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Background: Physical activity significantly influences physiological biomarkers, including irisin and osteocalcin, which are pivotal for metabolic and bone health. Understanding the differential impacts of various exercise modalities on these biomarkers is essential for optimizing health benefits., Objectives: The study aimed to compare the effects of endurance training and high-intensity resistance training (HIRT) on the levels of irisin and osteocalcin and determine which exercise modality more effectively influences these health-related biomarkers., Methods:  The study was conducted at the Nimra Institute of Medical Sciences in Andhra Pradesh, India, where 100 healthy male participants aged between 21 and 35 were recruited. These participants, who were not regularly active and had no metabolic or bone diseases, were divided into two groups to undergo an eight-week training from March to April 2022. One group participated in endurance training involving running and cycling, while the other engaged in HIRT, both targeting a heart rate set at 75% of the maximum. Baseline and follow-up measurements of irisin and osteocalcin were taken before and after the training using blood samples collected after fasting. The study used paired t-tests to analyze changes in biomarker levels, and Pearson correlation coefficients to explore the relationship between the biomarkers, with results processed using statistical software and presented as mean ± standard deviation (SD)., Results: Post-intervention, both exercise groups showed significant increases in irisin and a modest increase in osteocalcin levels. The HIRT group exhibited a higher increase in irisin levels (+119.33 pg/mL, p<0.015) compared to the endurance group (+108.32 pg/mL, p<0.023). Similarly, osteocalcin levels increased modestly in both groups, with the HIRT group showing a higher mean difference (+0.75 pg/mL, p<0.001) than the endurance group (+0.70 pg/mL). The study also found a link between changes in irisin and osteocalcin levels. This link was stronger in the HIRT group (r = +0.22; p < 0.039) than in the endurance group (r = +0.20; p < 0.038)., Conclusion: Both endurance and high-intensity resistance training are effective in enhancing metabolic and bone health, evidenced by increases in irisin and osteocalcin levels. Although the differences in mean values suggest that HIRT may have a marginal advantage in boosting these biomarkers, confirming the statistical significance of this difference is essential. Further research is required to understand the mechanisms behind these effects and to assess their long-term impacts on health and disease prevention., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Adilakshmi et al.)

Background : Irisin and adipomyokine are proteins secreted by the body during exercise and exhibit potential therapeutic effects for chronic disorders. Gaining insights into how high-intensity resistance training and endurance training influence irisin and adipomyokine secretion could shed light on optimizing exercise regimens for potential therapeutic applications. Such knowledge could pave the way for personalized exercise prescriptions and contribute to the development of novel treatments for chronic conditions, enhancing overall health and well-being. Objectives: To investigate the effects of high-intensity resistance training (HIRT) and endurance training on irisin and adipomyokine levels in healthy individuals. Methods : An 8-week interventional comparative study was conducted at Nimra Institute of Medical Sciences, Andhra Pradesh, India. One hundred healthy male individuals aged 21 to 35 were divided into two groups: HIRT and endurance. The HIRT group performed high-intensity resistance training, while the endurance group performed endurance training. Ethical approval was obtained, and baseline and post-intervention values of the participants were recorded and analyzed using SPSS software. Results : After 8 weeks, irisin levels were significantly elevated in the HIRT group (167.39±11.27) compared to the endurance group (155.39±11.28). A positive correlation was observed between skeletal muscle and irisin levels in both the HIRT group (χ 2 -16.38; p=0.04) and the endurance group (χ 2 -18.36; p=0.01). Additionally, TNF-α (HIRT: 81.47±4.02 and Endurance: 61.19±4.00) and interleukin-6 (IL-6) (HIRT: 46.84±4.46 and Endurance: 36.15±3.89) levels significantly increased in the HIRT group. However, there was no significant change in leptin levels in either group (HIRT: 3.75±0.58 0.58 and 4.15±0.58). Conclusion : The findings of this study indicate that HIRT is more effective in increasing irisin levels compared to endurance training. However, the notable elevation of IL-6 and TNF-α in the HIRT group raises concerns about potential chronic inflammation. To optimize outcomes, a combined approach, coupling HIRT and endurance training, may be beneficial. Additionally, the results emphasize the significance of skeletal muscle as a primary source of irisin secretion, implying that increased muscle contraction contributes to higher irisin release even in healthy individuals. These insights can guide exercise prescriptions and potentially enhance therapeutic strategies for chronic disorders., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Adilakshmi et al.)

Background: SARS-CoV-2 infection during pregnancy may cause adverse maternal, neonatal and placental outcomes. While tissue hypoxia is often reported in COVID-19 patients, pregnant women with anemia are suspected to be more prone to placental hypoxia-related injuries., Methods: This hospital-based cross-sectional study was conducted between August-November 2021, during COVID-19 second wave in India. Term pregnant women (N=212) admitted to hospital for delivery were enrolled consecutively. Since hospital admission mandated negative RT-PCR test for SARS-CoV-2 virus, none had active infection. Data on socio-demography, COVID-19 history, maternal, obstetric, and neonatal outcomes were recorded. Pre-delivery maternal and post-delivery cord blood samples were tested for hematological parameters and SARS-CoV-2 IgG. Placentae were studied for histology., Results: Of 212 women, 122 (58%) were seropositive for SARS-CoV-2 IgG, but none reported COVID-19 history; 134 (63.2%) were anemic. In seropositive women, hemoglobin ( p =0.04), total WBC ( p =0.009), lymphocytes ( p =0.005) and neutrophils ( p =0.02) were significantly higher, while ferritin was high, but not significant and neutrophils to lymphocytes ( p =0.12) and platelets to lymphocytes ratios ( p =0.03) were lower. Neonatal outcomes were similar. All RBC parameters and serum ferritin were significantly lower in anemic mothers but not in cord blood, except RDW that was significantly higher in both, maternal ( p =0.007) and cord ( p =0.008) blood from seropositive anemic group compared to other groups. Placental histology showed significant increase in villous hypervascularity ( p =0.000), dilated villous capillaries ( p =0.000), and syncytiotrophoblasts ( p =0.02) in seropositive group, typically suggesting placental hypoxia. Maternal anemia was not associated with any histological parameters. Univariate and multivariate logistic regression analyses of placental histopathological adverse outcomes showed strong association with SARS-CoV-2 seropositivity but not with maternal anemia. When adjusted for several covariates, including anemia, SARS-CoV-2 seropositivity emerged as independent risk factor for severe chorangiosis (AOR 8.74, 95% CI 3.51-21.76, p <0.000), dilated blood vessels (AOR 12.74, 95% CI 5.46-29.75, p <0.000), syncytiotrophoblasts (AOR 2.86, 95% CI 1.36-5.99, p =0.005) and villus agglutination (AOR 9.27, 95% CI 3.68-23.32, p <0.000)., Conclusion: Asymptomatic COVID-19 during pregnancy seemed to be associated with various abnormal placental histopathologic changes related to placental hypoxia independent of maternal anemia status. Our data supports an independent role of SARS-CoV-2 in causing placental hypoxia in pregnant women., Competing Interests: GR has received grant funding from and serves as a consultant for Sun Pharmaceuticals Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Surekha, Suneetha, Balakrishna, Putcha, Satyanarayana, Geddam, Sreenu, Tulja, Mamidi, Rutter and Meur.)

Aim Study the effect of coronavirus disease-19 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on the placenta and in turn study its effects on pregnancy and newborn outcomes. Methods In this cross-sectional study, which was conducted in the term pregnant women who underwent delivery, their placentas were collected after delivery along with the mothers' blood and cord blood. Results Among the 212 pregnant women recruited, the prevalence of marginal cord insertion (MCI) in the placentas after delivery, was found to be 23% (n=48). Among these 48 cases (n=48) with MCI, 58.33% (n=28) were COVID-19 positive. The placentas with MCI had significantly lower minimum placental circumference (probability value/p value=0.04) and significantly longer umbilical cord ( p-value =0.05). COVID-19 antibodies transfer from the mother to the umbilical cord (C/M antibodies ratio) was observed to be lower, albeit insignificantly. Both the weight of newborns ( p value=0.03) and their COVID-19 antibodies levels (p-value=0.05) were observed to be significantly lower in the MCI group. Univariate analysis shows that a body mass index (BMI) ≥ 23 of the mothers was significantly associated with abnormal MCI. Conclusion The prevalence of MCI was observed to be high in COVID-19-affected mothers in our study. MCI was associated with lower placental size, newborn weight, lesser transfer of COVID-19 antibodies from the mother to the fetus across the umbilical cord, and lower antibody levels in the cord blood when compared to maternal blood., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Mullapudi Venkata et al.)

Viruses that infect bacteria are emerging as attractive biocontrol agents and biopreservatives for foods. Since these bacteriophages kill the target pathogens by lysis and are also consumed along with food, it is essential to evaluate their collateral toxicity on the probiotic gut microbiota. In this study, we examined the acute oral toxicity of a Salmonella phage isolated from sewage in mice. Acute oral administration of the Salmonella phage for five consecutive days did not show any significant pathological changes in the vital organs like lung, kidneys, heart, liver, and intestine. In addition, growth of typical probiotic microbiota remained unaffected even after incubation up to 24 h with the Salmonella phage. The results of this study clearly showed that oral administration of the lytic Salmonella phage did not have any significant adverse effects on the animals, may not harm the probiotic gut microbiota, and are likely to be safe for use in food preservation., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Piper longum (Indian long pepper) is known for its use as an anti inflammatory agent in Indian Ayurvedic System of medicine. Therefore, it is of interest to document the molecular docking analysis of compounds from Piper longum with COX-2 using the Autodock Vina PyRx tool. Molecular docking results show that asarinine, sesamine, fargesin, and piperlonguminine have optimal binding energy of 10, 10, -9.5 and 9.4 Kcal/mol, respectively for further consideration., Competing Interests: The authors declare no conflicts of interest., (© 2021 Biomedical Informatics.)

The use of "kabasura kudineer" (liquid soup made from Indian medicinal plants) for combating COVID-19 has been common in the states of Tamilnadu and Puducherry, India during the pandemic. Therefore, it is of interest to document the molecular docking analysis of IL-6 inhibitors with potential antiviral compounds from "kabasura kudineer" extract. We show the optimal binding features of gallic acid and luteolin with the Interleukin-6 protein for further consideration., Competing Interests: None declared., (© 2021 Biomedical Informatics.)

Introduction: Quality improvement is recognized as a major factor that can transform healthcare management. This study is a clinical audit that aims at analysing treatment time as a quality indicator and explores the role of setting a target treatment time on reducing treatment delays., Materials and Methods: All newly diagnosed patients with breast cancer between September 2011 and August 2013 were included in the study. Clinical care pathway for breast cancer patients was standardized and the timeliness of care at each step of the pathway was calculated. Data collection was spread over three phases, baseline, audit cycle I, and audit cycle II. Each cycle was preceded by a quality improvement intervention, and followed by analysis., Results: A total of 334 patients with breast cancer were included in the audit. The overall time from first visit to initiation of treatment was 66.3 days during the baseline period. This improved to 40.4 and 28.5 days at the end of Audit cycle I and II, respectively. The idealized target time of 28 days for initiating treatment was achieved in 5, 23.5, and 65.2% of patients in the baseline period, Audit cycle I, and Audit Cycle II, respectively. There was improvement noted across all steps of the clinical care pathway., Conclusion: This study confirms that audit is a powerful tool in quality improvement programs and helps achieve timely care. Gains achieved through an audit process may not be sustainable unless underlying patient factors and resource deficits are addressed., (Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.)

Background: Currently available drugs are unsuccessful for the treatment of tye-2 diabetes due to their adverseside-effects. Hence, a search for novel drugs, especially ofplant origin, continues. Chrysin (5,7-dihydroxyflavone) is a flavonoid, natural component of traditional medicinal herbs, present in honey, propolis and many plant extracts that hasbeen used in traditional medicine around the world to treat numerous ailments., Objective: The present study was aimed to identify the protective role of chrysin on the expression of insulin-signaling molecules in the skeletal muscle of high fat and sucrose-induced type-2 diabetic adult male rats., Materials and Methods: The oral effective dose of chrysin (100 mg/kg body weight) was given once a day until the end of the study (30 days post-induction of diabetes) to high fat diet-induced diabetic rats. At the end of the experimental period, fasting blood glucose, oral glucose tolerance, serum lipid profile, lipid peroxidation (LPO) and free radical generation, as well as the levels of insulin signaling molecules and tissue glycogen in the gastrocnemius muscle were assessed., Results: Diabetic rats showed impaired glucose tolerance and impairment in insulin signaling molecules (IR, IRS-1, p-IRS-1Tyr(632), p- Akt(Thr308)), glucose transporter subtype 4 [GLUT4] proteins and glycogen concentration. Serum insulin, lipid profile, LPO and free radical generation were found to be increased in diabetic control rats. The treatment with chrysin normalized the altered levels of blood glucose, serum insulin, lipid profile, LPO and insulin signaling molecules as well as GLUT4 proteins., Conclusion: Our present findings indicate that chrysin improves glycemic control through activation of insulin signal transduction in the gastrocnemius muscle of high fat and sucrose-induced type-2 diabetic male rats.

Background: Azadirachta indica (Neem) is a medicinal plant, used in Ayurveda for treating various diseases, one of which is diabetes mellitus. It is known to possess antiinflammatory, antipyretic, antimicrobial, antidiabetic and diverse pharmacological properties. However, the molecular mechanism underlying the effect of A. indica on insulin signal transduction and glucose homeostasis is obscure., Objective: The aim was to study the effects of A. indica aqueous leaf extract on the expression of insulin signaling molecules and glucose oxidation in target tissue of high-fat and fructose-induced type-2 diabetic male rat., Materials and Methods: The oral effective dose of A. indica leaf extract (400 mg/kg body weight [b.wt]) was given once daily for 30 days to high-fat diet-induced diabetic rats. At the end of the experimental period, fasting blood glucose, oral glucose tolerance, serum lipid profile, and the levels of insulin signaling molecules, glycogen, glucose oxidation in gastrocnemius muscle were assessed., Results: Diabetic rats showed impaired glucose tolerance and impairment in insulin signaling molecules (insulin receptor, insulin receptor substrate-1, phospho-IRS-1(Tyr632), phospho-IRS-1(Ser636), phospho-Akt(Ser473), and glucose transporter 4 [GLUT4] proteins), glycogen concentration and glucose oxidation. The treatment with A. indica leaf extract normalized the altered levels of blood glucose, serum insulin, lipid profile and insulin signaling molecules as well as GLUT4 proteins at 400 mg/kg b.wt dose., Conclusion: It is concluded from the present study that A. indica may play a significant role in the management of type-2 diabetes mellitus, by improving the insulin signaling molecules and glucose utilization in the skeletal muscle.

Objective: To estimate the frequency and type of prescription errors in patients receiving cancer chemotherapy., Settings and Design: We conducted a cross-sectional study at the day care unit of the Regional Cancer Centre (RCC) of a tertiary care hospital in South India., Materials and Methods: All prescriptions written during July to September 2013 for patients attending the out-patient department of the RCC to be treated at the day care center were included in this study. The prescriptions were analyzed for omission of standard information, usage of brand names, abbreviations and legibility. The errors were further classified into potentially harmful ones and not harmful based on the likelihood of resulting in harm to the patient. Descriptive analysis was performed to estimate the frequency of prescription errors and expressed as total number of errors and percentage., Results: A total of 4253 prescribing errors were found in 1500 prescriptions (283.5%), of which 47.1% were due to omissions like name, age and diagnosis and 22.5% were due to usage of brand names. Abbreviations of pre-medications and anticancer drugs accounted for 29.2% of the errors. Potentially harmful errors that were likely to result in serious consequences to the patient were estimated to be 11.7%., Conclusions: Most of the errors intercepted in our study are due to a high patient load and inattention of the prescribers to omissions in prescription. Redesigning prescription forms and sensitizing prescribers to the importance of writing prescriptions without errors may help in reducing errors to a large extent.

Communication between chromophores is vital for both natural and non-natural photophysical processes. Spatial confinements offer unique conditions to scrutinize such interactions. Polynorbornene- and polycyclobutene-based ladderphanes are ideal model compounds in which all tetraarylethylene (TAE) linkers are aligned coherently. The spans for each of the monomeric units in these ladderphanes are 4.5-5.5 Å. Monomers do not exhibit emission, because bond rotation in TAE can quench the excited-state energy. However, polymers emit at 493 nm (Φ=0.015) with large Stokes shift under ambient conditions and exhibit dual emission at 450 and 493 nm at 150 K. When the temperature is lowered, the emission intensity at 450 nm increases, whereas that at 493 nm decreases. At 100 K, both monomers and polymers emit only at 450 nm. This shorter-wavelength emission arises from the intrinsic emission of TAE chromophore, and the emission at 493 nm could be attributed to the excimer emission in the confined space of ladderphanes. The fast kinetics suggest diffusion-controlled formation of the excimer., (© 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Telemonitoring during the golden hour of patient transportation helps to improve medical care. Presently there are different physiological data acquisition and transmission systems using cellular network and radio communication links. Location monitoring systems and video transmission systems are also commercially available. The emergency patient transportation systems uniquely require transmission of data pertaining to the patient, vehicle, time of the call, physiological signals (like ECG, blood pressure, a body temperature, and blood oxygen saturation), location information, a snap shot of the patient, and voice. These requirements are presently met by using separate communication systems for voice, physiological data, and location that result in a lot of inconvenience to the technicians, maintenance related issues, in addition to being expensive. This paper presents design, development, and implementation of such a telemonitoring system for emergency patient transportation employing ARM 9 processor module. This system is found to be very useful for the emergency patient transportation being undertaken by organizations like the Emergency Management Research Institute (EMRI).

Nitric oxide, a unique messenger in biological system, is ubiquitously present virtually in all tissues revealing its versatile nature of being involved in diverse physiological functions such as vascular tone, inhibition of platelet aggregation, cell adhesion, neurotransmission and enzyme and immune regulation. The tremendous advancements made in the past few decades in this area suggests that the nitric oxide modulation either by its exogenous release through nitric oxide donors or inhibition of its synthesis by nitric oxide synthase inhibitors in physiological milieu may provide newer clinical strategies for the treatment of some diseases. In this review, an attempt is made to document and understand the biological chemistry of different classes of nitric oxide modulators that would prove to be a fruitful area in the years to come.

Background & Objectives: The present study was carried out on stored rice variety PAU 201 in Punjab that was not permitted for milling and public distribution due to the presence of damaged grains at levels exceeding the regulatory limits of 4.75 per cent. The aim of the study was to determine fungal and aflatoxin contamination in the rice samples to assess hazard from the presence of damaged grains. Presence of iron in discoloured rice grains was also assessed., Methods: Stored samples of paddy of PAU 201 rice variety were collected from six districts of Punjab, milled and analysed for presence of fungal and aflatoxin contamination. Scanning electron microscopy (SEM), energy dispersive X-ray (EDX) analysis and Prussian blue staining was used to determine fungal spores and presence of iron, respectively., Results: Aflatoxin analysis of rice samples indicated that none exceeded the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 tolerance limit of 30 μg/kg and majority of the samples had levels <15 μg/kg. The proportion of damaged grains exceeding the limit of 5 per cent was observed in 85.7 per cent of the samples. SEM and Prussian blue staining and EDX analysis of black tipped and pin point damaged rice grains did not show presence of fungal structures and presence of iron., Interpretation & Conclusions: The results of the study indicated that the stored rice samples did not pose any health concern with respect to aflatoxin contamination as per the criteria laid down by the Food Safety and Standards Authority of India.

Formal total synthesis of cyanolide A, aglycosidic dimeric macrolide is accomplished. The key reactions involved are asymmetric acetate aldol reaction, CBS reduction, and Shiina's lactonization.

This paper traces the evolution of measures and parameters for the evaluation of science and scientific journals from the first attempts during the early part of the last century to the development of the most popular, current and widely used metrics viz., citations, impact factor (IF) etc. The identification of measures of evaluation in science and scientific reporting paralled the post-war increase in funding in the United States of America. Biomedical and medical sciences continue to garner a major share, estimated to be almost two-thirds of total research and development funding of over US$ 350 billion. There has been a concomitant growth in the publications in learned journals. About 1.4 million papers are published every year in an estimated 20,000 journals. In India there are an estimated 100 journals in medical sciences. With a steady increase of about 10% every year, the competition for grants, awards, rewards etc., is fierce. This unrelenting increase in number of scientists and the resultant competition, the limitation of peer review was felt. A search was on for new quantifiable measures for informed decision making for funding, awards, rewards, etc. Now virtually all major decisions all over the world are based on some data linked to publications and/or citations. The concept of citations as tool for 'evaluating' science was first proposed by Eugene Garfield in 1955. The availability of Science Citation Index (SCI), Journal Citation Reports (JCR), Web of Science etc. and the relative ease with which they could be used (and abused) has spawned an entirely new area bibliometrics/scientometrics. As only a limited number of journals could be included in the Thomson Reuters (TR) databases (currently numbering about 10500), analyses based on such a limited dataset (also selected in a non-transparent way by the TR) has been widely and severely criticized by both the developed and developing countries. Yet, studies have shown that citation-based data and indicators (warts and all) could still be put to productive use for purposes of evaluation (as scientists just love numbers). There were simultaneous efforts to find alternative indicators using the TR databases, and through other innovative methods. Some of these include Google Scholar, PageRank, H-index, Y-factor, Faculty of 1000, Eigen Factor etc. The advantages and limitations of these indices are discussed. There is a need for a more critical look at these parameters from the Indian perspective to compute/ device/adapt these measures to suit our needs. There are 205 journals under the category Physiology and 201 in the Pharmacology category listed in the JCR. There are four major Indian journals under the category of Physiology and Pharmacology and none of them are listed in the TR databases reflecting the limitation of these databases. Eventually, and in the long run, the quality of our journals needs to be improved as the current era of globalization and web-access provides both a challenge and an oppportunity for the science and scientific journals published from India to get increased global visibility.

The racemic total synthesis of elegansidiol, farnesiferol B, and farnesiferol D has been obtained following a Diels-Alder approach. Gillman addition, cross metathesis reaction are the other key steps involved in the target synthesis., (Copyright 2010 Elsevier Ltd. All rights reserved.)

The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable, other better formulations and second line ARVs for adults and more drugs and formulations for paediatric groups, that are still to be widely available in India and other developing countries. To examine whether strong intellectual property (IP) protection systems are to be considered important barriers for the limited or lack of access to ARVs, we studied the patent profile of the ARVs of the originator companies within and outside India. We could record 93 patents in the United States Patent & Trademark Office (USPTO). The originator companies have been also aggressively filing and enforcing patents in India. There have been a few efforts by companies like Gilead and GSK to grant licenses to generic manufacturers in developing countries, ostensibly to promote access to ARVs through lower (two-tier) pricing. These steps are considered as too little and too late. There is an urgent need to look for alternative strategies to promote access to ARVs both linked to and independent of IPRs. Patent pooling as a viable strategy mooted by the UNITAID should be seriously explored to promote access to ARVs. India is ideally suited for trying out the patent pool strategy as most of the global requirement of affordable ARV drugs for HIV/AIDS treatment is sourced from Indian generic companies.

This paper examines the nexus between poverty and global health with specific focus on IPR protection and attempts to highlight the current global endeavours to overcome barriers to access to medicines for diseases of the poor. The number of very poor people in the world has increased by 10.4 per cent between 1987 and 2001 to 2735 million. India is now home to the largest number of millionaires in the developing countries. But over 800 million Indians who still survive on Rs 20.0 (US$0.5) a day, and rural poverty is on the rise. The link between poverty and health is well established with the underprivileged are more vulnerable to major health risks due to poor nutrition, inadequate access to clean drinking water, sanitation, exposure to indoor smoke, etc. all of which contribute to the huge and growing burden of disease in the poor countries. The global disease burden is not just huge but growing: over 10 million children die of preventable conditions including vaccine-preventable diseases, about 14 million are killed by infectious diseases every year, 90-95 per cent in poor countries. An estimated third of global population has limited or no access to essential medicines. While the number of poor and unhealthy is growing, Government expenditure on health is dwindling. Many of the diseases of the poor require new medicines and none are forthcoming as there is little R&D for these infections. There are several barriers to access to existing and the newly discovered drugs. One major reason is the general lack of interest by the pharma industry to discover new medicines for diseases of the poor due to very limited market in developing countries. In addition, global intellectual property rights (IPR) protection regimes like the Trade Related Intellectual Property Rights (TRIPS) are considered a major obstacle for the poor access to medicines. There have been some global initiatives on the need to improve affordability and accessibility of medicines. Some strategies to promote R&D on diseases of the poor such as Prize Fund Model, the Medical R&D Treaty and steps to invoke flexibilities in TRIPS read with Doha Declaration are discussed. Health of the poor is a global problem that requires global solutions with global participation and commitment.

During the process development of dutasteride in the laboratory analysis showed some impurity peaks in HPLC ranging from 0.05 to 0.1%. The same samples were analyzed by LCMS method and identified peak at m/z 508 (desmethyl dutasteride), 530 (dihydro dutasteride) and 528 (isomer of dutasteride). These impurities were synthesized individually and characterized based on the spectroscopic data (HPLC, IR, NMR and MS). The structures of these impurities were 17beta-N-[2,5-bis(trifluoromethyl) phenyl]carbamoyl-3-hydroxyl-4-azaestra-1,3,5,7,9-pentaene (desmethyl of dutasteride 2), 17beta-N-[2,5-bis(trifluoromethyl)phenyl]carbamoyl-4-aza-5alpha-androstane-3-one (dihydro impurity of dutasteride 3), and 17beta-N-[2,5-bis(trifluoromethyl) phenyl] carbamoyl-4-aza-5beta-androst-1-ene-3-one (beta-isomer of dutasteride 4), respectively. The formation and synthesis of dutasteride impurities are discussed.

As part of the Global Programme for Elimination of Lymphatic Filariasis (GPELF), India is implementing mass drug administration (MDA) with annual single dose of diethylcarbamazine (DEC) with and without albendazole (ALB). The impact of MDAs on filarial infections and soil-transmitted helminth (STH) infections was assessed during a 3-year period in two communities, one with DEC + ALB and the other with DEC alone. Prior to each MDA (during 2001, 2002 and 2003), filarial indices (microfilaraemia and antigenaemia) were assessed from blood samples of 450-650 persons aged 2-25 years and STH infections in stool samples (Kato-Katz method) from 325 to 500 children aged 9-10 years. Mosquitoes resting indoors were collected to determine the filarial infection status. The microfilaraemia prevalence decreased significantly (P < 0.05) in both arms, with the highest decline in the DEC + ALB arm (72%vs. 51%). Decline in micrefilaria intensity was also higher in the DEC + ALB arm (81.4%vs. 48.5%). In this arm alone, the antigenaemia prevalence was reduced significantly (62%; P < 0.001). The reduction in STH prevalence was lower in the DEC alone arm (6.5%; NS) than in the DEC + ALB arm (70.9%; P < 0.001). Also, the egg reduction in DEC alone arm was only half that of DEC + ALB arm (49%vs. 97%). Our community-based follow-up study showed higher and sustained benefits with regard to filarial and STH infections for the two-drug arm over the DEC alone arm. The trends suggest that at least 10 MDAs may be necessary to achieve the goal of elimination.