All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
“NEW DRUG”A new drug which is a modified or sustained release form of a drug or Novel Drug Delivery System (NDDS) of any drug approved by the Central Licencing Authority; or a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug shall continue to be a new drug forever. However, new drugs covered other than above categories shall be considered as a new drug for a period of 4 years of their approval by the CLA.
An “investigational new drug (IND)” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.
“SUBSEQUENT NEW DRUG”A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug also includes a new drug already approved in the country
Regulation of DrugsThe regulation of Drugs in India, with respect to manufacturing and importing of drugs is primarily governed by the Drugs and Cosmetic Act and Rules , New Drug and Clinical Trials Rules 2019 and various other regulations that are issued by the Government from time to time. These regulations are implemented in India by a 3 tier system, i.e., the Central Drug Standard and Control Organisation(CDSCO), the Zonal offices of CDSCO and the State FDA.
We, at Transparon, help the manufacturers and importers in navigating these regulations at various levels by formulating watertight strategies and infallible dossiers, so that our clients get their approvals in a time bound manner. At Transparon, we guide our clients throughout the various stages of drug approval, constantly monitoring and advising our clients, on dossier preparation to clinical trials, SEC meetings to Medical writing, market research to legal documentation, among other services.
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.
# |
Form Applied form |
Approval Recieved form |
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 |
 |
|
| 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 |
|
|
| 3 | Form 40 Application To Import Drugs |
Form 41 License To Import Drugs |
USD 10000 For Plant USD 5000 For Product (Per Product) |
|
|
| 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/- |
|
|
| 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/- | |
|
| 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/- | |
|
| 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 | |
|
| 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 | |
|
| 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/- |
|
|
| 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/- | |
|
| 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/- | |
|
| 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) |
|
|
| 18 | Shelf Life Extension/Reduction | Amendment of Certificate | USD 1800 | |
|
| 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 | |
|
| 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 | |
|
| 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 | |
