Unveiling the crucial role of intercellular adhesion molecule-1 in secondary diabetic complications.

Diabetes mellitus is associated with secondary complications such as diabetic retinopathy (DR), nephropathy (DN), and cardiomyopathy (DCM), all of which significantly impact patient health. Intercellular adhesion molecule-1 (ICAM-1) has been implicated in inflammatory responses and endothelial dysfunction, both crucial in the pathogenesis of these complications. The goal of this review is to investigate at potential therapy methods that target ICAM-1 pathways and to better understand the multifaceted role of ICAM-1 in secondary diabetic problems. A meticulous analysis of scholarly literature published globally was conducted to examine ICAM-1involvement in inflammatory processes, endothelial dysfunction, and oxidative stress related to diabetes and its complications. Elevated ICAM-1 levels are strongly associated with augmented leukocyte adhesion, compromised microvascular function, and heightened oxidative stress in diabetes. These pathways contribute significantly to DR, DN, and DCM pathogenesis, highlighting ICAM-1 as a key player in their progression. Understanding ICAM-1 role in secondary diabetic complications offers insights into novel therapeutic strategies. Targeting ICAM-1 pathways may mitigate inflammation, improve endothelial function, and ultimately attenuate diabetic complications, thereby enhancing patient health outcomes. Continued research in this area is crucial for developing effective targeted therapies.

From Evidence to Practice: A Comprehensive Analysis of Side Effects in Synthetic Anti-Depressant Therapy.

Depression, a pervasive mental health disorder, affects millions worldwide, necessitating the widespread use of synthetic anti-depressant medications. While these pharmaceutical interventions have demonstrated efficacy in alleviating depressive symptoms, they are not without their associated side effects. This review provides a comprehensive overview of the side effects of synthetic anti-depressants, aiming to enhance the understanding of their clinical implications. Common side effects explored include gastrointestinal disturbances, sexual dysfunction, insomnia, weight gain, and cognitive impairments. Additionally, this review delves into less frequent but potentially severe adverse events, such as serotonin syndrome, hyponatremia, and cardiac complications associated with specific classes of synthetic anti-depressants. Moreover, the review examines the interplay between side effects and treatment adherence, emphasizing the importance of monitoring and managing these effects in clinical practice. It also discusses strategies to mitigate side effects, including dose adjustments, combination therapy, and alternative treatment approaches. In conclusion, this comprehensive review sheds light on the multifaceted landscape of side effects associated with synthetic anti-depressants. By providing clinicians with a nuanced understanding of these effects, it aims to facilitate informed decision-making, personalized treatment plans, and improved patient outcomes in managing depression.

Prevalence of Sensory Processing Deficits in Children with Spastic Cerebral Palsy - An Indian Caregiver's Perspective.

This study aims to analyze the prevalence and patterns of sensory processing deficits (SPD) in Indian children with spastic cerebral palsy (CP) using child sensory profile-2 (CSP-2) caregiver questionnaire. The authors surveyed 230 caregivers of children aged 3 to 14 y with spastic CP, using CSP-2. The difference in prevalence and distribution of SPDs among the CP subtypes and Gross Motor Function Classification System (GMFCS) levels was done. Overall prevalence of "Definite" (>2 SD) SPDs was 83%. Forty-seven percent had definite SPDs in more than one sensory subsection. Prevalence of definite SPDs was similar among the spastic CP subtypes. "Conduct" domain had more affection among hemiplegics and quadriplegics. "Avoiding" pattern was observed more in quadriplegics and "Seeking" pattern was observed less in diplegics. Severe GMFCS levels had more definite sensory processing deficits. SPDs are highly prevalent in children with spastic CP with unique patterns of affection among the spastic CP subtypes.

A comprehensive quality control and cost comparison study of branded and generic angiotensin receptor blockers.

This study was designed to assess both the quality and cost aspects of various branded and generic formulations of angiotensin receptor blockers, specifically Irbesartan, Losartan Potassium, Olmesartan Medoxomil, Telmisartan, and Valsartan. The collected samples underwent distinct quality evaluations using the methods outlined in different global Pharmacopoeias (British Pharmacopoeia/European Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia). These drugs were characterized using Fourier-Transform Infrared Spectroscopy and Nuclear Magnetic Resonance techniques, while their quality and concentration were analysed using High Performance Liquid Chromatography. The release profile of the drugs was examined through dissolution testing. Additionally, a cost comparison analysis was carried out by determining the prevailing market prices of the drugs. The evaluated branded and generic angiotensin receptor blockers were found to meet the established standards for impurities, active drug content, and dissolution as set by these Pharmacopoeias, indicating their optimal quality. Notably, the generic drugs exhibited significantly lower costs compared to their branded counterparts. This study confirms that the quality of generic angiotensin receptor blockers is equivalent to that of their branded counterparts. Consequently, these findings support the practicality of utilizing generic drugs as a more economically sustainable and cost-effective approach to managing diseases, especially those of chronic nature.

Recent advances in synthetic strategies and SAR of thiazolidin-4-one containing molecules in cancer therapeutics.

Cancer is one of the life-threatening diseases accountable for millions of demises globally. The inadequate effectiveness of the existing chemotherapy and its harmful effects has resulted in the necessity of developing innovative anticancer agents. Thiazolidin-4-one scaffold is among the most important chemical skeletons that illustrate anticancer activity. Thiazolidin-4-one derivatives have been the subject of extensive research and current scientific literature reveals that these compounds have shown significant anticancer activities. This manuscript is an earnest attempt to review novel thiazolidin-4-one derivatives demonstrating considerable potential as anticancer agents along with a brief discussion of medicinal chemistry-related aspects of these compounds and structural activity relationship studies in order to develop possible multi-target enzyme inhibitors. Most recently, various synthetic strategies have been developed by researchers to get various thiazolidin-4-one derivatives. In this review, the authors highlight the various synthetic, green, and nanomaterial-based synthesis routes of thiazolidin-4-ones as well as their role in anticancer activity by inhibition of various enzymes and cell lines. The detailed description of the existing modern standards in the field presented in this article may be interesting and beneficial to the scientists for further exploration of these heterocyclic compounds as possible anticancer agents.

Solanum nigrum L. in COVID-19 and post-COVID complications: a propitious candidate.

COVID-19 is caused by severe acute respiratory syndrome coronavirus-2, SARS-CoV-2. COVID-19 has changed the world scenario and caused mortality around the globe. Patients who recovered from COVID-19 have shown neurological, psychological, renal, cardiovascular, pulmonary, and hematological complications. In some patients, complications lasted more than 6 months. However, significantly less attention has been given to post-COVID complications. Currently available drugs are used to tackle the complications, but new interventions must address the problem. Phytochemicals from natural sources have been evaluated in recent times to cure or alleviate COVID-19 symptoms. An edible plant, Solanum nigrum, could be therapeutic in treating COVID-19 as the AYUSH ministry of India prescribes it during the pandemic. S. nigrum demonstrates anti-inflammatory, immunomodulatory, and antiviral action to treat the SARS-CoV-2 infection and its post-complications. Different parts of the plant represent a reduction in proinflammatory cytokines and prevent multi-organ failure by protecting various organs (liver, kidney, heart, neuro, and lung). The review proposes the possible role of the plant S. nigrum in managing the symptoms of COVID-19 and its post-COVID complications based on in silico docking and pharmacological studies. Further systematic and experimental studies are required to validate our hypothesis.

Mobile App Interventions to Improve Medication Adherence Among Type 2 Diabetes Mellitus Patients: A Systematic Review of Clinical Trials.

BACKGROUND: Medication adherence in type 2 diabetes mellitus (T2DM) patients is often suboptimal resulting in complications. There has been a growing interest in using mobile apps for improving medication adherence. OBJECTIVE: The objective of this work was to systematically review the clinical trials that have used mobile app-based interventions in T2DM patients for improving medication adherence. METHODOLOGY: A systematic search was performed to identify published clinical trials between January 2008 and December 2020 in databases-PubMed, Cochrane Library, and Google Scholar. All studies were assessed for risk of bias using quality rating tool from the Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: Seven clinical studies having 649 participants were studied. The median sample size was 58 (range = 41-247) and the median age of participants was 53.2 (range = 48-69.4) years. All studies showed improvements in adherence; however, only three studies reported statically significant improvements in adherence measures. Selected studies were deemed as unclear in their risk of bias and the most common source of risk of bias among the studies was the absence of objective outcome assessment. CONCLUSIONS: Mobile apps appear to be effective interventions to help improve medication adherence in T2DM patients compared with conventional care strategies. The features of the App to improvise medical adherence cannot be defined based on the meta-analysis because of heterogeneity of study designs and less number of sample size. Systematically planned studies would set up applicability of mobile apps in the clinical management of T2DM.

Virulence Characteristics and Emerging Therapies for Biofilm-Forming Acinetobacter baumannii: A Review.

Acinetobacter species is one of the most prevailing nosocomial pathogens with a potent ability to develop antimicrobial resistance. It commonly causes infections where there is a prolonged utilization of medical devices such as CSF shunts, catheters, endotracheal tubes, and similar. There are several strains of Acinetobacter (A) species (spp), among which the majority are pathogenic to humans, but A. baumannii are entirely resistant to several clinically available antibiotics. The crucial mechanism that renders them a multidrug-resistant strain is their potent ability to synthesize biofilms. Biofilms provide ample opportunity for the microorganisms to withstand the harsh environment and further cause chronic infections. Several studies have enumerated multiple physiological and virulence factors responsible for the production and maintenance of biofilms. To further enhance our understanding of this pathogen, in this review, we discuss its taxonomy, pathogenesis, current treatment options, global resistance rates, mechanisms of its resistance against various groups of antimicrobials, and future therapeutics.

Recent advances in microbial toxin-related strategies to combat cancer.

It is a major concern to treat cancer successfully, due to the distinctive pathophysiology of cancer cells and the gradual manifestation of resistance. Specific action, adverse effects and development of resistance has prompted the urgent requirement of exploring alternative anti-tumour treatment therapies. The naturally derived microbial toxins as a therapy against cancer cells are a promisingly new dimension. Various important microbial toxins such as Diphtheria toxin, Vibrio cholera toxin, Aflatoxin, Patulin, Cryptophycin-55, Chlorella are derived from several bacterial, fungal and algal species. These agents act on different biotargets such as inhibition of protein synthesis, reduction in cell growth, regulation of cell cycle and many cellular processes. Bacterial toxins produce actions primarily by targeting protein moieties and some immunomodulation and few acts through DNA. Fungal toxins appear to have more DNA damaging activity and affect the cell cycle. Algal toxins produce alteration in mitochondrial phosphorylation. In conclusion, microbial toxins and their metabolites appear to have a great potential to provide a promising option for the treatment and management to combat cancer.

Role of ACE2-Ang (1-7)-Mas axis in post-COVID-19 complications and its dietary modulation.

Severe acute respiratory syndrome-coronavirus-2 (COVID-19) virus uses Angiotensin-Converting Enzyme 2 (ACE2) as a gateway for their entry into the human body. The ACE2 with cleaved products have emerged as major contributing factors to multiple physiological functions and pathogenic complications leading to the clinical consequences of the COVID-19 infection Decreased ACE2 expression restricts the viral entry into the human cells and reduces the viral load. COVID-19 infection reduces the ACE2 expression and induces post-COVID-19 complications like pneumonia and lung injury. The modulation of the ACE2-Ang (1-7)-Mas (AAM) axis is also being explored as a modality to treat post-COVID-19 complications. Evidence indicates that specific food components may modulate the AAM axis. The variations in the susceptibility to COVID-19 infection and the post-COVID its complications are being correlated with varied dietary habits. Some of the food substances have emerged to have supportive roles in treating post-COVID-19 complications and are being considered as adjuvants to the COVID-19 therapy. It is possible that some of their active ingredients may emerge as the direct treatment for the COVID-19.

Systemic study of selected histone deacetylase inhibitors in cardiac complications associated with cancer cachexia.

Cancer cachexia is mainly characterized by wasting of skeletal muscles and fat and body weight loss, along with severe complications of major organs like liver, heart, brain and bone. There can be diminishing performance of these major organs as cancer cachexia progresses, one such drastic effect on the cardiac system. In the present study, differential effect of histone deacetylase inhibitors (HDACi) on cardiac complications associated with cancer cachexia is studied. Two models were used to induce cancer cachexia: B16F1 induced metastatic cancer cachexia and Lewis lung carcinoma cell - induced cancer cachexia. Potential of Class I HDACi entinostat, Class II HDACi MC1568, and nonspecific HDACi sodium butyrate on cardiac complications were evaluated using the cardiac hypertrophy markers, hemodynamic markers, and cardiac markers along with histopathological evaluation of heart sections by Periodic acid-Schiff staining, Masson's trichrome staining, Picro-sirius red staining, and haematoxylin and eosin staining. Immunohistochemistry evaluation by vimentin and caspase 3 protein expression was evaluated. Entinostat showed promising results by attenuating the cardiac complications, and MC1568 treatment further exacerbated the cardiac complications, while non-conclusive effect were recorded after treatment with sodium butyrate. This study will be helpful in evaluating other HDACi for potential in cardiac complications associated with cancer cachexia.

Nanotechnology Enabled Solutions to Combat Covid-19: Prevention, Treatment, and Diagnosis.

Changes in human lifestyles and environmental deterioration globally cause the emergence of new viruses, posing research challenges. The outburst of COVID-19 (nCoV19) is a recent example, wherein effective management of virus, using the conventional medication and effective diagnostic measures is a challenge. While many ongoing strategies from vaccine development to drug repurposing are currently being investigated, a targeted approach with nanotechnology can be helpful to meet the demand for preventive and diagnostic measures. The significant results of nanotechnology in providing better efficacy of pharmaceutical drugs is expected to combat nCoV19 by using nanotechnology- based solutions, preventive treatment, and diagnosis. This article addresses the dire need for nanotechnology-based solutions in the current pandemic, as well as analyzes the ongoing innovation and existing patents that can be used to provide better solutions. Multiple applications of nanotechnology are considered to be helpful in preventive and diagnostic measures, immune response modulation, and immunity boosters, along with projecting a pathway for industry and academic researchers for addressing such a pandemic.

Impact of telehealth interventions on physiological and psychological outcomes in breast cancer survivors: A meta-analysis of randomised controlled trials.

Introduction: The use of telehealth interventions has been evaluated in different perspectives in women and also supported with various clinical trials, but its overall efficacy is still ascertained. The objective of the present review is to identify, appraise and analyze randomized controlled trials on breast cancer survivors who have participated in technology-based intervention programs incorporating a wide range of physical and psychological outcome measures. Material and methods: We conducted electronic search of the literature during last twenty years i.e., from 2001 till August 10, 2021 through four databases. Standardized mean difference with 95% confidence interval was used. Results: A total of 56 records were included in the qualitative and 28 in quantitative analysis. Pooled results show that telehealth interventions were associated with improved quality of life (SMD 0.48, 95% CI 0.03 to 0.92, p=0.04), reduced depression (SMD -1.27, 95% CI =-2.43 to -0.10 p=0.03), low distress and less perceived stress (SMD -0.40, 95% CI =-0.68 to -0.12, p=0.005). However, no significant differences were observed on weight change (SMD -0.27, 95% CI =-2.39 to 1.86, p=0.81) and anxiety scores (SMD -0.09, 95% CI =-0.20 to 0.02, p=0.10) between the two groups. Improvement in health care competence and fitness among participants was also reported. Conclusion: Study concludes that telehealth care is a quick, convenient and assuring approach to breast cancer care in women that can reduce treatment burden and subsequent disturbance to the lives of breast cancer survivors.

Emerging Role of Flavonoids as the Treatment of Depression.

Depression is one of the most frequently observed psychological disorders, affecting thoughts, feelings, behavior and a sense of well-being in person. As per the WHO, it is projected to be the primitive cause of various other diseases by 2030. Clinically, depression is treated by various types of synthetic medicines that have several limitations such as side-effects, slow-onset action, poor remission and response rates due to complicated pathophysiology involved with depression. Further, clinically, patients cannot be given the treatment unless it affects adversely the job or family. In addition, synthetic drugs are usually single targeted drugs. Unlike synthetic medicaments, there are many plants that have flavonoids and producing action on multiple molecular targets and exhibit anti-depressant action by affecting multiple neuronal transmissions or pathways such as noradrenergic, serotonergic, GABAnergic and dopaminergic; inhibition of monoamine oxidase and tropomyosin receptor kinase B; simultaneous increase in nerve growth and brain-derived neurotrophic factors. Such herbal drugs with flavonoids are likely to be useful in patients with sub-clinical depression. This review is an attempt to analyze pre-clinical studies, structural activity relationship and characteristics of reported isolated flavonoids, which may be considered for clinical trials for the development of therapeutically useful antidepressant.

Therapeutic opportunities of edible antiviral plants for COVID-19.

The pandemic of Serious Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2) that produces corona virus disease (COVID-19) has challenged the entire mankind by rapidly spreading globally in 210 countries affecting over 25 million people and about 1 million deaths worldwide. It continues to spread, afflicting the health system globally. So far there is no remedy for the ailment and the available antiviral regimens have been unsatisfactory for the clinical outcomes and the mode of treatment has been mainly supportive for the prevention of COVID-19-induced morbidity and mortality. From the time immortal the traditional plant-based ethno-medicines have provided the leads for the treatment of infectious diseases. Phytopharmaceuticals have provided potential and less toxic antiviral drugs as compared to conventional modern therapeutics which are associated with severe toxicities. The ethnopharmacological knowledge about plants has provided food supplements and nutraceuticals as a promise for prevention and treatment of the current pandemic. In this review article, we have attempted to comprehend the information about the edible medicinal plant materials with potential antiviral activity specifically against RNA virus which additionally possess property to improve immunity along with external and internal respiration and exhibit anti-inflammatory properties for the prevention and treatment of the disease. This will open an arena for the development of novel nutraceutical herbal formulations as an alternative therapy that can be used for the prevention and treatment of COVID-19.

A Case Study: Analysis of Patents on Coronaviruses and Covid-19 for Technological Assessment and Future Research.

BACKGROUND: Protecting intellectual property rights are important and particularly pertinent for inventions that are an outcome of rigorous research and development. While the grant of patents is subject to establishing novelty and inventive step, it further indicates the technological development and is helpful for researchers working in the same technical domain. The aim of the present research work is to map the existing work through an analysis of patent literature in the field of Coronaviruses (CoV), particularly COVID-19 (2019-nCoV). CoV is a large family of viruses known to cause illness in humans and animals, particularly known for causing respiratory infections, as evidenced in earlier times, such as in MERS i.e., Middle East Respiratory Syndrome; and SRS i.e., Severe Acute Respiratory Syndrome. A recently identified novel-coronavirus, known as COVID-19, has caused pandemic situations across the globe. OBJECTIVE: To expand the analysis of patents related to CoV and 2019-nCoV, an evaluation has been conducted by patenting trends of particular strains of identified CoV diseases by present legal status, main concerned countries via the earliest priority years and its assignee types and inventors of identified relevant patents. The global patent documents were analyzed to check the scope of claims along with focuses and trends of the published patent documents for the entire CoV family, including 2019-nCoV through the present landscape. METHODS: To extract the results, the Derwent Innovation database was used by a combination of different keystrings. Approximately 3800 patents were obtained and further scrutinized and analyzed. The present write-up also discusses the recent progress of patent applications in a period of the year 2010 to 2020 (present) along with the recent developments in India for the treatment options for CoV and 2019-nCoV. RESULTS: Present analysis showed that key areas of the inventions were the vaccines and diagnostic kits apart from the composition for the treatment of CoV. It was also observed that no specific vaccine treatments are available for the treatment of 2019-nCov; however, developing novel chemical or biological drugs and kits for early diagnosis, prevention, and disease management is the primary governing topic among the patented inventions. The present study also indicates potential research opportunities for the future, particularly to combat 2019-nCoV. CONCLUSION: The present paper analyzes the existing patents in the field of Coronaviruses and 2019-nCoV and suggests a way forward for the effective contribution in this upcoming research area. From the trend analysis, an increase in the filing of the overall trend of patent families was observed for a period of 2010 to the current year. This multifaceted analysis of identified patent literature provides an understanding of the focuses on present ongoing research and a grey area in terms of the trends of technological innovations in disease management in patients with CoV and 2019-nCoV. Furthermore, the findings and outcome of the present study offer insights for the proposed research and innovation opportunities and provide actionable information in order to facilitate policymakers, academia, research-driven institutes and also investors to make better decisions regarding programmed steps for research and development for the diagnosis, treatment and taking preventive measures for CoV and 2019-nCoV. The present article also emphasizes the need for future development and the role of academia and collaboration with industry for speedy research with a rationale.

Management of Glioblastoma Multiforme by Phytochemicals: Applications of Nanoparticle-Based Targeted Drug Delivery System.

The Glioblastoma Multiforme (GBM; grade IV astrocytoma) exhorts tumors of star-shaped glial cells in the brain. It is a fast-growing tumor that spreads to nearby brain regions specifically to cerebral hemispheres in frontal and temporal lobes. The etiology of GBM is unknown, but major risk factors are genetic disorders like neurofibromatosis and schwannomatosis, which develop the tumor in the nervous system. The management of GBM with chemo-radiotherapy leads to resistance, and current drug regimen like Temozolomide (TMZ) is less efficacious. The reasons behind the failure of drugs are due to DNA alkylation in the cell cycle by enzyme DNA guanidase and mitochondrial dysfunction. Naturally occurring bioactive compounds from plants referred as phytochemicals, serve as vital sources for anti-cancer drugs. Some prototypical examples include taxol analogs, vinca alkaloids (vincristine, vinblastine), podophyllotoxin analogs, camptothecin, curcumin, aloe-emodin, quercetin, berberine etc. These phytochemicals often regulate diverse molecular pathways, which are implicated in the growth and progression of cancers. However, the challenges posed by the presence of BBB/BBTB to restrict the passage of these phytochemicals, culminates in their low bioavailability and relative toxicity. In this review, we integrated nanotech as a novel drug delivery system to deliver phytochemicals from traditional medicine to the specific site within the brain for the management of GBM.

Keeping abreast about ashwagandha in breast cancer.

ETHNOPHARMACOLOGICAL RELEVANCE: Ashwagandha has been used as an ayurvedic medicine in the form of 'Rasayana' (as a tonic) even before 3000 BCE in India. As per Ayurveda, it has long been used traditionally for the treatment of inflammation, weakness, impotence, pulmonary tuberculosis. This plant is also beneficial in lumbago and leucorrhea in the female. In the recent past, Withania has shown its anti-cancerous activity in various experimental models. In addition, Withania also possesses many other properties such as anti-oxidant, anti-stress, adaptogenic, and regenerative which will eventually be beneficial and safe in treating cancer patients. AIM OF THE STUDY: This review aims to provide experimental evidence along with a deeper insight into molecular mechanisms of Ashwagandha (Withania somnifera (L.) Dunal) through which it acts as a chemotherapeutic agent against different types of breast cancer. MATERIALS AND METHODS: Literature searches with the help of electronic online databases (Elsevier, Google Scholar, Scopus, Springer Link, ScienceDirect, ResearchGate, PubMed) were carried out. The timeline for collection of data for the review article was from 2000 to 2019. The plant name was validated from The Plant List (2013). Version 1.1. Published on http://www.theplantlist.org/(accessed 21st March 2020). RESULTS: Various forms of Withania somnifera were used and several in vitro, in vivo, and clinical studies were reported by researchers. They found ashwagandha to exhibit anti-apoptotic, anti-metastatic, anti-invasive and anti-inflammatory properties and gave the evidence that ashwagandha has a capability for averting and treating breast cancer. CONCLUSION: Various in vitro and in vivo studies suggested Ashwagandha may possess a potential for treating breast cancer, especially ER/PR positive breast cancer and triple-negative breast cancer. A clinical trial has also been conducted in the past that suggested its potential in refining quality of life in breast cancer patients. Studies directed towards molecular pathways have helped in unravelling the key mechanisms of ashwagandha. Future research should be directed towards translational studies involving breast cancer patients. These will reinforce the ancient power of our Ayurvedic medicine.

Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System.

Recombinant drug products successfully treat many life-threatening and chronic diseases. The high cost of these drugs makes them inaccessible to the patients particularly in developing countries. Patent expiration of innovator recombinant drug products has led to the development of biosimilars or similar biologics by several manufacturers. Unlike generics, these are not identical to their innovator products because of the differences in the manufacturing process; however, they are similar in quality characteristics, biological activity, safety, and efficacy. The regulatory procedures used for generic drugs cannot be applied for biosimilars as they are large complex structures produced from living cells and can produce potential risk of immune-based adverse reactions. Out of several safety issues related to biosimilars, two main safety concerns are variable potency and immunogenicity, for which a robust long-term pharmacovigilance system is needed. Various guidelines have been issued for the regulatory approval and pharmacovigilance of biosimilars by USFDA, EU, and pharma-emerging countries like China and India. The article includes the pharmacovigilance plan of biosimilars in these countries, discusses the challenges and opportunities in pharmacovigilance through spontaneous reporting systems, and suggests amendments in the existing suspected adverse event reporting form of the Pharmacovigilance Programme of India.

Impact of COVID-19 outbreak on mental health and perceived strain among caregivers tending children with special needs.

BACKGROUND: While COVID-19 outbreak has had adverse psychological effects in children with special needs, the mental state and burden on their caregivers during this pandemic has yet to be reported. AIMS: The objectives of this study were to describe the mental health status and the change in perceived strain among caregivers during the COVID-19 outbreak. METHODS AND PROCEDURES: Two hundred sixty four caregivers completed an online survey that assessed demographics, use and perspective on tele-rehabilitation, homecare therapy, caregiver's strain and mental health. OUTCOMES AND RESULTS: The prevalence of depression, anxiety and stress symptoms were found to be 62.5 %, 20.5 % and 36.4 % respectively. A significant difference in caregiver strain (p <  0.001, effect size = 0.93) was observed during the outbreak compared to levels pre-outbreak (pre-outbreak strain was measured retrospectively). Caregivers not using tele-rehabilitation along with a perception of it being a poor medium for rehabilitation were at greater risks for poor mental health whereas a negative perception on homecare therapy were strongly associated with higher psychological symptoms and strain. CONCLUSIONS AND IMPLICATIONS: This study identified a high prevalence of depression and significant change in strain displayed by caregivers during the COVID-19 outbreak. We identified several factors associated with poor mental health and perceived strain that can be used to help safeguard caregivers.