Introduction

Global clinical trials (GCT) have become the backbone of modern drug development. With regulators demanding diverse patient populations and real-world data, sponsors are increasingly turning to geographies beyond North America and Europe.

India, with its unique advantages, has emerged as a strategic hub for global clinical research. From a large treatment-naïve population and a wide range of diseases to cost efficiencies and robust investigator networks, the country offers compelling reasons for inclusion in international drug development programs. For sponsors looking to expand, clinical trials in India offer both speed and scale.

This article provides a practical, evidence-based overview of why India deserves a seat at the table in multiregional clinical trial (MRCT) programs.

India’s Growing Role in Global Clinical Trials

India is home to 18% of the world’s population; however, according to recent studies (Cherian et al, 2025), only 5- 6% of total global clinical trials are conducted in India, thereby depriving Indian patients of the latest innovative treatments. From the regulations and the quality of clinical trials perspective, India has steadily positioned itself as a preferred destination for clinical research. The New Drugs and Clinical Trials Rules (NDCTR), 2019, laid down a transparent and predictable regulatory framework, thereby strengthening investor and sponsor confidence (CDSCO, 2019).

Far more than a cost-effective location, clinical trials in India are now seen as a strategic hub for generating high-quality data for global clinical trials with a faster recruitment rate, thanks to its vast, diverse patient pool and representation of a wide spectrum of disease patterns.

Dr. Deepa Arora, Founder, Director, and CEO of CLINEXEL, explains, “We conduct detailed feasibility studies for all potential projects to thoroughly evaluate the feasibility of conducting clinical studies in India, including potential regulatory approval (challenges, if any) and the potential recruitment rate. We also provide our due inputs on the standard of care (SOC) in India, the feasibility of administering treatment mentioned in the protocols, thereby giving our inputs regarding the feasibility and potential recruitment rate to avoid any future mismatched expectations at the sponsor’s end.”

Let’s take a closer look at the unique benefits of running global clinical trials in India.

Advantages of Including India in Global Clinical Trials

1. Large treatment population

Treatment-naïve patient population

India has over 1.4 billion people with diverse demographics and a significant burden of both communicable and noncommunicable diseases. This offers a vast pool of treatment-naïve patients, which helps accelerate patient recruitment and achieve robust statistical power in trials. Conducting clinical trials in India allows sponsors to tap into this unmatched diversity.

For example, in cancer clinical trials, many patients in India lack access to comprehensive healthcare or insurance coverage. Coupled with low disease awareness, screening for conditions such as breast cancer often begins late, leading to diagnosis at advanced stages. As a result, a significant pool of treatment-naïve, late-stage cancer patients becomes available for participation in clinical trials. Another example is treatment-naïve patients for costly biologics/ biosimilars. For example, treatment of AMD (age-related macular degeneration) with anti-VEGF (Vascular Endothelial Growth Factor) drugs is the norm, and these drugs are available to most patients in the USA and Europe. 

Despite ongoing government initiatives, universal health insurance and costly biologics remain out of reach for a significant portion of India’s population. Conducting clinical trials in these patients creates a win-win situation for patients as well as pharma, as patients are benefitted by getting quick access to much-needed treatment, and sponsors are benefitted by a large, specific patient pool as per the eligibility criteria in the protocol, thereby reducing the recruitment period.

Treatment-Resistant population

India has a large pool of patients with treatment-resistant diseases, particularly in chronic conditions such as diabetes mellitus and hypertension. Many patients are already on second- or third-line therapies, creating opportunities to evaluate novel drugs and combination regimens in real-world settings. This makes India a valuable hub for testing innovative treatments there.

Dr. Arora further adds, “India represents nearly one-fifth of the world’s population, with substantial heterogeneity across age, socioeconomic status, and health profiles. This can help sponsors test therapies across a wide spectrum of infections, chronic diseases, and comorbidities.”

Varied Genomic Population

Population diversity also extends to genomics. India is recognized for deep sub-population structure and genetic variation, which can be valuable for understanding treatment response variability and safety signals, which is a key to equitable medicine development.

Cultural practices also add to India’s genetic diversity. Traditionally, marriage between close blood relatives is less common in many Indian communities, reducing the frequency of certain inherited disorders. However, in some regions and communities, consanguineous marriages are still practiced, leading to a higher prevalence of autosomal recessive disorders such as thalassemia, congenital hearing loss, and certain metabolic syndromes. The coexistence of populations with both low and high rates of consanguinity provides researchers with a living laboratory to study the impact of genetic variation on disease risk, drug efficacy, and adverse event profiles.

Many oncology drugs are mutation-specific, targeting genetic alterations such as EGFR, ALK, or KRAS mutations in cancers like lung adenocarcinoma and colorectal cancer. Conducting trials in India’s genetically diverse population enables researchers to evaluate these targeted therapies across a wide spectrum of tumor mutation profiles, ensuring the broader applicability of results.

2. High Quality with Cost Efficiency

India is broadly recognized as a cost-efficient environment for site operations, monitoring, and certain lab and imaging services, while generating high quality data as per the international ICH GCP guidelines. Peer-reviewed and policy literature note meaningful per-patient and operational savings relative to many Western markets, one factor behind the long-standing trend toward globalized development (Bajpai, 2013).

Conducting clinical trials in India can reduce overall development costs by 30–60% compared with the US and EU. This includes savings on investigator fees, site operations, and patient management. Importantly, India’s cost advantages are matched by high-quality data, with sites adhering to ICH-GCP standards, ultimately ensuring good outcomes that meet the stringent requirements of global regulators such as the FDA and EMA.

3. Early recruitment speeds up trials

India’s large patient pools for high-burden conditions (e.g., cardiovascular, respiratory, and endocrine disorders) can support faster recruitment.

4. Diverse disease epidemiology supports global trials

India has a high prevalence of infectious diseases such as tuberculosis and malaria, alongside chronic noncommunicable diseases like diabetes, cancer, neurological and cardiovascular disorders. This epidemiological diversity enables global trials to test investigational products across varied patient populations for a range of indications.

5. Skilled investigators and site infrastructure

India has a strong presence of English-speaking physicians and study teams familiar with ICH-GCP and international sponsor standards. A long history of participation in GCT, particularly in cardiometabolic, infectious disease, oncology, and respiratory trials, means several clinical trial sites have SOPs, data systems, and quality cultures that fit global programs. (CDSCO 2019)

Dr. Arora adds to this, “India has a strong base of trained investigators, with many having prior experience in MRCT. The presence of tertiary-care hospitals with dedicated research units further supports the high-quality conduct of clinical studies.”

6. Regulatory reforms and transparency

The New Drugs and Clinical Trials Rules (NDCTR), 2019, provide greater regulatory clarity and streamlined processes, making it easier for sponsors to conduct global clinical trials in India with confidence and compliance. (CDSCO, 2019).

Dr. Mukesh Kumar, Chief Scientific Officer at CLINEXEL, who has conducted training sessions for CDSCO staff, quotes the CDSCO NDCTR: “The objective is to promote clinical research in India while ensuring that the rights, safety, and well-being of trial subjects are protected.” He adds that at CLINEXEL, this vision is realized through rigorous compliance with ICH-GCP standards, strong ethical oversight, and a patient-centric approach that builds trust with both regulators and sponsors.

7. Phase 2 and Phase 3 Trials: Easier to Conduct in India

India has a distinct advantage for Phase 2 and Phase 3 clinical development. India’s epidemiology, scale, and regulatory clarity make it one of the most attractive destinations for Phase 2 and Phase 3 trials in global programs.

Large patient pools for recruitment

India’s high prevalence of both communicable and noncommunicable diseases provides a ready pool of treatment-naïve patients across therapeutic areas. This accelerates recruitment in Phase 2 proof-of-concept studies and large-scale Phase 3 confirmatory trials.

Dr. Arora explains further, “While India provides a huge opportunity for conducting high-quality and cost-effective clinical trials with a relatively high recruitment rate, it’s important to remember that each trial is unique. Therefore, we always duly assess all protocols together with our KOLs (Key Opinion Leaders) who are specialists in their therapy areas, to give a clear picture of the feasibility of conducting the study in India with an accurate recruitment rate to avoid any future mismatched expectations at the sponsor end.”

Experienced Phase 2/3 networks

Investigators and CROs in India have over two decades of experience running Phase 2 and 3 trials in oncology, vaccines, metabolic, and cardiovascular diseases. This ensures smooth execution with internationally compliant processes.

Regulatory clarity

In India, Phase I clinical trials are not permitted for products that are not developed in India. However, Phase I data generated in other countries are accepted to support subsequent trials, provided there are no safety concerns. For clinical trials already approved in regulated markets such as the US, EU, or Australia, India allows parallel participation in global trials. Importantly in India, , the global protocol is accepted as such, unless modifications are required to address specific safety concerns, if any.

Clinicians in India follow international treatment guidelines set by leading associations, such as the American Diabetes Association (ADA) and the American Gastroenterological Association (AGA). Clinical trial investigators are duly trained in ICH-GCP E6(R3) guidelines, ensuring that trial conduct meets international ethical and scientific standards.

In India, both sponsors and investigators are mandated to report all serious adverse events (SAEs) promptly to the CDSCO, India’s regulatory agency. This is different from other regulated markets, where only sponsors report (Suspected Unexpected Serious Adverse Reactions) SUSARs.

A structured compensation mechanism is in place to provide adequate compensation for the patients who died or suffered injury due to the investigational product. This approach safeguards patient rights, reflecting the country’s strong regulatory commitment to the safety of the trial participants.

Challenges in Conducting Clinical Trials in India: Perception Vs. Realty check

While India presents immense opportunities for global clinical trials, sponsors often identify certain challenges. Some of these are listed below:

• Reporting of Serious Adverse Events (SAEs):

1. Perceived Challenge: In India, sponsors and investigators are required to report all SAEs, whereas in many other countries, only SUSARs are reported. Sponsors may initially see this as an added burden.
2. Fact: Globally, all SAEs are received and processed to identify SUSARs. Thus, as such, it’s a minimal additional work of timely submission of SAEs.

• Structured Compensation Mechanism:

1. Perceived Challenge: Sponsors sometimes view India’s mandatory compensation framework for trial-related injuries as a financial and operational concern.
2. Fact: A transparent and well-defined compensation system improves patient trust, boosts willingness to participate in trials, and demonstrates India’s commitment to ethical standards, aligning with international expectations.

• Ethics Committee (EC) Jurisdiction:

1. Perceived Challenge: Ethics Committees (Independent or Institutional) in India, which are known as Institutional Review Boards (IRBs) internationally, have jurisdiction limited to a 50 km radius for approving clinical trials. Thus for each site, approval from nearby EC is required,, which sponsors may perceive as restrictive.
2. Fact: This is an additional burden vis-à-vis one central EC providing approval for all sites across India; however, considering the huge diversity in India, this structure ensures localized oversight, familiarity with site-specific challenges, and faster, context-sensitive decision-making. The impact on budget and efforts is minimal, considering the huge advantage that India offers in terms of cost and timelines.

• Limited Global Visibility Despite a Vast Patient Pool 

1. Perceived Challenge: Indian investigators have access to a vast patient database, yet their participation in large-scale global registries remains limited.
2. Fact: There is minimal adoption of electronic health records (EHRs) for systematic patient registration, which restricts the visibility and integration of Indian data into international research platforms. This makes its representation in global clinical registries remain disproportionately low.

• Multilingual Landscape:

1. Perceived Challenge: With India’s diversity of languages, sponsors may worry about translation requirements delaying trial setup
2. Fact: Only patient-facing materials (e.g., informed consent forms, patient diaries) require translation. Unlike regions such as China or Latin America, regulatory dossiers do not need translation, significantly reducing costs and administrative burden. There are good translation agencies that have a quick turnaround time and are cost-efficient.

While sponsors may initially view India’s clinical trial requirements as challenging, these frameworks are designed to enhance patient protection, data reliability, and regulatory transparency. These help in building public trust, thereby making the country a strategically strong destination for high-quality clinical research.

How High-performing CROs Mitigate the Challenges?

While India presents multiple advantages, a few challenges have been noted. Structured site-readiness programs and robust CROs partnerships with full-service global CROs like CLINEXEL mitigate these issues.

• Enrolment speed can differ widely due to protocol complexity, limited awareness, and competing priorities, leading to recruitment variability across sites. Additionally, infrastructure variance, administrative workload, and training needs can affect timelines. Early and continuous feasibility checks, site-tailored outreach, and dedicated coordinators improve performance.
• CLINEXEL brings strong local expertise, together with an understanding of India’s regulatory environment, the experience of principal investigators (PIs), cultural practices, and even practical aspects such as PI availability and holiday calendars.

Conclusion

India The country offers a unique combination of large treatment-naïve patient pools, diverse epidemiology, cost efficiency, skilled investigators, and transparent regulations.

Dr. Kumar concludes, Importantly, Phase 2 and Phase 3 trials are easier and more efficient to conduct in India, thanks to rapid recruitment, lower costs at scale, and established research networks. Ethical safeguards and transparent systems further strengthen the reliability of the data generated.”

For sponsors and CROs seeking to design resilient, globally relevant development programs, India is an indispensable partner in advancing clinical innovation.

Partner with CLINEXEL for Your Global Clinical Trials

At CLINEXEL, we understand the complexities of running MRCTs in India and the unique opportunities it offers. With our deep expertise in Phase 2 and Phase 3 trials, strong investigator networks, and commitment to ICH-GCP–compliant processes, we help sponsors accelerate recruitment, reduce costs, and generate high-quality data trusted by regulators worldwide.

Beyond clinical operations, CLINEXEL provides seamless coordination with local centralized laboratories and GMP-compliant warehouses, ensuring smooth sample management and drug supply logistics. We also offer local sponsor services, making us a one-stop solution for end-to-end clinical trial management in India.

Whether you are expanding an existing program or designing a new development strategy, CLINEXEL ensures seamless trial execution with patient safety, transparency, and regulatory compliance at the core.

Partner with CLINEXEL today to unlock India’s potential in your global drug development journey.

Contact us at info@clinexel.com

References:

1. Central Drugs Standard Control Organization (CDSCO). (2019). The New Drugs and Clinical Trials Rules, 2019 (Official Gazette). Central Licensing Authority, Ministry of Health & Family Welfare, Government of India.
2. Central Drugs Standard Control Organization (CDSCO). (n.d.). Public notice/updates: New Drugs and Clinical Trials Rules (resources page). https://cdsco.gov.in/opencms/en/Clinical-Trial/CRO/NDCTR/ (Accessed August 18, 2025)
3. Central Drugs Standard Control Organization (CDSCO). (n.d.). Ethics Committee —Registration and list. https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/Ethics-Committee/ (Accessed August 18, 2025).
4. Indian Council of Medical Research (ICMR). (2017). National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.
5. Cherian, J. J., Poomali, A., Mukherjee, A., Gupta, T. M., Medhi, B., Mukherjee, S., … & Raghuvanshi, R. S. (2025). Increasing early phase clinical trials capacity in India. Communications Medicine, 5(1), 255.
6. Dandona, L., Dandona, R., Kumar, G. A., Shukla, D. K., Paul, V. K., Balakrishnan, K., … & Thakur, J. S. (2017). Nations within a nation: variations in epidemiological transition across the states of India, 1990–2016 in the Global Burden of Disease Study. The Lancet, 390(10111), 2437-2460.
7. Bajpai, V. (2013). Rise in the industry for clinical trials in India: An analysis. International Scholarly Research Notices, 2013(1), 167059.

Authors:

Dr. Deepa Arora- CEO- CLINEXEL ( https://www.linkedin.com/in/deepaarora2019/ )

Dr Deepa is a physician with 25+ years of industry experience in leadership positions with pharma in Clinical Development, Medical Research, and Drug Safety departments.

Dr. Deepa led an industry consortium for the implementation of additional risk minimization measures in Europe. Her experience includes the development and execution of clinical development strategy and conducting clinical trials for NCEs, biosimilars, vaccines, complex generics, and repurposed drugs. 

Deepa has experience in interacting with various regulators- USFDA, EMA, MHRA, MEB, Health Canada, WHO, TGA for scientific advice, pre-IND meetings, end of phase meetings to discuss clinical development path, clinical trial designs, and post-marketing commitments, including PMS/ Phase IV studies and paediatric investigation plan (PIP). 

Dr. Mukesh Kumar– Chief Scientific Officer- CLINEXEL (https://www.linkedin.com/in/dr-mukesh-kumar-m-d-6223457/)

A Physician (MD) with over 25 years of deep expertise in clinical R&D, Dr Kumar’s career is a testament to innovation and excellence in clinical trials, clinical pharmacology, translational research, biopharmaceutics, and clinical development. His contributions have driven global product registrations across regulatory landscapes, including the USFDA, EMA, India, PMDA, and ROW regions.

Dr. Kumar’s illustrious career includes clinical R&D leadership roles at global pharmaceutical giants (Sanofi and Daiichi Sankyo) and large Indian pharma companies (CIPLA, DRL, and LUPIN), where he supported early and late phase clinical trials of innovative products, including repurposed drugs via 505(b)(2) path, complex generics, and biosimilars. He has played a key role in transforming the R&D business through clinical risk mitigation strategies and high-quality clinical trial executions. With a proven track record of significant contributions in clinical development of over 100 successful product registrations in the U.S. and Europe, he has redefined efficiencies in clinical strategies by implementing cost-effective, innovative clinical trials and pharmacology studies.

As CLINEXEL’s CSO, Dr. Kumar oversees clinical trial operations (Phases I-IV) and clinical program management. His value-added support is available for CLINEXEL-managed clinical trials in optimizing clinical strategies, global clinical development, and driving impactful scientific negotiations for innovative therapies, biosimilars, and complex generics.