India Named Patient Import (Form 12B)
Form 12BRegulated30 days
Description & Eligibility
Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs...
Eligibility Criteria
Patient must have no alternative licensed treatment available in India.
Legal Reference / Source
CDSCO GSR 354(E)
Countries Using This Pathway (1)
India Named Patient Import (Form 12B)
| Approval Form | Form 12B |
| Timeline | 30 days |
| Legal Status | Regulated |
| Source Ref. | CDSCO GSR 354(E) |
| Countries | 1 countries |
Compliance Check
Legal Review3/11/2026
Global ValidityVerified