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A comprehensive picture of provider coalitions in health policy making remains incomplete because of the lack of empirically driven insights from low- and middle-income countries. The authors examined the politics of provider coalitions in the health sector in Karnataka, India, by investigating policy processes between 2016 and 2018 for developing amendments to the Karnataka Private Medical Establishments Act. Through this case, they explore how provider associations function, coalesce, and compete and the implications of their actions on policy outcomes. They conducted in-depth interviews, document analysis, and nonparticipant observations of two conferences organized by associations. They found that provider associations played a major role in drafting the amendments and negotiating competing interests within and between doctors and hospital associations. Despite the fragmentation, the associations came together to reinterpret the intentions of the amendments as being against the interests of the profession, culminating in a statewide protest and strike. Despite this show of strength, provider associations only secured modest modifications. This case demonstrates the complex and unpredictable influence of provider associations in health policy processes in India. The authors' analysis highlights the importance of further empirical study on the influence of professional and trade associations across a range of health policy cases in low- and middle-income countries.

ObjectiveTo explore the accessibility and quality of existing haemodialysis services in an urban setting.SettingThe study was conducted in Bangalore city, India.ParticipantsA total of 28 stakeholders including 2 nephrologists, 7 duty doctors, 13 dialysis technicians and 6 patients on long-term haemodialysis were selected from 20 dialysis centres in Bangalore city.Design and methodsQualitative study using in-depth interviews. A thematic analysis was done using the Availability, Accessibility, Acceptability and Quality Framework of WHO and the Bruce’s Quality of Care Framework.ResultsThe study found several gaps with regard to the access and quality of existing services for patients with end-stage kidney disease (ESKD). The charges for dialysis sessions across settings displayed a wide variance. Patients often started dialysis services in private and later shifted to government and non-governmental organisations-run centres and reduced the number of weekly dialysis sessions due to financial constraints. Most standalone dialysis centres did not have the facilities to manage any emergencies. Most centres did not admit patients with hepatitis or HIV. The quality of care in dialysis centres seemed to be variable and most centres were managed solely by dialysis technicians. There were no psychosocial interventions available to the patients irrespective of the settings. Cost-cutting practices such as employing underqualified technicians, reusing dialysis equipment and using substandard water for dialysis were common.ConclusionThe study highlights the need for more financial and personnel investments in ESKD care in India to ensure optimal care for the growing patient population. The study points towards the need for comprehensive management practices, including diet counselling and psychosocial support. While there are comprehensive guidelines on the establishment and management of dialysis services, more policy attention needs to be on effective implementation of these, to ensure better accessibility and quality of existing services.

Background Parental consent rates for neonatal interventional trials are significantly higher in Low and middle-income countries (LMIC) than in high-income countries, raising concerns about the credibility of the consent processes (Patterson et al PLOS One 2021). We conducted a mixed-methods study to understand the informed consent process in a neonatal cooling trial [Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial] conducted in India, Sri Lanka and Bangladesh. Methods Term infants with neonatal encephalopathy, aged less than six hours were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed the A-V records of the consent process using a 5-point Likert scale on three parameters – Empathy, Information, Autonomy. Additionally, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 health care professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts. Results In HELIX trial, a total of 475 parents were approached, of which 408 (86%) consented. Of these, 294 A-V records were analysed. Median (Interquartile range) score for empathy, information, autonomy was 5 (0), 5 (1) and 5 (1) respectively. However, thematic analysis suggested that the parental decision to participate was based on a unreserved trust in the treating doctors, therapeutic misconception, and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial, nor the nature of the intervention. Lower levels of parental education and misinformation further convoluted the voluntary informed consent process. Parents were visibly incapacitated, and many told the doctor to do whatever is best for the baby. Clinicians lacked equipoise and were biased towards cooling therapy as it was already a standard of care in high-income countries, and this influenced parental decision making. However, the HELIX trial results subsequently showed cooling was harmful and increased mortality in these settings. Conclusion Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context appropriate strategies to ensure truly informed trial participation.

Background A large proportion of non-communicable diseases (NCDs) are treatable within primary health care (PHC) settings in a cost-effective manner. However, the utilization of PHCs for NCD care is comparatively low in India. The Access-to-Medicines (ATM) study examined whether (and how) interventions aimed at health service optimization alone or combined with community platform strengthening improve access to medicines at the primary health care level within the context of a local health system. Method A quasi-randomized cluster trial was used to assess the effectiveness of the intervention (18 months) implemented across 39 rural PHCs (clusters) of three sub-districts of Tumkur in southern India. The intervention was allocated randomly in a 1:1:1 sequence across PHCs and consisted of three arms: Arm A with a package of interventions aimed at health service delivery optimization; B for strengthening community platforms in addition to A; and the control arm. Group allocation was not blinded to providers and those who assessed outcomes. A household survey was used to understand health-seeking behaviour, access and out-of-pocket expenditure (OOP) on key anti-diabetic and anti-hypertension medicines among patients; facility surveys were used to assess the availability of medicines at PHCs. Primary outcomes of the study are the mean number of days of availability of antidiabetic and antihypertensive medicines at PHCs, the mean number of patients obtaining medicines from PHC and OOP expenses. Result The difference-in-difference estimate shows a statistically insignificant increase of 31.5 and 11.9 in mean days for diabetes and hypertension medicines availability respectively in the study arm A PHCs beyond the increase in the control arm. We further found that there was a statistically insignificant increase of 2.2 and 3.8 percentage points in the mean proportion of patients obtaining medicines from PHC in arm A and arm B respectively, beyond the increase in the control arm. Conclusion There were improvements in NCD medicine availability across PHCs, the number of patients accessing PHCs and reduction in OOP expenditure among patients, across the study arms as compared to the control arm; however, these differences were not statistically significant. Trial registration Trial registration number CTRI/2015/03/005640. This trial was registered on 17/03/2015 in the Clinical Trial Registry of India (CTRI) after PHCs were enrolled in the study (retrospectively registered). The CTRI is the nodal agency of the Indian Council of Medical Research for registration of all clinical, experimental, field intervention and observation studies.

BackgroundA large proportion of non-communicable diseases (NCD) are treatable within primary health care (PHC) settings in a cost-effective manner; however, dependence on PHCs for NCD care is comparatively low in India. The Access to Medicines (ATM) study examined the effect of a community-level and health service level package of interventions on improving availability of generic medicines at PHCs and decreasing expenditure on medicines.Method A baseline-endline quantitative experimental approach was used to assess effectiveness of the intervention (18 months) implemented across all 39 rural PHCs of three sub-districts of Tumkur district in southern Karnataka, India. Intervention consisted of three arms with A & B consisting of package of interventions aimed at health service delivery optimization within PHC, and strengthening community platforms respectively; C was the control arm. A cluster randomised household survey was used to understand health seeking behaviour, access and out-of-pocket expenditure (OOP) on key anti-diabetic and anti-hypertension medicines; similarly, facility surveys across these PHCs were conducted to assess availability of medicines. Primary outcomes of the study are mean number of days of availability of medicines, mean number of patients obtained medicines from PHC, OOP expenses and mean number of days for which medicines were procured.Result Below 50% of patients only sought care from PHCs in intervention arms and around 30% who visited got patient health records. Mean number of days of key NCD medicines availability at home did not show statistically significant differences across study arms. There was overall increase in mean days of availability of key NCD medicines at PHCs across all study arms. Although there was an overall decrease in OOP on NCD medicines and increase in number of patents visiting PHC for NCD medicines between intervention arms and control from baseline to endline the difference was not statistically significant. ConclusionThe intervention effects were not uniform within the study groups. Depending on local context some PHCs were able to overcome health system barriers better than the others. Health service interventions at PHC and community level could be hindered by wider health system challenges beyond control of localized study interventions.Trial RegistrationTrial registration number CTRI/2015/03/005640. Retrospectively Enrolled

Introduction Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. Methods The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. Results The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients’ and health workers’ perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Conclusion Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services.

Background India has the distinction of financing its healthcare mainly through out-of-pocket expenses by individual families contributing to catastrophic health expenditure and impoverishment. Nearly 70 % of the expenditure is on medicines purchased at private pharmacies. Patients with chronic ailments are especially affected, as they often need lifelong medicines. Over the past years in India, there have been several efforts to improve drug availability at government primary health centres. In this study, we aim to understand health system factors that affect utilisation and access to generic medicines for people with non-communicable diseases. Methods This study aims to understand if (and how) a package of interventions targeting primary health centres and community participation platforms affect utilisation and access to generic medicines for people with non-communicable diseases in the current district context in India. This study will employ a quasi-experimental design and a qualitative theory-driven approach. PHCs will be randomly assigned to one of three arms of the intervention. In one arm, PHCs will receive inputs to optimise service delivery for non-communicable diseases, while the second arm will receive an additional package of interventions to strengthen community participation platforms for improving non-communicable disease care. The third arm will be the control. We will conduct household and facility surveys, before and after the intervention and will estimate the effect of the intervention by difference-in-difference analysis. Sample size for measuring effects was calculated based on obtaining at least 30 households for each primary health centre spread across three distance-based clusters. Primary outcomes include availability and utilisation of medicines at primary health centres and out-of-pocket expenditure for medicines by non-communicable disease households. Focus group discussions with patients and in-depth interviews with health workers will also be conducted. Qualitative and process documentation data will be used to explain how the intervention could have worked. Discussion By taking into consideration several health system building blocks and trying to understand how they interact, our study aims to generate evidence for health planners on how to optimise health services to improve access to medicines. Trial registration Protocol registered on Clinical Trials Registry of India with registration identifier number CTRI/2015/03/005640 on 17th March 2015. Electronic supplementary material The online version of this article (doi:10.1186/s12913-016-1680-3) contains supplementary material, which is available to authorized users.

Introduction Non-communicable diseases (NCDs) have become a major public health challenge worldwide; they account for 28 million deaths per year in low-and-middle-income countries (LMICs). Like many other LMICs, India is struggling to organise quality care for a large NCD-affected population especially at the primary healthcare level. The aim of this study was to assess local health system preparedness in a south Indian primary healthcare setting for addressing diabetes and hypertension. Methods This paper draws on a mixed-methods research study on access to medicines conducted in Tumkur, Karnataka, India. We used quantitative data from household and health facility surveys, and qualitative data from focus group discussions and in-depth interviews with health workers and patients. We identified systemic drivers that influence utilisation of services at government primary health centres (PHCs) using thematic analysis of qualitative data and a systems framework on access to medicines to assess supply and demand side factors. Results Majority of households depend on private facilities for diabetes and hypertension care because of the lack of laboratory facilities and frequent medicine stockouts at PHCs. Financial and managerial resource allocation for NCDs and prioritisation of care and processes related to NCDs was suboptimal compared to the prominence of this agenda at global and national levels. Primary healthcare has a limited role even in the activities under the national programme that addresses diabetes and hypertension. Discussion The study finds critical gaps in the preparedness of PHCs and district health systems in organising and managing care for diabetes and hypertension. Due to the lack of continuous care organised through PHCs, patients depend on expensive and often episodic care in the private sector. There is a need to improve managerial and financial resource allocation towards diabetes and hypertension (and other NCDs) at the district level. Trial registration number CTRI/2015/03/005640; Pre-results.

Launching of the the National Rural Health Mission (2005) has brought a sharp policy attention to maternal health with its several initiatives such as (a) cash and material benefits to pregnant women; (b) strengthening health institutions especially of First Referral Units (FRUs); and (c) conducting regular maternal death audits to ensure quality Emergence Obstetric Care (EmOC). In spite of these efforts, the decline in maternal mortality ratio is rather slow and not achieved as per the MDG 5 goal. This study was undertaken to understand why despite infusion of such vast resources into the health system, timely and quality EmOC services have not been implemented.

Background Prevalence of tobacco use among adolescents in India is very high. Despite many epidemiological studies exploring tobacco use among youth, there is no published data on adolescents' perceptions about smokers in Indian society and its implications on tobacco control. Methods A cross-sectional study was conducted using a stratified random sampling with probability proportional to school-type (government or private owned). Data was collected using a pretested, self-administered, anonymous questionnaire with a mix of close and open-ended questions from a sample of 1087 students. Chi-square test was used to measure associations. Qualitative data was analysed through inductive coding. Results The response rate for the study was 82.5% and the sample population had a mean age of 16.9 years (SD = 1.9) with 57.8% male students. Majority of respondents (84.6%) reported negative perceptions about smokers while 20.4% of respondents reported positive perceptions. Female students reported significantly higher disapproval rate (negative perceptions) for smoking compared to male students (89.7% Vs 71.6% in case of male smoker; 81.2% Vs 67.3% in case of female smoker). Dominant themes defining perceptions about smokers included 'hatred/hostility/Intolerance', 'against family values/norms', 'not aware of tobacco harms' and 'under stress/emotional trauma'. Themes like 'culture', 'character' and 'power' specifically described negative social image of female smoker but projected a neutral or sometimes even a positive image of male smoker. There was a significant association between adolescents' positive perceptions of smokers and tobacco use by themselves as well as their close associates. Conclusions Adolescents' stereotypes of smokers, especially female smokers are largely negative. We suggest that tobacco control interventions targeting adolescents should be gender specific, should also involve their peers, family and school personnel, and should go beyond providing knowledge on harmful effects of smoking to interventions that influence adolescents' social construct of smoking/smoker.

Evidence shows that eight per cent of maternal mortality in India is caused by unsafe abortions. India was one of the pioneer countries to legalize its abortion services as early as 1971. The Medical Termination of Pregnancy Act (MTP) is an enabling regulation, which allows MTP on both medical and social grounds and thus facilitates access to safe abortion services. However, despite this supposedly progressive law, which has existed for more than four decades, ‘illegal’ and unsafe abortions are still a reality in India particularly in rural areas. There is a large body of research on MTP that examines barriers to access safe abortion services from the users’ perspectives. This paper turns the research gaze from the users to the providers particularly at the primary health care level to examine the persistence of illegal and unsafe abortions in rural Karnataka.