Mint Explainer | Budget 2026: How India plans to fix its biggest clinical trials bottleneck

The government’s plan to build a national network of more than 1,000 accredited clinical trial sites, announced on 1 February in the Union Budget for 2026-27 under the Biopharma Shakti scheme, is designed to tackle that gap.

The proposal targets a critical bottleneck in India’s clinical-research ambitions. While global demand for trials is rising and sponsors increasingly view India as an attractive destination, trial sites remain unevenly equipped, concentrated in large cities, and burdened by variable processes.

A network of accredited sites, experts say, could turn trial-ready hospitals and clinics into standardized facilities, reducing start-up time and widening participation. But the impact will hinge on whether India can build enough trained personnel and strengthen regulatory capacity.

“Bringing in these accredited sites will definitely accelerate the process of being able to start the trials because they will have certain processes and capabilities already established," said Saurabh Arora, managing director of Delhi-based contract research organization (CRO) Auriga Research.

Why clinical trials are in focus

India’s large population and growing incidence of non-communicable diseases such as diabetes, cardiovascular diseases and cancer make it an attractive destination for global trials. Costs for trials, which account for a significant share of the R&D bill for innovative drugs, are also lower in India.

Another driver is the government’s push to make India a biopharma hub and domestic drugmakers’ pivot towards biosimilars. Unlike generics, which mainly require a bioequivalence study to show they work the same as the innovator drug, biosimilars are not exact copies and require human trials to establish safety and efficacy.

While clinical trial activity in India has been historically low, regulatory reforms have led to better growth since 2014. Following the new regulations, the number of sites increased by 40% between 2014 and 2022, a PwC report from 2023 noted.

India’s contribution to global clinical trials was about 4% between 2012 and 2022, the report said. This increased to 9.38% as of June 2025, according to the World Health Organization’s dashboard. India is the third largest country for clinical trials after the US and China, and among the few countries to not see a decrease since the peak of trials during the pandemic.

How trials are conducted today

Clinical trials are conducted either by drugmakers directly or are largely outsourced to CROs, which are governed by the central drug regulatory authority. CROs identify and connect with medical institutions, hospitals or large clinics and centres to conduct trials.

All clinical trials in India must be registered with the Clinical Trials Registry–India (CTRI), with the site required to register its Ethics Committee reviewing the trial with the Drugs Controller General of India (DCGI).

A total of 102,825 trials have been registered with CTRI so far 2007, according to the registry’s website. Registrations with CTRI were made mandatory in 2009.

Demand continues to rise. Trials sponsored by the global top 20 pharmaceutical companies in India increased by 10% between 2013 and 2022, with AstraZeneca, Novartis, Eli Lilly, Pfizer, and J&J the top sponsors, according to the PwC report.

A 2023 study on the CRO sector in India by the Department of Pharmaceuticals (DoP) forecast the sector to grow at a compound annual growth rate of 10.75% and reach $2.5 billion by 2030.

Within R&D, clinical development accounts for the largest share of cost. For the global pharma R&D outsourcing market, projected to reach $90.4 billion by 2030, an estimated $61.2 billion, or 67%, will come from outsourcing for clinical development, the DoP report said.

Why accreditation matters

Doctors and industry executives say accreditation could lower entry barriers for hospitals and clinics that currently lack the internal systems required to host trials.

For a hospital or clinic to be a valid site for clinical trials, it needs significant infrastructure and manpower, and hospitals and clinics in tier-1 cities are better equipped for this, the PwC report said.

Government accreditation may expand the scope of trial sites, said Dr Ashish Joshi, oncologist and co-founder of M|O|C Cancer Care & Research Centre, a chain of cancer day-care centres that also act as trial sites.

“For organizations which do not have the ecosystem or a bandwidth to create a research wing, it will be very helpful and could probably democratize the research much more, which is currently a preserve of only very few institutes," Joshi said.

Having a defined set of standards reduces the wide variation seen today in how studies are conducted and provides clearer expectations around infrastructure, trained personnel and ethics processes. From a regulatory standpoint, operating against common benchmarks allows for more effective and uniform oversight.

“What is required is to provide the necessary clinical trial-specific training and processes to the site personnel so that the clinical trials we run meet the highest standards of patient care and data quality," said Sanjay Vyas, president and managing director of Parexel India, part of global CRO Parexel.

What is the biggest roadblock?

Infrastructure alone will not solve India’s trial bottlenecks.

Clinical trial sites require not just facilities but trained clinicians and support staff, Joshi said.

Regulatory timelines remain another deterrent for international drugmakers. While amendments since 2013 have partially streamlined approvals and reduced timelines by 30-40%, delays have significantly impacted the CRO industry, the DoP report said.

There is also a need for scientific and technical experts within the regulator and in ethics committees, Arora of Auriga said.

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), a step aimed at addressing this.