OrphanDrug
OrphanDrug
Pharma Knowledge Base

CDSCO Compassionate Use (Rule 96) – India

CDSCO CU ApplicationNDCT Rules 2019 Rule 9621 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

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.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

CDSCO New Drugs and Clinical Trials Rules 2019

Countries Using This Pathway (1)

IN
India
IN
CDSCO Compassionate Use (Rule 96) – India
Approval FormCDSCO CU Application
Timeline21 days
Legal StatusNDCT Rules 2019 Rule 96
Source Ref.CDSCO New Drugs and Clinical Trials Rules 2019
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified
CDSCO Compassionate Use (Rule 96) – India — Regulatory Pathway | OrphanDrug