Conducting Clinical Trials in India: The Pharma Industries Next Big Advantage

Introduction

India is emerging as a strategic hub for high-quality, diverse, and globally relevant clinical trials. With a population exceeding 1.4 billion and a disease spectrum that mirrors global health challenges, the country offers unparalleled opportunities for pharmaceutical companies looking to advance drug development efficiently and effectively. 

Poor recruitment rate in clinical trials is a double-edged sword, as it not only delays the trial completion, but trial costs also increase substantially due to increased timelines. Many sponsors initially plan trials in the US or EU, where numerous competing studies often make patient enrollment even more difficult.

There is a huge burden of infectious diseases like pneumonia, tuberculosis, vector-borne diseases like malaria, dengue, contaminated food and water-borne diseases like typhoid, leptospirosis, etc. Over the last two decades, India has also witnessed a rapid increase in non-communicable and lifestyle diseases like stroke, diabetes, cardiovascular disease, dementia, and cancer. India’s patient base covers almost all therapeutic areas except for a few diseases such as yellow fever, Ebola and Melanoma. And with cancer rates on the rise, now one of the leading health burdens, the country provides both volume and diversity for conducting clinical trials in India in a range of patients. 

Clinical Trial Sites That Meet Global Standards

India’s clinical research infrastructure includes:

• Experienced Investigators and clinical trial sites that are regularly participating in late-stage (Phase II and Phase III) clinical trials of large MNCs like Pfizer, Novartis, Roche, and Sanofi. 
• Dr. Mukesh Kumar, Chief Scientific Officer at CLINEXEL, who has to his credit conducting multi-center trials across the globe with companies like Sanofi, Daiichi Sankyo, Dr Reddy’s Lab, and Cipla, with experience of more than 50 GCP inspections of clinical trials sites, states, “Achieving quality is simple when an organization fosters a culture committed to it. By adopting a Quality by Design approach, which emphasizes continuous focus on quality and timely planning, execution, monitoring, and continuous optimization, we ensure excellence at every stage.” He further adds that the leadership team at CLINEXEL brings extensive experience in generating high-quality clinical data from several clinical trial sites with successful product approvals by agencies like the USFDA.
• Access to high-speed internet even in Tier II & Tier III cities
• Strong IT infrastructure to support electronic diaries, ePROs, and decentralized trial designs.
• Additionally, patients are tech-savvy, making it easy to collect real-time data in patient diaries and monitor adherence. 

A Growing Pool of Skilled Healthcare Professionals that is Industry Ready

India graduates thousands of physicians, nurses, pharmacists, and life sciences every year. This talent pool isn’t limited to conventional MD doctors; graduates from doctor of pharmacy programs (PharmD), master’s degrees in pharmacy, and physicians who have upskilled with clinical research diplomas, and even practitioners of alternative medicine, are increasingly entering the clinical research space. 

India graduates thousands of physicians, nurses, pharmacists, and life sciences every year. This talent pool, with its English-speaking ability, makes clinical research in India easier for sponsors who require globally compliant teams and also it isn’t limited to conventional MD doctors; graduates from doctor of pharmacy programs (PharmD), master’s degrees in pharmacy, and physicians who have upskilled with clinical research diplomas, and even practitioners of alternative medicine, are increasingly entering the clinical research space.

Dr. Deepa Arora, CEO at CLINEXEL quotes the Medical Council of India Statistics, 2022: “With more than 50,000 doctors graduating annually, India’s clinical talent pool continues to expand, strengthening the backbone of its trial infrastructure.’’

A Strong and experienced English speaking Health Care Practitioner (HCP) Talent Base

One of India’s biggest strengths for global trials is the high quality of its physicians, keen on participating in clinical trials as Investigators. In India, all medical education is in English. Thus, English remains the universal language for all trial documentation, source data entry, and communication between sponsors, CROs, regulatory authorities, and investigators. Only patient-facing materials are required to be translated into local languages, such as the informed consent form and patient diaries, thus ensuring a high level of linguistic and operational efficiency. This means minimal translation costs and faster turnaround times, benefits rarely matched in other large patient markets.

Dr. Arora adds, “In global clinical trials, we have noticed a significant increase in the cost and timelines resulting from the translation of dossiers, essential documents, and regulatory communication, for example, in Latin America. Whereas in India, only the patient-facing materials need to be translated. These factors greatly support sponsors when Conducting Clinical Trials in India, making the process faster and more efficient.”

Tapping into India’s Genetic and Lifestyle diversity

India’s vast cultural and ethnic diversity is a unique strength for clinical research in India. The population spans multiple genetic backgrounds, dietary habits, and lifestyle factors, which can influence disease prevalence, treatment response, and pharmacogenomics.

 The Mongoloid groups of North-East India share genetic affinities with East and Southeast Asian populations, the Caucasoid (Indo-Aryan) groups dominate much of North and Central India with links to Indo-European ancestry, while the African-origin Siddis (often referred to as Bantu descendants), mainly settled in Karnataka, Gujarat, and Goa, trace their lineage to migrants from East Africa, together enriching India’s genetic pool for clinical research.

Beyond genetics, India is also a vast country with immense diversity in geography, landscape, culture, health insurance coverage, and healthcare facility access. This means a “one-size-fits-all” approach is not feasible across trial sites, and researchers must account for site-specific challenges when designing and conducting studies.

This diversity enables researchers to select and study highly specific patient subgroups, for example, populations with a higher genetic predisposition to diabetes or cardiovascular disease, making trials more representative and relevant to global healthcare needs. Such population variety enhances external validity and supports the development of treatments that can be effective across different demographic segments, further increasing the value of Conducting Clinical Trials in India for global drug development programs.

A Regulatory Framework That’s Transparent and Evolving in the Right Direction

India operates under a dual regulatory structure:

• Central Licensing Authority – The Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI), oversees clinical trial approvals in India  for drugs and medical devices. CDSCO is a single authority responsible for clinical trial approvals in India, overseeing the clinical trials and approvals of new products.
• State Licensing Authorities – There are State FDAs in each state that are responsible for approvals for manufacturing and distribution licenses.

The New Drugs and Clinical Trials Rules, 2019, are the applicable Rules for conducting clinical trials in India. These Rules were drafted after careful consideration of the applicable regulations and guidance in different countries, with a careful and meaningful adoption in the Indian context. These rules have streamlined the procedure for clinical trial applications, timelines, clarified responsibilities of various stakeholders, and provided details on the regulatory requirements for ongoing trials like regulatory notifications, SAE reporting, etc, thereby ensuring improved transparency. For most well-prepared applications, the approval process now moves much faster than in the past, helped by the fact that all regulatory communications are conducted in English.

“Additionally, the clinical trial approval in India has been streamlined by the introduction of timelines for review and approval, enhancing predictability for sponsors”, mentions Shivani Nayak, Head of Regulatory Affairs at CLINEXEL, quoting the Ministry of Health and Family Welfare (MoHFW). She adds further, “Considering the different nature of the products, separate regulations have been laid down for drugs, medical devices, and food products.”

Ethics Oversight

• All Institutional Ethics Committees and Independent Ethics Committees in India are required to be registered with CDSCO, the Central Licensing Authority that also provides oversight for the Ethics Committees
• The ICMR’s National Ethical Guidelines (2017) provide comprehensive guidance for clinical research in India across 12 domains, from informed consent and multi-center ethics review to public health research and data governance (ICMR, 2017)
• Additional updates include ethical addendums for Integrative Medicine, AI-driven research, and clinical studies in public health emergencies (ICMR, 2025).

Mohd. Nabid, Head of Quality Assurance at CLINEXEL, further adds: “The Indian Council of Medical Research (ICMR) National Ethical Guidelines (2017) emphasize protecting participant rights while promoting research integrity.”

Patient Management and Standard of Care (SOC) at Par with Global Treatment Standards

India’s standard of care in most therapeutic areas aligns with international guidelines such as the American Society of Clinical Oncology (ASCO), American Gastroenterological Association  (AGA), American Diabetes Association (ADA), and American Heart Association (AHA), meaning that it is a quite straightforward process to align the standard of care in global clinical trials involving other countries like the USA, Europe, Canada, Australia, South Africa, etc.

Phase I Capacity Is Expanding

Partnering with a reliable and experienced CRO can make a significant difference in the success of clinical trials. This is especially true in India, where CROs vary in focus and specialized expertise is critical. CLINEXEL stands out as a top-tier, full-service CRO for early-phase clinical trials, including First-in-Man (FIM) studies, offering a unique blend of global standards and local insights to strengthen your clinical development programs.

“CLINEXEL provides comprehensive, value-added support across every stage of the trial process, ranging from protocol design and site selection to regulatory approvals, monitoring, data management, medical writing, and clinical study reporting. Our approach balances global requirements with efficiency drivers to ensure seamless development”, quotes Dr. Kumar.

The CLINEXEL leadership team comprises highly experienced physicians and doctorates, many with strong backgrounds in pharmaceutical and biotech R&D. Their scientific expertise and strategic insights are central to the credibility and quality of our trial design and execution.

“By combining the rigor of global clinical trial standards with the flexibility required for India’s dynamic research environment, CLINEXEL effectively bridges the best of both worlds. With proven experience conducting global trials across the US and Europe, we bring regulatory fluency, robust infrastructure, and full-service capabilities that make CLINEXEL an ideal partner for efficiently managing trials from Phase I through IV in India and beyond”, Dr. Kumar adds further.

What This Means for Sponsors

In practical terms, sponsors conducting clinical trials in India can expect:

• Faster approvals for well-prepared submissions.
• Easier recruitment thanks to large, diverse, and treatment-naïve patient pools.
• Reduced translation and administrative costs as the regulatory agency, as well as clinical trial sites, communicate in English.
• High compliance potential with internationally aligned standard of care protocols.
• Availability of skilled HCPs and trained clinical research professionals.

Dr. Kumar mentions, “At CLINEXEL, we do recommend good sites from tier 2 cities where we have had good experience of conducting high-quality clinical trials. We recommend sites with good potential for high recruitment (high patient footfall). We work closely with these sites to ensure the availability of qualified site staff for CLINEXEL trials and conduct detailed protocol training and continuous monitoring with prompt feedback. These are the tools to ensure protocol compliance.”

Challenges to Be Mindful Of

While the opportunities are strong, there are still hurdles:

• Public awareness and perceptions of clinical trials remain limited, making patient education a critical step. There are specific steps to be followed for the advertisements for clinical trials. Targeted education campaigns and transparent communication are essential to building trust.
• Site Infrastructure Variability
  While Tier-1 cities host world-class research facilities, infrastructure in Tier-2 and Tier-3 cities can vary in terms of equipment, trained staff, and quality assurance systems. Sponsors must invest in site training and capacity building to maintain protocol compliance.

Dr. Arora further explains, “India’s regulatory framework has evolved significantly since 2019. Before these reforms, limited clarity and the absence of globally aligned regulations meant that sponsor were hesitant to conduct clinical trials in India. At that time, the market was dominated by Indian pharmaceutical companies and a few large multinationals, resulting in fewer competitive trials.”

The key is partnering with experienced CROs such as CLINEXEL, where team members have extensive experience in conducting clinical trials and know how to mitigate risks while maintaining speed and quality. 

CLINEXEL: Your Trusted CRO Partner for Clinical Trials in India

When pursuing clinical trials in India, partnering with a reliable and experienced Clinical Research Organization (CRO) can make all the difference. CLINEXEL stands out as a top-tier, full-service CRO that brings both global standards and local insight to your clinical development efforts. CLINEXEL offers comprehensive support through every phase, from protocol design and site selection to regulatory approvals, monitoring, data management, medical writing, and clinical study reporting. Their leadership includes experienced physicians and doctorates, many with extensive backgrounds in pharmaceutical and biotech leadership.

This scientific depth informs CLINEXEL’s quality and credibility in trial design and execution. CLINEXEL bridges the best of both worlds: the rigor of global clinical trial standards and the agility needed for India’s dynamic ecosystem, making it an ideal partner for sponsors conducting clinical trials in India across therapeutic areas. They have the experience of conducting global trials across the US and Europe. Their full-service capabilities, regulatory fluency, robust infrastructure, and presence across global markets make them an ideal partner for efficiently launching and managing clinical trials from Phase I through IV in India.

Why Act Now

Global competition for trial participants is intense. A report by Reuters states that as of 2022, India accounts for 8% of global clinical trials, with a projected market exceeding US$2 billion by 2030. Experts recommend reforms like trial advertising and faster approval channels to harness this growth. India’s combination of scale, diversity, skilled workforce, and regulatory progress makes it uniquely positioned for rapid growth in the next five years.

“India’s clinical research ecosystem offers a unique blend of diversity, technology adoption, and regulatory clarity, making it a global hub for high-quality trials”, adds Ms. Nayak, quoting the CDSCO Annual Report, 2023

The adoption of technology, including telehealth solutions, electronic diaries, and remote monitoring, has improved patient engagement and could significantly enhance compliance and data quality in Indian trials. Studies have shown that telemedicine in India reduces costs, increases access, and improves patient satisfaction, which are directly transferable to clinical trial operations. (Kaur et al., 2023; Sharma et al., 2022).

Delaying entry could mean missing out on the early-mover advantages that many multinational companies are already securing.

If you’re considering India for your next clinical trial, now is the time to engage. The opportunity landscape is expanding, and those who act early will reap the greatest benefits.

At CLINEXEL, we have helped global and domestic pharma, biotech, and medical device companies design, execute, and deliver compliant, high-quality clinical trials across India. Our expertise spans:

• Regulatory navigation under CDSCO and state authorities.
• Feasibility assessment and site selection from our strong network of investigator sites.
• Patient recruitment strategies tailored to India’s diverse population.
• Operational excellence aligned with international GCP and audit-readiness standards.

We don’t just manage trials, we help you de-risk, accelerate, and optimize them for the Indian context.

Leverage CLINEXEL’s expertise today to unlock India’s clinical trial potential. Get in touch to start your journey toward faster, smarter, and globally compliant trials in one of the most promising research markets in the world.

Reach out to us at info@clinexel.com to start your journey!

References:

1. ICMR. (2017). National Ethical Guidelines for Biomedical and Health Research. 
2. ICMR. (2025). Ethical addendum for Integrative Medicine.
3. Central Drugs Standard Control Organisation. (2025).
4. Clinical Trials Registry – India (CTRI). (2025)
5. CDSCO. New Drugs and Clinical Trials Rules, 2019. Cdsco.gov.in. Retrieved August 13, 2025, from https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/ 
6. Saxena, P., & Saxena, R. (2014). Clinical trials: changing regulations in India. Indian Journal of Community Medicine, 39(4), 197-202.
7. Garg, T., Singh, O., & Arora, S. (2011). Opportunities and growth of conduct clinical trials in India. Int J Pharm Sci Rev Res, 8(1), 152-160.
8. Maiti, R., & Raghavendra, M. (2007). Clinical trials in India. Pharmacological research, 56(1), 1-10.
9. Venkataraman, A., Fatma, N., Edirippulige, S., & Ramamohan, V. (2024). Facilitators and barriers for telemedicine systems in India from multiple stakeholder perspectives and settings: a systematic review. Telemedicine and e-Health, 30(5), 1341-1356.
10. Gupta, N., Gupta, M. K., Joshi, N. K., Mantri, N., Sridevi, G., Patel, M., … & Bhardwaj, P. (2023). Is telemedicine a holy grail in healthcare policy: clinicians’ and patients’ perspectives from an Apex Institution in Western India. BMC Health Services Research, 23(1), 161.

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