Agonisingly slow clinical trial is stopping Indian pharma become global innovator from supplier

In 2006, Biocon launched BIOMAb EGFR - India's first indigenously developed novel biologic monoclonal antibody used as treatment for certain kinds of cancer - after completing clinical trials entirely in India. At the time, an Indian biotech could discover a molecule, develop it domestically, and work with the regulator to bring it to patients without navigating today's layers of complexity. Replicating that journey today would be far harder, as the regulatory pathway has become increasingly challenging.

Following legitimate concerns over clinical trial practices, India rightly tightened oversight. In 2013, Supreme Court intervention led to stronger safeguards and scrutiny of clinical trial approvals. While the resulting framework strengthened oversight, its regulatory interpretation over the past decade has also added procedural complexity and multiple layers of review.

The result has been that first-in-human (FIH) trials - essential for innovative biotech companies to translate scientific discoveries into medicines - have become painfully slow to initiate here. India can emerge as a preferred destination for select FIH and early-phase studies, but approvals can take 6 mths, and often a year or much longer.


As approvals became harder, clinical development of innovative medicines increasingly shifted overseas. That bottleneck is now more urgent as AI, computational biology and advanced technology platforms accelerate discovery, enabling companies to identify targets, design molecules and develop candidates in months rather than years, while moving them from the lab into the clinic remains slow and complex.

Clinical developments are taken to labs abroad, even though design, development and manufacture happen here in India. This isn't because India lacks the science, medical expertise or patients who might benefit from the therapy, but because conducting those trials here has become too uncertain.

When Indian companies discover and manufacture candidates here but conduct early clinical trials abroad, IP, clinical expertise, investment, jobs and, ultimately, enterprise value migrate with them. Indian biotechs increasingly conduct FIH trials in Australia, the US and Europe, despite higher costs. As a result, fewer Indian discoveries reach the clinic, and they rely more on foreign investors to finance those that do.

Meanwhile, other countries are moving faster. US FDA operates with a 30-day review period for clinical trial applications. Australia combines ethics committee oversight with risk-based regulatory pathways, allowing many trials to proceed rapidly while reserving more intensive regulatory review for higher-risk studies.

India, by contrast, relies heavily on subject expert committees (SECs) within the Central Drugs Standard Control Organisation (CDSCO) framework. A limited number of committees must review many applications, often requiring multiple meetings, additional queries and repeated submissions. AI may compress drug-discovery timelines from years to months, but that advantage disappears if a promising candidate waits 6 mths, a year or longer for permission to enter human studies.

China has transformed its regulatory environment and, by some estimates, now conducts more than 1,000 FIH trials of novel medicines each year, compared with fewer than 50 in India. Combined with its extraordinary speed in preclinical development, faster clinical trial initiation has enabled Chinese companies to advance innovative medicines at a remarkable pace. It has rapidly built a globally significant novel drug pipeline, and recorded 76 innovative drug approvals in 2025.

In the same year, Chinese companies signed out-licensing transactions with headline values exceeding $130 bn, many based substantially on early-stage clinical data. Indian companies collectively did not reach even $2 bn. This widening gap should concern us.

The issue is not whether clinical trials should be regulated. They must be. Patient safety, scientific rigour and ethical standards are non-negotiable. But rigour does not require regulatory delay. A system of specialised, accountable expert review could preserve rigour, while improving the depth, predictability and speed of scrutiny. India should decentralise and accelerate clinical trial approvals while maintaining rigorous oversight.

Accredited hospitals, medical colleges, universities and research institutions should be empowered to establish CDSCO-registered expert committees with prescribed qualifications, composition, governance and operating procedures. These committees should follow internationally accepted ICH standards and provide time-bound scientific and ethical recommendations, giving CDSCO statutory authority for final permission and system-wide oversight.

Companies should be able to approach accredited committees, rather than wait in a single national queue. CDSCO should set standards, audit the system, inspect trial sites, intervene where necessary, and retain the authority to suspend trials when genuine safety concerns arise.

Regulation should shift from controlling every decision to creating a trusted, accountable system in which qualified institutions can make those decisions. Convergence of AI and bio gives India a rare opportunity to move beyond being one of the world's great suppliers of generic medicines, and become a leading developer of novel medicines.

Novo Nordisk's impact on Denmark through medicines such as Ozempic demonstrates the extraordinary national economic value that a globally successful innovation-driven biopharma industry can create, given the right ecosystem impetus. India has the scientific talent, digital capabilities, manufacturing base, entrepreneurial ambition and capital. What we need most urgently is a regulatory system that accelerates and infuses the innovation ecosystem.