Claims

  • Objectivity: Claims must be clear, consistent with definitions of herbal medicines, and ensure safety and effectiveness.

  • Evidence Quality: Claims must be supported by high-quality, relevant scientific evidence.

Types of Claims

  1. Traditional Health Use:

    • Claims based on traditional knowledge and usage.

  2. Traditional Treatment:

    • Claims derived from traditional medicinal practices.

  3. Scientifically Established Treatment:

    • These claims require significant scientific data supporting their efficacy and safety.

Claim Verification

  • Evidence for Claims: Verification includes:

    • Documented traditional usage over generations.

    • Preclinical and clinical research supporting efficacy.

  • Harmonization with International Standards: Aligning local herbal medicine claims with international evidence such as WHO guidelines.

Preclinical Testing

  • Toxicology Testing:

    • Regulations (BPOM 10/2022) outline requirements for preclinical toxicity testing to assess safety.

  • Pharmacodynamics: Evaluates how herbal products affect biological systems.

Clinical Testing Regulations

  • Clinical Trials:

    • Must ensure compliance with ethical guidelines and BPOM regulations.

    • Different phases of trials needed depending on whether the products are new or existing in the market.

Conclusion

  • Final Thoughts:

    • The regulation of herbal medicines in Indonesia is comprehensive, focusing on safety, efficacy, and transparency. Continuous monitoring ensures consumer safety and product integrity.