Drug Export Research Articles

A Review on Pharmaceutical Regulatory Authority of India, USA, UK, Australia

Medicines play an important role in saving lives, maintaining health, preventing disease, curbing epidemics and promoting national economic development. This is why people, governments, the pharmaceutical industry and research institutes pay for drugs. However, to do this, the drugs must be safe, effective and of high quality. This means that the development, production, import, export and distribution of drugs are regulated to ensure that they meet prescribed standards. To effectively regulate medicines, the government has established strong National Regulatory Authorities (NRAs) to ensure that medicines are effectively regulated to protect and promote public health. Pharmaceutical regulations around the world play an important role in ensuring the safety, quality and efficacy of medicines. Medicines regulatory agencies are responsible for enforcing regulations and issuing guidelines for the development, licensing, registration, manufacture, labelling, storage, marketing, distribution, pricing of drugs, drug importation and post marketing studies. While seeking international markets, the pharmaceutical industry must comply with the pharmaceutical regulations of other countries with different regulatory requirements. A single regulatory approach for marketing authorization (MA) applications for medicines in different countries is difficult. Therefore, the Common Technical Document (CTD) was developed to provide a common format for the electronic submission of drug registration applications.

Strategies to enhance the response of liver cancer to pharmacological treatments.

In contrast to other types of cancers, there is no available efficient pharmacological treatment to improve the outcomes of patients suffering from major primary liver cancers, i.e., hepatocellular carcinoma and cholangiocarcinoma. This dismal situation is partly due to the existence in these tumors of many different and synergistic mechanisms of resistance, accounting for the lack of response of these patients, not only to classical chemotherapy but also to more modern pharmacological agents based on the inhibition of tyrosine kinase receptors (TKIs) and the stimulation of the immune response against the tumor using immune checkpoint inhibitors (ICIs). This review summarizes the efforts to develop strategies to overcome this severe limitation, including searching for novel drugs derived from synthetic, semisynthetic, or natural products with vectorial properties against therapeutic targets to increase drug uptake or reduce drug export from cancer cells. Besides, immunotherapy is a promising line of research that is already starting to be implemented in clinical practice. Although less successful than in other cancers, the foreseen future for this strategy in treating liver cancers is considerable. Similarly, the pharmacological inhibition of epigenetic targets is highly promising. Many novel "epidrugs," able to act on "writer," "reader," and "eraser" epigenetic players, are currently being evaluated in preclinical and clinical studies. Finally, gene therapy is a broad field of research in the fight against liver cancer chemoresistance, based on the impressive advances recently achieved in gene manipulation. In sum, although the present is still dismal, there is reason for hope in the non-too-distant future.

Inhibition of the transmembrane transporter ABCB1 overcomes resistance to doxorubicin in patient-derived organoid models of HCC.

Transarterial chemoembolization is the first-line treatment for intermediate-stage HCC. However, the response rate to transarterial chemoembolization varies, and the molecular mechanisms underlying variable responses are poorly understood. Patient-derived hepatocellular carcinoma organoids (HCCOs) offer a novel platform to investigate the molecular mechanisms underlying doxorubicin resistance. We evaluated the effects of hypoxia and doxorubicin on cell viability and cell cycle distribution in 20 patient-derived HCCO lines. The determinants of doxorubicin response were identified by comparing the transcriptomes of sensitive to resistant HCCOs. Candidate genes were validated by pharmacological inhibition. Hypoxia reduced the proliferation of HCCOs and increased the number of cells in the G0/G1 phase of the cell cycle, while decreasing the number in the S phase. The IC50s of the doxorubicin response varied widely, from 29nM to >1µM. Doxorubicin and hypoxia did not exhibit synergistic effects but were additive in some HCCOs. Doxorubicin reduced the number of cells in the G0/G1 and S phases and increased the number in the G2 phase under both normoxia and hypoxia. Genes related to drug metabolism and export, most notably ABCB1, were differentially expressed between doxorubicin-resistant and doxorubicin-sensitive HCCOs. Small molecule inhibition of ABCB1 increased intracellular doxorubicin levels and decreased drug tolerance in resistant HCCOs. The inhibitory effects of doxorubicin treatment and hypoxia on HCCO proliferation are variable, suggesting an important role of tumor-cell intrinsic properties in doxorubicin resistance. ABCB1 is a determinant of doxorubicin response in HCCOs. Combination treatment of doxorubicin and ABCB1 inhibition may increase the response rate to transarterial chemoembolization.

Abstract 1073 Production and reconstitution in lipid nanoparticles of an engineered chimera construct of the Mtb EfpA drug exporter with apolipoprotein

Abstract 1073 Production and reconstitution in lipid nanoparticles of an engineered chimera construct of the Mtb EfpA drug exporter with apolipoprotein

Bacteroides fragilis бактериясының карбапенемге төзімділіктің молекулалық механизмдер

Carbapenems are generally the most successful group of antibacterial drugs due to the combination of a wide spectrum of activity, rapid bactericidal effect, greater potential for the selection of resistant strains and resistance compared to other classes of antibacterial drugs. Carbapenems are potent antimicrobial agents that effective against a wide range of bacteria, including both gram-positive and gram-negative types. Bacteroides fragilis is one of the important and frequently isolated bacteria in clinical laboratories for mono- and polymicrobial infections. Bacteroides fragilis is also resistant to macrolides, beta-lactams, metronidazole, and some newer fluoroquinolones. Carbapenem resistance is considered a rapidly growing problem due to overuse of the drug in therapy. Molecular mechanisms of carbapenem resistance in bacteria involve several factors. The first mechanism is associated with the development of multidrug resistance in microorganisms through the export of drugs via efflux systems. This process enables bacteria to avoid the negative effects of antibiotics. The second mechanism involves the synthesis of beta-lactamases, which is a key factor in the resistance of Bacteroides fragilis to beta-lactam compounds, including carbapenems. These enzymes are capable of hydrolyzing the beta-lactam ring of antibiotics, rendering them inactive. The third mechanism involves changes in the structure of penicillin-binding proteins (PBPs), which are the target sites for carbapenems. Mutations in genes encoding PBPs can lead to decreased affinity of carbapenems to these proteins, making them less sensitive to the antibiotic. The cfiA gene plays an important role in carbapenem resistance, especially in B. fragilis. It encodes a protein that confers resistance to carbapenems and other beta-lactam antibiotics. This gene can be horizontally transferred between different bacteria, increasing the risk of resistance spreading. Understanding the mechanism of antimicrobial resistance is important to avoid pitfalls when selecting alternative antimicrobials for the treatment and prevention of severe infections. This article examines several mechanisms that influence the resistance of B. fragilis strains to carbapenems.

Analysis of Narcotics Smuggling from Malaysia Through the Indonesian Sea Route Based on the Perspective of International Law

Narcotics Smuggling is one of the illegal narcotics distribution activities which may involve the import, export, distribution or illegal production of narcotics and illegal drugs. Narcotics smuggling involves the movement of narcotics across national borders or through illegal channels with the aim of avoiding security and legal controls in force in a country. Narcotics smuggling that still occurs a lot in Indonesia is narcotics smuggling from Malaysia through the Indonesian sea route. In the perspective of International Law, there are national laws and regulations governing narcotics smuggling, which can involve international cooperation in law enforcement and the extradition of perpetrators. International organizations such as the Narcotics and Organized Crime Agency (UNODC) also play a role in providing technical assistance and supporting countries' efforts to prevent and enforce laws against narcotics smuggling.

Characteristics of ABCC4 and ABCG2 High Expression Subpopulations in CRC—A New Opportunity to Predict Therapy Response

Background: Our previous findings proved that ABCC4 and ABCG2 proteins present much more complex roles in colorectal cancer (CRC) than typically cancer-associated functions as drug exporters. Our objective was to evaluate their predictive/diagnostic potential. Methods: CRC patients’ transcriptomic data from the Gene Expression Omnibus database (GSE18105, GSE21510 and GSE41568) were discriminated into two subpopulations presenting either high expression levels of ABCC4 (ABCC4 High) or ABCG2 (ABCG2 High). Subpopulations were analysed using various bioinformatical tools and platforms (KEEG, Gene Ontology, FunRich v3.1.3, TIMER2.0 and STRING 12.0). Results: The analysed subpopulations present different gene expression patterns. The protein–protein interaction network of subpopulation-specific genes revealed the top hub proteins in ABCC4 High: RPS27A, SRSF1, DDX3X, BPTF, RBBP7, POLR1B, HNRNPA2B1, PSMD14, NOP58 and EIF2S3 and in ABCG2 High: MAPK3, HIST2H2BE, LMNA, HIST1H2BD, HIST1H2BK, HIST1H2AC, FYN, TLR4, FLNA and HIST1H2AJ. Additionally, our multi-omics analysis proved that the ABCC4 expression correlates with substantially increased tumour-associated macrophage infiltration and sensitivity to FOLFOX treatment. Conclusions: ABCC4 and ABCG2 may be used to distinguish CRC subpopulations that present different molecular and physiological functions. The ABCC4 High subpopulation demonstrates significant EMT reprogramming, RNA metabolism and high response to DNA damage stimuli. The ABCG2 High subpopulation may resist the anti-EGFR therapy, presenting higher proteolytical activity.

Exosomes in Cancer Progression and Therapy Resistance: Molecular Insights and Therapeutic Opportunities.

The development of therapy resistance still represents a major hurdle in treating cancers, leading to impaired treatment success and increased patient morbidity. The establishment of minimally invasive liquid biopsies is a promising approach to improving the early diagnosis, as well as therapy monitoring, of solid tumors. Because of their manifold functions in the tumor microenvironment, tumor-associated small extracellular vesicles, referred to as exosomes, have become a subject of intense research. Besides their important roles in cancer progression, metastasis, and the immune response, it has been proposed that exosomes also contribute to the acquisition and transfer of therapy resistance, mainly by delivering functional proteins and RNAs, as well as facilitating the export of active drugs or functioning as extracellular decoys. Extensive research has focused on understanding the molecular mechanisms underlying the occurrence of resistance and translating these into strategies for early detection. With this review, we want to provide an overview of the current knowledge about the (patho-)biology of exosomes, as well as state-of-the-art methods of isolation and analysis. Furthermore, we highlight the role of exosomes in tumorigenesis and cancer treatment, where they can function as therapeutic agents, biomarkers, and/or targets. By focusing on their roles in therapy resistance, we will reveal new paths of exploiting exosomes for cancer diagnosis and treatment.

Drug exporter expression correlates with group 3 innate lymphoid cell resistance to immunosuppressive agents

Allogeneic hematopoietic cell transplantation (HCT) is often complicated by graft versus host disease (GvHD), an alloreactive immune response triggered by tissue damage. Interleukin (IL)-22 producing type 3 innate lymphoid cells (ILC3) protect epithelial tissues against chemo(radio)therapy-induced damage, suppress alloreactive T cells and mitigate acute GvHD symptoms after allogeneic HCT. Relatively high numbers of ILC before and after allogeneic HCT has been associated with significantly reduced tissue damage and less acute GvHD. While most transplantation conditioning and GvHD prophylaxis regimens are aimed at eliminating host and alloreactive donor lymphocytes, the effect of these regimens on ILC remain elusive. Here, we studied the effect of conditioning chemotherapy and immunosuppressive agents on the survival, proliferation, activation and function of human ILC3 in vitro. Tonsil-derived ILC3 were activated and incubated with agents commonly used to prevent and treat GvHD. While fludarabine, rapamycin, mycophenolic acid and prednisolone suppressed ILC3 to a similar degree as T cells, the effect of other agents, including cyclosporine A, methotrexate, imatinib, ibrutinib and ruxolitinib, was milder on ILC3 than on T cells. ILC3 are less sensitive to immunosuppressants potentially because of their expression of functionally active ATP Binding Cassette Subfamily B Member 1 (ABCB1) drug exporter proteins. This suggests less intracellular accumulation of immunosuppressive agents, which renders ILC3 resistant to these compounds. The present findings may help to develop strategies to simultaneously maintain the tissue protective properties of ILC3 and at the same time suppress alloreactive lymphocytes, which is important in the prevention and treatment of acute GvHD.

Structural Basis of the Allosteric Inhibition of Human ABCG2 by Nanobodies

ABCG2 is an ATP-binding cassette transporter that exports a wide range of xenobiotic compounds and has been recognized as a contributing factor for multidrug resistance in cancer cells. Substrate and inhibitor interactions with ABCG2 have been extensively studied and small molecule inhibitors have been developed that prevent the export of anticancer drugs from tumor cells. Here, we explore the potential for inhibitors that target sites other than the substrate binding pocket of ABCG2. We developed novel nanobodies against ABCG2 and used functional analyses to select three inhibitory nanobodies (Nb8, Nb17 and Nb96) for structural studies by single particle cryo-electron microscopy. Our results showed that these nanobodies allosterically bind to different regions of the nucleotide binding domains. Two copies of Nb8 bind to the apex of the NBDs preventing them from fully closing. Nb17 binds near the two-fold axis of the transporter and interacts with both NBDs. Nb96 binds to the side of the NBD and immobilizes a region connected to key motifs involved in ATP binding and hydrolysis. All three nanobodies prevent the transporter from undergoing conformational changes required for substrate transport. These findings advance our understanding of the molecular basis of modulation of ABCG2 by external binders, which may contribute to the development of a new generation of inhibitors. Furthermore, this is the first example of modulation of human multidrug resistance transporters by nanobodies.

Dilemma to Dominance: Decoding the Evolution of the Indian Pharmaceutical Industry - A Case Study

The Indian pharmaceutical industry has undergone a significant evolution, transitioning from a domestically-focused sector to a global powerhouse. Initially, Indian pharmaceutical companies primarily catered to domestic healthcare needs. However, with the implementation of economic reforms in the 1990s, the industry witnessed rapid growth and expanded into international markets. The Indian pharmaceutical industry has experienced a remarkable transformation, establishing itself as a global leader in the production and export of generic drugs. The industry has demonstrated superior growth performance, making it one of the fastest-growing sectors worldwide. Productivity levels and innovation play a significant role in determining competitiveness, and the Indian pharmaceutical industry has shown impressive capabilities in these areas. Government policies have been instrumental in driving the industry's self-sufficiency and internationalization. The establishment of public sector pharmaceutical enterprises and the introduction of intellectual property regulations, pricing control, and research and development (R&D) support have propelled the industry's growth.
 This case study aims to provide an in-depth analysis of the journey of the Indian pharmaceutical industry, exploring its growth, challenges, and the dilemma it faces in balancing innovation and affordability. By examining the sector's perspective, challenges, and identified dilemmas, this case study aims to equip readers with a comprehensive understanding of the industry. The case delves into the journey and challenges faced by the Indian pharmaceutical industry. It investigates the industry's growth, the perspective of Indian pharmaceutical companies, the challenges they encounter, and the identified dilemmas. The case also provides teaching notes and objectives to enhance the readers' knowledge and decision-making skills within the pharmaceutical industry.

Investigating and Ranking of Barriers Affecting Development of Pharmaceutical Industry Exports in Iran: AHP Method

Background: The study aimed to investigate and rank the barriers affecting the development of pharmaceutical industry exports in Iran's AHP method.
 Methods: The research applied and descriptive method, a field documentary. The study's statistical population was all pharmaceutical organizations that operate in the direction of export to other countries; the study's statistical population consisted of business managers and professors working in the field of export and marketing managers of exporting pharmaceutical companies. The method of data collection was using a questionnaire. The data analysis method was a hierarchical analysis method using a decision tree.
 Results: Evaluation of the results obtained for the barrier of workforce and knowledge of indicators of access to specialized and skilled labor in the field of drug production, skills and technical knowledge in the company in innovative design and development of new products, existing knowledge infrastructure for clinical trial studies In the country of origin, access to a specialized and skilled workforce in the field of drug export, the number of academic and research centers in the field of medicine, the relationship of academic and research centers in the field of medicine with industry and access to cheap labor and the necessary knowledge in compiling and collecting documents Necessary for export to target countries were approved.
 Conclusion: For many firms, the most important external factors that prevent barriers to entering international markets include tariff and non-tariff barriers, foreign exchange rates, fluctuations, competition in foreign markets, government policies, foreign trade practices, and different product and consumption standards. [18] Similarly, operational barriers include the terms of receipt and payment from foreign buyers, establishing transport arrangements, customs clearance, representation, and managing international distribution channels through international markets.

The Alternating Access Mechanism in Mammalian Multidrug Resistance Transporters and Their Bacterial Homologs.

Multidrug resistance (MDR) proteins belonging to the ATP-Binding Cassette (ABC) transporter group play a crucial role in the export of cytotoxic drugs across cell membranes. These proteins are particularly fascinating due to their ability to confer drug resistance, which subsequently leads to the failure of therapeutic interventions and hinders successful treatments. One key mechanism by which multidrug resistance (MDR) proteins carry out their transport function is through alternating access. This mechanism involves intricate conformational changes that enable the binding and transport of substrates across cellular membranes. In this extensive review, we provide an overview of ABC transporters, including their classifications and structural similarities. We focus specifically on well-known mammalian multidrug resistance proteins such as MRP1 and Pgp (MDR1), as well as bacterial counterparts such as Sav1866 and lipid flippase MsbA. By exploring the structural and functional features of these MDR proteins, we shed light on the roles of their nucleotide-binding domains (NBDs) and transmembrane domains (TMDs) in the transport process. Notably, while the structures of NBDs in prokaryotic ABC proteins, such as Sav1866, MsbA, and mammalian Pgp, are identical, MRP1 exhibits distinct characteristics in its NBDs. Our review also emphasizes the importance of two ATP molecules for the formation of an interface between the two binding sites of NBD domains across all these transporters. ATP hydrolysis occurs following substrate transport and is vital for recycling the transporters in subsequent cycles of substrate transportation. Specifically, among the studied transporters, only NBD2 in MRP1 possesses the ability to hydrolyze ATP, while both NBDs of Pgp, Sav1866, and MsbA are capable of carrying out this reaction. Furthermore, we highlight recent advancements in the study of MDR proteins and the alternating access mechanism. We discuss the experimental and computational approaches utilized to investigate the structure and dynamics of MDR proteins, providing valuable insights into their conformational changes and substrate transport. This review not only contributes to an enhanced understanding of multidrug resistance proteins but also holds immense potential for guiding future research and facilitating the development of effective strategies to overcome multidrug resistance, thus improving therapeutic interventions.

Functionally distinct mutations within AcrB underpin antibiotic resistance in different lifestyles

Antibiotic resistance is a pressing healthcare challenge and is mediated by various mechanisms, including the active export of drugs via multidrug efflux systems, which prevent drug accumulation within the cell. Here, we studied how Salmonella evolved resistance to two key antibiotics, cefotaxime and azithromycin, when grown planktonically or as a biofilm. Resistance to both drugs emerged in both conditions and was associated with different substitutions within the efflux-associated transporter, AcrB. Azithromycin exposure selected for an R717L substitution, while cefotaxime for Q176K. Additional mutations in ramR or envZ accumulated concurrently with the R717L or Q176K substitutions respectively, resulting in clinical resistance to the selective antibiotics and cross-resistance to other drugs. Structural, genetic, and phenotypic analysis showed the two AcrB substitutions confer their benefits in profoundly different ways. R717L reduces steric barriers associated with transit through the substrate channel 2 of AcrB. Q176K increases binding energy for cefotaxime, improving recognition in the distal binding pocket, resulting in increased efflux efficiency. Finally, we show the R717 substitution is present in isolates recovered around the world.

The role of DNA methylation in ovarian cancer chemoresistance: A narrative review.

Ovarian cancer (OC) is the most lethal gynecological cancer. In 2018, it was responsible for over 180,000 deaths worldwide. The high mortality rate is the culmination of a lack of early diagnosis and high rates of chemotherapy resistance, which is synonymous with disease recurrence. Over the last two decades, an increasingly significant role of epigenetic mechanisms, in particular DNA methylation, has emerged. This review will discuss several of the most significant genes whose hypo/hypermethylation profiles are associated with chemoresistance. Aside from functionally elucidating and evaluating these epimutations, this review will discuss recent trials of DNA methyltransferase inhibitors (DNMTi). Finally, we will propose future directions that could enhance the feasibility of utilizing these candidate epimutations as clinical biomarkers. To perform this review, a comprehensive literature search based on our keywords was conducted across the online databases PubMed and Google Scholar for identifying relevant studies published up until August 2022. Epimutations affecting MLH1, MSH2, and Ras-association domain family 1 isoform A (DNA damage repair and apoptosis);ATP-binding cassette subfamily B member 1 and methylation-controlled J (drug export); secreted frizzled-related proteins (Wnt/β-catenin signaling), neurocalcin delta (calcium and G protein-coupled receptor signaling), and zinc finger protein 671all have potential as biomarkers for chemoresistance. However, specific uncertainties relating to these epimutations include histotype-specific differences, intrinsic versus acquired chemoresistance, and the interplay with complete surgical debulking. DNMTi for chemoresistant OC patients has shown some promise; however, issues surrounding their efficacy and dose-limiting toxicities remain; a personalized approach is required to maximize their effectiveness. Establishing a panel of aberrantly methylated chemoresistance-related genes to predict chemoresponsiveness and patients' suitability to DNMTi could significantly reduce OC recurrence, while improving DNMTi therapy viability. To achieve this, a large-scale prospective genome-wide DNA methylation profile study that spans different histotypes, includes paired samples (before and after chemotherapy), and integrates transcriptomic and methylomic analysis, is warranted.

Cisplatin in Ovarian Cancer Treatment-Known Limitations in Therapy Force New Solutions.

Cisplatin is one of the most commonly used anticancer drugs worldwide. It is mainly used in the treatment of ovarian cancer, but also used in testicular, bladder and lung cancers. The significant advantage of this drug is the multidirectional mechanism of its anticancer action, with the most important direction being damaging the DNA of cancer cells. Unfortunately, cisplatin displays a number of serious disadvantages, including toxicity to the most important organs, such as kidneys, heart, liver and inner ear. Moreover, a significant problem among patients with ovarian cancer, treated with cisplatin, is the development of numerous resistance mechanisms during therapy, including changes in the processes of cellular drug import and export, changes in the DNA damage repair mechanisms, as well as numerous changes in the processes of apoptosis and autophagy. Due to all of the mentioned problems, strategies to increase the effectiveness of cisplatin in the treatment of ovarian cancer are intensively sought. The most important strategy includes the development of less toxic cisplatin analogs. Another important direction is combination therapy, involving the simultaneous use of cisplatin with different anticancer drugs, substances derived from plants, temperature or radiotherapy. Many years of observations accompanying the presence of cisplatin in the therapy made it possible to provide a series of verifiable, statistically significant data, but also to show how, over time, with the new information and scientific discoveries, it is possible to describe and understand the therapeutic problems observed in practice, such as the acquisition of drug resistance by tumor cells or induction of changes in the tumor microenvironment. According to the authors, confronting what we knew so far with what new trends offer has a profound meaning. This paper presents information on the history of cisplatin and describes the molecular mechanisms of its action and the development of resistance by cancer cells. In addition, our goal was to highlight a number of therapeutic strategies to increase the effectiveness of cisplatin in the treatment of ovarian cancer, as well as to identify methods to eliminate problems associated with the use of cisplatin.

Necessary and sufficient molecular determinants of quaternary ammonium antiseptic export by small multidrug resistance transporters.

The small multidrug resistance (SMR) family of transporters are exceptional models for studying polyspecific drug transport. The family is functionally split between two major clusters: the selective Guanidinium exporters (Gdx) that selectively transport the metabolite, guanidinium, and the polyspecific quaternary ammonium compound (Qac) drug exporters that transport a range of man-made compounds with different structural properties. Members from each cluster are small, structurally similar, and only differ in what substrates they transport which makes them ideal models for investigating the molecular determinants required for multidrug transport. Using a combination of directed evolution, high throughput mutagenesis, and next generation sequencing, we identified six mutations that are necessary and sufficient to convert a selective Gdx into a polyselective quaternary ammonium transporter. Biochemical, biophysical, and structural characterization of this transporter will reveal the mechanistic basis for promiscuous transport in the SMR family.

Supply Chain Management of Dual-Use Drugs using Blockchain

Supply chain management is a critical aspect of the pharmaceutical industry, as it ensures the timely and efficient delivery of essential drugs to end users. Dual-use drugs are those drugs which have both medical and non-medical applications. However, the management of dual-use drugs presents additional challenges, due to the possibility of misuse, diversion, and tampering. To address these challenges, it is necessary to track the supply chain of these dual-use drugs from the manufacturer to the end user. This research study investigates the use of blockchain technology in the supply chain management of dual-use drugs. This study explores the potential benefits of blockchain in improving the transparency, traceability, and security of the supply chain while reducing the risk of fraud and misuse. Additionally, the consensus algorithm inherent in blockchain technology makes it an ideal solution for preventing the manipulation and illegal export of dual-use drugs.

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.

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.