A Mixed-Methods Assessment of India’s Health Technology Assessment Ecosystem

Abstract

Objective

This study aims to evaluate the technical quality of health technology assessment (HTA) studies conducted in India. Second, we aim to identify process-related challenges across the life cycle of an HTA from commissioning to policy translation.

Methods

A mixed-methods approach was employed to assess HTA studies conducted between 2018 and 2023 conducted by ten regional resource centers. The quantitative assessment involved reviewing 26 HTA reports using the Indian HTA Quality Appraisal Checklist. The qualitative component included semi-structured interviews with staff from six regional resource centers and the Health Technology Assessment in India secretariat to explore the processes of topic selection, study conduct, stakeholder engagement, and evidence to policy translation. Quantitative data were analyzed through scoring and categorization into quality ratings, while qualitative data were analyzed thematically using the framework method.

Results

In the quantitative assessment, 14% (n = 3) of studies were found to be of excellent quality, 50% (n = 11) were deemed to be of good quality, 32% (n = 7) were of average quality, and only one (4%) of poor quality. The qualitative findings highlighted limited adherence to guidelines, challenges in framing the topic, and gaps in technical expertise for advanced analyses. Additionally, a high staff turnover, the need for better stakeholder consultations, and strategies to disseminate the evidence were also highlighted.

Conclusions

These findings emphasize the need for improvements in adherence to guidelines, transparency in topic selection, and alignment of HTA findings with policy needs. Investments in training, advanced methodology guidance, and systematic communication between researchers and policy makers are crucial to enhancing HTA’s impact in India.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40258-025-00995-4.

Key Points for Decision Makers

Key findings include limited adherence to guidelines, especially among newer regional resource centers facing capacity constraints, and barriers such as inadequate data access and gaps in technical expertise (e.g., uncertainty analysis, equity evaluation, budget impact).

Limited stakeholder consultations, a high staff turnover, and weak communication between regional resource centers and user departments, i.e., those who request and use the health technology assessment evidence generated, further compounded the challenges.

While strides have been made in building processes, capacity, and data systems, challenges remain in guideline adherence, data quality, and stakeholder engagement. Priorities include mandating tools such as the Health Technology Assessment Quality Appraisal Checklist, enhancing stakeholder collaboration, and implementing targeted capacity building to retain skilled personnel.

Strengthening partnerships among regional resource centers, user departments, and stakeholders can improve ownership and policy translation of health technology assessment findings. These insights and recommendations are valuable for other low- and middle-income countries institutionalizing health technology assessment in healthcare systems.

Introduction

Health technology assessment (HTA) has long been recognized as a valuable tool for enhancing evidence-based decision making in healthcare [1]. Health technology assessment is a multidisciplinary process that examines the clinical, social, economic, organizational, and ethical dimensions of health interventions or technologies [2]. It evaluates the case for reimbursing new technologies typically by assessing clinical effectiveness and conducting cost-effectiveness and budget impact analyses. Health technology assessment agencies have been established within governmental bodies, academic institutions, and other organizations in different countries to support such evidence-driven policy making. Notable examples include the Canadian Agency for Drugs and Technologies in Health (CADTH), the National Institute for Health and Care Excellence (NICE) in the UK, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), and Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) [3–9]. In addition to these high-income countries, several low- and middle-income countries, including India, have also integrated HTAs into their healthcare decision-making frameworks. Countries such as Malaysia, Thailand, South Korea, Brazil, and Indonesia have made significant strides in incorporating HTAs into their health policy structures [10, 11].

While HTA is a rapidly evolving field essential for enhancing evidence-based decision making [12], the technical rigor of HTA studies, and hence the confidence level in evidence is central to improving clinical and policy outcomes [13, 14]. Globally, HTA bodies face key challenges, including the need for standardized methods for economic evaluations and evidence grading, as well as addressing evidence gaps and managing data limitations, particularly for emerging technologies. Overcoming these challenges, along with adherence to national guidelines, is essential for improving the quality and comparability of economic evaluations [15–18]. As evident from the literature, most of the identified gaps relate to methodological practices, and it is crucial to explore the reasons behind these shortcomings.

A systematic review conducted in 2015 that evaluated the quality of HTA studies in India reported substantial shortcomings across the board [19], particularly the failure to adequately address uncertainties in modeling (with only about one third of the studies assessing structural uncertainties), to conduct sub-group analyses for heterogeneity, or to address methodological uncertainty [19]. In a more recent review, 23 studies were rated as excellent, 8 as very good, and 4 as good, with an average quality score of 19.21 out of 24 [20]. However, these evaluations only provide an answer to “what” is the quality, but does not answer “why” is the quality good or bad and “how” it can be improved. To gain a comprehensive understanding of the same, it is essential to complement quantitative assessments with qualitative insights into the constraints in capacity. Second, these evaluations from India reflect the situation before the institutionalization of the HTA agency, i.e., the Health Technology Assessment in India (HTAIn) [21]. Since then, several advancements have occurred, including the establishment of methodological guidelines [22–25], reference cases for economic evaluations [26], the development of a cost database [27], the EQ-5D-5L value set [28], and several efforts towards building capacity. Therefore, it is necessary to assess the current status of HTA practices under the HTAIn to understand the progress and ongoing challenges since its institutionalization.

Third, another critical aspect to consider is whether this HTA evidence translates into policy, and the facilitators and barriers to this process. Research from upper to middle- and high-income countries shows that the relationships, engagement, and contact between stakeholders are pivotal to policy translation [29]. Additionally, the availability of credible and relevant research is ranked as a top facilitator [29]. Another study highlighted that personal contact, timely relevance, and providing policy recommendations with summaries were among the most frequently mentioned facilitators [30]. Similarly, findings from Colombia identified the most significant barriers as an inadequate presentation format, the absence of policy networks, and insufficient legal support [31]. However, the evidence about this aspect is limited in the context of low- and middle-income countries including India.

Given this context, it is essential to assess both quantitative and qualitative aspects of HTA practices in India. While earlier reviews highlighted key methodological gaps before the HTAIn was institutionalized, significant strides have since been made with the expansion of Regional Resource Centers (RRCs), from 1 in 2017 to 30 by 2024 [32, 33]. These RRCs are academic and research institutions that form the spokes of the HTAIn and undertake HTA assessments on topics commissioned by the HTAIn. In this view, we aim to evaluate the technical quality of HTA assessments, the processes followed during the conduct of an HTA, and the translation of evidence into policy both qualitatively and quantitatively.

Methodology

Study Design

A mixed-methods approach was employed to assess the HTA studies. A total of 26 HTA studies undertaken by ten RRCs between 2018 and 2023 were reviewed using the Indian HTA Quality Appraisal Checklist (HTA-QAC) [22]. Second, we conducted interviews with key HTA researchers from the RRCs. To do so, we used an open-ended, descriptive, and qualitative approach to undertake in-depth interviews [34]. Staff from six RRCs and the HTAIn secretariat were interviewed.

Study Tool Development, and Data Collection

The methodological quality of the studies was assessed using the HTA-QAC [22]. The HTA-QAC is divided into two parts: a self-reporting section completed by the author, and a reviewer section completed by the evaluator. The reports of the HTA studies were retrieved from the HTAIn website [21]. We then filled out the reviewer section to assign scores to each of the 26 HTA studies, evaluating aspects such as the appropriate choice of modeling technique, input parameters, appropriateness of results, and generalizability of findings (Annexure I of the Electronic Supplementary Material [ESM]). The HTA-QAC provides multiple scoring options, including binary, Likert scale, guided 1- to 10-point ratings, and subjective assessments. To account for variations in methodological choices and allow for a thorough evaluation of each study, each study was independently reviewed by YC, PB, and NK, and any disagreements were resolved through discussions with reviewers SP and SJ.

For the interviews, a semi-structured interview guide was developed to elicit narratives of the process of conducting an HTA from the conception of the topic to the dissemination of the research findings and policy translation. The development of the interview guide was preceded by a review of HTA processes followed by various HTA agencies. Following this, the process evaluation team deliberated the processes, components, and stakeholders related to HTAs, and developed a list of topics to be explored in the interviews. The interview guide comprised three sections (Annexure II of the ESM). The first section focused on the conception phase of HTA studies, examining the factors guiding topic selection. The second section delved into the role of the HTAIn and its Technical Appraisal Committee (TAC), factors enabling study conduct, and challenges related to data and staff capacity. The third section explored stakeholder engagement, research evidence dissemination, and the translation of evidence into policy.

The virtual interviews were conducted by PB, YC, and JKL with two to four members of each RRC as per their involvement in the HTA study and their availability. The interviews were conducted between May and September 2022. To seek consent, participants were initially sent an e-mail outlining the study’s objectives and requesting their agreement to participate. This was followed by obtaining verbal consent before recording their responses. The in-depth interviews were conducted in English, and the conversations were audio-recorded. Subsequently, the recorded interviews were transcribed verbatim by a professional transcription service provider. Following transcription, the interviewers reviewed the transcripts for accuracy and rectified transcription errors. Furthermore, the interviewers took detailed notes of their observations during the interviews, capturing not only the verbal responses but also non-verbal cues such as hesitation and indications of caution displayed by the respondents.

Data Analysis

As part of the process evaluation, we initially included 26 studies for a quantitative assessment using the HTA-QAC; however, four studies were eliminated as they were not considered full HTAs. Each study was scored, by the process evaluation team, based on the variables in the HTA-QAC. Three team members (YC, PB, and NK) independently assigned scores for each study. Following that, any disagreement was resolved through discussion with SP and SJ. Scores were assigned to each variable, or the response was recorded as “Not done,” “Not reported,” or “Not applicable.” The overall score for each study was calculated by dividing the total score obtained by the maximum possible score. The maximum score varied for each study, as questions marked “Not reported” or “Not applicable” were excluded from the denominator. Final scores were then used to determine overall quality ratings, categorized as follows: poor (< 0.4), average (0.4–0.69), good (0.7–0.89), and excellent (≥ 0.9). [22]

For the qualitative assessment, ten interviews were conducted with the RRC staff, with two to four members of the RRC at each interview, and the HTAIn secretariat. The respondents in each interview included the principal investigator, research scientists, as well as the administrative assistant. As the study aimed to capture challenges faced throughout the HTA process from commissioning of the study to its dissemination, it was deemed important to incorporate the viewpoints of all the staff involved in the conduct of the particular study.

Interview data were analyzed thematically, using the framework method [35]. The interview guide (see Annexure II of the ESM) yielded a priori codes, for example, ‘raising HTA topics,’ ‘internal challenges to the conduct of HTA,’ ‘dissemination of findings,’ and ‘stakeholder engagement.’ Emergent codes were formed from reading and discussion of the interview transcripts, for example, ‘others’ awareness of HTA.’ Analytic themes were developed from the synthesis of coded and interpreted material, for example, ‘valuing people and skills.’ The transcripts were coded independently by YC, PB, and JKL. Any disagreements were resolved through discussions among the coders, and with SJ and SP.

Ethical Considerations

The study ensured informed consent by providing participants with comprehensive information and obtaining their voluntary agreement. Participant confidentiality was maintained using pseudonyms and secure handling of interview data. Ethics approval was obtained from the Institute Ethics Committee of the Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Findings

The findings of both quantitative and qualitative assessments are summarized below. Themes derived from the qualitative analysis are elaborated, with illustrative quotes from some of the interviews. Names of persons and places have been anonymized, and some explanations added by the process evaluation team, in brackets within the quotes, to aid clarity.

Quantitative Assessment

In the quantitative assessment, 14% (n = 3) of studies were found to be of excellent quality; 50% (n = 11) were deemed to be of good quality, and 32% (n = 7) were of average quality. Only one study (4%) was found to be of poor quality. Overall, over 64% of the studies were of good or excellent quality (Fig. 1).

Fig. 1.

Overall quality of studies conducted by Health Technology Assessment in India (HTAIn)

Table 1 presents a comparison of methods and analysis of the studies conducted, with Annexure III of the ESM (Table 1) providing a detailed quality assessment. In the study methods, the majority of the studies appropriately selected both short- (95%) and long-term outcomes (91%). The source of effectiveness was deemed appropriate in 86% of the studies. However, in about 24% of the studies, the costs were either not aligned or only partially aligned with the study perspective, and the choice of utility measure was inappropriate. International conversion rates for the costs were not reported in 32% of the studies, although among those that did report this information, the conversion rates were appropriate in all. Discounting was appropriate in 82% (18) of the studies, where applied. It was not required in the remaining four studies. Regarding the identification of uncertainties, heterogeneity and parameter uncertainty were most commonly identified, with 95% and 86% of the studies reporting them, respectively. Structural uncertainty was identified in 50% of the studies, while only 32% of the studies addressed any form of methodological uncertainty. Additionally, 59% of the studies explored equity considerations quantitatively or qualitatively, and around 45% conducted a budget impact analysis.

Table 1.

Comparison of methodological and analytical aspects of health technology assessment studies conducted

S. No.	Parameters	Yes/not applicable	Partially/no	Not reported
I.	Methods
1.	Costs in line with the study perspective	17 (77%)	5 (23%)	–
2.	Appropriate conversion rates of costs	15 (68%)	–	7 (32%)
3.	Appropriate source of effectiveness	19 (86%)	3 (14%)	–
4.	Appropriate short-term outcomes	21 (95%)	1 (5%)	––
5.	Appropriate long-term outcomes	20 (91%)	2 (9%)	–
6.	Appropriate utility measures	17 (77%)	5 (23%)	–
II.	Analysis
1.	Discounting	18 (82%)	2 (9%)	2 (9%)
2.	Future costs and outcomes discounted	15 (68%)	–	7 (32%)
3.	Past costs and outcomes discounted	16 (73%)	–	6 (27%)
III.	Uncertainty identified
1.	Methodological	7 (32%)	15 (68%)	–
2.	Structural	11 (50%)	11 (50%)	–
3.	Heterogeneity	21 (95%)	1 (5%)	–
4.	Parameter	19 (86%)	3 (14%)	–
IV.	Type of analysis
1.	Equity	13 (59%)	9 (41%)	–
2.	Budget impact	10 (45%)	12 (55%)	–

In the reporting of information, the Population, Intervention, Comparator, Outcome (PICO) framework was accurately described in 95% of the studies. However, only 77% of the studies had appropriate titles. In the discussion and conclusion sections, approximately 50% of the studies did not address the generalizability of the findings or compare the results with the existing global and local literature. Additionally, only half of the studies provided clear recommendations for policy makers (see Annexure III, Table 1 of the ESM).

Qualitative Assessment

Data Availability, Access, and Usage

Data limitations were recognized as one of the challenges, impacting HTA studies’ quality. First, respondents mentioned that it was difficult to obtain data on quality of life in the Indian population. Data from other countries were not readily applicable to India, and primary data collection was not feasible for every study. Second, accessing disaggregated data, such as metrics specific to different socioeconomic groups, was particularly challenging, preventing a meaningful analysis of equity outcomes.

“We do not have data, disaggregated data for the different income quintiles, let’s say, or like, for different castes … So disaggregated data is something [that] I think is really important to be able to do an equity analysis.” [Interview 3]

Finally, data related to costs were very scarce, and primary data collection was resource intensive and demanding of technical capacity that the teams lacked.

“The primary data collection part for the costing, that also was quite time consuming because asking for costing data, especially dealing with accounts departments in the government sector.” [Interview 3]

In contrast to obtaining data on costs and quality of life, which was rated as very difficult, obtaining demographic details and effectiveness estimates was relatively easy. Researchers reported that good rapport with the state governments had facilitated their access to relevant data. Further, the TAC members had also facilitated access to relevant information using their networks. The TAC is a multidisciplinary body with experts from different areas such as economists, clinicians, researchers, social scientists, and health policy experts. Overall, the role of the TAC was very significant and appreciated by all teams. In addition to data acquisition, the TAC supported the research teams in most phases of the HTA, including proposal development, refining of methods, review and finalizing of results, and drawing implications from findings. While the TAC was not very involved in the analysis per se, they critically reviewed the results of the HTA.

“Technical appraisal committee is a … in a way you can say it is the backbone of our overall HTA process because they are the ones who review our proposal as well as outcome reports because they consist of expert clinicians and economic evaluation specialists. They also review our outcome report and recommendations.” [Interview 9]

“Through TAC, through HTAIn, we approached the state of X, and in the state of X, we did primary data collection for estimating the cost of screening with A, B, and C [diagnostic techniques]. So, that somehow, basically, provided us with the resources in terms of … and provided us with some solution, in terms of operational solution which we were facing. And TAC also, you know, helped us to identify some of the stakeholders, who, basically, helped us in identifying some of the input parameters. So, initially, we did not find any, you know.” [Interview 5]

Furthermore, administrative processes, especially obtaining permission to access data from government departments, emerged as a recurring challenge. While good relationships with state governments facilitated some researchers, the lack of an institutionalized mechanism often resulted in delays.

“Obtaining data requires multiple levels of approval, and it often depends on personal networks rather than a formalized system. This can be time-consuming and unpredictable.” [Interview 2]

Respondents suggested that the government should promote the standardization of data, and place all required data in the public domain for wider use among researchers. The ongoing initiatives related to the development of the national cost database were also acknowledged [36, 37].

“I think registries could be more functional, I think, data management systems, they are in place that can capture that information, especially, because now we have a very good established system for the cost, you know, the cost databases there and all that.” [Interview 6]

Further, the limited access to research databases was cited as an impediment to credible evidence generation, and the need to provide subscriptions to databases was emphasized.

“I feel like if we were having, as part of HTAIn, if we can have access to EMBASE or other databases and we inquired about the subscription charges … They are pretty high so taking those subscription by an institute might not be feasible. So, at the national level, if we can get a subscription and then share some of the access scores with RRC, it’ll definitely help us to have a much better literature review.” [Interview 7]

Process of HTA Conduct

The funding, timelines, and technical assistance provided for HTAs by the Department of Health Research (DHR) were appreciated by the RRCs. However, several challenges were cited concerning the process of HTA conduct. A key observation was the variability in adherence to existing guidelines for analysis. This is supported by the quantitative assessment as the average score for consistency to the Indian reference case was reported to be 7.13 (out of 10) with a wide variation that ranged from a minimum of two to a maximum of ten. Further, while foundational frameworks exist, gaps remain in providing directives for advanced methodologies.

“The guidance we have works well for standard evaluations, but when analyses demand more nuanced approaches, there is a lack of detailed direction.” [Interview 7]

Another issue pertains to the formulation of HTA research questions, which is critical for ensuring that studies are both technically robust and policy relevant. Several participants highlighted challenges from limited interaction between researchers and end-user departments during the initial stages.

“We often had to refine the allocated topics extensively because the problem, intervention, and outcomes were not fully articulated. Direct discussions with policymakers would have improved this alignment.” [Interview 5]

Topic selection and prioritization process also pose some challenges. Many respondents noted that the topic allocation process had limited transparency and was centralized, with limited communication channels between the DHR and RRCs.

“Process in which the topics are selected at the centre, or at the state is unclear … We did try to get certain topics at the centres in X and Y [in the state], but at the centre, whatever topics are got, maybe it would be nice to have it more transparent … transparency about what topics they are getting? How are they getting it and how are they prioritizing which topics should be assigned to the different resource hubs. That prioritisation exercise was not very transparent, I think, during our time. I don’t know if that's changed now.” [Interview 3]

Respondents also felt that the communication framework should allow for better alignment of research priorities with policy needs.

“The channel of communication is indirect—through HTAIn—which leaves us guessing the precise expectations of the user departments. Direct engagement would have helped clarify the research priorities better.” [Interview 5]

Stakeholder consultations were recognized as valuable but inconsistent: some research teams reported intensive involvement of stakeholders in the refining of the HTA protocol and review of findings, while others reported more peripheral inputs from stakeholder consultations. For four of the studies for which interviews were conducted, detailed stakeholder engagements were reported at both the state and central levels. Stakeholders for each HTA were identified from the public and private sectors, and civil society. This process began with consultations within government departments, and went on to general searches for implementation and advocacy being conducted in the areas of work under study, followed by official invitations to potential stakeholders from the DHR. Most stakeholders responded positively to the invitations and attended the meetings. In situations in which they were unable to attend the meetings, they deputed a colleague to attend. Some research teams reported a few non-responses to the invitations. While consultations aimed to incorporate diverse perspectives, a few respondents observed that critical inputs were sometimes missed. The absence of patient or community voices was noted, reflecting an opportunity for greater inclusivity in future engagements. In addition, the indirect communication structure often led to misalignments between research objectives and stakeholder expectations.

“While the process includes stakeholders, there were cases where the representative was not a subject-matter expert, which limited the depth of insights we could gather.” [Interview 5]

“And many times, that particular resource centre is not in direct contact of the stakeholder who has proposed the topic. The channel of communication is via HTAIn. And because of that kind of communication, most of the times, researchers, they don’t know what policy makers want.” [Interview 5]

In addition to stakeholder consultations tailored to each HTA, a channel for the collection of expert inputs on proposed and ongoing HTAs was to publish the objectives and protocols on the website and invite comments.

Health technology assessment findings in India are disseminated through various channels, including policy briefs, conferences, workshops, and stakeholder engagements, to reach a wide array of audiences, including policy makers, researchers, and healthcare professionals. While publishing results in academic journals is an important dissemination method, it was reported as insufficient in ensuring a broad reach and impact. Although the process of conducting HTAs in India was supported by adequate funding and technical assistance from the DHR, resources for the article processing charges to publish in scientific journals are limited. As a result, HTA findings often had a limited reach and impact beyond the immediate commissioning department. Researchers expressed concern about the limited visibility of their findings beyond the requesting department.

“The findings are usually shared in government circulars or policy briefs, but there is no mechanism to ensure they reach other relevant departments or states.” [Interview 1]

Capacity to Undertake an HTA

The effective conduct of HTA hinges on adequate human resources, appropriate training, and the retention of skilled professionals. All the respondents echoed that the efforts to build capacity and the training organized by the HTAIn were useful. A common concern raised by respondents was the limited availability of trained personnel in RRCs, attributed to a high staff turnover.

“When we started, we didn’t have sufficient in-house expertise, and many team members were learning on the job. It took time to build the necessary capacity.” [Interview 8]

Further, impediments to the retention of trained personnel emerged as a recurring theme. Many RRCs reported difficulties in retaining staff because of competing opportunities in the private sector.

“After gaining experience, several colleagues left for better-paying positions, which impacted the continuity of our work, and necessitated retraining new hires.” [Interview 10]

Another issue identified was a gap between the training curriculum and the practical requirements of HTA teams. While training programs have provided valuable foundational knowledge, some respondents felt that they did not fully address the technical challenges encountered in advanced analyses.

“The training sessions were helpful, but we found ourselves needing more guidance on applying the methods to real-world scenarios, particularly for advanced analyses.” [Interview 5]

“Equity analyses are discussed extensively but are rarely conducted, primarily because we lack both disaggregated data and sufficient technical expertise to execute them effectively.” [Interview 3]

This highlights the need for more hands-on and context-specific training approaches. Furthermore, newly established RRCs often had to build expertise from scratch, which delayed study timelines and impacted quality.

“The centre was new, and most of us had no clue about conducting cost-effectiveness analysis. It was a very steep learning curve.” [Interview 8]

Most difficulties were encountered in primary cost data collection and analysis, handling transition probabilities, and conducting advanced analyses. Despite the resource constraints, there were positive developments, which were widely acknowledged, including efforts to establish academic courses in HTA.

“DHR has introduced an MSc course in HTA, and letters have been circulated to all universities, which is a promising development for the field.” [Interview 10]

Evidence to Policy Translation

The translation of HTA evidence into policy was variable, with outcomes heavily influenced by political will and the interests of end users. In some cases, evidence directly led to policy changes, especially when findings aligned with state or national health priorities. When the topics were raised by the end users, the outcomes were well received and were more likely to be translated to policy. The end users were very keen on hastening the analysis process so as to disseminate findings, which could guide decision making in health.

“Our study led to immediate policy uptake in states X and Y, where they issued government orders based on our evidence.” [Interview 1]

However, several respondents reported that their findings were underutilized or ignored because of a lack of proactive dissemination or a misalignment with decision-maker priorities.

“We had high hopes that our findings would be adopted, but without political support, it didn’t see the light of day.” [Interview 3]

The coronavirus disease 2019 pandemic also impacted the evidence-to-policy translation. One team described how their HTA on a diagnostic device was fast-tracked because of the pandemic situation, highlighting the impact of situational factors on the evidence-to-policy translation cycle.

“The pandemic brought our HTA to the forefront and into immediate policy application.” [Interview 4]

However, some HTA findings faced logistical and regulatory obstacles that delayed their implementation, highlighting the need for more streamlined pathways from evidence generation to policy action.

Several respondents advocated for more structured dissemination strategies, led by the HTAIn, to ensure that findings reach broader audiences, including states and departments that might benefit from the evidence but were not directly involved in the HTA.

“Relying on DHR to circulate policy briefs is not enough … HTAIn should take a more active role in dissemination to maximize evidence utilisation.” [Interview 1]

Systematic communication processes embedded within the HTAIn could strengthen the role of HTAs in informing health policy. Overall, the respondents felt that the quality of evidence, support from the stakeholders, and health system preparedness are the factors that drive the evidence-to-policy translation.

A pragmatic move suggested by some respondents was to take up the assessments requested by end users of evidence rather than to propose new topics, as the former ensured an appetite for HTAs and enhanced the possibility of uptake of the evidence generated, paving the path to a generally more efficient process. Table 2 (Annexure III of the ESM) presents other quotes.

Discussion

The current study provides a comprehensive evaluation of the HTA process in the Indian context, focusing on the journey from study inception to evidence translation, with the challenges and enablers encountered along the way. The findings underscore several areas for potential improvement. First, limited adherence to established guidelines and standards was observed, which is more likely to be in studies conducted by newer RRCs, which may face capacity constraints. Second, challenges related to data availability and access to the published literature emerged as significant barriers to a rigorous analysis. These limitations were compounded by gaps in technical expertise in critical areas such as uncertainty analysis, equity evaluation, and budget impact assessment. The study also highlighted the need to enhance stakeholder consultations, both in terms of the breadth of participation and the frequency of engagements. Additionally, issues such as a high staff turnover and limited communication between RRCs and user departments were identified as key areas for improvement. Studies from other developing countries have similar findings, indicating that specific technical limitations hamper the quality of HTA studies. These include the absence of sensitivity analyses, reliance on low-quality data sources, and a failure to disclose details such as potential sources of bias, and the appropriate methods for conducting a cost analysis [38–40]. Other studies have also identified limited adherence to guidance on uncertainty and a budget impact analysis, as well as the discussion of equity, despite the availability of relevant guidance. This has been attributed to a relatively lower capacity to comprehend and apply existing guidance, as well as a lack of clarity in adherence standards [41, 42]. Our assessment of the quality of HTA studies conducted in India revealed methodological and reporting gaps similar to those identified in other developing countries. In Nigeria, a systematic review found that two thirds of the studies scored below optimal quality [38]. A similar pattern was observed in South Africa, where approximately half of the studies were rated as low to fair in quality [39]. Notably, studies with foreign authorship demonstrated high quality and methodological rigor, underscoring the need for capacity building and the development of local expertise.

In our analysis, we also observed capacity constraints and a high staff turnover within HTA RRCs, which may contribute to challenges in maintaining consistent study quality. Reporting practices in Indian HTA studies were also inconsistent, with key elements such as the generalizability of findings, comparison with the existing literature, and the inclusion of clear policy recommendations frequently underreported. Despite the availability of national guidance, a budget impact analysis was not consistently incorporated. This pattern aligns with findings from Indonesia, where the introduction of HTA guidelines did not significantly improve methodological quality or reporting standards in practice [41].

To address these challenges, the mandatory application of methodological guidelines by HTA appraisal committees, along with regular training programs and workshops to support guideline implementation, are critical steps toward improving adherence and enhancing the overall quality of HTA studies in India. Since its establishment, the HTAIn has made several efforts and continues to work towards addressing these challenges to facilitate the conduct of HTAs in the country (Fig. 2). The HTAIn network has experienced rapid growth in the number of RRCs and this expansion has been supported by a considerable increase in scientific and technical staff, totaling approximately 72 professionals across the country [43]. Further, efforts have been concentrated on advancing formal HTA frameworks by establishing structured processes and guidelines. This includes creating a national reference case for economic evaluations and implementing budget impact analysis protocols [22, 24–26, 44–47]. In addition, the HTAIn has prioritized capacity building through investment in training programs, which range from demand-driven workshops to certification courses and online exercises. Moreover, a Master’s level course in Health Economics and Technology Assessment has now been initiated at various institutions to build the HTA workforce [48].

Fig. 2.

Health Technology Assessment in India (HTAIn) initiatives and developments from 2018 to 2024. EQ-5D-5L EuroQol 5 Dimensions 5 Level, HTA health technology assessment

To ensure quality and standardization of the conduct, the HTA-QAC was developed for reporting and reviewing the studies commissioned by the HTAIn. Currently, all HTA studies submitted to the HTAIn are reviewed by members of the TAC, who assess the overall quality and robustness of the evidence and analysis presented using this checklist. Further, to address data gaps and establish repositories, multicentric studies have been conducted for estimates of health system costs housed at the national health system cost database website [27]. To address the data limitation on quality of life, a primary multicentric study was undertaken to develop the Indian value set [49]. Further, the primary data were also collected to generate the estimates of health-related quality of life for different cancers that will be housed at the cancer database website [50].

More recently, the development of the Topic Selection and Prioritization manual is also underway aimed at bringing more transparency to the process. To further strengthen the HTA ecosystem in India, the HTAIn resource centers with outstanding technical capabilities have been upgraded to HTA resource hubs. A total of six hubs have been established to support HTA activities across various regions, including the north, west and central, south, union territories, and the northeast zones. Their roles include facilitating the conduct of HTA studies, building the capacity of RRC, organizing sensitization workshops for state and central government programs to promote the use of HTA, and ensuring efficient evidence dissemination. Additionally, they will also oversee quality assurance for ongoing studies and contribute to drafting policy briefs to guide informed decision making. Another initiative by the central government has been the One Nation One Subscription (ONOS), which aims to provide nationwide access to over 13,000 high-quality e-journals across disciplines by consolidating subscriptions from 30 major publishers [51]. It will be replacing fragmented subscriptions with a centralized model and will support Indian authors by funding article processing charges for publishing in reputable open-access journals, fostering research dissemination, and strengthening India’s global research presence. This is likely to address the concerns raised by several RRCs about limited access to the published literature.

Recommendations

In addition to the various ongoing initiatives, this study’s findings suggest several potential strategies to further support the HTAIn’s vision of strengthening evidence-informed decision making in India (Fig. 3). First, strengthening adherence to existing guidelines and mandating the use of the HTA-QAC can enhance the quality and standardization of HTA studies. Sensitizing the TAC for rigorous quality appraisal and scoring, supported by periodic refresher sessions for RRCs, can further bolster analytical rigor. The establishment of resource hubs provides an ideal platform to streamline these efforts [21]. Second, developing methodological guidance to integrate equity considerations is critical for ensuring more comprehensive and inclusive analyses. Moreover, leveraging real-world evidence from government departments and encouraging primary data collection can enrich the evidence base for HTA studies.

Fig. 3.

Recommendations for the optimization of health technology assessments (HTAs) in India. DHR Department of Health Research, govt. government, RRCs Regional Resource Centers

Third, addressing the gaps in training and mentorship is critical for strengthening HTA capacity in India. Resource hubs can play a pivotal role by providing structured practical training opportunities to bridge the shortage of experts and hands-on experience in HTAs. However, high turnover rates among HTA personnel remain a challenge, underscoring the need for retention strategies. Establishing permanent positions with competitive compensation packages is essential to attract and retain skilled professionals.

The framing of HTA topics has also been identified as a challenge by several RRCs, often because of limited communication and coordination with stakeholders. Enhancing stakeholder engagement is vital for institutionalizing HTA in evidence-based policy making [52]. Resource hubs, along with the HTAIn/DHR and RRCs, can play a central role in sensitizing government departments, fostering collaboration with researchers, and engaging private sector actors, manufacturers, and academia. Initiatives such as the formation of State-level HTA committees further strengthen this by coordinating local efforts and ensuring stakeholder ownership [21]. Consultations during HTA studies and awareness campaigns through education and public forums can increase understanding of HTA’s significance, ensuring its integration into health policy and decision making.

Most HTA RRC teams observed that the HTA evidence translated into policy and practice, informing guidelines, programs, and protocols for healthcare. Some researchers especially appreciated the diverse inputs that came from the stakeholders, government departments, development partners, and private entities, which helped in translating evidence into policy. However, some HTA teams were disappointed to note that despite the strong recommendations arising from their findings, policies did not change, demonstrating that notwithstanding its acknowledged value, an HTA is not the only input into decision making, and other factors, such as logistical and legal considerations, public health emergencies, and political will, leading to divergent stakeholder priorities, could well swing decisions away from those indicated by the HTA. In India, the non-statutory use of HTA in policy making reduces its overall impact. Often, policy changes based on HTA findings are overlooked or delayed because of competing stakeholder interests. Resource hubs, in collaboration with the HTAIn/DHR and RRCs, can play a key role by improving how evidence is communicated and used. Specifically, they can help standardize formats for policy briefs, ensure a strong collaboration between researchers and decision makers by constituting formal committees, and optimize the strategic dissemination of evidence to align with policy decision-making cycles and stakeholder priorities.

Strengths and Limitations

The study methodology demonstrates several strengths, notably its comprehensive approach to assessing the quality of studies conducted under the HTAIn. By employing a mixed-methods approach, combining quantitative and qualitative assessments, the study offers a multifaceted understanding of the experiences of research teams engaged in HTA studies. Interviews facilitated a detailed exploration of various aspects of HTA, including topic selection, stakeholder engagement, and policy translation. However, the study’s reliance on data from a specific time frame may limit the generalizability of findings beyond that period. Additionally, the study is limited by the small sample size of ten interviews, which may constrain the generalizability of findings. However, the inclusion of all early-established HTAIn RRCs ensures rich contextually grounded insights into the HTA process in India. Further, our study captured the perspectives of the generators of the evidence to understand the translation of evidence to policy. The perspectives of the decision-making bodies, policy makers, and relevant stakeholders involved in the utilization of HTA are pivotal to understand the uptake of evidence for policy use, and is an important area of future research. Another important area for future research could be exploring the changes in quality over time, which our study did not explore because of various confounding factors. Despite these limitations, the study provides valuable insights into the complexities of conducting HTA studies, and offers recommendations for enhancing their quality and impact.

Conclusions

This study provides critical insights into the processes, challenges, and opportunities in the evolving HTA landscape in India. While significant strides have been made, particularly in building formal processes, capacity, and data systems, areas such as adherence to guidelines, access to quality data, and stakeholder engagement require further attention. To address these challenges, it is essential to ensure adherence to established guidelines, mandate the use of quality assurance tools such as the HTA-QAC and focus on stakeholder engagement for effective conduct and dissemination of HTA evidence. Implementing targeted capacity-building initiatives and strategies to retain skilled personnel will be critical for maintaining and strengthening expertise within the system. Additionally, fostering a greater collaboration between RRCs, user departments, and diverse stakeholders can enhance ownership of HTA findings and their translation into policy. Our findings offer valuable insights into the challenges and opportunities in the HTA ecosystem and recommendations that can be beneficial for other low- and middle-income countries in the process of institutionalization of HTAs in their healthcare systems.

Supplementary Information

Below is the link to the electronic supplementary material.

Declarations

Funding

Open Access funding enabled and organized by CAUL and its Member Institutions. No funding was received for the conduct of this study or the preparation of this article.

Conflict of interest

Yashika Chugh, Josyula K. Lakshmi, Pankaj Bahuguna, Navneet Kaur, Stephen Jan, and Shankar Prinja have no conflicts of interest that are directly relevant to the content of this article.

Ethics approval

The study was approved by the Institute Ethics Committee of the Post Graduate Institute of Medical Education and Research, Chandigarh, India, vide letter no. IEC-09/2020-1767, dated 1 October, 2020.

Consent to participate

Verbal and e-mail consent was sought from the members who participated in the study.

Consent for publication

Informed consent was sought from the participants via e-mail.

Availability of data and material

All the required data are mentioned in the article and as supplementary material.

Code availability

Not applicable.

Author contributions

Conceptualization: SP, SJ. Data curation: YC, PB, LKJ, N. Methodology: SP, SJ. Formal analysis and investigation: YC, LKJ, PB, NK. Project administration: SP, SJ. Supervision: SP, SJ. Validation: SP, SJ. Writing (original draft preparation): YC, LKJ, PB, NK. Writing (review and editing): all authors.