Routes of the same type are on the same row. Compare other markets.
12 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.
Japan: Approval of a drug with a new active ingredient, 365 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 | Japan | India |
|---|---|---|
| Full application, new active substance | Approval of a drug with a new active ingredientArticle 14 approval · target 365 days · fee ¥36,538,400 Approval of a regenerative medical product (cell or gene therapy)Article 23-25 · target 365 days · fee ¥18,803,400 | 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.
Approval of a known active ingredient with a new route, indication, dosage form or doseArticle 14 approval or partial change approval · fee ¥36,538,400 |
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 | Approval of a generic prescription drugArticle 14 approval · target 304 days · fee ¥649,100 | 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 | Approval of a biosimilarApplication category (7) | Similar biologic (biosimilar) approvaltarget 90 days |
| Non-prescription application | Approval of a non-prescription drug (including switch OTC)OTC application categories (1) to (8) · target 365 days · fee ¥1,627,300 | - |
| Conditional or accelerated approval | Conditional approvalArticle 14-2-2 and 23-2-6-2 Conditional and time-limited approval of a regenerative medical productArticle 23-26 · fee ¥9,411,700 | Accelerated approvalSecond Schedule para 1(2)(ii)(A) · target 90 days |
| Priority or accelerated review | Priority reviewArticle 14(11), 23-2-5(11) and 23-25 · target 274 days | Expedited reviewSecond Schedule para 1(2)(ii)(B) |
| Intensive development support designation | Pioneering product designation (SAKIGAKE)Article 77-2(2) · target 183 days | - |
| Orphan or rare disease designation | Orphan designationArticle 77-2(1) · fee ¥30,618,800 | Orphan drug provisionsRule 2(1)(x) · target 90 days |
| Emergency or temporary authorisation | Special approval for emergencies (based on foreign approval)Article 14-3 · relies on US, GB, CA, DE, FR Emergency approval (time-limited)Article 14-2-2-2 and 23-26-2 | - |
| 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 | Fast priority review of a product already sold abroad during a supply shortageArticle 14(9) and 23-2-5(9) · relies on US, GB, CA, DE, FR | Local clinical trial waiver for drugs approved in specified countriesRule 101 · target 90 days · relies on US, GB, JP, AU, CA, EU |
| Device: premarket notification | Notification of a Class I device or a low-risk IVDArticle 23-2-12 |
| Device: premarket approval by the regulator | Approval of a new medical deviceArticle 23-2-5 · target 426 days · fee ¥16,431,300 Approval of an improved medical deviceArticle 23-2-5 · target 304 days · fee ¥9,381,400 Approval of a generic (equivalent) medical deviceArticle 23-2-5 · target 122 days · fee ¥2,244,900 Approval of an in vitro diagnosticArticle 23-2-5 · target 213 days | 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 | Third-party certification by a registered certification bodyArticle 23-2-23 | 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 |
| Other route | Approval held by a foreign manufacturer through a designated marketing authorization holderArticles 19-2, 23-2-17 and 23-37 Specific-use product designationArticle 77-2(3) | Registration certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 |