FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
New Drugs and Clinical Trials Rules, 2019
What approvals does a clinical trial in India need, and in what order?
What this route requires
The New Drugs and Clinical Trials Rules, 2019 govern clinical trials, bioavailability and bioequivalence studies, and new drug approval in India. They set the application routes, the timelines the authority works to, and the responsibilities carried by sponsors, investigators and ethics committees.
Two approvals are needed before a trial begins, and they can run in parallel rather than in sequence: regulatory approval from CDSCO, and approval by an ethics committee registered under the Rules. Treating them as sequential is one of the more common causes of avoidable delay.
The Rules also carry obligations that run for the life of the trial — safety reporting, and compensation in defined circumstances — which need a framework in place before the first participant is enrolled, not after.
Applies to
Sponsors, CROs and academic investigators running clinical trials or BA/BE studies in India.
Our scope
How Prequel supports it
- Determine the applicable application route for the study
- Prepare the CDSCO application and supporting dossier
- Coordinate ethics committee submissions and responses in parallel
- Set up the safety reporting and compliance framework the Rules require
- Manage regulatory queries through to approval
Delivered by Prequel. Where a step needs a specialist partner — laboratory testing in particular — we define the scope and review the output, and we say so rather than implying it is in-house.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Not sure NDCT 2019 — clinical trials is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.