Decision No. 81/2009/QĐ-TTg Approving the Master Plan for the Development of the Chemical Pharmaceutical Industry until 2015, with a vision to 2025

Pursuant to …;

Regarding the approval of the Planning for the Development of the Chemical Pharmaceutical Industry until 2015, with a vision to 2025

_______________________

PRIME MINISTER

Pursuant to the Law on Organization of the Government dated December 25, 2001;
Pursuant to Decision No. 343/2005/QĐ-TTg dated December 26, 2005 of the Government approving the Planning for the Development of the Chemical Industry in Vietnam until 2010 (with consideration up to 2020);
Pursuant to Decision No. 55/2007/QĐ-TTg dated April 23, 2007 of the Government approving the List of Priority Industries and Leading Industries for the period 2007-2010, with a vision to 2020, and some encouraging policies for development;
Considering the proposal of the Minister of Industry and Trade,

DECISION:

Clause 4 of Article 6Approves the Planning for the Development of the Chemical Pharmaceutical Industry until 2015, with a vision to 2025 (hereinafter referred to as the Planning) with the following main contents:

I. DEVELOPMENT OBJECTIVES

1. General Objective:

- To build a chemical pharmaceutical industry with a relatively complete product structure, including major chemical pharmaceutical products such as: groups of antibiotic raw materials; groups of raw materials for treating heart diseases, blood vessels, and cancer; groups of raw materials for vitamins and supplements; groups of raw materials for pain relief, fever reduction, and anti-inflammatory drugs; groups of raw materials for HIV/AIDS treatment and detoxification; groups of excipients and additives, gradually meeting domestic market requirements, replacing imports, and moving towards exporting pharmaceuticals;

- Gradually build the chemical pharmaceutical industry towards modernization, using advanced technology, creating many competitive products on the domestic, regional, and global markets. Combine domestic research to create high-quality technologies with importing and mastering advanced foreign technologies to produce chemical raw materials for the development of the pharmaceutical industry;

- Exploit, process, and use natural resources reasonably and effectively to serve the development goals of the chemical pharmaceutical industry based on prioritizing the conservation and development of rare and valuable medicinal plant genetic resources. Strive to ensure the supply of most inorganic chemical pharmaceuticals and common excipients; a portion of high-grade excipients, organic chemical pharmaceuticals extracted from plants and medicinal herbs for domestic use and export; ensuring sufficient essential medicines from inorganic chemical raw materials;

- Leverage the potential and strengths of medicinal herbs, combined with the essence of traditional medicine to create valuable chemical pharmaceutical products with high therapeutic effects, suitable for the disease model of the country;

- Invest in modern technology, update equipment and management practices to build the chemical pharmaceutical industry capable of gradually meeting the needs of drug formulation raw materials. Establish antibiotic production facilities and other essential chemical pharmaceutical production facilities, producing raw materials for drugs with strengths, especially raw materials from medicinal herbs;

- Focus investment on developing chemical production facilities and drug raw material production facilities. Prioritize the production of chemical pharmaceutical raw materials to serve the production of essential medicines, export-oriented medicines, medicines from medicinal herbs, and generic medicines to replace imported medicines. Emphasize the development of medicinal herb cultivation and planting areas. Closely integrate human resources and equipment from the pharmaceutical and chemical industries with those from other industries, effectively linking scientific research with the production of chemical pharmaceuticals and pharmaceutical products by chemical pharmaceutical enterprises;

- Implement appropriate policies to encourage all economic sectors, particularly non-state production organizations, to participate in the development of medicinal herb cultivation and processing according to the national overall development plan. Emphasize the development of small and medium-sized enterprises in the production and processing of chemical pharmaceutical products;

- The State actively invests in the production of high-demand active ingredients and excipients requiring advanced technology and essential for public health safety, such as vaccines and new-generation antibiotics; while encouraging foreign investors to invest in these important fields;

2. Specific objectives

- Domestic production ensures meeting 20% of the demand for raw materials serving the drug formulation industry by 2015; 40% by 2020 and 70% by 2025;

- Establish raw material production zones: plan to establish production zones and effectively utilize natural resources such as minerals, tropical plant-based raw materials, and marine biological resources to ensure sustainable development. Focus on developing the production of products with large domestic demand and export potential where we have resource advantages, such as products extracted from medicinal herbs and semi-synthetic compounds from natural substances, etc.;

- Raw material exploitation and processing: exploit, process, and use natural resources reasonably and effectively to serve the development goals of the chemical pharmaceutical industry based on prioritizing the conservation and development of rare and valuable medicinal plant genetic resources. Strive to ensure the supply of most inorganic chemical pharmaceuticals and common excipients; a portion of high-grade excipients, organic chemical pharmaceuticals extracted from plants and medicinal herbs for domestic use and export; ensuring sufficient essential medicines from inorganic chemical raw materials;

- Science, technology, and environment: the chemical pharmaceutical industry needs to apply advanced technologies to create high-quality products at low costs, competitive on the market. For products requiring advanced technology and modern equipment, actively import and purchase advanced technology and equipment with high levels of automation from abroad. After mastering the technology, actively conduct research to domestically manufacture and localize parts, eventually producing entire production lines, serving domestic project investments. Pay attention to environmental protection, emphasizing clean and environmentally friendly technologies that produce minimal waste and pollution; proactively implement comprehensive waste treatment solutions to meet environmental standards before disposal;

- Investment for development: based on the demand for chemical drug products, the capacity to supply, exploit and process raw materials during each period, proactively invest in projects to build chemical drug manufacturing plants, establish a system of chemical drug enterprises under all forms of ownership, create favorable markets for chemical drug products, contribute to sustainable development of the chemical pharmaceutical industry.

II. DEVELOPMENT PLANNING

1. Establishing raw material production areas:

a. Plant and animal raw materials:

Establish raw material production areas according to the principle of concentrating on plant and animal species that have strengths in our country such as: Artemisia annua, Sophora japonica flowers, Areca catechu, Broussonetia papyrifera, Mentha arvensis, papaya, turmeric, Eclipta prostrata, bitter melon, sophora root, basil, Polygonum tinctorium, ginger, Leonurus japonicus, Silybum marianum, Aloe vera, Desmodium styracifolium, cinnamon, fennel, Morinda officinalis, bitter orange, goldenseal, Sophora flavescens, Ligustrum lucidum, bitter gourd, Coptis chinensis...;

Prioritize the establishment of stable raw material sources in terms of quantity and quality to supply to extraction factories. Avoid the situation of purchasing scattered wild medicinal herbs and fragmented cultivation as this will reduce the quality of medicinal herbs and increase production costs.

Consolidate and develop specific raw material areas as follows:

- Consolidate, maintain and expand existing medicinal herb planting bases in Sa Pa (Lao Cai), Tam Dao (Vinh Phuc), Cao Bang, Lang Son, Hung Yen, Da Lat;

- Develop a comprehensive area for planting Artemisia annua in the North (Vinh Phuc, Hung Yen, Hai Duong, Lang Son...) sufficient for the extraction of 10 to 15 tons of artemisinin;

- Build intensive planting areas for Sophora japonica flowers in Thai Binh, Hung Yen, Hai Duong...;

- Conserve, regenerate and plant new bitter orange and goldenseal trees in Northwest provinces, striving to meet the raw material requirements for berberine extraction to serve domestic diarrhea treatment needs, aiming towards export;

- Consolidate and expand the planting area for Areca catechu in central coastal provinces;

- Conserve, rationally exploit and plant new red pine trees in Da Lat (Lam Dong);

Based on climatic conditions, soil types, traditional and experience in cultivation of each locality, develop raw material areas serving the separation and semi-synthesis of chemical drugs from natural compounds (Annex I attached to this Decision).

b. Organic, inorganic and mineral raw materials:

- Raw materials derived from seawater: establish a post-salt industrial cluster in Ninh Thuan to produce industrial salt and chemical drugs such as NaCl, MgCO3, MgSO4, etc.;

- High-purity inorganic chemicals used in the chemical and pharmaceutical industries will be produced at chemical enterprises and some chemical research institutes;

- Basic and intermediate organic products used in the chemical drug industry: select the development of certain products consistent with the development roadmap of the basic organic chemical industry and the petrochemical industry.

2. Exploitation and processing of raw materials:

a. Exploitation and processing of raw materials for the production of antibiotics and other essential medicines:

From now until 2015, focus on producing beta-lactam group antibiotics such as ampicillin, amoxicillin, and cephalosporins, antibiotic raw materials requiring imports (6-APA, 7-ADCA). Vigorously utilize the results of the "National Key Scientific and Technological Research Program for Developing the Chemical Pharmaceutical Industry until 2020" to semi-synthesize 6-APA, 7-ADCA from imported penicillin G. During the period from 2016 to 2025, use products from the Penicillin G production plant to produce intermediate raw materials 6-APA, 7-ADCA domestically supplied to antibiotic manufacturing plants built in previous stages.

For basic and intermediate organic raw materials and high-purity chemicals used in the production of other essential medicines, part will be imported for those chemicals not yet produced domestically, while the rest will be supplied by the domestic chemical and petrochemical industries.

b. Exploitation and processing of raw materials for the separation and semi-synthesis of natural compounds:

Implement a strategy for the rational exploitation of natural medicinal herbs; the yield of natural medicinal herbs will depend on the growth cycle of each species and ensure the principle of maintenance and regeneration. Organize training for organizations and individuals involved in the exploitation of natural medicinal herbs on policies, harvesting techniques, initial processing, and preservation of medicinal herbs to ensure their quality;

Based on the development planning of raw material areas, establish procurement and initial processing stations in raw material areas where farmers participate in developing raw materials to ensure raw materials meet standards;

For medicinal herb cultivation areas managed by enterprises: encourage the application of scientific achievements in seed varieties and cultivation techniques; encourage and provide mechanisms and policies to support enterprises participating in the separation and production of chemical drugs, ensuring the expansion and sustainable development of raw material areas based on the participation of multiple economic sectors in the development of the chemical pharmaceutical industry;

Utilize by-products from the processing of aquatic and marine products in the Central and Southwest regions to produce glucosamine, gelatin, and certain fatty acids for the production of chemical drugs.

c. Exploitation and processing of raw materials for the production of sorbitol and vitamin C: use starch raw materials for sorbitol production from cassava starch processing plants already built and being constructed in the country. Ensure adequate and high-quality supply of sorbitol for vitamin C production.

d. Exploitation and processing of raw materials for the modification of starch and cellulose as excipients: raw materials for modified starch production are sourced from starch processing plants already built and being constructed in the country; cellulose is supplied from paper pulp mills, imports, and extracted from cottonseed cultivation areas in South Central Vietnam;

e. Exploitation and processing of raw materials for the production of anti-cancer drugs, cardiovascular disease treatments, HIV/AIDS medications, and addiction treatment support drugs:

From now until 2015, efforts should focus on exploiting and developing drugs from natural raw materials. For synthetic chemical drugs, those with significant impacts on drug security should be selected for development. Planning for the exploitation and processing of raw materials to serve the production of drugs in this group must follow the above orientation.

For certain types of drugs: anti-cancer, cardiovascular disease treatment, HIV/AIDS treatment, and addiction withdrawal treatments derived from natural sources will be extracted from domestic medicinal herbs and semi-synthesized such as taxol from red pine trees, vinblastine and other alkaloids from dogbane, etc.

3. Science and technology:

The technology used in projects to develop pharmaceutical chemicals must comply with the following principles:

- Technology, techniques, and equipment must ensure advancement and modernity to produce products meeting quality standards as prescribed;

- Technology must consume little energy, raw materials, and resources to use resources efficiently and sustainably;

- Technology must be clean and environmentally friendly, while also having effective measures to control and treat emissions (exhaust gases, wastewater, solid waste, etc.) during production, complying with environmental technical standards and regulations.

a. Technology for producing antibiotics and other essential drugs:

From now until 2015, focus on importing technology for antibiotic production. Concentrate on first and second generation cephalosporin production technology. From 2016 to 2025, intensify the application of research results from the "National Key Scientific and Technological Research Program for Developing the Pharmaceutical Chemical Industry until 2020" to produce some semi-synthetic third and fourth generation cephalosporins, while simultaneously importing technology from abroad to produce other important antibiotics.

For essential organic and inorganic drugs that do not require high technology, utilize domestic production capacity;

For essential drugs requiring high and complex technology, concentrate on transferring, receiving, mastering, and applying advanced technology imported from abroad.

b. Technology for extracting and semi-synthesizing compounds from natural sources:

Focus on exploiting pharmaceutical raw materials that are strengths of Vietnam. Prioritize using domestically developed technology to extract and semi-synthesize natural compounds. Only import a portion of high-tech equipment that cannot yet be produced domestically. From now until 2015, focus on reviewing, evaluating, and perfecting extraction processes for compounds such as artemisinin, berberine, rutin, rotenone, A-carotene, vinblastine, etc., and use these technologies in building and operating factories for extracting and semi-synthesizing pharmaceutical chemicals from natural compounds. Focus on the following main areas:

- Extracting artemisinin and its derivatives (artesunate and artemether), producing artesunate;

- Extracting active ingredients from natural sources for cancer-fighting drugs from dogbane and red pine trees, hepatitis B treatment from toothed spikemoss, etc.;

- Extracting and semi-synthesizing some natural origin antibiotics for pain relief, anti-inflammatory, and rheumatism treatments, etc.;

- Extracting polyunsaturated fatty acids from marine organisms for cancer prevention and treatment, anti-aging, and enhancing body resistance;

- Perfecting the production process for berberine, rutin, and soluble rutin;

- Producing crystalline menthol for domestic use and export;

- Extracting and semi-synthesizing various products from pine oil;

- Producing preparations from phytin derivatives for diabetes treatment;

- Producing high-grade hormones from cinnamon oil, etc.;

c. Technology for producing sorbitol and Vitamin C:

Select appropriate technology for continuous or batch sorbitol production. Import foreign technology for Vitamin C production (using advanced and widely used technology in Vitamin C production).

d. Technology for modifying starch and cellulose as excipients:

Prioritize using domestically developed technology combined with importing equipment that cannot yet be produced domestically to produce certain excipients from starch and cellulose.

Import foreign technology to produce high-end excipients in the initial phase to learn and master the technology. In the expansion phase, use domestically developed technology.

đ. Technology for producing anti-cancer drugs:

Import complete technology and equipment from abroad to produce chemically synthesized anti-cancer drugs;

Utilize part of the domestically researched technology combined with advanced technology from other countries to produce anti-cancer drugs from natural compounds and semi-synthesized natural compounds.

e. Technology for producing cardiovascular disease treatment drugs:

Prioritize developing and using domestically created technology to produce cardiovascular disease prevention and treatment drugs, while selecting a few essential cardiovascular disease treatment drugs to import technology for production to meet essential drug requirements.

From 2016 onwards: carefully consider, select, and prioritize using domestically researched technology.

g. Technology for producing HIV/AIDS treatment drugs and addiction withdrawal support drugs: apply scientific and technological achievements researched over recent years to produce HIV/AIDS treatment and addiction withdrawal support drugs with Vietnamese characteristics, while importing advanced technology to produce some HIV/AIDS treatment drugs such as AZT, NVP, etc.

4. Investment and Development:

a. From now until 2015:

- Research and create advanced technology suitable for domestic production conditions; implement pilot-scale product production trials; intensify technology transfer and application in production, combining the use of advanced technology imported from abroad to produce pharmaceutical chemicals raw materials.

- Coordinate with the pharmaceutical sector to implement certain investment projects for building chemical raw material factories to produce medicines on an industrial scale in order to rapidly and strongly develop the chemical pharmaceutical industry, ensuring the achievement of the following main objectives:

+ Produce 300 tons of antibiotic raw materials per year, meeting 40-45% of domestic demand for antibiotic raw materials;

+ Produce 200 tons of active ingredients per year from natural raw materials, meeting 100% of domestic demand and participating in exports;

+ Produce 10,000 tons of sorbitol raw materials per year for producing Vitamin C, functional foods, and cosmetics, meeting 80-90% of domestic demand;

+ Produce 1,000 tons of excipients per year, meeting 20% of domestic demand;

- Utilize effectively the capacity of the scientific and technological workforce and existing chemical pharmaceutical technical infrastructure in the country.

b. From 2016 to 2025:

- Develop the chemical pharmaceutical industry into a modern and advanced industry; form and develop a system of chemical pharmaceutical enterprises, creating a favorable and transparent market to proactively produce chemical raw materials, basically meeting essential drug raw material needs, moving towards mastering the production of domestically produced medicinal drugs, contributing to sustainable development of the chemical pharmaceutical industry in the country.

- Build and strongly develop the chemical pharmaceutical industry into a leading economic and technical sector to produce high-quality and competitive chemical products on the market, increasing contributions to the national economy.

III. MAJOR INVESTMENT PROJECTS OF THE CHEMICAL PHARMACEUTICAL INDUSTRY

The major investment projects of the chemical pharmaceutical industry in the Plan are listed in Appendices II, III, and IV attached to this Decision.

IV. SYSTEM OF IMPLEMENTATION MEASURES AND POLICIES FOR THE PLAN

1. Overall measures and policies:

- Strengthen and diversify investment sources to effectively and timely implement the contents of the Plan;

- Accelerate the development of the chemical pharmaceutical industry based on forming and sustainably developing chemical pharmaceutical enterprises of all economic sectors; have preferential mechanisms and policies to encourage enterprises to invest in developing the chemical pharmaceutical industry; speed up technology transfer and innovation, machinery and equipment lines; apply advanced technologies to produce high-quality chemical products capable of competing on the market; promote brand promotion and create a favorable market for chemical products;

- Strengthen scientific research, technology transfer, and application in the production of chemical raw materials, contributing to the development of the chemical pharmaceutical industry; build strong potential for science and technology in the field of chemical pharmaceuticals;

- Expand and strengthen international cooperation in the field of chemical pharmaceuticals;

- Complete the construction of a system of mechanisms, policies, and regulatory legal documents to serve the development of the chemical pharmaceutical industry.

2. Specific measures and policies:

a. Financial and credit measures:

- Encourage and create all conditions for enterprises of all economic sectors both within and outside the country to invest in developing the chemical pharmaceutical industry;

- The State provides preferential loans to enterprises producing special drug raw materials, especially essential drug raw materials serving health care and protection for the people; issue mechanisms and policies to encourage the use of domestically produced drugs and drug raw materials (health insurance drugs, drugs for national target programs on health,...);

- Have specific and stable preferential mechanisms and policies to create an attractive environment for foreign investors;

- State budget capital is concentratedly invested in key projects, not spread out, including projects producing chemical raw materials for essential drugs.

b. Tax measures:

- Reduce or exempt taxes on imported raw materials for producing essential drugs serving national target programs on drugs and export production;

- Projects producing chemical raw materials for export at 50% or more of production volume can obtain preferential loans from banks according to the provisions of the law;

- Projects producing drug raw materials, especially raw materials for producing antibiotics and other essential drugs, enjoy tax preferences on imported goods according to the provisions of the law on export tax and import tax.

c. Market measures:

Create a favorable and transparent market for domestically produced chemical products, while improving mechanisms and policies to effectively prevent the importation of low-quality and unsafe chemical raw materials and products from abroad. Strengthen anti-counterfeiting and anti-smuggling efforts. Overseas representative offices of Vietnam and government delegations are responsible for assisting enterprises in seeking export markets and customers.

d. Measures to attract foreign investment:

Create an attractive and competitive environment compared to countries in the region and Northeast Asia for investors to effectively invest in technology and export chemical products.

đ. Measures for research, technology transfer, and application of science and technology:

Vigorously apply research results, actively transfer technologies, technical progress, chemical raw materials, and new advanced production lines from the "National Key Scientific and Technological Research Program for Developing the Chemical Pharmaceutical Industry until 2020" into production.

Organize well the research and development network at all three levels:

- Basic research for universities and basic research institutes;

- Technology development research at group companies, companies, and applied research institutes;

- Research to perfect and apply transferred technologies implemented at enterprises.

e. Management organization solutions: Strengthening the capacity and role of the Ministry of Industry and Trade and other ministries and sectors in managing the sustainable development of the chemical industry. Promoting restructuring and reform of state-owned enterprises to enhance production capacity and competitiveness. Encouraging the establishment of enterprises of all economic components and encouraging investment in raw material processing and chemical product manufacturing. Building databases and websites on the list of chemical product manufacturing enterprises and auxiliary raw materials for the pharmaceutical industry, and the list of priority chemical products for development.

g. Environmental protection and sustainable development solutions:

- Ensuring sufficient resources for environmental protection projects and waste treatment from factories to industrial zones. Encouraging enterprises to increase accumulation and form capital to support environmental protection activities;

- Fully implementing monitoring, measurement, and management of environmental technical standards and indices; strengthening inspections and checks on enterprises' compliance with environmental regulations;

- Limiting and reducing the degree of pollution in chemical product manufacturing. New chemical product manufacturing facilities must apply advanced technology, be equipped with complete waste treatment equipment, and ensure compliance with environmental technical standards. Investment permits will not be granted for chemical product manufacturing projects without or without an environmental impact assessment report or environmental standard registration;

- Implementing plans to renovate and gradually phase out the use of outdated technologies and equipment in operating chemical product manufacturing facilities to limit and eventually eliminate pollution sources;

- Strictly controlling the safety of chemicals, exhaust gases, wastewater, and solid waste, especially highly toxic chemicals in production facilities and chemical laboratories;

- Planning relocation and deep investment to minimize environmental pollution for chemical product manufacturing facilities located in areas requiring relocation in cities or densely populated regions.

h. Human resource development solutions:

- Training new and retraining scientific and technological cadres and managers at domestic and foreign universities to meet the quality requirements for human resources in the chemical industry;

- Attracting the support of governments of developed countries to train human resources for the chemical industry. Encouraging foreign direct investment (FDI) enterprises to participate in training chemical industry human resources;

- Increasing investment in infrastructure and technology for research and education institutions to proactively train specialized cadres; enhancing cooperation with foreign partners to train high-level human resources to serve the development of the chemical industry;

- Investing in new vocational training facilities, establishing additional chemical colleges near production plants, developing training programs and practical criteria to train skilled workers;

- Providing preferential policies and mechanisms for highly skilled chemical industry cadres, promoting the attraction of talent and intellect, including overseas Vietnamese, to work domestically;

- For important chemical projects, if necessary, permission may be granted to hire foreign technical experts and excellent managers to work in Vietnam;

V. IMPLEMENTATION

1. Ministry of Industry and Trade: shall take the lead and coordinate with relevant ministries, sectors, and localities to effectively implement the contents and tasks of the Master Plan according to schedule, and report annually to the Prime Minister on the results;

2. The Ministry of Health: shall coordinate with the Ministry of Industry and Trade to effectively implement the related contents and tasks in the Master Plan; effectively applying the results of the "National Key Scientific and Technological Research Program for Developing the Chemical Industry until 2020" to serve the sustainable development of the pharmaceutical industry in Vietnam;

3. Ministries: Planning and Investment, Finance, Science and Technology, Education and Training, Natural Resources and Environment, Agriculture and Rural Development, and other relevant ministries and sectors shall, based on their functions, tasks, and scope of state management, be responsible for effectively implementing the related contents and tasks in the Master Plan;

4. The People's Committees of provinces and centrally governed cities: based on their functions, tasks, and scope of state management at the local level, shall be responsible for effectively implementing the related contents and tasks in the Master Plan;

12/2025/TT-BNNMT dated June 19, 2025 issued by the Minister of Agriculture and EnvironmentThis Decision takes effect from July 25, 2009.

Article 3. The Minister of Industry and Trade, ministers, heads of ministerial-level agencies, heads of government agencies, Chairmen of provincial and centrally-administered city People's Committees are responsible for enforcing this Decision./.