Madani H¹ * ( PhD Student) , Shahhosseiny MH² ( PhD) , Khamse A³ (PhD Student)

  ¹ Department of Technology Management, Science and Research Branch, Islamic Azad University, Tehran. Iran

  ² Department of Microbiology, Shahr-e-Qods Branch, Islamic Azad University,Tehran, Iran

  ³ Department of Technology Management, Karaj Branch, Islamic Azad University, Karaj, Iran

  Received: 26 Jul 2010, Accepted: 19 Apr 2011

  Abstract

  Introduction: After Islamic revolution in Iran, huge steps were taken towards self-sufficiency in drug production among which was the establishment of novel drug system (generic project). However, this project could not reach the rank of designated projects for production of raw material, herbal medicine and drugs for treatment of obstinate diseases. This paper aims to provide analysis of the following issues: 1) The reason for carrying out generic project 2) The outcome of the generic project performance and its status in the current drug industry and 3) Obstacles to generic project.

  Methods: In order to gather data in this survey, we used documents, records, interviews, and questionnaires. Of 30 companies recruited to the study, 17 completed the questionnaires. Data were presented using descriptive analyzes methods.

  Results: Generic project has been able to meet the needs of low-cost and essential drug production in vulnerable situations. In addition, it has created infrastructures such as highly skilled human resources in formulation processes, management improvement and establishment of production lines for new drugs. However, due to the subsidy protective policies and lack of effective collaboration with national and international research centers, this project was confined to only generic drug reproductions until 2008. Absence of innovative projects and Research and Development (R&D) systems has made the pharmaceutical industry stagnant, and hence industrial R&D could not benefit from academic research. Furthermore, licensed projects could not increase the capabilities of R&D systems due to the lack of fundamental pharmaceutical disciplines for innovations.

  Conclusion: Generic project has been started at appropriate time and was able to meet the needs for low-cost and essential drug production in vulnerable situations and also built up infrastructures. Monopolistic conditions has stopped generic plan in the level of brand generic drugs production. This trend resulted in limited activities in innovative projects and R&D systems and made the pharmaceutical industry stagnant.

  Key words: Generic Project, Research and development, Pharmaceutical industry, Technology Capabilities

  Hakim Research Journal 2011 14(1): 23- 31.

  * Corresponding Author: Department of Technology Management, Science and Research Branch, Islamic Azad University.Tehran. Iran. Telefax: +98- 21- 88370765, E-mail: shmadani@gmail.com