In January 2016, India's Central Drugs Standard Control Organisation (CDSCO) introduced SUGAM, an online portal, for filing applications of various services. After that Indian regulatory authorities revised and publish new guideline for Clinical trial as a NDCT rules in March 2019. Base on NDCT rules, there are number of changes have been made in various applications and their conditions. This presentation contains basic information for biological products applications and submission through SUGAM Portal. Also, short process flow for approval of drug product process.

1. DCGI
(Drug Controller General of India)
Applications & Submissions at SUGAM Portal
For Biological Products
Mr. Akshay G. Kakde
M. Pharm QA,
Sr. Executive RA
1
10/7/2023

2. Insides
10/7/2023 2
Sr. No Title
1 Abbreviations
2 Drug Controller General of India:- Roles
3 Drug Controller General of India:-Responsibilities
4 Type Of NOC’s Applications For DCGI
5 Other Applications at SUGAM
6 Applications Details and Fees
7 Timeline for applications Old vs New
8 Regulatory approval at various stages of development of Biological Products
9 Drug Approval Process for New Drug Product Biological
10 Applications and Approval
11 Rules for application of NOC’S: NDCT Rule 2019
12 Checklist for Applications
13 Q&A

3. Abbreviations
DCGI Drug Controller General of India
NOC No objections Certificate
BA Bio Availability
BE Bio Equivalence
IND Investigational New Drug
CT Clinical Trial
SAE Serious Adverse Event
PSUR Periodic Safety Update Report
IBSC Institutional Biosafety Committee
RCGM Review Committee on Genetic Manipulation
LMOs/GMOs Living Modified Organism/ Genetically Modified Organism
10/7/2023 3

4. Definitions of New Drug
“New Drug” means,
i. A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not
been used in the country to any significant extent, except in accordance with the
provisions of the act and the rules made thereunder, as per conditions specified in the labelling
thereof and has not been approved as safe and efficacious by the central licensing authority with
respect to its claims; or
ii. A drug approved by the central licensing authority for certain claims and proposed to be marketed
with modified or new claims including indication, route of administration, dosage and dosage
form; or
iii. A fixed dose combination of two or more drugs, approved separately for certain claims and
proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an
approved combination is proposed to be changed with certain claims including indication, route of
administration, dosage and dosage form; or
10/7/2023 4

5. Cont..
iv. A modified or sustained release form of a drug or novel drug delivery system of any drug
approved by the Central Licensing Authority; or
v. A vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified
organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or
xenografts, intended to be used as drug;
• Explanation:
The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be
new drugs for a period of four years from the date of their permission granted by the
Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall
always be deemed to be new drugs;
10/7/2023 5

6. Drug Controller General of India:- Roles
1. Follows D&C Act under which regulations for manufacture, sale &
distribution of drugs is primarily concern of state authorities while
the central authorities are responsible.
2. Approval to New Drugs, Clinical trials in the country, laying down
the standard for drugs.
3. Control over the quality of drug products, imported drugs.
6
10/7/2023

7. Drug Controller General of India:-Responsibilities
• DCGI is responsible for approval of NOC’S and licenses of specified
categories of Drugs as follows
Pharmaceuticals & Biopharmaceuticals
Vaccine & Sera
Blood and blood products
I. V. Fluids
Medical device and diagnostics
Clinical trials & BA/BE studies
Cosmetics
10/7/2023 7
Ref.:- https://cdscoonline.gov.in/CDSCO/homepage

8. Type Of NOC Applications For DCGI
Sr.
No Old Application Form
New Application Form for NOC’S at
SUGAM
1 Form 8- License to Import drugs (other than
schedule X) No Change
2 Form 8A- License to Import drugs schedule X No Change
3 Form 40- License of registration certificate
(RC) for import of drug into India. No Change
4 Form 12-License to import drugs for purpose of
examination, test or analysis
Form CT 16- Grant license to import new drug
or IND for CT or BA/BE study or test
examination & analysis
10/7/2023 8
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.

9. Cont..
10/7/2023 9
Sr.
No
Old Application
Form
New Application Form for NOC’S at SUGAM
5
Form 12-
Application for
license to import
drugs for the
purposes for
examination, test or
analysis
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-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-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 30 :- Application to grant of permission to manufacture drugs for
purposes of clinical trial, examination, test or analysis. (State FDA).
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.

10. Cont..
10/7/2023 10
Sr.
No Old Application Form New Application Form for NOC’S at SUGAM
6
Form 44- Permission to
import or manufacture a new
drug or to undertake clinical
trial.
Form CT-04 Application for grant of permission to conduct
clinical trial of new drug or Investigational new drug
Form CT-21 Application for grant of permission to manufacture
new drug formulation for Sale or for distribution
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.

11. Other Applications at SUGAM
• Mapping of CT site and doctors
• SAE Reporting/ Submission
• PSUR Reporting/Submission
• BA/BE NOC
10/7/2023 11
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage

12. Other Applications at SUGAM
• Export NOC country specific
• Export NOC alteration of strength
• WHO GMP Application
• Additional Product Permission
10/7/2023 12

13. Applications Details and Fees
Sr.
No.
Name of
Application
Details Fees (INR)
1. Form CT-04
Application for grant of permission to conduct clinical trial of new drug or
Investigational new drug
P I- 3 lac
P II- 2 lac &
P III- 2 lac
2. Form CT-06 Permission to conduct clinical trial of new drug or investigational new drug
3. 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
5000/
Product
4. 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
10/7/2023 13

14. Cont…
10/7/2023 14
Sr.
No.
Name of
Application
Details
Fees
(INR)
5. 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
5000/
Product
6. Form CT-14
Permission to manufacture formulation of unapproved active pharmaceutical Ingredient for test or
analysis or clinical trial or bioavailability or Bioequivalence study
7. 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
5000/
Product
8. 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
9. Form CT-16
Application for grant of license to import new drug or investigational new drug For
clinical trial or bioavailability or bioequivalence study or for Examination, test and
analysis
5000/
Product
10. Form CT-17
License 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

15. Time duration for applications approvals
as per old process
10/7/2023 15
Sr.
No.
Application
Type
Old timeline
in day’s
New Timeline
in day’s at
SUGAM
1 Form CT-10 60 38
2 Form CT-12 60 38
3 Form CT-13 60 38
4 Form CT-16 60 45
5 Form CT-04 180 120
6 Form CT-21 180 120 may vary
Time duration for applications approvals as
per new process at SUGAM
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.

16. Regulatory approval at various stages of development of
Biological Products
Sr.
No.
Stages Agency Application Approvals
1
Manufacturing permission NOC for
CT, test, analysis & examination
DCGI/ CDSCO
Form CT-10, CT-12
and CT-13
Form CT-11,CT-14
and CT-15
2
Manufacturing license for CT, test,
analysis & examination
State FDA Form 30 Form 29
3 R&D
Institutional Biosafety
Committee(IBSC)
-
Permission IBSC
minutes
4 Non clinical studies permission RCGM Form C3 -
10/7/2023 16
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.

17. Cont..
10/7/2023 17
Sr.
No.
Stages Agency Application Approvals
5 Submission of Non-clinical study report RCGM Form C5 -
6 Clinical Trial DCGI Form CT-04 Form CT-06
7 Manufacturing license for CT batches
State FDA (Subject
to CT NOC)
Form 30 Form 29
8 Manufacturing & Marketing Permission DCGI Form CT-21
Form CT-22- Bulk
Drugs (API)
Form CT-23-
Finished
Formulations
9
Commercial Manufacturing License
(Biologicals)
CDSCO/ State FDA Form 27D Form 28D
Ref.:- 1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.

18. Drug Approval Process for New Drug Product Biological
10/7/2023 18
Proposed Drug Product
IBSC Meetings
RCGM Clearance
Ref.:-
1. https://ibkp.dbtindia.gov.in/ (IBKP Portal)
2. https://cdscoonline.gov.in/CDSCO/homepage
3. The gazette of India : NDCT Rule March 2019.
4. https://fdamfg.maharashtra.gov.in/login.aspx
(XLN India Portal)
Information To conduct
Pre-clinical Trial in Form C1
Application To conduct
Pre-clinical studies in Form C3
Submission of Pre-clinical study
reports in Form C5
Study Report Evaluation
Proposal for Study of rDNA
origin product or
LMOs/GMOs products
D
r
u
g
S
u
b
s
t
a
n
c
e

19. Cont…
19
Test lic Approval in Form 29 from SFDA
Drug product mfg for CT & test batches at
R&D
Ref.:-
1. https://cdscoonline.gov.in/CDSCO/homepage
2. The gazette of India : NDCT Rule March 2019.
3. https://fdamfg.maharashtra.gov.in/login.aspx
(XLN India Portal)
4. D&C Act 1940 and Rule 1945.
Application for Clinical Trial
Application to manufacture IND drug Product
for Test lic & CT batches NOC Form CT-
10,CT-12 & CT-13
Permission to manufacture of ND, IND Test
lic & CT batches NOC in Form CT-11, CT-14
& CT-15
Application for Test lic & CT batches to
SFDA in Form 30
Application review, queries &
query responses
Joint Inspection SFDA,
CDSCO HQ & WZ

20. 10/7/2023 20
10/7/2023
Application for grant of permission to conduct
clinical trial in Form CT-04
(CT Phase I,II & III)
SEC Meeting and CT study presentation
Permission to conduct clinical trial in Form
CT-06 (Phase I,II & III)
Compilation of CT study reports and results
Clearance from SEC panel and Drug Product
consider for approval
Proposed CT Phases I,II & III
SEC recommendation &
suggestions
Clinical Trial Performed
Reports and results discussion
with SEC Panel

21. Cont…
10/7/2023 21
Application for Grant of permission to manufacture new drug
formulation for sale or for distribution in Form CT-21 (MHA)
Joint Inspection form SFDA, CDSCO HQ & WZ
Ref.:-
1. https://cdscoonline.gov.in/CDSCO/homepage
2. NDCT Rule March 2019.
3. https://fdamfg.maharashtra.gov.in/login.aspx
(XLN India Portal)
4. The gazette of India : NDCT Rule March 2019.
Permission to manufacture new active pharmaceutical
ingredient for sale or For distribution in Form CT-22
Application for Product Permission to SFDA
Final Product Approval.
Application review,
queries & query
responses
Compliance to
observations and
inspection report
Signed by SLA &
Counter signed by
CLA
Permission to manufacture pharmaceutical formulation
of new drug for sale or For distribution in Form CT-23
Application for Stockpiling (In case of Emergency)
Approval for Stockpiling (In case of Emergency)

22. Applications and Approval
Sr. No. Applied Forms Application Approved Form Approval
1 Form CT-04 Form CT-06
2 Form CT-10 Form CT-11
3 Form CT-12 Form CT-14
4 Form CT-13 Form CT-15
5 Form CT-16 Form CT-17
6 Form CT-21 Form CT-23
10/7/2023 22

23. Rules for application of NOC’S: NDCT Rule 2019
• Rule are amended for NOC’s and clauses are mentioned for the application for NOC.
10/7/2023 23
Ref.:- The gazette of India : NDCT Rule March 2019.

24. Checklist of Application
• Various documents required for application as per application type.
1. Checklist for Form CT-04
2. Checklist for Form CT-10
3. Checklist for Form CT-12
4. Checklist for Form CT-13
5. Checklist for Form CT-16
6. Checklist for Form CT-21
10/7/2023 24

25. Q&A
10/7/2023 25

26. 10/7/2023 26
Thank You!!