Global Pharma Research Articles

A Comprehensive Assessment of Quality of Antimalarial Medicines in Mainland Tanzania: Insights from Five Years of Postmarket Surveillance.

Sustainable access to high-quality antimalarial medicines is pivotal to achieving universal and effective malaria control. Poor-quality antimalarial medicines are prevalent in sub-Saharan Africa, impeding malaria control initiatives and claiming the lives of many children. Regular monitoring of the quality of antimalarial medicines is crucial to ensure the quality of service to the community. A cross-sectional study using a postmarket surveillance (PMS) approach was conducted from 2019 to 2023. Samples were collected from the port of entry, local manufacturers, and various distribution outlets in 15 regions of mainland Tanzania. The samples were subjected to tier 1 evaluation, comprising a product information review (PIR) and identification using the Global Pharma Health Fund-Minilab® techniques. Samples that failed the identification tests and 10% of the samples from distribution outlets that passed the tests were subjected to confirmatory testing (tier 2), which included assays, related substances, dissolution, and sterility per the pharmacopeial monographs. During five annual PMSs, 2,032 antimalarial samples were collected and subjected to quality tests. All samples complied with the standard specifications for identity, dissolution, related substances, sterility, physical evaluation, disintegration, and assay. A total of 292 (55.5%) tested samples failed the PIR evaluation, with incomplete package information in leaflets contributing to 64.7% of all deviations. Antimalarial medicines circulating in the mainland Tanzanian market meet expected quality standards. Continuous monitoring of the quality of antimalarial medicines is recommended.

Advancing inclusive research (AIR) in Africa: Strengthening healthcare systems to enhance access on the continent through the Africa AIR site alliance model.

e13778 Background: While Africa makes up 17% of the total world population, it has 24% of the global disease burden. Furthermore, although Africa is rich in genomic diversity, Africans make up <4% of the patients in global pharma studies and 1% of the global genomic database. In 2020 there were only 63 African patients in Roche global clinical trials. The Africa AIR Site Alliance model was undertaken to address the growing importance of interventional clinical trials with advanced diagnostics and therapies in Africa, as well as the lack of representation of the African population in global datasets, which contribute to continued health disparities, poor outcomes and existing inequities. Methods: In countries with a legal research framework, no clinical trial holds and who have conducted at least 1 Roche clinical trial during the last 5 years potential Centers of Excellence for the Africa AIR Site Alliance were identified. For patients, sites had invoiceable services to ensure they were supported and could potentially include education about clinical trial participation, reasonable travel and accommodation, or covering the cost of missed work or childcare. Sites participated in training on how to conduct clinical trials, including opportunities to share best practices across sites. Results: Four pilot countries were selected and had Centers of Excellence identified to work as partners with Roche for global clinical trials: Morocco (Marrakech University Hospital Center), Nigeria (University College Hospital Ibadan), Kenya (University of Nairobi Institute of Tropical and Infectious Diseases) and South Africa (Limpopo Cancer Research Institute). After entering the Africa AIR Site Alliance, sites reported consistent application of standard operating procedures and manuals, trained and empowered staff, increased organization and appropriate patient support, plus knowledge and experience with industry trials. Sites are successfully participating in an increased number of global clinical trials in various therapeutic areas with 23 patients enrolled at the Africa AIR Site Alliance sites in oncology and ophthalmology studies. Conclusions: The Africa AIR Site Alliance model is a groundbreaking initiative that has the potential to revolutionize clinical research in Africa with a positive long-term impact on the African healthcare ecosystem and clinical care delivery. Limited diversity and representation in genomic, safety and efficacy data have hampered scientific and medical progress on the continent. The Africa AIR Site Alliance provides critical support, knowledge and skills for conducting clinical trials and assists in removing barriers for underrepresented patients to participate in these trials. Future work will focus on expanding to additional countries in Africa and creating a robust network of Centers of Excellence for innovative research.

Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability.

The complexity and inter-connectedness of operating in a global world for drug product supply has become an undeniable reality, further underscored by the COVID-19 pandemic. For Post-Approval Changes (PACs) that are an inevitable part of a product's commercial life, the impact of the growing global regulatory complexity and related drug shortages has brought the Global PAC ManagementSystem to an inflection point in particular for companies that have their products marketed in many countries.This paper illustrates through data analyzed for the first time from 145,000 + PACs for 156 countries, collected by 18 global pharma companies over a 3-year period (2019-2021), how severe the problem of global regulatory complexity is. Only PACs requiring national regulatory agency (NRA) approval prior to implementation were included in the data set. 1 of the 156 country NRAs approved all submitted PACs within a period of 6months. The 6-month timeline was chosen because it is the recommended review timeline for major changes in the WHO guidance for vaccines and biotherapeutic products. 10 out of the 156 (6%) countries had no more than 10% of the PACs reviewed and approved in > 6 months. In 33 (22%) countries more than half of the PACs took > 6 months for approval. It is rare that the same PAC is approved globally within 6 months as individual NRAs take from a few months to years (in some cases > 5 years) for their review.The global PAC management complexity has steadily grown over the past 20years. Attempts thus far to solve this problem have not made any meaningful difference. Senior leaders and decision-makers across the interdependent components of the complex Global PAC Management System (industry and regulators) must come together and collaboratively manage the problem holistically with the objective of ensuring global drug product availability instead of continuing with distinct stakeholder or country-focused solutions, which can tend to worsen the problem.In this paper, the Chief Quality Officers (CQOs) from 18 of the largest innovator pharma companies (see Acknowledgements) are speaking with One-Voice-of-Quality for PACs (1VQ for PACs Initiative). They are recommending a set of 8 approaches to activate a holistic transformation of the Global PAC Management System. This article presents their view on the problem of global regulatory complexity for managing PACs, it's impact on continual improvement and the risk to drug product supply, as well as approaches that can help alleviate the problem.

Quality Assessment of Selected Essential Antimicrobial Drugs from Drug Retail Outlets of Selected Cities in Eastern Ethiopia.

The prevalence of substandard and falsified (SF) antimicrobial drugs is increasing around the globe. This poses a great concern for the healthcare system. The consumption of SF antimicrobial drugs has the potential to result in treatment failure, emergence and development of antimicrobial resistance, and ultimately a rise in mortality rate. The objective of this study was to assess the quality of four commonly used antimicrobials marketed in the cities of Dire Dawa and Jijiga and the town of Togo-Wuchale, which have high potential for illegal drug trade activities in Ethiopia because they are located near the border with Somalia. A total of 54 brands/samples of amoxicillin, amoxicillin/clavulanic acid, ciprofloxacin, and norfloxacin formulations were collected covertly from 43 facilities using a convenience sampling strategy from March 16 to March 29, 2022. The samples were first screened using Global Pharma Health Fund (GPHF)-Minilab protocols and then analyzed using U.S. Pharmacopoeial and British Pharmacopoeia official methods. The quality evaluation detected no falsified product; however, it showed that 14.3% of the samples failed the GPHF-Minilab screening test semiquantitatively. Overall, 22.2% of the products analyzed did not meet any of pharmacopoeial specifications assessed: 13%, 12.2%, and 11.1% of the products failed in assay, dissolution, and weight variation, respectively. Additionally, 56.3% of amoxicillin samples, 60% of amoxicillin/clavulanate, 20% of ciprofloxacin, and 54.5% of norfloxacin samples were found to be pharmaceutically nonequivalent with their respective comparator products regarding dissolution profiles. The study showed the presence of substandard antimicrobial medicines in the eastern Ethiopian market.

Global pharma departure from Nigeria: A threat to public health.

Global pharma departure from Nigeria: A threat to public health.

The use of Artificial Intelligence in Pharmacy

As the use of technology can save time and money thereby providing the aid to the pharma sector. Artificial Intelligence is a branch of computer science which deals with the problem solving by the aid of symbolized programming. AI has evolved into a science of problems solving with enormous applications in business, health care and engineering. This article provides insight of the AI used in drug discovery, various tools of AI, AI’s importance in global pharma pricing & market access debates, Application of AI in pharma.

Novartis Oncology Spain: Agile innovation and the RWE cell

Healthcare and life science companies are transforming their business models from product development toward precision medicine. Vasant Narasimhan was appointed in 2018 as the new CEO of Novartis—a global pharma company. He champions a multi-faceted strategic intent: 1) transform the company from “selling pills” to investing heavily in discovering of new treatments that combine life sciences and digital technologies. In Spain, José Marcilla, the Director General of Novartis Oncology, pioneered an organizational transformation by developing (1) a cell-based innovation organization and process and (2) a new startup accelerator. This case explores both initiatives and their far-reaching consequences. The “Spanish experiment” helped to develop of digital services that reach the patient in a highly regulated environment. This duo of cases—Novartis Oncology Spain: Agile Innovation and The RWE (real wold evidence) Cell—gives students the opportunity to examine the motivations behind the transformation at Novartis, explore the implementation of its strategic intent, and ask what is the appropriate pace for such a dramatic change. The case is taught as a single class for decision-making regarding which cells and startups are suitable to be continued given the innovation horizons. By walking with students through these innovation horizons, the case enables decisions to be made about whether this pioneering Spanish program should be continued or not.

Digital Tools-Regulatory Considerations for Application in Clinical Trials.

During the last few years, the pharmaceutical industry has adopted digital technologies/digital health technology (DHT) to improve the drug development process and the commercialization of new products. Technological advances are strongly supported by both the US-FDA and the EMA, but the regulatory landscape in the US seems to be more suitable to promote innovation in the digital health sector (e.g. Cures Act). In contrast, the new Medical Device Regulation sets high hurdles for Medical Device software to pass regulatory scrutiny.On both sides of the Atlantic, a digital tool must be fit-for-purpose for the intended use in the clinical drug trial. Irrespective of its status as a Medical Device, at least the basic safety and performance requirements according to local regulations should be met, quality system and surveillance requirements should be fulfilled, and the sponsor must ensure conformity with GxP and the local data privacy and cybersecurity legislations.There is an overlap in technical and clinical validation for drug development tool qualification in both regions to ensure that the digital tools deliver reliable data with tangible clinical benefits. Based on an analysis of the regulatory framework of the FDA and the EMA, this study proposes regulatory strategies for a global pharma company: It would be prudent for drug development companies to a) use approved solutions or b) consider qualification of drug development tools early and in parallel to clinical development. Early engagement with the FDA and the EMA/CA is recommended to define evidentiary standards and corresponding regulatory pathways for different contexts-of-use and to clarify regulator's expectations as to what extent data collected by digital tools are acceptable to support marketing authorization applications (MAA).Hence a harmonization of the partly disparate regulatory requirements in the US and the EU accompanied by further development of the regulatory landscape in the EU, could further foster the use of digital tools in drug clinical development. The outlook for the use of digital tools in clinical trials is hopeful.

Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study.

The prevalence of substandard and falsified medicines in low- and middle-income countries (LMICs) is a major global public health concern. Multiple screening technologies for post-market surveillance of medicine quality have been developed but there exists no clear guidance on which technology is optimal for LMICs. This study examined the return on investment (ROI) of implementing a select number of screening technologies for post-market surveillance of amoxicillin quality in a case study of Kenya. An agent-based model, Examining Screening Technologies using Economic Evaluations for Medicines (ESTEEM), was developed to estimate the costs, benefits, and ROI of implementing screening technologies for post-market surveillance of substandard and falsified amoxicillin for treatment of pediatric pneumonia in Kenya. The model simulated sampling, testing, and removal of substandard and falsified amoxicillin from the Kenyan market using five screening technologies: (1) Global Pharma Health Fund's GPHF-Minilab, (2) high-performance liquid chromatography (HPLC), (3) near-infrared spectroscopy (NIR), (4) paper analytical devices / antibiotic paper analytical devices (PADs/aPADs), and (5) Raman spectroscopy. The study team analyzed the population impact of utilizing amoxicillin for the treatment of pneumonia in children under age five in Kenya. We found that the GPHF-Minilab, NIR, and PADs/aPADs were similar in their abilities to rapidly screen for and remove substandard and falsified amoxicillin from the Kenyan market resulting in a higher ROI compared to HPLC. NIR and PADs/aPADs yielded the highest ROI at $21 (90% Uncertainty Range (UR) $5-$51) each, followed by GPHF-Minilab ($16, 90%UR $4 - $38), Raman ($9, 90%UR $2 - $21), and HPLC ($3, 90%UR $0 - $7). This study highlights screening technologies that can be used to reduce costs, speed up the removal of poor-quality medicines, and consequently improve health and economic outcomes in LMICs. National medicine regulatory authorities should adopt these fast, reliable, and low-cost screening technologies to better detect substandard and falsified medicines, reserving HPLC for confirmatory tests.

Decision Criteria for Partial Nationalization of Pharmaceutical Supply Chain: A Scoping Review

(1) Background: Any disturbance in the pharmaceutical supply chain (PSC) can disrupt the supply of medicines and affect the efficiency of health systems. Due to shortages in the global pharma supply chain over the past few years and the complex nature of free trade and its limitations when confronted by a major global health and humanitarian crisis, many countries have taken steps to mitigate the risks of disruption, including, for example, recommending the adoption of a plus one diversification approach, increasing safety stock, and nationalizing the medical supply chains. (2) Objective: To scope findings in the academic literature related to decision criteria to guide national policy decisions for the “Partial Nationalization of Pharmaceutical Supply Chain” (PNPSC) from the viewpoints of the three main stakeholders: industry, payers (government and health insurance), and patients. (3) Methods: These consist of a scoping review of the peer-reviewed literature. (4) Results: A total of 115 studies were included. For local manufacturing decisions, five criteria and 15 sub-criteria were identified. Weighting, decision-making, risk assessment, and forecasting were the main data analysis tools applied; (5) Conclusions: The findings could serve as a baseline for constructing PNPSC frameworks after careful adaptation to the local context.

Indian Biosimilars and Vaccines at Crossroads-Replicating the Success of Pharmagenerics.

The global pharma sector is fast shifting from generics to biologics and biosimilars with the first approval in Europe in 2006 followed by US approval in 2015. In the form of Hepatitis B vaccine, India saw its first recombinant biologics approval in 2000. Around 20% of generic medications and 62% of vaccines are now supplied by the Indian pharmaceutical industry. It is this good position in biologics and biosimilars production that could potentially improve healthcare via decreased treatment cost. India has witnessed large investments in biosimilars over the years. Numerous India-bred new players, e.g., Enzene Biosciences Ltd., are keen on biosimilars and have joined the race alongside the emerging giants, e.g., Biocon and Dr. Reddy's. A very positive sign was the remarkable disposition during the COVID-19 pandemic by Bharat Biotech and the Serum Institute of India. India's biopharmaceutical industry has been instrumental in producing and supplying preventives and therapeutics to fight COVID-19. Despite a weak supply chain and workforce pressure, the production was augmented to provide reasonably priced high-quality medications to more than 133 nations. Biosimilars could cost-effectively treat chronic diseases involving expensive conventional therapies, including diabetes, respiratory ailments, cancer, and connective tissue diseases. Biologics and biosimilars have been and are being tested to treat and manage COVID-19 symptoms characterized by inflammation and respiratory distress. Although India boasts many universities, research centers, and a relatively skilled workforce, its global University-Industry collaboration ranking is 24, IPR ranking remains 47 and innovation ranking 39. This reveals a wide industry-academia gap to bridge. There are gaps in effective translational research in India that must be promptly and appropriately addressed. Innovation demands strong and effective collaborations among universities, techno-incubators, and industries. Many successful research findings in academia do not get translation opportunities supposedly due to low industrial collaboration, low IP knowledge, and publication pressure with stringent timelines. In light of this, a detailed review of literature, including policy papers, government initiatives, and corporate reviews, was carried out, and the compilation and synthesis of the secondary data were meticulously summarized for the easy comprehension of the facts and roadmap ahead. For easy comprehension, charts, figures, and compiled tables are presented. This review assesses India's situation in the biosimilar space, the gaps and areas to improve for Indian investment strategies, development, and innovation, addressing need for a more skilled workforce, industrial collaboration, and business models. This review also proposes forward an approach to empowering technopreneurs to develop MSMEs for large-scale operations to support India in taking innovative thoughts to the global level to ultimately realize a self-reliant India. The limitations of the compilation are also highlighted towards the end.

Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi.

To assess the prevalence and factors associated with substandard and falsified (SF) medicines among antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi. We conducted a cross-sectional study in 23 public, faith-based and private health facilities in Zomba, Machinga and Nsanje districts. We analyzed oral medicine samples of commonly used medicines among antibiotics, antimalarial, antihypertensive and antidiabetics in accordance with Malawi Essential Medicines List and local treatment guidelines. These medicines were subjected to visual inspection for any defects and screening for the content of active pharmaceutical ingredient and disintegration of dosage units. Samples that failed during screening and at least 10% of those that passed were subjected to pharmacopeia assay and dissolution test for confirmation. We used thin layer chromatography and disintegration test methods provided in the Global Pharma Health Fund minilab® for the screening purposes. We conducted confirmatory test using High-Performance Liquid Chromatography (HPLC) or ultra-violet/visible spectrophotometer and dissolution. Of the 293 medicine samples collected, 14.3% were SF medicines. Among the SF medicines were 12.5% of Amlodipine (1/8), 19.2% of Amoxicillin (5/26), 72.2% of Atenolol (8/11), 21.2% of Ciprofloxacin (7/33), 14.3% of Enalapril (1/7), 44.4% of Flucloxacillin (4/9), and 35.7% of sulfadoxine/ pyrimethamine (10/28). Medicine quality was associated with therapeutic medicine class, stated origin of manufacturer, primary packaging material and geographical location. Antimalarial and antidiabetic medicines were of better quality as compared to antibiotics, odds ratio OR 4.2 (95% CI 1.7-9.49), p < 0.002 and OR 5.6 (95% CI 1.21-26.09), p < 0.028 respectively. In terms of stated country of origin, the prevalence of SF medicines was 30% (15/50), 33% (9/27), 26.7% (4/15) and 6.6% (8/122) for medicines stated to be manufactured in Malawi, China, Kenya and India respectively. This study presents the first findings on the assessment of quality of medicines since the establishment of the national pharmacovigilance center in 2019 in Malawi. It is revealed that the problem of SF medicines is not improving and hence the need for further strengthening of quality assurance systems in Malawi.

ALTERING LANDSCAPES IN THE PHARMA WORLD AN ANALYSIS OF THE PANDEMIC-INDUCED CHANGES IN THE PHARMACEUTICAL INDUSTRY, ALONG WITH A CASE STUDY ON THE GROWTH TRENDS OF 'CIPLA' - A LEADING INDIAN-BASED MULTINATIONAL PHARMA BRAND

Interning at the marketing team of Emcure Pharmaceuticals Ltd. Pune, India, in June 2022, I researched on changing trends in the global pharma sector due to the ongoing pandemic. While individual pharma rms navigated several of these amendments, some alterations were steered industry-wide and exterior aspects, including public and government involvement, also inuenced the shaping of the new normal healing situation, which are discussed here. Further, this white paper analyzes the current and future trends of the Indian pharmaceutical world including - the market value of the sector, pharma exports and imports from which nations, the advantages faced by this industry and the investments in research and development within this sector as a percentage of pharmaceutical sales. This report talks about the establishment of Cipla; the brand's core values; its robust progress in India as well as in its prime international markets of North America and South Africa in terms of - branded prescriptions, trade generics and consumer wellness, digital leap and revenue enhancement. It concludes with information on the pandemic-centric new operating models leapfrogging the pharma world, the fresh technological skills adopted by the industry to enhance future growth and the rethinking of strategies for progress.

An open-source smartphone app for the quantitative evaluation of thin-layer chromatographic analyses in medicine quality screening

Substandard and falsified medicines present a serious threat to public health. Simple, low-cost screening tools are important in the identification of such products in low- and middle-income countries. In the present study, a smartphone-based imaging software was developed for the quantification of thin-layer chromatographic (TLC) analyses. A performance evaluation of this tool in the TLC analysis of 14 active pharmaceutical ingredients according to the procedures of the Global Pharma Health Fund (GPHF) Minilab was carried out, following international guidelines and assessing accuracy, repeatability, intermediate precision, specificity, linearity, range and robustness of the method. Relative standard deviations of 2.79% and 4.46% between individual measurements were observed in the assessments of repeatability and intermediate precision, respectively. Small deliberate variations of the conditions hardly affected the results. A locally producible wooden box was designed which ensures TLC photography under standardized conditions and shielding from ambient light. Photography and image analysis were carried out with a low-cost Android-based smartphone. The app allows to share TLC photos and quantification results using messaging apps, e-mail, cable or Bluetooth connections, or to upload them to a cloud. The app is available free of charge as General Public License (GPL) open-source software, and interested individuals or organizations are welcome to use and/or to further improve this software.

Surveillance for substandard and falsified medicines by local faith-based organizations in 13 low- and middle-income countries using the GPHF Minilab

This study evaluates the use of the Global Pharma Health Fund (GPHF) Minilab for medicine quality screening by 16 faith-based drug supply organizations located in 13 low- and middle-income countries. The study period included the year before the COVID-19 pandemic (2019) and the first year of the pandemic (2020). In total 1,919 medicine samples were screened using the GPHF Minilab, and samples showing serious quality deficiencies were subjected to compendial analysis in fully equipped laboratories. Thirty-four (1.8%) of the samples were found not to contain the declared active pharmaceutical ingredient (API), or less than 50% of the declared API, or undeclared APIs, and probably represented falsified products. Fifty-four (2.8%) of the samples were reported as substandard, although the true number of substandard medicines may have been higher due to the limited sensitivity of the GPHF Minilab. The number of probably falsified products increased during the COVID-19 pandemic, especially due to falsified preparations of chloroquine; chloroquine had been incorrectly advocated as treatment for COVID-19. The reports from this project resulted in four international WHO Medical Product Alerts and several national alerts. Within this project, the costs for GPHF Minilab analysis resulted as 25.85 € per sample. Medicine quality screening with the GPHF Minilab is a cost-effective way to contribute to the global surveillance for substandard and falsified medical products.

Quality of selected anti-retroviral medicines: Tanzania Mainland market as a case study

BackgroundAntiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.MethodsThis was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review.ResultsA total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements.ConclusionsThe quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.

Poor-Quality Medicines in Cameroon: A Critical Review.

Poor-quality medicines are the cause of many public health and socioeconomic problems. We conducted a review to acquire an overview of the situation concerning such medicines in Cameroon. Different searches were performed on databases from several websites of the WHO, the Ministry of Public Health of Cameroon, the Anti-Counterfeit Medicine Research Institute, the Global Pharma Health Fund, and the Infectious Disease Data Observatory. We identified 92 publications comprised of 19 peer-reviewed studies and 73 alerts. Based on studies completed, 1,664 samples were analyzed, and the prevalence of substandard and falsified (SF) medicines could be estimated for 1,440 samples. A total of 67.5% of these samples were collected from the informal sector, 20.9% from the formal sector, and 11.6% from both sectors. We found a prevalence of SF medicines across the peer-reviewed studies of 26.9%, whereas most of the SF medicines belonged to the anti-infective class. The problem of SF medicines is not studied sufficiently in Cameroon; therefore, efforts should be made to conduct adequate studies in terms of representativity and methodology.

Evaluation of the Impact of Minimal Residual Disease, FLT3 Allelic Ratio, and FLT3 Mutation Status on Overall Survival in FLT3 Mutation-Positive Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) in the Chrysalis Phase 1/2 Study

Evaluation of the Impact of Minimal Residual Disease, FLT3 Allelic Ratio, and FLT3 Mutation Status on Overall Survival in FLT3 Mutation-Positive Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) in the Chrysalis Phase 1/2 Study

Comparative Assessment of FLT3 Variant Allele Frequency By Capillary Electrophoresis and Next-Generation Sequencing in FLT3mut+ patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Who Received Gilteritinib Therapy

Comparative Assessment of FLT3 Variant Allele Frequency By Capillary Electrophoresis and Next-Generation Sequencing in FLT3mut+ patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Who Received Gilteritinib Therapy

Indian Pharmaceutical Industries Current Status and Togetherness to Overcome Speed Breakers in Term of Quality Issues to make India as a Global Pharma Destination

Regulatory is the heart of the pharmaceutical industries which acts as an interface between the industries and government authorities for the growth and development of the pharmaceutical industry of any country. In 2017, India was a pharmaceutical country valued at USD(United States Dollar)13 billion and accounting for 20 percent of worldwide exports, making the country the main supplier of generic drugs worldwide. Ministry of chemicals and fertilizers, and the Department of Pharmaceutical Products said that the national pharmaceutical market&amp;#039;s gross revenue reached approximately US $ 18.12 billion in 2018 (Rs 129,015), growing 9.4% year-on-year and export retention in 2018 was US $ 17.88 billion and 19.14 billion US$ in 2019.The Union Ministry of Health and Family Welfare has increased by 13.1 percent to Rs 61,398 crore (US $ 8.98 billion) in the Union Budget 2019-20.The Indian pharmaceutical market is facing many difficulties such as central and state regulatory compliance, data integrity, ethics committee in clinical trials, governmental control over the price of medicine, lack of research and so on. We are discussing in our article top 10 pharmaceutical companies in business, their turnover in 2020 and challenge in today&amp;#039;s era. We discuss future plans and solutions to problems, so that they can be ranked first in the world.