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Applied Drug Research, Clinical Trials and Regulatory Affairs - Online First
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Impact of Contract Research Organizations on Pharmaceutical Industries: A Review
Authors: Neeta Solanki, Jaya Verma, Satyender Kumar, Seema, Jyoti Mundlia, Rajesh Saini and Sapna SainiAvailable online: 10 December 2024More LessContract Research Organizations are bodies that offer research and development services on a contract basis to the pharmaceutical, biotechnology, medical device, and other industries. These organizations offer a wide range of services to support the drug discovery, development, and commercialization process. Initially, CROs begin with clinical trial management facilities and assisting sponsors with clinical study design, whereas laboratory CROs provide drug discovery, manufacturing, and bioanalytical services, including site feasibility. Their services mainly cover pharmaceutical and biotechnology industry based work such as drug development, pharmaceutical product development, clinical and preclinical trials, analytical method developments, pharmacovigilance, medical writing, etc. India presents itself as a wonderful platform for CROs attributing to its huge population, varied disease conditions, accessible human resources, large number of hospitals and low treatment cost. In the clinical trial process, CROs are engaged by the sponsor to accomplish a number of duties, taking into account various administrative and technical responsibilities on behalf of the sponsor. The current manuscript highlights the globalization of clinical trials, the concept of CRO, roles and responsibilities, functions of CROs, regulatory infrastructure of CRO, criteria for selection of suitable CRO, Indian CRO market and impact of Covid-19 pandemic on it.
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Compliance with Regulatory Standards: A Comprehensive Review on Ocimum sanctum (Tulsi)
Authors: Sanyam Sharma, Subh Naman, Jayesh Dwivedi, Mahendra Singh Ashawat, Arun Chandan and Ashish BaldiAvailable online: 06 November 2024More LessIn response to the surging global demand for medicinal products, the herbal industry faces significant challenges in ensuring the quality of herbal formulations. Regulatory bodies, actively set wanted acceptance limits to different parameters and tries to uphold quality standards. However, the complexities of herbal manufacturing, characterized by batch-to-batch variations and heavy metal residues, pose formidable obstacles. This article also focuses on Ocimum sanctum as a model plant, revealing its cultural, medicinal, ecological, and economic significance in brief. The primary objective of this work is to consolidate diverse quality standards prescribed by different regulatory agencies and to create an empowering resource for farmers to adhere to regulatory parameters for cultivating quality produce. The research employs detailed evaluations, covering macroscopic, microscopic, physicochemical, and toxicity assessments to address the challenges encountered by stakeholders in herbal sector. The study emphasizes the in depth research of verify regulatory standards set by entities such as the Indian Pharmacopoeia, Ayurvedic Indian Pharmacopoeia, Food Safety and Standards Authority of India and World Health Organization to ensure the quality and safety of medicinal products. It underscores the difficulties in maintaining consistent quality with herbal products, including batch variations and exceeding permissible limits of contaminants etc. Despite regulatory efforts, the scattered nature of data necessitates assimilation for effective quality control. Focused on the model plant Ocimum sanctum, the research highlights the imperatives for farmers to adhere to regulatory parameters from inception of cultivation. Additionally, it seeks to consolidate information aiming to bridge the knowledge gap and empower farmers for quality cultivation. In conclusion, the research emphasizes collaborative efforts among regulatory bodies, scientific research, and the agricultural sector to sustain consistent quality standards in the herbal industry and present a comprehensive compilation of quality standards of Ocimum sanctum as a model herb for further commercial exploration in simplified manner.
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Navigating Biosimilar Regulatory Pathways in Emerging Markets: 
Insights from Brics Nations
Authors: Niraj Patil, Animesh Ranjan, Gaurav, Debanjan Mukherjee, Brajesh Kumar Panda, Diksha, Komal, Raj Kumar Narang and Amandeep SinghAvailable online: 06 November 2024More LessThis comprehensive review delves into the intricate landscape of biosimilars, offering a nuanced exploration of their background, pivotal role in emerging markets like BRICS, and the multifaceted considerations spanning regulatory, quality, manufacturing, pricing, reimbursement, intellectual property, pharmacovigilance, and future trends. The backdrop on biosimilars unravels their significance as a transformative force in healthcare, providing cost-effective alternatives to biologics. The focus then shifts to the emerging markets encapsulated by BRICS, where economic and healthcare landscapes are pivotal determinants in shaping the biosimilar ecosystem. Navigating the regulatory landscape becomes imperative for biosimilar developers, and an overview of regulatory agencies within BRICS underscores the need for harmonized guidelines. Delving deeper, the paper outlines the intricate registration requirements, providing insights into key considerations pivotal for successful biosimilar submissions. Quality, manufacturing, and marketing of biosimilars form a critical triad. Quality attributes and similarity assessments, coupled with analytical methods and characterization, emerge as focal points ensuring the safety and efficacy of these biologic counterparts. Pricing, reimbursement, and market access, the linchpin for successful biosimilar integration, are dissected comprehensively. Pricing policies and strategies, reimbursement considerations, and the plethora of challenges and opportunities associated with market access are examined, offering a holistic understanding of the economic dynamics at play. The intellectual property landscape, delineated through patent regulations, data exclusivity, challenges, and litigation, adds a layer of complexity to biosimilar development and market entry. Pharmacovigilance and post-marketing surveillance emerge as crucial pillars ensuring the ongoing safety of biosimilars. Safety monitoring, risk management plans, and post-marketing surveillance requirements are essential components in this ever-evolving field. The exploration culminates in case studies and market insights, providing tangible examples of successful biosimilar submissions and approvals within the BRICS nations. This segment unveils the current market dynamics, competitive landscapes, and the intricacies of navigating these diverse markets. Looking forward, the paper outlines potential growth prospects and anticipates future trends and opportunities in the biosimilar landscape. It concludes by addressing the evolving policy and regulatory developments, offering stakeholders a comprehensive guide for navigating the dynamic and promising future of biosimilars within the BRICS nations. This work serves as a vital resource for industry professionals, policymakers, and researchers involved in the intricate journey of biosimilar development and market access.
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Assessment and Monitoring of Adverse Drug Reactions at a Tertiary Care Hospital
Authors: Manvi Sharma, Prince P. George, Ranjeet Kumar, Amit Sharma and Rojin G. RajAvailable online: 07 October 2024More LessBackgroundIncidences of adverse drug reactions were reported through spontaneous reporting at an ADR monitoring unit in a tertiary care hospital.
AimsThis study was conducted to describe the distribution pattern of adverse drug reaction (ADR).
ObjectiveThe objective of this study was to monitor and report the adverse drug reactions (ADRs) occurring in a tertiary care hospital and to evaluate the incidence, causality, severity, and preventability of adverse drug reactions.
MethodsA prospective, observational study was conducted at a tertiary care hospital in Punjab for 6 months. All patients admitted to the hospital above 18 years of age were included in the study.
ResultsA total of 103 ADRs were observed over the study period of 6 months. The majority of them were females (60), comprising of 58.25%. The therapeutic class of drug associated with most of the ADRs was antibiotics 18 (17.5%). Maximum number of ADRs occurred in the general medicine ward with frequency of 27 (26.2%) and were of type b 58 (56.3%). Causality was assessed using the Naranjo scale, and most of the ADRs came out to be probable 64 (62.1%) in nature. Severity was assessed using Hartwig’s severity assessment scale, and most of the cases, 66 (64.1%), were moderate in intensity. ADR preventability was assessed using the Schumock and Thornton preventability scale, and it was observed that most of the cases, 82 (79.6%), were not preventable.
ConclusionThis study seeks to strengthen the ADR database through analysis of spontaneous reporting patterns of ADRs from various clinical departments of a tertiary care teaching hospital, thereby increasing awareness and improving the reporting culture among health care practitioners. It can be concluded that continuous medication monitoring and a well-organized and committed pharmacovigilance system led by a clinical pharmacist in a hospital setting would undoubtedly lower the incidence of adverse drug reactions.
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