PHARMACEUTICALS

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1

List of Pending GEAC Proposals as on
30.11
.2005


S. No

Title of the Proposal

Received on

Referred to

Status


PHARMACEUTICALS


1.


Import and marketing of
recombinant Bovine Somatropin
from M/s. L.G. Chemicals Pvt. Ltd.
New Delhi

18.7.2003

Dept. Of Animal
H
usbandry and
Dairying
,
DBT, MoFPI.

The proposal was considered in
the GEAC meeting held on
10.10.2005. Additional
clarification on the
feed and

fodder policy and protocol for
restrictive use
was

sought from
the Dept of Animal Husbandry
on 21.10.2005.


Com
ments received from the
Dept of Animal Husbandry
would be considered in the
GEAC meeting scheduled for
14.12.2005.


2.


Import and marketing of r
-
human
DNA Hepatitis B Vaccine Hexavac.
By M/s Aventis Pasteur India Ltd.
From M/s. Aventis Pasteur’s
䙲cnce.



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the‴M
th

GEAC meeting on
31.03.04. The committee
decided to await the views of
DCGI with specific reference to
safety and efficacy of the
pro
duct and MOH/ICMR on the
issue of bringing IPV component
in the vaccine before taking a
final view.


Comments from ICMR have
been received on 12.7.2004.


Comments from MOH/DCGI are
awaited. Reminder again issued
on 3.10.2005


3.


Permission for import of r
-
hu
-
Epidermal Growth factor for
manufacturing in India a fixed
dose combination of 10 ug/GM
and Silver Suphdiazin 1% as a
Cream for Topical in burn cases
from GGE and Biotechnology Cuba
by M/s Glenmark Laboratories Pvt.
Ltd. Mumbai

26.2.2004*

DBT & DCGI on
25.7.2002.

The matter was considered by
the GEAC in the meeting held on
11.8.2004. Views of DCGI
regarding the waiver of Phase
-
III clinical trials/ approval for
PMS are awaited.


Reminder again issued on
3.10.2005

4.


Permission for import and
marketing of
finished product in
India r
-
Human G
-
CSF, 300mcg in
prefilled syringes by M/s Clarisis
Life sciences Ltd. Ahmedabad
from North China Pharmaceuticals
(NCPC) Genetech Biotechnology
Co, Ltd. China.



12.8.2004

Sent to DCGI, DBT,
IISc Banglore,
IMTech, Chandiga
rh
on 17.8.2004

Considered in the GEAC meeting
on 13.10.2004 wherein the
applicant was advised to submit
revised application taking into
consideration the views of DBT.


Details are awaited.




2

5.


Import of
Finase PC enzyme for
formulation and marketing in
India by M/s. Textan Chemicals
(P) Ltd. Germany

3.3.2005

Circulated to all the
members of GEAC
and
Dept of
Animal
Husbandry on
3.3.2005,

Considered in the GEAC meeting
on 13.
4.
200
5

wherein

it was
decided
to await the specific
comments of DBT and
Dept of
A
nimal Husbandry
.


Comments
are
awaited
.
R
eminder sent on 10.5.2005,
20.10.2005 and 26.11.2005
.


6.


Import of r
-
Leisg
-
111 F by
institute of Medical Sciences,
BHU, Varanasi.

7.3.2005

Circulated to all
Members of GEAC on
18.3.2005.

Considered in the GEAC me
eting
on 13.4.2005. It was decided to
await the recommendation of
ICMR Ethical Committee.


Letter issued on 1.9.2005.
Reminder issued on 25.10.2005.


7.


Permission for manufacture and
market of r
-
insulin supplied by
M/s Biocon by M/s Cadilla
Pharmaceutical
s Ahmedabad.

2.6.2005

Circulated to all
Members of GEAC on
16.6.2005

Considered in the GEAC meeting
on 10.8.2005 wherein it was
decided to seek clarification
from Biocon regarding their
installed capacity. Information
received.


C
onsidered in the GEAC mee
ting
on 23.11.2005.

Additional
clarification awaited.


8.


Permission for manufacture of
hepatitis C Viral antigens for
commercialization by M/s.
Sudershan Biotech Ltd.
Hyderabad.

20.6.2005

Circulated to all
Members of GEAC on
20.6.2005

Considered in the G
EAC meeting
on 10.8.2005.


Committee decided to call for
additional information on the
tests conducted at the Center
for Liver Research and
Diagnostics and validation report
from NIB.


Information is awaited.


Reminder issued on 25.10.2005.


9.


Permission f
or manufacture and
market formulation of
Recombinant
-
human
-
insulin of 3
types, soluble insulin, insulin
Isophane, 30:70 combination of
soluble insulin + Isophane insulin
in India
-
Bulk Insulin crystals to be
procured from M/s. Biocon by
Lupin.

23.6.2005

Cir
culated to all
Members of GEAC on
4.7.2005

Considered in the GEAC meeting
on 10.8.2005 wherein it was
decided to seek clarification
from Biocon regarding their
installed capacity. Information
received.


C
onsidered in the GEAC meeting
on 23.11.2005.

Additi
onal
clarification awaited.



3

10.


Permission for manufacture and
marketing of human insulin from
M/s Biocon Ltd by M/s. Ranbaxy
Laboratories Ltd.

29.7.2005

Circulated to all
Members of GEAC on

29.8.2005.

Considered in the GEAC meeting
on 10.8.2005.


Committee

decided to obtain
clarification from Biocon
regarding their installed
capacity. Information received.


C
onsidered in the GEAC meeting
on 23.11.2005.

Additional
clarifications awaited.


11.


Permission for import of Actilyse
(recombinant human tissue type
pl
asminogen activator) 50 mg for
ExTRACT study from Germany

by
M/s Sanofi Aventis from Mumbai.


12.8.2005

Circulated to all
Members of GEAC on
2.9.2005.

Considered in the GEAC meeting
on 14.9.2005


Committee decided to obtain the
following information.


a.

How
long the product has
been in use by the Company
and the quantity imported
so far?

b.

Whether the product has
been earlier imported with
the approval of DCGI?

c.

Reasons for not obtaining
the approval of GEAC.



Information is awaited.


12.


Permission to import of
Zolair
(omalizumab) humanized anti

IgE anti body (murine monoclonal
antibody) by M/s Novratis

29.8.2005

Circulated to all
Members of GEAC on

12.9.2005.

Considered in the GEAC Meeting
on 10.10.2005


Additional information on the
status of approval in ot
her
countries and details of clinical
tries sought.

13.


Permission to conduct large scale
process optimization studies (for
R & D purpose only) for oral
Insulin in

105 pecursens to be
used for the production of oral
formulation of r
-
human Insulin by
M/s Bi
ocon

12.9.2005

Circulated to all
Members of GEAC on

22.9.2005.

Considered in the GEAC Meeting
on 10.10.2005.


Additional information on the
containment conditions and
details about the chemical
disinfections protocols
received
has been circulated to the
members of the GEAC.


To be reconsidered in the GEAC
meeting on 14.12.2005.


14.


Import of AVI
-
005 (Interferon
alpha

2b) and conduct of human
clinical trials in India from M/s
Avi
-
Genics USA by BV Feed
Supplements
, manufacturing
Company Ltd. Pune.

16.9.2005

Circulated to all
Members of GEAC on
5.10.2005

C
onsidered in the GEAC Meeting
on 23.11. 2005
. Additional
information awaited.




4

15.


Permission to conduct clinical
trials of r
-
human interferon alpha
2b (Reliferon) tm and to
manufacture
batches for
proposed
clinical trials by Reliance
life Sciences. Mumbai

4.10.2005

Circulated to all
Members of GEAC on

5.10.2005

C
onsidered in the GEAC Meeting
on 23.11. 2005
.


Decision on the proposal was
deferred as the members
informed that they have not
received the projec
t documents.


The Company has been advised
to circulate the same.


16.


Permission to import for conduct
of Phase II trails of Chamerivax
TM
-
JE and Japanese Encephalitis
in activated Mouse Brain Vaccine
in children of desending age and
assessment of possible

interaction
with concomitant measles vaccine
by M/s Quintiles.

19.10.2005

Circulated to all
Members of GEAC on
19.10.2005

C
onsidered in the GEAC Meeting
on 23.11. 2005
.


It was decided to obtain
comments of medical experts
from All India Institute of
Me
dical Science, National
Institute of Immunology, New
Delhi, National Institute of
Virology, Pune and Indian
Council of Medical Research.


17.


Permission to import r
-
human
Granulocyte colony stimulating
factor (rhg
-
GSF) and conduct of
clinical trials of by M/
s Sun
Pharmaceuticals Industries Ltd
Mumbai.

20.10.2005

Circulated to all
Members of GEAC on
20.10.2005

C
onsidered in the GEAC Meeting
on 23.11. 2005
.


Additional information awaited.

18.


Permission for import and
marketing of enzyme (Phytase)
from M/s. Su
nson Industry Group
Co. Ltd
Jinfeng Distt.
China by
M/s Chembond Chemicals Ltd.

M
umbai

25.10.2005

Circulated to all
Members of GEAC on
25.11.2005

To be considered in the GEAC
Meeting on 14.12. 2005

19.


Permission for import of EPREX R

(Epoetin alpha) from
M/s. Fisher
Clinical Services, Singapore for
conducting phase III clinical trials
in India by M/s Synchron
Research Services Pvt
.

Ltd.
Ahmedabad.

11.11.2005

Circulated to all
Members of GEAC on
25.11.2005

To be considered in the GEAC
Meeting on 14.12. 200
5

20.


Permission for conducting phase
III clinical trials on r
-
human
Granulocyte
Colony Stimulating

Factor ( rh GCSF) and scale
-
up of
the production process for R&D
purpose only by M/s Biocon Ltd.
Bangalore
.




18.11.2005

Circulated to all
Members of GEAC on

25.11.2005

To be considered in the GEAC
Meeting on 14.12. 2005

21.


Permission for conducting phase
III clinical trials on r
-
Streptokinase

and scale
-
up for R&D purpose by
M/s Biocon Ltd.
Bangalo
re
.



18.11.2005

Circulated to all
Members of GEAC on
25.11.200
5

To be considered in the GEAC
Meeting on 14.12. 2005


5


TRANSGENIC CROPS


22.


Permission to export limited
quantity seed of transgenic cotton
containing ‘vip 3A’ insect
-
resistance gene Event COT
-
202
for research purposes to Burkina
Faso, Africa Permit by M/s

Syngenta Seeds India Pvt. Ltd.

12.5.2005

Circulated to all
Members of GEAC on
16.6.2005.

Reconsidered in the GEAC
meeting on 10.8.2005.

It was decided to await

the
recommendation of the Agro
Biodiversity Task Force
constituted by NBA and
comments of NBPG
R.


23.


Permission for export of Bt
Eggplant transgenic seeds
containing the
cry 1 Ac
gene to
Institute of Plant Breeding.
College of Agriculture, University
of Philippines, Los Banos,
Philippines, East West Seeds
(Bangladesh) Ltd. Bangladesh &
Banglades
h Agriculture Research
Institute Bangladesh.

21.6.2005

Circulated to all
Members of GEAC on
22.6.2005.

Considered in the GEAC meeting
on 10.8.2005.


It was decided to await

the
recommendation of the Agro
Biodiversity Task Force
constituted by NBA and
comm
ents of NBPGR.