Special Access Scheme in India
How the special access scheme pathway operates in India.
About Special Access Scheme
Australia's TGA-operated pathway for unapproved therapeutic goods.
How Special Access Scheme 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 Special Access Scheme 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.