51st Meeting of Genetic Engineering Approval Committee

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Dec 11, 2012 (4 years and 8 months ago)

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51
st

Meeting of Genetic Engineering Approval Committee



Date


:



10.2.2005


Venue

:


624, Paryavaran Bhawan, CGO Complex, Lodhi


Road, New Delhi
-

110 003


Time


:


11.00 A.M.


Agenda Item No.1


Welcome by Chairperson


Agenda Item No.2

Confirmation of M
inutes of 50
th

Meeting of GEAC held on 12.1.2005.


Agenda Item No.3


Follow up on the decision taken in the 50
th

GEAC meeting.


Agenda Item No.4


Leave of Absence


Agenda Item No.5



Consideration of Proposals.




5.1



Permission for manufacture and mar
keting of Diphtheria, Tetanus and Perturisis and
Hepatitis
-

B combination vaccine (DPTH) by M/s. Shantha Biotechnics Ltd. Hyderabad.


5.2



Permission for manufacture and marketing of the bulk and finished formulation of r
-
human
Erythropoietin (r
-
h
-
EPO) by M/
s. Intas Pharmaceuticals Ltd. Ahmedabad.


5.3



Permission to import Erythropoietin (EPREX
-

with HAS, EPREX
-
without HAS and
Neorecormon) for Test Analysis by M/s Wockhardt Ltd. Mumbai.


5.4



Permission to import Denimax 399S from M/s Novoenzyme Denimax by
M/s Lumis Biotech
Ltd. Mumbai from Denmark.


5.5



Permission to import and marketing of L.G. Leucostin Injection filgrastim (r
-
human
Granulocyte colony Stimulating factor) by M/s. L.G. Life Sciences Pvt. Ltd. New Delhi.


5.6



Permission for manufacture and ma
rketing of r
-
human Epidermal Growth factor by M/S
Bharat Biotech International Ltd. Hyderabad.


Agenda Item No. 6



Other Items


6.1

Comments on draft ground rules for operationalizing the good practices in environmental
regulation.


6.2

Any other items with the

permission of the Chair.


**
Information to Project Proponents:


Proponents who wish to present their case before the GEAC may be available during the
meeting on 10.2.2005