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.
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 | Brazil | India |
|---|---|---|
| Full application, new active substance | Registration of a new medicinefee R$157,416 | 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 |
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.
| Full or mixed application, known active substance | Registration of an innovative medicinefee R$37,231 | 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 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 | 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 | - |
| Non-prescription monograph | - |
| Conditional or accelerated approval | Accelerated approvalSecond Schedule para 1(2)(ii)(A) · target 90 days |
| Priority or accelerated review | Expedited reviewSecond Schedule para 1(2)(ii)(B) |
| Orphan or rare disease designation | Special procedure for new medicines for rare diseasestarget 60 days | 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 | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, JP | 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 or II medical devicetarget 30 days |
| 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 | Registration of a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days | 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 | Good manufacturing practice certification (CBPF)target 365 days | Registration certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 |