Routes of the same type are on the same row. Compare other markets.
11 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
Australia: Registration of a new prescription medicine (standard pathway), 220 days. India: Permission to import or manufacture a new drug with a new molecule, 90 days. These are official targets, not actual review times.
| Pathway type | Australia | India |
|---|---|---|
| Full application, new active substance | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 | Permission to import or manufacture a new drug with a new moleculeForm CT-18 / CT-21 · target 90 days · fee ₹500,000 Vaccine approval and lot releasetarget 90 days Cell and gene therapy productstarget 90 days |
| Full or mixed application, known active substance |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
Permission for new claims of an approved new drugForm CT-18 / CT-21, Table 3 · target 90 days Permission for a fixed dose combinationForm CT-18 / CT-21 · target 90 days · fee ₹500,000 |
| Generic application | Permission for a new drug already approved in India (subsequent applicant)Form CT-18 / CT-21, Table 2 · target 90 days · fee ₹200,000 State manufacturing licence for drugs that are not new drugsForm 24 / Form 25 · fee ₹6,000 |
| Biosimilar application | Similar biologic (biosimilar) approvaltarget 90 days |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 | - |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 | Accelerated approvalSecond Schedule para 1(2)(ii)(A) · target 90 days |
| Priority or accelerated review | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 | Expedited reviewSecond Schedule para 1(2)(ii)(B) |
| Orphan or rare disease designation | Orphan drug provisionsRule 2(1)(x) · target 90 days |
| Early or compassionate access | - | Import of an unapproved new drug by a government hospitalForm CT-24 / CT-25 · fee ₹10,000 Manufacture of an unapproved new drug under trial for individual patientsForm CT-26 / CT-27 · fee ₹5,000 |
| Reliance route, abridged review | Comparable overseas regulator report-based process, approach ACOR-A · relies on US, EU, GB, CA, CH, JP, SG Comparable overseas regulator report-based process, approach BCOR-B · relies on US, EU, GB, CA, CH, JP, SG | Local clinical trial waiver for drugs approved in specified countriesRule 101 · target 90 days · relies on US, GB, JP, AU, CA, EU |
| Reliance route, recognition or verification | Register inclusion of medical devices and IVDs using manufacturer evidencefee A$1,603 · relies on EU, US, CA, JP, SG, GB | - |
| Work-sharing or joint review | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US | - |
| Device: premarket notification |
| Device: premarket approval by the regulator | - | Permission for a medical device without a predicateForm MD-26 / MD-27 · fee ₹100,000 · relies on GB, US, AU, CA, JP, EU Permission for a new in vitro diagnostic deviceForm MD-28 / MD-29 · fee ₹25,000 |
| Device: conformity assessment by a certification body | Manufacturing licence for Class A and B devicesForm MD-3 / MD-5 |
| Device: registration or licence with the regulator | - | Import licence for medical devices and IVDsForm MD-14 / MD-15 · relies on AU, CA, JP, EU, US, GB Manufacturing licence for Class C and D devicesForm MD-7 / MD-9 · target 45 days |
| Device: breakthrough or priority program | - |
| Other route | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 | Registration certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 |