Expanded Access Program (EAP) in India

About Expanded Access Program (EAP)

Structured programs offering access to investigational drugs outside of clinical trials.

How Expanded Access Program (EAP) 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 Expanded Access Program (EAP) 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 Expanded Access Program (EAP) in India