MUMBAI: India's ambitious drive to position itself as a premier global hub for pharmaceutical research and drug development is confronting a fundamental infrastructure challenge. The nation currently lacks an adequate number of standardized, trial-ready hospitals and clinics necessary to scale up operations and meet the anticipated surge in demand from international sponsors.
Government's Strategic Response: The Biopharma Shakti Initiative
To bridge this critical gap, the government unveiled a comprehensive plan in the Union Budget for 2026-27. Announced on February 1, the Biopharma Shakti scheme proposes the establishment of a national network comprising more than 1,000 accredited clinical trial sites. This initiative directly targets a significant bottleneck that has long hampered India's clinical-research aspirations.
While global demand for clinical trials continues to rise, with India increasingly viewed as an attractive destination due to cost advantages and a large, diverse patient pool, the existing trial infrastructure remains inconsistent. Current sites are often unevenly equipped, predominantly concentrated in major metropolitan areas, and plagued by variable operational processes that can delay study initiation.
Why Clinical Trials Are a Focal Point for India's Growth
Several factors converge to make India a strategically important location for global clinical research. The country's vast population, coupled with a growing prevalence of non-communicable diseases like diabetes, cardiovascular conditions, and cancer, provides a substantial patient base for trials. Furthermore, the cost of conducting trials—a major component of research and development expenditure for innovative drugs—is significantly lower in India compared to Western nations.
This focus is further amplified by the government's concerted push to establish India as a biopharma powerhouse and the strategic shift by domestic drug manufacturers towards biosimilars. Unlike traditional generic medicines, which primarily require bioequivalence studies, biosimilars are complex biological products that are not exact copies of original drugs. Consequently, they mandate comprehensive human clinical trials to rigorously establish their safety and efficacy profiles.
The Current Landscape and Growth Trajectory
Historically, clinical trial activity in India was relatively modest. However, a series of regulatory reforms implemented since 2014 have catalyzed better growth. A 2023 report by PwC highlighted that the number of clinical trial sites in India increased by approximately 40% between 2014 and 2022 following these regulatory changes.
India's contribution to the global clinical trial landscape was around 4% between 2012 and 2022. Notably, this figure had risen to 9.38% as of June 2025, according to data from the World Health Organization's dashboard. India now ranks as the third-largest country for clinical trials globally, trailing only the United States and China, and stands among the few nations that have not experienced a decline in trial activity since the peak observed during the pandemic.
Operational Mechanics: How Trials Are Conducted Today
Clinical trials in India are typically conducted either directly by pharmaceutical companies or, more commonly, are outsourced to specialized Contract Research Organizations (CROs). These CROs operate under the oversight of the central drug regulatory authority and are responsible for identifying and collaborating with medical institutions, hospitals, clinics, and specialized centres to execute trials.
A mandatory requirement for all clinical trials in India is registration with the Clinical Trials Registry–India (CTRI). Additionally, each trial site must register its Ethics Committee, which reviews and approves the trial protocol, with the Drugs Controller General of India (DCGI). Since its inception in 2007, the CTRI has registered a total of 102,825 trials, with registration becoming compulsory in 2009.
Demand for clinical trials in India shows a consistent upward trend. Trials sponsored by the world's top 20 pharmaceutical companies in India grew by 10% between 2013 and 2022. Leading sponsors during this period included industry giants such as AstraZeneca, Novartis, Eli Lilly, Pfizer, and Johnson & Johnson.
A 2023 study on the CRO sector by the Department of Pharmaceuticals (DoP) forecasted that the sector would expand at a compound annual growth rate of 10.75%, potentially reaching a valuation of $2.5 billion by 2030. Within the broader research and development spectrum, clinical development constitutes the largest cost component. For the global pharmaceutical R&D outsourcing market, which is projected to hit $90.4 billion by 2030, an estimated $61.2 billion (or 67%) is expected to originate from outsourcing specifically for clinical development activities.
The Critical Role of Standardization and Accreditation
Medical professionals and industry leaders assert that the proposed accreditation framework under the Biopharma Shakti scheme could significantly lower entry barriers for hospitals and clinics that currently lack the internal systems and protocols required to host clinical trials. The PwC report noted that to qualify as a valid trial site, a hospital or clinic needs substantial infrastructure and specialized manpower, resources more readily available in tier-1 cities.
Dr. Ashish Joshi, an oncologist and co-founder of M|O|C Cancer Care & Research Centre, which operates as a trial site, emphasized the potential impact. "For organizations which do not have the ecosystem or the bandwidth to create a dedicated research wing, government accreditation will be very helpful. It could democratize clinical research, which is currently largely the preserve of only a few well-established institutes," he explained.
Establishing a defined set of national standards would help reduce the wide variations currently seen in how studies are conducted across different sites. It would provide clearer expectations regarding necessary infrastructure, trained personnel, and ethical review processes. From a regulatory perspective, operating against common, transparent benchmarks would facilitate more effective and uniform oversight by authorities.
Sanjay Vyas, President and Managing Director of Paraxel India, part of the global CRO Parexel, highlighted the training imperative. "What is required is to provide the necessary clinical trial-specific training and processes to site personnel. This ensures that the trials we run meet the highest international standards of patient care and data quality," he stated.
Persistent Challenges and Roadblocks Ahead
However, experts caution that infrastructure development alone will not resolve India's clinical trial bottlenecks. Dr. Joshi pointed out that trial sites require not just physical facilities but also a cadre of trained clinicians, research coordinators, and support staff proficient in Good Clinical Practice (GCP) guidelines.
Regulatory timelines continue to be a concern for international drugmakers. Although amendments since 2013 have partially streamlined approval processes and reduced timelines by an estimated 30-40%, persistent delays still significantly impact the CRO industry, as noted in the DoP report.
A critical shortage of scientific and technical experts within the regulatory bodies and institutional ethics committees further compounds these challenges. Saurabh Arora, Managing Director of Delhi-based CRO Auriga Research, identified this as a key constraint.
In a move aimed directly at this issue, the Biopharma Shakti scheme has announced the creation of a dedicated cadre of scientific and technical experts for the Central Drugs Standard Control Organisation (CDSCO). This step is designed to strengthen regulatory capacity and ensure more efficient and scientifically robust review processes, which are essential for sustaining long-term growth in India's clinical trial sector.
