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Open research questions in Pharmaceutical Quality and Counterfeiting

70 unresolved questions extracted from the limitations and future-work sections of 356 Pharmaceutical Quality and Counterfeiting papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • The issue of substandard and falsified medical products is a complex problem that requires a comprehensive approach. The challenge of addressing the root causes of the problem, including institutionalised corruption and transnational illicit trade networks. The need for integrated strategies that strengthen public accountability and promote equitable access to quality-assured medicines.

    The Political Economy of Substandard and Falsified Medicines: A Theoretical Framework for Supply Chain Analysis in the Greater Horn of Africa · 2026 · DOI

  • The current literature lacks a fully integrated political economy perspective that explains the underlying mechanisms of the problem. Existing research often treats political economy factors as peripheral rather than central explanatory variables. The proposed framework aims to address this gap.

    The Political Economy of Substandard and Falsified Medicines: A Theoretical Framework for Supply Chain Analysis in the Greater Horn of Africa · 2026 · DOI

  • The presence of hidden prescription drugs in over-the-counter supplements is a concern. There is a need for awareness among nurses and patients about the potential risks associated with these supplements.

    More warnings about over-the-counter supplements containing hidden drugs · 2026 · DOI

  • The complexity of the EU REACH restriction and its implications for pharmaceutical supply chains. The need for pharmaceutical excipient suppliers to support medicinal product manufacturers in achieving regulatory compliance. The potential for the restriction to necessitate reformulation, with phase-in timelines that depend on product type.

    Microplastics matter: practical implications of the EU REACH restriction for the pharmaceutical industry · 2026 · DOI

  • Ensuring regulatory compliance and quality control in the development and manufacturing of oral solid dosage forms. Maintaining product consistency and ensuring patient safety during scale-up and commercial manufacturing. Balancing commercial factors such as packaging, labeling, and pricing with the need for product safety and efficacy.

    An Overview of Pharmaceutical Product Lifecycle of An Oral Solid Dosage Form · 2026 · DOI

  • Complexity and ambiguity of regulatory frameworks - Differences in regulatory requirements across jurisdictions - Need for compliance with regulatory requirements

    A COMPARATIVE STUDY OF REGULATORY REQUIREMENTS FOR DIETARY SUPPLEMENTS IN INDIA, THE UNITED STATES, AND THE EUROPEAN UNION · 2026 · DOI

  • To develop standardized and prospective metrics of outcomes to assess PV vendor management. To test the proposed model in different settings and contexts. To explore the application of the model in other areas of the pharmaceutical and biotechnology sector.

    Risk-Based Vendor Oversight: Governance in Global Pharmacovigilance · 2026 · DOI

  • The lack of standardized and prospective metrics of outcomes to assess PV vendor management. The need for a governance framework that incorporates regulatory expectations, quality risk management principles, and continuous intelligence-led assurance.

    Risk-Based Vendor Oversight: Governance in Global Pharmacovigilance · 2026 · DOI

  • The study did not conduct a formal qualitative study. The consultations were limited to five participants from the Government Pharmaceutical Organization and two provincial hospitals in Lamphun. The study relied on a non-systematic desk review of academic literature and official reports.

    Is AI-driven drug forecasting feasible in Thailand? · 2026 · DOI

  • Further research is needed to address the identified barriers and improve the pharmaceutical system in Thailand. Studies can explore the application of AI-driven forecasting in other low- and middle-income countries facing similar health-system and digital-readiness constraints. Research can also focus on developing and implementing integrated platforms that track medicines across procurement, delivery, use, and reimbursement under the UCS.

    Is AI-driven drug forecasting feasible in Thailand? · 2026 · DOI

  • The need for efficient mechanisms for innovation built on well-characterized clinical assets. The need for reformulation products that can improve patient compliance.

    Development Analysis and Strategic Insights from a 505(b)(2) Reformulation Product: Enzalutamide · 2026 · DOI

  • Pharmaceutical colonialism - Dependence on external sources of medicines - Limited access to effective and safe medicines

    Global pharmaceutical sector and ‘medicines security’ of nations in the ground of the sovereignty, security and postcolonial theories – economic and public policy perspective · 2026 · DOI

  • Communication gaps, - Fragmentation of information, - Medication-related problems

    European Society of Clinical Pharmacy: bridging gaps—clinical pharmacy in the digital transition of care · 2026 · DOI

  • The two-phase fine-tuning strategy for EfficientNet-B0 (Phase 1: frozen backbone, Phase 2: full network fine-tuning) was effective but lacks systematic ablation studies comparing alternative transfer learning approaches, different backbone architectures, or hybrid CNN-Vision Transformer models for pharmaceutical counterfeit detection.

    Recommendation Based AI Powered Medicine Expiry and Counterfeit Detection System · 2026 · DOI

  • Integration with hospital inventory management systems and CDSCO regulatory databases is mentioned as a future enhancement but lacks technical specifications for data synchronization, API standards, security protocols, and validation of the system's detection history tracking against official pharmaceutical regulatory records.

    Recommendation Based AI Powered Medicine Expiry and Counterfeit Detection System · 2026 · DOI

  • Future research will focus on conducting comparative analyses of the opportunities for implementing telephar- macy in Bulgaria in relation to other European Union Member States and countries worldwide to identify best practices and context-specific challenges. Additionally, further investigation is warranted into the role of telephar- macy as a reliable and evidence-based source of health in- formation for patients, potentially serving as a preferable alternative to general internet searches.

    Telepharmacy as an innovative concept for the delivery of pharmaceutical services in Bulgaria · 2026 · DOI

  • This narrative review has several limitations. First, the number of studies specifically addressing the applica- tion of telepharmacy in Bulgaria is limited, which may affect the depth of the analysis in the national context. Second, the restriction to English and Bulgarian lan- guage sources may have resulted in the exclusion of rel- evant studies published in other languages. Third, the time frame limited to publications from 2010 onwards may have excluded earlier studies that could provide valuable insights into the historical development of the field. Finally, as a narrative review, the study does not follow a fully systematic protocol, which may intro- duce a degree of selection bias and limit reproducibility compared to systematic reviews. Due to the narrative nature of the review, a formal risk- of-bias assessment was not performed; however, priority was given to high-quality peer-reviewed sources. A the- matic synthesis approach was applied to organize and in- terpret the findings. References were managed using Zotero. Grey literature sources, including policy documents and reports from international organizations, were also considered. As a narrative review, the study is subject to potential publication bias. No review protocol was regis- tered prior to conducting this narrative review.

    Telepharmacy as an innovative concept for the delivery of pharmaceutical services in Bulgaria · 2026 · DOI

  • The implementation of AI-enabled QA systems is hindered by regulatory barriers. The lack of standardized metadata and data integration creates challenges for AI-enabled QA systems. The processing of employee records and supplier information through AI systems creates potential privacy issues.

    STANDARDIZATION AND DATA INTEGRATION CHALLENGES IN AI-ENABLED PHARMACEUTICAL QUALITY ASSURANCE SYSTEMS: REGULATORY BARRIERS AND FUTURE DIRECTIONS · 2026 · DOI

  • Future research directions include the development of advanced regulatory frameworks and digital systems. Future research directions include the evaluation of the potential of AI and machine learning to enhance process efficiency and predictive analytics.

    STANDARDIZATION AND DATA INTEGRATION CHALLENGES IN AI-ENABLED PHARMACEUTICAL QUALITY ASSURANCE SYSTEMS: REGULATORY BARRIERS AND FUTURE DIRECTIONS · 2026 · DOI

  • The lack of clear status of marketplaces creates risks for consumer health. The lack of liability of aggregators for the quality of medicines is a problem.

    FEATURES OF REQUIREMENTS FOR THE CIRCULATION OF MEDICINES ON MARKETPLACES IN RUSSIA · 2026 · DOI

  • AND rural leaving To appreciate why e-pharmacies found such rapid acceptance in India, it is necessary to first understand the limitations of the traditional pharmacy infrastructure the country relied upon for decades. India's retail pharmacy network, though numerically large with nearly 900,000 licensed outlets, has historically suffered from multiple structural problems. First, geographical concentration has been severely skewed — the vast majority of pharmacies operate in urban centres, India underserved. According to a 2019 study, approximately 65% of India's population residing in rural areas has access to only 30% of the country's pharmacy outlets. [2] This means a significant segment of the population must travel considerable distances, sometimes more than 20 kilometres, to purchase prescribed medicines. Second, medication continuity for patients with chronic diseases such as diabetes, hypertension, and cardiovascular conditions has been a persistent challenge. Patients in smaller towns often face stockouts of specific branded or even generic medicines, and there is no seamless mechanism for prescription refill reminders or record-keeping at the consumer level. Third, and perhaps most critically, the standard of pharmacy practice at the retail level has been inconsistent. The Pharmacy Act of 1948 mandates that a registered pharmacist must be present at every licensed pharmacy at all times. In practice, this requirement is widely violated — many retail pharmacies are operated by individuals with minimal pharmaceutical training, disorders, thyroid INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES 2103 | P a g e Tooba Rizvi, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 5, 2102-2113 |Review interaction warnings, and increasing the risk of incorrect dispensing, missed inappropriate drug advice to patients. [3] Fourth, pricing transparency has been a long-standing consumer grievance. While the government regulates the prices of medicines under the National List of Essential Medicines through the Drug Price Control Order (DPCO), non-essential drugs carry no such price ceiling, are inconsistent and often opaque. These structural weaknesses created the conditions for a disruption. The emergence of e-pharmacies was not purely a technology story — it was, at its root, a response to genuine gaps in the traditional system. retail markup practices and THE GROWTH OF E-PHARMACIES IN INDIA: A PHASED ANALYSIS Phase 1: Foundation and Early Operations (2013–2016) (initially like 1mg as medicine The first wave of e-pharmacy activity in India was characterised by cautious entry and limited scope.

    Rise of E-Pharmacies in India: A Case Study on Growth, Operational Models, Regulatory Framework, and Future Prospects · 2026 · DOI

  • While the linkage between pharma- ceutical risk control and disciplinary supervision has been established, the long-term impact of this “technological anti-corruption” mecha- nism on physicians’ prescribing behaviors and their underlying psy- chological motivations remains unexplored through systematic qualitative or longitudinal analysis.

    The role of digital pharmaceutical governance in alleviating health inequality: a case study of the “Sanya Model” for centralized regional prescription review · 2026 · DOI

  • There is a gap in basic documentation practices, including incomplete batch manufacturing records and missing raw analytical data. There is a need for improved data integrity, including data traceability and compliance culture.

    ASSESING RELIABLE DATA COMPLIANCE IN INDIAN PHARMACEUTICALS MANUFACTURING FACILITIES –A Review · 2026 · DOI

  • There is a need to understand the marketing authorization procedures in different countries. The regulatory frameworks, clinical evaluations, and post-marketing surveillance involved in the procedures are not well understood.

    MARKETING AUTHORIZATION OF PHARMACEUTICALS IN UNITED STATES (US), EUROPEAN UNION (EU) AND INDIA · 2026 · DOI

  • The lack of a clear understanding of the implications of the EU REACH restriction on synthetic polymer microparticles for the pharmaceutical industry. The need for an operational decision-making framework to interpret the restriction for pharmaceutical excipients and drug-delivery systems.

    Microplastics matter: practical implications of the EU REACH restriction for the pharmaceutical industry · 2026 · DOI

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70 open questions have been extracted from the limitations and future-work passages of 356 Pharmaceutical Quality and Counterfeiting papers in our library. Each one below links back to the study that raised it, so you can read the original claim in context.

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