Recommendations of the SEC (Endocrinology & Metabolism)

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Recommendations of the SEC (Endocrinology & Metabolism) made in its 62nd meeting held on 19.12.2019 at CDSCO HQ New Delhi:

S.No File Name & Drug Firm Name Recommendations Name, Strength New Drugs Division

The applicant presented the proposal for Clinical Trial. The Committee observed that there are many deficiencies in the protocol in respect of inclusion/exclusion Dr. R. criteria, assessment criteria, Karthikeyan, discontinuation and withdrawal Shanmuga criteria etc. Also the Committee noted 12-01/18-DC (Pt.-387) Medical 1 that this is a multi centric trial and the Teneligliptin Research protocol does not address the safety Foundation issues of the patients during the trials Trust, Salem, at different centers and approval of Tamilnadu Ethics Committee from only one center is submitted. Therefore the committee did not recommend approval of the trial in its present form. The firm presented their proposal to update the prescribing information of 12-01/18-DC (Pt-07) PU- Linagliptin tablets 5 mg. M/s. Boehringer 2 015 After detailed deliberation, the Ingelheim Linagliptin tablets 5 mg committee recommended for approval to update the prescribing information as presented by the firm. Biological Division In light of the earlier SEC recommendation dated 24.10.2019, firm presented the results of Phase 1 and Phase 1b/2a trials. BIO/Form44/FF/2019/143 M/s. Accutest After detailed deliberation, the 71 Research committee recommended for grant of 3 Long lasting recombinant Laboratories permission for conduct of the PK/PD growth hormone Pvt. Ltd. study as per the proposed protocol subject to condition the principal investigator of the study should be minimum MD (Pharmacology) / MD (Internal Medicine) or equivalent. In light of the earlier SEC recommendation dated 20.11.2019, the firm presented the protocol for BIO/Form44/FF/2019/140 single and multiple dose PK study of M/s. Levim 4 31 Liraglutide 0.6 mg in healthy Biotech LLP Liraglutide volunteers. After detailed deliberation, the committee recommended for grant of permission for conduct of the PK

62nd SEC (Endocrinology & Metabolism) 19.12.2019 S.No File Name & Drug Firm Name Recommendations Name, Strength study with Liraglutide 0.6mg as per the proposed protocol. SND Division In light of the recommendation of the SEC meeting held on 24.10.2019 firm SND/CT/19/000037 presented the revised Phase III clinical Hydroxychloroquine in trial protocol. type 2 Diabetes patients M/s IPCA After detailed deliberation the 5 uncontrolled on Laboratories committee recommended for grant of Metformin and permission to conduct the trial subject Sulfonylurea combination to condition that the firm should ensure recording of photographs of fundus examination of all the subjects. The firm presented updated package SND/IMP/19/000029 M/s Astra insert in-line with the EU-SmPC. Dapagliflozin film-coated 6 Zeneca Pharma After detailed deliberation the tablets 5mg and 10mg Ltd committee recommended for approval (Updates package insert) of the updated package insert. SND/MA/19/000114 The firm didn’t turn up for the Vildagliptin Extended presentation. 7 Release Tablets 100 mg M/S Abbott as additional dosage form (Modified Release) The firm presented the proposal for PK/PD study along with protocol. After detailed deliberation the committee recommended for the grant of permission to conduct the study subject to following conditions: 1. The assessment of DPP-IV SND/CT/19/000055 M/s. Genmark inhibition should be carried 8 Teneligliptin Pharmaceuticals out by LC-MS/MS method. Hydrobromide 10 mg Limited 2. The principal investigator of the study should be minimum MD (Pharmacology) / MD (Internal Medicine) or equivalent. Accordingly, the firm should submit the revised protocol to DCGI for approval. FDC Division FDC/MA/19/000040 M/s. Dr. The firm presented the results of BE Gliclazide IP (as Reddy’s Study before the committee. After extended release form) + Laboratories detailed deliberation, the committee 9 Metformin HCl IP (as Ltd. recommended for grant of permission extended release form) for manufacturing and marketing of (60mg + 1000mg) the FDC. uncoated bilayer tablet 4-27/2012-DC (Pt. Sun) M/s. Sun Firm presented their Phase- IV 10 Voglibose IP Pharma Clinical trial Protocol before the

62nd SEC (Endocrinology & Metabolism) 19.12.2019 S.No File Name & Drug Firm Name Recommendations Name, Strength 0.2mg/0.2mg/0.3mg/0.3m Laboratories committee. After detailed g+Glimipiride IP deliberation, the committee 1mg/2mg/1mg/2mg+Metf recommended for grant of permission ormin Hydrochloride (SR) to manufacture and market the 500mg/500mg/500mg/50 proposed FDC and also to conduct the 0mg uncoated bilayered Phase-IV study and results of the tablets phase IV study should be submitted within one year for review by the committee. FDC/MA/19/000151 M/s. Glenmark The firm presented the proposal for Remogliflozin etabonate Pharmaceutical Phase III Clinical trial of the FDC 100mg + Teneligliptin Ltd. based on PK/PD Study of Hydrobromide 10mg Teneligliptin HBr 10mg BD to be Tablets conducted. After detailed deliberation the committee recommended that the firm 11 should conduct and submit the results of PK/PD study of Teneligliptin 10mg BD along with plan for PK assessment of Teneligliptin in its proposed FDC with Remogliflozin and the Phase III Clinical Trial Protocol. GCT Division CT/73/19 M/s. ClinSync The firm presented the proposal for 5-ALA Hcl/SFC Phase 2a Clinical trial of 5- aminolevulinic acid hydrochloride co- administered with Sodium Ferrous Citrate (5-ALA HCl/SFC) in the treatment of adult type 2 diabetes mellitus patients. After detailed deliberation the committee recommended for grant of permission subject to condition that the protocol should be revised as under: 1. Only newly diagnosed type 2 12 diabetic patients or patients with duration of diabetics with less than six months should be included in the study. Accordingly, inclusion exclusion criteria should be modified. 2. Subjects with uncontrolled hypertension should not be included. 3. The investigator should be minimum MD Medicine or equivalent. 4. The guidelines and facility for

62nd SEC (Endocrinology & Metabolism) 19.12.2019 S.No File Name & Drug Firm Name Recommendations Name, Strength management of hypoglycemia should be ensured at all the trial sites. Accordingly, the firm should submit the revised protocol to CDSCO for approval.

62nd SEC (Endocrinology & Metabolism) 19.12.2019