Intermediate-Size Expanded Access in India

About Intermediate-Size Expanded Access

US FDA framework for groups of patients.

How Intermediate-Size Expanded Access works in India

India's CDSCO permits import of unapproved drugs under Rule 36 for personal use by patients with a prescription from a registered medical practitioner. Named Patient import is common for rare-disease indications.

Patients in India seeking access under Intermediate-Size Expanded Access typically follow this flow: a licensed physician in India issues the prescription and clinical justification, the regulator reviews and authorises, and an authorised operator coordinates import.

Documents required in India

• Physician prescription and clinical-justification letter.
• Patient identification and consent.
• Country-specific NPP/personal-import form.
• Hospital or clinic attestation where required.

Typical timeline

End-to-end 2-6 weeks in most tier 1 jurisdictions. Cellular and gene therapies may require additional ethics-committee review.

Start a request

Start a request under Intermediate-Size Expanded Access in India