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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

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