India · Central Drugs Standard Control Organisation · New drugs
Review target
-
Not published
Legal time limit
274 days
regulation
Steps
5
4 requirements
Application fee
₹10,000
Drugs Rules, 1945 as compiled to July 2024
Drugs made abroad need a registration certificate for the foreign manufacturing site and each drug, and the importer needs an import licence. The foreign maker or its authorised agent in India applies to the licensing authority appointed by the central government. The rules set a nine month limit for issuing the certificate when the file is complete. Any drug made outside India for sale in India, after any new drug permission that applies.
The import licence fee for a single drug is ₹10,000 for Drugs Rules, 1945 as compiled to July 2024.
1. Application in Form 40; 2. Possible inspection of the foreign site; 3. Review and issue of registration certificate (274 days); 4. Registration certificate in Form 41; 5. Import licence in Form 10.
Outcome: Registration certificate in Form 41, then import licence in Form 10. Valid for 3 years.
Legal basis: Drugs and Cosmetics Act, 1940; Drugs Rules, 1945, rules 23 to 29A and Schedules D-I and D-II
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 274 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. Nine months in the rules for a complete application, with up to three more months in exceptional cases. This is the time limit written in the rules. It is an official target, not a measured review time. | 274 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Fee for inspection or visit of the foreign manufacturing premisesInspection · Drugs Rules, 1945 as compiled to July 2024 | $25,000 |
| Registration fee for each foreign manufacturing premisesEstablishment · Drugs Rules, 1945 as compiled to July 2024 | $10,000 |
| Import licence fee for a single drugApplication · Drugs Rules, 1945 as compiled to July 2024 · Each additional drug costs 1000 rupees. | ₹10,000 |
| Registration fee for each drugProduct · Drugs Rules, 1945 as compiled to July 2024 | $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, State manufacturing licence for drugs that are not new drugs, Similar biologic (biosimilar) approval, 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, Vaccine approval and lot release. 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.