scholarly journals Genotoxic impurities in pharmaceutical products – regulatory, toxicological and pharmaceutical considerations

2021 ◽  
Vol 90 (1) ◽  
pp. e502
Author(s):  
Katarzyna Regulska ◽  
Marcin Michalak ◽  
Marek Murias ◽  
Beata Stanisz
Keyword(s):  
Pharmaceutical Industry ◽  
Pharmaceutical Products ◽  
Genotoxic Impurities ◽  
Threshold Of Toxicological Concern ◽  
Further Development

This article provides an overview of the most important aspects around the detecting and reporting of genotoxic impurities in the pharmaceutical industry. It focuses on relevant regulatory, toxicological, and pharmaceutical considerations. In this regard, the concept of Threshold of Toxicological Concern is explained and the most common genotoxic impurities are described. Furthermore, toxicological methods for genotoxic impurities screening are presented. Finally, the article emphasises several issues regarding further development.

scholarly journals Analysis of import substitution model in Russian pharmaceutical industry

2020 ◽  
Vol 18 (3) ◽  
pp. 32-41
Author(s):  
Svetlana N. Khobotova
Keyword(s):  
Pharmaceutical Industry ◽  
Mixed Model ◽  
Positive Impact ◽  
Import Substitution ◽  
Pharmaceutical Products ◽  
Substitution Model ◽  
Substitution Policy ◽  
The One ◽  
Further Development ◽  
Support Evaluation

The article discusses the internal-oriented, external-oriented and mixed import substitution models that are implemented in the economies of various countries, including Russia. The essence, features and effects of import substitution in the industry are analyzed depending on the goals and possibilities of economic development of countries aspect. The results of the import substitution policy based on a mixed model in the pharmaceutical industry of Russia are revealed. The necessity of implementing the import substitution model on the basis of innovative development is indicated, which should, on the one hand, reduce the import of foreign-made medicines, and on the other hand, increase the export of this product group. It is emphasized that the implementation of such a policy requires comprehensive investment, infrastructure, and research governmental support. Evaluation of the efficiency of the industry development in the context of import substitution is calculated on the basis of state statistics and data of the Federal Customs Service of the Russian Federation. Mainly the positive impact of the import substitution policy for 2011-2018 on the Russian pharmaceutical industry is proved, the problems of further development of the industry are identified. The need to increase the international competitiveness of Russian pharmaceutical products is noted.

Problems Facing the Arab Pharmaceutical Industry: A Case Study from Yemen

2016 ◽  
Vol 2 (4) ◽  
pp. 234-241
Author(s):  
Mohammed Al-Shakka ◽  
Ebtesam Abood ◽  
Adel Al-Dhubhany ◽  
Sami Abdo Radman Aldubai ◽  
Khaled Said ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Low Income ◽  
Well Being ◽  
Pharmaceutical Products ◽  
Domestic Market ◽  
Raw Material ◽  
Political Crisis ◽  
Pharmaceutical Manufacturer ◽  
University Graduates ◽  
Pharmaceutical Drugs

Because of the almost-instant connection with the welfare and well-being of individuals, pharmaceutical industry stands prominently as a very important factor for the improvement and progress of a healthy productive nation. These days, pharmaceutical industry thrives as one of the largest and exponentially expanding global industries. Nonetheless, millions of people in low income developing countries, have to suffer from the fatal consequences of the inaccessibility and non-availability of essential drugs. This is also happening in Yemen, where the pharmaceutical manufacturers sector have to face up to many challenges. The Yemen Drug Company (YEDCO) was founded in 1964 by the Yemeni government as it collaborated with private investors. It was endorsed as a company with the expertise in the medicinal drug marketing. YEDCO started its work by taking in drugs from foreign companies and then locally marketing and distributing them. In 1982, YEDCO built the first medicinal factory for drugs in Sana’a. Since then, seven companies were set up to manufacture medicines in Yemen. The expanding population has led to the need to have more pharmaceutical products. It may be understandable that pharmaceutical manufacturer companies are also hit by the political crisis in the country. Inadequate amount of fuel and raw material as well as low security status were some of the underlying factors behind these ill-effects in Yemen. Imported drugs make up about nearly 90% % of the pharmaceutical market compared to 10% drugs from the domestic market. This situation has led to an additional burden being shouldered by the national economy, where Yemen spends about US$263 million annually on pharmaceutical drugs, in reference to the national Supreme Drugs Authority. Although there is a very quick growth in the population and drugs consumption, the pharmaceutical industry has not been very active, where global pharmaceutical products play their role dominantly on the domestic market. The pharmaceutical production necessitates skilled human resources like university graduates. By contrast, the government and the private sector should also motivate the pharmaceutical industry and make use of the local employment

Actual issues of hygienic regulation and creation of safe working conditions at pharmaceutical manufacturing enterprises

2020 ◽  
Vol 60 (10) ◽  
pp. 640-644
Author(s):  
Vadim M. Vasilkevich ◽  
Ruslan V. Bogdanov ◽  
Elena V. Drozdova
Keyword(s):  
Pharmaceutical Industry ◽  
Working Conditions ◽  
Experimental Studies ◽  
Pharmaceutical Products ◽  
Laboratory Animals ◽  
Production Environment ◽  
Basic Principles ◽  
Toxicological Studies ◽  
Health Disorders ◽  
Safe Working

Introduction. The working conditions of pharmaceutical industry workers are characterized by the combined effect of unfavorable factors of the production environment, among which the leading one is chemical. The aim of study is to substantiate the basic principles and criteria for hygienic regulation of pharmaceutical products in their production to ensure safe working conditions for employees based on the results of their own research and existing requirements of technical regulations. Materials and methods. Analysis of working conditions and the prevalence of health disorders in pharmaceutical workers (according to literature data), toxicological studies of pharmaceutical substances on laboratory animals, scientific justification of hygiene standards in the air of the working area. Results. Among employees of the pharmaceutical industry, the predominant forms of production-related health disorders are diseases of the respiratory system, as well as skin dermatitis of allergic origin, liver and biliary tract diseases. Based on the results of experimental studies of domestic pharmaceutical products for the treatment of cardiovascular, oncological and mental diseases that have priority socio-economic significance, the basic principles and features of the practice of justifying the hygienic standards of medicines in the air of the working area are developed and systematized. Conclusions. During hygienic rationing of medicines, it is necessary to use a differentiated approach that allows, based on the analysis of information about the chemical structure, physical and chemical characteristics, production conditions, pharmacotherapeutic activity, and the results of studying the toxic effect in an experiment on laboratory animals, to determine the maximum permissible content in the air of the working area of medicines or to justify the prohibition of isolation with reasoned recommendations for their safe production.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

scholarly journals Coiled-Coil N21 of Hpa1 in Xanthomonas oryzae pv. oryzae Promotes Plant Growth, Disease Resistance and Drought Tolerance in Non-Hosts via Eliciting HR and Regulation of Multiple Defense Response Genes

2020 ◽  
Vol 22 (1) ◽  
pp. 203
Author(s):  
Zhao-Lin Ji ◽  
Mei-Hui Yu ◽  
Ya-Yan Ding ◽  
Jian Li ◽  
Feng Zhu ◽  
...  
Keyword(s):  
Drought Tolerance ◽  
Coiled Coil ◽  
Pharmaceutical Products ◽  
Full Length ◽  
Xanthomonas Oryzae ◽  
Disease Symptoms ◽  
Pathogenic Factors ◽  
Defense Response Genes ◽  
Underlying Mechanisms ◽  
Further Development

Acting as a typical harpin protein, Hpa1 of Xanthomonas oryzae pv. oryzae is one of the pathogenic factors in hosts and can elicit hypersensitive responses (HR) in non-hosts. To further explain the underlying mechanisms of its induced resistance, we studied the function of the most stable and shortest three heptads in the N-terminal coiled-coil domain of Hpa1, named N21Hpa1. Proteins isolated from N21-transgenic tobacco elicited HR in Xanthi tobacco, which was consistent with the results using N21 and full-length Hpa1 proteins expressed in Escherichia coli. N21-expressing tobacco plants showed enhanced resistance to tobacco mosaic virus (TMV) and Pectobacterium carotovora subsp. carotovora (Pcc). Spraying of a synthesized N21 peptide solution delayed the disease symptoms caused by Botrytis cinerea and Monilinia fructicola and promoted the growth and drought tolerance of plants. Further analysis indicated that N21 upregulated the expression of multiple plant defense-related genes, such as genes mediated by salicylic acid (SA), jasmonic acid (JA) and ethylene (ET) signaling, and genes related to reactive oxygen species (ROS) biosynthesis. Further, the bioavailability of N21 peptide was better than that of full-length Hpa1Xoo. Our studies support the broad application prospects of N21 peptide as a promising succedaneum to biopesticide Messenger or Illite or other biological pharmaceutical products, and provide a basis for further development of biopesticides using proteins with similar structures.

Happy families in the pharmaceutical industry

1983 ◽  
Vol 21 (20) ◽  
pp. 77-79
Keyword(s):  
Pharmaceutical Industry ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Parent Companies

Many large pharmaceutical companies operate subsidiaries or divisions with separate names and identities. Some of these subsidiaries have been specially created while others are survivors, in name, of take-overs or mergers. This has led to an increase in the number of trading companies promoting pharmaceutical products and to the practice of transferring established products from the parent companies to their subsidiaries. The results of the proliferation and re-organisation of companies will affect prescribers.

scholarly journals Stakeholders’ Perspective of Role of Policy and Legislation in Achieving Medicines’ Security

2020 ◽  
pp. 66-73
Author(s):  
Obi Peter Adigwe
Keyword(s):  
Pharmaceutical Industry ◽  
Age Groups ◽  
Significant Proportion ◽  
Access To Medicines ◽  
Pharmaceutical Products ◽  
Similar Proportion ◽  
Security Issue ◽  
The Government ◽  
Almost All

Background: The role of the pharmaceutical industry in a country such as Nigeria in the provision of safe, high quality and efficacious pharmaceutical products to meet the healthcare need of the populace, cannot be over-emphasized. This study was undertaken to critically look at the issues affecting Medicines’ Security in Nigeria. Methods: A self-completion questionnaire was used for data collection. The questionnaire was administered to participants of an Industry event in September 2017. Data collected were analyzed using Statistical Package for Social Science. Results: A total number of 800 questionnaires were administered to the participants and 529 of the questionnaires were included for analysis. Male participants (58.6%) were more than female participants, all age groups were well represented and more than a third of the respondents had first degree as their minimum qualification. Majority of the respondents (91.3%) indicated that Ministry of Health and its agencies were key to protecting the pharmaceutical sector, while slightly less of that proportion (79.1%) indicated that they patronized Nigeria pharmaceutical products. Almost all the participants (91.7%) supported the need for the local pharmaceutical industry to have access to sustainable funding and other incentives. A similar proportion (89.6%) of the respondents indicated that the local pharmaceutical industry should be prioritized in policy making and implementation. A significant proportion of the study participants (82.3%) indicated that access to medicines in Nigeria is a security issue. Conclusion: To ensure Medicines’ Security and attain medicines self-sufficiency in Nigeria, radical policies must therefore be put in place, together with enabling good business and industrial environment by the government in order to protect, promote and grow the local pharmaceutical industry in Nigeria.

3D PRINTING OF PHARMACEUTICALS – LEADING TREND IN PHARMACEUTICAL INDUSTRY AND FUTURE PERSPECTIVES

2020 ◽  
pp. 10-16
Author(s):  
SHANKHADIP NANDI
Keyword(s):  
Drug Delivery ◽  
Pharmaceutical Industry ◽  
3D Printing ◽  
Computer Aided Design ◽  
Release Kinetics ◽  
Research Work ◽  
Economic Benefits ◽  
Pharmaceutical Products ◽  
Dosage Forms ◽  
Fused Deposition

3D printing technology is a rapid prototyping process based on computer-aided design software that is proficient to construct solid objects with various geometrics by depositing numerous layers in a sequence. The major advantages of three-dimensional printing (3DP) technology over the traditional manufacturing of pharmaceuticals include the customization of medications with individually adjusted doses, on-demand tailored manufacturing, unprecedented flexibility in the design, manufacturing of complex and sophisticated solid dosage forms, and economic benefits. Recently, many researchers have been invested their efforts in applying 3DP technology to the pharmaceutical development of drug products and different drug delivery systems. Selective laser sintering, fused deposition modeling, semi-solid extrusion, stereolithography, etc., are the multiple 3DP technologies that can be established in several customized and programmable medicines. Sublingual, orodispersible, and fast-dissolving drug delivery formulations by 3DP technology have been already manufactured. Controlled-release formulations with different characteristics, doughnut-shaped multi-layered tablets with linear release kinetics, and drug-loaded tablets with modified-release characteristics are recently fabricated using 3DP. However, few 3DP methods produce uneven shapes of dosage forms and comparatively porous structures. Cost of transition, adaptation to the existing facility, achieving regulatory approval, etc., are the present challenges that can restrict the extensive application of 3DP technology to pharmaceutical products. Intense research work for modifying the 3DP methods is simultaneously sustained for by-passing the flaws and current limitations of this technology. 3DP technology can act as a convenient and potential tool for the pharmaceutical industry which will set a revolutionary manufacturing style in the near future to facilitate patient-centered health care.

Applications of Operations Research in Production and Distribution Management of Pharmaceutical Products

2017 ◽  
pp. 49-77
Author(s):  
Mahsa Yousefi Sarmad ◽  
Mir Saman Pishvaee
Keyword(s):  
Supply Chain ◽  
Pharmaceutical Industry ◽  
Human Life ◽  
Pharmaceutical Products ◽  
Pharmaceutical Supply Chain ◽  
Distribution Management ◽  
Global Industry ◽  
Production And Distribution ◽  
Recent Developments ◽  
Business Entities

Pharmaceutical industry is considered as a global industry because of its effects on the human life. Many researchers used optimization tools to manage the pharmaceutical supply chain (PSC) efficiently. A supply chain may be defined as an integrated process where several business entities work together to produce goods and/or services and deliver them to the end customer. The issue of PSC which includes strategic, tactical and operational decisions, is still a quite hot issue. The intended mission of this chapter is to introduce and discuss the recent developments of procurement, production and distribution management of pharmaceutical products in order to pave the way for the readers who are interested in this area of research. Notably, the focus of the chapter is on quantitative OR-based models which enable the decision makers to appropriately coordinate and manage the whole pharmaceutical industry.

scholarly journals Development of an enzyme-based fiber optic biosensor for detection of haloalkanes

Sensor Review ◽  
2019 ◽  
Vol 39 (6) ◽  
pp. 810-818 ◽  
Author(s):  
Nurul Hazwani Daud ◽  
Siti Nurbaya Oslan ◽  
Thean Chor Leow ◽  
Abu Bakar Salleh
Keyword(s):  
Structural Modification ◽  
Positive Control ◽  
Pharmaceutical Products ◽  
Significant Loss ◽  
Label Free ◽  
Binding Interaction ◽  
Content Type ◽  
Continuous Response ◽  
Genotoxic Impurities ◽  
Practical Implications

Purpose The main purpose of this study is to demonstrate the development of an enzyme-based sensor for haloalkane detection. Haloalkane is a toxic compound that is found as genotoxic impurities in pharmaceutical products and contaminants in waste. The need to investigate the genotoxic level in pharmaceutical manufacturing is very crucial because of its toxicity effects on human health. The potential of mini protein as an alternative bioreceptor was explored with the aim to be more effective and stable under extreme conditions. Design/methodology/approach Mini proteins of haloalkane dehalogenase (HLD) were computationally designed and experimentally validated. Tapered multimode fiber (TMMF) was bio-functionalized with a bioreceptor either native (positive control) or mini protein. The absorbance-based sensor resulting from the binding interaction of mini protein with haloalkane was monitored through a wavelength range of 200-1,300 nm. Findings An increment of the UV absorption is observed at 325 nm when haloalkane interacted with the immobilized bioreceptors, native or mini protein. Both biosensors displayed a continuous response over the range of 5-250 µM haloalkane. They also had the capability to detect haloalkanes below 1 min and with an operational stability of up to seven days without significant loss of sensitivity. Practical implications The results indicate the potential viability of the enzyme HLD-based sensor to monitor the existence of haloalkane in both pharmaceutical and environmental products. Originality/value The paper describes an outcome of experimental work on TMMF-based biosensor coated with HLD for label-free haloalkane detection. Mini protein can be used as an effective bioreceptor with some structural modification to improve functionality and stability.

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