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Named Patient Import – Form 12B (CDSCO) – India

Form 12BNDCT Rules 2019, Rule 10130 days

Contents

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

Description & Eligibility

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.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

CDSCO GSR 354(E) 2019

Countries Using This Pathway (1)

IN
India
IN
Named Patient Import – Form 12B (CDSCO) – India
Approval FormForm 12B
Timeline30 days
Legal StatusNDCT Rules 2019, Rule 101
Source Ref.CDSCO GSR 354(E) 2019
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified