DRUG REGISTRATION SERVICES
Clinical Trials
Under the New Drugs & Clinical Trial Rules 2019, GSR NO 227 ,” clinical trial” in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its,-
- clinical or;
- pharmacological including pharmacodynamics, pharmacokinetics or;
- adverse effects,
It is Important to establish the Safety and Efficacy of a Drug Product before it is put in use for Population at large.Conducting Clinical trials in India require mandatory approvals from the Central Licensing authority i.e. CDSCO.
download actApplication Form:
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Form applied |
Approval received |
Government Fees |
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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 |
Rs-50,000/- |
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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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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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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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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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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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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/- |
What are “phases” of clinical trial?
Phase I clinical trials, researchers test a new drug or treatment for the first time in a small group of normal, healthy volunteers (about 20 to 80) to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II clinical trials, the study drug or treatment is given to a larger group of people (about 100 to 300), including patients with the particular disease, to see if the drug or treatment is effective, and to further evaluate its safety.
Phase III clinical trials, the study drug or treatment is given to large groups of people (from 1,000 to 3,000), including patients, to confirm its effectiveness, monitor side effects, compare it to other commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV clinical trials, are done after the drug or treatment has been approved by the DCGI and marketed for public use. These studies continue testing the drug or treatment to collect information about its effect in various populations and gather data on any side effects associated with long-term use.
Registration of Ethics Committee
Every Ethics Committee, constituted under rule 7, shall make an application for grant of registration to the Central Licencing Authority for Registration at the SUGAM Portal in Form CT-01.
The Ethics Committee shall furnish such information and documents as specified in Table 1 of the Third Schedule along with the application made in Form CT-01.
The Central Licencing Authority,
- shall scrutinise the information and documents furnished with the application under sub-rule (2); and
- make such further enquiry, if any, considered necessary and after being satisfied, that the requirements of these rules have been complied with, may grant registration to Ethics Committee in Form CT-02; and if the Central Licencing Authority is not satisfied with the compliance of these rules by the applicant Ethics Committee, it may, reject the application, for reasons to be recorded in writing, within a period of forty-five working days, from the date of the receipt of the application made under sub-rule (1).
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Form applied |
Approval received |
Government Fees |
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CT-01 Application for registration/renewal of ethics committee relating to clinical trial or bioavailability and bioequivalence study or biomedical health research |
CT-02 Grant of registration of ethics committee relating to clinical trial or bioavailability and bioequivalence study |
Rs-50000/- not sure as I have not found in rules |
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CT-01 Application for registration/renewal of ethics committee relating to clinical trial or bioavailability and bioequivalence study or biomedical health research |
CT-03 Grant of registration of ethics committee relating to biomedical health research |
Rs-50000/- not sure as I have not found in rules |
Registration of Ethics Committee is Valid for 5 years
ICMR has initiated a free record system for registration of all Clinical Trials being conducted in India called as Clinical Trial Registry India.
As per the notification of Drugs Controller General India (DCGI) all Clinical trials being done in India need to be mandatorily registered in the Clinical Trial Registry India i.e. CTRI.
Applicants seeking various permissions to conduct Clinical Trials need detailed planning and thorough understanding of the New Drugs & Clinical Trial Rules 2019. We at NKG, we understand the procedure for the same and work closely with our clients to obtain various permissions for conducting clinical trials such as Phase I, II & III permissions.
Why NKG for Drug Regulatory Services
Our team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.
NKG experts are well versed with dossiers for registration under the New Drugs & Clinical Trial Rules 2019 . Our team makes the process of filing and approval under these rules efficient and predictable.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
