Pharmaceutical Exports Research Articles

Strategic insights: Unveiling the potential of Pharmaceutical exports from India to Regulated markets

India is a major exporter of medicinal products in the world. India's pharmaceutical sector has grown significantly to contribute largely to the GDP of the nation because of its rapidly expanding economy and abundance of highly skilled labor. However, exporting pharmaceuticals to markets that are subject to regulations can be a difficult procedure that requires a lot of paperwork. This all-inclusive handbook will assist in navigating the documentation and export regulatory requirements for pharmaceutical exports from India to regulated markets. It also provides export projections for the future, enabling exporters to adapt their export strategy. This handbook will give you the knowledge needed to be successful in the pharmaceutical export business, regardless of whether an experienced exporter or a recent entry into the market. A study on Indian Pharmaceutical Exporter together with future forecasts and SWOT Analysis of Indian Pharmaceutical manufacturers.

Mathematical modeling and analysis of export trends for certain pharmaceutical groups

Background. The analysis of the exports of medicines of the Russian Federation (RF) by group 30 (pharmaceutical products) of the commodity nomenclature of foreign economic activity of the Eurasian Economic Union (equal to Harmonized System Code 30, HS 30) is an important task for determining the economic potential of the country in the pharmaceutical industry.Objective: building an export regression model. Development of an alternative mathematical model of pharmaceutical products’ export, suitable for making the forecast.Material and methods. Statistical data on HS 30 exports from 2010 to 2021 were taken from an open source: The International Trade Center (Trade Map). Data for 2022 and later for the Russian Federation are not available in open sources. Registration on the website is not required to collect statistics on export and import volumes based on annual data. The well-known statistical methods and methods of mathematical modeling were used. An alternative approach to regression analysis was developed. Technical data analysis was performed using MAPLE (Watcom Products Inc., Canada) and R (Bell Laboratories, USA) software.Results. Two models were constructed: Model I – a differential model based on cumulative data by year, and Model II – a model of standard regression analysis, the input parameters of which were quarterly export data, and the influencing parameters were a certain group of factors. Model I allowed considering the dynamics of changes in pharmaceutical exports over time (dynamic factors and nonlinear interactions). Model II, in turn, made it possible to determine the dependence of the volume of pharmaceutical exports on various economic indicators, such as gross domestic product, the volume of government procurement, and measures of protectionism. The relative error of Model I does not exceed 10%, which makes it suitable for forecasting.Conclusion. The construction and analysis of specified models help to provide main information about the trends in pharmaceutical product exports in the RF and assess its potential in the global market. The obtained results can be useful for developing strategies of the pharmaceutical industry development, making management decisions and forecasting future exports.

Medical Sanctions Against Russia: Arresting Aggression or Abrogating Healthcare Rights?

Since 2022, the EU, US, and other nations have imposed medical sanctions on Russia to block the export of pharmaceuticals and medical devices and curtail clinical trials to degrade Russia’s military capabilities. While international law proscribes sanctions that cause a humanitarian crisis, an outcome averted in Russia, the military effects of medical sanctions have been lean. Strengthening medical sanctions risks violating noncombatant and combatant rights to healthcare. Each group’s claim is different. Noncombatants and severely injured soldiers who cannot return to duty enjoy the right to adequate health care that sanctions cannot undermine. Combatants falling captive enjoy the same medical care that adversaries provide their own troops. Combatants yet to renounce hostilities, however, have no claim to medical attention and remain subject to sanctions. Nevertheless, medical sanctions prove unworkable in this complex environment of conflicting rights and command no place in a sustainable sanction regime.

An Overview and Membership Process of PIC/S and ICH and its Requirement for Global Regulatory Harmonization of Drugs

Abstract: Due to the increased globalization of regulatory authorities, it has become important to enhance harmonization efforts in creating regulatory requirements, checking and determining GMP compliance, licensing production locations, recalling defective batches, and boosting information interchange. ICH and PIC/S are the international platforms that provide an appealing and stable framework for addressing such globalization concerns. A country having a membership of PIC/S or ICH gives an assurance of the quality, safety, and efficacy of their medical products exported across the globe. Joining such international platforms helps the Pharmaceutical Industries and Regulatory System of that country to improve quality standards. In the present study, the main objective is to gain knowledge regarding the procedures to obtain membership in international platforms such as ICH and PIC/S, and to know the changes/modifications that needs to be done at the institutional/organizational level before applying for the membership, also, to gain knowledge of the eligibility criteria for the application and to know the differences in regulatory guidance in GMP aspects of different regulatory authorities. By joining these international platforms, ICH and PIC/S, non-member countries will be able to tap into the potential for pharmaceutical exports, especially in the largest countries of the globe. After joining these international platforms, the semi or low-regulated nations’ pharmaceutical industries will be benefited greatly in terms of cost savings, export convenience, and most importantly, market access. Membership in ICH and PIC/S will be able to provide the semi or low-regulated Drug Regulatory Authority a global footprint and give foreign regulatory agencies confidence in semi or low-regulated regulatory agencies.

Industrial prospects on regulatory gaps and barriers in pharmaceutical exports and their counteraction: Local experiential with global implication.

The pharmaceutical sector in Pakistan has grown over a period with export potential, however, there are certain barriers in the framework that regulate the growth and export of domestically manufactured pharmaceuticals. The purpose of this study was to highlight the current challenges that hinder the export of pharmaceuticals, especially to the countries with stringent regulatory authorities (SRA), as perceived by the domestic pharmaceutical industry experts, and to highlight the facilitators that may help to resolve the identified challenges. In a qualitative study, the data were collected from the consented experts from the pharmaceutical industries in Lahore, Karachi, Peshawar, and Quetta. Industrial experts with a minimum of 10 years of experience and who were serving at managerial levels or above were recruited through purposive sampling. The semi-structured interviews were conducted for the collection of data from industrial experts. Thematic content analysis was applied to conclude the data. Data analysis generated 4 themes and 16 codes. The export of pharmaceuticals, despite having greater potential was regarded as poor, which was attributed to the following: (a) inadequate industrial research and development, particularly on new molecules (b) non-compliance with the cGMP standards, (c) absence of high-tech equipment, (d) unwillingness of the pharmaceutical companies for bioequivalence studies on their generics, (e) unavailability of locally manufactured active pharmaceutical ingredients, (f) disruption in the supply of imported raw material, (g) poor international market perception about local pharmaceutical products and (h) lack of support from regulatory in process expedition. The respondents also suggested the measures for overcoming the above challenges to boost the export of domestic pharmaceuticals and expand their international market share in countries with SRA. Export from Pakistan to the SRA countries can be enhanced with mandatory bioequivalence studies during generic registration. The pharmaceuticals export could effectively contribute to the national economy.

An exploratory perspective on reciprocal pharmaceutical export operations and their underlying dynamic capabilities

An exploratory perspective on reciprocal pharmaceutical export operations and their underlying dynamic capabilities

Refinement of Drug Regulation and Russian Pharmaceutical Export

Strategy on development of the pharmaceutical industry for the period up to 2030 (Pharma-2030 Strategy), adopted in the Russian Federation this year, includes tasks to further saturate the national market with domestic medicines and to “realize the export potential of the pharmaceutical industry”. National drug regulation has a significant stimulating effect on the export of medicines. To identify the most important elements of this regulation related to the development and maintenance of sustainable pharmaceutical export, different aspects of national drug regulatory systems were studied. Countries belonging to different segments of the global pharmaceutical export market were included in the research. The results of the analysis of drug regulation in top export countries were published earlier. This article presents the results for pharmerging countries with a fastgrowing pharmaceutical sector and formulated common strategies for these countries that are aimed at achieving leadership positions of the national pharmaceutical industry in both the domestic and foreign markets. Several measures have been proposed for inclusion in the implementation plan for the Pharma-2030 Strategy, which, in our opinion, will contribute to achieving the goals set both to stimulate exports and to saturate the Russian market with domestic medicines.

Pharmaceutical Exports of Iran in OIC Region and Entering International Markets

Background: There are various pharmaceutical companies in Iran with high potential. Due to the lack of business with international markets for exports, Iranian pharmaceutical products are mostly traded in domestic markets. Despite numerous studies on pharmaceutical exports in the literature, the performance of Iran in pharmaceutical exports to the Organization of Islamic Cooperation (OIC), remains yet to be evaluated. The novelty of the present work lies in filling this research gap and helping develop policies to expand pharmaceutical exports of Iran.
 Materials and Methods: Analysis of results on the current performance of Iranian pharmaceutical exports indicated groups of factors. The most significant factors were product quality and government policies according to questionnaire survey.
 Results: Analysis of results on the current performance of Iranian pharmaceutical exports indicated groups of factors. The most significant factors were product quality and government policies according to questionnaire survey.
 Conclusion: It was concluded that supervision regulations of pharmaceutical exports were not developed to motivate the expansion of exports. Supervision and control of Iranian pharmaceutical industries would enhance the quality of pharmaceutical products and strongly contribute to the expansion of pharmaceutical exports. It was also found that the quality improvement of pharmaceutical products was a key factor in increasing pharmaceutical exports to international markets.

Regional Employment Implications of U.S. Pharmaceutical Exports

ABSTRACT We develop an industry-specific sub-national model of exports that takes into account international and domestic shipping costs. We generate econometric estimates of these shipping costs for the U.S. pharmaceutical and medicine manufacturing industry by fitting the model to 2017 U.S. export data at the district level. Then, we use the econometric model to estimate the value of exports originating from production in each state. Our estimates of states’ export intensities provide indicators of the exposure of workers in individual states to pharmaceuticals-related changes in patent protection, tariffs, and macroeconomic conditions in export markets.

Drug Regulation in Top Exporters of Pharmaceutical Products

This year, the Russian Federation adopted the Strategy for the Development of the Pharmaceutical Industry for the Period until 2030. The document sets the task of ensuring the production in the country of medicines that are competitive in the domestic and foreign markets, and “realizing the export potential of the pharmaceutical industry.” A feature of the pharmaceutical industry is the significant impact of various aspects of drug regulation on exports of medicines. The purpose of the study is to make an analysis of the experience of foreign countries and to identify the most important elements of drug regulation that contribute to the formation and development of sustainable export of medicines taking in the account the existing oligopoly structure of the export segment of the global pharmaceutical market. Considering the volume and diversity of the data obtained, the study was divided into two parts: an analysis of drug regulation in countries that are leaders in pharmaceutical export and in countries that are called pharma emerging markets. This article examines the features of export of pharmaceutical products and drug regulation, in general, provides an analysis of top exporters and demonstrates the main factors associated with successful pharmaceutical export, and shows current trends being taken by drug regulation authorities to maintain leadership in this area. The identified patterns and regulatory solutions can be used to solve the problems of regional markets at the national level.

The impact of the pharmaceutical industry on the innovation performance of European countries

There are significant differences in innovation performance between countries. Additionally, the pharmaceutical sector is stronger in some countries than in others. This suggests that the development of the pharmaceutical industry can influence a country's innovation performance. Using the Global Innovation Index and selected performance measures of the pharmaceutical sector, this study examines how the pharmaceutical sector influences the innovation performance of countries from the European context. The dataset of 27 European countries was analysed using simple, and multiple linear regressions and Pearson correlation. Our findings show that only three indicators of the pharmaceutical industry, more precisely pharmaceutical Research and Development, pharmaceutical exports, and pharmaceutical employment explain the innovation performance of a country largely. Pharmaceutical Research and Development and exports have a significant positive impact on a country's innovation performance, whereas employment in the pharmaceutical industry has a slightly negative impact. Additionally, global innovation performance has been found to positively influence life expectancy. We further outline the implications and possible policy directions based on these findings.

An exploratory perspective on reciprocal pharmaceutical export operations and their underlying dynamic capabilities

An exploratory perspective on reciprocal pharmaceutical export operations and their underlying dynamic capabilities

Regulatory pathway for pharmaceutical drug product registration and export in Gulf countries

The Indian pharmaceutical market is the third largest in terms of generic production. It has developed a reputation as a center of industry and research in the international market. India offers some of the costeffective manufacturing facilities globally. The Gulf cooperation council (GCC) region is regarded as a “developing market for pharmaceutical export”. This study assessed the regulatory frameworks of the GCC member countries of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE) to build a coordinated approach. GCC regions are exposed to a partially regulated market. Most regulatory changes and developments must be kept up to date by pharmaceutical businesses, and GCC adopted the international council for harmonization common technical document (ICH CTD) format for new product registration. To fulfill the public demand for safe and effective treatments, regulations are needed for pharmaceutical drug products urgently due to rising healthcare costs, R&D expenditures, and other factors. Harmonizing the data on quality, safety, and efficacy reported in the application dossier is a main concern for the ICH committee. This review article provides the regulatory framework of GCC countries for effective control of pharmaceutical products.

Lebanese Pharmaceuticals and Healthcare Industry: Investing in the Pharmaceutical Industry to Promote Exports

Compared to importation, the pharmaceutical production in Lebanon is still weak. The generics prescription is neglected according to the medicines of origin as only big brands dominate the Lebanese market. Despite the agreements between Lebanon and other Arab countries, the nature of the regulatory environment in the latter is likely to be a substantial obstacle that prevents the access of the Lebanese medicines to the markets of the Arab countries. On the other hand, the development of a new market access remains a necessity for increasing the volume of pharmaceutical exports. This paper aims to demonstrate, based on the Lebanese market analysis the significance of supporting local pharmaceutical manufacturing since it contributes as a primary factor in reducing the cost of the medical bill for citizens, public institutions, and payers. The paper concludes with a set of recommendations to strengthen the pharmaceutical sector as well as to stimulate and develop the local production of pharmaceutical medications.

The Challenges of Iran's Pharmaceutical Export: A Qualitative Content Analysis

Background: Development of non-oil exports, including pharmaceutical products is one of the most important economic development strategies. This study aims to explain challenges of pharmaceutical export in Iran by using the sources and content of online media news.
 Methods: This was a qualitative study which analyzed the content of general and specialized online media news in Iran (conventional approach) from January 20, 2017 to January 20, 2020. Data sources were selected using the purposive sampling method .Then, the eligible news was determined by quota sampling method and was inductively analyzed in MAXQDA10.
 Results: The identified challenges were divided into five main categories including the domestic market of medicines, pharmaceutical manufacturing, financing, marketing and diplomacy. The most important challenges were related to financing and marketing.
 Conclusion: Iran's position regarding worldwide export of drugs is not satisfactory. The target markets for drug exports should be developed using a national economic program and appropriate diplomacy, in addition to improving the quality of drug production.

An Analysis of Indian Pharmaceutical Exports to East African Community (EAC)

An Analysis of Indian Pharmaceutical Exports to East African Community (EAC)

Глобальные рынки передового производства — новая возможность для технологического обновления России

New technologies, including Industry 4.0, are rapidly changing traditional and high-tech industries, and forming the advanced manufacturing sector within the industrial complex. By now Russia has been characterized by a modest presence in the world advanced manufacturing markets – Russia’ share is less than 0.6% in certain markets and less than 0.4% in global advanced manufacturing. This is partially explained by the scarce commodity range in the Russian export basket, which determines weak representation of Industry 4.0 goods. Large part in the Russian advanced manufacturing exports is traditional for the Russian economy goods — airplanes, turbojet engines, fuel rods. However, we observe positive structural changes in Russian exports caused by the COVID-19 pandemic. Russia has increased exports of goods with bio- and additive technologies, optoelectronics. It seems that the entry to new advanced manufacturing markets for Russia can form the basis for long-term growth. International experience shows that advanced manufacturing exports are often supported by advanced manufacturing imports. We find that Russian economy significantly underutilizes this channel. Although Russian advanced manufacturing imports are gradually growing, it is focused primarily on final consumer goods. We consider industrial robots as a case of advanced manufacturing imports that deserves special attention as a widespread cross-cutting technology that can significantly transform the technological level of industries. Our estimates show that, although the robotics market in Russia is relatively small and has low growth rates relatively to investment in fixed assets, companies importing industrial robots are larger and more productive. This evidence allows us to determine the import of industrial robotics as one of the priority directions of modernization of the Russian manufacturing. Based on the analysis we identify and discuss three growth opportunities for Russia in global advanced manufacturing: 1) support of exports of services in optoelectronics and ICT through the use of accumulated human capital and competencies and taking into account fast transformation of business models in industry, 2) support of exports of biotechnology products, taking into account positive reputational effects and expanding Russian pharmaceutical exports under the COVID-19 pandemic; 3) support of technology companies in wide number of advanced manufacturing taking into account current favorable environment for the birth of tech startups in Russia.

Determinants of Internationalization as Levers for Sustainability: A Study of the Portuguese Pharmaceutical Sector

The pharmaceutical industry is facing the pressure of a global economy, loss of value in local markets and the highly intense innovation that characterizes this sector. This has a heavy impact, particularly in smaller economies. With this investigation, we intend to identify the determinants of internationalization as levers for sustainability in the pharmaceutical export sector of a small economy. Data was collected from a sample representing 63% of the total universe, Portuguese pharmaceutical organizations with exporting activity. A contextualization of the sector and a bibliographic review were previously carried out, which laid the groundwork for the empirical framework. This study revealed a deeply internationalized sector conditioned by a few shortcomings, namely a certain lack of sustainable competitive advantages, relatively low investment in research and development (R&D), insufficient innovation in internationalization strategies as well as scarce institutional support. Our findings may help pave the way for a more complete understanding of the dynamics of internationalization in highly competitive sectors.

Evaluating the potential for growth in high-tech exports from Russia

Subject. The article discusses exports of high-tech products manufactured by the Russian enterprises. Objectives. We outline an approach to evaluating the potential for high-tech exports. Methods. To identify the export potential, we referred to statistical data on the dynamics of high-tech exports and integral indicators of international trade, including the Revealed Comparative Advantage (RCA). The export potential was quantified by assessing the Export Potential Indicator (EPI) with the International Trade Center (ITC) technique, which is based on modern statistical models, including the gravitational model of international trade. To interpret the results, we compared and adjusted then with respect to external macroeconomic factors and domestic national policy, including the analysis of the return on governmental funds invested in export. Results. We analyzed the current dynamics of high-tech exports and imports in Russia, scrutinized indicators of export and import of electrical machines, equipment and pharmaceuticals. We determined the principal trade partners of Russia for the above group of commodities. We evaluated Russia’s export potential for the above categories and spotlighted priority countries for further trade cooperation. The article indicates whether governmental support is sufficient for unfolding the export potential. Conclusions and Relevance. The way we suggest evaluating the potential for high-tech exports allows to determine the most promising sectors in terms of locked export potential, quantify the export potential and, finally, set up limitations or targets so that it would be possible to assess the adequacy of governmental programs and enhance them and choose export support actions.

Фармацевтическое лидерство стран: роль накопительного эффекта расходов на НИОКР и эффекта непрерывности импорта

The pharmaceutical industry is one of the key sectors of the world modern economy, both in terms of its innovativeness and in terms of its contribution to GDP. Many countries and companies strive to achieve pharmaceutical leadership in the global market, by which we mean the volume of foreign sales (we distinguish between country and corporate pharmaceutical leadership). The aim of this article is to identify a number of factors that (to one degree or another) determine the leadership of countries in the global pharmaceutical industry or in the global pharmaceutical market. We hypothesize that the volume of national pharmaceutical exports depends on domestic R&D expenditures carried out by national companies, as well as on the volume of national pharmaceutical imports, that is, on the degree or depth of participation of pharmaceutical companies in the internationally fragmented pharmaceutical chain. Based on the conducted econometric analysis, the authors come to the conclusion that both R&D expenditures and participation in fragmented production have a significant impact on the volume of national pharmaceutical exports. At the same time, in the latter case, the effect of the continuous growth of imports of previous periods for the growth of exports of subsequent periods gets special significance. In the case of R&D expenditures, a special role is played by the cumulative effect of these costs, rather than individual, albeit large investments in pharmaceuticals. When modelling the volumes of pharmaceutical exports, the countries “outpacing” the market were identified, that is, countries with the rates of national pharmaceutical exports exceeding the world ones. Among them were both countries where the headquarters of Big Pharma are located, and countries where there are no major pharmaceutical companies leading. This conclusion means that countries that do not have the headquarters of Big Pharma companies on their territory, which include, in particular, Russia, Kazakhstan and Belarus, also have certain potential windows of opportunity to take a leading position in the global pharmaceutical market. Acknowledgements. The article was prepared with the support of the RFFI as part of the research project “Comparative analysis of the benefits and risks of embedding national companies in global value chains: on the example of the Russian pharmaceutical industry. Belarus and Kazakhstan” (no. 20-014-00011/20).