17th SEC- (Antimicrobial) meeting held on 07-04-2015 at CDSCO (HQ), FDA Bhawan,
Kotla road, New Delhi – 110 002
Recommendation:The 17th SEC (Antimicrobial) meeting deliberated the proposals on 07-04-2015 and
recommended the following:
Agend
a
No
File Name
& Drug
name,
Strength
Firm Name
1
12-130/11-DC
Amphotericin
Dndi
(Dr. Bhawna
Sharma)
2
12-44/14-DC
Verapamil
Recommendations
New Drug Proposals
The firm has presented the result of the pilot project
safety and effectiveness of treatment modalities for
the management of visceral Leishmaniasis. The firm
has conducted the three arms study: viz single dose
Liposomal Amphotericin B Injection, oral
Miltefosine and i.m. Paromomycin, single dose
Liposomal Amphotericin B Injection and
oral
Miltefosine.
The results have shown significant clinical efficacy in
all the arms. The Committee deliberated the matter in
detail and recommended that all the three treatments
as used in the study can be used for the treatment of
visceral leishmaniasis.
Dr. Soumya
The proposal for conduct of the clinical trial was
Swaminathan,
deliberated in the SEC dated 08.12.2014 and the
Director,
National Institute Committee recommended to submit revised protocol
with certain amendment . The applicant presented the
of Research in
Tuberculosis
revised protocol. After detailed deliberation the SEC
recommended as under:
Single dose Verapamil (I.R) 120mg is to be used
for the pharmacokinetic study as per suggestion of
SEC dated 08.12.2014 and the data of the study to
be presented before the Committee for
consideration of further higher and multiple doses.
Accordingly the title of the study should be
modified.
The applicant shall submit revised protocol to the
DCGI office for necessary permission for
initiation of the study.
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17th Antimicrobial 07-04-2015
3
12-45/08DC(Pt-PhaseIV)
Ulinastatin
injection
M/s. Bharat
serum
The firm submitted the application for conducting a
Phase IV trial. The firm presented the proposed
protocol to be conducted in 300 patients. The
Committee deliberated the proposal in detail and
recommended for grant of permission to conduct the
clinical trial.
Subsequent New Drug Proposals
4
04-45/2008dc(pt-lupin)-1
Ulinastatin for
injection 50000
I.U/100000 I.U
M/s Lupin
5
12-25/2015dc(ptGlenmarkSND)
Garenoxacin
Mesylate
200mg tablet
12-70/2013dc(pt-Akums)
Meropenem
injection
2mg/vial
M/s Glenmark
6
7
8
9
CT/62/13
methyprednisol
one
31-1108MD/2012-DC
(End.01)
Collacare G
Sponge
31-1405MD/2013-DC
BIOPATCH
Protective Disc
with CHG
(Chlorhexidine)
M/s Akums
The firm submitted the revised protocol for
conducting a Phase IV trial as per the
recommendations of SEC held on 18.9.2014. After
deliberation committee recommended for conducting
the phase IV study.
The firm did not turn up for presentation.
The proposal was deliberated and committee opined
that firm did not satisfy the concerns raised in SEC
held on 25/07/2014 and did not approve the proposal
for additional strength of Meropenem injection.
GCT Proposals
M/s
George The proposed trial was referred by the SEC
clinical
(Cardiology & Nephrology) to examine the
requirement of Quantiferon Gold tests to rule out the
Latent TB cases from being recruited in this study.
After detailed deliberation the committee opined
that “Quantiferon Gold Test” in Tube can be done to
rule out the latent TB cases.
Medical Devices Proposals
M/s. Optimus Firm did not turn up for the presentation.
Pharma
Consulting,
Hyderabad
M/s. Johnson &
The firm applied for import permission of
“BIOPATCH
Protective Disc with Chlorhexidine
Johnson,
Gluconate”
manufactured
by M/s. Ethicon Inc., New
Mumbai
Jersey, USA having manufacturing premises at M/s.
Integra Neurosciences, Puerto Rico USA. The firm is
already holding the import Registration Certificate and
Form 10 for the proposed product subject to the
clarification of
SEC (Antimicrobial & Anti-viral)
regarding it’s use in Indian context. The case was
reviewed by SEC – Antimicrobial & Anti-viral in its
meeting held on 30.01.2015. The committee after
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17th Antimicrobial 07-04-2015
deliberation recommended that the firm should submit
adequate safety and efficacy data on the product for
further examination by the SEC.
The present committee after
deliberation have observed the following;
today’s
1.There is not enough data to prove the superiority
over the universal standard precautions which are
usually being practiced in the use of catheter
insertion
2.Since Chlorhexidine Gluconate has only
bacteriostatic activity which can contribute to
development of antimicrobial resistance.
In light of the above, the committee feels that product
may not have any distinct advantage over the
standard care.
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