Hospital Ethics Committee Approval in India

About Hospital Ethics Committee Approval

Institutional pathway requiring IEC or IRB approval.

How Hospital Ethics Committee Approval 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 Hospital Ethics Committee Approval 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 Hospital Ethics Committee Approval in India