VCL-HYDRA-0120I4, Version No. 3.

0
Protocol No. followiny
the Revised Study Principal Investipator with the
The firn has submitted National Coordinator and
signed by the
Dated 20.11.2015 duly
changes.
Definition for High Risk Patients. cardiologist and anaesthetist
to
STS score 80. interventional
a. surgeon. one
U One clinical site cardiac
determine paticnt eligibility. discase
ofagc. dysfunction. (OPD. lung
C. Any patient
that is over 70 years (Renal
. d. Has other
etc.,)
c0-Morbidities with aortic
stenosis

(2)other study Centers. Dr. Ajit Kumar

Technology. Trivandrum, Investigators.
Addition of following two Institute for Medical
Sciences and Ganapathi as
a. Sree Chitra Tirunal Harikrishnan Sivadasan Pillai, Dr. Sanjay
Valaparambil Kumar, Dr. asthe Investigator.
Hospital, Cochin, Dr. Rony MatthewAppendix II.
b. Lisie "STS" and 'COPD" in
Inclusion of acronyms documents submitted bv
Committee:-The Comnittee reviewed the
explanation subnittcd
Recommendationof the Technical Patients. The Committee accepted the
criteria of High Risk recommendation.
the firm regarding the Phase Illclinical trial as per S[:C
recommended for conduct of
by the firm and
import and
Item No. 10: Pvt. Limited for grant of permission to
Laboratories (India) Eyc Drops.
Proposal of M/s Alcon mg/ ml+ Brimonidine 2 mg/ml
Brinzolamide 10
marketing of FDC of luport and
Bangalore has applicd lor grant of pernission to
(India) Pvt. Limited.
MsAleon Laboratories ml + Brimonidine 2 mg/ml
Eye Drops.
Brinzolamide l0 mg/ presented subset
Marketing of FDC of dated l1.09.2015:- During the meeting the firm
Recommendation of the SEC meeting global clinical
138 eyes)which wereincluded in the study as a part of
analysis of 69 Indian patients (i.e. said sample size is statisticaly significant. The
justification showing that the
trial. Firm also presented significant reduction in intraocular pressure using the
shows a statistically Further the Committee noted that
he
result of the subset analysis drugs given together.
the individual Import and
FDC which was comparable to Australia, UK etc. Hence the Committee recommended for
FDC is also approved in USA, part of
conducted above trial in 69 Indian pat ients (i.e. 138 eyes) as a
Marketing of the FDC. Firm had
global clinical trial.
The Commitlee recomnmended or mport and
Committec:-
Recommendation of the Technical Dropsas per
mg/ ml+ Brimonidine 2 mg/ml Eye
Brinzolamide 10
marketing permission of the FDCof
SEC recommendation.

Item No. 1l: "A Phase

Pharmaceuticals Pvt. Ltd. to conduct Phase Il clinical trial entitled,
Proposal of M/s Issur Genopep l(Issar l) in a Non-Randomized,
and Safety of the
I|Clinical Study to Assess the Efficacy Design in Indian Adult Patients with Relapsed/ Recurrent/
Open-Label, Single-Arm, Multi-Centre
Resistant Solid Tumours".