Thien Duoc Co., Ltd has announced to undertake agriculture, collection, and formulation of Crinum latifolium L. in Long Thanh - Dong Nai under GACP-WHO criterion (Good Agriculture and Collection Practices for medicinal plants as recommended by World Health Organization). Reportedly, this is the first Crinum latifolium L. plantation in Vietnam complying with this criterion. According to experts, the implementation of GACP-WHO criterion helps control the quality of medicines, especially difficulties in medicine origin traceability in recent years.
 

Science & Life Newspaper 23/03/2012

Pharmacist - Dr. Nguyen Thi Ngoc Tram - Director of Thien Duoc Company shared some information related to medicine production from Crinum latifolium L. under the above criterion. Reporter: How do you cultivate Crinum latifolium L. under GACP-WHO criterion? Pharmacist - Dr. Nguyen Thi Ngoc Tram: Thien Duoc Company established Crinum latifolium L. plantation with an area of 15 ha in Long Thanh - Dong Nai in 1999. Since November 2010, Thien Duoc has implemented the cultivation, caring and collection of Crinum latifolium L. plant under GACP-WHO standard. This plant is popular in many places, but originates mainly from the coastal area of Ba Ria - Vung Tau province and is acclimatized to grow in imperial palaces in Hue. We select seedlings from wild plants based on genetic characteristics (DNA) of Crinum latifolium L. validated botanically by the leading botanists of Vietnam (Prof. Dr. Sc. Do Tat Loi, Assoc. Prof. Dr. Vo Van Chi, Prof. Dr. Sc. Tran Cong Khanh) as Crinum latifolium L. belonging to Amaryllidaceae family.

The company has selected healthy seedlings whose leaves have sufficient bioactive substances for Crila production for BPH and uterine fibroids. Crinum latifolium L. has been asexually multiplicated since 1990 until now. To have sufficient raw materials for the production of Crila medicine, Crilin and Crinum latifolium L. tea, Thien Duoc Company has conducted cultivating Crinum latifolium L. in Long Thanh - Dong Nai, which is a clean medicinal material plantation under GACP-WHO guideline that stabilizes the content of bioactive substances: the plant is grown in dry and hot climate areas. The plantation has favorable location which 1 km away from main roads, unpolluted with crowded residential areas, not near factories, enterprises, hospitals, and cemeteries, with suitable climate for the plant. The plantation use water in accordance with national technical standards of running-water quality according to provision QCVN 01: 2009/BYT issued by the Ministry of Health. In cultivating process, no chemical fertilizers, growth stimulants and pesticides are accepted but use hands or pheromones – a synthetic substance with the same chemical structure as extract from female worm – to catch caterpillars by luring male. This helps to prevent female from fertilizing and laying eggs.

Reporter: In fact, many production facilities commonly face with difficulties in training workers during the improvement. How does Thien Duoc Co., Ltd manage this task?

 Pharmacist - Dr. Nguyen Thi Ngoc Tram: To accomplish the above task, we must hold proper staff apparatus. At the plantation, we have one manager, one technical supervisor, one storekeeper, one production record managing officer, one manager for electromechanics, 3 leaders of production group, and more than 60 workers.

The company organizes regular training courses for staff to master techniques as well as standards and principles in the process of cultivation, caring and collection. Especially since the deployment of GACP-WHO criterion, we set up quarterly plans to disseminate principles and standards of GACP-WHO criterion applied for planting, caring and collecting medicinal materials. Our company has a motto that is to change farmers into agricultural workers who master techniques in cultivating and collecting this plant according to GACP-WHO criterion, work for the company for a long time and have stable income. Rules of personal hygiene and rules of primary processing area and warehouses are formed into documents to instruct employees to perform seriously. Other activities related directly and indirectly to the quality of medicinal materials are informed in details in the form of documents for employees to perform, update the results, and record.

Reporter: According to authorities, the test results of the quality of traditional medicine on the market showed that nearly 10% of all tested samples don’t meet registered criteria. What’s your opinion on this matter?

Pharmacist - Dr. Nguyen Thi Ngoc Tram: As the demand for herbal medicines, along with the expansion of the health service system with traditional medicine have developed rapidly in recent years, the number of facilities manufacturing medicinal materials and traditional medicine is increasing ceaselessly. However, in terms of herbal medicine quality on the market, 10% of the total tested samples are substandard. Based on this fact, to improve the quality of herbal materials and traditional medicines on the market, the Ministry of Health organized the second national medicinal materials conference ‘Development of medicinal materials till 2015 and the vision of 2020’. At this conference, Dr. Nguyen Van Tuu of Central Drug Testing Institute gave a presentation ‘Status of medicinal material and traditional medicine quality in the past few years and intention in the coming years’. Herein, Dr. Nguyen Van Tuu said, ‘To ensure the quality of medicinal materials and traditional medicines, we need to standardize medicinal materials and traditional medicines. To standardize them, the Ministry of Health has issued 276 standards in terms of medicinal material quality and 36 standards of traditional medicine quality published in Vietnamese Pharmacopoeia III as a basis for assessing medicinal material quality before putting it into production. This is a proper direction for regional countries’. The basic factor in standardizing medicinal materials is to determine “true, good, pure, and offer a management regulation”. To achieve the three above criteria, "real medicinal materials need identifying as correct names, species, and used parts. It’s necessary to standardize their characteristics of appearance, microsurgery, powder, and specific reaction of their active substances. Good medicinal materials are plants which are grown in accordance with GAP criterion - Good Agriculture Practices, collected at the right time, processed under proper method, without mold or termites, etc and satisfy stipulated specifications, qualitative and quantitative features of active substances or specific active substances. In terms of purity, it is necessary to gain specified impurity ratio such as ash insoluble in hydrochloric acid, strange medicinal materials or other parts of plants, humidity and some heavy metal such as bronze, lead, arsenic and mercury and aflatoxin-free". With regard to management regulations: the plants have to be cultivated, collected, and processed according to GACP-WHO criterion, factory should meet GMP criterion in producing medicinal materials and traditional medicine, which helps to guarantee the products.

Reporter: Vietnam must depend almost entirely on foreign medicines, especially medicines for incurable diseases while we have a quite abundant source of medicinal materials. In your opinion, how to take the initiative in  medicinal material sources?

Pharmacist - Dr. Nguyen Thi Ngoc Tram: In this regard, we need to acknowledge it and learn from India, which self-produces 70% herbal medicines treating diseases for its people, and nowadays India has a very large number of drugs exported to the world market. India has recognized the problem of self-medication for over 50 years. Our country is recorded to have nearly 4,000 species of medicinal plants, over 400 species of medicinal animals and nearly 50% of the 11,000 types of holothurians and marine creatures that have therapeutic effects. With such a rich and diverse source of medicinal herbs, herbal medicine production should have developed its inherent potential. However, whole country just has nearly 300 facilities producing medicines from medicinal materials, most of which work in small-and-ragged-scale.

When taking the initiative in medicinal materials, we will create new products from clean materials with high quality. New Vietnamese medicinal products will help stabilize escalating medicine at present. The more meaningful thing is to bring Vietnamese specific medicines to the international pharmaceutical market with low cost, high quality to serve low-income patients in our country and all over the world.

Currently, foreign medicine firms are bringing a large number of their products to Vietnam and vice versa, we also need to bring Vietnamese medicinal materials and traditional medicines to foreign markets. In order to help our medicine brand stand firmly and compete with the same type of products from foreign countries, immediately in domestic market, standardization in the process of planting and collecting medicinal materials should be attached special importance. This means that we have to create medicinal material sources with high content of active substances in accordance with GACP criterion.

 

Reported by DONG HUONG

GACP – ‘Good Agriculture and Collection Practices’ can be applied for food crops, vegetables, fruit trees, etc., especially medicinal plants. Because medicines should satisfy the standards of quality, safety, and efficacy, medicinal materials must also meet these requirements. GACP criterion plays a very important role in the creation of raw materials meeting these standards. It consists of two main topics: Good Agriculture Practices (GAP) and Good Collection Practices (GCP). Each process has several stages; each stage has its own criterion for each specific medicinal plants. It depends on the natural environment, ecological conditions, seedlings, soil, cultivation methods, care, pest prevention, collection, transportation, post-harvest process, packaging, and medicinal material storage in warehouse. Facilities should conform to natural conditions and farmed and collected objects such as working house, drying area, warehouse, production tool, processing area and laboratory with measuring and quality-testing equipment.