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 |
Will Confirm You Soon Not Found In Rule |
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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 |
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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 |
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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 |
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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 |
Shelf Life Extension/Reduction |
Amendment of Certificate |
USD 1800 |
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19 |
Personal Use Form 12A Application for the issue of a permit to import small quantities of drugs for personal use |
Form 12 B Permit for the import of small quantities of drugs for personal use |
Zero |
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20 |
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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21 |
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 |
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