India · Central Drugs Standard Control Organisation · New drugs
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
The rules define an orphan drug as one for a condition that affects not more than 500,000 people in India. Orphan drugs pay no fee for clinical trial applications, can use the expedited review, and can have the local trial or Phase IV requirement relaxed. Drugs for conditions affecting not more than 500,000 people in India.
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. Orphan status claimed in the application; 2. Review under the new drug rules (90 days); 3. Decision.
Outcome: Lower fees and more flexible data requirements in the new drug pathways.
Legal basis: New Drugs and Clinical Trials Rules, 2019, rule 2(1)(x), rule 75(7), Second Schedule and Sixth Schedule Note 1
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. General decision limit for new drug permissions. 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, Local clinical trial waiver for drugs approved in specified countries, Accelerated approval, Expedited review, 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.