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Recommendations of the SEC (Endocrinology & Metabolism) Made in Its 66Th Meeting Held on 01.07.2020 at CDSCO HQ New Delhi: S

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Recommendations of the SEC (Endocrinology & Metabolism) Made in Its 66Th Meeting Held on 01.07.2020 at CDSCO HQ New Delhi: S Recommendations of the SEC (Endocrinology & Metabolism) made in its 66th meeting held on 01.07.2020 at CDSCO HQ New Delhi: S.No File Name & Drug Name, Firm Name Recommendations Strength Subsequent Drugs Division SND/MA/18/000062 M/s Akums The firm did not turn up for meeting 1. Vitamin D3 (Cholecalciferol) 800IU/ml Drops SND/MA/19/000084 M/s Glenmark Pharma The firm presented the proposal for Remogliflozin Etabonate Phase III clinical trial along with BE Tablets 50 mg study waiver. After detailed deliberation the committee recommended for grant of permission to conduct the Phase III clinical trial with the condition that:- 1. Duration of the study should be for atleast 24 weeks 2. 2. Exclusion criteria should be clearly defined to exclude patients with Severe hepatic insufficiency 3. Sponsor should provide centrally calibrated weighing balance to all the trial sites. Accordingly, the firm should submit the revised Phase III clinical trial protocol to CDSCO for permission. SND/MA/20/000108 M/s Macleods Pharma The firm presented the proposal Thyroxine Sodium tablets along with justification for the 112 mcg waiver of BE and CT study. Justification for BE waiver was presented with proportional similarity of formulation and BE study report of Thyroxine sodium tablet of 300 mcg. 3. Thyroxine Sodium tablets 112 mcg is already approved in US and EU. After detailed deliberation the committee recommended for grant of permission to manufacture and market additional strength of Thyroxine Sodium tablets 112 mcg Biological Division Firm presented the protocol of Phase I (PK-PD) clinical trial before the BIO/CT04/FF/2019/17976 committee. M/s M.J.Biopharm Pvt. 4. Insulin Glargine Injection After detailed deliberation the Ltd 100IU/ml committee recommended for grant of permission to conduct the Phase I clinical trial. 66th SEC (Endocrinology & Metabolism) 01.07.2020 S.No File Name & Drug Name, Firm Name Recommendations Strength In-light of the recommendations of the SEC meeting held on 20.02.2020, firm presented their revised protocol BIO/IMP/19/000090 for Phase I (PK-PD) clinical trial M/s Stelis Biopharma 5. Insulin Glargine Injection before the committee. Private Limited 100IU/mL After detailed deliberation, the committee recommended for grant of permission to conduct the Phase I (PK-PD) clinical trial. Firm presented the protocol of Phase I (PK-PD) clinical trial before the committee. BIO/CT04/FF/2020/18792 6. M/s BioGenomics Ltd. After detailed deliberation, the lnsulin Glargine 100 U/mL committee recommended for grant of permission to conduct the Phase I (PK-PD) clinical trial. Firm presented the protocol of Phase I (PK-PD) clinical trial before the BIO/CT04/FF/2020/18793 committee. 7. lnsulinAspart Mix 30; 100 M/s BioGenomics Ltd. After detailed deliberation, the U/mL committee recommended for grant of permission to conduct the Phase I (PK-PD) clinical trial. FDC Division FDC/IMP/18/000012 M/s. Astra Zeneca The firm presented the Phase IV CT Saxagliptin protocol. After detailed deliberation, 5mg+Dapagliflozin 10mg the committee opined as under: tablets 1. The proposed sample size of 110 patients is not justified 2. Inclusion and Exclusion criteria shall be modified to 8. make these more objective. The committee recommended that the firm should revise the protocol accordingly and submit the same within 01 month for review by the committee. FDC/MA/19/000041 M/s.Reddy’s Laboratories The firm presented their proposal Vildagliptin + Metformin Ltd. with Phase III CT waiver. After Hydrochloride IP detailed deliberation, the committee (50mg/50mg + 500/1000mg) reiterated its previous sustained release tablet recommendation dated 23.01.2020 and did not agree for Phase III CT 9. waiver. However, the committee opined that if the firm revises the proposed indication in line with the already approved indication for the FDC, the committee may re-examine the same. 66th SEC (Endocrinology & Metabolism) 01.07.2020 S.No File Name & Drug Name, Firm Name Recommendations Strength FDC/MA/20/000059 M/s.Pure& Cure The firm presented their proposal Metformin Hydrochloride Healthcare along with the BE study protocol. (As Sustained Release) After detailed deliberation, 1000mg +Gliclazide 80mg committee recommended for grant of tablets permission to conduct the proposed 10. BE study. The results of Bioequivalence study should be presented before the committee for further consideration including the requirement of conducting clinical trial. GCT Division CT/12/20 M/s Parexel The firm did not turn up for meeting 11. Relamorelin 66th SEC (Endocrinology & Metabolism) 01.07.2020 66th SEC (Endocrinology & Metabolism) 01.07.2020 .
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