India · Central Drugs Standard Control Organisation · New drugs
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
₹300,000
Sixth Schedule rates in force since 2019
A drug already approved for some claims needs new permission before it is marketed with a new indication, dosage form, route of administration or strength. The application includes local clinical trial results unless waived. An approved new drug proposed for a new indication, new dosage form, new route of administration or new strength.
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.
The permission to import an approved new drug for new claims is ₹300,000 for Sixth Schedule rates in force since 2019. A reduced fee of ₹150,000 applies in some cases (Micro, small and medium enterprises pay half).
1. Application with Table 3 data; 2. Scrutiny by the Central Licencing Authority (90 days); 3. Deficiency letter and response (clock stopped); 4. Permission or rejection.
Outcome: Permission to import or manufacture the drug with the new claims.
Legal basis: New Drugs and Clinical Trials Rules, 2019, rules 75(4) and 80(4), Second Schedule Table 3, Sixth Schedule
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 |
|---|---|
| Permission to import an approved new drug for new claimsSupplement · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half. | ₹300,000reduced ₹150,000 |
| Permission to manufacture an approved new drug for new claimsSupplement · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half. | ₹300,000reduced ₹150,000 |
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 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, Manufacture of an unapproved new drug under trial for individual patients. 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.