How is the quality of vaccines assured by the ... - The INCLEN Trust
How is the quality of vaccines assured by the ... - The INCLEN Trust
How is the quality of vaccines assured by the ... - The INCLEN Trust
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Presented By :-<br />
Satyapal Shani –<br />
Dy. Drugs Controller(I),<br />
Biological Div<strong>is</strong>ion<br />
CDSCO H.Q.,<br />
FDA Bhawan, New Delhi<br />
<strong>How</strong> <strong>is</strong> <strong>the</strong> <strong>quality</strong> <strong>of</strong><br />
<strong>vaccines</strong> <strong>assured</strong> <strong>by</strong> <strong>the</strong><br />
National Regulatory<br />
Authority?<br />
(Market Authorization and<br />
Licensing Activities)<br />
24 th Sep, 2011
Quality <strong>of</strong> Vaccine Produced or<br />
Imported in <strong>the</strong> country are<br />
Regulated <strong>by</strong> CDSCO (NRA)
Regulatory Requirement for Market Authorization <strong>of</strong> Biological Products<br />
‣ Drugs and Cosmetics Act & Rules, 1945 <strong>the</strong>re<br />
under.<br />
‣ Guidance for Industry<br />
• Specific for Biological Products<br />
‣ Indian Pharmacopoeia or any o<strong>the</strong>r<br />
Pharmacopoeia/ WHO TRS for Biological<br />
Specification
Guidance for<br />
Industry<br />
• Subm<strong>is</strong>sion <strong>of</strong> Clinical Trial<br />
Application for Evaluating Safety<br />
and Efficacy<br />
• Requirements for perm<strong>is</strong>sion <strong>of</strong><br />
New Drugs Approval<br />
• Post approval changes in<br />
biological products:<br />
Quality safety and Efficacy<br />
Documents<br />
• Preparation <strong>of</strong> <strong>the</strong> Quality<br />
Information for Drug Subm<strong>is</strong>sion<br />
for New Drug Approval:<br />
Biotechnological/Biological<br />
Products
Functions <strong>of</strong> NRA<br />
‣ Functions <strong>of</strong> <strong>the</strong> regulatory system<br />
• Marketing authorization and licensing activities<br />
• Post-marketing surveillance including surveillance for<br />
Adverse Events Following Immunization (AEFI)<br />
• Lot (Batch) release process<br />
• Laboratory support for vaccine testing<br />
• Regulatory inspections <strong>of</strong> Good Manufacturing<br />
Practices (GMP)<br />
• Authorization and approval <strong>of</strong> Clinical Trials <strong>of</strong><br />
<strong>vaccines</strong>.
Flow Chart <strong>of</strong> <strong>the</strong> process (Indigenously developed Vaccine )<br />
Application in Form 44<br />
Zonal /<br />
Sub Zonal<br />
Office<br />
Onsite<br />
evaluation<br />
CTD format :<br />
Module 1, 2, 3,<br />
4 & 5<br />
Expert<br />
Committee<br />
CDL<br />
Kasauli<br />
Test Reports<br />
Module 3 (CMC)<br />
Review<br />
Market Authorization<br />
(Under rule 122B)<br />
Form 46<br />
Manufacturing License<br />
in Form 28 D
DCG(I)<br />
QA Div<strong>is</strong>ion Headed <strong>by</strong> DDC(I)<br />
Pre-screening<br />
On qualifying <strong>the</strong> Pre-screening, dossier will be forwarded to<br />
Technical Div<strong>is</strong>ion<br />
Applicant<br />
ADC(I)<br />
TO/DI<br />
ADC(I) will forward <strong>the</strong><br />
application to respective<br />
TO / DI, who will mark it<br />
to TDA, module w<strong>is</strong>e<br />
Final dec<strong>is</strong>ion and<br />
approval <strong>by</strong> DCG(I)<br />
(may also call <strong>the</strong> review<br />
team for d<strong>is</strong>cussion )<br />
DCG(I)<br />
DCGI(Drugs<br />
Controller<br />
General <strong>of</strong> India)<br />
TDA<br />
TDAs start technical<br />
evaluation <strong>of</strong> dossiers with<br />
<strong>the</strong> help <strong>of</strong> SOPs. And<br />
submit <strong>the</strong> report <strong>of</strong><br />
evaluation to respective<br />
TO/DI<br />
Final approved dec<strong>is</strong>ion<br />
or recommendation will<br />
be forwarded to <strong>the</strong> QA<br />
Div<strong>is</strong>ion for fur<strong>the</strong>r<br />
validation<br />
QA<br />
Div<strong>is</strong>ion<br />
DDC(Dy. Drug<br />
Controller)<br />
ADC(Ass<strong>is</strong>tant<br />
Drug Controller)<br />
TO/DI<br />
TO / DI validate <strong>the</strong><br />
report submitted <strong>by</strong><br />
TDAs and prepare <strong>the</strong><br />
validation report and<br />
forward to ADC vaccine<br />
for group d<strong>is</strong>cussion<br />
ADC(I) prepare Final<br />
Executive summary for<br />
DCG(I) on <strong>the</strong> bas<strong>is</strong> <strong>of</strong><br />
<strong>the</strong> validation report<br />
and group d<strong>is</strong>cussion<br />
and comments <strong>of</strong> CDL<br />
ADC(I)<br />
DI(Drug<br />
Inspector)/<br />
TO (Technical<br />
Officer)<br />
Group D<strong>is</strong>cussion<br />
ADC vaccine <strong>is</strong> <strong>the</strong> observer<br />
Team members: TO/DI & TDAs<br />
NCL-CDL,<br />
Kasuali<br />
TDA(Technical<br />
Data Associate)
DDC (S.P Shani)<br />
(Bio Div. Head)<br />
DCGI (Dr. Surinder<br />
Singh)<br />
DDC<br />
(S.Manivannan)<br />
(Q.A. Head)<br />
ADC (AK)<br />
ADC (SS)<br />
Compl<br />
iance<br />
to <strong>the</strong><br />
NRA<br />
Asses<br />
sment<br />
–<br />
DI(Sus<br />
hant)<br />
First<br />
time<br />
approval<br />
<strong>of</strong><br />
Vaccine-<br />
TO<br />
(Hurra) &<br />
DI(Yoges<br />
h)<br />
Import<br />
&<br />
Reg<strong>is</strong>t<br />
ration-<br />
TO(Ba<br />
su)<br />
Veteri<br />
nary<br />
Vacci<br />
ne-<br />
DI(Yo<br />
gesh)<br />
CLAA,<br />
Form-<br />
29 &<br />
Rule-<br />
37<br />
DI(Raje<br />
sh<br />
Verma)<br />
PSUR,<br />
AEFI,<br />
SAE<br />
D I<br />
(Rajes<br />
h<br />
Verma)<br />
Subseque<br />
nt<br />
approval<br />
<strong>of</strong> Vaccine<br />
–TO<br />
(Hurra), &<br />
DI(Yogesh<br />
)<br />
Recombi<br />
nant &<br />
Stem<br />
Cells-<br />
TO(Jayan<br />
t),DI-<br />
Shradha,<br />
DI-<br />
Sushant<br />
Blood<br />
Produ<br />
ct –<br />
DI(Raj<br />
esh<br />
Verm<br />
a)<br />
Post<br />
Appro<br />
val –DI<br />
(Vinod)<br />
Issues<br />
relate<br />
d to<br />
PSUs-<br />
DI(Shr<br />
adha)<br />
Issues<br />
related<br />
CDL<br />
Kasauli<br />
and NIB,<br />
Noida-<br />
DI(Susha<br />
nt)<br />
Updation<br />
& Follow<br />
up <strong>of</strong> NRA<br />
Assessm<br />
ent<br />
DI(Sushan<br />
t)<br />
Viral<br />
vaccine-<br />
TO(H)-<br />
TDA<br />
(Rahul) &<br />
TDA<br />
(Suvarna)<br />
Bacterial<br />
Vaccine<br />
DI(Y)-TDA<br />
(Garima )<br />
& TDA<br />
(Suramya)<br />
TDA<br />
(Zahida)<br />
TDA<br />
(Rekha)<br />
TDA<br />
(Jitendra)<br />
Viral<br />
vaccine-<br />
TO(H)-<br />
TDA<br />
(Rahul) &<br />
TDA<br />
(Suvarna)<br />
Bacterial<br />
Vaccine<br />
DI(Y)-TDA<br />
(Garima ) &<br />
TDA<br />
(Suramya)<br />
TDA -<br />
Man<strong>is</strong>ha,<br />
Amita,<br />
Punit,<br />
Ritu<br />
TDA<br />
(Rahul<br />
Malik)<br />
TDA<br />
(Sundeep)
Thank you<br />
for your attention