Recommendations of the SEC ( &Rheumatology) made in its 51thmeetingheld on 19.06.2019 at CDSCO HQ New Delhi:

Age File Name & Drug Firm Name Recommendations nda Name, Strength No Introductory remarks New Drug Division 1 Firm presented their proposal along with phase III clinical trial data before the committee. The committee observed that the drug is approved in South Korea in 2015 & clinical data is available in a published ND/MA/19/000004 report of phase III clinical trial on 441 AP107001 & M/s Ajanta Limited patients with 146 patients in polmacoxib AP207002(Polmacoxib) group. Further no PMS data of the drug was presented. After detailed deliberation, committee recommended that based on data submitted proposal for phase III clinical trial cannot be considered for approval because of inadequate safety data. 2 The committee deliberated recommendation of NCC-PvPI. After detailed deliberation, the 12-01/18-DC(Pt-337) committee recommended that CDSCO to associated NCC-PvPI request the state Drug controllers to Nicolau’s syndrome direct the manufacturers of Diclofenac injection to include Nicolau’s syndrome as an ADR in the prescribing information of Diclofenac injection. SND Division 3 In light of recommendation of the 12-68/2018-DC (Pt- committee on 26-07-2018 the firm Panacea-SND) presented their proposal along with M/s Panacea Biotech Ointment protocol for Phase III clinical trial. Ltd 1.5 % w/w (Add. After detailed deliberation, committee Dosage form) recommended for grant of permission to conduct the Phase III clinical trial. 4 The firm presented the proposal for HCl 25 mg capsules as additional lower strength. SND/MA/19/000119 The Tapentadol HCl 25 mg strength is Tapentadol HCI 25mg M/s Pharose approved in many countries including capsule (Add. Lower Remedies Ltd. UK, Sweden, Denmark etc. strength) 25 mg Tapentadol HCl can be used for dose adjustment to meet individual patient requirements.

51thSEC (Analgesic & Rheumatology)_19.06.2019

Age File Name & Drug Firm Name Recommendations nda Name, Strength No After detailed deliberation, committee recommended for grant of permission to manufacture the proposed additional lower strength of Tapentadol HCl 25 mg capsules. Medical Division

5 M/s Meril Life In light of earlier recommendation of the CI/MD/2018/3730 Sciences committee on 24.10.2018 & 11.04.2019, Freedom Total Knee instead of protocol for a pilot study, the system with the PEEK- Firm presented the same clinical trial OPTIMA Femoral protocol which was submitted along with Component their initial proposal.

Committee after detailed deliberation recommended that the firm should submit the pilot study protocol along with the supporting safety data including clinical data from other countries in light of findings of a study which has demonstrated that neither of PEEK and CFR-PEEK materials would be a suitable replacement for polyethylene in a low conformity total knee replacement articulating with a hard femoral bearing (Ref-C.L. Brockett et al. / Wear 374-375 (2017) 86–91). The protocol should be a pilot study protocol with details of safety & performance assessment criteria of the product. Further the protocol should also include details of the evaluation of the product in-situ. Biological Division 6 The firm presented their Phase IV clinical trial Protocol before the committee. After detailed deliberation, the committee recommended for the grant of permission for conduct of BIO/Form44/FF/2019/1 clinical trial subject to the following 4191 Reliance Life conditions – (BIO/CT/19/000025) Sciences Pvt Ltd 1. The patients enrolled should be Etanercept stratified based upon indications and age groups. 2. The study duration should be atleast one year. Accordingly, the firm should submit a revised protocol.

51thSEC (Analgesic & Rheumatology)_19.06.2019