The US moves to defend its lead
In June 2026 the US Department of Health and Human Services launched Operation TrialBlazer, a roadmap to stop early-stage clinical research from drifting offshore. The anxiety is explicitly about China: by the document’s own account, China’s share of Phase 1 trials overtook the United States in 2021, and in 2024 China registered over 7,100 trials, which is 39% of the global total. The US capital markets increasingly fund first-in-human data generated in China rather than at home.
TrialBlazer’s fixes are sensible but modest. The FDA will clarify what chemistry-manufacturing and toxicology data sponsors actually need before a Phase 1 trial (companies routinely over-produce it out of caution), trim unnecessary animal studies, add a real-time tracker for protocol amendments, pilot an “Expedited-IND” process using qualified research institutions and rolling review, and push a single-IRB model for multi-site trials. All of this seems like useful housekeeping. The key issue through all of these reforms though is about making the existing FDA gatekeeper faster and more predictable. None of them removes the gatekeeper.
It feels like the name is the best part of this policy. Take a second look - it is trialblazer and not trailblazer!
Two Benchmarks, but takes a third approach
That is precisely Alex Tabarrok’s critique. The US invokes China and Australia as exemplars, but takes neither road. China’s speed in cutting-edge modalities for cell, gene, radioligand and stem-cell therapies comes from letting trials proceed on an investigator-initiated basis, paired with heavy industrial policy. A drug can enter humans, in the roadmap’s own words, “if a researcher has an interest and funding.”
Australia, the other leader in this segment, has promised approvals within 21-28 days and it achieves this in a different way. Under its Clinical Trial Notification scheme, the regulator does not prospectively evaluate most early trials at all. An ethics committee clears the protocol; the sponsor then merely notifies the Therapeutic Goods Administration. Australia, in Tabarrok’s phrase, certifies the certifiers, and reserves hands-on review for the highest-risk biologics.
The US has chosen a third path: keep the “gold standard” reviewer and its full decision-making authority, and just make it quicker. Reasonable, perhaps, but it leaves the structural bottleneck untouched.
India isn’t even in the frame
Despite being the pharmacy of the world (the largest maker of generics), India is not mentioned in the document once. And it makes sense, because India does not develop novel medicines. There are fewer than 40 first-in-human Phase 1 trials of new drugs in India each year, against 800-plus in the US and 1,000-plus in China.
The big money in pharma is in new molecules, not old ones, which is why India’s entire pharmaceutical industry earns roughly $50 billion a year while Merck alone earns about $64 billion. India runs plenty of trials, but they are overwhelmingly later-phase, generic and biosimilar work, or low-cost sites for multinationals’ global studies and not the origination of novel drugs tested first on Indian soil. The impediment is regulatory, and here the parallel with TrialBlazer is exact. On paper, the New Drugs and Clinical Trials Rules, 2019 gave India-developed drugs a 30-day deemed-approval clock. In practice, approval can take up to two years, because CDSCO (Central Drugs Standard Control Organisation) refers each application to a Subject Expert Committee and there is only one SEC per therapeutic area, so a single overburdened committee sits on every file at once. There is broad consensus within the drug manufacturers that the 30 day clock only exists on paper and has no real world significance. An application is filed, the committee responds on the 29th day and the clock can reset. A resettable deadline serves nobody.
Back to the regulatory reforms, India made the same move the US is now making: it tried to make the gatekeeper faster (more reviewer capacity, and this year’s Biopharma SHAKTI initiative promising to strengthen CDSCO) rather than rethinking the gate. And as AI-first drug design accelerates the pipeline of novel candidates, more reviewer capacity will not keep pace.
The fix is distribution, not more capacity and it is the very reform that is required in the US as well as India. One idea for India is that any qualified hospital, medical college, university, or ICMR/CSIR/DBT institute should be able to constitute its own Subject Expert Committee for Phase 1 and 2 trials, registered with CDSCO to a fixed minimum composition, for example, including a physician, a biomedical researcher, a manufacturing expert, a biostatistician. Sponsors could apply to any registered SEC, which could grant permission and CDSCO would be notified but would not sit in the decision. Crucially, CDSCO already does exactly this to register ethics committees, so it needs updated rules, not new legislation. This is Australia’s model of the last 30 years, which includes gold-standard data, no worse safety record than the US and it is reportedly part of the US Senate health committee’s own reform package. India could get there first.
The binding constraint on Indian biotech is not science or capital; it is a single centralised chokepoint. Remove it, and a country with both computer-science and biologics depth is positioned to lead AI-first drug discovery. Leave it in place, and India stays the world’s generics factory while others develop and price the cures for the diseases that kill Indians.