India
INSouth Asia
Regulatory Overview
India is regulated by the Central Drugs Standard Control Organization (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
Central Drugs Standard Control Organization (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.
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.
Under India's New Drugs and Clinical Trials Rules 2019, a named patient can import unapproved drugs...
Drugs Available (67)
| ISO Code | IN |
| Region | South Asia |
| Regulatory Authority | Central Drugs Standard Control Organization (CDSCO) |
| Pathways | 3 documented |
| Drugs Available | 67 drug(s) |