Recommendations of the SEC (Oncology & Haematology) made in its 107 th meeting held on

10.03.2021 & 11.03.2021 at CDSCO HQ New Delhi.

Agenda File Name & Drug Recommendations

Firm Name
No Name, Strength
New Drugs Division
M/s Astra Firm presented their Phase IV clinical trial
12-68/16-DC (Pt- Zeneca report.
phase-IV)
After detailed deliberation, the committee
1.
Osimertinib 80 mg noted that there is no new safety signal in
Tablets the presented clinical trial phase IV clinical
trial report.

In light of earlier recommendation dated

21.07.2020 & 22.07.2020, the firm
presented the BE study report before the
committee.
After detailed deliberation, the committee
opined that the drug is proposed to be
M/s BDR indicated for the rare life threatening
ND/MA/20/000010 Pharmaceutical disease and there is an unmet medical need
Internationals in the treatment of the same. Drug is
2. Rucaparib 300 mg Pvt. Ltd approved as Orphan drug by USFDA.
Tablets
After detailed deliberation the committee
recommended the grant of permission to
manufacture and marketing of the drug
subject to condition that the firm should
conduct a phase-IV clinical trial in 100
patients for which details of the protocol
should be submitted to CDSCO within
three month of approval of the drug.

The firm presented the amendment for the

ND/CT/18/00002 M/s Bharat protocol version no 6 dated 10.11.2020

Leuprolide acetate Serums &

3. After detailed deliberation the committee
3.75mg Depot Vaccines Ltd recommended for approval of the amended
protocol version 6 dated 10.11.2020.

4. ND/CT/18/FF/ M/s Astra The firm presented their proposal for grant
2020/22226 Zeneca India of permission to import and marketing of
Ltd. Bangalore the drug along with local clinical trial
Selumetinib 10 mg waiver.
and 25 mg capsules
The committee noted that the drug is
proposed to be indicated for the rare life
SEC (Oncology & Haematology) made in its 107th meeting held on 10.03.2021 & 11.03.2021 at
CDSCO HQ New Delhi
 threatening disease and there is an unmet
medical need in the treatment of the same.
The drug is approved by USFDA.

After detailed deliberation, the committee

recommended for grant of permission to
import and marketing of the drug.

12-01/20-DC(Pt-47) The applicant presented their proposal for

Institutional the Academic Trial before the committee.
Losartan plus m-
Folfirinox Ethics
5. committee, After detailed deliberation the committee
(oxaliplatin,
Irinotecan,Leucovori TMH, Mumbai recommended that there is no objection for
the proposed academic trial as presented.
n &5Fluorouracil)

ND/IMP/21/000009 Firm didn’t turn up for presentation.

M/s Bayer
Darolutamide 300 mg Pharmacetical
6.
Film coated Tablets Pvt Ltd
Nubeqa®

Biological Division
4-16/DRL/PAC-R- Firm didn’t turn up for presentation.
Denosumab M/s Dr.
(Xgeva)/18-BD Reddy’s
7.
Laboratories
Denosumab (Xgeva) Ltd

CT/236/10-DCG(I) Firm presented the efficacy & safety results

M/s Roche
(Part-I) from Global Phase II Clinical Trial along
Products
8. with study results from India sub-set.
(India) Pvt.
Pertuzumab After detailed deliberation the committee
Ltd.,
noted the results of the study.
In-light of the recommendation of earlier
SEC meeting held on 03.12.2019, the firm
presented the comparative safety data
generated from local Phase IV clinical trial
4-32/Roche/PAC-R- M/s Roche and PSUR of global Phase-III study.
Pertuzumab/17-BD Products India
9. Pvt. After detailed deliberation, the committee
Pertuzumab noted the comparative results and
recommended that CDSCO may consider
deletion of condition stipulated in new drug
permission regarding conduct of Phase IV
clinical study.
10. 4-95/BMS/PAC-R- M/s BMS In-light of the recommendations of SEC
Nivo+Ipili/2020-BD meeting dated 06.01.2021 & 07.01.2021,
the firm presented their proposal for
SEC (Oncology & Haematology) made in its 107th meeting held on 10.03.2021 & 11.03.2021 at
CDSCO HQ New Delhi
 addition of new indication & dosage for use
of Nivolumab in combination with
Ipilimumab in NSCLC based on efficacy
and safety results from global studies along
Nivolumab with Asian subpopulation.

After detailed deliberation, the committee

recommended for grant of permission for
the proposed indication as approved by US
FDA.
Firm presented the proposal for marketing
authorization in the country based on
efficacy and safety results of Phase III
clinical study.
BIO/CT21/BO/
Committee noted that the drug is orphan
2020/23432 M/s Enzene drug for a rare indication.
11.
Biosciences After detailed deliberation, the committee
Romiplostim recommended for grant of permission to
market the drug subject to the condition that
the firm shall conduct Phase IV clinical
study in the country. Accordingly, the firm
shall submit the protocol etc to CDSCO.
SND Division
The firm presented the proposal along with
the waiver for BE and CT study.
The committee noted that the Azacitidine
SND/MA/21/000014
Tablets 300 mg is already approved in USA
M/s Intas
Azacitidine Tablets in Sep, 2020.
12. Pharma After detailed deliberation the committee
300 mg recommended that the firm is required to
conduct BE study.
Accordingly, the firm should submit BE
study protocol for review by the committee.
Firm presented the results of Phase III
12-80/2016-DC (Pt- Clinical Trial of Heparin Sodium 1000
Troikaa-SND) IU/ml.
M/s Troikaa
After detailed deliberation, the committee
13. Pharma
Heparin Sodium recommended for grant of permission for
1000 IU/ML additional indication of Heparin sodium
1000 IU/ml for prevention of infusion
associated phlebitis.
14. SND/CT/21/000006 M/s Shilpha The firm presented the proposal for Phase II
Medicare Clinical trial of Ursodeoxycholic acid
Ursodeoxycholic acid injection 625 mg/25 ml (25mg/ml) along
injection 625mg/25 with Pre-clinical study summary with the
mL (25 mg/mL) proposed additional indication “treatment
of non-alcoholic Steatohepatitis (NASH),
Critical primary biliary cholangitis
(Previously known as primary biliary
SEC (Oncology & Haematology) made in its 107th meeting held on 10.03.2021 & 11.03.2021 at
CDSCO HQ New Delhi
 cirrhosis (PBC)) and as an adjuvant to
chemotherapy in solid hepatic tumour”.
After detailed deliberation the committee
opined that the firm should first conduct
dose finding study in patients with hepatic
disease indications. Accordingly, firm
should submit revised Phase II Clinical trial
protocol.
Further, the proposal may be deliberated in
the SEC Hepatology for approval of the
protocol and firm may present a separate
protocol for oncology indication in the later
phase of the clinical trial.

GCT Division
CT/14/19 M/s. PPD Firm presented the proposed protocol
amendment before the committee.
Online Submission
(9768) After detailed deliberation the committee
15.
recommended for approval of the proposed
SB12 protocol amendment 4 (version5.0) dated
21Aug 20

CT/28/19 M/s. In light of earlier SEC recommendation dated

AstraZeneca 09.02.2021 &10.02.2021, the firm presented
Online Submission their justification for proposed protocol
(10704) amendment before the committee.
16. After detailed deliberation the committee
Osimertinib recommended for approval of the proposed
protocol amendment version5.0 dated 30
October 20.
CT/16/21 M/s. Sanofi Firm presented the proposal before the
committee.
Online Submission
After detailed deliberation, the committee
(23834)
17. opined that the firm is required to submit the
details of phase 1 and phase 2 data as per the
Amcenetrant+
NDCT-Rules-2019 for further review by the
Palbociclib committee.

18. CT/17/21 M/s. Novartis Applicant presented their proposal along

with study protocol for phase IV clinical
Online Submission study before the committee.
(23897)
Assessment of risk versus benefit to the
Ruxolitinib patients- The safety profile of the study
drug from various preclinical toxicology
studies and clinical studies justify the

SEC (Oncology & Haematology) made in its 107th meeting held on 10.03.2021 & 11.03.2021 at
CDSCO HQ New Delhi
 conduct of the trial.

Innovation vis-a-vis existing therapeutic-

T o evaluate long term safety data i.e. SAEs
and AEs

Unmet medical need in the country- The

Phase IV rollover protocol for patients who
have completed a prior global Novartis or
Incyte sponsored ruxolitinib (INC424)
study or ruxolitinib and panobinostat
(LBH589) combination study, and are
judged by the investigator to benefit from
continued treatment.

After detailed deliberation, the committee

recommended for grant of permission to
conduct the study.

CT/21/21 M/s. CBCC Firm presented the Phase II clinical trial

Global proposal before the committee.
Online Submission Research Assessment of risk versus benefit to the
(24130) patients-The safety profile of the study
OQL011 drug from preclinical and clinical studies
justify the conduct of the trial.

Innovation vis-a-vis existing therapeutic-

To evaluate the safety and efficacy of
OQl011 on VEGFR inhibitor-associated
hand-foot skin reaction in cancer patients.
Unmet medical need in the country- The
19. test drug used for treatment with hand-foot
skin reaction in cancer patients.
After detailed deliberation, the committee
recommended for the grant of permission to
conduct the Phase II clinical trial study
subject to following conditions:
1) Firm is required to submit Part –I data
before the committee for review prior to
initiation of Part –II of the study.
2) The protocol needs to be amended to
include a separate analysis for the subjects
where the VEGFR anticancer drug product
needs to be stopped or discontinued.

20. CT/23/21 M/s. Firm presented the Phase III clinical trial
proposal before the committee.
SEC (Oncology & Haematology) made in its 107th meeting held on 10.03.2021 & 11.03.2021 at
CDSCO HQ New Delhi
 Online Submission AstraZeneca Assessment of risk versus Benefit to the
(24207) patient: The safety profile of the drug from
pre-clinical toxicological studies and
Trastuzumab clinical phase I & II studies, may justify the
Deruxtecan conduct of the study.

Innovation vis –a- vis exiting therapeutic:

The primary objective of the study is to
assess the efficacy of T-DXd ± pertuzumab
compared with THP in terms of PFS
according to BICR

Unmet Medical need in the country: The

test drug may be an alternative treatment
option in patients with HER2-positive,
First-line Metastatic Breast Cancer.

After detailed deliberation, the committee

recommended for grant of permission to
conduct the study.

CT/07/19 Online M/s Paraxel Firm presented the proposed protocol

submission (10445) amendment before the committee.

21. Rituximab After detailed deliberation the committee

recommended for proposed protocol
amendment 4 dated 04 Nov 2020.

SEC (Oncology & Haematology) made in its 107th meeting held on 10.03.2021 & 11.03.2021 at
CDSCO HQ New Delhi