Antibiotic prescriptions for oral diseases in India: evidence from national prescription data.

INTRODUCTION: The key objective of this research was to describe the prescription rate of various antibiotics for dental problems in India and to study the relevance of the prescriptions by analysing antibiotic types associated with different dental diagnoses, using a large-scale nationally representative dataset. METHODS: We used a 12-month period (May 2015 to April 2016) medical audit dataset from IQVIA (formerly IMS Health). We coded the dental diagnosis provided in the medical audit data to the International Statistical Classification of Diseases and Related Health Problems (ICD-11) and the prescribed antibiotics for the diagnosis to the Anatomic Therapeutic Chemical (ATC) -2020 classification of the World Health Organization. The primary outcome measure was the medicine prescription rate per 1,000 persons per year (PRPY1000). RESULTS: Our main findings were-403 prescriptions per 1,000 persons per year in the year 2015 -2016 for all dental ailments. Across all ATC level 1 classification, 'Diseases of hard tissues' made up the majority of the prescriptions. 'Beta-lactam', 'Penicillin,' and 'Cephalosporins' were the most commonly prescribed antibiotics for dental diagnoses followed by 'Macrolides' and 'Quinolones'. 'Dental caries', 'Discoloration of tooth', and 'Toothache' were the most common reasons for 'Beta-Lactams' and 'Penicillin' prescriptions. CONCLUSION: To conclude our study reports first ever country (India) level estimates of antibiotic prescription by antibiotic classes, age groups, and ICD-11 classification for dental ailments.

Effect of Cell Derived Matrices on growth and differentiation of human Wharton's jelly derived Mesenchymal Stem Cells.

Cell derived matrices (CDMs) are scaffolds constructed by decellularization of cellular matrices from different tissues and organs. Since cell derived matrices mimic the ECM of native tissues, CDM plays an essential role in the preparation of bioscaffolds. CDM scaffolds from Mesenchymal Stem Cells (MSCs) have been reported to support cell adhesion and proliferation of its own cells. Therefore, in this study we aimed to test if growth of human Wharton's jelly derived MSCs (hWJ-MSCs) may be enhanced when cultured on their own cell derived matrices. To do this, MSCs were induced to generate ECM using ascorbic acid. Thus, obtained matrices were decellularized and characterized quantitatively for changes in their biochemical components (total protein, collagen, glycosaminoglycans) and qualitatively for fibronectin, laminin and collagen (I & IV) by immunostaining. Our results show the retention of essential ECM components in the decellularized WJ-CDM. The influence of WJ-MSC-derived CDM on proliferation and differentiation of WJ-MSCs were evaluated by comparing their growth on collagen and fibronectin only coated plates. A non-coated tissue culture polystyrene plate (TCPS/WC) served as control. Our cell proliferation results show that no significant changes were observed in the proliferation of MSCs when cultured on WJ-MSC derived CDM as compared to the bio-coated and non-coated cultures. However, gene expression analysis of the differentiation process showed that osteogenic and adipogenic differentiation potential of the WJ-MSCs was significantly increased upon culturing them on WJ-MSC-CDM. In conclusion, the present study reveals that the WJ-MSCs cultured on WJ-MSC-CDM may augment osteogenic and adipogenic differentiation.

Cost of delivering primary healthcare services through public sector in India.

Background & objectives: Public health spending on primary healthcare has increased by four times (in real terms) over the last decade and continues to constitute more than half of the total public health expenditure. The present study estimated the cost of providing healthcare services at sub centre (SC) and primary health centre (PHC) level in four selected States of India. Methods: A total of 51 SCs and 33 PHCs were selected across the four States (Himachal Pradesh, Odisha, Kerala and Tamil Nadu) of India. The economic cost of delivering health services at these facilities was assessed using bottom-up costing methodology during the reference year of 2014-2015. The cost of capital items was annualized and allocation of shared resources was based on appropriate apportioning statistics. Results: The mean annual cost of providing health services at SC and PHC was ₹ 0.69 million (US$ 11,392) and ₹ 5.1 million (US$ 83,837), respectively. Nearly 3/4th and 2/3rd of this cost at the level of SC (74%) and PHC (63%) were spent on salaries. In terms of unit cost, the costs per antenatal care and postnatal care visit were ₹ 221 (173-276) and ₹ 333 (244-461), respectively, at SCs. Similarly, the costs of per patient outpatient consultation and per bed day hospitalization at PHC level were ₹ 121 (91-155) and ₹ 1168 (955-1468), respectively. Interpretation & conclusions: The cost estimates from the present study can be used in economic evaluations, assessing technical efficiency and also for providing valuable information during scale-up of health facilities.

Multimorbidity, healthcare use and catastrophic health expenditure by households in India: a cross-section analysis of self-reported morbidity from national sample survey data 2017-18.

BACKGROUND: The purpose of this research is to generate new evidence on the economic consequences of multimorbidity on households in terms of out-of-pocket (OOP) expenditures and their implications for catastrophic OOP expenditure. METHODS: We analyzed Social Consumption Health data from National Sample Survey Organization (NSSO) 75th round conducted in the year 2017-2018 in India. The sample included 1,13,823 households (64,552 rural and 49,271 urban) through a multistage stratified random sampling process. Prevalence of multimorbidity and related OOP expenditure were estimated. Using Coarsened Exact Matching (CEM) we estimated the mean OOP expenditure for individuals reporting multimorbidity and single morbidity for each episode of outpatient visits and hospital admission. We also estimated implications in terms of catastrophic OOP expenditure for households. RESULTS: Results suggest that outpatient OOP expenditure is invariably lower in the presence of multimorbidity as compared with single conditions of the selected Non-Communicable Diseases(NCDs) (overall, INR 720 [USD 11.3] for multimorbidity vs. INR 880 [USD 14.8] for single). In the case of hospitalization, the OOP expenditures were mostly higher for the same NCD conditions in the presence of multimorbidity as compared with single conditions, except for cancers and cardiovascular diseases. For cancers and cardiovascular, OOP expenditures in the presence of multimorbidity were lower by 39% and 14% respectively). Furthermore, around 46.7% (46.674-46.676) households reported incurring catastrophic spending (10% threshold) because of any NCD in the standalone disease scenario which rose to 63.3% (63.359-63.361) under the multimorbidity scenario. The catastrophic implications of cancer among individual diseases was the highest. CONCLUSIONS: Multimorbidity leads to high and catastrophic OOP payments by households and treatment of high expenditure diseases like cancers and cardiovascular are under-financed by households in the presence of competing multimorbidity conditions. Multimorbidity should be considered as an integrated treatment strategy under the existing financial risk protection measures (Ayushman Bharat) to reduce the burden of household OOP expenditure at the country level.

Did the poor gain from India's health policy interventions? Evidence from benefit-incidence analysis, 2004-2018.

BACKGROUND: Health policy interventions were expected to improve access to health care delivery, provide financial risk protection, besides reducing inequities that underlie geographic and socio-economic variation in population access to health care. This article examines whether health policy interventions and accelerated health investments in India during 2004-2018 could close the gap in inequity in health care utilization and access to public subsidy by different population groups. Did the poor and socio-economically vulnerable population gain from such government initiatives, compared to the rich and affluent sections of society? And whether the intended objective of improving equity between different regions of the country been achieved during the policy initiatives? This article attempts to assess and provide robust evidence in the Indian context. METHODS: Employing Benefit-Incidence Analysis (BIA) framework, this paper advances earlier evidence by highlighting estimates of health care utilization, concentration and government subsidy by broader provider categories (public versus private) and across service levels (outpatient, inpatient, maternal, pre-and post-natal services). We used 2 waves of household surveys conducted by the National Sample Survey Organisation (NSSO) on health and morbidity. The period of analysis was chosen to represent policy interventions spanning 2004 (pre-policy) and 2018 (post-policy era). We present this evidence across three categories of Indian states, namely, high-focus states, high-focus north eastern states and non-focus states. Such categorization facilitates quantification of reform impact of policy level interventions across the three groups. RESULTS: Utilisation of healthcare services, except outpatient care visits, accelerated significantly in 2018 from 2004. The difference in utilisation rates between poor and rich (between poorest 20% and richest 20%) had significantly declined during the same period. As far as concentration of healthcare is concerned, the Concentrate Index (CI) underlying inpatient care in public sector fell from 0.07 in 2004 to 0.05 in 2018, implying less pro-rich distribution. The CI in relation to pre-natal, institutional delivery and postnatal services in government facilities were pro-poor both in 2004 and 2018 in all 3 groups of states. The distribution of public subsidy underscoring curative services (inpatient and outpatient) remained pro-rich in 2004 but turned less pro-rich in 2018, measured by CIs which declined sharply across all groups of states for both outpatient (from 0.21 in 2004 to 0.16 in 2018) and inpatient (from 0.24 in 2004 to 0.14 in 2018) respectively. The CI for subsidy on prenatal services declined from approximately 0.01 in 2004 to 0.12 in 2018. In respect to post-natal care, similar results were observed, implying the subsidy on prenatal and post-natal services was overwhelmingly received by poor. The CI underscoring subsidy for institutional delivery although remained positive both in 2018 and 2004, but slightly increased from 0.17 in 2004 to 0.28 in 2018. CONCLUSIONS: Improvement in infrastructure and service provisioning through NHM route in the public facilities appears to have relatively benefited the poor. Yet they received a relatively smaller health subsidy than the rich when utilising inpatient and outpatient health services. Inequality continues to persist across all healthcare services in private health sector. Although the NHM remained committed to broader expansion of health care services, a singular focus on maternal and child health conditions especially in backward regions of the country has yielded desired results.

Legacy persistent organochlorine pollutants and polycyclic aromatic hydrocarbons in the surface soil from the industrial corridor of South India: occurrence, sources and risk assessment.

Conversion of agricultural fields into the industrial corridor under the State Industries Promotion Corporation of Tamil Nadu Limited (SIPCOT) necessitated the investigation of soil-borne organic contaminants. This study is the first attempt to evaluate the occurrence of organochlorine pesticides (OCPs), polychlorinated biphenyls (PCBs) and polycyclic aromatic hydrocarbons (PAHs) in soils from Mambakkam and Cheyyar SIPCOT belt, along the residential, industrial and agricultural transects. Concentrations of Σ28PCBs, Σ16PAHs and OCPs were in the range 0.3-9 ng/g, 33-2934 ng/g and nd-81.4 ng/g, respectively. Residential areas showed higher OCP concentrations than other site types, probably due to their frequent use in vector control programmes. DDT isomers and α-isomer of endosulfan showed low concentrations indicating past usage of these OCPs. Principal component analysis indicated that high-temperature combustion and industrial processes might be the major sources of high molecular weight PAHs, while low-temperature combustion processes might be responsible for low molecular weight PAHs. PCBs in soil were probably attributed to unaccounted combustion processes of e-waste in the region. Carcinogenic PAHs and Σ28PCBs were higher in the industrial sites. Mean Σ28PCBs at Mambakkam (4.8 ng/g) was significantly higher (p < 0.05) than that at the incipient industrial corridor Cheyyar (2.7 ng/g). Lower chlorinated PCBs (3-Cl and 4-Cl) amounted to more than half of Σ28PCBs in 75% of the sites. Total toxic equivalents (TEQs) of PAHs (total BaPeq) were found to be maximum in industrial areas. Maximum contribution to TEQs due to dioxin-like-PCBs was from PCB-157, followed by PCB-189.

What is the private sector? Understanding private provision in the health systems of low-income and middle-income countries.

Private health care in low-income and middle-income countries is very extensive and very heterogeneous, ranging from itinerant medicine sellers, through millions of independent practitioners-both unlicensed and licensed-to corporate hospital chains and large private insurers. Policies for universal health coverage (UHC) must address this complex private sector. However, no agreed measures exist to assess the scale and scope of the private health sector in these countries, and policy makers tasked with managing and regulating mixed health systems struggle to identify the key features of their private sectors. In this report, we propose a set of metrics, drawn from existing data that can form a starting point for policy makers to identify the structure and dynamics of private provision in their particular mixed health systems; that is, to identify the consequences of specific structures, the drivers of change, and levers available to improve efficiency and outcomes. The central message is that private sectors cannot be understood except within their context of mixed health systems since private and public sectors interact. We develop an illustrative and partial country typology, using the metrics and other country information, to illustrate how the scale and operation of the public sector can shape the private sector's structure and behaviour, and vice versa.

Have Socioeconomic Inequalities in Tobacco Use in India Increased Over Time? Trends From the National Sample Surveys (2000-2012).

INTRODUCTION: India has experienced marked sociocultural change, economic growth and industry promotion of tobacco products over the past decade. Little is known about the influence of these factors on socioeconomic patterning of tobacco use. This study examines trends in tobacco use by socioeconomic status (SES) in India between 2000 and 2012. METHODS: We analyzed data in 2014 from nationally-representative repeated cross-sectional National Sample Surveys (NSS) in India for 1999-2000, 2004-2005 and 2011-2012 (n = 346 612 households). Prevalence and volume trends in cigarette, "bidi" and smokeless tobacco use were examined by household expenditure, educational attainment and caste/tribe status using Two-part model. RESULTS: Prevalence of any tobacco use remained consistent in the poorest households (61.5% to 62.7%) and declined among the richest (43.8% to 36.8%) between 2000-2012. Bidi use declined across all groups (poorest: 26.3% to 16.8%, richest: 19.8% to 10.7%) while cigarette use increased (poorest: 1.2% to 1.3%, richest: 6.5% to 7.0%). Relative to educated and general caste households, between 2000 and 2012 cigarette use in illiterate households increased by 38% and among Scheduled Tribe households increased by 32%. Smokeless tobacco use increased for all households (poorest: 26.2% to 33.9%, richest: 11.4% to 13.5%, Scheduled Tribe: 31.1% to 34.8%, general caste: 13.6% to 18.5%), with greater increases among richer, more educated and general caste households. CONCLUSION: Marked SES patterning of tobacco use has persisted in India. Improving enforcement of tobacco control policies and monitoring comprehensive smoke-free legislations are needed to address this growing burden. IMPLICATIONS: We found "resilient" tobacco patterns in the last decade despite prevention interventions. SES continues to be inversely associated with tobacco products, with the exception of cigarettes. The declines in bidi use may be getting replaced by increase in cigarette use trends, especially among lower SES groups. The use of smokeless tobacco products has increased across all SES groups and the volume of smokeless tobacco use is not been declining despite a number of policies on tobacco use. This may be attributed to inadequate attention to chewed forms of tobacco in current policies, particularly to implementing pictoral warnings and regulating surrogate advertising. Evaluating the implementation of anti-tobacco policies and ensuring equity dimensions in interventions is urgently needed to address tobacco use inequalities.

Smokeless tobacco control policies in South Asia: a gap analysis and recommendations.

INTRODUCTION: Almost a fifth of the world's tobacco is consumed in smokeless form. Its consumption is particularly common in South Asia, where an increasing array of smokeless tobacco (SLT) products is widely available. Mindful of the growing public health threat from SLT, a group of international academics and policy makers recently gathered to identify policy and knowledge gaps and proposed strategies to address these. METHODS: We reviewed key policy documents and interviewed policy makers and representatives of civil society organizations in 4 South Asian countries: Bangladesh, India, Nepal, and Pakistan. We explored if SLT features in existing tobacco control policies and, if so, the extent to which these are implemented and enforced. We also investigated barriers to effective policy formulation and implementation. The findings were presented at an international meeting of experts and were refined in the light of the ensuing discussion in order to inform policy and research recommendations. RESULTS: We found that the existing SLT control policies in these 4 South Asian countries were either inadequate or poorly implemented. Taxes were low and easily evaded; regulatory mechanisms, such as licensing and trading standards, either did not exist or were inadequately enforced to regulate the composition and sales of such products; and there was little or no cessation support for those who wanted to quit. CONCLUSIONS: Limited progress has been made so far to address the emerging public health threat posed by SLT consumption in South Asia. International and regional cooperation is required to advocate for effective policy and to address knowledge gaps.

Determinants of private-sector antibiotic consumption in India: findings from a quasi-experimental fixed-effects regression analysis using cross-sectional time-series data, 2011-2019.

The consumption of antibiotics varies between and within countries. However, our understanding of the key drivers of antibiotic consumption is largely limited to observational studies. Using Indian data that showed substantial differences between states and changes over years, we conducted a quasi-experimental fixed-effects regression study to examine the determinants of private-sector antibiotic consumption. Antibiotic consumption decreased by 10.2 antibiotic doses per 1000 persons per year for every ₹1000 (US$12.9) increase in per-capita gross domestic product. Antibiotic consumption decreased by 46.4 doses per 1000 population per year for every 1% increase in girls' enrollment rate in tertiary education. The biggest determinant of private sector antibiotic use was government spending on health-antibiotic use decreased by 461.4 doses per 1000 population per year for every US$12.9 increase in per-capita government health spending. Economic progress, social progress, and increased public investment in health can reduce private-sector antibiotic use.

Evaluating the impact of price regulation (Drug Price Control Order 2013) on antibiotic sales in India: a quasi-experimental analysis, 2008-2018.

BACKGROUND: In India, due to a lack of population-level financial risk protection mechanisms, the expenditure on healthcare is primarily out-of-pocket in nature. Through Drug Price Control Orders (DPCOs), the Indian Government attempts to keep medicine prices under check. The aim of this study was to measure the potential impact of DPCO 2013 on the utilization of antibiotics under price regulation in India using large nationally representative pharmaceutical sales data. METHODS: We used interrupted time series analysis, a quasi-experimental research design to estimate the impact of DPCO 2013 on the utilization of antibiotics in the private sector in India. Indian pharmaceutical sales data set, PharmaTrac from a market research company-All Indian Origin Chemists and Distributors Limited-was used for the study. The data are collected from a panel of around 18,000 stockists across 23 different regions of the country. The primary outcome measure is the percentage change (increase or decrease) in the sales volume of the antibiotics under DPCO 2013, measured in standard units (SUs). RESULTS: Our estimates suggest that post-intervention (after notification of DPCO 2013) there was an immediate reduction (level change) in the sales of antibiotics under DPCO 2013 by 3.7% (P > 0.05), followed by a sustained decline (trend change) of 0.3% (P > 0.05) as compared to the pre-intervention trend at the molecule level, but both changes were statistically insignificant. However, in terms of 'average monthly market share,' the DPCO 2013 notification resulted in a sharp reduction of 579% (P < 0.05) (level change) followed by a sustained increase of 9.5% (P > 0.05) (trend change) in the 'market share of antibiotics under DPCO' as compared to pre-intervention trend. CONCLUSIONS: The impact of DPCO 2013 in terms of the overall increase in the utilization of antibiotics under price regulation was limited but there was a switch from non-price controlled antibiotics to price regulated antibiotics (notified under DPCO 2013). We argue that policies on price control need to be complemented with continuous monitoring of market behavior to have a measurable and long-term impact.

Impact of the Drug Prices Control Order (2013) on the Utilization of Anticancer Medicines in India: An Interrupted Time-Series Analysis.

Objectives The National Pharmaceutical Pricing Authority introduced a series of Drug Prices Control Orders since 1970 to regulate the prices of essential medicines in India. This study evaluated the impact of the Drug Prices Control Order of 2013 on the utilization of anticancer medicines in the Indian private sector. Methods We used monthly sales audit data for a period of 2012-15, provided by Intercontinental Medical Statistics (IMS) Health. Through interrupted time series design and segmented regression models, we estimated the change in utilization of anticancer medicines following the drug pricing policy implementation. Results Of 1556 anticancer drug packs, 22.3% (n= 347) were price-controlled. The policy led to an immediate monthly reduction of 27.3% (95% CI -38.6%, -13.9%; p=0.001) and a long-term monthly reduction of 0.7% (95% CI -1.6%, 0.3%; p=0.16) in price-controlled formulation's utilization. In the final study month, the price-controlled formulation's utilization was 5.03 thousand standard units lower than what would have been expected without the policy. Melphalan showed the highest immediate reduction, and alpha-interferon showed the highest long-term reduction in utilization. Conclusion Drug prices control order 2013 caused an immediate and long-term decline in the utilization of anticancer medicines in the Indian private sector. However, study data was limited to a specific part of the Indian anticancer drug market, which must be considered when interpreting findings.

Antibiotic consumption in India: geographical variations and temporal changes between 2011 and 2019.

Objectives: To describe and compare private sector systemic (J01) antibiotic consumption across Indian states from 2011 to 2019. Methods: We used the nationally representative PharmaTrac dataset to describe the consumption rates in DDD across national, state and state-group [high focus (HF) and non-high focus (nHF)] levels. We used median and IQRs to describe and compare across states and state groups, and relative change and compound annual growth rate (CAGR) to examine temporal changes. Results: The annual consumption rate decreased by 3.6% between 2011 and 2019. The share of Access antibiotics decreased (13.1%) and the Access/Watch ratio declined from 0.59 to 0.49. State consumption rates varied widely (HF states reported lower rates) and the inappropriate use increased over the years, especially among HF states. The HF and nHF states showed convergence in the share of the Access and the Access/Watch ratio, while they showed divergence in the use of Discouraged fixed-dose combinations. Conclusions and implications: India's private-sector antibiotic consumption rate was lower than global rates. The rates varied across states and appropriateness of use decreased in most states over the years. States with an increase in appropriate use over time could serve as best practice examples. Studies to understand the factors affecting inappropriate use are required alongside improved data systems to monitor the public-sector provision of antibiotics to understand the total consumption.

Quantifying antibiotic use in typhoid fever in India: a cross-sectional analysis of private sector medical audit data, 2013-2015.

OBJECTIVES: To estimate the antibiotic prescription rates for typhoid in India. DESIGN: Cross-sectional study. SETTING: Private sector primary care clinicians in India. PARTICIPANTS: The data came from prescriptions of a panel of 4600 private sector primary care clinicians selected through a multistage stratified random sampling accounting for the region, specialty type and patient turnover. The data had 671 million prescriptions for antibiotics extracted from the IQVIA database for the years 2013, 2014 and 2015. PRIMARY AND SECONDARY OUTCOME MEASURES: Mean annual antibiotic prescription rates; sex-specific and age-specific prescription rates; distribution of antibiotic class. RESULTS: There were 8.98 million antibiotic prescriptions per year for typhoid, accounting for 714 prescriptions per 100 000 population. Children 10-19 years of age represented 18.6% of the total burden in the country in absolute numbers, 20-29 year age group had the highest age-specific rate, and males had a higher average rate (844/100 000) compared with females (627/100 000). Ten different antibiotics accounted for 72.4% of all prescriptions. Cefixime-ofloxacin combination was the preferred drug of choice for typhoid across all regions except the south. Combination antibiotics are the preferred choice of prescribers for adult patients, while cephalosporins are the preferred choice for children and young age. Quinolones were prescribed as monotherapy in 23.0% of cases. CONCLUSIONS: Nationally representative private sector antibiotic prescription data during 2013-2015 indicate a higher disease burden of typhoid in India than previously estimated. The total prescription rate shows a declining trend. Young adult patients account for close to one-third of the cases and children less than 10 years account for more than a million cases annually.

Consumption of systemic antibiotics in India in 2019.

Background: Inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations (FDC) and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country. Methods: We analyzed cross-sectional data from PharmaTrac, a nationally representative private-sector drug sales dataset gathered from a panel of 9000 stockists across India. We used the AWaRe (Access, Watch, Reserve) classification and the defined daily dose (DDD) metrics to calculate the per capita private-sector consumption of systemic antibiotics across different categories: FDCs vs single formulations; approved vs unapproved; and listed vs not listed in the national list of essential medicines (NLEM). Findings: The total DDDs consumed in 2019 was 5071 million (10.4 DDD/1000/day). Watch contributed 54.9% (2783 million) DDDs, while Access contributed 27.0% (1370 million). Formulations listed in the NLEM contributed 49.0% (2486 million DDDs); FDCs contributed 34.0% (1722 million), and unapproved formulations contributed 47.1% (2408 million DDDs). Watch antibiotics constituted 72.7% (1750 million DDDs) of unapproved products and combinations discouraged by the WHO constituted 48.7% (836 million DDDs) of FDCs. Interpretation: Although the per-capita private-sector consumption rate of antibiotics in India is relatively low compared to many countries, India consumes a large volume of broad-spectrum antibiotics that should ideally be used sparingly. This, together with significant share of FDCs from formulations outside NLEM and a large volume of antibiotics not approved by the central drug regulators, call for significant policy and regulatory reform. Funding: Not applicable.

Out-of-pocket expenditure on childhood infections and its financial burden on Indian households: Evidence from nationally representative household survey (2017-18).

The key objective of this research was to estimate out of pocket expenditure (OOPE) incurred by the Indian households for the treatment of childhood infections. We estimated OOPE estimates on outpatient care and hospitalization by disease conditions and type of health facilities. In addition, we also estimated OOPE as a share of households' total consumption expenditure (TCE) by MPCE quintile groups to assess the quantum of the financial burden on the households. We analyzed the Social Consumption: Health (SCH) data from National Sample Survey Organization (NSSO) 75th round (2017-18). Outcome indicators were prevalence of selected infectious diseases in children aged less than 5 years, per episode of OOPE on outpatient care in the preceding 15 days, hospitalization in the preceding year and OOPE as a share of households' total consumption expenditure. Our analysis suggests that the most common childhood infection was 'fever with rash' followed by 'acute upper respiratory infection' and 'acute meningitis'. However, the highest OOPE for outpatient care and hospitalization was reported for 'viral hepatitis' and 'tuberculosis' episodes. Among the households reporting childhood infections, OOPE was 4.8% and 6.7% of households' total consumption expenditure (TCE) for outpatient care and hospitalization, respectively. Furthermore, OOPE as a share of TCE was disproportionately higher for the poorest MPCE quintiles (outpatient, 7.9%; hospitalization, 8.2%) in comparison to the richest MPCE quintiles (outpatient, 4.8%; hospitalization, 6.7%). This treatment and care-related OOPE has equity implications for Indian households as the poorest households bear a disproportionately higher burden of OOPE as a share of TCE. Ensuring financial risk protection and universal access to care for childhood illnesses is critical to addressing inequity in care.

Comparison of mammosphere formation from stem-like cells of normal breast, malignant primary breast tumors, and MCF-7 cell line.

BACKGROUND: Mammosphere formation assay has become a versatile tool to quantify the activity of putative breast cancer stem cells in non-adherent in vitro cultures. However, optimizing the suspension culture system is crucial to establish mammosphere cultures from primary breast tumors. METHODS: This study aimed at determining the self-renewal and sphere-forming potential of breast cancer stem-like cells derived from human primary invasive ductal carcinoma and normal breast tissue samples, and MCF-7 breast cancer cell line using an optimal suspension culture system. Mammosphere-forming efficiency of the mammospheres generated from the tissue samples and cell line were compared. We evaluated the expression of CD44+/CD24-/low and CD49f+/EpCAM-/low phenotypes in the stem-like cells by flow cytometry. CK-18, CK-19, α-SMA, and EpCAM marker expression was assessed using immunohistochemical staining. RESULTS: Breast epithelial cells isolated from the three samples formed two-dimensional spheroids in suspension cultures. Interestingly, mammospheres formed from patient-derived primary breast tumors were enriched in breast cancer stem-like cells with the phenotype CD44+/CD24-/low and exhibited a relatively more number of large spheres when compared to the normal breast stem cells. MCF-7-derived SCs were more aggressive and resulted in the formation of a significantly higher number of spheroids. The expression of CK-18/CK-19 and α-SMA/EpCAM proteins was confirmed in breast cancer tissues. CONCLUSIONS: Thus, the use of primary tumor specimens and breast cancer cell lines as suitable models for elucidating the breast cancer stem cell activity was validated using mammosphere culture system.

Health policy and systems research: an inconsistent priority in South East Asia.

Objectives and importance of study: The need for sufficient and reliable funding for health policy and systems research (HPSR) has attracted varying responses globally. Countries assisted by the South East Asian Regional Office (SEARO) of the World Health Organization (WHO) together make up one-quarter of the world's population. HPSR is not given a high priority in several SEARO countries, so there is a need to understand the barriers and facilitators that influence national HPSR funding. Our study aimed to fill this gap in the literature by studying the barriers to HPSR in five SEARO countries - Republic of Maldives, Nepal, Sri Lanka, Thailand and India - and the key political factors influencing HPSR funding. STUDY TYPE: Mixed methods. METHODS: We conducted an in-depth desk review to obtain a general overview of HPSR in the five SEARO member countries. The review findings were used to frame a discussion guide for semi-structured interviews with key policy makers, health system experts and academics in the intervention countries. During the interviews, we validated the data from the desk review and explored the following key themes: a) the existing health system landscape of the country; b) organisations involved with HPSR; c) the nature of HPSR funding in the country (demand/supply led); d) budgetary allocations for HPSR; e) barriers to HPSR funding; f) measures to strengthen HPSR funding; and g) suggestions for the right mix for future HPSR funding. The study was conducted from October to December 2020. RESULTS: Thailand is the only country among those studied with a well-established institution dedicated to HPSR. India, Sri Lanka, Republic of Maldives and Nepal are still lagging in providing a solid foundation for HPSR. Most of the countries lack a common definition of HPSR and a dedicated stream for HPSR funding. There is also a lack of local capacity to independently lead and conduct HPSR in most of the study countries. CONCLUSION: We have provided a profile of the existing landscape of health systems in the SEARO member countries and highlighted the determinants of HPSR funding. A common definition and interpretation of HPSR is required, which extends beyond geographical and disciplinary boundaries. There is a need for enhanced core domestic funding along with increased recruitment and availability of HPSR researchers in the study countries.

Evidence-based National Vaccine Policy.

India has over a century old tradition of development and production of vaccines. The Government rightly adopted self-sufficiency in vaccine production and self-reliance in vaccine technology as its policy objectives in 1986. However, in the absence of a full-fledged vaccine policy, there have been concerns related to demand and supply, manufacture vs. import, role of public and private sectors, choice of vaccines, new and combination vaccines, universal vs. selective vaccination, routine immunization vs. special drives, cost-benefit aspects, regulatory issues, logistics etc. The need for a comprehensive and evidence based vaccine policy that enables informed decisions on all these aspects from the public health point of view brought together doctors, scientists, policy analysts, lawyers and civil society representatives to formulate this policy paper for the consideration of the Government. This paper evolved out of the first ever ICMR-NISTADS national brainstorming workshop on vaccine policy held during 4-5 June, 2009 in New Delhi, and subsequent discussions over email for several weeks, before being adopted unanimously in the present form.

The impact of stringent prescription-only antimicrobial sale regulation (Schedule H1) in India: an interrupted time series analysis, 2008-18.

OBJECTIVES: To assess the impact of Schedule H1 regulation notified and implemented in 2014 under the amended rules of the Drugs and Cosmetics Act (DCA), 1940 on the sale of antimicrobials in the private sector in India. METHODS: The dataset was obtained from the Indian pharmaceutical sales database, PharmaTrac. The outcome measure was the sales volume of antimicrobials in standard units (SUs). A quasi-experimental research design-interrupted time series analysis-was used to detect the impact of the intervention. RESULTS: We observed a substantial rise in antimicrobial consumption during 2008-18 in the private sector in India, both for antimicrobials regulated under Schedule H1 as well as outside the regulation. Key results suggested that post-intervention there was an immediate reduction (level change) in use of Schedule H1 antimicrobials by 10% (P = 0.007), followed by a sustained decline (trend change) in utilization by 9% (P > 0.000) compared with the pre-intervention trend. Segregated analysis on different antimicrobial classes suggests a sharp drop (level changes) and sustained decline (trend changes) in utilization post-intervention compared with the pre-intervention trend. Our findings remained robust on carrying out sensitivity analysis with the oral anti-diabetics market as a control. Post-intervention, the average monthly difference between antimicrobials under Schedule H1 and the control group witnessed an immediate increase of 16.3% (P = 0.10) followed by a sustained reduction of 0.5% (P = 0.13) compared with the pre-intervention scenario. CONCLUSIONS: Though the regulation had a positive impact in terms of reducing sales of antimicrobials notified under the regulation, optimizing the effectiveness of such stand-alone policies will be limited unless accompanied by a broader set of interventions.