Road Map for the Development of Drug Industry in Egypt

Document Type : Original Article

Authors

1 Faculty of Pharmacy, Mansoura University

2 Faculty of Pharmacy, Fayoum University

3 Zewail City of Science and Technology

4 Faculty of Medicine, Assiut University

5 Faculty of Pharmacy, Ain-Shams University

6 Faculty of Pharmacy, Assuit University

7 National Research Center

8 Faculty of Pharmacy, British University

9 Nasr Company for Drug Chemicals

10 Faculty of Pharmacy, Cairo University.

Abstract

Drug is a strategic commodity related to the country's national security due to its direct impact on the health of the citizens and its important role in shaping up the economy that may affect the country's international decisions. Therefore, the development of the pharmaceutical sector in Egypt in order to provide a high-quality medication to citizens and to increase the competitiveness of the Egyptian pharmaceutical products to reach an advanced world ranking is an essential goal.
To achieve this goal, it is necessary to work at all levels and to use all available resources and capabilities to meet two main challenges. First, is to improve the quality of drug manufacturing and dosage forms, which requires the convergence of all scientific expertise and competencies. Second, is to obtain an internationally recognized and accredited bioequivalence and bioavailability studies. Therefore, this road map aims are: to develop a complete vision on how to start improving the quality of Egyptian medicine as a pivotal issue in pharmaceutical industry and to raise the quality of Egyptian medicine through the establishment of an internationally accredited national center for pharmaceutical consultancy and another for bioequivalence and bioavailability studies similar to what is known internationally as "Contract Research Centers".
Pillars of the road map

A Study targeting the establishment of a national consultative center for the development of pharmaceutical industries:

Pharmaceutical industry in Egypt suffers from the differences in the therapeutic efficiency of the locally manufactured medicine compared to that produced in international factories, which reduces the chances of their availability in the international markets, despite the presence of the same active pharmaceutical ingredient in both products. The Egyptian pharmaceutical industry, should regain its earlier lead of the development of the pharmaceutical industry in Africa and in the Arab world. Although there are several attempts to link the pharmaceutical industry with research centers through several methods and mechanisms, it did not achieve its role at the required level due to number of challenges and obstacles. Based on the above, this map aims to introduce a complete proposal for the implementation and establishment of a national center for the advancement of the pharmaceutical industry. This map is looking forward for informing all beneficiaries of the importance of establishing such a national consultancy center for the pharmaceutical industry and how to develop a strategy that allows solid efforts in accordance with a scientific method and the use of experts in all relevant fields.

A Study targeting the initiation of the Egyptian capabilities in the field of bioequivalence and bioavailability studies of the drug

Bioequivalence and bioavailability studies are the main pillar and the decisive stage that precedes the registration of drug material coming from abroad, manufactured locally, or new formulation seeking its license for use. There have been sporadic attempts by the government and private sector to establish centers to carry out this task, including those who exist and those who have stopped working. Therefore, none of these centers was able to obtain the necessary accreditation locally, regionally or internationally tube exported and competes in the Arab or African countries markets. This represents the major challenge facing the national pharmaceutical industry in Egypt. Therefore, it became necessary to put in place new mechanisms and methods to establish a national reference center for bioequivalence and bioavailability studies. This center will seek its accreditation by the lead international accreditation bodies. This center would serve as a point of focus for all Egyptian bioequivalence and bioavailability centers. This would restore confidence in the Egyptian pharmaceutical sector, in addition to Egypt's restoration of its position in the pharmaceutical industry. The proposed bioequivalence and bioavailability center will be a regional center in Egypt for conducting studies for the Middle East and Africa.
The roadmap aims to find a mechanism on how to maximize the utilization of the Egyptian country's capabilities to establish a national reference center for bioavailability studies and to study all available opportunities, constraints, weaknesses and strengths through conducting a number of questionnaires and conducting environmental analysis, in addition to interviews with the beneficiary community and holding workshops to learn how to direct the country potential to contributes in the project implementation.
Elements of the study

Launching a number of questionnaires to study the current situation of the pharmaceutical industry from the beneficiaries.
Holding seminars for the concerned parties.
Conducting a SWOT analysis that includes strengths, weaknesses, opportunities and challenges
Organizing workshops to present and discuss the results.
Drafting the Road Map.
Announcing the study and presenting it to strategic partners.

Expected results of the study
Linking the Egyptian pharmaceutical industry with research centers to develop and increase the competition in the international pharmaceutical market. In addition to enabling the country various sectors to establish a national reference center for bioavailability studies, a practice occurring in USA and China, to be accredited by the largest accreditation bodies, through:

Developing a roadmap on how to establish an accredited consultative center for the development of the Egyptian pharmaceutical industry.
Developing a roadmap on how to establish an accredited reference center for bioavailability studies.

This will:

Increase the Egyptian pharmaceuticals exports to international markets.
Increasing the competitiveness of the Egyptian medicine in the international markets

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