Recommendations of the SEC (Endocrinology & Metabolism) made in its 40thmeeting held on 09.11.2017 at CDSCO HQ New Delhi: Age File no./Drug Name Name of firm/ Recommendations nda Institute no. Subsequent New Drugs Division 1 12-116/2017-DC (Pt- Firm didn’t turn up for the presentation. Zydus-snd) M/s.Zydus Teneligliptin tablet 40mg add strength Biological Division 2 4- M/s.BioGenomi The firm presented the pre-clinical data and 438/BioGenomics/17 cs Ltd. Phase I PK/PD data generated in healthy BD volunteers. Recombinant insulin After detailed deliberation committee aspart observed that the request of the firm for Phase III clinical trial waiver cannot be considered. The committee recommended that the firm should submit Phase III clinical trial protocol for review. 3 4-42/Biocon/PAC-R- M/s. Biocon The firm presented their proposal for Insulin Glargine/17- Limited. approval for extension of age group in the BD already approved indication to “2 years and Insulin Glargine above” from “6 years and above”. After detailed deliberation, the committee recommended for approval of the proposed change. 4 4-436/Novo M/s. Novo The firm was not in position to present their Nordisk/17BD Nordisk India proposal so the case was deferred. Fast acting insulin Pvt. Ltd aspart 5 4- M/s. Novo The firm presented the supportive data 83/NovoNordisk/PAC Nordisk India including clinical data for the proposed -R-Liraglutide/17-BD Pvt. Ltd. expansion of the indication. Liraglutide Injection The committee after detailed deliberation, recommended that the indication may be expanded as follows: “To reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease”. 6 4-76/Novo M/s. Novo The firm presented the supportive data for Nordisk/PAC-R- Nordisk India updating the package insert. Insulin Degludec/17- Pvt. Ltd. After detailed deliberation, the committee BD recommended for approval of the proposed Insulin Degludec update in the package insert. (Tresiba) 40thSEC (Endocrinology & Metabolism)_09.11.2017 .