India · Central Drugs Standard Control Organisation · New drugs
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
-
The Central Licencing Authority can waive the local clinical trial for a new drug already approved and marketed in countries it has specified. The countries named are the United States, the United Kingdom, Japan, Australia, Canada and the European Union. The waiver is used for five categories of drugs, and the applicant commits to a Phase IV trial in India. New drugs approved and marketed in a specified country that fall in one of the five listed categories, or drugs already in an ongoing global trial in India that are then approved in a specified country.
The official review target is 90 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Application in Form CT-18 or CT-21 with waiver request; 2. Scrutiny by the Central Licencing Authority (90 days); 3. Permission or rejection; 4. Phase IV clinical trial in India.
Yes. It relies on approvals from Australia, Canada, European Union, United Kingdom, Japan, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: Permission to import or manufacture without a new local clinical trial, with a Phase IV commitment.
Legal basis: New Drugs and Clinical Trials Rules, 2019, rules 75(7), 80(7) and 101
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 90 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetregulation. This is the time limit written in the rules. It is an official target, not a measured review time. | 90 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in India: Permission to import or manufacture a new drug with a new molecule, Permission for a new drug already approved in India (subsequent applicant), Permission for new claims of an approved new drug, Permission for a fixed dose combination, Registration certificate and import licence for imported drugs, Accelerated approval, Expedited review, Orphan drug provisions, Import of an unapproved new drug by a government hospital, Manufacture of an unapproved new drug under trial for individual patients, Cell and gene therapy products. See all routes on the India page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.