The speedy progress of the domestic pharmaceutical industry is reflected in quantity input of pharmaceutical companies, the creation and introduction of new original medicines, the improvement of the drug management system and the strengthening of its quality control.
The State Pharmacopoeia is a set of modern requirements for the quality of medicines and medical products, which, on the one hand, determines the level of development of the pharmaceutical industry in a particular country, and on the other hand, forms the basis for further improving the quality of medicines.
We talked about the process of preparation and publication of the State Pharmacopoeia with Doctor of Pharmaceutical Sciences, Professor Habibulla Karimovich JALILOV, Editor-in-Chief of the State Pharmacopoeia of the Republic of Uzbekistan.
– Could you please tell us, why was it necessary to develop and publish the State Pharmacopoeia? What goals does it pursue?
– The Law of the Republic of Uzbekistan No. ZRU-399 dated on January 4, 2016 «On Amendments and Additions to the Law of the Republic of Uzbekistan» About Medicinal Products and Pharmaceutical Activity «assigns a mission to develop and approve the State Pharmacopoeia. According to the legislation, the State Pharmacopoeia of the Republic of Uzbekistan is a collection of general and private certified pharmacopeial description (monographs), individual texts, tables, etc., establishing quality requirements for medicines and medical products, as well as individual auxiliary substances and raw materials used in their production.
The authorized body for preparing of the publication of the State Pharmacopoeia is the Pharmacopoeia Committee of the Ministry of Health of the Republic of Uzbekistan.
The Decree of the President of the Republic of Uzbekistan no PP-5707 dated April 10, 2019 «On further measures for the accelerated development of the pharmaceutical industry of the republic in 2019-2021» defines the task of developing the State Pharmacopoeia in a short time, harmonized with the international pharmacopoeia, regional and widely recognized pharmacopoeias of developed countries, embodying increased requirements and responsibility in the further development of various areas of the pharmaceutical industry in our country.
– How did the development of the State Pharmacopoeia begin?
– During the implementation of the above-mentioned instruction of the Head of State, the Agency for the Development of the Pharmaceutical Industry signed Order No. 24 dated July 17, 2019 «On the organization of work on preparation for the publication (reissue) of the State Pharmacopoeia of the Republic of Uzbekistan», whereby:
● for the first time, a system was developed to prepare the redaction of the State Pharmacopoeia;
● a structure consisting of an editorial board as the highest body approving the structure and content of the State Pharmacopoeia, as well as a working body developing drafts of general and private certified pharmacopeial description, uniting the editorial board, and eleven specialized expert commissions with their respective working groups
● a mechanism for compiling and conducting a subsequent three-stage examination of draft certified pharmacopeial description has been developed
● the sequence of consideration and approval of materials prepared by specialized expert commissions at meetings of the editorial board with subsequent approval by the editorial board has been established
● test procedure settlements and ensuring compliance with quality standards established by the requirements of the State Pharmacopoeia.
At the same time, in order to harmonize the general requirements of the State Pharmacopoeia with the modern achievements of the industry, regional and national pharmacopoeias of developed countries of the world and, of course, the international pharmacopoeia issued by the World Health Organization were preliminarily analyzed at the preparatory stage. The structure and content of the pharmacopoeias of Europe, America, Great Britain, Japan, Germany, and the CIS countries have been studied.
The current level of development of the pharmaceutical industry in the Republic of Uzbekistan, namely, the presence of a number of research institutions and higher educational institutions engaged in the training of highly qualified specialists for the pharmaceutical industry, as well as the development of new original innovative medicines, the functioning of more than 200 domestic pharmaceutical enterprises that produce more than 3 thousand names of medicines and a number of others related to the above preconditions contribute to the creation of our own national pharmacopoeia, which meets the highest modern international standards.
– Surely, all the existing pharmacopoeias in the world are different. Whose pharmacopoeia was taken as a basis and why?