New Drugs and Clinical Trials Rules, 2019
What approvals does a clinical trial in India need, and in what order?
- AuthorityCDSCO — NDCT 2019
- JurisdictionIndia
- Type Market-access route
- Our scopeDelivered by Prequel
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.
For applicable new drug and investigational new drug clinical trials, both Central Licensing Authority permission and ethics committee approval are necessary before initiation, and the trial at each site is initiated only after that site’s ethics committee has approved the protocol and supporting documents. Certain academic clinical trials meeting the conditions set out in the Rules are treated differently.
The two dossiers overlap substantially, so the preparation can be carried out together rather than one package after the other. That is a saving in preparation time, not a licence to begin at a site before its approvals are in place — which is a distinction worth being precise about, because getting it wrong is a compliance failure rather than a 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.
Sponsors, CROs and academic investigators running clinical trials or BA/BE studies in India.
How Prequel supports it
- Determine the applicable application route for the study
- Prepare the CDSCO application and supporting dossier
- Prepare and coordinate ethics committee submissions alongside the CDSCO dossier
- 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.
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.