2026-09-01

Dr. Seema Pai, President, Indian Society for Clinical Research (ISCR), speaks exclusively to Pharma Industrial India on India’s growing global role in clinical research, regulatory excellence, technology adoption, participant protection and the future of multinational clinical trials.

Q. Kindly describe your role and responsibilities at the Indian Society for Clinical Research (ISCR).

Dr. Seema Pai: As President of ISCR, my role is to provide strategic leadership to India’s clinical research ecosystem by representing the collective interests of clinical research professionals and engaging with industry, regulators, academia, investigators, patients and patient advocates.

My focus is on advancing clinical research in India by strengthening the country’s position as a preferred destination for global clinical trials, improving research quality and efficiency and advocating for a more predictable and enabling regulatory environment. A key priority is ensuring that patient centricity remains at the heart of clinical research through greater patient awareness, trust, engagement and patient-centered communication.

I am also committed to fostering collaboration across regulators, policymakers, industry, academia, clinical research sites and patient organisations to shape the future of clinical research in India. Through ISCR, we are advancing strategic priorities in areas such as clinical operations, translational research, AI and digital innovation, site development, training, real-world evidence and patient-centric research models. By bringing together diverse stakeholders and strengthening partnerships, we aim to build a more innovative, trusted and patient-focused clinical research ecosystem that delivers better outcomes for patients and society.

Q. What role is ISCR playing in strengthening India’s position as a global clinical research destination? How is ISCR preparing the industry for technology-driven clinical research?

Dr. Seema Pai: ISCR was established with the objective of building awareness of clinical research in India as a credible speciality, in addition to advocating for the associated quality and ethics of clinical trials. As the regulatory environment matured, particularly with the 2019 New Drugs and Clinical Trials (NDCT) Rules, our role evolved from advocacy to actively shaping practice alongside regulators, industry and academia.

Today, one of our key priorities is integrating Artificial Intelligence (AI)-based, decentralised and hybrid trial models responsibly into how research is conducted in India. Additionally, technologies like AI-assisted monitoring, adaptive trial designs and umbrella trials are already helping researchers identify issues faster and move promising therapies to patients more efficiently. Alongside this, we are also focused on ensuring India’s global credibility on data quality and deepening patient-centricity, because speed and innovation can never come at the cost of ethics or patient safety.

Q. What are the key regulatory protocols followed while recruiting and onboarding participants for clinical trials? Additionally, what types of compensation or support are provided to trial participants in accordance with regulatory guidelines?

Dr. Seema Pai: At ISCR, we believe that participation in clinical research must be guided by ethics, transparency, informed choice and patient safety. Before enrolment, every clinical trial must receive the necessary regulatory and Ethics Committee approvals, and participants should be provided with clear, easy-to-understand information about the study, including its purpose, procedures, potential benefits, risks and their rights as participants. Informed consent is a critical part of this process. Participation must always be voluntary, free from coercion or undue influence, and participants have the right to withdraw at any time. Information should be communicated in a way that enables participants to make a truly informed decision.

The regulatory framework also provides important safeguards around financial compensation and medical management. Participants may receive approved, proportionate reimbursement or payment for travel, loss of wages, etc., where applicable. Importantly, this should not become an inducement to participate. In the event of a trial-related injury, medical management is essential to be provided for as long as necessary, or until it is established that the injury is not related to the trial. Where a trial-related injury occurs, compensation is provided in accordance with the applicable regulatory provisions.

Ultimately, the objective is not simply regulatory compliance. Every participant should enter a clinical trial with an understanding of their rights, the risks and benefits involved, and the assurance that their safety and wellbeing remain paramount throughout the research process.

Q. How does ISCR ensure trials are fair, compliant and scientifically robust?

Dr. Seema Pai: At ISCR, we see our role as reinforcing this rigor through training, standard-setting and stakeholder align development.

Clinical trials are among the most regulated, controlled stages of drug development; a compound undergoes several years of lab research before reaching human studies, with only 1 in every 1,000 molecules tested ever progressing that far. Once human participation begins, ethics committee review, informed consent, eligibility reviews, safety processing, regular quality monitoring and oversight, apart from continual regulatory supervision, apply.

ISCR works via our councils, chapters, accredited member organisations, life members and workstreams to ensure the latest changes across the field, apart from capability, can be developed to ensure the above.

The 4 trial phases themselves act as safety filters, from establishing dosing (phase 1) to monitoring long-term safety post-approval (phase 4). If a molecule is stopped at any stage, that reflects the system working correctly, not failure.

Clinical trials are among the most regulated, controlled stages of drug development; a compound undergoes several years of lab research before reaching human studies, with only 1 in every 1,000 molecules tested ever progressing that far.

Once human participation begins, ethics committee review, informed consent, eligibility reviews, safety processing, regular quality monitoring and oversight, apart from continual regulatory supervision, apply.

ISCR works via our councils, chapters, accredited member organisations, life members and workstreams to ensure the latest changes across the field, apart from capability, can be
developed to ensure the above.

The 4 trial phases themselves act as safety filters, from establishing dosing (phase 1) to monitoring long-term safety post-approval (phase 4). If a molecule is stopped at any stage, that reflects the system working correctly, not failure.

Q. What are the current gaps in India’s clinical trial industry? How is ISCR reducing them?

Dr. Seema Pai: A significant gap in the industry is India’s under–representation in the early phases of research. Despite nearly 20 percent of the global population, India hosted only about 1.5 percent of global phase 1 studies between 1992 and 2022. This was primarily due to historical uncertainty around regulations, limited availability of specialised infrastructure and sponsor caution.

Even though India remains a preferred and credible destination for large phase 2/3 studies, becoming competent in early phase trials requires strategic investment in specialised infrastructure. This is an area ISCR is actively working to address. Through our regulatory council, we engage directly with regulators to push for consistent implementation and faster approvals under the 2019 NDCT Rules.

There is work ongoing with the external ministries within the government to take forward the opportunities that have recently emerged due to the Biopharma Shakti announcement. On talent specifically, we treat capability-building as a year-round effort rather than a one-time exercise, running continuous training for investigators, coordinators and biostatisticians, alongside our national awards for academic clinical research designed to draw more clinician-researchers into the ecosystem and strengthen India’s early-phase readiness over time.

Q. Tell us the biggest milestones for India’s clinical trials ecosystem over the past few years.

Dr. Seema Pai: Over the course of 25 years, since the 2000s, India has engaged in global, local, academic and indigenous trials which has ultimately equipped our clinical research understanding with unmatched depth. The 2019 NDCT Rules was a landmark moment, maturing India’s regulatory environment and shifting ISCR’s role toward actively shaping practice.

Additionally, developing our own indigenous CAR-T cell therapy, NexCAR19 , marks India’s growing capability to create advanced medical solutions domestically, further reflected in the global capability centers international and local companies have established here.

Q. How do you see India’s role evolving in multinational clinical trials over the next 5 years?

Dr. Seema Pai: India’s clinical trials market is projected to grow from USD 1.68 billion in 2025 to nearly USD 3.6 billion by 2035, a genuine inflection point. Countries like China and South Korea grew by aligning with global ICH standards and investing heavily in site capability; India has equally powerful strengths, scientific talent, genetic diversity, large patient populations, but needs stronger institutional capability and globally trusted quality frameworks to match that ambition.

Over the next 5 years, I expect AI and real-time data oversight to meaningfully reshape trials here, improving recruitment, safety monitoring, and data quality, provided ethical oversight and patient trust remain central. As global regulators emphasise diversity in trials, India’s genetic and demographic diversity across oncology, diabetes, cardiovascular, and infectious disease research is becoming a genuine strategic advantage, not just a cost one. In 5 years, India should be known for scientific leadership, reliability, and patient trust, not just affordability.