India · Central Drugs Standard Control Organisation · New drugs
Review target
-
Not published
Legal time limit
90 days
regulation
Steps
4
4 requirements
Application fee
₹10,000
Sixth Schedule rates in force since 2019
A medical officer of a government hospital or government medical institution can import a new drug not approved in India but approved in its country of origin, to treat a patient with a life threatening or seriously disabling disease or an unmet need. The authority decides within 90 days. Treatment of individual patients in government hospitals when no approved option exists in India.
The import of an unapproved new drug by a government hospital or medical institution is ₹10,000 for Sixth Schedule rates in force since 2019.
1. Application in Form CT-24; 2. Review by the Central Licencing Authority (90 days); 3. Licence in Form CT-25; 4. Half yearly stock and use report.
Outcome: Import licence in Form CT-25, valid for three years. Valid for 3 years.
Legal basis: New Drugs and Clinical Trials Rules, 2019, Chapter XI, rules 86 to 90
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
| Legal time limitregulation. This is the time limit written in the rules. It is an official target, not a measured review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Import of an unapproved new drug by a government hospital or medical institutionApplication · Sixth Schedule rates in force since 2019 | ₹10,000 |
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, Orphan drug provisions, 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.