Patient Experience from Rural India (PERI) for the Global Medical Product Lifecycle

China and India hold the first and third largest share of global gross domestic product (GDP) at purchasing power parity (PPP) – and have led the broader shift in global economic power towards emerging market and developing economies (EMDEs). India is growing rapidly, and is projected to reduce its share gap with the United States (US), the second largest contributor to global GDP (PPP), to just 3.5 percentage points within 5 years.¹

Rural India accounts for 46% of India’s GDP,² and receives an estimated USD 36–48 billion (2024) in domestic remittances³ as well as a share of international remittances (USD 151 billion in 2025) – of which India has been the world’s largest recipient over the past 2 decades.⁴ It is also home to 64% of India’s population,⁵ and bears 77% of its recorded deaths due to non-communicable diseases (NCDs).⁶ Yet, rural India remains a large market that innovative medical companies do not research and reach well.

Patient experience data (PED) from rural India can inform the global medical product lifecycle of these companies. Before launch, they can shape no-regret design choices in target product profiles (TPPs) that, at once, work for rural India and traditional advanced economy markets. After launch, they can offer an early return on investment by showing how patients judge the efficacy, safety, quality and price of medicines, why and when they start and stop treatment, and what they are willing to pay for – insights that can sharpen market access, medical affairs and adherence programs.

PED are increasingly being used in regulatory decision-making. The US Food and Drug Administration (FDA) considers PED throughout the drug development and review process – a consideration that “begins even before a sponsor initiates a formal drug development program”. PED were mentioned in reviews of 73% of new molecular entities (NMEs) it approved during 2021–25. However, the FDA has also highlighted gaps. For instance, submitted PED may underrepresent “individuals with low health literacy” – with weaknesses in qualitative, quantitative and mixed methods studies undermining their rigour.⁷ The European Medicines Agency (EMA) notes that there is less experience with qualitative data, that qualitative preference studies are “most suitable for situations where knowledge is still limited, such as the early phases of a medicine’s lifecycle”.⁸

This Brief provides a snapshot of patient experience from rural India, with NCDs as a case study. It is based on what the FDA describes as a quantitatively driven sequential study design⁹ – involving 22 mixed methods, semi-structured, in-depth interviews (IDIs) with NCD patients as well as 8 focus group discussions (FGDs) with village communities and 19 with 164 primary health staff in the Rampur district of Uttar Pradesh – home to 20% of India’s rural population.^5,10

• Multiple conditions. Most patients (14 of 22) reported multimorbidity or multiple long-term conditions (MLTCs) that tend to adversely synergise each other.
• Monitoring conditions. Most patients don’t have monitoring devices at home, and often rely on “feelings” (symptoms) to get a sense of their blood glucose or blood pressure levels. They sometimes get their blood glucose or blood pressure levels tested at private or public facilities – but there are some who rarely get tested due to fear of needles and blood. Nevertheless, there is a willingness to have devices for home monitoring.
• NCD training and awareness. Lack of proper NCD training of frontline health workers and awareness among rural communities is the most fundamental challenge for the screening, prevention, treatment and management of NCDs.
• Symptomatic rather than chronic care. Almost all NCD patients adopt a symptomatic approach to treatment – they take medicines when they feel unwell and discontinue them when they feel well. The sense of chronic care is missing.
• Medicines that work and enable work. Patients want medicines that work (real-world effectiveness) and enable them to work – without causing weakness or adverse effects from long-term use, especially to the kidneys.
• Willingness to pay. Some poor patients are willing to invest up to 30% of their monthly income in such medicines – and work extra hard to afford them – so that they can continue to work and earn.
• Preference for private care. Most NCD patients turn to private care and view government medicines (cheap generics) as low quality and ineffective. However, some, including the better-off, trust and use public care.

Regulators in the US and Europe have been making efforts “to steer medicine development towards programmes that not only meet the requirements for quality, safety and efficacy of individual products, but also incorporate the broader perspectives of patients and carers”.⁸ According to the US Food and Drug Administration (FDA), patients “are experts on what it is like to live with the condition”, and are “in a unique position to contribute to an understanding of benefit and risk considerations throughout the medical product development process”.¹⁶ The European Medicines Agency (EMA) argues that “patients may value different aspects of their disease and available treatments than medicine developers”, and “an optimal patient-relevant medicine development programme incorporates patients’ perspectives and documents their experience”.⁸

United States

The FDA’s focus on Patient-Focused Drug Development (PFDD) goes back to 2012, when it pioneered PFDD meetings as “a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation”.¹⁷ In subsequent years, more clarity was provided in the US on the meaning of patient experience data (PED) and methods for their collection.

Section 3001 of the 21st Century Cures Act, 2016 outlined that PED are “intended to provide information about patients’ experiences with a disease or condition, including—(A) the impact of such disease or condition, or a related therapy, on patients’ lives; and (B) patient preferences with respect to treatment of such disease or condition”. Section 3002 required the FDA to develop guidance documents for the collection of PED and their use in drug development.¹⁸

The FDA issued 4 PFDD guidance documents between 2020 and 2025; Guidance 4 is still a draft.¹⁹ Guidance 1 (2020) included “the signs and symptoms patients experience” and how they “affect their day-to-day functioning and quality of life” within the ambit of PED. It also noted that “qualitative, quantitative, or mixed methods may be appropriate for collection of” PED. Guidance 2 (2022) set out best practices in qualitative research, noting that “focus groups could be used in preliminary research to explore a broad topic followed by one-on-one interviews to obtain more detailed information on the topic of interest”, and described quantitatively and qualitatively driven sequential and concurrent mixed methods designs. Guidance 3 (2025) helps sponsors select, develop or modify “fit-for-purpose” clinical outcome assessments (COAs) – measures of how patients feel or function. It notes that where a concept closely reflects patients’ daily lived experience, “patients’ input regarding the items/setup/tasks (e.g., through qualitative studies) is important”. Study samples should “reflect the clinical characteristics and demographics of the target patient population”, and include “reporters who reflect the range of literacy and numeracy in the target population”.¹⁹

A 2026 assessment – based on focus group discussions (FGDs) with FDA staff and a review of 800 drug and biologic submissions approved between February 2021 and December 2025 – found that “FDA reviewers consider and use patient experience data throughout drug development and the review process”, and that “FDA’s consideration of patient experience data begins even before a sponsor initiates a formal drug development program”. PED are “evaluated in support of regulatory decisions, including benefit-risk determinations and labeling claims”.⁷

According to the assessment, “early stage discussions of patient experience data with FDA include conversations about the appropriateness of planned qualitative research methods, how patient experience data will inform the sponsor’s target product profile, and early endpoint planning including the feasibility of collecting data in the intended population (e.g., patient preference studies which can inform endpoint selection or hierarchy…)”. PED also “informs discussions about which concepts to target for measurement, such as symptoms, functioning, and health-related quality of life, and whether those concepts are salient and meaningful to patients”. It “further informs discussions about clinical trial design and conduct”, including dosing regimens, routes of administration and the burden that trials place on patients.⁷

Europe

The EMA’s draft reflection paper on PED (2025) defines them as data that “directly reflect the experience of a patient or carer, without input or interpretation by a healthcare professional, third party or (artificial intelligence [AI]-based) device”. Patient experience can include “health and functional status, disease symptoms, disease course, treatment preferences, QoL [quality of life], factors impacting treatment adherence, treatment outcomes and side effects”. It can be collected through quantitative methods, such as patient-reported outcome measures (PROMs); “qualitative methods (e.g., interviews, focus groups or qualitative surveys that reflect the wider perspective of patients’ experience)”; or mixed methods. Key points from the paper include:⁸

• Lifecycle approach. PED “should be systematically considered for informing medicines development from the earliest stages (including non-clinical stages) through to post marketing”, and can also inform health technology assessment (HTA), pricing and reimbursement. Stakeholders “are therefore encouraged to embed PED across all stages of medicine development”.
• Key gaps. PED “are not systematically included in all aspects of medicine development”. While patient-reported outcomes (PROs) “have already been accepted as efficacy endpoints for clinical trials, there is less experience with other PED types such as patient preferences or with qualitative data from patient engagement activities”.
• Early qualitative data. Early patient engagement by medicines developers in research and development “can contribute to establishing the right research questions, providing insights into patients’ preferred outcomes and selection of appropriate measures (such as PROs), medicine characteristics and their views on the balance between risks and benefits”. Qualitative preference studies are “most suitable for situations where knowledge is still limited, such as the early phases of a medicine’s lifecycle”.
• Representativeness. Patients’ perceptions of disease burden and treatment preferences “may differ across geographical areas” – and PED representativeness can be improved “by involving a wider range of patients, using varied methods of data collection”.
• Early advice. Existing guidelines on PED in the European Union (EU) are “either fragmented or outdated”, which “creates uncertainties for medicines developers”, and the reflection paper itself “does not include detailed methodological guidance”. The EMA, therefore, encourages developers to seek its scientific advice on PED at the earliest possible stage, preferably jointly with HTA bodies.

International Council for Harmonisation (ICH)

The ICH’s draft E22 guideline on patient preference studies (2025) notes that qualitative preference studies “may be useful, for example, in the form of interviews, to identify which attributes are important to patients”, and that studies conducted in other regions “may inform regulatory drug assessment and related decisions in the local region”, provided applicants offer a justification.²⁰ Its E5 guideline (1998) recognises “extrinsic” ethnic factors, “associated with the environment and culture in which a person resides”, including “medical practice, diet”, “socioeconomic status” and “compliance with prescribed medications”.²¹

To begin with, UHC360 is collecting PED from NCD patients in the rural areas of UP’s Rampur district – where it is also supporting the public primary health system (PPHS) for robust collection and analysis of NCD data. PPHS staff are supposed to collect data on metabolic, behavioural and environmental risks and symptoms as well as screen all adults aged 30 years and above – 719 million in India, 107 million in UP – for common NCDs.⁵

We began with UP as it is home to 20% of India’s rural population, and has the world’s 6th highest burden of NCD DALYs and 8th highest burden of NCD deaths. Rampur was chosen because it had the 5th lowest literacy rate (53%)²² in UP, and a lower NCD service coverage (8%)¹³ than the 4 districts with a lower literacy rate. There is enormous unmet need for NCD care as well as willingness to pay.

Following FDA Guidance 2 – that “focus groups could be used in preliminary research to explore a broad topic followed by one-on-one interviews to obtain more detailed information on the topic of interest”⁹ – we began with 8 FGDs (February to April 2026) with village communities to explore their broad perspectives on the local prevalence and determinants of NCDs as well as their treatment pathways, preferences and challenges. Since April 2026, we have interviewed 22 NCD patients (Exhibit 2), and conducted 19 FGDs with 164 primary health staff for baseline evaluation of NCD data collection by the PPHS.²³ All field research was led by the author, who has 21 years of experience in mixed methods research, and recently led an endline evaluation of a primary health intervention, implemented by the Johns Hopkins University with its partner institutions in rural Gujarat, India.

PED interviews

Interviews took place in Rampur’s Swar and Saidnagar blocks – 6 at a brick kiln, whose owner mobilised respondents from nearby villages through his staff, and the rest at PPHS facilities, where staff either called in NCD patients who lived nearby or asked doctors to send visiting NCD patients to a room set aside for the interviews. PPHS facilities served mainly as venues: some of those interviewed there were not receiving any treatment; some were being treated privately, and others at the PPHS. Thanks to their regular household visits, frontline health workers (FHWs) tend to know NCD patients in their respective areas. During our recent visit (31 October to 3 November 2026), we also interviewed the owners of a private radiology centre, a private pharmacy and a Janaushadhi Kendra – a government-supported, privately owned pharmacy for highly affordable generics.

Others were present during most of the interviews, but this did not appear to affect their responses. At PPHS facilities, respondents were able to talk openly about the challenges in their services – an FHW even said that she seeks private care because medicines in the PPHS are not effective. Even at the brick kiln, respondents openly discussed the impact of NCDs on their ability to work and earn in front of the owner. PPHS staff, too, have been forthcoming about their challenges and weaknesses.

Verbal consent was sought from the respondents in Hindi, UP’s and the author’s native language. Only the FGDs with village communities were audio-recorded; handwritten notes were taken in all other cases. Health conditions reported during patient interviews were coded according to the World Health Organization’s (WHO) International Classification of Diseases, 11th Revision (ICD-11) (Exhibit 2).²⁴

Interview tool

Given repeated references to mental health problems during village FGDs, we decided to use the self-translated Hindi version of the World Health Organization-Five Well-Being Index (WHO-5) for structured questions during our first 6 patient interviews.²⁵ Since family emerged as a major driver of well-being in these interviews, we started searching the literature for other relevant tools for the structured component of our future interviews. Realising that none of the existing tools could be used in their current form in our context, we decided to select and adapt questions from some of them. We developed a tool that we piloted for 9 patient interviews in July 2026 – and whose revised version we used for the remaining 7 interviews during our recent visit.

It is a mixed methods, semi-structured tool, designed to build rich patient experience narratives, following what the FDA describes as a quantitatively driven sequential design.⁹ It begins with structured questions that cover patients’ medical profile (diseases, treatment, willingness to pay, functional and financial impact), social determinants of health, life satisfaction, overall, mental, social and family well-being. Several of these questions were adapted for our context from the WHO-5, the WHO World Health Survey Plus and the Hong Kong Family Wellbeing Index.^25–27 A semi-structured IDI then explores potential interconnections between their responses and elicits other information that patients consider important.

Limitations

Our field research has so far been exploratory and based on convenience rather than purposive sampling. Our findings should, therefore, not be seen as comprehensive or representative in any way. Their aim, in any case, was to provide a snapshot of patient experience from rural India and illustrate its value for the global medical product lifecycle.

Both the FDA and the EMA see a role for PED across the medical product lifecycle (Chapter 2). Given the growing shift in global economic power towards emerging market and developing economies (EMDEs) like India, that lifecycle needs to be increasingly global, from the design phase itself, for research-based, patient-centric companies in particular. Before launch, PED from EMDE contexts like rural India can help shape no-regret design choices for products that work, at once, for EMDE and traditional advanced economy contexts. An example is GE Healthcare’s handheld electrocardiogram (ECG) device, which was developed with rural India in view, but sold in the US as well.²⁸ After launch, such PED can offer an early return on investment by showing how patients judge the efficacy, safety, quality and price of medicines, why and when they start and stop treatment, and what they are willing to pay for – insights that can sharpen market access, medical affairs and adherence programs.

Exhibit 3 maps our key PED from rural India onto the medical product lifecycle – from the type of medicines patients want to how they use them. Across stages, patients’ health care decisions appear to be strongly shaped by self, society and systems – what they feel (their symptoms), what others say and what the local health system offers.

Medical anthropologist Merrill Singer coined the term “syndemics” in the early 1990s, and defined it “as the aggregation of two or more diseases or other health conditions in a population in which there is some level of deleterious biological or behaviour interface that exacerbates the negative health effects of any or all of the diseases involved”.⁴²

Evidence from the US and Europe indicates that diabetes and depression frequently cluster in patients – decreasing their adherence to treatment and healthy lifestyle, worsening their overall health and quality of life, and heightening the risk of admission to intensive care units and mortality. However, despite the potential of such adverse health effects, “depression remains underdiagnosed and undertreated in people with diabetes” even in such high-income countries, while “the best treatments to address medical and psychological outcomes simultaneously in patients with depression and diabetes are not known”.⁴³ Further, “the exact direction of this relationship remains unclear”.⁴⁴

A 60-year-old father of 6 told us how rising age had reduced his capacity to earn and contribute to family expenses, which made his married elder sons unsupportive and left him lonely and depressed. A daughter, whom he had sent to another city for higher education, refuses to marry, which is another source of stress for him. He strongly felt that his family circumstances made him depressed, which led to his diabetes, diagnosed 5–6 years ago.

He took diabetes medicines for some time, but since they were not very effective and his food restrictions were making him feel weak, he gave up his prescribed treatment and lifestyle. Depressed, with no desire to get better, he now eats jaggery before and after work. He feels excessively thirsty at night and often wakes up to drink water and urinate, which disturbs his sleep and leads to further depression and fatigue at work – making his life neeras (dull).

Our findings – and the case study in particular – are better understood within the demographic and socioeconomic context in which patients live and work.

Demographic and socioeconomic changes

India’s population is ageing rapidly – its elderly (60 years and above) population is estimated to be 218 million (15.4%) in 2026, and is projected to rise to 325 million (20.4%) by 2051.⁴⁵ The man in our case study (Exhibit 4) linked his depression, diabetes and disturbed sleep to his changing demographic and socioeconomic conditions. He was not alone. For instance:

• A woman (over 60) said her 2 married sons do not care for her, and that her children say their parents have done nothing for them.
• A man (60), whose married children work and earn, but do not support him financially, works extra hard to afford his treatment and household expenses; after buying medicines, he said, there is no flour at home.

Our baseline evaluation found a similar pattern among FHWs: some over 70 continue to work because they feel that their children do not care for them, and “that they have to continue working to support themselves financially and be physically active to stay healthy”.²³

Why women want to work

Our baseline evaluation of FHWs – all of them women – points to several reasons why women want to work in a predominantly patriarchal rural context:²³

• Hope of empowerment. The hope of Nari Shakti (women’s empowerment) – and of better work status in the future – motivates them to continue working.
• Freedom. Working outside the home provides “freedom from the confines of the house, and from the domestic drudgery that comes with it”.
• Financial independence. Whatever little they earn offers “a degree of financial independence” – to spend on themselves or, often, on the education of their children or grandchildren. An FHW (57) continues to work so that she has some money of her own and can support her daughters and their families. Another FHW (32), who suffers from several health challenges, continues to work so that she can send her children to better schools.
• Respect. Contributing to household expenses raises their respect (izzat) within the family, and they are respected and sought after in the community for the health care support they provide.
• Peer support. Working with other FHWs gives them social support that helps them overcome personal challenges.

Paid work does not replace unpaid domestic work. The FHW (32), whose illness has substantially reduced her capacity to work, said her official work has to be completed, despite the fact that it affects her domestic work and ability to monitor her children’s education – and that she is not valued at home because she cannot attend properly to domestic work.

What this means for medicines

Medicines that work and enable people to work are, therefore, not just a concern of the male working-age population, but extend to a wider population across gender and age: older people who need to remain independent and active, and women who manage both paid and unpaid work. The FHW (32) said she wishes to get good treatment so that she can work well both at home and at work.

Economic hardship does not mean an absence of demand: even poor patients who could use free public care pay for private treatment out-of-pocket because they trust it works and enables them to work.

UHC360 usually conducts quantitatively driven sequential mixed methods research – beginning with structured quantitative questions, followed by IDIs with patients and carers, and key informant interviews (KIIs) with public and private providers as well as other key experts and stakeholders. The health conditions that patients report during the interviews are coded to WHO’s ICD-11 to facilitate use by clinical teams. Our aim is to build rich patient narratives on NCDs and other health concerns, on multimorbidity, syndemics and the socioeconomic and demographic context in which patients make treatment decisions. Our IDIs build on each patient’s cluster of conditions and circumstances, captured through structured questions at the beginning.

Although we do not run large surveys or generate extensive quantitative data ourselves, we are supporting the PPHS to collect robust population data on NCDs – and can help design or adapt instruments for quantitative studies as well as help analyse their findings based on our research. Exhibit 5 sets out what we can and cannot do at each stage of the lifecycle.

Examples of potential studies

In the light of our field research and findings so far, following are a few studies that could be helpful as far as PERI is concerned. However, we would be glad to conduct mixed methods or qualitative studies around a company’s own themes and research questions as well as tailor the study design, scope, sample size, etc. to its needs.