Biological products, or biologics, are medical products derived from natural sources such as humans, animals, or microorganisms. These products, like traditional drugs, are often developed to treat diseases and medical conditions. Additionally, some biologics play a crucial role in preventing or diagnosing diseases.
At Transparon, we assist clients in preparing and filing dossiers for biological products, conducting gap assessments, and ensuring the successful submission of applications to regulatory authorities.
Examples of biological products include:
- Vaccine/r-DNA/Biosimilars
- Vaccines
- Blood and blood products for transfusion or further manufacturing
- Allergenic extracts used for diagnosis and treatment (e.g., allergy shots)
- Human cells and tissues used for transplantation (e.g., tendons, ligaments, and bone)
- Gene therapies
- Cellular therapies
- Tests to screen blood donors for infectious agents such as HIV
Let Transparon help you navigate the complex regulatory requirements and achieve successful product approval.
overview of various
FORMS & FEES
A clear regulatory strategy and thorough understanding of the regulatory framework under the Drugs & Cosmetics Act 1940 are crucial for obtaining successful approvals from the Licensing Authority. At Transparon, we work closely with importers and manufacturers to prepare and submit regulatory dossiers. Our team’s expertise has proven to be an invaluable asset to our clients, ensuring a smooth and efficient approval process.
| # | Application form | Approval Recieved form | Govt. Fees | CDSCO | SLA |
|---|---|---|---|---|---|
| 1 | Form 8 Application For Licence To Import Drugs (Excluding Those Specified In Schedule X) To The Drugs And Cosmetics Rules, 1945 |
Form 10 Licence To Import Drugs (Excluding Those Specified In Schedule X) To The Drugs And Cosmetic Rules, 1945 |
Rs.10000/- For One Product Rs.1000/- For Additional Product |
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| 2 | Form 8A Application For Licence To Import Drugs Specified In Schedule X To The Drugs And Cosmetics Rules, 1945 |
Form 10A Licence To Import Drugs Specified In Schedule X To The Drugs And Cosmetics Rules, 1945 |
Rs.10000/- For One Product Rs.1000/- For Additional Product |
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| 3 | Form 40 Application To Import Drugs |
Form 41 License To Import Drugs |
USD 10000 For Plant USD 5000 For Product (Per Product) |
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| 4 | Form CT-01 Application For Registration/Renewal Of Ethics Committee Relating To Clinical Trial Or Bioavailability And Bioequivalence Study Or Biomedical Health Research |
Form CT-03 Grant Of Registration Of Ethics Committee Relating To Biomedical Health Research Form CT-02 Grant Of Registration Of Ethics Committee Relating To Clinical Trial Or Bioavailability And Bioequivalence Study |
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| 5 | Form CT-04 Application For Grant Of Permission To Conduct Clinical Trial Of New Drug Or Investigational New Drug |
Form CT-06 Permission To Conduct Clinical Trial Of New Drug Or Investigational New Drug |
Phase I-Rs.3,00,000/- Phase II,III & IV- Rs. 2,00,000/- |
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| 6 | Form CT-05 Application For Grant Of Permission To Conduct Bioavailability Or Bioequivalence Study |
Form CT-07 Permission To Conduct Bioavailability Or Bioequivalence Study Of New Drug Or Investigational New Drug |
Rs.2,00,000/- | |
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| 7 | Form CT-08 Application For Registration/Renewal Of Bioavailability Or Bioequivalence Study Centre |
Form CT-09 Grant Of Registration Of Bioavailability Or Bioequivalence Study Centre |
Rs.5,00,000/- | |
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| 8 | Form CT-10 Application For Grant Of Permission To Manufacture New Drug Or Investigational New Drug For Clinical Trial Or Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Form CT-11 Permission To Manufacture New Drug Or Investigational New Drug For Clinical Trial, Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Rs.5000/- Per Product | |
|
| 9 | Form CT-12 Application For Grant Of Permission To Manufacture Formulation Of Unapproved Active Pharmaceutical Ingredient For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Form CT-15 Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For The Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Rs.5000/- Per Product | |
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| 10 | Form CT-13 Application For Grant Of Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Form CT-15 Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For The Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Rs.5000/- Per Product | |
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| 11 | Form CT-14 Permission To Manufacture Formulation Of Unapproved Active Pharmaceutical Ingredient For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Form CT-15 Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For The Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Rs.5000/- Per Product | |
|
| 12 | Form CT-16 Application For Grant Of Licence To Import New Drug Or Investigational New Drug For Clinical Trial Or Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Form CT-17 Licence To Import New Drug Or Investigational New Drug For The Purpose Of Clinical Trial Or Bioavailability Or Bioequivalence Study Or For Examination, Test And Analysis |
Rs.5000/- Per Product | |
|
| 13 | Form CT-18 Application For Grant Of Permission To Import New Drug For Sale Or For Distribution |
Form CT-20 Permission To Import Pharmaceutical Formulations Of New Drug For Sale Or For Distribution Form CT-19 Permission To Import New Active Pharmaceutical Ingredient For Sale Or For Distribution |
Rs.5,00,000/- Rs.5,00,000/- |
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| 14 | Form CT-21 Application For Grant Of Permission To Manufacture New Drug Formulation For Sale Or For Distribution |
Form CT-22 Permission To Manufacture New Active Pharmaceutical Ingredient For Sale Or For Distribution Form CT-23 Permission To Manufacture Pharmaceutical Formulation Of New Drug For Sale Or For Distribution |
Rs.5,00,000/- Rs.5,00,000/- |
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| 15 | Form CT-24 Application For Licence To Import Of Unapproved New Drug For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Government Medical Institution |
Form CT-25 Licence To Import Unapproved New Drug For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Medical Institution |
Rs.10,000/- | |
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| 16 | Form CT-26 Application For Grant Of Permission To Manufacture Unapproved New Drug But Under Clinical Trial For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Medical Institution |
Form CT-27 Permission To Manufacture Unapproved New Drug But Under Clinical Trial For Treatment Of Patients Of Life Threatening Disease In A Government Hospital Or Medical Institution |
Rs.5000/- | |
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| 17 | Renewal or Re-Registration Form 40 – Application for Import of Drugs |
Form 41 License To Import Drugs |
USD 10000 For Plant USD 5000 For Product (Per Product) |
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| 18 | Personal Use Form 12A – Application for the issue of a permit to import small quantities of drugs for personal use |
Form 12B Permit for the import of small quantities of drugs for personal use |
Zero | |
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| 19 | CT-28 Application for import of unapproved new drug for Compassionate use for treatment of patients by hospitals or and medical institution |
CT-29 Grant of licence for import of new drug for compassionate use |
N.A | |
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| 20 | CT-30 Application for the permission to manufacture new drug for Compassionate use |
CT-31 Grant of the permission to manufacture new drug for Compassionate use |
N.A | |
