We’re excited to introduce our new blog!

We’ll be sharing the topics that make us stop, think, and want to sit down and write about them 😊 — from different aspects of clinical research and experiences across countries to our own perspectives and insights.

Most importantly, we want this blog to be a space for discussion, exchange, and different points of view.

So, if you’re ready, here comes our very first blog! 🌍

Our first journey takes us to India, exploring the challenges and complexities of the regulatory landscape and clinical trial submissions.

We hope you enjoy the read — and we’d love to hear your thoughts and experiences in the comments!

 

Navigating India’s Clinical Trial Approval Maze:

What Global Sponsors Need to Know

India has firmly established itself as a preferred destination for global clinical trials — a large, treatment-naïve patient pool, skilled investigators, and a growing base of world-class trial sites make it hard to ignore. The regulatory approval processes have significantly improved over time. But sponsors and CROs who are currently running a multi-country protocol through India’s regulatory system know that the path to a CT-NOC (Clinical Trial No Objection Certificate) needs further smoothening as the market opportunity suggests.

Having tracked the process closely, here is an honest look at where the challenge still lies — and where things are, slowly, improving.

1. The SEC gatekeeping step

Every global clinical trial application in India is routed through CDSCO’s preliminary document evaluation, and if it clears that stage, it goes to the relevant Subject Expert Committee (SEC) — one of roughly 25 therapy-specific panels of independent experts who advise the Drugs Controller General of India (DCGI) on scientific merit, safety and risk-benefit. SECs are advisory, but in practice, their recommendation is what drives the final CDSCO decision. Of late, the queries from document evaluation team are getting merged with the recommendations received from SEC committee members and issued together for Sponsor’s response.

2. The “no fixed slot” problem

The most operationally painful issue for global sponsors: SEC meetings don’t come with a fixed presentation time. A sponsor may be told their protocol is on the agenda for a meeting that could run anywhere between roughly 12 PM and 6 PM — and where exactly in that window their turn comes up is often uncertain until the day itself.

For an Indian affiliate team, that is an inconvenience. For a global sponsor coordinating clinical, regulatory, medical and biostatistics leads across US, EU or APAC time zones, it is a genuine logistical headache:

  • Key opinion leaders and global medical experts often need to be on standby for an open-ended window, sometimes well into the night for teams calling in from the Americas

  • Last-minute rescheduling within the window means the “team on call” must stay alert throughout.

  • It can also be frustrating when a monthly meeting is cancelled or postponed to the following month because the planned schedule cannot accommodate all applicants for review.

A fixed or narrower time-slot allocation per applicant — even a rough sequencing published a day in advance — would materially ease this without requiring any change to the scientific rigor of the review itself.

3. Timelines: from unpredictable to structured, but still tight

Prior to 2025, Invitation email for SEC presentations would often arrive only one or two days before the meeting, leaving sponsors limited time to prepare for their presentation. The logistics of joining the presentation slot itself could also be uncertain — the call to join the presentation would come through only shortly before the session began, requiring sponsors to be ready to join with a little notice. Even SEC’s recommendations would sometimes take time to be issued, meaning sponsors could experience a gap between the meeting and formal communication of the outcome.

However, CDSCO’s new SEC Guidance Document (Version 1.0, 2025) is trying to address all of these meaningfully towards predictability:

  • Meeting notice: at least 5 days’ advance intimation to sponsors and SEC members — a marked increase from the shorter notice periods sponsors previously experienced.

  • Briefing pack: a concise, focused submission — a one-page summary plus no more than a 20–25 slide deck — covering product overview, non-clinical/clinical data, ADR summaries, full protocol with statistical rationale, waiver justifications, and global regulatory status

  • Recommendation turnaround: SEC members are expected to submit written recommendations within a structured window post-meeting — introducing a defined timeline.

On paper, this is a welcome move toward predictability for all parties involved. In practice, sponsors are still working against a compressed clock: assembling a scientifically rigorous, India-specific dossier within days of notice, while simultaneously preparing to defend it live in front of a panel that may raise fresh queries on the spot — queries that then trigger another round of resubmission and re-deliberation before the file even reaches CDSCO for a final call.

4. The site-mix expectation

For global and multi-centric trials, there is a well-known (if informally applied) expectation that approximately half of proposed trial sites should be government-affiliated institutions, alongside an even geographic spread across India. The intent — broadening access, strengthening public-sector research capacity, ensuring trials are not concentrated only in private, urban centres — is reasonable and necessary for a country of India’s size and diversity.

But for sponsors, this can complicate site feasibility planning: government hospital sites often carry longer ethics approval and clinical trial agreement signature timelines, inadequate infrastructure or resource readiness, and less flexibility in trial management than established private research sites. When this mix comes as a condition of recommendations, sponsors sometimes have to go back, re-identify sites, and re-run feasibility — adding weeks and months to an already tight approval clock.

5. Post-approval is not the finish line

Even after a CT-NOC is granted conditionally, adding a new site or changing a Principal Investigator has historically meant a fresh — and often slow — approval cycle. But this is now genuinely getting better:

  • Under the new framework, a proposed site addition is deemed approved if CDSCO raises no objection within 30 days, and PI changes are deemed approved from the date a complete application is received, subject to checklist compliance.

This “deemed approval” clock is a meaningful improvement — it gives sponsors a predictable worst-case timeline instead of an indefinite wait, and it reflects CDSCO’s broader push toward portal-based, time-bound regulatory workflows.

Where this leaves global sponsors

None of this makes India a difficult market to run trials in — it makes it a market that rewards preparation. The practical takeaways for sponsors and CROs:

  • Build in real time (not just calendar buffer) for SEC query-response cycles and have your India regulatory and medical teams empowered to respond fast.

  • Plan site feasibility with the government-site expectation in mind from the outset, rather than as an afterthought after SEC push-back.

  • For SEC presentation day, staff for the full 12–6 PM window across relevant time zones and confirm sequencing as close to the meeting date as possible.

  • Lean on the SUGAM portal’s deemed-approval timelines for post-approval site/PI changes — and track the 30-day clock closely.

India’s regulatory framework is evolving in the right direction — more digitization, clearer SEC guidance, time-bound post-approval processes. The next frontier is operational: fixed timeslots for SEC presentations, and more transparency on how site-mix expectations get applied trial-by-trial. Sponsors should plan around today’s systems and realities — rather than assuming a “standard” global timeline.