Building India’s Future in Clinical Research: Inside SRM’s Growing Role in Clinical Trials

India’s Potential as a Global Hub for Clinical Trials

India’s unique advantages make it an attractive destination for conducting clinical trials. Dr. Melvin George, Professor of Clinical Pharmacology & Chief Investigator at the Centre for Clinical Trials & Research, SRM Medical College​, identifies several key factors that set India apart, including its large, diverse population, world-class healthcare infrastructure, and cost-effective treatment options.

“The sheer size of the population is one of India’s biggest advantages,” he explains. “Moreover, the healthcare available here is comparable to what you’d find in Western countries. The cost factor is another major attraction. Clinical trials in India are significantly more affordable than in the West, which makes it an appealing choice for international pharmaceutical companies. The sheer numbers make it more plausible for a trial to be completed ​in a shorter time when Indian patients are included for a global clinical trial.”​ He also points to India’s growing pool of highly trained professionals. “Our clinical trial staff is well-versed in the processes and regulations of international research. Moreover, English is widely spoken across the country, especially in major cities. This ease of communication makes it easier for global pharmaceutical companies to collaborate here,” Dr. George adds.

Another positive development is the increasing role of ethics committees. The government has empowered these committees to oversee trials more effectively, and significant efforts are underway to train them further. This ensures that trials are conducted ethically and in compliance with global standards​. In recent years, the ICMR and other funding agencies in India have given a huge fillip to the clinical trials by encouraging more translational research that has direct relevance to the patient. 

 

Overcoming Patient Reluctance: Building Trust in Clinical Trials

Despite these advantages, one of the most significant challenges faced in India’s clinical trial ecosystem is patient reluctance. Many patients are unfamiliar with the concept of participating in clinical research and often view it with suspicion.

“Patients typically visit hospitals for treatment, not for research. When we introduce the idea of participating in a clinical trial, it can be difficult for them to understand why their doctor is suggesting it. There is often a lot of fear and misunderstanding, particularly due to negative media coverage surrounding clinical trials,” Dr. George explains.

Furthermore, there is a cultural aspect at play. In India, decisions are often made collectively by families rather than individuals. This can delay the decision-making process. Even if a patient is initially willing to participate, they may encounter opposition from family members, which leads to hesitation​.

Dr. George emphasizes that this reluctance often leads to delays in recruitment. “What we expect to be a six-month recruitment period can often stretch to a year. And sometimes, to meet the target numbers, sponsors have to involve additional hospitals, which poses challenges in terms of consistency and quality.” However, those patients who participate in clinical trials realize its value immensely. A trial participant invariably gets access to the latest innovations, subsidized care in some instances, greater access to the physician with lesser waiting times at the hospital​, and better health care overall owing to the need for intense monitoring that the trial protocol mandates. This usually translates into better patient satisfaction​, and a lot of these patients have expressed their gratitude for having been given the opportunity to be research participants in global clinical trials. 

 

The Shift from Generics to Original Drug Development in India

For years, Indian pharmaceutical companies have been recognized for their dominance in the generics market. However, a noticeable shift is occurring as more Indian companies move into original drug development. Dr. George sees this as a game-changer for the country’s clinical trial landscape.

Indian companies like Cipla, Dr. Reddy’s, Sun Pharma​, and Biocon are no longer just producing generics. They are investing heavily in the development of original molecules. This is a major step forward​. With these companies venturing into drug development, we can expect an increase in clinical trials within India. Since these companies will likely target the Indian market first, it will naturally drive more research and trials here.​ Dr. George believes this trend will have long-lasting positive effects on the clinical trials ecosystem in India. As Indian companies expand into drug development, India is positioned to become an even more important player in the global pharmaceutical landscape​.

 

From Humble Beginnings to a Leading Clinical Trial Center

Looking back on SRM Medical College’s journey from a modest participant in clinical trials to a major research hub, Dr. George reflects on the institution's key milestones.

“When we began in 2013, SRM had very limited facilities. It was just myself, Dr. Satyajit, and a few other staff members, and we operated in a very restricted environment. Clinical trials were still a new concept for the hospital, and resources were minimal,” Dr. George recalls.

However, SRM’s commitment to excellence soon paid off. One of the early successes at SRM was the rotavirus vaccine study, which became a part of India’s universal vaccination program after successful trials here. That was a landmark achievement​.

Today, SRM boasts a state-of-the-art, 7,000-square-foot clinical trial facility. ​Today, SRM has come a long way. ​Now they conduct both​ early-phase and late-phase trials. The COVID-19 pandemic also brought significant attention to ​their work, particularly through ​t​heir involvement in all three phases of the Covaxin trials.

 

SRM’s Evolving Role: Coordinating Multi-Hospital Clinical Trials

As SRM Medical College continues to grow, its role has evolved from being a participant in clinical trials to becoming a coordinating center for multi-hospital studies. Dr. George describes this transition as a significant step forward for the institution.

SRM Medical College Hospital holds the distinction of having an ICMR approved Phase 1 clinical trial centre that can be used to conduct first-in-man studies with drugs and vaccines. SRM is also an ICMR INTENT Centre for clinical trials under the Med Tech Mitra, an innovative scheme to encourage indigenous development of medical products under ICMR & CDSCO. 

SRM is no longer just one of the participants in a clinical trial; ​they have partner​ed with several institutions to undertake clinical research. ​They manage multi-site studies, working closely with hospitals across the country​.“Our experienced staff, who have been doing clinical trials for over a decade, help guide clinicians across various specialties—from cardiology and oncology to dermatology and pulmonology—through the complexities of trial management​,”​ Dr. George explains. 

This shift allows SRM to have a greater impact on the future of clinical research in India. “We’ve been involved in several major studies that have led to FDA-approved drugs for heart disease prevention. Our involvement in international research is growing, and this is helping establish India’s credibility on the global stage,” Dr. George adds.

 

A Bright Future for Clinical Trials in India

India’s growing role in clinical trials, driven by strong research institutions like SRM, the increasing involvement of Indian pharmaceutical companies in drug development, and improvements in regulatory oversight, points to a bright future for the country’s clinical research ecosystem.

“We are at the threshold of a major transformation in clinical trials,” says Dr. George. “With increased investment in infrastructure, training, and ethical standards, India is becoming an increasingly attractive destination for global clinical trials. In the years ahead, we can expect to see more trials being conducted here​ and more Indian companies leading the way in original drug development.”​ India’s potential to become a global hub for clinical trials is clear. With a large, diverse patient population, a rapidly improving regulatory framework, and an increasingly sophisticated research infrastructure, the country is poised to take its place as a leader in global clinical research. As SRM Medical College’s involvement in groundbreaking trials shows, India’s journey is just ​the beginning—and the future of clinical trials in India looks incredibly promising.