Current Indian Science - Volume 2, Issue 1, 2024

Targeted gene and drug delivery vector developments have completely changed the therapeutic intervention by providing previously unheard-of levels of accuracy and efficacy in treating various illnesses. Cancer is one such fatal disease plaguing people across the globe. This review article highlights the potential uses of targeted delivery systems in the field of cancer treatment while providing a thorough examination of the state of the art. Chemotherapy and radiation therapy are being used to cure cancer, yet they can be frequently ineffective and have serious adverse effects. Novel techniques for therapy have to be designed. Existing chemotherapy is being superseded by particular gene therapy used for genetic diseases. Therefore, to deliver the therapeutic agent to the targeted place, a carrier or vector is needed. The current review is focused on targeted gene/drug delivery vectors concerning i) cationic lipids that target single receptors ii) ligand-peptide conjugated cationic lipids iii) modalities for targeting dual ligands for cancer therapy iv) passive versus active targeting v) properties of nano-formulations for gene and drug delivery. The most recent developments in lipid customization for certain receptors overexpressed in cancer cells are covered to reduce side effects and improve treatment results. By delving into the above areas, this review presents a broad overview of the changing field of cationic lipids in cancer therapy, giving scientists and medical professionals insightful knowledge about the many strategies for ensuring precise and efficient drug delivery in the battle against cancer.

The COVID-19 emergency built pressure on US regulatory bodies to unlock the optional and short pathway of approval for urgently required pharmaceuticals to accomplish population demand for medicinal products within the shortest possible time to limit the suffering and deaths associated with insufficiency of medicinal products in need. During the pandemic, many medicinal products got emergency use authorization (EUA) according to the EUA guidelines provided by the US Food Drug Administration (USFDA). The requirement of abbreviated data submission for EUA attracted many pharmaceutical companies to launch their products as investigational drugs. Clinical data collected from the population is also permitted to get final approval. Comirnaty and Remdesivir got full approval using this regulatory tool. EUA does not ensure the existence of the medicinal product for an extended period. Whenever the emergency is over or the products are no longer needed, the USFDA revokes those according to their legislation. However, after Hydroxychloroquine phosphate and chloroquine sulfate were revoked due to failure to show efficacy, it grabbed the attention of many healthcare stakeholders in the country. It demanded more transparency in the approval pathway of present EUA guidelines. Two attributes, i.e., Current Good Manufacturing Practice exemption and expiry date extension, affect the quality of the medicinal products used during the pandemic. The most critical product distribution data, voluntary in EUA, remarkably endorse the black-marketing and shortage of specific COVID-19-related medicinal products in the pandemic situation. Amendments to the existing guidelines minimize the upcoming public health risk.

Over the past few centuries, life-saving tools have been extensively used across the globe. The use of medical devices has increased adverse events associated with them. Materiovigilance is the process of identifying, collecting, reporting, and examining unfavorable events connected to medical devices in order to prevent the recurrence of such occurrences. Several countries keep an eye on medical products once they are commercialized. Other nations with similar programs include France, Australia, and the United Kingdom, in addition to the Medical Device Reporting (MDR) programme in the United States. This article addressed how some types of medical equipment might be dangerous and how a Materiovigilance programme is essential.

This page provides information about how to report adverse reactions to these medical devices, as well as what they are.

In many countries, post-marketing surveillance for medications has been initiated but is not as reliable and advanced as it is today. By monitoring adverse events related to medical devices, generating safety data, educating stakeholders, and recommending appropriate procedures and interventions, the Indian Pharmacopeia Commission established the committee on July 6, 2015.

Monitoring adverse events related to medical device usage can increase patient safety. On the basis of safety data gathered and generated, the Central Drugs Standard Control Organization (CDSCO) will make recommendations about the safe use of medical devices in the Indian population.

Tezepelumab is a first-in-class human IgG2λ monoclonal antibody used to treat severe, uncontrolled asthma. Tezepelumab acts by hindering the action of thymic stromal lymphopoietin (TSLP), an epithelial-derived cytokine that triggers an immunological response by binding to TSLP and thereby preventing its binding with the TSLP receptor complex. TSLP has a critical role in Th2 immunity and plays an important role in the pathogenesis of asthma because it stimulates the production of Th2-associated inflammatory mediators, such as interleukin-4, interleukin-5, interleukin-9, and interleukin-13. It is the first biologic with no phenotypic or biomarker restrictions that has been approved for use in severe asthma. Tezepelumab is indicated in severe, uncontrolled asthma patients due to its safety, tolerability, and efficacy. Adults with severe, uncontrolled asthma experienced considerably lower annualised asthma exacerbation rates (AAERs) when administered with tezepelumab compared to a placebo. These preliminary results indicated that the TSLP-induced release of T2 inflammatory mediators may be reduced, and the sustained inhibition was maintained over a 52-week treatment period. In this review, we have summarised various phase III clinical trials and the mechanism of action of tezepelumab in severe, uncontrolled asthma.

At present, there is a growing interest among researchers in studying the structure and function of the bee brain in relation to their cognitive behavior. The bee brain, despite its small size of approximately 1 million neurons, is known for its ability to facilitate effective communication and collaboration. Just like humans, the bee brain is also controlled by biogenic amines like dopamine, serotonin and tyramine, octopamine, and histamine. The honey bees communicate with each other by using a complex language called the “waggle dance”. Despite existing knowledge about the bee brain's neuroanatomy, there is still a need to understand which specific regions control cognition and social behavior in bees. This review aims to explore the different major parts of the bee brain and how each part contributes to modulating social behavior.

Diabetes Mellitus (DM) is a compounded, persistent illness symbolized by an increased range of glucose levels in the blood caused by cellular resistance to insulin action, insufficient insulin production by pancreatic -cells, or both. Type 1 Diabetes Mellitus (T1DM), the extremely widespread form of DM, is recorded for almost 85-90% of worldwide cases. T2DM is mostly common in middle-aged and older people, and its causes are multifaceted. The use of efficient and profitable solutions for DM screening is critical to ensure pre-identification and minimising patients' risk of acquiring the life-compromising illness. Identification of innovative biomarkers with test methods of DM is therefore critical in order to establish vigorous, non-invasive, pain-free, highly sensitive, and precise procedures for screening. The purpose of this review article is to mention and review all the necessary biomarkers that play a vital role in disease diagnosis and to highlight the present-day findings of the latest clinically validated and traditional biomarkers and procedures for determining them, which provide cost-efficient options for T2DM screening with early detection. It is concluded that various biomarkers, both conventional and innovative, go hand in hand to diagnose the DM of any type.

The pharmaceutical industry is witnessing a growing demand for complex generic products, which are generic versions of drugs that possess complex formulations, delivery systems, or active ingredients. However, the approval process for these complex generic products poses unique challenges compared to traditional generics. There is no specific regulatory procedure available for the approval of complex generics, unlike small-molecule generics and biosimilars. This led to controversial arguments in the past about the scientific evidence needed for applications, which led to lengthy approval processes. The regulatory frameworks that are currently being used for complex generics are debatable and unclear. Complexity in the molecular structure, mechanism of action, route of delivery, and complex manufacturing process makes proving bioequivalence and pharmaceutical equivalence difficult. There is a need for harmonization of the regulatory framework by the agencies to help the generic manufacturers by providing scientific advice, defining the submission requirements for complex products, and fastening the approval process.

This review begins by discussing the regulatory landscape surrounding complex generic products in various regions, including the United States and Europe. It examines the specific guidelines and requirements set forth by regulatory authorities to ensure the safety, efficacy, and quality of these products. Additionally, the review explores the differences in terminology and definitions used to classify complex generics across different jurisdictions. Furthermore, it delves into the challenges faced by both regulatory agencies and pharmaceutical companies in evaluating and approving complex generic products. These challenges include establishing appropriate bioequivalence criteria, determining interchangeability with the reference product, addressing patent and exclusivity issues, and ensuring consistent quality throughout the product lifecycle. The impact of these challenges on market entry and competition is also discussed. The review highlights the need for harmonization and streamlining of regulations for complex generic products worldwide. It emphasizes the importance of clear and consistent guidelines to enable timely approvals, foster innovation, and facilitate patient access to affordable alternatives.

The nutritional and therapeutic potential of medicinal plants is constantly being investigated. This is especially relevant in today's world, where an increasing number of people are turning to complementary and alternative therapies to address their health-related concerns. Traditional knowledge, as a valuable resource, plays a crucial role in the development of new herbal medicines. Abroma augusta stands out as one such medicinal plant that has a rich history of use in traditional medicine. It has been employed to address a wide spectrum of health issues, including diabetes, menstrual irregularities, respiratory problems, musculoskeletal disorders, urinary ailments, and sexual dysfunctions, among others. While various parts of this plant species are believed to possess pharmacological properties, the active compounds and underlying mechanisms remain largely unexplored. To facilitate the development of innovative drugs for the benefit of individuals, this study places significant emphasis on delving into the phytochemical and ethnomedicinal attributes of A. augusta. Moreover, it seeks to bolster its findings with scientifically validated pharmacological investigations conducted through both in vivo and in vitro methodologies.

The cellular and biochemical stages of the wound-healing process are interrelated and work to repair the wound. The body heals wounds in stages, and each stage that is postponed raises the risk of microbial infection. The time needed for healing can be sped up, and unwanted events can be reduced to improve wound healing. To aid in the healing of the wounds, the medications are administered locally or systemically. In order to promote wound healing, antibiotics, antiseptics, desloughing agents, extracts, etc. have been employed. Due to their adverse effects, several synthetic medications are subject to restrictions. Investigation, identification, and formulation of plants or plant-derived combinations are required for the management and therapy of wound healing. Because they have fewer adverse effects and have been used to treat wounds for a longer period, medicinal plants are becoming more popular for use in wound healing. According to studies, medicinal herbs help diabetic, infected, and opened wounds heal more quickly. It has been claimed that medicinal herbs can speed up wound healing through a variety of processes. Many medicinal plants, including Allium sativum, Commiphora myrrha, Curcuma longa (L.), Rauwolfia serpentia, and Vateria indica, have demonstrated the ability to treat wounds.

Digitalis purpurea L. belongs to the Scrophulariaceae family. The most significant is digitoxin, a very toxic substance that builds up in the body and is impenetrable in water. For millennia, people have utilized the medication Digitalis to treat cardiac problems induced by obesity. External triggers like strenuous exercise, emotional stress, eating, exposure to extreme weather, sexual activity, coffee and alcohol consumption, and use of cocaine or marijuana temporarily increase the risk of having a myocardial infarction. A person's genetic makeup influences disease progression, the presence of chronic risk factors, and lifestyle choices. Despite various educational programs, the fight against obesity does not appear to be successful. According to WHO (World Health Organisation) statistics, 13 percent of adults over the age of 18 are obese, and 39 percent are overweight. Being overweight or obese significantly raises the chance of developing disorders, including coronary heart disease. Digitalis is primarily used to treat heart conditions. It encourages and stimulates the action of all muscle tissues in cases of clogged heart failure. The herb improves heart nutrient absorption by forcing more blood into the coronaries. Digitalis aids in the repair and regulation of the heart's function when blood circulation is hampered.

A chronic skin condition called psoriasis can manifest as plaque, flexural, guttate, pustular, and erythrodermic lesions, among other clinical symptoms. Sixty million people are believed to be affected by psoriasis worldwide. In India, the frequency ranges from 0.44 to 2.8%, with males affected two times more frequently than females in their third or fourth decade of life. An immune-mediated inflammation condition with a sizable genetic component is psoriasis. Due to its connection to psoriatic arthritis and the increased prevalence of cardiometabolic, hepatic, and psychiatric problems, a thorough and interdisciplinary strategy for treatment is required. Corticosteroids and analogs of vitamin D are examples of topical treatments for psoriasis. Phototherapy includes NB-UVB, psoralen, and ultraviolet radiation (PUVA). Standard systemic treatments include methotrexate, acitretin, and ciclosporin. This disease is useful for physicians and scientists since it might be used as a model for research into the underlying causes of chronic inflammation. It is also crucial for clinical trial scientists as a first-choice disease indication for preliminary research of new pathogenesis-based treatment approaches. This review covers both the therapeutic choices that have resulted from the analysis of the aggressive psoriatic pathways and the processes involved in the onset and progression of the disease. We start by writing regarding the important cell kinds and inflammatory mechanisms that initiate and maintain psoriatic inflammation. Next, we discuss how skin flora interacts with heredity, related epigenetic processes, and the pathogenesis of psoriasis. Finally, we provide a thorough analysis of recently targeted medications as well as well-known, extensively used treatments.