India
INSouth Asia
Regulatory Overview
India is regulated by the CDSCO. The country has 3 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
CDSCO
Regulatory Pathways (3)
Rule 96 of NDCT Rules 2019 allows compassionate use of new drugs for patients with serious or life-threatening diseases who are not eligible for clinical trials and have no other treatment options.
Application Form: CDSCO CU Application
Legal Basis: NDCT Rules 2019 Rule 96
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: CDSCO New Drugs and Clinical Trials Rules 2019
Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs on Form 12B with CDSCO approval for personal use to treat a specific disease.
Application Form: Form 12B
Legal Basis: NDCT Rules 2019, Rule 101
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: CDSCO GSR 354(E) 2019
Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs...
Application Form: Form 12B
Legal Basis: Regulated
Eligibility: Patient must have no alternative licensed treatment available in India.
Reference: CDSCO GSR 354(E)
Drugs Available (84)
India
| ISO Code | IN |
| Region | South Asia |
| Regulatory Authority | CDSCO |
| Pathways | 3 documented |
| Drugs Available | 84 drug(s) |