Clinical Trial Support
End-to-end clinical trial regulatory support — from protocol design and CDSCO/IEC approval to investigational drug management and final study report submission.
Service Overview
Clinical trials in India are regulated by CDSCO under Schedule Y of the Drugs & Cosmetics Rules and the New Drugs and Clinical Trials Rules 2019 (NDCT Rules). All interventional clinical trials require CDSCO approval before initiation.
The regulatory process involves Investigational New Drug (IND) application filing, Ethics Committee (EC) registration and approval, site selection regulatory review, investigational drug import/export licensing, and comprehensive documentation throughout the trial lifecycle.
MedRegX India provides full-spectrum clinical trial regulatory support to pharmaceutical companies, CROs, academic institutions, and device manufacturers — from protocol development guidance and regulatory strategy to final Clinical Study Report (CSR) submission.
Key Takeaways
- Every interventional clinical trial in India needs CDSCO approval before it starts, under the New Drugs and Clinical Trials Rules, 2019 and Schedule Y.
- Approval runs on two parallel tracks — the CDSCO regulatory submission and Ethics Committee clearance — and the trial cannot begin until both are in place.
- Investigational products usually require an import/manufacture licence (Form CT-06) before they can be supplied to trial sites.
- Registration on the Clinical Trials Registry–India (CTRI) is mandatory before enrolling the first participant.
- Robust pharmacovigilance and Serious Adverse Event (SAE) reporting must be in place from day one, not added mid-trial.
The Two Approval Tracks Every Trial Must Clear
A clinical trial in India does not hinge on a single approval — it depends on two that run in parallel. The first is the regulatory track: an application to CDSCO (Form CT-04 for the trial, with the supporting IND package) that the Subject Expert Committee reviews for scientific and safety rationale. The second is the ethics track: submission of the protocol, Investigator Brochure and Informed Consent Form to a registered Ethics Committee for each site. A trial may not enrol a single participant until both the CDSCO permission and the Ethics Committee approval are in hand.
Sponsors frequently underestimate how tightly these tracks interlock. An Ethics Committee will question a protocol that CDSCO has flagged, and CDSCO expects to see the ethics pathway progressing. We manage both submissions as one coordinated timeline — aligning the protocol, consent documents and safety plan so the same questions are not answered two different ways to two different bodies, which is a common cause of avoidable delay.
- CDSCO regulatory permission — Form CT-04, reviewed by the Subject Expert Committee.
- Ethics Committee approval — protocol, Investigator Brochure and ICF, per site.
- Form CT-06 — import or manufacture licence for the investigational product.
- CTRI registration — mandatory before the first participant is enrolled.
Safety Reporting and Trial Conduct: Where Compliance Is Ongoing
Approval is the start line, not the finish. Once a trial is live, the NDCT Rules impose strict, time-bound obligations that continue for its full duration. Serious Adverse Events must be reported to CDSCO, the Ethics Committee and the sponsor within defined windows, and any death or serious injury linked to the trial triggers a compensation assessment. Protocol amendments, site additions and changes to the investigational product all require fresh regulatory notification or approval before they take effect.
This is where trials most often fall out of compliance — not at approval, but in the discipline of ongoing reporting. We set up the pharmacovigilance and SAE-reporting framework before the trial opens, define who owns each reporting deadline, and handle amendment filings as they arise, so the sponsor stays continuously compliant rather than scrambling to reconstruct records ahead of an inspection or the final Clinical Study Report submission.
Required Documentation
"Accurate documentation is 70% of the battle. Our experts pre-audit every file before submission."
Our Delivery Workflow
Regulatory Strategy
Define the optimal regulatory pathway, study design, and submission strategy for your clinical program.
IND Preparation
Compile and submit the Investigational New Drug application to CDSCO with complete clinical and non-clinical data package.
Ethics Approval
Submit protocol to registered Ethics Committees, manage queries, and coordinate multi-site EC approvals.
Trial Execution Support
Provide ongoing regulatory support during trial execution, including amendments, SAE reporting, and regulatory updates.
Frequently Asked Questions
Have questions? Find direct, humanized answers about the regulatory approvals and timelines.
Launch Your Product In Record Time
Red tape shouldn't decide your launch date. We keep the paperwork moving and the queries answered, so approvals come through sooner.