Recommendation:-

The 24th SEC (Endocrinology) meeting deliberated the proposals on 22-03-2016 and recommended the following:-

Agend File Name &Drug Firm Name Recommendations a name, Strength No New Drug Division 1 12-65/13-DC(Pt-E) M/s. Glenmark The proposal is withdrawn voluntarily Phase-IV Pharmaceutical as the proposal for the conduct of clinical trial s Ltd. Teneligliptin Phase-IV clinical trial is not mandatory. 2 12-47/14-DC (Pt-B) M/s. Lupin The firm has applied for grant of Anagliptin permission to conduct a Phase-III clinical trial of Anagliptin in Type-2 Diabetes Mellitus patients. The firm presented the protocol.

The Committee deliberated in detail the protocol. The committee observed that the protocol was grossly inadequate and not properly designed. Therefore the committee recommended to amend the protocol and resubmit the same for consideration. Subsequent New Drug Division 3 12-113/2015-DC M/s IPCA The firm has applied for grant of Hydroxychloroquine permission to conduct a Phase-III 200,300,400mg clinical trial for Hydroxychloroquine 200, 300, 400mg titled as “Efficacy and safety of Hydroxychloroquine in the treatment of Mellitus: A double Blind, Randomized comparison with ” The committee deliberated in detail and recommended for grant of approval for conduct of the trial subject to following amendments 1. Patients who are drug naive and/ or who are treated with more than 1000 mg for three months shall be recruited in the trial. Patients who are drug naive should be given a run in period of Metformin 1000 mg/day for 12 weeks. 2. The Limits of Hb1AC should be revised to 7 to 10

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Agend File Name &Drug Firm Name Recommendations a name, Strength No 3. Withdrawal and rescue criteria should be clearly specified. Accordingly revised protocol should be submitted to the office of DCGI for approval. FDC Division Proposal 4 4-100/2008-DC(Part-I) M/s Novartis The committee recommended the +Metformi Health care proposed study with following n Hcl conditions: 1. Patients with HbA1c >8% shall be enrolled. 2. Minimum 50% sites shall be from Government Institutes. 3. The patients who are already on this combination for minimum 8 weeks shall only be enrolled in the study. 4. All serious adverse events shall be reported as per Drugs & Cosmetics Act. 5. Expenses for all the investigations during the study shall be borne by the company and investigations should be done from an accredited laboratory. 6. Report of the study shall be produced before the committee. Biological Division Proposal 5 4-152/Sandor/PAC-R- M/s Sandor The firm has presented the changes Thyrotropin alfa/14 BD made in the package insert of the Thyrotropin alfa Thyrotropin alfa, after deliberation the committee recommended for the proposed changes in the package insert. 6 4-251/Wockhardt/16- M/s The firm has presented the protocol of BD Wosulin 200 Wockhardt the proposed study, after deliberation the committee recommended the protocol for the conduct of PK/PD study. 7 04-32/Sanofi/PAC-R- M/s. Sanofi After detailed deliberation the glargine-16BD committee opined that proposed 300 product falls under the definition of U/mL new drug. The company has shown the clinical trial results of said product in USA where they have shown different PK/PD properties of this drug as compared to Glargine 100 U/ml. The firm has not done any clinical trial (efficacy and safety studies) in Indian

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Agend File Name &Drug Firm Name Recommendations a name, Strength No population. Therefore the committee recommended for the conduct of local clinical trials for consideration for the grant of Marketing Authorization of the product. GCT Division Proposal 8 CT/49/15 M/s Novo Risk vs Benefit to the patients: In light Insulin Nordisk of the fact that the test drugs are already Degludec/ approved and marketed in India, justify the conduct of the study. Innovation vis a vis against existing therapy : The purpose of the study is to compare the long term glycaemic control of /liraglutide (IDegLira) versus insulin glargine therapy in subjects with type 2 diabetes mellitus. Unmet need- The test may provide alternate treatment option for insulin naïve subjects with T2DM inadequately controlled with oral antidiabetic drugs.

After detailed deliberation the committee recommended the conduct of the study with the following condition 1. The doses of any OADs to be used during the trial needs to be clearly defined. Accordingly India specific Annexure to the protocol must be submitted to CDSCO. (Dr. Rajesh Rajput did not take part in decision making) 9 CT/55/15 M/s Novo CT/55/15 BIASP-30 Nordisk Risk vs Benefit to the patients: In light of the fact that the test drug is already approved and marketed in India, justify the conduct of the study. Innovation vis a vis against existing therapy : The purpose of the study is to compare efficacy and safety of thrice daily versus twice daily NovoMix® 30 (Biphasic 30) in subjects with type 2 diabetes inadequately controlled with basal insulin. Unmet need- More safety data will be generated from this study.

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Agend File Name &Drug Firm Name Recommendations a name, Strength No After detailed deliberation the committee recommended the conduct of the trial with the condition that the ICF should be able to take three meals during the trial and any exception should be excluded from the trial. Subject with impaired Kidney function should be excluded from the study as subjects should be receiving OADs. 10 CT/56/15 M/s Novo After detailed deliberation the Nordisk committee noted that there is no justification for dose escalation irrespective of glycemic control. It should be based on glycemic target rather than fixed dose escalation. Subjects with fasting glucose level more than 270mg/dl at the time of randomization should be excluded from the study. Hence the committee did not recommend the conduct of the study in its presented form. ( Dr. Rajesh Rajput did not take part in decision making)

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