BA/BE Study Indian regulatory approval timelines
| Regulatory body | Approval | Time |
| Drugs Controller General of India (DCGI) |
Bioequivalence No Objection Certificate |
5-6 Weeks |
| Test License to import investigational products (T License) |
5-6 Weeks |
|
| Regulatory approval for conducting clinical trials in India | 8-10 Weeks |
|
| Drugs Controller General of India (DCGI) |
Sample Shipment NOC (Export NOC) |
2-3 weeks |
| Ethics Committees | Approval (meets twice in a week) |
1-2 weeks |
* BENOC is required from DCGI for those products
which fall under 'New Drug'
category in India.
* T License is required to import investigational products to India.
* Export NOC is required to export biological samples outside India.
* BENOC, T License and ethics committee approval are processed in parallel.
