In a world racing toward tomorrow, India is building the smartest roadmap to get there.
Imagine a revolutionary new drug that can cure a rare disease or a financial technology that can bring banking to millions of unserved citizens. Now imagine it stuck in regulatory approval for years, its potential help delayed by a slow, outdated system.
This is the critical challenge regulatory science aims to solve. It is the unsung hero of innovation, the discipline that ensures groundbreaking discoveries are not only brilliant but also safe, effective, and accessible to those who need them.
For India, which has climbed to the 38th rank in the 2025 Global Innovation Index , the need to empower its vibrant startup and research ecosystem is more pressing than ever. The country is a powerhouse of knowledge output, ranking as the world's third-largest startup hub and the third-highest producer of research papers globally . Yet, this potential is constrained by regulatory hurdles, including complex licensing and an average patent pendency of 42 months . Regulatory science is the key to transforming this landscape, acting not as a gatekeeper, but as a catalyst that builds the essential bridges between a laboratory's eureka moment and its real-world impact.
Global Innovation Index Rank
Largest Startup Hub
Months Patent Pendency
R&D as % of GDP
The European Medicines Agency (EMA) defines 'regulatory science' as "the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine" 3 . In simpler terms, it's the sophisticated toolkit that regulators use to evaluate everything from a new vaccine to an artificial intelligence-based diagnostic tool.
"Modern regulatory science is about navigating multiple, often divergent regulatory frameworks while striving for global development strategies, and highlighting opportunities for convergence, reliance and faster global access to medicines." 1
It encompasses the development of new standards, tools, and methods to keep pace with scientific advances. As one industry leader from Parexel International notes, the ultimate goal is smarter compliance, global harmonization, and future-proofing the entire regulatory process.
A controlled environment for live testing of innovations with relaxed regulations.
Example: The RBI's sandbox for experimenting with new blockchain-based financial products 4 .
Using technology to enable continuous, automated regulatory monitoring.
Example: SEBI monitoring transactions on fintech platforms in real-time to detect systemic risk 4 .
A check to ensure AI models are fair, transparent, and non-discriminatory.
Example: A regulator reviewing the code of a loan-approval AI to ensure it does not create bias 4 .
Aligning national regulatory standards with international ones.
Example: Accepting data from international clinical trials to speed up drug approval in India 1 .
Incorporating feedback from patients, industry, and academia into policy.
Example: The EMA's workshops and surveys to build its Regulatory Science Strategy 9 .
India's innovation engine is roaring, but it faces significant headwinds. The country's gross expenditure on R&D, while growing, remains at 0.64% of GDP, far below China (2.4%) and South Korea (4.8%) . This resource constraint makes it even more critical that every rupee invested in innovation is efficiently guided to the market. Streamlining regulation through science is a powerful force multiplier.
Faster, more predictable approvals mean innovators can iterate quickly and scale their solutions.
Adopting internationally recognized standards and practices makes Indian products more competitive in global markets.
Rigorous, transparent evaluation processes build public trust in new technologies, from fintech apps to gene therapies.
Efficient regulatory processes maximize the impact of limited R&D investment, creating a higher return on innovation spending.
India's R&D Investment
Target: 2% of GDPIndia's fintech sector is experiencing a true renaissance, characterized by bold and adaptive regulatory approaches 4 .
A move to replace cumbersome separate approvals for payments, lending, and investments with a single, unified license 4 .
The Reserve Bank of India (RBI) and Securities and Exchange Board of India (SEBI) have established "safe zones" where innovators can test new products in a controlled environment with real users without facing the full burden of regulation 4 .
India's new regime insists that AI used in financial decision-making must be explainable and auditable. The Supreme Court, in the landmark MobiPay case (May 2025), upheld the regulator's power to demand transparency and anti-bias controls in automated decisions 4 .
Regulators are shifting from periodic paperwork to API-based, real-time monitoring of transactions, allowing for proactive risk detection 4 .
These measures have helped propel India's fintech adoption rate to nearly 87%, well above the global average, and set the stage for the sector to reach a projected value of USD 550 billion by 2030 4 .
In the life sciences sector, the focus is on global harmonization. As highlighted in the upcoming DIA India Annual Meeting 2025, a major industry goal is "navigating multiple, often divergent regulatory frameworks" and finding opportunities for "convergence, reliance and faster global access to medicines" 1 .
This involves regulators and companies collaborating to align clinical trial standards, data requirements, and approval processes with international benchmarks. The aim is that a drug or vaccine developed in India can meet the standards for not just the domestic market but for the world, accelerating its global reach and solidifying India's position as the "pharmacy of the world."
Aligning Indian regulatory standards with international benchmarks to accelerate global access to medicines.
Months Average Patent Pendency
India's journey is part of a global movement. The Organisation for Economic Co-operation and Development (OECD) encourages regulatory experimentation as a means to promote "adaptive learning and innovative and better-informed regulatory policies and practices" 2 .
The EMA has been a pioneer with its Regulatory Science Strategy to 2025, which aims to catalyze the integration of science and technology in medicine development and advance patient-centred access to therapies 3 9 .
The strategy was developed through extensive stakeholder consultation, incorporating the views of patients, healthcare professionals, academia, and industry—a model of inclusive policy-making that India can emulate 9 .
However, scholars caution that poorly designed experiments can have legal and methodological consequences, potentially violating principles of legal certainty and equal treatment 5 .
This underscores that for regulatory sandboxes and experiments to be effective, they must be scientifically sound, transparent, and objective.
Key Insight: Successful regulatory innovation balances experimentation with legal certainty and equal treatment.
For India to realize its ambition of becoming a global innovation hub by 2047, a concerted, whole-of-nation approach is essential . Strategic measures must include:
Increase public and private R&D spending towards the target of 2% of GDP, with specific incentives for high-priority sectors .
Foster joint labs and research projects to ensure that academic research addresses real-world problems and can be commercialized effectively .
Expand the use of regulatory sandboxes beyond fintech, streamline the patent process to reduce pendency, and fully implement the proposed unified licensing systems 4 .
Implement reskilling initiatives and "Reverse Brain Drain" programs to attract and retain the world-class talent needed to drive and regulate innovation .
Establish dedicated DeepTech funds and government-backed angel schemes to provide the patient, early-stage funding that high-risk innovation requires .
| Metric | Rank / Status | Key Insight |
|---|---|---|
| Overall GII Rank | 38th | Top rank among lower-middle-income economies |
| Strength | Knowledge & Technology Outputs (22nd) | Driven by strong ICT exports and a vibrant startup ecosystem |
| Weakness | Business Sophistication (64th) & Infrastructure (61st) | Reveals gaps in research-driven enterprises and logistical support |
| R&D Investment | 0.64% of GDP | Constrains innovation potential compared to global peers |
| Patent Applications | 64,480 (2023) | Sixth globally, with double-digit growth for five years |
Regulatory science is far more than a set of rules; it is the essential enabler of a nation's innovative spirit. For India, the path is clear. By embracing smarter, more agile, and scientifically robust regulatory frameworks, the country can unlock the full potential of its innovators.
The future of Indian innovation is not just about brilliant ideas in labs and startups; it is equally about building the intelligent pathways that allow those ideas to travel swiftly and safely into our lives, empowering every citizen and shaping a self-reliant, developed Viksit Bharat by 2047.
Fintech Adoption Rate
Projected Fintech Value by 2030
Viksit Bharat Target
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