1.

Checklist for Grant of permission to manufacture/import of Bulk Drug already

approved in the country

Enclosed Page no
S no Documents required to be submitted
Yes No
1. Name of Applicant with address
2. Name of Drug
3. Therapeutic Class
4. Date of Approval
5. Application in Form-44 duly filled and signed by the
competent authority
6. Treasury Challan of INR 50,000/- upto 1 year from initial
approval and INR 15,000/- for other drugs upto 4 years
7a. For manufacturing:-
Copy of manufacturing license in Form-25/ Form-26 for any bulk
drug to manufacturer and Form-29
7b. For import:-
Copy of drug sale license in Form 20B and 21B
8. Pharmaceutical & Chemical Information
A. Manufacturing Process including flowcharts detailed
manufacturing procedure,
i. In process check procedure and report control
ii. Batch manufacturing record
iii. Process validation report.
B. Complete monograph Specifications, methods of analysis
including analytical method validation report, with
i. Identification/ quantification of impurities
ii. Enantiomeric purity
iii. Residual solvent/ other volatile impurities (OVI) estimation
C. Structural elucidation data
methods
D. Three batch Certificate of analysis
E. Stability data of three different lots as per Schedule –Y of
Drugs and Cosmetics Rules ( should be presented in tabular form
with details of Batch no, Batch size, Date of manufacturing, Date
of initiation, Packaging details)
F. Material Safety data sheet
G. Reference product characterization
H. Draft specimen Label
9. Sub-acute toxicity data generated with the applicant’s bulk
drug in two species.
10. CDTL/IPC Test report *
* In case of application is for grant of NOC for lab testing serial no 10 may be submitted at the
time of approval of bulk drug.
 Note:
A) Submission requirements / methodology:
i. Please submit ONE hard copy and THREE soft copies i.e. Compact Disc (CD)
(PDF format, properly bookmarked for navigation) of the dossier.
ii. Hard copy: Sides and front of each volume/ file /binder must be labelled with the name
of the applicant company, date of submission, name of the drug(s) and the file
number (Numbering of files: ‘x’ of ‘y’ files e.g. if there are 10 files, file number 6 will
be labelled as File No. 6 / 10).
iii. Use of multiple volumes/ files/ binders is recommended than binding all the
documents and modules in a very huge file. Preferably volumes/ files /binders
should not be more than 3 inches thick and use of good quality binders is
recommended. All the files should be kept together, bound by a good quality wire or
thread (If there are too many volumes e.g. more than 10, then multiple grouping should be
done).
iv. CDs have to be labelled using a marker pen with the name of the applicant company, date
of submission and name of the drug(s). If there are multiple CDs for one submission
dossier, then the numbering as mentioned above should be followed.
v. Scanned copies of only signed documents like test reports, signature pages will be
acceptable and rest of the document has to be in PDF format with optical character
recognition (OCR).
vi. The table of content under each head should be linked to the files (s) or relevant document
for easy tracking in CD’s.
vii. Applicant should preserve a duplicate copy of the submitted dossier for any future
reference and should be able to submit multiple copies, if required by CDSCO.
2. Approvals of a New drug (Formulation) already approved in the country

Enclosed Page
S No Documents required to be submitted
Yes No no.
1. Application for permission to Manufacture /Import: (Purpose should
be mentioned clearly)
2. Name of the applicant and address
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
d. Therapeutic rational for proposed dosage form
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by
authorized personal
6. Treasury challan of INR 15,000 New Drug approved in
India for more than one year, or ` 50,000 of New Drug is approved
for less than one year duly signed and stamped by Bank of
7. Copy
Barodaof valid manufacturing license in Form 25/28/26
8. Copy of valid Test license in Form 29
9. Source of bulk drugs along with current regulatory status of
the source with copy of Form 46A/45A. (if obtained)
10. Consent letter and copy of manufacturing licence form supplier of
bulk drug
11. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) API Specification including impurity profile
c) Method of Analysis with analytical method validation report
d) Certificate of Analysis for three batches
12. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure/ Master manufacturing Record
c) Product development report with Excipient compatibility
study and force degradation study.
d) Process validation protocol and Report
e) Finished product specification including impurity profile
f) Finished product Method of Analysis
g) Finished product Analytical method validation report
h) Finished product Certificate of Analysis for three batches/
three validation batches
i) In process quality control check specifications
 j) Stability study data report as per requirements of schedule Y
mentioning batch size. ( should be presented in tabular form
with details of Batch no, Batch size, Date of manufacturing,
Date of initiation, Packaging details)
k) Dissolution Release Profile (in case of oral dosage form)
l) Comparative Dissolution Release Profile with the Approved
formulation (in case of oral dosage form)
m) Comparative evaluation with pharmaceutical equivalence
with international brand(s) or approved Indian brands,
if applicable
n) Copy of proposed Package Insert which should include
generic name of all active ingredients; composition; dosage
form/s, indications; dose and method of administration; use
in special populations; contraindications; warnings;
precautions; drug interactions; undesirable effects; overdose;
pharmacodynamics and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information;
storage and handling instructions.
o) Draft specimen of Label and Carton
13. Regulatory status in other countries, as appropriate.
a) Names of the countries where the drug is
marketed/approved for proposed Dosage Form / New
Route of Administration along with package insert and/or
copies of approval in key countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
14. Bio Equivalence/Bioavailability study Protocol (As the case
may be)
a) BE protocol
b) Study synopsis
c) Undertaking by investigators as per Appendix VII od
schedule Y and CV.
d) Inform consent form (with assurance of providing audio-
video recordings, Address, qualification, occupation,
annual income of subjects along with, name and address of
e) Compensation
nominee. clause as per Rule 122 DAB
f) Copy of ‘Ethics Committee’ approval letters along with
registration details.
15. Justification on Bio equivalence study waiver, if requested
16. In case of parenteral formulation, Sub-acute toxicity data
conducted with the proposed drug formulation.
 17. Submit 11 sets of technical literature (whenever applicable) (10
soft copy and one hard copy) for expert opinion. Each
attachment shall not be more than 20 MB in size and shall be
properly numbered and named reflecting various sections of the
application.

Note :
A) Submission requirements / methodology
i. Please submit ONE hard copy and THREE soft copies i.e. Compact Disc (CD) (PDF
format, properly bookmarked for navigation) of the dossier.
ii. Hard copy: Sides and front of each volume/ file /binder must be labelled with the name
of the applicant company, date of submission, name of the drug(s) and the file
number (Numbering of files: ‘x’ of ‘y’ files e.g. if there are 10 files, file number 6
will be labelled as File No. 6 / 10).
iii. Use of multiple volumes/ files/ binders is recommended than binding all the
documents and modules in a very huge file. Preferably volumes/ files /binders
should not be more than 3 inches thick and use of good quality binders is
recommended. All the files should be kept together, bound by a good quality wire or
thread (If there are too many volumes e.g. more than 10, then multiple grouping should be
done).
iv. CDs have to be labelled using a marker pen with the name of the applicant company, date
of submission and name of the drug(s). If there are multiple CDs for one submission
dossier, then the numbering as mentioned above should be followed.
v. Scanned copies of only signed documents like test reports, signature pages will be
acceptable and rest of the document has to be in PDF format with optical character
recognition (OCR).
vi. The table of content under each head should be linked to the files (s) or relevant document
for easy tracking in CD’s.
vii. Applicant should preserve a duplicate copy of the submitted dossier for any future
reference and should be able to submit multiple copies, if required by CDSCO.

B) In case the application is for Clinical Trial /Bio equivalence permission:

a. Adequate chemical and pharmaceutical information should be provided to ensure the proper
identity, purity, quality & strength of the investigational product, the amount of information
needed may vary with the Phase of clinical trials, proposed duration of trials, dosage forms
and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of all
the new changes incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the country
and should also include clinical sites which have their own Institutional Ethics Committee.
3. A drug already approved by the Licensing Authority mentioned in Rule 21
proposed to be marketed with new indication

S No Documents required to be submitted Enclosed Page

Yes No no
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
d. Therapeutic rational for proposed indication
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for less
than one year and not submitted challan earlier for the same
7. drug.
Copy of valid manufacturing license in Form 25/28/26
8. Copy of valid Test license in form 29
9. In case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (if
obtained)
10 Consent letter and copy of manufacturing licence form supplier of bulk
drug
11. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) API Specification with impurity profile
c) Method of Analysis with method validation report
d) Certificate of Analysis for three batches
12. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure/ Master manufacturing Record
c) Product development report with Excipient compatibility and
forced degradation study
d) Process validation protocol/ Report
e) Finished product specification
f) Finished product Method of Analysis
g) Finished product Analytical method validation report
h) Finished product Certificate of Analysis for three consecutive
batches/ three validation batches
i) In process quality control check specifications
j) Stability study data report as per requirements of schedule Y
mentioning batch size. ( should be presented in tabular form with
details of Batch no, Batch size, Date of manufacturing, Date of
initiation, Packaging details)
 k) Dissolution Release Profile (in case of oral dosage form)
l) Comparative Dissolution Release Profile with the Approved
formulation (in case of oral dosage form)
m) Comparative evaluation with pharmaceutical equivalence with
international brand(s) or approved Indian brands, if
applicable
n) Copy of proposed Package Insert which should include
generic name of all active ingredients; composition; dosage
form/s, indications; dose and method of administration; use in
special populations; contraindications; warnings; precautions;
drug interactions; undesirable effects; overdose;
pharmacodynamics and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information; storage and
handling instructions.
o) Draft specimen of Label and Carton
Sr No 10 to 12 is not applicable, if applicant holds manufacturing or Import and
marketing permission for the proposed drug product [ Except 11(n) and 11(o)]
13. Therapeutic Rationale and justification for the proposed
Additional Indication
14. Regulatory status in other countries, as appropriate.
a) Names of the countries where the drug is
Marketed/ approved for proposed indication along with package
insert and/or copies of approval in key countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
15. Bio Equivalence/Bioavailability study Protocol (As the case may be)

a) BE protocol
b) Study synopsis

c) Undertaking by investigators as per Appendix VII od schedule

Y and CV.
d) Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income
of subjects along with, name and address of nominee.
e) Compensation clause as per Rule 122 DAB

f) Copy of ‘Ethics Committee’ approval letters along with

registration details.
16. Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Checklist already given in New
Drug application)
I. CT protocol
II. Study synopsis
III. Undertaking by investigators as per Appendix VII of schedule
Y and CV.
 IV. Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income
of subjects along with, name and address of nominee.
V. Compensation clause as per Rule 122 DAB
VI. Copy of ‘Ethics Committee’ approval letters along with
registration details.
VII. Case record form (CRF)
VIII. Site details, which includes Investigators name and address,
Type of Hospital (Multispecialty/ Government/ Private) ,
Number of beds, emergency facilities, Ethics Committee
registration details, etc)
17. Justification on Clinical trial waiver, if requested.
18. Published report of Clinical trial/Journal/literature with respect to
proposed Additional Indication.
19 Submit 11 sets of technical literature (whenever applicable) (10 soft copy
and one hard copy) for expert opinion. Each attachment shall not be more
than 20 MB in size and shall be properly numbered and named reflecting
various sections of the application.

Note:
A) Submission requirements / methodology
i. Please submit ONE hard copy and THREE soft copies i.e. Compact Disc (CD) (PDF
format) of the dossier.
ii. Hard copy: Sides and front of each volume/ file /binder must be labelled with the name
of the applicant company, date of submission, name of the drug(s) and the file
number (Numbering of files: ‘x’ of ‘y’ files e.g. if there are 10 files, file number 6 will
be labelled as File No. 6 / 10).
iii. Use of multiple volumes/ files/ binders is recommended than binding all the
documents and modules in a very huge file. Preferably volumes/ files /binders
should not be more than 3 inches thick and use of good quality binders is
recommended. All the files should be kept together, bound by a good quality wire or
thread (If there are too many volumes e.g. more than 10, then multiple grouping should be
done).
iv. CDs have to be labelled using a marker pen with the name of the applicant company, date
of submission and name of the drug(s). If there are multiple CDs for one submission
dossier, then the numbering as mentioned above should be followed.
v. Scanned copies of only signed documents like test reports, signature pages will be
acceptable and rest of the document has to be in PDF format with optical character
recognition (OCR).
vi. The table of content under each head should be linked to the files (s) or relevant document
for easy tracking in CD’s.
vii. Applicant should preserve a duplicate copy of the submitted dossier for any future
reference and should be able to submit multiple copies, if required by CDSCO.

B) In case the application is for clinical trial / Bio equivalence permission:

a. Adequate chemical and pharmaceutical information should be provided to ensure the proper
identity, purity, quality & strength of the investigational product, the amount of information
 needed may vary with the Phase of clinical trials, proposed duration of trials, dosage forms
and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of all
the new changes incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the
country and should also include clinical sites which have their own Institutional Ethics
Committee.
4. A drug already approved by the Licensing Authority mentioned in Rule 21
and proposed to be marketed as a ‘New Dosage Form / New Route of
Administration’.

S No Documents required to be submitted Enclosed Page

Yes No No
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
b. Proposed Dosage Form
c. Proposed indication
d. Therapeutic rational for proposed New Dosage Form / New
Route
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form and route of administration
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for less
than one year and not submitted challan earlier for the same drug.
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. In case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (if
obtained)
10. Consent letter and copy of manufacturing licence form supplier of bulk
drug
11. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) API Specification with impurity profile
c) Method of Analysis with method validation report
d) Certificate of Analysis for three batches
12. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure/ Master manufacturing Record
c) Product development report with Excipient compatibility study
and forced degradation study.
d) Process validation protocol/ Report
e) Finished product specification
f) Finished product Method of Analysis
g) Finished product Analytical method validation report

h) Finished product Certificate of Analysis for three consecutive

batches/ three validation batches
i) In process quality control check specifications
 j) Stability study data report as per requirements of schedule Y
mentioning batch size. ( should be presented in tabular form with
details of Batch no, Batch size, Date of manufacturing, Date of
initiation, Packaging details)
k) Dissolution Release Profile (in case of oral dosage form)

l) Comparative Dissolution Release Profile with the Approved

formulation (in case of oral dosage form)
m) Comparative evaluation with pharmaceutical equivalence with
international brand(s) or approved Indian brands, if
applicable
n) Copy of proposed Package Insert which should include
generic name of all active ingredients; composition; dosage
form/s, indications; dose and method of administration; use in
special populations; contraindications; warnings; precautions;
drug interactions; undesirable effects; overdose;
pharmacodynamic and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information; storage
and handling instructions.
o) Draft specimen of Label and Carton
13. Therapeutic Rationale and justification for the proposed
new dosage form / new route of administration
14. Regulatory status in other countries, as appropriate.
a) Names of the countries where the drug is
marketed/approved for proposed Dosage Form / New Route of
Administration along with package insert and/or copies of approval
in key countries.
b) Names of the countries where the drug is withdrawn, if any, with
reasons
c) Free sale certificate (FSC) or Certificate of Pharmaceutical Product
(COPP), in case of import.
15. Bio Equivalence/Bioavailability study Protocol (As the case may
be)
a) BE protocol
b) Study synopsis

c) Undertaking by investigators as per Appendix VII od schedule

Y and CV.
d) Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income
of subjects along
e) Compensation with,asname
clause and address
per Rule 122 DABof nominee.
f) Copy of ‘Ethics Committee’ approval letters along with
registration details.
16. Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Checklist already given in New
Drug application)
a) CT protocol
b) Study synopsis
 c) Undertaking by investigators as per Appendix VII of schedule
Y and CV.
d) Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income of
subjects along with, name and address of nominee.
e) Compensation clause as per Rule 122 DAB
f) Copy of ‘Ethics Committee’ approval letters along with
registration details.
g) Case record form (CRF)
h) Site details, which includes Investigators name and address, Type
of Hospital (Multispecialty/ Government/ Private) , Number of
beds, emergency facilities, Ethics Committee registration details,
etc)
17. Bio Equivalence study requirement (in case of oral dosage form as
appropriate as per Appendix X of Schedule Y)
18. Justification on Clinical trial and Bio equivalence study waiver,
if requested.
19. Animal toxicology data as per Schedule Y.
a). Systemic toxicity studies,
i. single dose toxicity
ii. repeated dose toxicity
b). Local toxicity
i. Dermal toxicity (for products meant for topical (dermal)
application)
ii. Ocular toxicity (for products meant for ocular
instillation)
iii. Inhalation toxicity (conducted with the formulation proposed
to be used via inhalation route)
iv. Vaginal toxicity (for products meant for topical
application to vaginal mucosa)
v. Photoallergy or dermal phototoxicity (required if the drug or
a metabolite is related to an agent causing photosensitivity
or the nature of action suggests such a potential)
c). Rectal tolerance test (For all preparations meant for rectal
administration)
20. Published report of Clinical trial/Journal/literature with respect to
proposed Dosage Form / New Route of Administration.
21. Submit 11 sets of technical literature (whenever applicable) (10 soft copy
and one hard copy) for expert opinion. Each attachment shall not be
more than 20 MB in size and shall be properly numbered and named
reflecting various sections of the application.
 Note:
A) Submission requirements / methodology
i. Please submit ONE hard copy and THREE soft copies i.e. Compact Disc (CD) (PDF
format) of the dossier.
ii. Hard copy: Sides and front of each volume/ file /binder must be labelled with the name
of the applicant company, date of submission, name of the drug(s) and the file
number
(Numbering of files: ‘x’ of ‘y’ files e.g. if there are 10 files, file number 6 will be
labelled as File No. 6 / 10).
iii. Use of multiple volumes/ files/ binders is recommended than binding all the
documents and modules in a very huge file. Preferably volumes/ files /binders
should not be more than 3 inches thick and use of good quality binders is
recommended. All the files should be kept together, bound by a good quality wire or
thread (If there are too many volumes e.g. more than 10, then multiple grouping should be
done).
iv. CDs have to be labelled using a marker pen with the name of the applicant company, date
of submission and name of the drug(s). If there are multiple CDs for one submission
dossier, then the numbering as mentioned above should be followed.
v. Scanned copies of only signed documents like test reports, signature pages will be
acceptable and rest of the document has to be in PDF format with optical character
recognition (OCR).
vi. The table of content under each head should be linked to the files (s) or relevant document
for easy tracking in CD’s.
vii. Applicant should preserve a duplicate copy of the submitted dossier for any future
reference and should be able to submit multiple copies, if required by CDSCO.

B) In case the application is for clinical trial / Bio equivalence permission:

a. Adequate chemical and pharmaceutical information should be provided to ensure the proper
identity, purity, quality & strength of the investigational product, the amount of information
needed may vary with the Phase of clinical trials, proposed duration of trials, dosage forms
and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of all
the new changes incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the
country and should also include clinical sites which have their own Institutional Ethics
Committee.
 5. A drug already approved by the Licensing Authority mentioned in Rule 21
now proposed to be marketed as a ‘Modified release dosage form’.
Enclosed Page
S No Documents required to be submitted
Yes No no
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
d. Therapeutic rational for Modified release dosage form
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form and route of administration
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for less
than one year and not submitted challan earlier for the same drug.
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of valid Test license in form 29
9. In case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (if
obtained)
10. Consent letter and copy of manufacturing licence form supplier of bulk
drug
11. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) API Specification with impurity profiling
c) Method of Analysis with method validation report
d) Certificate of Analysis for three batches
12. Data on Formulation
Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure/ Master manufacturing Record
c) Product development report with Excipient compatibility study
and forced degradation study.
d) Process validation protocol/ Report
e) Finished product specification
f) Finished product Method of Analysis
g) Finished product Analytical method validation report
h) Finished product Certificate of Analysis for three consecutive
batches/ three validation batches
i) In process quality control check specification
j) Stability study data report as per requirements of schedule Y
mentioning batch size. ( should be presented in tabular form with
details of Batch no, Batch size, Date of manufacturing, Date of
initiation, Packaging details)
k) Dissolution Release Profile (in case of oral dosage form)
 l) Comparative Dissolution Release Profile with the Approved
formulation (in case of oral dosage form)
m) Comparative evaluation with pharmaceutical equivalence
international brand(s) or approved Indian brands, if
applicable
n) Copy of proposed Package Insert which should include
generic name of all active ingredients; composition; dosage
form/s, indications; dose and method of administration; use in
special populations; contraindications; warnings; precautions;
drug interactions; undesirable effects; overdose;
pharmacodynamic and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information; storage
and handling instructions.
o) Draft specimen of Label and Carton
13. Therapeutic Rationale and justification for the proposed
new dosage form / new route of administration
14. Regulatory status in other countries, as appropriate.
a) Names of the countries where the drug is
marketed/approved for proposed Modified Dosage Form along
with package insert and/or copies of approval in key countries.

b) Names of the countries where the drug is withdrawn, if

any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
15. Bio Equivalence/Bioavailability study Protocol (As the case may
be)
a) BE protocol

b) Study synopsis

c) Undertaking by investigators as per Appendix VII od schedule

Y and CV.
d) Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income
e) of subjects along
Compensation with,asname
clause and address
per Rule 122 DAB of nominee.

f) Copy of ‘Ethics Committee’ approval letters along with

registration details.
16. Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Checklist already given in New
Drug application)
a) CT protocol
b) Study synopsis
c) Undertaking by investigators as per Appendix VII of schedule
Y and CV.
 d) Inform consent form (with assurance of providing audio-
video recordings, Address, qualification, occupation, annual
income of subjects along with, name and address of
nominee.
e) Compensation clause as per Rule 122 DAB
f) Copy of ‘Ethics Committee’ approval letters along with
registration details.
g) Case record form (CRF)
h) Site details, which includes Investigators name and address,
Type of Hospital (Multispecialty/ Government/ Private) ,
Number of beds, emergency facilities, Ethics Committee
registration details, etc)
17. Bio Equivalence study requirement (in case of oral dosage form
as appropriate as per Appendix X of Schedule Y)
18. Justification on Clinical trial and Bio equivalence study waiver, if
requested.
19. Published report of Clinical trial/Journal/ literature with respect to
proposed Modified Dosage Form.
20. In case of injectable formulation, sub-acute toxicity data
conducted with the applicant drug formulation.
21. Submit 11 sets of technical literature (whenever applicable) (10 soft
copy and one hard copy) for expert opinion. Each attachment shall not
be more than 20 MB in size and shall be properly numbered and named
reflecting various sections of the application.

Note:
A) Submission requirements / methodology
i. Please submit ONE hard copy and THREE soft copies i.e. Compact Disc (CD) (PDF
format) of the dossier.
ii. Hard copy: Sides and front of each volume/ file /binder must be labelled with the name
of the applicant company, date of submission, name of the drug(s) and the file
number (Numbering of files: ‘x’ of ‘y’ files e.g. if there are 10 files, file number 6
will be labelled as File No. 6 / 10).
iii. Use of multiple volumes/ files/ binders is recommended than binding all the
documents and modules in a very huge file. Preferably volumes/ files /binders
should not be more than 3 inches thick and use of good quality binders is
recommended. All the files should be kept together, bound by a good quality wire or
thread (If there are too many volumes e.g. more than 10, then multiple grouping should be
done).
iv. CDs have to be labelled using a marker pen with the name of the applicant company, date
of submission and name of the drug(s). If there are multiple CDs for one submission
dossier, then the numbering as mentioned above should be followed.
v. Scanned copies of only signed documents like test reports, signature pages will be
acceptable and rest of the document has to be in PDF format with optical character
recognition (OCR).
vi. The table of content under each head should be linked to the files (s) or relevant document
for easy tracking in CD’s.
vii. Applicant should preserve a duplicate copy of the submitted dossier for any future
 reference and should be able to submit multiple copies, if required by CDSCO.

B) In case the application is for clinical trial / Bio equivalence permission:

a. Adequate chemical and pharmaceutical information should be provided to ensure the proper
identity, purity, quality & strength of the investigational product, the amount of information
needed may vary with the Phase of clinical trials, proposed duration of trials, dosage forms
and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of all
the new changes incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the
country and should also include clinical sites which have their own Institutional Ethics
Committee.
6. A drug already approved by the Licensing Authority mentioned in Rule 21
proposed to be marketed with Additional Strength

Enclosed Page
S No Documents required to be submitted
Yes No No
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved Strength along with Indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for less
than one year and not submitted challan earlier for the same
7. drug.
Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. in case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (If
obtained)
10. Consent letter and copy of manufacturing licence form supplier of bulk
drug
11. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) API Specification with impurity
c) Method of Analysis with method validation report
d) Certificate of Analysis for three batches
12. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure/ Master manufacturing Record
c) Product development report
d) Process validation protocol/ Report with Excipient compatibility
study and Forced degradation profile.
e) Finished product specification
f) Finished product Method of Analysis
g) Finished product Analytical method validation report
h) Finished product Certificate of Analysis for three consecutive
batches/ three validation batches
i) In process quality control check specification
j) Stability study data evaluation a s per requirements of schedule Y
mentioning batch size. . ( should be presented in tabular form with
details of Batch no, Batch size, Date of manufacturing, Date of
initiation, Packaging details)
 k) Dissolution Release Profile (in case of oral dosage form)

l) Comparative Dissolution Release Profile with the Approved

formulation (in case of oral dosage form)
m) Comparative evaluation with international brand(s) or
approved Indian brands, if applicable
n) Copy of proposed Package Insert which should include
generic name of all active ingredients; composition; dosage
form/s, indications; dose and method of administration; use in
special populations; contraindications; warnings; precautions; drug
interactions; undesirable effects; overdose; pharmacodynamics and
pharmacokinetic properties; incompatibilities; shelf-life;
packaging information; storage and handling instructions.
o) Draft specimen of Label and Carton
Information on active ingredients:
13. Therapeutic Rationale and justification for the proposed
Additional Strength
14. Regulatory status in other countries, as appropriate.
a) Names of the countries where the drug is
Marketed/ approved for proposed additional strength along with
package insert and/or copies of approval in key countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
15. Bio Equivalence/Bioavailability study Protocol (As the case may be)

a) BE protocol

b) Study synopsis

c) Undertaking by investigators as per Appendix VII od schedule

Y and CV.
d) Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income
of subjects along
e) Compensation with,asname
clause and address
per Rule 122 DABof nominee.

f) Copy of ‘Ethics Committee’ approval letters along with

registration details.
16. Clinical trial protocol in case of proposed Additional Strength is not
approved in key countries. (Checklist already given in New
Drug application)
a. CT protocol
b. Study synopsis
c. Undertaking by investigators as per Appendix VII of schedule
Y and CV.
 d. Inform consent form (with assurance of providing audio-video
recordings, Address, qualification, occupation, annual income
of subjects along with, name and address of nominee.
e. Compensation clause as per Rule 122 DAB
f. Copy of ‘Ethics Committee’ approval letters along with
registration details.
g. Case record form (CRF)
h. Site details, which includes Investigators name and address,
Type of Hospital (Multispecialty/ Government/ Private) ,
Number of beds, emergency facilities, Ethics Committee
registration details, etc)
17. Justification on Clinical trial and Bio equivalence study waiver, if
requested.
18. Published report of Clinical trial/Journal/literature with respect to
proposed Additional Strength.
19. In case of injectable formulation, sub-acute toxicity data
conducted with the applicant drug formulation.
20. Submit 11 sets of technical literature (whenever applicable) (10 soft
copy and one hard copy) for expert opinion. Each attachment shall not
be more than 20 MB in size and shall be properly numbered and named
reflecting various sections of the application.

Note:
A) Submission requirements / methodology
i. Please submit ONE hard copy and THREE soft copies i.e. Compact Disc (CD) (PDF
format) of the dossier.
ii. Hard copy: Sides and front of each volume/ file /binder must be labelled with the name
of the applicant company, date of submission, name of the drug(s) and the file
number (Numbering of files: ‘x’ of ‘y’ files e.g. if there are 10 files, file number 6
will be labelled as File No. 6 / 10).
iii. Use of multiple volumes/ files/ binders is recommended than binding all the
documents and modules in a very huge file. Preferably volumes/ files /binders
should not be more than 3 inches thick and use of good quality binders is
recommended. All the files should be kept together, bound by a good quality wire or
thread (If there are too many volumes e.g. more than 10, then multiple grouping should be
done).
iv. CDs have to be labelled using a marker pen with the name of the applicant company, date
of submission and name of the drug(s). If there are multiple CDs for one submission
dossier, then the numbering as mentioned above should be followed.
v. Scanned copies of only signed documents like test reports, signature pages will be
acceptable and rest of the document has to be in PDF format with optical character
recognition (OCR).
vi. The table of content under each head should be linked to the files (s) or relevant document
for easy tracking in CD’s.
vii. Applicant should preserve a duplicate copy of the submitted dossier for any future
reference and should be able to submit multiple copies, if required by CDSCO.
B) In case the application is for clinical trial / Bio equivalence permission:

a. Adequate chemical and pharmaceutical information should be provided to ensure the proper
identity, purity, quality & strength of the investigational product, the amount of information
needed may vary with the Phase of clinical trials, proposed duration of trials, dosage forms
and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of all
the new changes incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the
country and should also include clinical sites which have their own Institutional Ethics
Committee.