Policy & Regulation

India Is Building 1,000 Clinical Trial Sites Under Biopharma SHAKTI — The Plan That Could Make India the World's Clinical Research Hub

By Mustafa, Editor in Chief · April 10,2026 · 5 min read

Summary

• Budget 2026 launched Biopharma SHAKTI with ₹10,000 crore over five years. Here is a complete breakdown of what the scheme does, its 1,000 clinical trial site plan, and whether India can execute on this ambition.

India has long been described as the pharmacy of the world — the generic drug manufacturer that supplies over half of Africa's medicines, fills 40% of the US's generic drug prescriptions, and exports pharmaceuticals to 191 countries. But generic drugs are a volume and cost game. The next phase of global pharmaceutical value — biologics, biosimilars, monoclonal antibodies, gene therapies — is a different game entirely. It requires deep scientific capability, sophisticated manufacturing infrastructure, and crucially, a robust clinical trial ecosystem to validate new therapies.

Budget 2026-27 launched Biopharma SHAKTI — the Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation — with a ₹10,000 crore allocation over five years. It is the most ambitious single pharmaceutical policy initiative India has attempted in a decade. And its most structurally important component is one that has received relatively little attention: the creation of a national network of over 1,000 accredited clinical trial sites across India.

Why Clinical Trials Are the Missing Link

India has extraordinary assets for becoming a clinical research powerhouse: a population of 1.4 billion with high disease burden across multiple therapeutic categories, significant genetic diversity that makes Indian patient populations scientifically valuable, a large pool of trained medical professionals, cost structures dramatically lower than Western markets, and — increasingly — digital health infrastructure that enables remote patient monitoring and data collection.

Despite these assets, India's share of global clinical trials remains disproportionately small. The reasons are well-documented: regulatory delays at CDSCO, inconsistent ethics committee standards across institutions, inadequate site infrastructure at most secondary and tertiary hospitals, and a historical lack of coordination between academia, industry, and the clinical research ecosystem. The result is that global pharmaceutical companies have systematically chosen China, South Korea, and Eastern European countries over India for many trial programmes — even when Indian patient populations would be scientifically superior.

The 1,000 clinical trial site network that Biopharma SHAKTI proposes is a direct response to this gap. By creating accredited sites with standardised infrastructure, trained investigator teams, and coordinated ethics review, the government is attempting to remove the friction that has kept global trials out of India.

The Biologics Shift and Why India Needs to Move Now

India's disease burden has fundamentally shifted. Non-communicable diseases — cardiovascular disease, diabetes, cancer, chronic respiratory illness, autoimmune disorders — now account for approximately 63% of all deaths in India, up from 38% in 1990. These conditions increasingly require biologic therapies: complex medicines derived from living organisms, including monoclonal antibodies, recombinant proteins, and gene therapies. India currently imports a significant portion of these therapies at prices that make them inaccessible to the vast majority of its population.

Biopharma SHAKTI addresses this problem from both ends: by building domestic manufacturing capability for biologics and biosimilars (reducing import dependence and cost), and by building the clinical research infrastructure to develop and validate new therapies using Indian patient data and Indian clinical sites. Finance Minister Nirmala Sitharaman described biologic medicines as key to longevity and quality of life at affordable costs — framing this as a public health intervention, not just an industrial strategy.

What the Scheme Specifically Funds

Beyond the 1,000 clinical trial sites, Biopharma SHAKTI allocates capital across several interconnected pillars. Three new National Institutes of Pharmaceutical Education and Research will be established, and seven existing NIPERs will be upgraded into centres of excellence for translational research — bridging the gap between laboratory discovery and commercial application. A biopharma-focused institutional network will support industry-academia collaboration. And CDSCO, India's drug regulator, will be strengthened through a dedicated scientific review cadre and specialist appointments — addressing the regulatory capacity constraint that has historically slowed both clinical trial approvals and manufacturing certifications.

A defining feature of the scheme is the promotion of Non-Animal Methodologies for drug safety testing — including organoids, organ-on-a-chip technology, and 3D bioprinting. These advanced testing approaches use human cells to replicate human biology more accurately than animal models, improving the predictive accuracy of safety testing while reducing costs and ethical concerns.

Can India Execute?

The honest answer is: potentially, but the history of Indian healthcare policy is littered with ambitious schemes that underperformed due to implementation failures. The Biopharma SHAKTI scheme is well-designed on paper. Its success will depend on whether CDSCO can be genuinely strengthened to meet international approval timeframes, whether the 1,000 clinical trial sites receive the regulatory harmonisation and infrastructure investment they need rather than just accreditation certificates, and whether the NIPERs can genuinely become translational research hubs rather than simply larger teaching institutions.

BHC Perspective

At Bengaluru Health Community, Biopharma SHAKTI is the most important government initiative for the Indian biotech and clinical research ecosystem in years. Bengaluru is already India's largest life sciences cluster — home to Biocon, Syngene, AstraZeneca India, GSK R&D, and dozens of clinical-stage startups. If the 1,000 clinical trial site network is executed with genuine quality standards, Bengaluru's hospitals, medical colleges, and research institutions will be primary beneficiaries. For founders building in clinical research technology, data management, or contract research services — this policy creates a decade of commercial opportunity.

Frequently Asked Questions

Q: What is Biopharma SHAKTI?
A: Biopharma SHAKTI is India's ₹10,000 crore, five-year initiative launched in Budget 2026-27 to develop India as a global biologics and biosimilars manufacturing and research hub. It includes 1,000 accredited clinical trial sites, 3 new NIPERs, 7 NIPER upgrades, and CDSCO strengthening.

Q: Why is India building 1,000 clinical trial sites?
A: India has enormous advantages for clinical research — large diverse patient population, lower costs, trained medical professionals — but a disproportionately small share of global trials due to regulatory delays and inadequate site infrastructure. The 1,000-site network aims to remove these barriers and attract global pharmaceutical companies.

Q: What are Non-Animal Methodologies under Biopharma SHAKTI?
A: Non-Animal Methodologies include organoids, organ-on-a-chip technology, and 3D bioprinting — advanced testing approaches that use human cells to model drug behaviour more accurately than traditional animal testing, improving safety prediction accuracy and reducing development costs.