Compassionate Use in India
How the compassionate use pathway operates in India.
About Compassionate Use
A regulatory pathway allowing seriously ill patients access to investigational or unregistered drugs.
How Compassionate Use 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 Compassionate Use 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.