Recommendations of the SEC ( &Rheumatology) made in its 56th meeting held on 16.10.2019 at CDSCO HQ New Delhi:

Agenda File Name & Drug Firm Name Recommendations No Name, Strength

New Drug Division

1 The firm presented their proposal along with the published literature before the ND/MA/19/000045 M/s Zydus committee. Polmacoxib 2mg Healthcare The committee highlighted that no PMS Capsule Limited data was presented for the drug which is currently marketed only in South Korea. Hence the firm is advised to present safety data in regard to Polmacoxib 2mg Capsule. Biological Division 2 BIO/CT/19/000047 Dr. Reddy Labs The firm presented their Phase I (PK-PD) Tocilizumab Ltd. clinical trial protocol in healthy human volunteers. After detailed deliberation, the committee recommended for grant of permission to conduct of the Phase I (PK-PD) study subject to the following conditions – 1. The Phase I study site (in-house) should have facilities to diagnose and manage emergencies arising from this study. 2. The PI should be minimum MD in Pharmacology. 3. There should be a team of physicians with post graduate qualification should be readily available for managing emergencies and ADRs. 4. Name of the drugs acting through IL-6 receptors should be mentioned in the exclusion criteria. 5. ECG should also performed at appropriate time points (such as Cmax) during the study. Accordingly, the firm should submit the revised protocol and submit the same to this office. Subsequent New Drugs Division

3 The firm presented their proposal along SND/MA/19/000022 with the BE study and Clinical Trial Iguratimod SR tablet M/s Synokem protocols. 50mg (modified Pharma Ltd After detailed deliberation the committee dosage form) recommended for grant of permission to conduct the BE study subject to following

56th SEC (Analgesic &Rheumatology) _16.10.2019 Agenda File Name & Drug Firm Name Recommendations No Name, Strength conditions: 1. The study site should have facilities to diagnose and manage emergencies arising from this study. 2. There should be a team of physicians with post graduate qualification should be readily available for managing emergencies and ADRs. In regards to Clinical Trial protocol, the committee recommended that the firm should submit revised CT protocol including detailed inclusion and exclusion criteria for exclusion of TB patients from the study, dosage and administration etc. for further review by the committee. FDC Division 4 M/s.Aglowmed Firm presented their proposal for Phase IV Ltd. CT before the Committee. After detailed deliberation committee recommended for grant of permission for conducting the 04-43/2017- Phase IV study with following conditions: DC(PSC- 1. Only the patients with acute painful Aglowmed) traumatic condition of orthopedics- such as Ankle sprains shall be Potassium BP + included IP 2. Inflammatory markers as well as +Trypsin and physical measurements shall be Chymotrypsin included as assessment criteria in (50mg+325mg+50,0 secondary objective. 00 armour)film 3. More Govt. sites and only coated tablets orthopedic surgeon should be included as investigator. Firm should submit the Phase IV report within 1 year. 5 M/s. Synokem Firm presented their proposal for Phase IV Pharmaceuticals CT before the Committee. After detailed 04-126/2013-DC deliberation committee recommended for Trypsin- grant of permission for conducting the Chymotrypsin Eq. to Phase IV study with following conditions; Trypsin- 1. Only the patients with acute painful Chymotrypsin traumatic condition of orthopedics- 50,000AU such as Ankle sprains shall be + Eq. to included Aceclofenac 100mg 2. Inflammatory markers as well as +Paracetamol IP physical measurements shall be 125mg film coated included as assessment criteria in tablets secondary objective. Firm should submit the Phase IV report within 1 year.

56th SEC (Analgesic &Rheumatology) _16.10.2019 Agenda File Name & Drug Firm Name Recommendations No Name, Strength GCT Division 6 CT/09/17 Klinera The committee has examined the proposed Filgotinib protocol amendment 3.0 and agreed for the same subject to condition: Accordingly the firm is advised to present the safety related data of the ongoing trial subjects globally before the committee for review. 7 CT/75/19 IQVIA RDS The firm presented their proposal before Otilimab the committee. (GSK3196165) Assessment of risk versus benefit to the patients- The safety profile of the study drug from various preclinical toxicology studies and clinical studies justify the conduct of the trial. Innovation vis-a-vis existing therapeutic- To evaluating efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate..

Unmet medical need in the country- To develop alternative, safe and efficacious treatment in moderately to severely active rheumatoid arthritis patients who have an inadequate response to methotrexate.

After detailed deliberation the committee recommended for grant of permission to conduct the study subject to the following conditions: 1. The primary outcome should be ACR 50 instead of ACR 20. 2. The patients for the study should be recruited equally from all geographical regions of the country including Government & Private Hospitals. 3. Specific tests to rule out presence of TB should be carried out in all patients before they are recruited. 4. The speciality of principal investigator should be mentioned and they should be qualified rheumatologist, orthopedicians & physicians with special interest in rheumatology. 5. There should be special instructions

56th SEC (Analgesic &Rheumatology) _16.10.2019 Agenda File Name & Drug Firm Name Recommendations No Name, Strength for clinical diagnosis and confirmatory test to rule out VTE, especially in the high risk patients.

Medical Device Division 8 4-MD/CT-233/2019- M/s Synkromax The firm didn’t turn up for the presentation DC Biotech Pvt. Bovine pericardial Ltd., Tamilnadu patch (Syncroscaff)

56th SEC (Analgesic &Rheumatology) _16.10.2019