AsemconnectVietnam - To construct phamaceutical industry having product structure relatively complete, including mainly pharmaceutical products such as antibiotics raw materials group ; group of raw material of medicines treating heart disease, circulatory and anti-cancer ; group of raw material of vitamin.
I. Development goals
1. Overall Goal
- To construct pharmaceutical industry having product structure relatively complete, including mainly pharmaceutical products such as antibiotics raw materials group ; group of raw material of medicines treating heart disease, circulatory and anti-cancer ; group of raw material of vitamin ; group of raw material of painkiller, lower fever, anti-inflammatory; group of raw material of drug treating HIV / AIDS ; group of pharmaceutical additives, gradually meet the domestic market demand, replace import and look forward exporting the drug.
- To step by step construct modern pharmaceutical industry, use advanced technology, create products which can be competitive on the domestic market, in the region and the world. Combining the research to create technology with high quality in the country with the import and owning modern foreign technology to produce raw materials for development of pharmacy industry;
- To exploit, process, use suitably and effectively natural resources for development of pharmacy industry on the basis of focusing on conservation and development of sources of rare medicine genetic. Strive to ensure supply in most of common pharmaceutical raw material; a part of senior pharmaceutical raw material, organic pharmaceutical raw material from plants, medicinal herbs used in domestic and for export; ensure sufficient essential medicines deriving from pharmaceutical raw materials;
- To promote potentiality, strength on pharmaceutical raw materials, combining with the quintessence of health traditional medicine to create goods products which have high effective treatment, suitable for disease model of our country;
- To invest in modern technology, renew equipment and business management to build pharmacy industry gradually meet the raw material demand of manufacturing drugs. Construct bases of producing antibiotics and other essential pharmacy, manufacturing advantage pharmaceutical raw materials, especially drugs from medicine raw materials;
- To invest in developing bases of producing chemicals and materials for manufacturing medicines. Give priorities in investing in producing pharmaceutical raw materials for producing of essential medicines, drug for export, drug from the pharmaceutical herb and generic medicine to replace the imported medicines. Focus on development of areas of breeding, growing medicinal herbs. Closely combine human resources and equipment of pharmacy, chemical industries with the resources of other sectors, mount effectively process of science research with the production of medicine, pharmacy of medicine entrepreneur;
- To have appropriate policies to encourage all economic sectors, especially the non- State production organizations participating in cultivating and processing all kinds of medicine raw material that originate from agriculture, forestry, fisheries under common development plan of the State. Focus on development of small and medium –sized enterprises in producing and processing pharmaceutical products;
- The State actively invest in producing pharmaceutical products requiring high-tech and large needs, essential for community health safety , such as type of vaccines, new generation antibiotics , while encourage foreign investors to invest in this important area.
2. Specific Goal
- Domestic production guarantees to meet 20% of the demand of raw materials for pharmaceutical industry in 2015; 40% in 2020 and 70% in 2025;
- To construct areas producing raw materials: have plan to build production region and use effectively the kinds of resources such as minerals, the types of materials that originated from types of tropical plants, sea animals to ensure sustainable development. Focus on investment in developing products having great demand in domestic and export that we have advantages in resources, such as products separating from medicine, natural materials...
- To exploit and process materials: harvest, process, use suitable and effectively natural resources for goals of developing pharmacy industry on basis of focusing on conservating and developing rare genetic sources. Striving to ensure supply in most of common pharmaceutical raw material; a part of senior pharmaceutical raw material, organic pharmaceutical raw material from plants, medicinal herbs used in domestic and for export; ensure sufficient essential medicines deriving from pharmaceutical raw materials - Science, technology and environment: pharmaceutical industry should be applied advanced, modern technology to create products with high quality, lower price, enough to compete on the market. For products that require high technology, modern equipment it should actively import high-tech, modern equipment with high automatic level from foreign countries. After owning the technology, it needs to actively research to manufacture, localize a part in home country, looking forward manufacturing entire production line, equipment, to serve other domestic investment projects. Pay attention to environmental protection, focusing on the use of clean technology, environmental friendly, less waste and pollution; actively apply the solution to thoroughly process waste, reach environmental standards before disposing to the environment;
- To invest in development: base on the needs of the pharmaceutical products and ability to provide, exploit and process raw materials in each period to actively invest in projects of building medicine manufacturing factories, build a system of pharmaceutical enterprises of all economic sectors, create favorable market for medicine products , contribute to sustainable development in pharmaceutical industry.
II. Development planning
1. Build areas producing raw materials
1.1. Plant, animal material
To build areas of producing materials on the principles of focusing on animals, trees those we have strength such as luscious, garlic, soya, ginger, cinnamon, hearse... Giving priorities in building material which are stable in quantity and quality to provide for factories. Avoid purchasing wild medicine material in small scale and scattered cultivation because this will reduce quality and increase cost of production. Strengthen and develop specific material areas as follows:
- To strengthen, maintain and expand available bases of planting medicinal herbs in Sa Pa (Lao Cai), Tam Dao (Vinh Phuc), Cao Bang, Lang Son, Hung Yen, Da Lat;
- To conservate, exploit and cultivate newly red towering sources in Da Lat (Lam Dong); Due to climate conditions, tradition and experience of farming of each localities, develop materials for separated industry (Annex I attached to this decision).
1.2. Organic materials, and the variety of minerals
- Additional materials originated from the sea: build post - salt industrial park in Ninh Thuan to produce industrial salt and other goods such as NaCl, MgCO3, MgSO4, ...
- Types of reagent chemical used in pharmaceutical industry and pharmaceutical products will be made in the chemicals business and some chemicals research institutes;
- Basic organic products and intermediaries for the pharmaceutical industry:
- To develop some products in accordance with development route of basic organic chemicals manufacturing industry.
2. Exploit and process materials
2.1. Exploiting and process raw materials for producing antibiotics and other essential medicine
From now to 2015, focus on producing antibiotics b-lactam group: such as ampicilin, amoxicillin and cephalosporin, materials for producing antibiotics 6-APA, 7-ADCA. Promote use of research results of “Key national science - technology research program on developing pharmaceutical industry by the year 2020" to produce 6-APA, 7-ADCA, replacing imported penicillin G. In the period from 2016 to 2025, use products of a factory of producing penicillin G to produce intermediary material between 6-APA, 7-ADCA to supply for factories of manufacturing antibiotics which have been constructed in previous periods. For basic, intermediary organic materials, reagent chemical which are used for producing of other essential medicines, it will imports the chemical which has not produced, the rest will be supplied by domestic chemical industry.
2.2. Exploiting and process raw materials to serve separation, combination of natural substances
Implement suitably a strategy for exploiting sources of natural medicine materials; exploitation output of natural medicine material will depend on growth cycle of each species and ensure a principle of re-maintaining, re-generating. Organize training for organizations and individuals involving exploiting natural medicine material about harvest policies and technologies, the initial processing, material storage in order to ensure quality of material; Base on a plan of developing material areas, construct purchasing, initial processing stations in material areas, in which, farmers involves in development of materials, to ensure quality standards materials; For material areas managed by enterprises: encourage application of scientific achievements of seed, cultivation techniques; encourage and have mechanisms, policies to support enterprises involving in separation and production of pharmacy, ensure expansion and sustainable development of expanded materials area on the basis of participation of various economic sectors to development of pharmaceutical industry; Utilize sub-products of seafood processing industry in the Central and West -South region to produce glucosamin , gelatin and several fat acids for pharmaceutical production.
2.3. Exploiting and process materials for producing sorbitol and vitamin C: using powder material for producing sorbitol by factories of processing cassava flour which have been built in our country. Ensure to provide enough, stable sorbitol with high quality for production of vitamin C.
2.4. Exploiting and process materials to serve processing of powder and xellulo as pharmaceutical nursery: material for producing powder ge is from factories of processing powder which have been built in our country; xellulo provided from factories of processing pulp, from import and exploited cotton cultivation areas in South Central region;
2.5. Exploiting and process raw materials for producing anti-cancer drugs, drug of treating cardiovascular disease, and drugs of treating HIV / AIDS: From now to 2015, it needs to focus on exploiting and developing medicines from natural material sources. For drugs from chemical synthesis, drugs which have huge impacts on drug security to develop. Plan exploitation and processing of raw materials for production of medicines under this group due to above –mentioned orientation; For some drugs: anti-cancer, cardiovascular disease treatment, treatment of HIV / AIDS will be separated from domestic medicine material such as taxol from red towering trees, vinblastin and alcaloid exhausted from coconut, ...
3. Science and Technology
Technology used in projects of developing pharmacy must comply with following principles:
- Technology, techniques and equipment must ensure advance, modern to create products reaching quality standards as prescribed;
- Technology must spend less energy, raw materials and resources in order to use savings and sustainable resources;
- Technology must be clean, environmentally friendly, and must have effective measures to control and handle pollution caused by all kinds of wastes (gas waste, water waste, solid waste ...) to meet environmental standards as stipulated.
3.1. Technology for producing antibiotics and other essential medicines
From now to 2015, focus on importing technology of manufacturing antibiotics. Focus on technology of producing cephalosporin 1st generation and 2nd generation. During period from 2016 to 2025, promote application of research results of " Key national science - technology research program on developing pharmaceutical industry by the year 2020" to produce some antibiotics under cephalosporin group of 3rd and 4th generation, combining with importing technology from abroad to produce some other important kinds of antibiotics ; For essential organic medicines which does not require high technology: use production ability in the country; For essential medicines requires high, complex technology: focus on transferring, receiving, owning and applying advanced technologies imported from abroad.
3.2. Technology of separating substances from natural
Focus on exploiting medicinal material which are advantages of Vietnam. Give priority to use technologies created in the country to split natural substances. Import only a part of high technology equipment that domestic production is not. In the period from now to 2015, focus on reviewing, evaluating and perfecting technology process of separation: artemisinin, berberin, rutin, rotudin, A-carotene, vinblastin ... while using the this technology to build and operate factories of separating medicinal materials from natural substances. It should focus on some main areas as follows:
- Separate artemisinin and artesunat and artemether, artesunat production;
- Separate natural substances for producing anti-cancer medicine from coconut trees and red towering tree...;
- Separate some natural – originated antibiotics for producing drugs of painkillers, anti-inflammation...;
- Separate a fat acids from marine animals for producing drugs of supporting prevention of cancer, anti-aging and increase of resistance of body;
- Improve processes of producing becberin, rutin and rutin under dissolve forms;
- To produce crystal metol to serve domestic and export;
- Separate to create multiple products from towering oil; - Manufacture products from phytin for treating diabetes;
- To produce of kinds of senior hormon...
3.3. Technology of producing sorbitol and vitamin C
Apply appropriate technology to produce sorbitol (continuous or interrupted hydrogen). Import technology of producing vitamin C from abroad (using advanced and popular technology in production of vitamin C);
3.4. Technology of changing powder and xellulo as pharmaceutical nursery
Give priority to use domestic technology in conjunction with imported equipments which can not be manufactured domestically to produce some kinds of nursery from powder and xellulo; Import technology from abroad to produce high quality pharmaceutical nursery in the beginning to learn experience and own technology. Phase of production expansion and develop more products will use technology created in the country.
3.5. Technology of producing anti-cancer drug
Import technology and equipment from abroad to produce anti-cancer drugs originated from chemical synthesis; Use a part of domestic – researched technology in conjunction with technology from developed countries to produce anti-cancer drugs from the natural substance sources and semi-synthesis from natural substance.
3.6. Technology of producing cardiovascular drug
Give priority to develop and use technology of producing medicine from natural substances which have been manufactured domestically to produce drugs for treating cardiovascular disease as well as few essential drugs in treating cardiovascular disease to import technology for production in order to meet requirements of essential drugs; Period from 2016: consider, and give priority to use technology which have been researched and manufactured in the country.
3.7. Technology of producing drugs for treating HIV / AIDS: apply science and technological achievements in recent years to produce drugs for treating HIV / AIDS while importing advanced technology to produce drug for HIV / AIDS treatment such as AZT, NVP...
4. Development investment
4.1. Period from now to 2015
- Research to create advanced technologies, suitable to domestic production conditions ; implement test production at pilot scale, promote transfer and application of technology in production, combine with using advanced technology imported from abroad to produce pharmaceutical raw materials;
- Coordinate with pharmacy sector to implement some investment projects of building pharmaceutical raw materials factories in order to develop strongly pharmaceutical industry, ensure achieving main goals as follow:
+ Producing 300 tons of antibiotics materials per year, meeting 40 - 45% domestic antibiotics material needs;
+ Produce 200 tons of active substances per year from natural raw materials to meet 100% domestic demand and export;
+ Producing 10,000 tons of sorbitol material per year to produce vitamin C, functional food and cosmetic products, meeting 80 - 90% of domestic needs;
+ Producing 1,000 tons pharmaceutical nursery/ year, meeting 20% of domestic needs.
- Use effectively science, technology cadre staff and medicine infrastructure and equipment in our country.
4.2. Period from year 2016 to 2025
- Develop a pharmaceutical industry to be advanced, modern industry; establish and develop system of pharmacy enterprises, creating favorable, ventilation market to produce actively pharmaceutical materials, meet basically raw materials for producing essential medicines, own production of medicines in the country, contributing to sustainable development pharmaceutical industry in our country. - Construct and develop pharmaceutical industry to be a key technique - economic sector to produce high quality pharmaceutical products, having high competitiveness on the market, increase contribution rates to national economic.
III. System of solutions and mechanisms and policies to implement a plan
1. Solutions, mechanisms and overall policies
- To strengthen and diversify sources of capital to implement effectively, in time contents of the plan;
- To strengthen process of construct pharmaceutical industry on basis of establishing and developing sustainably pharmaceutical enterprises of all economic sectors; have preferential policies, mechanisms to encourage enterprises investing in developing pharmaceutical industry; accelerate transfer and innovation of technology, production line, equipment; apply advanced, modern technologies to produce high quality pharmaceutical products, having enough competitiveness in market; promote brand advertisement and create preferential market for pharmaceutical products;
- To promote scientific research, transfer and application of technology in producing pharmaceutical raw materials, contribute to development of pharmaceutical industry; building a strong ability for science, technology in pharmaceutical sectors;
- To expand and strengthen international cooperation in a field of pharmacy;
- To perfect construction of system of mechanisms, policies, legal documents to serve development of pharmaceutical industry.
2. Specific solutions, mechanisms and policies
2.1. Solutions on financial, credit
- To encourage and create favorable conditions for enterprises of all economic sectors in domestic and foreign to invest in pharmaceutical industry;
- The State lends preferential capital to producers of pharmaceutical material, especially essential drug material to serve care, protection of health; issue policies, mechanisms to encourage use of domestic drugs and medicine materials ( health insurance drug, drug for national programs on health care...);
- There are specific preferential mechanisms, policies to create a attractive environment to foreign investors;
- State budget capital are focused on investing in key projects, not invest spread, including projects of producing pharmaceutical raw materials for essential drugs.
2.2. Tax Solutions
- To reduce or exempt tax for types of imported raw materials to produce essential medicines to serve national programs, goals on drugs and producing export goods;
- Projects of producing pharmaceutical raw materials for export above 50% of output are allowed to borrow preferential loans of banks under legal regulations;
- Projects of producing medicine materials, particularly materials for produce antibiotics and other essential drugs are eligible for preferential import duties for imported goods under the law on export tax, import duties.
2.3. Market solutions Create preferential, ventilation market for domestic pharmaceutical products as well as improve mechanisms and policies to prevent effectively the import of raw materials, pharmaceutical products in poor quality, not safe from foreign countries. Strengthen fight against fake goods and illegal imported goods. Representative office of Vietnam in foreign countries, missions of the Government is responsible for helping enterprise to search export market and partners
2.4. Solutions to attract foreign investment
- To create attractive, competitive environment compared with other countries in the region and the North East Asia for investors to invest effectively in the areas of technology and export of pharmaceutical products.
2.5. Solutions on research, transfer and application of science and technology
- To apply strongly results of scientific research, actively transfer technology, advanced techniques, pharmaceutical raw materials products and new, advanced equipment from " Key national science - technology research program on developing pharmaceutical industry by the year 2020 " into production. Organize well research and development network in all 3 levels:
- Basic research for basic universities and research institutes;
- Research to develop technology in corporations, companies and applications research institutes;
- Research and complete application of technologies which are transfer to implement in enterprises.
2.6. Solutions on organization, management
- To strengthen ability and State management role of the Ministry of Industry and Trade and other Ministries, Agencies for sustainable development of pharmaceutical industry. Promote innovation, re-arrangement of State-owned enterprises to improve capacity and competitiveness. Encourage establishment of enterprises in all economic sectors and encourage investment in processing raw materials and production of pharmaceutical products. Build databases and websites on list of auxiliary materials and pharmaceutical producers for pharmaceutical industry, list of products need to give priority to develop.
2.7. Solutions, policies on environmental protection and sustainable development
- To take enough resources for investment projects of environmental protection, waste treatment in both factories and industrial zones. Encourage enterprises to increase accumulation, set up capital sources to support activities of environmental protection;
- To implement fully tracking, monitoring, measurement and management of indicators, environment technique standards; strengthen inspection, checking enterprises’ implementation of regulations on protecting the environment;
- To limit and reduce level of increasing pollution in pharmaceutical production. Newly constructed pharmaceutical production factories must apply advanced, modern technology and fully equip with equipments to treat all kinds of waste to ensure environment technical standards. Not grant investment certification for pharmaceutical projects have not yet or have no report of environmental impact or registration of achieving environmental standards;
- To implement plan of renovation to gradually eliminate use of backward technology and equipment in operating factories of producing pharmaceutical products in order to limit, eliminate sources of pollution;
- To strictly control chemical safety, gas, wastewater and solid waste, especially chemicals having high toxic levels in pharmaceutical factories and laboratories;
- There are plans to move and invest depth to minimize environmental pollution pharmaceutical producers. h. Solution on developing and training human resources
- Train newly and re-train technology, science staffs, managers at universities in home and abroad, meeting full of quality human resources for development of pharmaceutical industry ;
- To engage support of the Governments of developed countries to train human resource for pharmaceutical industry. Encourage FDI enterprises to participate in training pharmaceutical human resources;
- To strengthen investment in infrastructure, technical facilities for research and education bases to actively train specialist staffs; strengthen cooperation with foreign partners to train human resources to serve development of pharmaceutical industry;
- To invest newly in some facilities of training technical workers, establish more chemicals colleges in areas associated with production factories, construct training program and practical criteria for training of high skilled workers;
- To have mechanisms, preferential policies for high skill pharmaceutical staffs; promote attraction of talents including overseas Vietnamese to work in the country;
- For some important pharmaceutical projects, if necessary, be allowed to hire well foreign technical, management experts to work in Vietnam.