India is seeking a larger role in multinational clinical research, and the argument is increasingly about more than cost.
In a recent interview with Pharma Industrial India, Dr. Seema Pai, President of the Indian Society for Clinical Research (ISCR), described India’s growing ambitions in global clinical trials. Her comments focused on regulatory maturity, technology adoption, patient protection, research quality and India’s ability to support more complex multinational studies.
For American pharmaceutical and biotechnology companies, the broader question is what these changes mean when deciding where to place clinical trials.
Pai: India Wants to Be Known for Quality, Not Just Affordability
Pai said ISCR’s role has evolved considerably as India’s clinical-research environment has matured.
She described ISCR’s priorities as strengthening India’s position as a preferred destination for global clinical trials, improving research quality and efficiency, supporting a more predictable regulatory environment, and keeping patients at the center of clinical research.
She also emphasized that India’s future competitiveness should not be based primarily on lower costs but also for scientific leadership, reliability, quality and patient trust.
Independent Context: India’s Regulatory Framework Has Matured
One important milestone was the introduction of India’s New Drugs and Clinical Trials Rules in 2019.
The rules established a more comprehensive framework covering clinical trials, ethics committees, investigational drugs, informed consent, safety reporting and regulatory oversight.
India’s Central Drugs Standard Control Organization, or CDSCO, manages clinical-trial applications and related regulatory processes.
For global sponsors, this regulatory maturation has made India a more structured environment for conducting clinical research and resulted in a higher volume of trials coming from Big Pharma coming to India.
“Technology Will Play a Larger Role”
Pai expects technology to significantly change the way clinical research is conducted in India.
She specifically identified artificial intelligence, decentralized and hybrid trial models, AI-assisted monitoring, adaptive trial designs and umbrella trials as technologies and approaches that are becoming more important.
In her view, these tools can help researchers identify problems more quickly, improve efficiency and potentially move promising therapies through development faster.
At the same time, Pai stressed that speed cannot come at the expense of ethics, patient safety or data quality.
Amritt Perspective
For global drug developers, the growth of technology-enabled trials is crucial but does not remove the importance of local execution and of choosing the best matched Indian partner. This, precisely is Amritt’s focus.
A sophisticated protocol still depends on selecting the right investigators, hospitals, contract research organizations and patient populations. India has a large number of hospitals and investigators, but capabilities can vary from one site to another so matching the sponsor’s needs with current availability in India is important.
Sponsors therefore need to feel confident about investigator experience, patient availability, enrollment performance, ethics committee processes, documentation quality and familiarity with international study expectations.
Pai: India’s Patient Population Is a Strategic Advantage
Pai highlighted India’s large and diverse patient population as another major strength. She specifically pointed to disease areas such as oncology, diabetes, cardiovascular disease and infectious diseases.
She also argued that India’s genetic and demographic diversity is becoming increasingly valuable as international regulators and pharmaceutical companies seek broader representation in clinical studies. Her point is significant because multinational clinical research is increasingly concerned not only with the number of patients enrolled, but also with whether trial participants reflect the populations that will eventually use the drug.
Trial Diversity Is Receiving Greater Attention
Regulators, including the U.S. Food and Drug Administration, have placed increasing emphasis on enrolling clinical-trial populations that better represent the patients who are likely to use an approved drug.
This has increased interest in trial designs that include participants from different demographic, geographic and clinical backgrounds. India can contribute to that objective because of the size and diversity of its population.
Of course, participation in India does not automatically make a study diverse. Trial design, disease prevalence, inclusion criteria and site selection still determine which patients are ultimately enrolled.
“India’s Clinical-Research Market Could Expand Significantly”
Pai cited an industry forecast estimating that India’s clinical-trials market could grow from approximately $1.7 billion in 2025 to nearly $3.6 billion by 2035. At Amritt, we believe that the actually market will be much larger by 2035.
Her broader point, however, is that India is entering what she sees as an important period of growth in clinical research. She expects artificial intelligence and real-time data oversight to contribute to that growth by improving recruitment, safety monitoring and data quality.
Amritt Perspective: What This Means for U.S. Drug Developers
For American biotechnology and pharmaceutical companies, India can serve several roles within a global clinical-development strategy.
- It can provide additional sites for a multinational trial, improve recruitment in indications where enrollment is difficult in the United States, provide access to large disease-specific patient populations, or become a more important component of an Asia-focused development program.
- Cost can still be an advantage and still drives decisions at emerging venture funded companies as well as at Big Pharma.
- The stronger case for India is the combination of patient access, scientific talent, experienced investigators, improving regulation and an expanding clinical-research infrastructure.
- India wants its future role in global clinical trials to be built on scientific credibility, quality and patient trust rather than affordability alone. For U.S. drug developers, that is a much more consequential proposition.
