PMUC joined efforts with six organizations in building a first-in-the-country manufacturing plant to produce GMP certified extracts from Mitragyna Speciosa Korth, or “Kratom” to be used specifically in medical and high-value food applications. The aim is to benefit community enterprises in the southern provinces, to provide consumers with high-standard products, and to enhance the nation’s competitiveness in the food and drugs in industry.
With the rising trend of herbal remedies recently, hemp and cannabis have been researched and applied in a wide variety of commercial products. Kratom is another medicinal plant that has caught the attention of many after having been taken off the list of Category 5 narcotics since August 24, 2021 under the Narcotics Act (No. 8) B.E. 2564. Kratom is a local plant in southern Thailand. And due to the geography and climate in the south suitable for growing Kratom, it can be found in many southern provinces. In the past, before Kratom was declared a Category 5 narcotic, southern villagers commonly used Kratom leafs to treat common ailments such as cough, diarrhea, abdominal pain, and toothaches. It was also used to treat chronic diseases such as diabetes and hypertension, and used as a substitute for other addictive drugs. In the present days, in many countries, Kratom leafs are being used in the treatment of drug addiction due to research showing that Kratom is easier to quit than other narcotics. Kratom has also been used as an alternative to morphine to relieve pain, as well as being processed into capsules for relief of common aches and pains, and used as an ingredient in energy-promoting tonics.
However, the medical application of Kratom is still not common in Thailand. For that reason,
Medical Science Research and Innovation Institute at Prince of Songkla University established a laboratory and a model extraction plant to produce standardized herbal extracts for use in medicine and food that meet the GMP standard: a sample study of Kratom as a prototype plant, which received funding from the Program Management Unit for Competitiveness (PMUC) with the goal of driving the commercial utilization of Kratom in medicine and health food applications. This was in cooperation with community enterprises in various southern provinces such as Ban Na San in Surat Thani province, Thung Song district in Nakhon Si Thammarat province, Kraburi district in Ranong province, some areas in Chumphon province, and Trang province, etc., all of which serve as farming areas to produce organic Kratom for medical and food applications.
In mid June 2022, Assoc. Prof. Siree Chaiseri, Ph.D., director of PMUC, along with the management team and staff from the Thai Center of Excellence for Life Sciences (public organization) or TCELS, a delegation from the Food and Drug Administration (FDA), K Agro-Innovate Institute (KAI) under the Kasikorn Thai Foundation, Inter Pharma Company Limited, Department of Science Service and the Federation of Thai Industries visited the prototype factory which produces herbal extracts for medical and food applications that meet the GMP standard at Prince of Songkla University and is located on the Southern Industrial Estate, Songkhla province. They also visited the production plots for high-quality Kratom under Good Agricultural Practices (GAP) and Organic standards, as well as observed the production of processed products from Kratom produced by community enterprises in the southern provinces.
Assoc. Prof. Siree Chaiseri, Ph.D. said that “This project is an example of funded research on high-value herbal extracts with tangible outcome. We want this project to be a model to be replicated for other medicinal plants with funding from PMUC. Incidentally, PMUC has worked with FDA because there are more research projects underway for other extracts and medicinal ingredients which also receive support from PMUC. Therefore, it is necessary for FDA to look into the production process to ensure safety and standardization, and to ascertain whether the process can be certified by FDA so that the research can be used in real-world applications. This project is a good example that we often reference because it is relatively comprehensive and serves as a clear example of research work being transferred to real application. The entire process begins at an extraction plant at Prince of Songkla University, and at a pharmaceutical plant to produce drugs from extracts at the Faculty of Medicine, Ramathibodi Hospital, where herbal medicines are used and tested, all the way to the end users which are the actual patients throughout the country, allowing us to see the entire picture. In addition, this project covers the entire process from upstream being the community enterprises in the southern provinces; the midstream being the production and processing of herbal extracts in extraction plants/pharmaceutical plants; and downstream which is the hospitals/patients who are end users of the drugs. And finally the process leads to full-scale commercialization, so it is a good model project. I would like to express my appreciation and gratitude for the research team.”
Prof. Sansanee Chairote, Ph.D., chairperson of the Health and Medicine Program Subcommittee at PMUC, and Executive Director of TCELS, said “We would like to give much credit to Prince of Songkla University and the team at Medical Innovation Research Institute as this is a real synergy of creative forces. From the beginning, we started just as an idea from a field trip to see cannabis production and came up with a research thesis. We then did some research and found that Prince of Songkla University has carried out the most extensive research on Kratom in the country, combined with the fact that Kratom is a plant native to the south. Thus, there came an initiative to support and enhance viability of universities in the southern provinces. From consultation with Asst. Prof. Worawit Wanichsuwan Ph.D., director of the Medical Innovation Research Institute at Prince Songkla University, as well as with FDA, Office of the Narcotics Control Board, and the Department of Science Services, in cooperation to develop an ISO 17025-standard laboratory for the detection of contaminants, quality assurance of Kratom extract as well as production of substances made to desired standard of quality. In this project, PMUC has provided the necessary equipment used in the factory and built a laboratory to meet the GMP and ISO17025 standards, respectively. I would like to express my appreciation to the research team, to the teachers in charge of cultivation as well as the QA/QC team, as well as to the laboratory staff and experts in charge of the ISO process, including database preparation and traceability. The project would have been very difficult to drive forward without someone to help spearhead the documentation process for the registration to obtain certification in order to be called a true Healthy Project. In addition, we must also thank the private sector who offered necessary capabilities, namely, a pharmaceutical plant which meets GMP/PICs standards to help in the matching process with partner factories and community enterprises, all to enable farmers to earn income from producing high-quality Kratom. Therefore, this project is a synergistic effort from all sectors to promote Kratom as a medicinal plant towards full commercial applications.”
Asst. Prof. Worawit Wanichsuwan, Ph.D., director of the Medical Innovation Research Institute at Prince of Songkla University, the project leader, said that “Currently, there are two types of Kratom in the market, dried and ground. And the Kratom that can be used in medicine and food products must be high-quality Kratom leaves. It must be cultivated in an area free of chemicals and heavy metals. The quality of the active ingredients in Kratom depends partly on the age of the Kratom leaves. The older the leaves, the more mitragynine is present. There is also the issue of cultivation area. Kratom that was cultivated in the southern regions was found to contain more mitragynine than the Kratom cultivated in other regions. Currently, Indonesia, the world’s number one exporter of Kratom, is also cultivating various Kratom species in southern Thailand. Therefore, it is an opportunity and an advantage of Thai Kratom because we have better quality Kratom than other countries. Establishment of a prototype extraction plant to produce GMP-standard herbal extracts for use in medicine and food products, by using Kratom as a prototype plant in the industrial estates of the southern provinces, will serve as a tool to help create high-value products for medical and food applications in a concrete way. In particular, if product development can be handed off to the private sector who possess GMP/PICs compliant factories, the scale of production can be expanded to the point where it becomes viable for the commercial market. This will help increase the competitiveness of the country in exporting Kratom extracts.”
In light of recent public policy to promote use of medical herbs in hospitals/infirmaries as an alternative to importing conventional drugs, combined with the consumption trend of the new generation who prefers to use herbs as an alternative to conventional health care, it is a good opportunity to promote Kratom to become one of the main industrial drops for the southern provinces in the future. In addition to its medicinal properties to treat various diseases, the use of Kratom in the treatment of addiction to other narcotic substances such as methamphetamine, heroin, ice and alcohol, offers a safer alternative, and extends the economic benefits to the Thai herbal industry.