29.04.2015

12th SEC- (Reproductive & Urology) meeting held on 29-04-2015 at
CDSCO (HQ), FDA Bhawan, Kotla road, New Delhi – 110 002
Recommendation:The 12th SEC (Reproductive and Urology) Meeting deliberated the proposals on 29-04-2015
and recommended the following:Agenda File Name &Drug
No
name, Strength
1
12-78/13-DC
Mirabegron film
coated tablets
25/50mg
2
12-01/12-DC(Pt.9Ajanta
pharma/febuxostat)
Febuxostat tablets
40/80/120 mg.
3
04-88/10-Dc(pt sun)
Alfuzosin
Hydrochloride
ER+Tadalafil
4
5
Firm Name
Recommendations
New Drugs Division proposals
M/s. Astellas
Query letter was issued to the firm by
Pharma India
the office of DCGI seeking clarification
Private Ltd
regarding efficacy of Mirabegron over
placebo for the applied indication. The
firm presented the justification before
the Committee. The Committee
deliberated the matter in detail &
opined that Mirabegron efficacy was
similar to the placebo in the Indian
subset analysis. Hence the Committee
is of the opinion that marketing
approval should not be given to the
firm based on the above fact.
M/s Ajanta Pharma
Limited.
The firm has not presented the safety
data Periodic Safety Update Data
(PSUR) with grades of adverse events.
The Committee has asked the firm to
resubmit the data of adverse events
with grades and comparison vis-a-vis
global data.
Fixed Dose Combination Division
M/s Sun pharma
The Firm did not turn up for the
presentation.
Biologicals Division Proposals
4-28/Intas/PAC-RM/s Intas
Already available strengths – 75,
FSH/14 BD
150,300,450,600 IU / in prefilled
Recombinant
syringe. The firm made its presentation
Human
Follicle
before the committee on the proposal.
Stimualating
The committee deliberated in detail and
Hormone
recommended for the manufacturing &
marketing of additional Strength 225
IU/0.36 ml in Prefilled Syringe.
4-27/serum/09BD
M/s Serum Institute The committee in its earlier meeting
r-hu-FSH
of India Limited
recommended changes to the Clinical
trial protocol. The firm made its
presentation before the committee on
12th SEC-Reproductive & Urology, 29-04-2015
Agenda File Name &Drug
No
name, Strength
6
7
8
Firm Name
Recommendations
the revised protocol. The committee
deliberated in detail and observed that
the study design, sample size and the
study sites have been revised. Hence,
the committee recommended for the
clinical Trial.
The Investigator has presented the
proposed protocol for the study. After
deliberation
the
committee
recommended the clinical trial as per
4-311/AIIMS/15 BD
Dr. Shivani Jain,
the protocol. However the investigator
Granulocyte colony
AIIMS
shall submit the exact protocol detail
stimulating factor
with ID number to this directorate
alongwith copy of the ethics committee
approval to this office before formal
approval.
Medical device proposals
29/Misc/3/2014-DC M/s. Regulatory
The company applied for importing and
(47)
Solutions, Gurgaon marketing the device. The firm
Minitouch device an
presented the safety and efficacy data
endometrial
generated on the product. The
ablation device
committee deliberated the matter and
opined that this device is indicated for
ablation of the endometrial lining of the
uterus for the treatment of menorrhea.
This device does not fall under the 14
category of notified medical devices as
per Drugs and Cosmetics Act and
Rules thereunder. Hence, it is not
regulated at present under D&C Act.
However, the committee recommended
that this device is critical in nature and
it need to be notified under the
provision of Drugs and Cosmetics act
and rules thereunder for its regulation
in the country. Necessary steps be
initiated.
31-1136-MD/2012- M/s. Coloplast
The applicant firm has applied
DC
(India) Pvt. Ltd.,
for permission to import and market
(a) Genesis
Guragon
“Genesis
Malleable
Penile
Malleable Penile
Prosthesis” a Class II-b orthopaedic
Prosthesis and (b)
implant
manufactured
by
M/s.
Titan Inflatale Penile
Coloplast A/S, West River Road
Prosthesis
North, Minneapolis, MN 55411, USA.
The proposed Penile Prosthesis with
claimed shelf-life of 13-years, consists
of a molded silicone elastomer shaft
that incorporates a silver wire coil and
silver wire core in the flexible center
section and a trimmable proximal
section. The distal end is shaped to
12th SEC-Reproductive & Urology, 29-04-2015
Agenda File Name &Drug
No
name, Strength
Firm Name
Recommendations
provide an anatomical fit under the
glans penis. The silver wire coil and
core in the flexible center section
enables the prosthesis to be moved into
an erect position for intercourse and
then moved into a lowered position for
concealment under clothing. Placed
within the corpus cavernosum and crus
of the penis, the prosthesis will fit
firmly at the ischial tuberosity. The
product is indicated for male patients
suffering from erectile dysfunction
(impotence) who are considered to be
candidates for implantation of a penile
prosthesis.
The company also wants to
import and market ”Titan Inflatable
Penile Prosthesis” another Class-II-b
Penile prosthesis with 5-years shelf life
and made up of Bioflex elastomer
cylinders reservoirs, deflate valves with
cobalt Nichol Chromium molybdenum
alloy, polysulfone. All components of
the titan prosthesis contain hydrophilic
coating. The product is a hydraulic
system designed to be surgically
implanted into te penis for the
management of erectile dysfunction
(impotence). This implant provides the
patient with voluntary control over the
erect and flaccid status of the penis and
therefore indicated for management of
impotence stemming from a variety of
causes
including
prostatectomy,
diabetes,
arteriosclerosis
and
hypertensive vascular disease.
Both the product are stated to
be marketing in USA, Canada,
Australia and European Union but no
predicate available in India.
After
detailed
technical
presentation of the two products and
cross examination by the experts, the
committee came to the conclusion that
the device may be permitted for import
& marketing in India with intra
corporeal
implantation
with
replacement warranty and monitoring
period of 10-years. The firm should
carry out Post Market surveillance
studies for 10 years with submission of
12th SEC-Reproductive & Urology, 29-04-2015
Agenda File Name &Drug
No
name, Strength
Firm Name
Recommendations
interim reports every 3rd year .
This should only be reserved for case
where male impotence is not
responding to any medical or
conservational
management.
12th SEC-Reproductive & Urology, 29-04-2015