India · Central Drugs Standard Control Organisation · Cell and gene therapy
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
-
Cell or stem cell derived products and gene therapy products are always new drugs. They follow the new drug permission rules, with the same 90 working day decision limit. Gene and cellular therapy products approved in the specified reference countries are one of the categories that can get a local trial waiver. Cell or stem cell derived products, gene therapy products and xenografts intended for use as drugs.
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; 2. Scrutiny by the Central Licencing Authority (90 days); 3. Permission or rejection; 4. Periodic safety update reports.
Outcome: Permission to import or manufacture the product, followed by a licence.
Legal basis: New Drugs and Clinical Trials Rules, 2019, rule 2(w)(v) and Chapter X
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: Local clinical trial waiver for drugs approved in specified countries, Accelerated approval, Expedited review, Orphan drug provisions, Import of an unapproved new drug by a government hospital. 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.