Routes of the same type are on the same row. Compare other markets.
7 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, reliance route, abridged review, device: registration or licence with the regulator 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 | India | Mexico |
|---|---|---|
| Full application, new active substance | 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 | Registration of a medicine with a new moleculeCOFEPRIS-04-030 · fee MX$198,496 Registration of an innovative biotechnology medicineCOFEPRIS-04-030 |
| 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.
| 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 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | Similar biologic (biosimilar) approvaltarget 90 days | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| Non-prescription application | - |
| Traditional or herbal registration | - | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 |
| 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 | 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 | Local clinical trial waiver for drugs approved in specified countriesRule 101 · target 90 days · relies on US, GB, JP, AU, CA, EU | Abbreviated reliance route for medicinesCOFEPRIS-04-040 · relies on US, EU, JP, CA, CH, WHO, BR Abbreviated reliance route for medical devicesCOFEPRIS-04-050 · relies on AU, BR, CA, CN, EU, JP, RU, SG, KR, CH, GB, US |
| Device: exempt or self-declared | - |
| 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 | Registration of a Class I medical deviceCOFEPRIS-04-060 · fee MX$16,499 Registration of a Class II medical deviceCOFEPRIS-04-060 · fee MX$24,198 Registration of a Class III medical deviceCOFEPRIS-04-060 · fee MX$30,798 Simplified registration of listed low-risk devicesCOFEPRIS-04-070 |
| Other route | Registration certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |