India · State Licensing Authorities (State Drugs Controllers) · Generics
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
5 requirements
Application fee
₹6,000
Drugs Rules, 1945 as compiled to July 2024
Drugs that are no longer new drugs, including generics and nonprescription products, are made under a manufacturing licence from the State Licensing Authority where the factory is located. The site must meet the good manufacturing practice rules in Schedule M. For some oral generics, bioequivalence results are required. Domestic manufacture of drugs that are not new drugs, such as generics more than four years after first approval in India.
The manufacturing licence fee, form 24 (up to ten items per category) is ₹6,000 for Drugs Rules, 1945 as compiled to July 2024.
1. Application in Form 24 to the State Licensing Authority; 2. Inspection of the manufacturing site; 3. Licence in Form 25.
Outcome: Manufacturing licence in Form 25 issued by the State Licensing Authority.
Legal basis: Drugs and Cosmetics Act, 1940; Drugs Rules, 1945, rules 69 to 74 and Schedule M
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Manufacturing licence fee, Form 24 (up to ten items per category)Application · Drugs Rules, 1945 as compiled to July 2024 | ₹6,000 |
| Inspection fee for each inspection, Form 24Inspection · Drugs Rules, 1945 as compiled to July 2024 | ₹1,500 |
Other routes in India: Permission for a new drug already approved in India (subsequent applicant), Registration certificate and import licence for imported drugs. 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.