India · Central Drugs Standard Control Organisation · New drugs
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
Accelerated approval can be granted for serious or life threatening conditions, rare diseases, diseases of special relevance to India, or unmet medical needs. Approval may rest on a surrogate endpoint, or on Phase II data when efficacy is remarkable. Post marketing trials then confirm the clinical benefit. New drugs for severe, rare or highly prevalent conditions with a likely meaningful benefit over existing treatment.
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 with surrogate endpoint or Phase II data; 2. Review by the Central Licencing Authority (90 days); 3. Accelerated approval; 4. Post marketing trials to confirm benefit.
Outcome: Marketing permission with an obligation to run post marketing trials.
Legal basis: New Drugs and Clinical Trials Rules, 2019, Second Schedule, paragraph 1(2)(ii)(A)
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, 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, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.