India’s clinical research ecosystem is standing at a pivotal inflection point. Once seen largely as a low-cost destination for outsourced trials, the country is now steadily redefining itself as a credible, innovation-driven hub powered by stronger regulation, digital enablement, and a sharper focus on ethics and patient centricity. In this conversation, Dr. Seema Pai, President of the Indian Society for Clinical Research (ISCR), reflects on how policy shifts, digital trials, and new talent pathways are reshaping India’s role in global research and what must happen next for the country to move from participant to true scientific leader.
- How would you describe the current clinical research landscape in India and the biggest shifts you’ve seen in the last few years?
India’s clinical research ecosystem is truly coming into its own. What was early seen largely as a cost advantage is now rapidly being recognized for its quality, capability and steadily credibility. NDCT 2019 regulations have further fortified the fact that the regulations are adapting to the needs of all stakeholders, keeping patients in mind. Use of digital tools has helped in building trust among global sponsors, while a stronger emphasis on ethics and patient centric practices has improved the way research is carried out at the base level.
India is also stepping into increasingly complex and more number of clinical studies as compared to the past & also has the government agencies supporting the research initiatives and working on it by backing improved infrastructure, development of a skilled talent pool and collaborations with local and global partners. There is a growing focus on research that addresses health challenges that are specific to India. While there is still room to improve capability and consistency. Overall, the direction is encouraging, as the ecosystem is becoming mature and patient centric.
- What are the key Union Budget 2026 announcements that you believe will directly impact clinical research and trials in India?
The Union Budget 2026-27 clearly signals a stronger push towards innovation in clinical research and biopharma. Initiatives like Biopharma Shakti and the expansion of clinical trial infrastructure are important steps towards strengthening India’s capabilities in clinical research. The focus on 1000+ clinical trial sites being presented in the opening remarks by the Hon. Finance minister has not only encouraged every hospital and clinical research professional to do better, but to have their site capabilities to be fully developed end-to-end to help widen patient access and support research holistically in oncology, immunology, diabetes, and other chronic diseases. At the same time, the budget addresses long-standing operational challenges by focusing on regulatory efficiency and ease of doing business. Strengthening regulatory review processes, easing tax and customs requirements, and increasing overall healthcare spending, together create a more supportive environment for high-quality clinical research. Overall, these measures reflect a clear intent to move India towards a more research-driven, globally aligned clinical ecosystem. All agencies have immediately started to work together in the spirit of a single clinical research community.
- Decentralized and virtual trials are gaining attention. Where is India genuinely progressing here, and what is still largely a buzz?
India is making real progress in decentralized clinical research, largely through practical hybrid models which are country tailored especially where we have seen investigator sites and ethics committees being more open to these methods. Digital platforms such as ABHA, along with tools like e-consent and electronic outcome assessments, are helping improve patient understanding of the trial better and data collection at their homes, helping real-time data transfers for routine parameters and helping data transparency in the longer run. Some of the measures, such as “direct to home” delivery of the drug for long-standing chronic diseases which started at the time of COVID need to be looked at once more with reliable tracking safeguards from a regulatory and logistical perspective. Thus, India’s approach today is best described as digital-first but site-supported, where technology enhances efficiency while medical oversight and patient safety continue to remain firmly anchored at the clinical site. The tailored oversight by the collaboration between sites, investigators and sponsors is a strength in India.
- How can we design digital and decentralized trials that remain inclusive for rural, older or low-income patients?
To keep digital and decentralized trials inclusive, the focus needs to shift from a digital-only approach to a more balanced physical and digital model. This means combining technology with on-ground support, using local health centres, mobile nursing services from the hospital where there is a cultural familiarity of the staff and the patient, not to forget the caregiver who plays an important part in the decision making, especially in India. The utilization of the social workers and community health worker,s apart from the site coordinator to stay connected with patients is an absolute must. The usage of telehealth by the investigators and adoption of a cadence of regular phone calls between the investigator and the patient go a long way in building trust and decentralization. Simpler devices in local languages and easier to use operating systems on these, while explaining the consent in the local language, equally important will be the visual media and explanation of the devices and companion diagnostic usage in the study.
The support for travel and involvement of the caregiver in the process apart from involving a patient advocate support group goes a long way in ensuring that rural, older, and low-income patients are able to participate meaningfully in clinical research without added burden and the decision making is well informed to all stakeholders.
- On regulation and policy, what recent changes matter most for sponsors and investigators, and where is regulatory harmonization still needed?
Recent regulatory changes have significantly improved efficiency for sponsors and investigators, particularly through faster approval timelines and simplified processes for certain low-risk studies and India centered studies. The move towards digital submissions and clearer regulatory pathways has helped reduce delays, while stronger data protection requirements under the Digital Personal Data Protection framework have increased accountability around patient consent and data security. That said, further scope for collaboration exists, especially with the recent announcements from the central budget, clarifications around speed of amendment approvals & more reforms that are being announced for speedier late phase approvals especially for innovator molecules that are globally approved in key markets. Collaboration between all stakeholders in areas such as a single ethics review system for multi-site trials and strengthening the dossier requirements for sponsors to ensure greater consistency and confidence for global sponsors operating in India will be a very positive move.
- Among clinical operations, data management, medical writing, biostatistics, pharmacovigilance and real-world evidence, where is India strongest today and where are the biggest capability gaps?
In 2026, India serves as the reliable “technical engine” for global research, where our mastery in Data Management has evolved from simple outsourcing into a sophisticated, hub operations powerhouse. While we are world-class at managing the heavy lifting of data and regulatory writing, a human gap is still present in our specialized fields where we still lack clinical development professionals at scale who can develop indigenous protocols from India for global drug development keeping the scientific tenor at pace. We are incredibly efficient at processing safety reports in Pharmacovigilance, yet we still need more veteran medical experts who can spot safety signals before they become problems and also efficiently work with the global data sets and triage them in India. Similarly, despite our massive digital health push, our Real-World Evidence is still finding its feet due to fragmented hospital records, and our capacity for Phase I trials remains limited to a few elite centers rather than being a nationwide reality. Our skilled manpower at sites is a strength where partnership with BIRAC, ICMR and all agencies working on the mission of 1000+ sites in India will be the opportunity for the upcoming years.
- In practical terms, what does truly patient-centric and ethics-led research look like at site level in India?
Truly patient-centric and ethics-led research at the site level in India means moving beyond compliance to genuine partnership with participants. Patients & their caregivers are treated as informed partners, with consent explained in simple, local languages and supported by assisted digital tools where needed. Patient’s are also ensured of flexible visit schedules, and remote monitoring where appropriate. The involvement of caregivers cannot be underscored as they are an important pillar of patient centricity. We also need involvement of the patient advocates to work to have the patient voice incorporated in our protocols so that the designs are such that they promote practical usage close to clinical practice as much as possible depending on the disease under study. The ethics committees are also partners in making this as simple for the patient as possible. Ultimately, ethical research today is about trust, transparency, and making participation practical and respectful for every patient and their caregivers.
- What has to change in academia-industry collaboration so that more India-originated protocols and investigator-initiated studies come through?
For India to move from being largely a site for global trials to becoming a creator of original research, academia and industry need to evolve from a transactional relationship to a true co-innovation partnership. Academic researchers bring scientific depth and understanding of local disease patterns, while industry brings funding, speed, and development expertise. Mechanisms such as the Anusandhan National Research Foundation, Medtech Mitra and expanded research funding can help de-risk early-stage, investigator-initiated studies. At the institutional level, stronger technology transfer offices and clearer IP support are essential so clinicians can focus on science. Most importantly, incentives must reward impactful innovation and India-originated protocols, not just publications.
- With the Budget’s focus on health education and research, how can we build clearer career pathways in clinical research for young professionals?
The Budget’s focus on health education and research provides an opportunity to formalize clinical research as a structured career path rather than an accidental one.
Clinical research as a mandatory subject in the medical and pharmacy curriculum will expose young scientists to pursue the field as a career pathway. Clearer pathways can be built through industry-aligned curricula, certified training programs, internships at accredited trial sites, and stronger academia-industry partnerships. Creating awareness about diverse roles beyond clinical operations, such as data sciences, safety, regulatory affairs, and medical writing, will help young professionals see long-term growth and purpose in this field. There could be specialized courses in clinical development that will help science flourish.
- What new roles and skills should students and early-career professionals focus on in areas like digital trials, data science and safety science?
Students should look beyond traditional roles and build skills in digital trial management, clinical data analytics, pharmacovigilance, regulatory science, and real-world evidence. Understanding AI-driven data tools, cybersecurity basics, and patient privacy laws will also be important. At the same time, strong fundamentals in ethics, communication, and problem-solving remain essential, as clinical research ultimately revolves around people, not just technology.
- By 2030, what concrete indicators would convince you that India has become a genuine global hub for clinical research, beyond just low cost?
By 2030, success would mean more India-led global trials, faster and predictable regulatory approvals, and strong global acceptance of Indian data. We should see higher participation in early-phase and innovative studies, stronger investigator-initiated research, and consistent quality across sites. Most importantly, India should be known for scientific leadership, reliability, and patient trust, not just affordability.
- As ISCR President, what two or three actions would you like industry, regulators and professional bodies to prioritize in the next 1–2 years?
Over the next one to two years, I would like industry, regulators, and professional bodies to focus on three priorities. First, strengthen regulatory harmonization and predictability to ensure India remains globally competitive while maintaining high ethical standards. Second, invest in capability building, particularly in clinical research at the hospital sites, within the industry and within academia, ethics committees and the regulatory bodies to build scientific expertise. Advanced data sciences and quality oversight need to remain as a cornerstone as we advance our journey in capability building ,as it is not volume but content. Third, instill patient-centricity into everyday practice by standardizing best practices across investigators and clinical sites along with partnerships across the government bodies and ISCR which will result in robust policy shaping for Viksit Bharat 2047 in clinical research. If we act collectively on these areas, we can accelerate India’s journey toward becoming a trusted global clinical research leader.
