Recommendation:- The 25th SEC (Endocrinology) meeting deliberated the proposals on 05-04-2016 and recommended the following:-

Agend File Name &Drug Firm Name Recommendations a name, Strength No Subsequent New Drug Division 1 12-15/2016-DC (pt-Zim- M/s Zim The proposal was deliberated and SND) Laboratory committee did not recommend the Orally waiver. Disintegrating Strips 0.2mg, 0.3mg FDC Division Proposal 2 4-27/2012-DC(Pt.Intas) M/s Intas The FDC of Glimepiride Pharmaceuticals IP+ HCl IP (In sustained IP+Metformin HCl IP (In release form) 0.5mg+1000mg is not sustained release form) recommended because of following 0.5mg+1000mg reasons 1. The dose of Metformin has to be uptitrated before considering addition of another drug. 2. The dose of Glimepiride that is 0.5 mg has not been studied adequately as compared to placebo regarding its effects ion Glycemic control in patient not achieving target HbA1c on Metformin therapy alone. 3 04-13/2016-DC M/s Glenmark The combination of Teneligliptin Teneligliptin Pharmaceuticals Hydrobromide Hydrate eq. to Hydrobromide Hydrate Teneligliptin+Glimepiride IP eq. to 20mg+1mg/2mg is not Teneligliptin+Glimepiride recommended for the following IP reasons: 20mg+1mg/2mg 1. There is no recommendation to add two drugs simultaneously as second line .There is a sequential approach that first line and second line drugs should be given in full dosage before adding the third drugs. 2. There is little justification supported with adequately powered studies to support the rationale of combining two secretogogue in

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Agend File Name &Drug Firm Name Recommendations a name, Strength No patients in sub therapeutic dosage. Also if such drugs are given in combination in untitrated manner may increase the chances of hypoglyceamia. 3. The proposed FDC is not approved anywhere in the world. GCT Division Proposal 4 CT/57/15 M/s Novo After detailed deliberation the Nordisk Committee did not recommend the conduct of the study for the following reasons: 1. The inclusion and exclusion criteria’s are not strictly defined and are solely left to the discretion of Investigators, though every OAD which is available in the Country is permissible in one of the arms. 2. During the trial safety and monitoring of the patients for any adverse events related to various drugs used during the trial had not been defined and this may cause safety concerns. 3. The design and outcome of this trial protocol is unlikely to add any significant new knowledge to the existing information. 5 CT/64/15 M/s Novo Assessment of Risk vs. Benefit to NNC0195-0092 Nordisk the patients: The safety profile of the study drug from preclinical pharmacology, repeat dose toxicity, genotoxicity, reproductive toxicity and two phase I clinical studies justify the conduct of the trial.

Innovation vis-à-vis Existing Therapeutic Option: The purpose of the study is to evaluate the efficacy of multiple dose regimen of once

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Agend File Name &Drug Firm Name Recommendations a name, Strength No weekly NNC0195-0092 after 26 weeks of treatment in growth hormone treatment naïve pre- pubertal children with growth hormone deficiency compared to once daily growth hormone administration (Norditropin® FlexPro®). Unmet Medical Need in the country: The test drug may provide alternate treatment option in children with growth hormone deficiency.

After detailed deliberation the committee recommended the conduct of the study with the following conditions- 1. High dose of glucocorticoids in children should be defined. (Dr. Rajesh Khadgawat did not participate in deliberation and decision making)

6 CT/38/15 M/s Novo Assessment of Risk vs. Benefit to Fast Acting N`ordisk the patients: In light of the fact that the Fast Acting Insulin Aspart is already approved and marketed in India, the safety profiles of the test drugs justify the conduct of the trial.

Innovation vis-à-vis Existing Therapeutic Option: The purpose of the study is to confirm efficacy in terms of glycaemic control of

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Agend File Name &Drug Firm Name Recommendations a name, Strength No treatment with mealtime faster- acting insulin aspart in combination with in adults with type 1 diabetes mellitus. . Unmet Medical Need in the country: The test drug may provide better treatment option in subjects with type 1 diabetes. After detailed deliberation the Committee now recommended the conduct of the study with the revised protocol. (Protocol Amendment no. 01 Version 4). (Dr. Rajesh Rajput did not participate in deliberation and decision making).

7 CT/05/16 M/s Novo The firm did not want to present the Fast Acting Insulin Aspart Nordisk protocol at this time. Biological Division Proposal 8 65/PMS/Elilly/16-BD M/s Eli lilly After detailed deliberation the India pvt Ltd committee recommended to carry out the study with following modifications: 1. At the time of screening, HbA1C should not be more than 10 %. 2. 50 % of the participating centers should be from Govt. sector.

9 4-22/Eli Lilly/PAC-R- M/s Eli lilly After detailed deliberation the Insulin/15BD India pvt Ltd committee recommended the waiver for Phase IV study as company produced comparability data for the detailed justification along with scientific data from the proposed site of manufacturing facility from France to Italy.

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Agend File Name &Drug Firm Name Recommendations a name, Strength No 10 4-24/Merck/PAC-R- M/s Merck After detailed deliberation the Somatropin/16BD committee observed that update on Somatropin Prescribing Information especially on association of pancreatitis and somatropin is not supported by adequate supportive literature (In Section Special warnings and special precautions for use). Committee suggested that the detailed supportive literature of experience of development of pancreatitis with use of somatropin in adult patients with HIV should be provided. The two other updations were approved. 11 29/Misc/03/2016-DC Mr. V.I. The committee deliberated on the Insulin Santhanam subject and two members were in favour of the uniformity suggested by the applicant and if technically and legally feasible it should be implemented. One of the members is of the opinion that it is beyond the preview of this expert committee to give any suggestion because technical integrity is involved in manufacture of different pens/patents involved in these drugs are not exactly known to the concerned persons. So it has to be explode before the final conclusion.

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