Tripura Medical College & Dr. B.R. Ambedkar Memorial Teaching Hospital

Background: Burn injuries continue to be a major public health concern and an important cause of unnatural deaths worldwide. Fatal burn cases frequently pose diagnostic and medicolegal challenges regarding determination of cause, manner, and timing of injuries. Clinicopathological correlation through autopsy examination provides valuable insights into burn pathology, mechanisms of death, and forensic interpretation. Objectives: To study the demographic profile, clinicopathological features, autopsy findings, causes of death, and medicolegal aspects of fatal burn cases. Materials and Methods: A prospective autopsy-based observational study was conducted on 150 consecutive fatal burn cases brought for medicolegal autopsy to the Department of Forensic Medicine of a tertiary care teaching hospital over a period of two years. Detailed information regarding age, sex, marital status, manner of death, total body surface area (TBSA) involvement, survival period, treatment history, clinical complications, and autopsy findings was collected. Histopathological examination of skin and internal organs was performed in selected cases. Data were analyzed using SPSS version 25.0. Chi-square test was used for statistical analysis and p <0.05 was considered significant. Results: The majority of victims belonged to the age group of 21–40 years (50.0%). Females constituted 62.0% of cases. Flame burns accounted for 86.0% of cases. Accidental burns were observed in 68.7%, suicidal burns in 24.0%, and homicidal burns in 7.3% cases. Septicemia (38.0%) was the most common immediate cause of death followed by shock (26.0%) and multiorgan dysfunction syndrome (14.7%). Mortality increased significantly with increasing TBSA involvement (p<0.001). Histopathological examination revealed coagulative necrosis, inflammatory infiltration, vascular congestion, edema, and granulation tissue formation. Conclusion: Fatal burn injuries predominantly affect young females and are commonly accidental in nature. Autopsy and histopathological examination provide crucial evidence regarding burn vitality, cause of death, and medicolegal interpretation. Comprehensive evaluation of burn deaths is essential for accurate forensic conclusions and administration of justice.

Background Ethical competence is a core component of professional practice in medical training and is central to the Attitude, Ethics, and Communication (AETCOM) framework under Competency-Based Medical Education (CBME) in India. Entrustable Professional Activities (EPAs) offer a structured approach to assessing clinical and ethical readiness during internship. However, evidence on the alignment between ethical competence and EPA-based entrustment among MBBS interns remains limited. Methods A cross-sectional mixed-methods study was conducted among 100 MBBS interns at a tertiary care teaching hospital. Interns completed a validated self-assessment questionnaire on ethical competence, while faculty independently rated interns’ entrustment levels using EPA-based tools. Quantitative data were analyzed using descriptive statistics and multivariable logistic regression. Qualitative data from open-ended responses were analyzed using thematic analysis following the Braun and Clarke framework. Integration of findings was achieved through joint display analysis. Results Seventy percent of interns demonstrated satisfactory entrustment (EPA ≥ 3). Interns with higher self-assessed scores, prior ethics training, and longer internship duration were significantly more likely to achieve EPA ≥ 3 (p < 0.05). Self-assessment scores were consistently higher than faculty ratings (p < 0.001). Qualitative analysis identified system-related constraints, hierarchical barriers, role ambiguity, and the need for structured ethics training as key themes influencing ethical practice. Integration of findings revealed that contextual and organizational factors were strongly associated with lower entrustment levels. Conclusion Ethical competence among interns is influenced by individual preparedness and systemic factors. EPA-based assessment provides a meaningful framework for evaluating ethical readiness. Strengthening structured ethics training may enhance ethical entrustment and professionalism.

Background: Accurate estimation of wound age is one of the most challenging aspects of forensic pathology. Conventional histopathological methods provide only approximate estimates, particularly during the early posttraumatic period. Inflammatory cytokines such as Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), and Interleukin-1β (IL-1β) have emerged as promising biomarkers for wound age estimation owing to their predictable temporal expression during wound healing. Aim: To evaluate the utility of inflammatory markers IL-6, TNF-α, and IL-1β in determining wound age through histopathological and immunohistochemical examination. Materials and Methods: A prospective clinicopathological study was conducted on 100 skin wound specimens obtained during medicolegal autopsies. Cases with known survival intervals were categorized into five groups according to wound age. Routine hematoxylin-eosin staining and immunohistochemical analysis for IL-6, TNFα, and IL-1β were performed. Expression intensity was assessed semi-quantitatively and correlated with known wound age. Results: A progressive increase in expression of IL-6 and TNF-α was observed with increasing wound age. IL-6 demonstrated the highest diagnostic accuracy with sensitivity of 88.4% and specificity of 81.6%. TNF-α showed sensitivity of 84.2% and specificity of 76.3%. IL-1β exhibited variable expression and lower predictive value. Significant positive correlations were found between cytokine expression and wound age (p<0.001). Conclusion: IL-6 and TNF-α are reliable inflammatory biomarkers for wound age estimation, especially during the early post-traumatic interval. Combining immunohistochemical markers with routine histopathology enhances the accuracy of forensic wound dating.

Background & Aim While guidelines for environmental monitoring (EM) programs in cGMP facilities exist, they often fail to address the unique requirements of CGT production or offer practical insights for academic settings particularly in LMICs. For academic centers like CAR T & Cell Therapy Centre (CTCTC), Tata Memorial Centre (TMC), India, this role is vital due to challenges such as limited resources & patient-specific manufacturing needs. At CTCTC, four years of EM data were analyzed to evaluate the program's effectiveness in maintaining controlled conditions for manufacturing ATMPs. Methodology The CTCTC facility was meticulously designed in compliance with ISO 14644 standards, FACT & US FDA. The facility is reviewed by national regulatory authorities and annually certified by third-party vendors for processing both minimally & more-than-minimally manipulated products.The EM program at CTCTC was developed in alignment with ISO, US FDA, USP, & national guidelines, tailored to meet the unique requirements of Phase 1 and Phase 2 studies. Results The EM program at CTCTC monitors cleanroom operations, contamination control, and product purity through non-viable particulates, viable microbial counts, and environmental conditions. Over 48 months, data showed higher particle counts during in-process EM than at-rest, reflecting active manufacturing's impact. However, ISO 7 and ISO 8 zones consistently met permissible limits, confirming the program's effectiveness.Deviations in air sampling were addressed with corrective actions like operator training and facility decontamination, demonstrating adaptability. Non-routine sampling identified high-risk zones in unclassified areas, enabling proactive contamination control.Manufacturing employs open culture systems in biosafety cabinets and semi-automated systems (Sepax, Clinimax Plus). Production timelines ranged from 1–6 weeks. Data from 2020–2024 indicated stable or decreasing trends in particulates & microbial contamination, validating the program's reliability. Non-routine sampling is crucial for identifying contamination risks, while increased in-process EM & advanced monitoring improved precision and compliance. Conclusion In conclusion, the EM program at CTCTC has been vital in maintaining a compliant ATMP manufacturing environment, serving as a model for academic GMP facilities.Since reports on EM program implementation & impact in academic CGT facilities in India and LMICs are scarce, this study underscores its significance for institutions in these regions.

Background & Aim The transition toward 3D in vitro models as alternatives to animal testing is reshaping regulatory frameworks globally. These technologies align with the 3Rs principles—Replacement, Reduction & Refinement—providing ethical, cost-effective solutions. While North America & Europe have made significant strides, LMICs & parts of Asia lag in adopting these methods. This abstract explores the adoption of 3Rs, focusing on CGT pathways. It examines advancements in North America & Europe, identifies gaps in LMICs & Asia and underscores the importance of implementing 3D in vitro models to reduce costs, improve translational relevance & harmonize global regulatory compliance. Methodology The FDA Modernization Act 2.0 (2022) United States introduced non-animal methods for drug & biologic testing with a 2023 update eliminating mandatory animal testing for new drugs. Similarly, the EMA has advanced 3Rs-aligned guidelines since 2016. Progress in Asia has been uneven. South Korea's revised Cosmetic Act imposes strict limits on animal testing for cosmetics, aiming to promote alternative methods. However, many countries in Asia lack formal guidelines or legislation encouraging the replacement of animal models in CGT. This lack of harmonized standards creates barriers to global consensus & underscores the need for regional advocacy.Japan has made progress in adopting alternative testing methods, especially in cosmetics and pharmaceuticals but faces challenges in fully integrating 3Rs principles, with a 2023 conceptual paper aligning regulatory expectations with in vitro and computational advancements to reduce animal use while ensuring safety and efficacy. Results Modern technologies like 3D bioprinting, organoids, and organ-on-chip systems are emerging as alternatives to animal models, offering improved physiological relevance and addressing ethical concerns. Disease-in-a-dish and organ-on-chip systems mimic human conditions, enhancing predictive accuracy and reducing preclinical failures. Regulatory requirements for non-genetically modified cell therapies present an opportunity to bypass animal testing with products like virus-specific T cells demonstrating how frameworks should evolve to accommodate human-relevant methodologies. Conclusion This abstract emphasizes the critical importance of prioritizing 3D in vitro model implementation in LMICs & Asia to drive cost-effective ethical & scientifically robust CGT pathways aligning with global efforts to redefine preclinical & clinical testing paradigms.