Recommendations of the SEC (Gastroenterology &Hepatology) made in its 21stmeeting held

on 22.08.2019 at CDSCO HQ New Delhi:

Agenda File Name & Drug Firm Name Recommendations

No Name, Strength
New DrugDivision
1 12-01/18-DC-DC(Pt- Firm didn’t turn up for presentation.
322)
IEC
Octreotide 200mcg

2 F. No. 12-01/12-DC (Pt- The committee opined that the interested

9 Cadila/Cinitapride Cadila companies may present their case before
Cinitapride the committee for deliberation.
3 12-01/12-DC(Pt-9 The committee opined that the interested
Sun/Camostat companies may present their case before
M/s Sun
CamostatMesylate the committee for deliberation.
Tablet 100 mg
SND Division
4 12-59/2018-DC (Pt- M/s Gurmail Firm did not turn up for presentation.
Gurmail Brother-SND) Brother
Midodrine HCI tablet
2.5mg (add. Indication)
5 SND/MA/19/000071 M/s Novartis The firm presented their proposal for
Tacrolimus hard gelatin Healthcare Ltd. Tacrolimus hard gelatin capsule 0.75mg
capsule 0.75mg (add. (add. lower strength)before the committee.
Lower strength)
After detailed deliberation the committee
recommended for grant of permission to
manufacture and market of the Tacrolimus
hard gelatin capsule 0.75mg (add. Lower
strength).
6 SND/CT/19/00027 M/s Cadila The firm withdraw their proposal.
Rabeprazole sodium for
inj 20mg/vial
FDC Division
7 FDC/MA/19/000042 M/s. Malik The firm presented their proposal before
Combikit of two tablets Lifesciences Pvt. the committee.
of Rabeprazole+two Ltd. After detailed deliberation the committee
tablets of opined that the firm may be asked to
Amoxicillin+two tablets present Indian data of clarithromycin
of Clarithromycin resistance to H.Pylori. Firm also did not
(20mg+750mg+500mg) present any added benefit of Rabeprazole
Tablets in the proposed combikit over the
previously approved combikits. If the firm
submits the satisfactory data, firm will be
required to conduct Phase-III comparative
clinical trial.

Accordingly, the firm should submit

21st SEC (Gastroenterology &Hepatology)_22.08.2019

Agenda File Name & Drug Firm Name Recommendations
No Name, Strength
details for further review by the
committee.

8 04-146/2007-DC(Pt.1)- M/s. The committee noted that this FDC was

08/2019 (zydus)/ 04- Zydus/Acme/Ak considered as rational by
45/2018- ums DTAB.However,in current medical
DC(Pt.Acme)/04- literature does not support this FDC in the
51/2019-DC (Pt. proposed dosage. The committee opined
Akums) that the firms may be given an opportunity
Ranitidine HCl IP eq. to to present their case before the committee.
Ranitidine+Domperidon
e IP (150mg+10mg)
Film coated tablets
GCTDivision
9 In light of recommendation of SEC held
on 18-07-2019, firm has presented
response along with details of the site with
volume of IBD patients.
After detailed deliberation committee
opined that choice of selection of the
CT/52/19
IQVIA centers are inappropriate. Firm is
Etrasimod
requested to submit the fresh list for the
centers where recruitment of the IBD
patients will be done.
Further, list of centers to be presented
before the committee for further
consideration.
10 In light of recommendation of SEC held
on 18-07-2019, firm has presented
response along with details of the site with
volume of IBD patients.
After detailed deliberation committee
opined that choice of selection of the
CT/53/19
IQVIA centers are inappropriate. Firm is
Etrasimod
requested to submit the fresh list for the
centers where recruitment of the IBD
patients will be done.
Further, list of centers to be presented
before the committee for further
consideration.
11 In light of recommendation of SEC held
on 18-07-2019, firm has presented
response along with details of the site with
volume of IBD patients.
CT/54/19 After detailed deliberation committee
Etrasimod IQVIA opined that choice of selection of the
centers are inappropriate. Firm is
requested to submit the fresh list for the
centers where recruitment of the IBD
patients will be done.Further, list of
centers to be presented before the

21st SEC (Gastroenterology &Hepatology)_22.08.2019

Agenda File Name & Drug Firm Name Recommendations
No Name, Strength
committee for further consideration.

12 Firm presented their proposal before the

committee.
Assessment of risk vs. Benefit to the
patients: The safety profile of the study
drugs from preclinical toxicology studies
including repeat dose toxicity and Phase-I
clinical study justify the conduct of the
trial.
Innovation vis-à-vis Existing
CT/56/19 Therapeutic option: The Purpose of the
Brazikumab Parexel study is to assess the efficacy of
Brazikumab in Patients with Moderately
to Severely Active Ulcerative Colitis
Unmet Medical need in the country:
The test drug may potentially provide
treatment in patients with moderately to
severely active ulcerative colitis (UC).

After detailed deliberation the committee

recommended for grant of permission to
conduct the study.
13 In light of recommendation of previous
SEC held on 18-07-2019,applicant
presented their response with study
protocol before the committee.
After detailed deliberation, committee
CT/46/19
opined that satisfactory response has been
CT-P13 M/s PPD
given for query number 1 & 2. However,
for the query number 3, choice of
selection of the centers is inappropriate.
Firm is requested to submit the fresh list
of the centers and to be presented before
the committee.

21st SEC (Gastroenterology &Hepatology)_22.08.2019