Biobanking in the Modern Era: Infrastructure, Ethical Challenges, and the Emerging Role of Umbilical Cord Stem Cells Venkateswara Raju Kalidindi, Harika Kommanaboyina, Lakshmi Prasanthi Nori Letters in Applied Nanobioscience, 2026 Biobanks are facilities that preserve biomaterials with high-quality and long-term preservation. To research the pathophysiology of illness, establish biomarkers for diagnosis, and work with human tissue to potentially uncover targeted therapeutic medicines, biological materials, and data are routinely captured and stored in this system. In addition to providing the best possible management of patient biomaterials for research and diagnostic purposes, biobanks serve as a unifying and complementary element across clinical and core disciplines. Implementing all these dynamics while abiding by international guidelines is crucial. Biobanking involves ethical concerns, as well as the information technology (IT) systems, collection, and preservation of materials. Financing is also necessary to cover the cost of the infrastructure. In the last few decades, umbilical cord (UC) biobanking has grown exponentially and has become a revolutionary concept in advancing the medical industry. Compared with other adult stem cell sources for clinical transplantation, primitive hematopoietic stem cells (HSCs) and mesenchymal stem cells (MSCs) are abundant in UC blood and tissues. However, in addition to creating efficient consent procedures to enable the potential therapeutic use of UC-derived stem cells and to build a sizable global UC-biobanking network, it is imperative to enhance and standardize UC processing, preservation, quality assurance protocols, and regulatory frameworks.
Unveiling the Intricacies of Orphan Drug Regulations in Australia, Japan and India Lakshmi Prasanthi Nori, Dhamasri Gopisetty, Manikiran S.S, Sankara Rao Routhu, K. Venateswara Raju International Journal of Pharmaceutical Sciences and Nanotechnology, 2026 This article delves into the intricate regulatory frameworks governing orphan drugs in Australia, Japan and India, with a complicated analysis aimed at giving a nuanced awareness of the particular mechanisms and difficulties related to various treatments. The investigation encompasses an exploration of the specific criteria and processes involved in orphan drug designation, marketing authorization and scrutinizing the regulatory landscapes of each region. By comparing and contrasting the regulatory pathways for marketing approval, the study aims to uncover the diverse approaches employed in guaranteeing the effectiveness and safety of orphan medications. Additionally, the research extends to an examination of the mechanisms governing market access, reimbursement and incentives for pharmaceutical innovation. Through a meticulous comparative analysis, this project seeks to identify regulation in Australia, Japan and India. The global market size from 2002 to 2029 has drastic increase. The findings are included to contribute to the collective knowledge base, guiding future policy decisions and strategic initiatives aimed at optimizing the creation and availability of orphan medications in India. It provides in detail information about orphan drug regulations in the three countries compared to the official website data.
The Drug Reboot: Finding New Life in Old Formulations Biointerface Research in Applied Chemistry, 2025 Drug repurposing, also known as drug repositioning, is a strategic approach aimed at discovering new therapeutic uses for existing drugs, whether they are currently on the market or have been withdrawn. This method effectively identifies and develops pharmaceutical compounds with new pharmacological or therapeutic activities. In recent years, many major pharmaceutical companies have adopted drug repositioning strategies within their research and development programs to explore new indications by targeting novel biological mechanisms. This approach can save time and costs while maintaining high effectiveness and reducing the risk of failure. By maximizing the therapeutic value of existing drugs, it enhances the likelihood of success. Repositioning drugs offers a valuable alternative to traditional drug discovery, which is often expensive, labor-intensive, and time-consuming. Drug repurposing builds on the established safety profiles of existing compounds, employing a combination of computational methods (in silico) and experimental techniques to uncover new applications. This emerging methodology aims to redirect medications that have already been safely tested in humans to address rare, hard-to-treat disorders and neglected diseases. Overall, drug repurposing represents a promising avenue for maximizing the potential of existing therapies and addressing unmet medical needs.
From Risk to Resilience: Uncovering Drug Recall Trends and Bolstering Safety Strategies Venkateswara Raju Kalidindi, Bandaru Mani Sai Durga, Lakshmi Prasanthi Nori Indian Journal of Pharmaceutical Education and Research, 2024 The process of officially calling something back to its original or initial location is termed as “recall.” Pharmaceutical recalls involve requesting to get back a product after it leaves the manufacturer to reach the distributor, retailer, or consumer. In place of the discovery of defect that affects the quality safety and efficacy of the product. Drug product recalls occur due to various reasons such as wrong or unapproved drugs, undeclared ingredients, contamination, incorrect information, and particulate issues. The probable risks or issues that arise due to a product recall or claims related to product liability and legal issues. A product recall should be perceived as an opportunity for the elimination of personal injury to the patient and damage to the reputation of the company products and rebuilding trust. Quality culture across the organization is a means of product recall prevention. In this comprehensive analysis, we delve into the drug recall statistics spanning the fiscal year 2018 to 2023 (up to July), focusing on the distinct challenges posed by recalls attributed to a lack of sterility assurance and those due to impurity profiles. Unveiling critical insights, the study highlights the impact of these issues on the pharmaceutical industry’s commitment to ensuring the safety and quality of drug products. This unique analysis presents a call to action for collaborative efforts between regulatory authorities, manufacturers, and healthcare professionals. Emphasizing the value of transparent communication and proactive measures, we explore avenues to mitigate recalls and reinforce public trust in pharmaceutical products. By drawing insights from past incidents, the industry can forge a path towards a safer, more reliable future, where drug recalls due to sterility and impurity issues become rare occurrences. Swift and thorough recalls are vital to ensure patient safety. The rising trend in recalls, caused by company discovery, customer complaints, or FDA observations, impacts sales, customer relations, and supply chains. Recalls involve planned actions, including depth of recall, public alerts, and effectiveness checks.
NLEM 2022: MILESTONES AND BACKGROUND BEHIND THE SELECTION OF MEDICINES Pharma Times, 2024
Revolutionizing Medicine: Unleashing the Power of Real-World Data and AI in Advancing Clinical Trials Venkateswara Raju Kalidindi, Sheik Rehana, Sarvan Manikiran Seethamraju, Lakshmi Prasanthi Nori Brazilian Journal of Pharmaceutical Sciences, 2024 In the biopharmaceutical industry, the conventional “linear and sequential” clinical trial approach is still the norm; however, it is frequently beset by issues with patient selection, retention
WEARABLE MEDICAL DEVICES: STANDARDS, APPROVAL PROCESS AND REGULATORY ISSUES Pharma Times, 2024
Impact of Dietary Supplements in Alleviating Human Lifestyle and their Regulatory Aspects Venkateswara Raju Kalidindi, Shankar Routhu, Dhamasri Gopisetty, Phanindra Varma Alluri, Lakshmi Prasanthi Nori Indian Journal of Pharmaceutical Education and Research, 2024 Dietary supplements generally items which have the goal of boosting the person's wellness and general well-being and are often ingested at mealtime or in scheduled times in order to improve a person's dietary routine. Once an individual has a nutritional unbalance or as a shortage of certain nutrients, supplementation needs to be taken. Classes of dietary supplements include Vitamins, Minerals, Proteins, Multivitamins, Multiminerals, Herbs, Carbohydrates, hormone activators and oil supplements are present in the form of pill, tablets, capsules and liquids. Supplements should enable individuals having limited nutritional consumption along with effectiveness and also have higher requirements, via strengthening nutrition significance. The risk associated with food supplements, toxicity of the supplements, market trends and future perspectives were also presented. Some include the technical as well as legislative obstacles currently encountered within supplements effectiveness, safety and quality studies. For each country there are separate regulatory approval frameworks and also labelling requirements for the import and export of the food product. So, dietary supplements play a crucial role in every individual.
CYBER AWARENESS OF CONNECTED MEDICAL DEVICES AND THEIR REGULATORY ASPECTS Pharma Times, 2023
MEDICAL DEVICES OF COSMETIC WORLD Pharma Times, 2023
MONKEY POX: GLOBAL REGULATIONS AND CONTEMPORARY UPDATES Pharma Times, 2023
A comprehensive review of microfinance in India and a study of microfinance institutions in Guntur District, Andhra Pradesh International Journal of Applied Business and Economic Research, 2017
A study on organized retail scenario in India and customer impulsiveness in the organized retail outlets International Journal of Economic Research, 2016
A study on brand switching and consumer preferences towards soft drinks with an emphasis on distribution processes and market expansion strategies and pricing implemented at Hindustan Coca-Cola Beverages Pvt Ltd Vijayawada International Journal of Applied Engineering Research, 2015
Antidiabetic mechanisms of saponins of Momordica cymbalaria Pharmacognosy Magazine, 2008
