Making India a Global Trials Hub: Talent, Infrastructure & Innovation

India is on the cusp of transforming into a global hub for clinical trials. With a rich talent base, strong pharmaceutical manufacturing leadership, and rapid adoption of digital health solutions, the country offers immense potential for sponsors and CROs. However, to realize this vision, India must strengthen regulatory agility, improve trial site quality, and enhance global trust in its clinical research ecosystem. This article explores India’s unique value proposition, current challenges, and strategic pathways for positioning itself as a global leader in clinical trials.

Introduction

Though India's pharmaceutical might earn it the title “Pharmacy of the World,” its share in global clinical trials remains modest. In 2021, India contributed approximately 6.2% of global clinical trial activity Clinical Trials Arena ProRelix Research and just 8% by 2022, compared to China's 29% and the U.S.'s 25% Reuters.

Meanwhile, India hosts ~20% of the global population but accounts for only 1.5%–3% of global clinical trial participation, underscoring the untapped potential PMC PwC.

With the convergence of skilled talent, expanding infrastructure, and digital innovation, India has a once-in-a-generation opportunity to establish itself as a preferred global destination for clinical research.

Global Benchmarking

Countries like the U.S., EU, and China lead clinical trial activity thanks to supportive regulations, trusted infrastructure, and efficient recruitment.

• The US benefits from the FDA’s streamlined regulatory pathways and strong patient advocacy networks.
• The EU leverages cross-country harmonization under EMA’s Clinical Trials Regulation (CTR).
• China has seen exponential growth, supported by policy reforms and government incentives for biopharma innovation.

India's regulators recently introduced the NDCTR-2019, replacing old schedules to simplify and speed up approvals—with rules such as deemed approval if regulators remain silent within deadlines DIA Global Forum Biorasi. Despite these reforms, global confidence still lags due to site variability and modest patient outreach.

Key Lesson for India: To compete globally, India must focus on predictable regulations, transparent ethics processes, and investment in site quality and digital readiness.

India’s Value Proposition

1. Talent

• India hosts one of the world’s largest pools of clinical research professionals—investigators, biostatisticians, trial managers, and data scientists.
• A robust CRO/CDMO industry has given Indian professionals global exposure across therapeutic areas.
• Academic institutions and teaching hospitals are increasingly offering specialized clinical research programs, ensuring a continuous pipeline of trained talent.

2. Infrastructure

• Over 600+ clinical research sites across metros and Tier-II cities are expanding trial access.
• India has rapidly embraced digital health platforms such as eConsent, ePRO, and remote monitoring solutions.
• Hospital–industry collaborations are creating multi-specialty networks capable of handling large, complex trials.

3. Innovation

• Startups are leveraging AI/ML, blockchain, and real-world data to improve patient matching, data quality, and trial efficiency.
• Decentralized Clinical Trials (DCTs), accelerated during the pandemic, are gaining momentum, making participation easier for patients across geographies.
• Home-grown CROs and CDMOs are moving up the value chain—offering end-to-end solutions, from trial design to global regulatory submissions.

Regulatory Landscape

India’s regulatory framework has undergone significant reform:

• The New Drugs & Clinical Trials Rules, 2019 (NDCTR) streamlined processes and codified GCP standards, with automatic approval declared after 30 working days for domestic trials and 90 for global ones DIA Global Forum.
• The CDSCO has also increased oversight and improved operational workflows post-2021 Biorasi.
• Ethics Committees are being strengthened to safeguard patient rights and ensure compliance.

Still, inconsistent timelines and varying site quality remain concerns for global sponsors. Increasing transparency, digitalizing approval workflows, and expanding regulator–industry dialogue will be key to building global confidence.

Challenges & Gaps

• Data Integrity & Safety Risks: Concerns persist due to inconsistent trial documentation and registry deficiencies (e.g., incomplete entries in CTRI) FrontiersPMC.
• Early Phase Trial Scarcity: From 2008 to 2022, India conducted only 220 Phase I first-in-human trials despite its population size PMC+1.
• Participation Gap: India's trial participation (2.9%) is low relative to its global disease burden—20% of respiratory infections and 14% of cardiovascular disease cases globally originate in India PwC.
• Low Patient Awareness: This contributes to recruitment challenges.

Strategic Pathways Forward

• Talent Development: National certification programs for investigators, global training in GCP, and academic–industry partnerships.
• Infrastructure Expansion: Develop trial-site networks across public and private hospitals; invest in digital platforms for monitoring and data capture.
• Innovation Acceleration: Promote AI-driven adaptive trial designs, real-world evidence generation, and DCT adoption.
• Policy Support: Incentivize global sponsors, create regulatory sandboxes for novel trial models, and encourage public–private partnerships.

Case Studies

• COVID-19 Vaccine Trials: Demonstrated India's ability to mobilize large-scale trials with speed, quality, and data integrity.
• DCGI Actions (2021–2024): Regulatory responsiveness improved, with ~160 trials approved in three years, reflecting dynamic engagement Reuters.

Future Outlook

• India’s clinical trial market, valued at USD 1.42 billion in 2024, is expected to grow at a CAGR of 8% through 2030 Grand View Research.
• With enhanced infrastructure, better regulation, and digital integration, India could capture 10–12% of global trial activity by 2030—a significant leap from current levels.

Conclusion

India’s rise as a global trials’ hub is not a question of capability—it is a question of strategy and execution. By addressing gaps in trust, quality, and awareness while capitalizing on its unmatched talent and innovation ecosystem, India can transform into a destination of choice for sponsors worldwide.