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Processing and utilization of NWFPs by Menjong SorigPharmaceuticals -Institute of Traditional Medicine Services(ITMS)

Prepared and presented by Phurba Wangchuk

Abstract

The traditional medical system in Bhutan is one of the most sustainable health caredelivery system since all its components including human resource development,manufacturing of traditional medicine and provision of health care services are donewithin the country. The Institute of Traditional Medicine Services (ITMS) is the guardianof this traditional medical system in Bhutan. The ITMS comprises of three units: NationalInstitute of Traditional Medicine, National Traditional Medicine Hospital and thePharmaceutical and Research Unit.

The Traditional Medicine Service in Bhutan is fully integrated with modem health caredelivery system and is available in all 20 district hospitals. There is a plan to establishTraditional Medicine Units in all the Basic Health Units in the country. Thecommercialization plan including an enhancement of product development activities havebeen started at PRU. These changes of policy and strategy would require heavyinvestment in the traditional medicine services for the development of human resourcesand for the production of traditional medicines.

In 2005, PRU have pro.cured 12.5 metric tons of raw materials mainly medicinal plantsand manufactured approximately 13.3 tons of products including commercial products.Sustainability of medicinal plants and traditional medicines has been always an issue ofconcern for PRU and the biggest challenge is securing its rich IPR. For PRU to have itsplace in modern era, R&D is the only way forward. But again advanced R&D cannotpick up at PRU simply because there is lack of expertise and equipments which involveshuge investments. Therefore, limited collaborative research both within and outside thecountry should spear head the R&D of PRU despite minimal risk for bio-intellectualpiracy.

Key words: NWFP, medicinal plants, traditional medicines, research and developmentand production

Introduction

The Institute of Traditional Medicine Services (ITMS) comprises of three units: National. Traditional Medicine Hospital, National Institute of Traditional Medicine and

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Pharmaceutical & Research Unit. '

The National Traditional Medicine Hospital is responsible for the development andprovision of quality traditional medical care range from behavioral modification,prescription of herbal medicines, herbal therapies including acupressure and herbo-aquatherapy, minor surgery and spiritual healing. Currently, there are 25 Traditional MedicineUnits at the districts and BHU level, attached to the district hospitals. There is plan toestablish Traditional Medicine Unit in all Basic Health Units in the country.

National Institute of Traditional Medicine is responsible for the development of humanresources required for the traditional medicine services.

Pharmaceutical and Research Unit is responsible for manufacturing and production ofmedicines, conducting quality control for both raw materials and finished products,carrying out research activities and marketing of the products.

The objectives of ITMS are to:

. Preserve and promote the unique culture and tradition related medical practices

. Provide the quality traditional medical health care in the country

. Conduct research and quality control of drugs. Develop human resources required for the traditional medical system

. Achieve excellence in traditional medical services in Bhutan.

Pharmaceutical and Research Unit

In the past, the quantity of medicines required were low and all these medicines wereproduced manually. Small scale mechanized production started only in 1982 with supportfrom WorId Health Organization and in 1998, the manufacturing unit was upgraded to thePharmaceutical and Research Unit (PRU).

The mandates ofPRU are:

1.Manufacturing and production of traditional medicines2.Carrying out research and quality control for both raw materials and finished products3.Marketing of the products

Therefore, to carry out these mandates, the PRU has established three main sections:-Procurement and Production, Research and Quality Control, and Marketing.

Procurement and Production Section

This section is responsible for manufacturing of traditional medicines based on thetraditional formula using latest production technology. The medicines are manufacturedbased on Good Manufacturing Practices (GMP) guidelines and Standard Manufacturing

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Instruction (SMI).

In the formulations of traditional medicine, mainly three categories of raw materials areused. They are:

sMen-zhingSa-sMenSog-cha-sMen

- Medicinal plants- Minerals- Animal origins

sMen-zhing (Medicinal Plants) is further classified as sNgo-sMen - H i g h a Itit u d emedicinal plants and Throg-sMen- Low altitude medicinal plants. In Bhutan, highaltitude medicinal plants are sourced from an altitude rariging from 2500 to 5000 metersabove sea level and low altitude from 95 to 2500 meter above sea level.

According to gSo-ba Rig-pa texts, more than 2990 different types of medicinal plants arereported for their uses in traditional medicine formularies. Out of which about 600medicinal plantShave been identified in Bhutan. However, at present only 265 differenttypes of raw materials including 4 plants used for their woods are used to produce 98essential traditional medicines and 14 commercial products. About 85% of raw materialsare available within the country and remaining 15% are imported from India.

The PRU procures or collects around 12.5 metric tons of raw materials on the average butthis quantity is expected to double within 2 to 3 three years. This would ultimately exertpressure on the natural resources if conservation issues are not addressed and strategicutilization and sources not identified. For this reason, PRU in collaboration withMedicinal and Aromatic Plant Section under Ministry of Agriculture have trained farmersin good collection practices and cultivation of medicinal herbs. Beside Lingzhi, PRUhave recently identified Bumthang as an alternative for collection of high altitudemedicinal plants.

The collection season for high altitude medicinal plants is from July to September and forthe low altitude medicinal plants, it is December to February. While collecting the wildmedicinal plants; first the annual requirements are calculated, geographical andpopulation density of the target medicinal plants species are determined, collectionpermits are obtained. Second, collection teams conversant in ethnographical information,identification and drying processes are organized. The quality control staffs accompanythe collection teams to monitor quality at source. The collection permits are obtainedfrom Department of Forest, Nature Conservation Division and Park Management. Afterpost harvest care, the dried medicinal plants a~e transported to PRU. Once again onreaching PRU, the dried medicinal plants are subjected to quality control tests and thequality passed materials are stored in the store.

Tbe raw materials are then issued for formulation of different types of products. In theyear 2005, of the 13.3 metric tons of total production, about 8 tons were produced as coretraditional medicines. When three year's productions out puts are compared, it was foundthat there is an increase of 5 tons (Chart 1). This increase is mainly attributed to the fact

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that PRU has scale up commercial production especially Tsheringma herbal tea togenerate income in a view to achieve self sufficiency and sustainability.

Chart 1: Production Outputs

14000.00

~ 12000.00= 10000.00

; 8000.00.~ 6000.00=& 4000.00

2000.00

0.00

2003 2004

Year

2005

-TM+CommerciaI --TMCore

For better patient compliance and management, products manufacutured at PRU aremade into different dosage forms such as pill, tablet, capsule, syrup, drop, ointment,medicated oil, fermented mixture, powder, balm and tea.

Research & Quality Control Section

This section is responsible for assuring quality, safety and efficacy of the traditionalmedicines manufactured by PRO. Researches are being carried out in the following areas:. Standardizations of raw materials and finished products including botanical

nomenclature, formulations and extracts. Scientific validation of traditional medicine including pharmacological analysis,which consists of clinical trials, claim validations and the fixation of expiry datesfor the raw materials and the finished products.. Pharmacognostical and phytochemical analysis including morphological, cellular,extraction, isolation and identification of bioactive phytochemicals. Thesesections have produced one monograph on twenty medicinal plants.. Product development activities under six product categories such aspharmaceutics, over the counter products, fragrance and essence, cosmetics andtoiletries, health promoting and nutraceuticals. Many products are underdevelopment.. Building quality control test parameters and standards and monitoring the qualityof the finished products and raw materials. Operational research including the survey and documentation of medicinal plants,local healer's practices and hot springs in Bhutan.

Marketing Section

The marketing section is responsible for market surveys, audits and selling the productsof PRU to the customers both within and outside the country. Essential traditional

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I.

medicines are sold to Drug Vaccine and Equipment Division (DVED), Ministry of Healthand about 14 commercial products are sold directly from the PRU sale counter. There arealso sales agents especially for Tsheringma herbal tea which is the popular product ofPRU at the moment. Cordyplus, which is a new product, is also gaining popularity. Thereare also few new products lined up for launching and marketing.

In 2005, PRU have spent Nu.3.9 million for the procurement of raw materials and thetotal sales amounted to almost NuA million including both ETM and commercialproducts. Main customer of PRU is the Ministry of Health. Although, officially there isno export business, unofficially many tourist and Bhutanese who go outside have takenwith them the herbal tea and incense powder as souvenir. Immediate plan is to launch fewproducts such as herbal teas (2), cordyplus (2), incense sticks (2) and herbal bath elixirsin the international markets. Therefore, market surveys and audits are completed inThailand, Singapore, Hongkong, Germany and UK.

Future plan, ne~ds and challenges

The Traditional Medicine Services in Bhutan is fully integrated with modern health caredelivery system and is available attached to 20 district hospitals and 5 basic health units.There is a plan to establish Traditional Medicine Units in all Basic Health Units in thecountry. This change of Government policy would require heavy investment in thetraditional medicine services for the development of human resources and for the scale upproduction of traditional medicines. PRU will also enhance development of commercialproducts both for domestic and export markets. This will need huge supply of rawmaterials especially NWFP and that is where PRU will need full support and effort fromthe MAP section under MoA in sustainable utilization of medicinal plants throughdomestications.

In future, PRU need capacity development and will focus on the following:(a) Up-gradation of existing facilities(b) Human resource development(c) Collaborationlinstitutionallinkages with other organizations both within and outside

the country.(d) Research and Development (R & D) activities.

R & D is essential as Drug Regulatory Authority (DRA) and Bhutan Agriculture andFood Regulatory Authority (BAFRA) is imposing their stringent regulations to ensurepublic safety. The biggest challenge is how to develop an appropriate research design andmethodology to test the safety and efficacy of traditional medicines. This is furthercomplicated by the fact that the herbal medicines are multi-ingredient compounds, whichmakes analysis more sophisticated. For developing an appropriate research design andmethodologies and also for carrying out meaningful and fruitful researches, PRU willrequire institutional linkages and collaborative partners. To facilitate this collaborativeresearch especially outside the country, it requires transfer of materials and thus theMaterial Transfer Act of Bhutan should be dynamic not rigid.

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Intellectual Property Rights (IPR) is another issue of concerns for PRU. This is becausebio-prospecting and collaborative research nurses high risk of bio-intellectual piracy.Patenting of new innovations is hardly possible simply because Bhutan cannot afford topay for it. Therefore, registering trademark is the only way to secure and protect theproducts and other innovations ofPRU.

As there is many plant based industries cropping up in Bhutan, within few years timePRU will have to compete for the raw materials and this would mean jeopardizing thesustainability of the traditional medicines. Better export prices of raw materials may alsohave adverse implications to the cost of production for PRU in particular and other plantbased industries in general.

The way forward

Having understood the opportunities as well as the challenges for PRU as describedabove, it is felt that capacity building in terms of HRD, infrastructure developmentinclusive of equipments, securing raw materials supply and research and development isthe way forward. The capacity building can be achieved through allocation of adequateresources, R & D collaboration within and outside the country with the technical supportof the collaborating partners. Transfer of knowledge and technology would not onlypromote more research work and help to ensure sustainability of resources and traditionalmedical system in the long run.

However, in line with the Government policy on conservation and biodiversity, everymeasure must be put in place to protect the traditional knowledge and prevent risk of bio-prospecting. Knowing the constraints and limitations of R & D at PRU, its collaborativework should, therefore, continue to move forward considering its immense benefits to thequality and the production capacities.

References:

1. RGOB (2005). An Introduction to Traditional Medicine Services in Bhutan, ITMS,Thimphu

2. WHO (2005). Review of Traditional Medicine in the South-East Asia Region, WHOSEARO, New Delhi

3. Bhutan-Japan Symposium (2006). Proceedings, ITMS and HMR, Thimphu.

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