New drug approval under the New Drugs and Clinical Trials Rules, 2019
The New Drugs and Clinical Trials Rules, 2019 govern how a new drug is approved for manufacture, import or marketing in India. Applications go to CDSCO supported by chemistry, manufacturing, preclinical and clinical data proportionate to the category. A drug remains a new drug for four years from the date permission is granted.
| CT series | Application forms scheduled under the 2019 rules |
|---|---|
| Form 29 | Test licence to manufacture for test, examination or analysis |
What counts as a new drug
Broader than most applicants expect. A substance not previously used in India, an already approved drug proposed for a new indication, a new route or a new dosage form, a modified release version, and a fixed dose combination of two or more approved drugs that has not itself been approved: all of these fall inside the definition.
The four-year clock matters commercially. For that period the approval sits with the Central Licensing Authority, and a State authority cannot grant a manufacturing licence for it without CDSCO permission. Companies that plan around a state filing sometimes find they have no route to it yet.
Fixed dose combinations
FDCs draw the most scrutiny and the most refusals. The application has to justify the combination itself, not just the safety of each component. That means a rationale for the ratio chosen, evidence that the combination offers something the components taken separately do not, and clinical data unless the combination falls into a category where a waiver is available.
Where a bridging study or a local clinical trial is required, we scope that before the application is drafted rather than discovering it in a deficiency letter.
Test licences and manufacturing for trial
Manufacturing a batch for test, examination or analysis, including batches destined for a bioequivalence study, needs a test licence in Form 29 from the State authority. It is a small filing that routinely becomes the critical path because nobody scheduled it.
We sequence the test licence, the ethics committee approval and the CDSCO permission so that none of the three is waiting on the other two.
What you need to supply
- Chemical and pharmaceutical information, including manufacturing process and specifications
- Preclinical safety data or published literature justification
- Clinical data appropriate to the category, or the case for a waiver
- Proposed prescribing information and label
- Stability data supporting the proposed shelf life
- Rationale document, for fixed dose combinations
Questions we get asked
How long does a drug stay classified as a new drug in India?
Four years from the date permission is granted. During that period the approval remains with the Central Licensing Authority, so a State Licensing Authority cannot independently grant a manufacturing licence for it. After four years it moves out of new drug status unless it is still under the definition on other grounds.
Is a local clinical trial always needed for a drug already approved abroad?
No. The 2019 rules provide for waivers in defined circumstances, including drugs approved in specified countries and certain orphan or unmet-need categories. Whether a waiver is available for your product is a case-specific reading and should be settled before the dossier is built, not after.
Do I need a separate approval to manufacture the trial batch?
Yes. A test licence in Form 29 from the State Licensing Authority permits manufacture for test, examination or analysis. It is separate from both the CDSCO permission and any eventual manufacturing licence, and it is frequently the item that delays a study start.
This page is orientation, not advice on your specific product. Statutory periods, fee schedules and compliance deadlines change. Confirm the current position before you plan around it. Last reviewed 23 August 2026.