Pharmacovigilance (PV) has emerged as an essential component of healthcare systems, aimed at identifying, evaluating, and preventing risks associated with medicines. With the rising complexity of therapeutics and the increasing burden of adverse drug reactions (ADRs), PV ensures that the benefits of drugs outweigh potential harms. This review presents an overview of the historical development of pharmacovigilance, the significance of ADR monitoring, and the functioning of global and national PV systems, including the World Health Organization’s International Drug Monitoring Programme (IDMP) and the Pharmacovigilance Programme of India (PvPI). The review further explores drug and disease classification systems, vaccine safety surveillance, methodologies for safety data generation, and the role of pharmacogenomics in predicting ADRs. Special focus is given to vulnerable populations such as children, pregnant women, and the elderly. Challenges of underreporting, the need for effective communication strategies, and the integration of digital tools and artificial intelligence are also discussed. By highlighting current practices and future directions, this paper emphasizes the importance of strengthening PV systems for global drug safety and patient well-being.

Nanostructured Lipid Carriers (NLCs) are very potential formulations for topical delivery of anti-inflammatory and anti-arthritic drugs. In the present study NLCs containing methotrexate and acelofenac were formulated for treatment efficiency in arthritis. The evaluation of different formulation parameters based on variation of solid lipid – liquid lipid ratio (SL: LL), Drug – lipid ratio (D:L), type of liquid lipid (LL), surfactant concentration was carried out. The NLCs were prepared by microemulsion technique method with fixed amount of methotrexate (100mg) using cetyl Alcohol, compritol 888 ATO and clyceryl monostearate. Optimization of process variables was carried out using Taguchi design. The particle size of the optimized batch for methotrexate (NLCMop) and aceclofenac (NLCAop) was found to be 136.2 nm and 145.3 nm, zeta potential -25.0 and -24.4 with drug entrapment of 89.47 ± 6.8 % and 77.46 ±0.76% respectively. Permeation rate and controlled release property of drugs loaded NLCs was studied through egg membrane and was found to be 89.038 ± 2.63% and 82.7±1.34 after 24 hrs. Stability study of the optimized formulation (NLCMop) and (NLCAop) showed that the formulation was more stable at 5 ± 1⁰C than room temperature. These results suggested that NLC based formulations can be potential for topical delivery of methotrexate and aceclofenac for the management of arthritis.

Background: Drug resistance persists in certain patients with epilepsy, despite the fact that it has long been regarded as one of the most common nervous system disorders. Centella asiatica has been used to treat epilepsy in traditional medicine. The antiepileptic efficacy of Centella asiatica was studied in a pentylenetetrazole (PTZ)-induced epilepsy model in order to develop an antiepileptic medication with minimal side effects. Methods: For the purpose of eliminating the gender component, 48 lab-bred female mice were divided into 6 equal groups for this experimental study. The experimental groups included control, standard, and four treatment groups that received the extract 30 minutes prior to PTZ injection at doses of 50, 100, 150, and 200 mg/kg (intraperitoneally). The frequency of epileptic symptoms and their contributing factors were also examined. Result: The mice in the 50 mg/kg dosing group showed the highest incidence of epileptic attacks, according to the results of utilising various doses of the extract. Myoclonic twitches were more common in samples that received the extract at doses of 50 and 200 mg/kg, respectively. The group that received a dose of 200 mg/kg experienced an increase in epileptic symptoms, a decrease in epilepsy frequency, and a drop in the death rate (p<0.05). Conclusion: Based on the results, a 200 mg/kg dose of Centella asiatica extract may be suggested as a medication that effectively prevents epilepsy in the animal model.

Traditional teacher-centered approaches to medical education are giving way to student-centered ones. By empowering students to take charge of their own education, self-directed learning (SDL) may improve long-term memory retention, critical thinking, and problem-solving skills. The purpose of this study was to assess how well undergraduate medical students learnt biochemistry through self-directed learning as opposed to traditional lecture-based instruction. The purpose of this study is to examine how well self-directed learning (SDL) and conventional lecture-based learning (LBL) enhance students’ knowledge, comprehension, and involvement in biochemistry. Methods: First-year MBBS students in the Department of Biochemistry participated in an experimental study. Batch A & Batch B were the two groups into which the participants were split. The subjects taught to both groups were the same. Validated multiple-choice and short-answer questions were used in the pre-test and post-test evaluations. A standardised feedback questionnaire was used to gather the opinions of the students. Results: Post-test scores significantly improved for both groups (p < 0.05). In contrast to the lecture group, the self-directed learning group experienced a greater mean increase in knowledge. The SDL group’s students reported increased motivation, stronger teamwork and communication abilities, and higher conceptual understanding. Conclusion: self-directed learning is a useful addition to conventional lectures in the teaching of medical biochemistry. It encourages students to actively participate, develop lifetime learning habits, and gain a deeper knowledge. A more well-rounded and productive learning environment can be produced in medical education by combining SDL techniques with lectures.

Background: During tonsillectomy, post-operative nausea and vomiting (PONV) is common and can lead to patient misery, a delayed recovery, and unscheduled hospital stays. At sub-hypnotic dosages, the intravenous anaesthesia propofol is said to have inherent antiemetic qualities. The effectiveness of a low-dose propofol bolus given at the conclusion of tonsillectomy in preventing PONV was assessed in this prospective research. Methods: Two groups of one hundred adult ASA I–II patients undergoing elective tonsillectomy under general anaesthesia were randomly assigned. At skin closure, Group P (n = 50) got 10 mg of propofol intravenously, while Group C (n = 50) received regular saline. Analgesia and anaesthesia were standardised. The incidence of PONV within 24 hours was the primary outcome; the severity of nausea, the usage of rescue antiemetics, and the time to first oral intake were the secondary outcomes. χ² and t tests were utilised in statistical analysis. χ² and t tests with p < 0.05 have been used in statistical analysis. Result: PONV affected 12% of participants in Group P and 34% in Group C (p = 0.009). The average nausea scores were lower (p = 0.03; 3.1 ± 1.0 vs. 5.2 ± 1.3). The need for rescue antiemetic was lower (8% vs. 28%; p = 0.01). The average time to oral intake was lower (5.2 ± 1.4 hours compared to 6.7 ± 1.8 hours; p < 0.001). Respiratory depression or sedation did not occur. Conclusions: The incidence and severity of PONV after tonsillectomy were considerably decreased by a 10 mg propofol bolus at skin closure. For PONV prevention, propofol is an easy, safe, and economical supplement.

Plasmid DNA is important for producing advanced therapy medicinal products (ATMPs) such as gene therapies, viral vectors, mRNA vaccines and engineered cellular therapies. Global demand has increased clinical and commercial manufacturing requirements for scalable, high-quality and regulatory-compliant pDNA manufacture. This review focuses on current pDNA manufacture strategies by evaluating upstream (host strain engineering, copy number optimization and high cell density fermentation) and downstream (alkaline lysis, chromatographic purification, and ultrafiltration/diafiltration) systems. It also discusses regulatory expectations from the FDA, EMA and ICH, particularly concerning process qualification, comparability, and lifecycle. There are challenges to ensuring pDNA is scalable, retains the desired topology and is free from impurities, which need resolution. In addition, novel manufacturing processes such as continuous processing, single-use technologies, cell-free DNA synthesis and artificial intelligence process monitoring may positively impact pDNA manufacture efficiency and quality. Collectively, these advances will help to shape the future of plasmid DNA biomanufacturing while providing ongoing support and facilitating the continued development of advanced therapeutic products.

Background: Newborn sepsis is still considered one of the important causes of morbidity and mortality among infants all around the world. As resistance develops to antibiotics and etiological agents vary with different clinical situations, it is now increasingly difficult to manage neonatal sepsis. Thus, knowledge about microbial flora and antibiotic susceptibility within a particular geographical area has become increasingly important. Aim: To investigate the cause of sepsis in the microorganisms present in the neonates admitted at the tertiary care hospital. Methodology: Hospital Level Observational Cross Sectional Study was conducted for one year in 120 babies with clinically confirmed sepsis admitted in NICU of Himalaya Medical College & Hospital, Paliganj, Patna, and Bihar, India. Blood samples from infants suffering from sepsis were subjected to culture and identification by traditional microbial methods. Isolated bacteria the sensitivity test was conducted using the Kirby-Bauer disc diffusion technique. All the data collected was subjected to statistical analysis through SPSS version 25.0. Results: A total of 40.0% (48/120) had positive blood cultures. The most commonly identified pathogens included K. pneumoniae which made up 31.3% of the isolates, S. aureus (25.0%), and E. coli (16.7%). Gram negative bacilli were the most common group of pathogens, constituting 62.5% of all isolates. Microorganisms showed high sensitivity to meropenem and piperacillin-tazobactam, but were highly resistant to ampicillin. Neonates that were preterm showed significantly more positive cultures than neonates that were not (56.5% vs. 29.7%; p = 0.008). Conclusion: Main bacteria that caused sepsis in babies were mainly Gram-negative organisms, and Klebsiella Pneumonia was the commonest. Continuous surveillance for these organisms is therefore important. It is equally crucial to prevent sepsis among babies through proper antibiotic use.

Background: Lymphadenopathy is among the diseases which are frequently seen due to many causative factors like infection, inflammation, reaction, and malignancy. Pathology of the disease remains the most reliable way of diagnosis of such diseases and differentiates whether the lesion is benign or malignant. Differential diagnosis of the lesions in lymph nodes gains importance. Aim: To retrospectively evaluate the demographic profile, histopathological spectrum, microscopic findings, and clinical management patterns of lymph node biopsies. Methodology: The present retrospective observational study was conducted on 180 patients’ cases who were biopsied at Department of Pathology, Gouri Devi Institute of Medical Sciences & Hospital, Durgapur, West Bengal, India during the period of 1 year. The statistical analysis for demographic characters, site of lymph node involvement, histological diagnosis, special stains, treatment modalities were done with SPSS 27.0. Results: The majority of the patients belonged to the age category of 21-40 years, accounting for 40.0%. Majority of the patients (56.7%) were males. Cervical lymph nodes were the most frequently seen organ in the patients and were seen in 55.6% of the patients. Reactive lymphadenitis, tuberculous lymphadenitis, metastasis, non-Hodgkin lymphoma, and Hodgkin lymphoma accounted for 35.0%, 25.0%, 20.0%, 10.0%, and 5.0%, respectively. Granuloma was seen in 27.8% of the patients, and caseous necrosis was seen in 22.2% of the patients. Ziehl-Neelsen stain was present in 16.7%, metastasis was present in 20.0%, and effacement was seen in 15.0% of the patients. Benign diseases underwent treatment through follow up and anti-tubercular therapy in 65.0% of the patients. Conclusion: Reactive and tubercular lymphadenitis represented the common types of lymphadenitis encountered among patients. Histopathology will continue to be a vital part of the diagnosis of lymphadenopathy because histopathology is one of the most effective means of diagnosing and treating patients.