Abstract Background: Biologics play a pivotal role in the treatment of cancer, autoimmune disorders, and other rare diseases. In view of the high demand for affordable alternatives, the use of biosimilars has significantly increased in India. The need was felt to review the regulatory landscape of biologics and biosimilars in India. Objective: The objective of the study is to review and analyze outcomes of the review process of subject expert committee (SEC) meetings pertaining to approvals of biologics and biosimilars. Materials and Methods: A retrospective, descriptive study was conducted using publicly available minutes of SEC-Biologics division meetings (January 2022–December 2023). Data on the type of agenda items, type of sponsors, therapeutic areas, decisions (approval, recommendation, or rejection), and clinical trial (CT) waivers were extracted and analyzed. Chi-square test and odds ratios were used to determine associations. Results: A total of 137 s meetings discussed 388 items, of which 258 were related to CT and marketing applications. Biosimilars (53.9%) outnumbered biologics (46.1%). CTs made up 49.6% of agenda items, with oncology and COVID-19 as leading therapy areas. Submissions from Indian pharma sponsors were more compared to multinational companies. Overall, 65% of applications were approved, and 60% of CT waiver requests were granted. Reasons for rejections or recommendations included inadequate safety, immunogenicity, or efficacy data, particularly in the local population. Conclusion: The regulatory review process for biologics and biosimilars appears to be timely and consistent. A higher number of CT and trial waivers indicate a patient-centric facilitatory approach without compromising safety, as there is emphasis on submission of local CT data.

Abstract Background: Medical devices are crucial in health care; however, adverse events (AEs) require safety evaluation. Causality assessment determines the contribution of the device to AEs and guides decisions. India lacks a standardized scoring tool, leading to inconsistent interpretation. Aim: This study aimed to develop and validate a reliable causality assessment tool for AEs associated with medical devices. Materials and Methods: A nine-question structured scale was developed from a literature review to classify causality as certain, probable, possible, or unlikely. Validity was established through expert comparisons using the European Union Causality Assessment Scale. Sensitivity, specificity, and area under the curve (AUC) were calculated. Reliability testing occurred in two phases using 50 random Manufacturer and User Facility Device Experience database cases (2014–2024) assessed by six raters (physicians, biomedical engineers, and pharmacists). After 6 weeks, the same cases were reassessed. Reliability was determined using Cronbach’s alpha and intraclass correlation coefficient (ICC). Results: The ICC values for phases 1 and 2 were 0.324 and 0.399, respectively ( P < 0.001), indicating moderate agreement. Validity testing showed a sensitivity of 90.95%, specificity of 83.25%, and AUC of 0.8605, demonstrating strong accuracy in determining causality. The scale demonstrated high reliability (Cronbach’s alpha = 0.893). Conclusion: The validated causality assessment tool enhances consistency and reduces subjectivity among evaluators. It provides a reliable scoring system to support regulatory decisions, improve safety, and enable postmarket surveillance. This tool enables systematic assessment of device-related AEs across healthcare settings.

Abstract Background: Rising healthcare expenses are an alarming issue globally. Healthcare professionals have the opportunity to substitute generics instead of branded medicines to reduce the cost of medicines, hence the overall reduced cost of health care. Objective: To assess the knowledge, attitude, and practice of healthcare professionals in Indore district regarding generic medicines and examine demographic associations. Subjects and Methods: This questionnaire-based cross-sectional survey was conducted among 122 healthcare professionals using a prevalidated 30 questionnaire. Data were collected via Google Forms. Responses were analyzed descriptively and through Chi-square tests. Results: Most participants (91%) correctly defined generic medicines, 75.4% were aware of bioequivalence requirements, and 70.5% acknowledged therapeutic equivalence. While 54.9% felt that branded medicines. Awareness of the Medical Council Act (78.7%) and Jan Aushadhi scheme (88.5%) was high. Over 75% prescribed generic medicines, but 61.5% reported perceived differences in efficacy. Chi-square analysis showed significant associations between gender, age, facility type, and perception of safety, efficacy, and bioequivalence, while years of practice had no significant impact. Conclusion: Healthcare professional in Indore prescribe generics widely, but misconceptions about efficacy and quality persist. Targeted continuing medical education programs, stricter regulatory monitoring, and patient awareness initiatives may help strengthen confidence in generic prescribing.

Abstract The messenger RNA (mRNA) vaccines have revolutionized vaccine development by enabling faster production compared to traditional methods. Comprehensive regulatory requirements for mRNA vaccines are required to ensure uniform quality, safety, and efficacy in this rapidly growing technology. Globally accepted World Health Organization (WHO) guidelines provide broad, adaptable recommendations to all national regulatory authorities, whereas others, such as the European Medicines Agencies (EMA’s) draft guideline, provide European Union specific legally binding, highly detailed technical requirements such as impurity thresholds, validated functional testing, and strict stability protocols. The distinctions reflect WHO’s function as a worldwide standard-setter against EMA’s regional enforcement responsibilities. For India, as one of the world’s major vaccine producers and a significant supplier to numerous countries and UN agencies, relying exclusively on WHO’s generalized framework may be insufficient. India presents unique issues such as varying population needs, disease burdens, and cold chain infrastructure limits. Developing India-specific mRNA vaccination rules that are aligned with WHO and incorporate analytical detail from EMA would boost domestic innovation, facilitate global export acceptance, and assure swift, safe responses to future public health catastrophes.

Background:Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) pose significant global health challenges with high mortality risks. Adverse drug reactions (ADRs) further complicate treatment, impacting patient adherence and outcomes. In India, the DOTS strategy under the Revised National Tuberculosis Control Programme has been widely implemented, yet TB management is hindered by limited patient awareness, socioeconomic constraints, and gaps in healthcare provider training. This study assesses the incidence of ADRs and their impact on treatment outcomes at a tertiary care hospital in Delhi.Materials and Methods:A cross-sectional study was conducted using retrospective medical record reviews of MDR-TB and XDR-TB patients (aged ≥18 years) registered at a university hospital in Delhi from January 2017 to August 2021. Data on ADRs and treatment outcomes were extracted from outpatient records for analysis.Results:Of 213 enrolled patients, 183 were analyzed, with 72.6% experiencing at least one ADR. Males had a higher ADR incidence (58%) than females (42%). The most common ADRs were gastrointestinal disorders (21.8%), eye disorders (14.3%), and musculoskeletal disorders (14.3%), primarily linked to pyrazinamide, ethambutol, and ethionamide. Serious ADRs occurred in 17.4% of cases.Conclusion:Gastrointestinal disorders, particularly nausea and vomiting, emerged as the most commonly reported ADRs. These findings emphasize the importance of early identification of high-risk patients and the need for close monitoring throughout anti-TB treatment to support adherence and improve outcomes. This study adds valuable evidence to strengthen pharmacovigilance efforts and inform the optimization of MDR/XDR-TB treatment protocols within India’s public healthcare system.

Aim:The aim of this study was to evaluate the comparative efficacy and safety of fixed-dose combinations of amlodipine 5 mg + hydrochlorothiazide 12.5 mg (A+H) (Group 1), telmisartan 40 mg + hydrochlorothiazide 12.5 mg (T+H) (Group 2), and ramipril 5 mg + hydrochlorothiazide 12.5 mg (R+H) (Group 3) in patients of essential hypertension.Materials and Methods:A prospective, randomized, open-labeled study was conducted for a period of 12 months (April 2023–March 2024), at a single tertiary care center involving 327 patients that were newly diagnosed with essential hypertension without any comorbid conditions. Patients were assessed at baseline, 15 days, 1 month, and then followed up at monthly intervals up to 6 months.Results:In the study, significant reductions in systolic blood pressure (SBP) were noted for A+H with R+H at 3 and 4 months and for T+H with R+H from 3 to 6 months. Diastolic blood pressure (DBP) reductions were significant for A+H with R+H at 15 days and 1 month. T+H was significantly more effective than A+H and R+H in reducing SBP, while all groups showed comparable efficacy in reducing DBP over 6 months. Adverse drug reactions (ADRs) were highest in the A+H group at 29.4% and lowest in the T+H group at 19.8%.Conclusion:This real-world clinical study provided valuable insights into the comparative efficacy of different antihypertensive drug combinations, with T+H being most effective in reducing SBP; in terms of DBP, all the groups were equally efficacious.

Context:Adverse drug reaction (ADR) reporting in pharmacovigilance is critical for patient safety but often limited by resource constraints and manual inefficiencies. The integration of artificial intelligence (AI) has the potential to address these challenges by streamlining the reporting process.Aims:The aim of the study was to assess the performance of an AI-enabled system for audio-to-text transcription, translation, ADR form completion, and causality assessment based on the World Health Organization-Uppsala Monitoring Centre scale.Settings and Design:A computational comparative, cross-sectional study involving healthcare professionals and patients to evaluate the AI system’s functionality in a real-world pharmacovigilance setting.Methodology:A hundred participants (50 healthcare professionals and 50 patients) provided audio-recorded ADR reports. These recordings were processed through the AI system to generate transcriptions, translations, and ADR forms. The system’s performance was assessed using transcription metrics (word error rate [WER], character error rate [CER], Sentence Error Rate [SER]), translation metrics (bilingual evaluation understudy [BLEU] score, Translation Edit Rate [TER]), and ADR form accuracy. Causality assessments by the AI were compared against expert evaluations.Statistical Analysis Used:Descriptive and analytical statistics (unpaired t-test) were applied to evaluate the performance metrics and compare results between the two participant groups.Results:The AI system demonstrated high accuracy in transcription (WER <0.05, CER <0.04, and SER <0.35) and translation (BLEU >0.85 and TER <0.05). ADR form completion achieved near-perfect accuracy with minor discrepancies. Causality assessments were consistent across healthcare professional and patient data (P = 1).Conclusions:The AI-enabled system effectively streamlined ADR reporting, ensuring accuracy in transcription, translation, and causality assessment while maintaining consistency across groups. Its integration into pharmacovigilance processes can reduce workloads, enhance reporting rates, and improve global health outcomes.

Purpose:Allergic rhinitis (AR) is a type 1 allergic disease of the nasal mucosa, characterized by paroxysmal repetitive sneezing, watery rhinorrhea, and nasal blockage with the prevalence of 25% worldwide. Bilastine is a newer second-generation H1 antihistaminic approved for the symptomatic treatment of AR and chronic urticaria in patients older than 12 years. To date, there are very few studies in the Indian population comparing the efficacy, safety, and its effect on cognition of bilastine with second-generation antihistaminics. Hence, the study was planned to assess and compare the efficacy, tolerability, and the effect on cognition of cetirizine and bilastine in patients of AR.Aim:The aim is to assess and compare the efficacy and tolerability of cetirizine and bilastine in patients with AR.Materials and Methods:It was a randomized, open-label, parallel-group, comparative study conducted on 80 patients of AR attending the ENT outpatient department of a tertiary care teaching hospital. Patients were divided into two groups of 40 each. They received either cetirizine 10 mg or bilastine 20 mg once daily for 2 weeks, and efficacy and tolerability were assessed at 2 weeks follow-up visits.Results:The difference in mean total symptom score was significant in bilastine as well as cetirizine, which showed that bilastine was equally efficacious as cetirizine. Adverse events were reported more in the cetirizine group.Conclusion:Bilastine is equally efficacious as cetirizine and a favorable tolerability profile may make it a more tolerable H1-antihistaminic than cetirizine.

INTRODUCTION Financial support from pharmaceutical sponsors influences the design and outcomes and leads to the reporting of results that favor sponsor interests across many fields, including oncology.[1] Medical writing bias (MWB) is a byproduct of this influence that manifests in the exaggeration or duplication of positive results and omission of unfavorable results, which risks both misinforming physician decisions and compromising patient outcomes. The market size for multiple myeloma (MM) treatments is rapidly increasing and is estimated to be worth $21.6 billion in 2023 and over $33 billion by 2030,[2] making this topic both relevant and important. We analyzed MWB in MM clinical research papers published between 2000 and 2023 involving one or more of the following drugs: bortezomib, carfilzomib, daratumumab, elotuzumab, isatuximab, ixazomib, lenalidomide, panobinostat, pomalidomide, and selinexor. METHODS We accessed clinical trial data from PubMed using the following search criteria: “(multiple myeloma) AND (Bortezomib OR Carfilzomib OR Ixazomib OR Lenalidomide OR Pomalidomide OR Selinexor OR Daratumumab OR Isatuximab OR Elotuzumab OR Panobinostat).” We filtered results to only include the following article types: Clinical Study, Clinical Trial, Clinical Trial Protocol, Clinical Trial Phase I, Clinical Trial Phase II, Clinical Trial Phase III, and Clinical Trial Phase IV. Next, we used the software extension “Multiple Search and Highlight” to find keywords within each paper, including “fund,” “assist,” “manuscript,” “acknowledge,” “medical writ,” “writ,” “editorial,” “sponsor,” “support,” “contract,” “author,” and “finance.” For the paper to be considered containing MWB, it had to study one or more of our 10 observed drugs, have the drug manufacturer(s) sponsor the trial, and acknowledge that the medical writing was done by the manufacturer’s employees, or the company directly funded the medical writing group. RESULTS We determined the combined MWB percentage for all drugs since 2000. There was 0% bias reported up until 2006. In 2007 and 2008, 4% MWB occurred in both years (2/53 and 2/57, respectively), and increased to 12% (5/42) in 2009. From 2010 to 2014, 16% (54/328) of papers exhibited MWB, which increased to 29% (137/469) from 2015 to 2019. Between 2020 and 2022, 35% (114/330) of papers showed MWB. Through March, 44% (12/27) of the manuscripts published in 2023 exhibited MWB. Next, we determined average MWB percentage since 2000 for each drug, which showed the following: isatuximab 93% (26/28), ixazomib 77% (36/47), daratumumab 76% (63/83), elotuzumab 71% (17/24), selinexor 62% (8/13), pomalidomide 55% (27/49), panobinostat 50% (9/18), bortezomib 47% (47/100), lenalidomide 46% (75/163), and carfilzomib 32% (15/47). Since 2000, the Blood, British Journal of Haematology, and Haematologica contained the highest number of articles with MWB at 42, 30, and 20, respectively. The Blood Cancer Journal, Annals of Hematology and Oncology, and European Journal of Haematology each reported 11 papers with MWB. The highest-impact journals, such as the New England Journal of Medicine (NEJM) and Lancet, had comparatively lower MWB frequencies at 9 and 6, respectively. Fourteen journals had a single occurrence of MWB. We also analyzed percentages of MWB since 2000. The Journal of Clinical Pharmacology, Future Oncology, and Cancer Chemotherapy and Pharmacology showed high percentages at 86% (6/7), 57% (4/7), and 50% (6/12), respectively. NEJM and Lancet showed rates of 33% (9/27) and 46% (6/13), respectively. Most (140/190) journals contained 0% MWB, whereas nine contained 100% MWB although these all had only one evaluable manuscript. DISCUSSION Previous studies report how commercial sponsors are more likely to have control over data analysis and interpretation than noncommercial sponsors;[3] real-world examples, such as the hormone replacement therapy lawsuits against Wyeth Pharmaceuticals, demonstrate how dangerous sponsor influences can be.[4] By favoring sponsor interests, clinical research may compromise patient well-being for financial gain which may lead to misguided treatment decisions and damaged public trust. Strategies to decrease the risk of MWB include regulating conflicts of interest, expanding reviewer and editorial board independent oversight, and choosing medical writers without ties to companies whose drug(s) are being evaluated. This should be explored in future studies by comparing the reporting of each drug’s efficacy and safety information across manuscripts funded with those not funded by each drug’s manufacturer, evaluating the types and extent of involvement that investigators have in the development of manuscripts. Financial support and sponsorship Nil Conflicts of interest There are no conflicts of interest.

Abstract Background: Approximately 13% of the world’s population is more than 65 years old, and they consume major proportion of all medicinal products. Geriatric population constitute the majority of patients for chronic conditions including cardiac disease, malignancies, metabolic disorders, neurodegenerative disorders among others. However, in clinical trials, the elderly population is not adequately represented. In clinical studies, age-related physiological changes that impact the drug’s pharmacokinetics and pharmacodynamics in the elderly are not adequately assessed. Additionally, concomitant medications and comorbid conditions make elderly individuals more vulnerable to side effects. Objective: To analyse the trends of clinical trials involving the geriatric population in India over the past 16 years registered under Clinical Trial Registry of India. Materials and Methods: All clinical trials registered under CTRI from July 2007 to December 2023 were reviewed and analyzed using the key words “geriatrics”, “elderly”, “old age” in the ‘trial search’ section. Data was extracted for the year of study, type of trial, therapeutic area and sites of study. Results: Out of a total of 63,063 studies were registered in CTRI, 254 studies (0.37%) had geriatric population in their inclusion criteria. Of these studies 157 studies (61.8%) were interventional in nature. 29.9% of the studies were related to improvement in quality of life in the elderly. Regulatory clinical trials which included geriatrics to evaluate the efficacy and safety of drugs were only 5.5%. A gradual increase in the number of trials including elderly population was noted over the last 5 years. Conclusion: There is a major dearth of clinical trials that evaluate the geriatric population. However, there is an increasing trend of inclusion of geriatric population in clinical trials over the recent years.