India · Central Drugs Standard Control Organisation · New drugs
Review target
90 working days
regulation
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
₹500,000
Sixth Schedule rates in force since 2019
A fixed dose combination of two or more drugs is a new drug when the drugs are combined for the first time or the ratio changes. It needs permission from the Central Licencing Authority, with data from Table 1, 2 or 3 of the Second Schedule as fits the case. Two or more drugs approved separately and combined for the first time in a fixed ratio, or an approved combination with a changed ratio.
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 fdc with one or more unapproved new molecules is ₹500,000 for Sixth Schedule rates in force since 2019. A reduced fee of ₹250,000 applies in some cases (Micro, small and medium enterprises pay half).
1. Application in Form CT-18 or CT-21; 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 combination.
Legal basis: New Drugs and Clinical Trials Rules, 2019, rule 2(w)(iii), rules 75(5) and 80(5), 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 FDC with one or more unapproved new moleculesApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half. | ₹500,000reduced ₹250,000 |
| Permission to import an FDC of approved ingredientsApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half. | ₹400,000reduced ₹200,000 |
| Permission to manufacture an FDC of approved ingredientsApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half. | ₹300,000reduced ₹150,000 |
| Permission to manufacture an FDC already approvedApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half. | ₹200,000reduced ₹100,000 |
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, 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.