India · Central Drugs Standard Control Organisation · New drugs
Review target
-
Not published
Legal time limit
90 days
regulation
Steps
4
3 requirements
Application fee
₹5,000
Sixth Schedule rates in force since 2019
When a government hospital doctor prescribes a new drug that is still in clinical trial in India for a patient with a serious or life threatening disease and no satisfactory therapy, a manufacturer can ask to make a limited quantity. The ethics committee recommends first, and the authority decides within 90 days. Serious or life threatening disease with no satisfactory therapy in India, using a drug under clinical trial in India.
The permission to manufacture an unapproved new drug under trial for patients is ₹5,000 for Sixth Schedule rates in force since 2019.
1. Patient consent and ethics committee recommendation; 2. Application in Form CT-26; 3. Review by the Central Licencing Authority (90 days); 4. Permission in Form CT-27.
Outcome: Permission in Form CT-27 to make a limited quantity.
Legal basis: New Drugs and Clinical Trials Rules, 2019, Chapter XI, rules 91 to 96
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 |
|---|---|
| Permission to manufacture an unapproved new drug under trial for patientsApplication · Sixth Schedule rates in force since 2019 | ₹5,000 |
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, 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.