Recommendations of the SEC (Endocrinology & Metabolism) made in its 55thmeeting held on 21.05.2019 at CDSCO HQ New Delhi: Agenda File Name & Drug Name, Firm Name Recommendations No Strength Introductory Remarks FDC Division 1. 4-27/2012-DC (Pt. Sun) M/s. Sun In light of recommendation of the Voglibose IP Pharma Committee dated 29.11.2018, the firm 0.2mg/0.2mg/0.3mg/0.3mg+ Laboratories presented their justification as follows: Glimipiride IP 1) The firm has conducted the 1mg/2mg/1mg/2mg+Metfor clinical trial as per the approved min Hydrochloride (SR) protocol. 500mg/500mg/500mg/500m 2) Comparative arms of the study g uncoated bilayered tablets protocol were not comparable in terms of dosage of Metformin. Therefore, the outcome of study was non-inferior. 3) The same combination is already marketed in the country by various firms. 4) Prof. Kokate Committee had earlier examined this FDC for other firms and classified the said FDC as category “D” recommending for conducting Phase IV clinical trial. After detailed deliberation the Committee recommended that the firm should conduct Phase IV clinical trial for which protocol should be submitted for review of their application for manufacturing permission of the product. 2. 4-56/2018-DC M/s. In light of the earlier recommendations Teneligliptin Hydrobromide Synokem of the committee dated 19.02.2019, the Hydrate eq. to Teneligliptin firm presented the raw data. The 20mg/20mg + Pioglitazone committee noted that there is a gross Hydrchloride eq. to inconsistency in the laboratory results of Pioglitazone 15mg/30mg patient no. 1 compromising the reliability film coated tablets of the data of the study. Therefore the committee recommended to repeat the bioequivalence study with the already approved protocol. 3. FDC/MA/19/000021 M/ s Stanfod The firm made a detailed presentation Pyridoxine HCL+Myo- Laboratories before the committee. The committee Ionositol+ChromiumPolynic noted that there is no scientific evidence otinate+Folicacid+Benfotiam for this FDC for the proposed ine(3mg+100mg+200mg+1.5 indications. Hence the committee didn’t 00mg+200mg+1500mcg)Tab recommend for approval. lets 55thSEC (Endocrinology &Metabolism) _21.05.2019 Agenda File Name & Drug Name, Firm Name Recommendations No Strength GCT Division 4. CT/64/15 Novo The firm presented their proposal for NNC0195-0092 Nordisk protocol amendment including long term extension trial. After detailed deliberation, the committee recommended for approval of the protocol amendment. 5. CT/09/19 M/s Sanofi In light of recommendation of the SAR341402 Mix 70/30 to committee dated 19.03.2019, the firm Novo Mix @30 presented their justification for waiver of PK/PD study & upper age limit of 65 years in the proposed clinical trial. The committee after detailed deliberation reiterated its earlier recommendation that PK/PD study should be conducted in Indian subjects as part of the trial. The committee however recommended for relaxation of upper age limit of 65 years subject to condition that the firm should ensure stringent monitoring of such subjects in the trial. The committee recommended for grant of permission to conduct the trial with above conditions. Dr. Rajesh Rajput and Dr. Deepak Khandelwal did not participated in the deliberation. 6. IQVIA-RDS Applicant presented their proposal for CT/26/19 Phase IV clinical trial along with study Insulin Glargine protocol before the committee. After detailed deliberation the committee recommended for grant of permission to conduct the study subject to following conditions: 1. The study should be conducted with 300 subjects from India. 2. The PI at each site should have minimum qualification MD (Medicine)/DNB (Medicine). 3. The cost of study drugs, investigations & other expenses in the trial should be borne by the sponsor/applicant. BABE Division 7. Firm presented the BE study protocol 12-09/2019/BA-BE/Misc- M/s. before the committee for export purpose. 23/DC Aurobindo After detailed deliberation, committee Hydrocortisone Modified Pharma recommended for conducting the Release Tablets 5mg proposed study with the condition that 55thSEC (Endocrinology &Metabolism) _21.05.2019 Agenda File Name & Drug Name, Firm Name Recommendations No Strength the PI should be MD (Pharmacology)/MD(Medicine). 8. Firm presented the BE study protocol before the committee for export purpose. 12-09/2019/BA-BE/Misc- M/s. After detailed deliberation, committee 24/DC Aurobindo recommended for conducting the Hydrocortisone Modified Pharma proposed study with the condition that Release Tablets 20mg the PI should be MD (Pharmacology)/MD(Medicine). Biological Division 9. The firm presented their proposal to update the package insert. After detailed 4-72/Novo Nordisk/PAC-R- Novo deliberation, committee recommended XULTOPHY/17-BD Nordisk that the firm should add the relevant information presented before the committee, under clinical section of Xultophy. 10. The firm presented their PMS protocol before the committee. However, the committee noted that the firm was accorded marketing authorization with a Novo 2/Phase IV/NovoNordisk/19- condition to conduct Phase IV study. Nordisk BD After detailed deliberation, committee recommended that the firm should revise the protocol for Phase IV clinical trial and submit the same for review within next 3 months. 55thSEC (Endocrinology &Metabolism) _21.05.2019 .