India · Central Drugs Standard Control Organisation · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
-
A sponsor can ask for an expedited review when clinical safety and efficacy are established even if not all trial phases are complete. The drug must treat a serious, life threatening or rare disease and offer a significant advantage. Orphan drugs and drugs for disaster or defense use can also qualify. New drugs for serious, life threatening or rare diseases with a significant safety or efficacy advantage; orphan drugs; drugs for disaster or defense use.
1. Request for expedited review; 2. Expedited review by the Central Licencing Authority; 3. Decision.
Outcome: Faster review of the marketing application.
Legal basis: New Drugs and Clinical Trials Rules, 2019, Second Schedule, paragraph 1(2)(ii)(B)
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
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, Orphan drug provisions, Import of an unapproved new drug by a government hospital, Manufacture of an unapproved new drug under trial for individual patients, Vaccine approval and lot release, Cell and gene therapy products. See all routes on the India page or explore them in the .
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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.