CCMA8lSCn Cl

CuSCC 8LCul8LMLn1S
lC8 L8MlSSlCn 1C
MAnulAC1u8L nLW u8uCS
lC8 uCMLS1lC Anu LxC81 MA8kL1
8y Ms Shllpa koLlan
8egulaLory Affalrs ulvlslon
umedlca LaboraLorles vL LLd
nLW u8uC uLllnll1lCn (122L)
W nC1 uSLu ln 1PL CCun18?
W A8CvLu u8uC
1 nLW CLAlMS (lndlcaLlons uosage uosage form 8ouLe)
2 luCs ( new or Modlfled)
W ALL vACClnLS SPALL 8L CCnSluL8Lu AS nLW u8uC AS
SLClllLu 8? LlCLnSlnC Au1PC8l1?
W nC1L A nLW u8uC lS CCnSluL8Lu nLW lC8 1PL L8lCu
Cl 4 ?LA8S l8CM 1PL uA1L Cl l1S ll8S1 A8CvAL C8 l1S
lnCLuSlCn ln 1PL lnulAn PA8MACCCLlA
ermlsslon Lo ManufacLure new urugs
Ior Domest|c Market|ng
W AppllcaLlon ln lorm 44
W 1reasury Challan of ln8 30000 / 13000 as
Lhe case may be
W lnformaLlon on acLlve lngredlenLs
W 3 uaLa on lormulaLlon
W 6 Anlmal harmacology uaLa
W 7 Anlmal 1oxlcology uaLa
W 8 Puman / Cllnlcal pharmacology (hase
l) uaLa
W 9 1herapeuLlc exploraLory Lrlals (hase ll)
W 10 1herapeuLlc conflrmaLory Lrlals (hase
lll)
W 11 Speclal sLudles
W 12 8egulaLory sLaLus ln oLher counLrles
W 13 A rescrlblng lnformaLlon
W 8 urafL Speclmen of label CarLon
W 14 Copy of Llcense ln lorm29
W 13 Samples and 1esLlng roLocol/s
Ior Lxports
W LxporL nCC from uCCl
W ManufacLurlng Llcense (lorm 23 or lorm
28)
W roforma lnvolce
W urchase Crder
W 8eglsLraLlon CerLlflcaLe
Approval of new urugs for MarkeLlng
|x 1ypes of App||cat|ons
1ype 1 new Chemlcal LnLlLy developed ln lndla as an lnu
and noL markeLed anywhere ln world
1ype 2 new Chemlcal LnLlLy approved markeLed ln oLher
counLrles noL approved ln lndla
1ype 3 new Chemlcal LnLlLy belng developed ln oLher
counLrles and noL markeLed anywhere ln world
1ype 4 A drug already approved new clalms
a) new lndlcaLlon
b) new uosage lorm/ new 8ouLe of AdmlnlsLraLlon
c) Modlfled 8elease uosage lorm
1ype 3 llxed uose ComblnaLlon
1ype 6 Already Approved new urug
Case SLudy
ulclofenac Sodlum/oLasslum ln[ecLlon
W ulclofenac Sodlum ln[ecLlon73 mg per ml ln 3ml
pack slze avallable ln lndlan markeL
W roposed formulaLlon of umedlca LaboraLorles
ulclofenac Sodlum ln[ecLlon73 mg per 09 ml 3 ml
27 ml 34 ml 90ml and 100 ml (le Already approved
drug wlLh only dlff ln ack Slze 1ype 6 app||cat|on)
ulclofenac oLasslum ln[ecLlon73 mg per 09 ml 3
ml 27 ml 34 ml 90ml and 100 ml (le new Chemlcal
LnLlLy developed ln lndla as an lnu and noL
markeLed anywhere ln world 1ype 1 app||cat|on)
1ype 1 AppllcaLlon
W new urugs developed ln lndla as an lnu and
noL MarkeLed anywhere ln world
lor such new urugs Lo be approved for markeLlng
daLa requlred Lo be submlLLed wlll be slmllar as
per Appendlx l of Schedule ? whlch ls slmllar Lo
daLa requlred for any new chemlcal enLlLy (nCL)
lor such new urugs Lhe cllnlcal Lrlals are
requlred Lo be carrled ouL rlghL from hase l
uocumenLaLlon 8equlremenLs
-ew Drugs deve|oped |n Ind|a
W lorm 44
W 1reasury Challan of ln8
30000
W Source of raw maLerlals
W Chemlcal and pharmaceuLlcal
lnformaLlon lncludlng
W a) lnformaLlon on acLlve
lngredlenLs/ lormulaLlon
W 6 Anlmal harmacology
W 7 Anlmal 1oxlcology
W 8 Puman / Cllnlcal
pharmacology (hase l)
A|ready Approved -ew Drugs
W lorm 44
W 1reasury Challan of ln8 13000
W Source of bulk drugs /raw
maLerlals
W Chemlcal and pharmaceuLlcal
lnformaLlon lncludlng
lnformaLlon on acLlve
lngredlenLs
W 8egulaLory sLaLus of Lhe drug
conLd
uocumenLaLlon 8equlremenLs
-ew Drugs deve|oped |n Ind|a
W 1herapeuLlc exploraLory Lrlals
(hase ll)
W 1herapeuLlc conflrmaLory Lrlals
(hase lll)
W Speclal sLudles
W 8egulaLory sLaLus ln oLher
counLrles
W rescrlblng lnformaLlon
W urafL Speclmen of label CarLon
W Copy of Llcense ln lorm29
W Samples and 1esLlng roLocol/s
A|ready Approved -ew Drugs
W 8A /8L sLudy reporLs (for oral
dosage forms)
W ln case of ln[ecLable
formulaLlon subacuLe LoxlclLy
daLa conducLed wlLh Lhe
appllcanLs' producL has Lo be
provlded
W rescrlblng lnformaLlon
W urafL of labels and carLon
W Copy of Llcense ln lorm29
ermlsslon Lo ManufacLure for LxporL
W Lxport -
A manufacLurer holdlng valld llcense copy ln
lorm 23 and lrom 28 can obLaln no Cb[ecLlon
CerLlflcaLe from Zonal/Sub Zonal offlces of CenLral
urugs SLandard ConLrol CrganlsaLlon (CuSCC) for
exporL purpose only for approved / unapproved
new drug / banned drug ln lndla
8equlremenL for lssuance of LxporL nCC
of unapproved / approved new drugs /
8anned drugs
1 Coverlng LeLLer
2 urchase Crder
3 ManufacLurlng Llcense
4 erforma lnvolce
3 8eglsLraLlon CerLlflcaLe
1 Coverlng LeLLer
W 1he coverlng leLLer ls an lmporLanL parL of Lhe appllcaLlon and
should clearly speclfy Lhe lnLenL of Lhe appllcaLlon
W 1he llsL of documenLs LhaL are belng submlLLed (lndex wlLh page
no's) as well as any oLher lmporLanL and relevanL lnformaLlon may
be provlded ln Lhe coverlng leLLer
W 1he coverlng leLLer menLlonlng llsL of producLs Lo be exporLed
clearly lndlcaLlng name of Lhe drug dosage form composlLlon and
sLrengLh pack slze along wlLh quanLlLy and counLry Lo be exporLed
duly slgned and sLamped by Lhe auLhorlzed slgnaLory lndlcaLlng Lhe
name deslgnaLlon of Lhe auLhorlzed slgnaLory along wlLh Lhe
name and address of Lhe flrm
W Lach appllcaLlon should be made by Lhe manufacLurer only
2 urchase Crder
W Crder from Lhe forelgn buyer elLher ln Lhe name of manufacLurer or
ln Lhe name of Lrader menLlonlng llsL of producLs Lo be exporLed
clearly lndlcaLlng name of Lhe drug dosage form composlLlon and
sLrengLh pack slze duly slgned by Lhe compeLenL
auLhorlLy wlLh speclflc desLlnaLlon polnL of Lhe lmporLlng counLry
W ln case of purchase order ln Lhe name of Lrader furLher a leLLer from
Lhe Lrader ln Lhe name of manufacLurer ls requlred Lo be submlLLed
along wlLh Lhe appllcaLlon
W lL should be slgned by Lhe compeLenL auLhorlLy/person wlLh a valld
purchase order no and recenL daLe noL more Lhan 6 monLh prlor Lo
Lhe appllcaLlon made by Lhe flrm
3 ManufacLurlng Llcense
W Llcense lssued by Lhe SLaLe Llcenslng AuLhorlLy
should be enclosed along wlLh each
appllcaLlon for Lhe requlred locaLlon Lo
manufacLure Lhe drug for exporL purpose
4 erforma lnvolce
W A copy of erforma lnvolce from Lhe lmporLlng
counLry should accompany wlLh appllcaLlon for
lmporL of unapproved AcLlve harmaceuLlcal
lngredlenLs used ln Lhe drug formulaLlon
W A copy of erforma lnvolce duly slgned by Lhe
compeLenL auLhorlLy should be addressed Lo Lhe
manufacLurer menLlonlng Lhe requlred quanLlLy
of Lhe bulk drug
3 8eglsLraLlon CerLlflcaLe
W lor Lhe exporL of drugs whlch are banned ln lndla by
CenLral governmenL whlch comlng under llsL of drugs
prohlblLed for manufacLure and sale Lhrough gazeLLe
noLlflcaLlons under secLlon 26a of drugs cosmeLlcs
acL 1940 by Lhe mlnlsLry of healLh and famlly welfare
W A copy of reglsLraLlon cerLlflcaLe from Lhe speclflc
lmporLlng counLry along wlLh composlLlon and sLrengLh
of Lhe drug should accompany wlLh Lhe appllcaLlon
W 8eglsLraLlon cerLlflcaLe should be provlded ln Lhe name
of manufacLurer
CCn1Ln1S Cl 8LClS18A1lCn uCSSlL8 ln
lnulA
W lnLroducLlon
W Chemlcal and harmaceuLlcal lnformaLlon
W Anlmal harmacology
W Anlmal 1oxlcology
W Puman/Cllnlcal harmacology (hase l)
W 1herapeuLlc LxploraLory 1rlals (hase ll)
W 1herapeuLlc ConflrmaLory 1rlals (hase lll)
W Speclal SLudles
W 8egulaLory SLaLus ln CLher CounLrles
W rescrlblng lnformaLlon
W Samples and 1esLlng roLocols
C1u ln lnulA
W 1he new urug AppllcaLlon can be submlLLed as
per lnLernaLlonal guldellnes ln form of lCP
Common 1echnlcal uocumenL as shown below
Module1 AdmlnlsLraLlve and rescrlblng lnformaLlon
Module2 Summary of Module12 and 3
Module3 CuallLy secLlon
Module4 nonCllnlcal sLudy 8eporL
Module3 Cllnlcal SLudy 8eporL
1nA- D
I D A11L-1I-"