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Division Name
. Biological Division
Document No.
BIR-P-06
Technical Review of Post Marketing
Revision No .
Surveillance /Phase IV ' clinical trial
Effective Date
ofr-DNA based Bio-Therapeutics
Prepared By
Name
Fahim Khan
Name
Designation Drugs Inspector Designation
2a.R, ,
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Sian
Sign
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Date
2?,,<Jr'~-) Date
00
01.08.2015
Page l of S "
Page No.
Approved By
Authorized By
Dr. S.E. Reddy
Dr. A. Ramkishan
Name
II
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DDqI)
Designation
Sign
JlJ.I..V .J
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r0t 4 ' 28.. C~\2Pi.r Date
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Control Status
1. PURPOSE
To describe the procedure for processing Post Marketing Surveillance / Phase IV clinical. trial of
r-DNA based Bio-Therapeuticsunder the provision of Drugs and Cosmetics Act 1940 & Rules
therein.
2. SCOPE
This document is applicable for processing Post Marketing Surveillance I Phase IV clinical trial
ofr-DNA based Bio-Therapeutics under the provision of Drugs and Cosmetics Act 1940 & Rules
therein.
.
.
.
3. DEFINITIONS
3.1
New Drug:
(a) A drug , as defined in the Act including bulk drug substance which has not been used
in the country to any significant extent under the conditions prescribed, recommended or
suggested in the labeling thereof and has not been recognized as effective and safe by the
licensing authority mentioned under rule 21 for the proposed claims.
Provided that the limited use, if any, has been with the 'permission of the licensing
authority. .
'
(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain
claims, which is now proposed to be marketed with modified or new Claims, namely ,
indications, dosage, dosage form (including sustained release dosage form) and route of
administration.
Explanation­
. All recombinant therapeutics are new drug.
3.2
Clinical Trial: 122-DAA, Definition of Clinical trial> For the purpose of this Part,
"Clinical trial" means a systematic study of new drug(s) inhuman subject(s) to generate
data for ..discovering and/or verifying the clinical , . pharmacological (including
pharmacodynamic and pharmacokinetic) and/or adverse effects with the objecti ve of
determining safety and / or efficacy of the new drug."
.
TDA : Technical data associate ADI: Assistant Drugs Inspector, DI: Drugs Inspector,
ADC (I): Assistant Drugs Controllerof India, DDC (I): Deputy Drugs Controller of India ,
JDC(I): Joint drugs Controller of India , DCG (I) : Drugs Controller General of India,
SEC: Subject Expert 'Committee, TC: Technical Committee, WHO: World Health
Organi zation ; TRS: Technical Report Series , PMS: Post Marketing Surveillance, CDSCO:
Central Drugs Standards Control Organization. CRU: Central Registry Unit;
.
3.3
- CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS
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TITLE
Division Name
Technical Review of Post Marketing
Surveillance /Phase IV clinical trial
of r-DNA based Bio-Therapeutics
Prepared By
Name
Fahim Khan
Name
Designation Dru gs Inspector Designation
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Sign
Sign
-2..'1 . d1. ~S:- Date
Date
Approved By
Dr . A. Ramki shan
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Biological Divi sion
Document No :
BIR-P-06 '
Revi sion No .
00
0 1.08.2015
Effective Date
Page 2 of5
Page No.
Authorized By
Dr . S.E. Redd y
Name
JDC(I )
Designati on
Sign
~
Date
-"P\.\() 1. t?pI :s­
4. RESPONSIBILITY
Overall responsibilities lies with .head of division and other responsibility are given 111 the
description below­
5. DESCRIPTION
5.1
S.
No.
5.1.1
5.1.2
5.1.3
5.1.4
Source
'FreqJWhe
Ref.Doc.
Review Criteria
Dru gs
and
Cosmetic Act s
1940 & Rule s
thereunder
Verification of the
,Initial
application
against
the
prescreening
checklist and other
relevant documents
Verifyin g
every
application if proper
Identification No. has
been allotted
n
Initial Application
111
form
44
received at pre­
screening
along
with
supporting
documents
Unique
Identification No .
(Diary No. and
FTS
No.)for
application
Responses
to
Queries
raised
during application
review
Firm seeking As per the
the NOC for , requirement
PMS/Phase of the firm
IV clinical
trial.
Central
Registering
Unit
Firm seeking
NOC for
, PMS/Phase
IV clinical
trial.
SEC
SEC
Committee
Committee
Recommendations
5.2
S. No.
5.2.1
Process Inputs
Input
After receipt
of
the
application
Nil
Only when
query
is
raised
Query letter and
other relevant
documents
Verification of ' the
query response to the
information
sought
vide the query letter
Only
if
opinions are
required to
be ' sought
from
respective
committees
Expert letter ,or
Agenda wherein
opinion
was
sought from the
exp erts
Verify if the Minutes
of meet ing or the
indi vidual letter from
exp ert
committees
provides
the
recommendation as
per
the
op1111On
sought
PROCESS INTERFACE
Activi
Pre-Sc reening of received applications
Ref. Doc.
Pre Screening
'1
A uthori~ed
, CENTRAL DRUGS STA NDARD CO NTROL ORGA NIZATION , DGHS
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Biolog ical Division
Document No .
BIR-P -06
Page No .
Prep a red By
Name
Fahim Khan
Designation Drugs Inspector
Uc:::v<'
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Sign
"ee­
Date
121- · .(Jr· ~
.
5.2.2
Division Name
T echnical Review of Post Marketing
Revision No .
Surveillance /Ph as e IV clinical trial
Effective Date
of r-D NA ba sed Bio-T hera peutics
DSCO
Name
Designation
Sign
Date
App roved By
Dr. A. Ramkishan
DDC(T)
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Name
Designation
Sign
Date
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Diary No.lFTS allotted to the received appl ication
00
0 1.08.2015
Page 3 of5
Aut ho rized By
Dr. S.E. Reddy
5.2.4
JDC(I)
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Checklist
F03(BIR-P-Ol)
CRU Section
DC / DDC
Applications will be assigned and marked to .the Biological
respective DI for furthe r review
Division
5.2.3
-
Preliminary Technical Review of app lication and TD A / ADIIDI Biological
documents.
Division
Second level Review of Scrutiny Sheet and Evaluate DI/ADC
/ Va lidate the report and include scientific
assessments
.
5.2.5
5.2.5.1
5.2 .5.2
5.2.5 .3
Personnel Only
Scrutiny sheet
submitted by
for
the
DI
review
ADC & DDC, Scrutiny sheet
JDC - Biological submitted by
DI
for
Division
the
review
Or forward the application to Subject Expert ADC & DDC,
JDC
Bio
logical
Committee for their expert opinion
Division
If submitted documents are sufficient and experts ADC & DDC, Recommendati
from SEC has recommended the proposal then JDC ---:- Biological ons from SEC
and the review
requisite permission may be cons idered for grant of Division
of doc uments
permission to the firm
Review Scrutiny Sheet 'and Scientific Assessments
of DI and decide whether submitted application and
documents are sufficient to grant permission / reject
the app lication
If submitted documents are not sufficient, query to
be raised to concerned app licant organization for
providing more details.
ADC '& DDC Biological
Division
CDSCO
Guidance ' For.
Industry
1. Drug &
Cosmetic Act
1940 & Rules
1945,
2.
CDSCO:
Gu idance For
Industry
3. Pharmaco­
poeal
Monographs
4. WHO TRS
Other
5.
and
national
international
guidelines
j
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS
Authorized Personn el Only
.TITLE
Div ision Na me
Biological Division
Docum ent No.
BIR-P-06
Technical Review of Post Marketing f - - - - - - ' - - - t - - -- ----'----I
Revi sion No.
00
Surveillance /Phase IV clinical trial f-- - - - +- - --,--..:....:....------i
Effective Date
01.08.201 5
.of r-DNA based Bio-Therapeutics
Page No .
Prepared By
Name
Fahim Khan
Name
Designat ion Dru gs Inspect or Designation
Sign '
r~
Sign
Date
Approved By
:
. Dr. .A. Ramkishan
(\ DDC(I) .
1<
Page 4 of5
Authorized By
Dr. S£ Redd y
Na me
JDC(I)
Designation
~\~ _
Sign
. ' , 2. 8' c>f'W.r Date
ADC
. & DDC -.
Biolo gical
Division
ADC , DOC &
DCG(I )
Biolo gical
. . Division
DDC ,
Issue of Permission to conduct PMS study as per the ·ADC,
JDC (I)
proved protocol.
5.2.6
Review 01 Assessment and recommendations of
SEC and decide whether to grant permi ssion / reject
the application
Or Issue the . quer y as per the recommendation of
SEC
5.2.7.1
5.2.8
5.3
S.No.
Recornmendati
ons from SEC
As
per
Schedule Y of
Drugs
and
Cosmetics Act,
1940 and Rule s
there
under
1945
Process Output
OUTPUT .
5.3.1
Issue of NOC to conduct the PMS
study
5.3.2
Quer y Letter
5.3.3
Application Letter and SuPP?rting
Documents
5.4
submitted and
replies to the
queries (raised
by the office)
submitted by
the firm and
reviewed by DI
Recommendati
ons from SEC
Process Monitoring
TO
Applicant Firm .
Applicant
Organization
SEC-Experts
REF.DOC.
As per Schedule Y, Drugs
and Cosmetics Act, 1940 and
Rule s there under 1945
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Biological Division
Document No.
BIR-P-06
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Authorized Personnel Only
~.
Technical Review of Post Mar keting
Revision No.
Surveillance /phase IV clinical trial
Effective Date
of r-DN A based Bio-Therapeutic s
I
It ,,·
. q."".f1l1. GO'/'''''''\~'·
Prepared By
Name
Fahim Khan
Designation Drugs Inspector
Sign
J2o/' ~
I2 7-00'!- ,~'5:
Date
01.08.20 15
Page 5 of5
Authori zed By
Dr. S.E. Reddy
Name
JDC(I)
Designation
Sign
~
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Date
Page No.
Ap proved .By
Name
Designation
Sign
Date
Dr. A. Ramkishan
I' DDC(I)
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No
5.4.1
MONITORING
BRIEF
Process Time
ACCEPTANCE
CRITERIA
180 days .
5.4.2
Pendency Status
180 days .
.. " .28, . Cff. '2.D~
FRE Q. /
WHEN
Every
Application
Every .Month
RESP;
REF. DO C.
JDC
Office Order dated
30.05.20 14
F 02 (BIR-P -Ol)
ADC/DD
C/JDC(I)
6.0
REFERENCES (incl. ext. origin docs):
.6.1
Drug & Cosmetic Act 1940 & Rule 1945
6.2
Pre-Screening Checklist & Appendix-I of Schedule Y,
6.3'
CDS CO Guidance for Industry
6.4
Office Order dated 30.05.2014
6.5
Schedule Y of Drugs and Cosmetics Act
6.6
Pharmacopeal Monographs
6.7
WHOTRS
7.0
RECORDS:
7.1
7.2
7.3
00
F 02 (BIR-P -Ol) - Pendency Status
F 03 (BIR-P-Ol) - Details of received application
Schedule Y, Drugs and Cosmetics Act , 1940 and Rules there under 1945