NDCT 2019 — clinical trials
What approvals does a clinical trial in India need, and in what order?
Pharmaceuticals & clinical research
How do I get this study approved and run in India?
How this sector is regulated
Clinical trials, bioavailability and bioequivalence studies and new drug approval in India are governed by the New Drugs and Clinical Trials Rules, 2019, administered by CDSCO. Ethics committees must be registered under those Rules, and their approval is required alongside the regulatory approval.
The Rules also set continuing obligations — safety reporting, and compensation in defined circumstances — that run for the life of the study and need to be operational before the first participant is enrolled.
Where programmes usually lose time
Running approvals in sequence
Regulatory approval and ethics committee approval can proceed in parallel. Teams routinely run them one after the other, then absorb the delay as if it were unavoidable. It is not: the dossiers overlap substantially and the two submissions can be prepared together.
Your route
Regulatory routes that apply here
Which one governs your product depends on its composition, its intended use and what you intend to claim.
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Delivery
The services behind that work
The route sets what has to be produced. These are the teams that produce it — the same functional capability we have run for CROs and sponsors for years.
Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Clinical Data Management
EDC/eCRF build & validation, DMP/edit checks, coding, queries, freeze/lock support.
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Biostatistics & Programming
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
Medical Writing
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
Quality Assurance & Audits
Internal/vendor/site audits support, TMF health, deviation/CAPA tracking, inspection readiness.
Site Management & Monitoring
On-site/remote visit execution, SDV/SDR and follow-ups per the client monitoring plan.
Clinical Trial Management
Program coordination from feasibility through closeout under client SOPs.
When people call us
Typical situations
First study in India
You have run trials elsewhere and need the Indian route, the ethics landscape and the local obligations set out before committing.
Capacity, not strategy
You know exactly what to do and need trained people to do it — data management, safety, programming or monitoring — inside your own systems and SOPs.
Database lock approaching
A deadline is fixed and query resolution, coding or statistical programming needs additional hands that already know the work.
Inspection readiness
An inspection is scheduled or anticipated and the TMF, documentation and CAPA position needs an honest assessment before someone else makes one.
Other sectors we work in
Nutraceuticals
FSSAI category and claims work for supplements, functional foods and foods for special dietary use.
Medical Devices
Classification, risk management, technical documentation and quality systems for CDSCO and EU routes.
Cosmetics
COS-1 and COS-2 import registration, State licensing, labelling and claim control for the Indian market.
Working on a pharmaceutical product?
Send us the product, the claims you want to make and the market you are going to. We will come back on the route and the evidence it needs — before anyone commissions a test.