Thailand: A Regulatory Overview Of The Manufacturing, Importing And Promoting Of Herbal Medicines Throughout The COVID-19 Pandemic

background

Studies conducted in Thailand have shown that Thai herbs, e.g. B. Andrographis paniculata (Burm.f.) and fingerwort (Kaempfer or Boesenbergia rotunda) can treat COVID-19 symptoms, and there is some evidence that these herbs can suppress SARS-CoV-2 and stop the virus from multiplying .

The COVID-19 pandemic in Thailand, along with results from research on Thai herbal medicines, has led to an increase in Thai herb sales. Therefore, many actors in this area should be aware of the regulatory framework for the manufacture and sale of such products in Thailand.

introduction

In 2019, the Plant Product Act BE 2562 (2019) (“HPA“) Was issued to review the Herbal Medicines Regulations at the Food and Drugs Administration (“FDA“) As the competent authority within the meaning of the HPA.

According to the HPA, “herbal product” is defined as follows:

  1. Herbal medicine including traditional Thai medicine, medicine developed from herbs, traditional medicine for human use according to medical laws, or medicines derived from the knowledge of alternative medicine as recommended by the Minter of Public Health on the recommendation of the committee for herbal products for the treatment, healing and relief of human diseases or for the prevention of diseases;
  2. Herbal products or products containing active ingredients composed of or processed from herbs which are ready for human use to improve health or body functions, to strengthen human body structure or functions or to reduce risk factors for diseases;
  3. Items intended to be used as ingredients in the manufacture of herbal products; and
  4. Other items prescribed and notified as herbal products by the Minister of Public Health on the recommendation of the Herbal Products Committee.

General regulatory compliance

The herbal product defined in points 1, 2 and 3 above excludes:

  1. Items intended to be used in agriculture, industry or other purposes prescribed and notified by the Minister of Health;
  2. Objects classified as modern medicine, traditional veterinary medicine, food for humans or animals, sports equipment, instruments or devices for health promotion, cosmetics, medical devices, psychotropic substances, narcotics, hazardous substances or other prescribed and indicated objects are classified by the Minister for Public Health on the recommendation of the Vegetable Products Committee.

Based on the risk level of the indications / health claims, which was determined and communicated by the Minister of Health on the recommendation of the Herbal Product Committee, there are four categories of herbal products:

  1. Herbal products for which a manufacturer, importer or seller must obtain licenses from the FDA (the “Licensed herbal products“);
  2. Herbal products for which a manufacturer or importer must be registered for sale and must receive a certificate of registration of herbal product formulas from the FDA (the “Registered Formula Herbal Products“);
  3. Herbal products that a manufacturer or importer must notify and obtain a notification receipt or listing receipt from the FDA for sale; (the “Notification herbal products“) and
  4. Herbal products the manufacture, import or sale of which is prohibited.

By notifying, registering or obtaining the appropriate license from the FDA, the herbal products under the HPA are exempt from compliance with the Medicines Act and the Food Act.

Licensed herbal products

Operators who wish to manufacture, import or sell licensed herbal products as per the notice from the Ministry of Health must apply for a license. Once licensed by the FDA, that operator can manufacture, import, or sell herbal products. A license to manufacture, import or sell herbal products is valid for five years from the date of issue.

Registered Formula Herbal Products

Operators wishing to manufacture or import for sale registered herbal formula products notified by the Department of Health must apply for registration of herbal products with the FDA. After receiving a certificate of product registration, the licensee can then manufacture or import such herbal products for sale. A certificate of registration of herbal products is valid for five years from the date of issue.

Certain herbal products do not require registration with the FDA. These herbal products are as follows:

  1. Samples of a herbal product to be manufactured or imported for use in applying for product registration;
  2. Manufacture or import of herbal products for research, analysis, exhibition or donation purposes;
  3. Materials used as an ingredient in the manufacture of a herbal product; and
  4. the manufacture or import of herbal products for the treatment of a specific patient as prescribed and notified by the Minister of Public Health on the recommendation of the Herbal Products Committee.

In the case of the manufacture or import of samples of herbal products according to (1) or the manufacture or import of herbal products for the purposes stated in (2), the manufacturers or importers must notify the FDA in accordance with the criteria, procedures and conditions established by the Minister of Public Health prescribed and communicated on the recommendation of the Committee for Herbal Products.

Promotion of herbal products

Operators are not allowed to advertise an herbal product or the benefits of an herbal product unless they have a license from the FDA.

The application for and the granting of an advertising license for herbal products must be processed in accordance with the criteria, procedures and conditions prescribed by the Secretary General of the FDA and published in the State Gazette. In this context, the Secretary General of the FDA can prescribe special conditions for advertising or restrict the use of advertising materials. An advertising license for herbal products is valid for three years from the date of issue.

Prohibited herbal products

Certain herbal products are not allowed to be imported or manufactured in Thailand. These herbal products are as follows:

  1. fake herbal products, e.g. B. Herbal products with incorrect information about the manufacturer’s name, trademark, place of manufacture, misleading labels or package inserts, expiry date, etc .;
  2. substandard herbal products;
  3. deteriorated herbal products;
  4. Herbal products that are not registered, notified, or listed, as the case may be; and
  5. herbal products for which the registration certificate, registration form or approval certificate has been revoked.

Penalties for non-compliance

Operators who manufacture, import or sell herbal products in Thailand without a license face penalties and fines, including imprisonment of up to three years and / or fines of up to THB 300,000. In addition, advertising for herbal products without a license or advertising for herbal products in a manner that violates the HPA, for a term of up to one year and / or fines of up to THB 100,000. In addition, depending on the offense, a daily fine is imposed on the offender in accordance with the provisions of the HPA. Revoking licenses is another sanction used to punish a perpetrator.

diploma

As the use of herbal treatments for COVID-19 has become more common and is being promoted by Thai authorities, operators should be aware of the regulations that control such herbal products. Fines and penalties can be severe for operators who violate the legal requirements for licensing, registering, and promoting herbal treatments under Thai law. As the pandemic continues to affect countless people around the world and in Thailand, the demand for alternative treatments is likely to increase. To avoid potential problems and violations of Thai law, operators should seek legal advice before starting their business, and existing operators should ensure that their business is in good standing with the relevant authorities.

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