Recommendations of the SEC (Reproductive & ) made in its 60th meeting held on 25.06.2021 & 28.06.2021 at CDSCO HQ New Delhi:

Agenda File Name & Drug Firm Name Recommendations No Name, Strength New Drugs Division 1. The firm presented their proposal along with Phase III CT protocol and BE report before the committee.

ND/MA/21/000061 MSN Laboratories The committee after detailed deliberation recommended that the Fumarate tab Pvt. Ltd. protocol needs to be revised, to compare the test drug with an active comparator of the same class, and submitted for review by the committee.

2. Translational health The applicant has submitted 12-01/21-DC(Pt-85) Science & Technology clarification on 24.06.2021 regarding and the academic clinical trial. Hence not taken up.

Biological Division 3. File No: M/s Bharat Serum and The firm presented their Phase IV BIO/CT/21/000039 vaccine Ltd., Mumbai clinical trial protocol before the 25.03.2021 committee. After detailed deliberation the phase-IV study of committee recommended for grant of recombinant Anti- Rho D permission to conduct the phase –IV formulation clinical trial subject to the condition that number of subjects should be NLT 300.

SND Division 4. SND/MA/21/000034- M/s Akums The firm didn’t turn up for Letrozole Tablets 5 mg presentation.

5. 12-14/20201-DC (Pt- M/s Synokem In light of suspension of Misc-SND) Ulipristal manufacturing of the drug and order of Acetate 5 mg the Hon’ble High Court of Delhi dated 22.02.2021, the firm presented their points on Ulipristal tablets 5mg along with the decision of EMA dated 11.01.2021. After detailed deliberation committee

60th SEC (Reproductive & Urology), Dated _25.06.2021 & 28.06.2021

Agenda File Name & Drug Firm Name Recommendations No Name, Strength recommended that the firm should submit PMS data of their product since firm has already marketed the product in the country. 6. Testosterone Gel 1.62% M/s Besins Health The firm didn’t turn up for w/v (Pump Pack presentation. Containing 1.62 % w/w testosterone

7. SND/CT/21/000015- M/s Sun Pharma The firm presented the Phase IV Dienogest Tablets 2 mg clinical trial protocol before the committee for approval. The committee noted that there has been considerable delay in conducting the Phase IV clinical trial. After detailed deliberation the committee recommended for grant of permission for conduct of Phase IV clinical trial as per the protocol presented, subject to condition that the firm should submit the Phase IV clinical trial report within 9 months of approval by enrolling more study centres. 8. SND/MA/19/000155- M/s Swati Spentose In light of recommendations of the earlier meeting held on 30.01.2020, the sodium 10 mg/ml Sterile firm presented the animal toxicity study data and clarification regarding Solution for Intravesical the withdrawal of the product from EU Instillation along with supporting documents. After detailed deliberation the committee recommended for grant of permission for manufacturing and marketing of Pentosan Polysulfate sodium 10 mg/ml Sterile Solution for Intravesical Instillation indicated for intravesical treatment of the bladder pain syndrome/ subject to condition that the firm should conduct the active PMS study. The firm should also present the PMS data for review by the committee. 9. SND/MA/21/000127- M/s Akums The firm presented their proposal of Medroxyprogesterone manufacturing and marketing of Acetate Sustained Release Medroxyprogesterone Acetate

60th SEC (Reproductive & Urology), Dated _25.06.2021 & 28.06.2021

Agenda File Name & Drug Firm Name Recommendations No Name, Strength (SR) Tablet 30mg Sustained Release (SR) Tablet 30mg along with the protocol for BE study and clinical trial.

After detailed deliberation the committee recommended for grant of permission to conduct the BE study. The committee also recommended for grant of permission to conduct the clinical trial subject to following conditions:

1. Patients testing positive for COVID-19 shall be excluded from the study.

2. Patients who do not adequately respond to the test product and those not responding to the rescue shall be excluded.

3. The clinical trial should be initiated only after the submission of BE study reports.

Accordingly, revised CT protocol along with BE report should be submitted to CDSCO.

GCT Division 10. CT/25/21 Ibuprofen & M/s CBCC Global The firm presented their proposed 400 mg+37.5 mg research phase III study protocol no.:FMLD- solution for infusion FEBETRADI2-44_FIII Version 1.0, 100ml dated 09Feb2021 before the committee. After detailed deliberation the committee asked the firm to present the proposal with detailed justification and rational for development for the proposed FDC with supportive 60th SEC (Reproductive & Urology), Dated _25.06.2021 & 28.06.2021

Agenda File Name & Drug Firm Name Recommendations No Name, Strength literature. The firm should also present data of other studies of the proposed FDC’s conducted on other countries with complete data.

FDC Division 11. FDC/IMP/20/000045- M/s. Abbott The firm presented the trial data with Dydrogesterone + respect to Asian population as per the Estradiol (2.5 mg + recommendation of earlier SEC held on 23.09.2020. 0.5mg) tablets After detailed deliberation the committee considered Phase III CT waiver and recommended for grant of permission for import and market of the subject FDC subject to the condition that the firm should submit the Phase IV clinical trial protocol within 3 months of approval of the FDC. 12. FDC/MA/21/000087- M/s. Ajanta Pharma The firm presented their proposal Each 5 gram contains: Ltd. before the committee. Sildenafil Citrate IP Eq. to After detailed deliberation, committee recommended for grant of permission Sildenafil 100mg + for conduct of the proposed BE study. Hydrochloride The firm should submit BE report & eq. to Dapoxetine 60mg present the same before the committee Oral Jelly for further consideration.

13. FDC/MA/21/000112- M/s Pure& Cure The firm presented their proposal Succinate I.P. Healthcare Pvt. Ltd. before the committee. 5mg/5mg, After detailed deliberation, committee noted the following that:- Extended 1. Both the individual ingredients Release25mg/50mg proposed in the combikit is Combikit already approved as FDC. 2. Combikit was not considered for approval earlier also by the SEC for another firm. 3. Individual drugs are already approved 4. The firm could not present any justification for the proposed combikit.

60th SEC (Reproductive & Urology), Dated _25.06.2021 & 28.06.2021

Agenda File Name & Drug Firm Name Recommendations No Name, Strength Hence, Committee did not recommend for approval of the proposed combikit.

14. FDC/MA/21/000119- M/s MSN Laboratories The firm presented their proposal Solifenacin Succinate (as Pvt. Ltd. before the committee. After detailed immediate release tablets) deliberation, committee recommended 5mg/5mg + Mirabegron for grant of approval for conducting (as extended release the proposed BE study with the tablet) 25mg/50mg condition that firm should use capsules approved FDC as comparator. Accordingly, firm should revise the protocol and submit to CDSCO. Further, firm should submit BE report before committee for further review. Medical Device Division 15. CI/MD/2021/35989 M/s Weinnovate The firm presented their proposal SilvoGuard Foley Balloon BiosolutionsPvt. Ltd before the committee. Catheter The committee opined that, during presentation, firm was not clear about the intended use of the proposed product.

After detailed deliberation, the committee recommended that the firm should clearly mention the intended use along with justification and present the protocol before the committee. 16. IMP/MD/2020/13990 M/s. Innovative In light of earlier recommendations Urethral Stent Therapeutics Pvt Ltd dated 24.11.2020, the firm presented their proposal before the committee. After detailed deliberation, the committee recommended to conduct clinical investigation in Indian patients, accordingly protocol should be submitted to CDSCO

60th SEC (Reproductive & Urology), Dated _25.06.2021 & 28.06.2021