1. Project Summary and Relationship to China's Agenda 21 This project aims to use the Chinese experience in traditional medicine, such as traditional proven formulations, in combination with modern scientific techniques and advanced equipment, or synthetic techniques to search for effective medicines that detoxify addiction to heroin, cocaine, opium or opium group drugs. In addition, the project plans to use these medicines to effectively prevent and treat drug addiction. Factories would be set up to mass produce these promising Chinese herbal medicines. These medicines would enter the international market to help other countries that face similar problems. This project is based on programme area 9A of China's Agenda 21, and is related to programme area 9C.
2. Background Addiction to narcotics is a poison to societies all over the world today. How to prevent and treat the addiction to heroin, cannabis, or cocaine has become a pressing problem throughout the world. The current common practice for treating drug addiction is to apply new low-dependency medicine to substitute for high-dependency factors of habit forming drugs. This step-by-step substitute method has problems such as a long therapeutic cycle, high recurrence rate, high cost, and new a dependency on the treatment drug. Therefore, many countries temporarily isolate their drug addicts by force rather than using the above treatment. Confronted with the serious situation of increasing numbers of drug addicts, all the countries are seeking a breakthrough in treatment methods. Among the promising solutions are the use of Chinese herbal medicines to prevent, treat or detoxify the addiction. However, the research and development of Chinese herbal medicines needs to be modernised. Researchers are still puzzled with the active mechanism of these medicines and the identification of their effective ingredients. Enterprises face problems such as modernisation of synthesis techniques, analysis and quality control. Therefore, through international collaboration under ìChinaís Agenda 21 Priority Programme" it would be a catalyst in the development of Chinese herbal medicines for detoxifying addiction and its international market. It will benefit China and whole worldís current and future generations. The Chinese Government has a clear-cut policy on banning narcotic drugs. It considers these drugs to be highly hazardous to human health, a cancerous tumour for the society and a major obstacle to sustainable social development. In order to search for preventative and therapeutic drugs, China is now researching and developing ìRecovery tablets JD-2000 series". Studies show that JD-2000 tablets are highly effective (withdrawal period only takes one week), has no side effects and a preventative low recidivity rate at a low cost (only up to 1/3 - 1/2 of modern medicine). In addition, they have both preventive and anti-smoking effects. They are the simple and convenient medicines for prevention, treatment and detoxification of addiction. The state drug administration authority has approved some Chinese herbal medicine for sale. Some pharmaceutical companies have finished acute toxicity test and carried out 3,500 cases of clinical trials in Guangzhou. It has proven to be successful, as the withdrawal rate from addictive drugs was 97.5%. Another cycle of closed clinical trials is to be carried out by the addiction unit of the Zhuhai Municipal Bureau of Public Security under the direction of the Chinese Society of Toxicology. In order to combine research, development, and production, Chinese herbal pharmacists have worked closely with famous toxicologists. Enterprises and researchers have co-operated as they seek to combine traditionally proven formulations and scientific analytical methods to transform the traditional preparation process into modern industrial production. The research will enhance the strength of pharmaceutical companies. These companies will help the medicines to gain greater market share in the world. This project would be implemented jointly by Chinese Society of Toxicology (experts with specialisation in pharmacology, clinical investigation, drug dependence and drug discovery) and Zhongnan (Group) Controlling Company under the organisation of Zhuhai Municipal Government. After completion of the research and development steps, the drug would be put on the market according to the regulations issued by the state drug administration authority.
3. Objectives 3.1 Long-term Objective To develop Chinese herbal medicines for detoxification of drug addiction with high efficacy and low recidivity rate, high quality, low cost and no side effects. The product could be mass produced to satisfy the domestic and international demand. 3.2 Immediate Objectives * To complete the chronic toxicity test, clinical trials and identification of effective chemical compounds of the Chinese herbal medicines for detoxification of drug addiction. A team of experts will be commissioned for an evaluation report; * To introduce advanced facilities for Chinese herbal medicine production and analysis, and to bring these new medicines to the international market. Modern production management and quality control will be implemented in these new factories which produce Chinese herbal medicines for drug detoxification; * To establish anti-addiction and rehabilitation demonstration Center.
4. Outputs and Activities 4.1 Completion of the clinical trials and identification of effective fractions experiment * Close system clinical trials would be performed jointly by Zhuhai Municipal Government, the Municipal Bureau of Public Security, Zhongnan (Group) Controlling Company and 168 hospitals in Zhuhai Anti-Addiction Institute. The test would be under the direction and supervision of an expert group of the Chinese Society of Toxicology, which would publish an evaluation report; * Identification of the effective ingredients in the detoxification drugs would be carried out by the Chinese Society of Toxicology and Zhongnan (Group) Controlling Company. They would jointly publish an appraisal report. Monitoring Indicators: evaluation report on clinical trials of the new drugs for detoxification of drug addiction, Appraisal report on effective ingredients in the new drugs for detoxification of drug addiction. Implementing Agencies: Chinese Society of Toxicology, Zhuhai Municipal Bureau of Public Security. Zhongnan (Group) Controlling Company, 168 hospital and international collaborators. Time Schedule: June 1996 - December 1996 4.2 Establishment of a Chinese traditional medicines factory which would mainly produce the new drugs for detoxification of drug addiction * Select a factory site in a special economic zone where state preferential policy is enforced. Responsible agencies should finish a feasibility study for the site; * Introduce a technical system for drug production, including raw material separation, pulverisation, extraction, weighing, split charging equipment, automatic inspection system (audit trial), and analytic test equipment. Financing of the import could be raised by stock, capital loan, and joint venture etc.; * Introduce product quality control measures: including technology management, expert direction etc.; * Train administration personnel and staff in the factory. Monitoring Indicators: two Chinese medicines factories which produce mainly new drugs for detoxification of drug addiction in large scale (i.e. 150 ton/year), with output value RMB 200 million/year, the quality of product to meet the criteria of national standards for non-prescriptive drugs, 500-750 trainees of administration personnel and staff. Implementing Agency: Zhongnan (Group) Controlling Company Time Schedule: January 1997 - December 1998 4.3 Development of the international market * Drug factories could be established abroad if the feasibicity study and selection of suitable sites are satisfactory; collaboration with foreign partners; * Set up distribution network abroad. Set up an international distribution network with international collaborators and select distribution agencies. Monitoring Indicators: construction of two new drug factories abroad, 10-20 representive agencies, 80-100 distribution stations. Implementing Agency: Zhounan (Group) Controlling Company Time Schedule: July 1997 - December 1998 4.4 Establishment of the Protective-therapeutic addiction and rehabilitation demonstration centre * The demonstration center would be established in Zhuhai, Guangzhou or Hainan; * The establishment of the center would need an environmental design, protective and therapeutic system designs, introduction of rehabilitation equipment, and advanced management; * Services of the center would include physical and psychological prevention and treatment to help the addicts regain confidence in their recovery and rehabilitation. The center would establish an example of medicinal, psychological and rehabilitation treatment for addicts in China and abroad. Monitoring Indicators: establishment of one protective-therapeutic addiction and rehabilitation demonstration center which could treat 500 patients every year. Implementing Agencies: ìDemonstration Center" should be performed by the local government, Chinese Society of Toxicology, Drug Dependence Research Institute and Zhongnan (Group) Controlling Company which are organized by competent state authorities. Time Schedule: January 1997 - December 1999
5. Inputs 5.1 Chinese Inputs Chinese inputs will cover experiment, factory construction, training, funds for the Chinese experts' salaries. 5.2 International Inputs International inputs will be used for importing equipment and facilities, exploiting international market, foreign experts payment and training expenses. 5.3 Budget The total budget for project implementation is estimated to be US$ 12 million. The Chinese side will input about US$ 6 million, and international inputs are expected to be US$ 6 million.
Table 1. Budget by Item (in million US dollars)
Table 2. Budget by Output (in million US dollars)
6. Benefits This project would benefit both the Chinese and the international communities. It will be of great significance to social stability, the maintenance of civil order, and will speed up sustainable social development. The whole society will benefit. This project has an obvious economic potential. The investors can expect the principal and interest to be paid back within 2-3 years. The profits for distributors will not be less than 15%.
7. Risks The key to this project is the production of a safe, high-efficiency and low-recidivity-rate drug for breaking addiction. The combination of the remarkable effectiveness of Chinese herbals medicines with foreign advanced manufacturing technology is the key to success. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||