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Analgesic & Rheumatology Recommendations of the SEC (Analgesic & Rheumatology) made in its 72nd meeting held on 24.06.2021 & 25.06.2021 at CDSCO HQ New Delhi. File Name & Recommendations Agenda Drug Name, Firm Name No Strength New Drugs Division ND/MA/21/000076 M/s Hetero Labs Ltd. The firm presented their proposal of Polmacoxib 2 mg Fresh Application Phase III clinical trial protocol capsules along with BE study protocol before committee. After detailed deliberation, the 1. committee recommended for grant of permission to conduct the BE study. The firm should present the results of BE study before committee for further consideration of phase III clinical trial protocol. Biological Division BIO/CT- The firm presented their proposal 18/FF/2021/24609- for marketing authorization and Belimumab (Marketing Authorization)- local clinical trial waiver based on Belimumab the results of GCT including sub set analysis on 66 Indian patients. The committee noted that the drug is not an unmet need in the country. M/s. GSK Further, the data presented by the 2. Pharmaceuticals firm in Indian sub-set is limited and Ltd. in different route of administration (intravenous) while the firm is seeking MA for subcutaneous route. After detailed deliberation, the committee did not recommend for grant of approval for marketing authorization. BIO/CT21/FF/2021/246 M/s Reliance Life The firm presented their proposal 79- Denosumab Sciences Pvt ltd for marketing authorization along 60mg/ml with the results of Phase-III clinical trial. 3. The committee noted that the Phase III trial was approved in 2017. After detailed deliberation, the committee SEC (Analgesic & Rheumatology) made in its 72stmeeting held on 24.06.2021 & 25.06.2021 at CDSCO HQ New Delhi recommended that the firm should present the following data again along with appropriate justification – 1) Efficacy percentage change in BMD from Baseline to 6 & 12 months 2) Results of Percent change in the secondary efficacy endpoints 3) Reasons for drop-outs of patients from evaluation arm along with appropriate evidence 4) Case wise details of drop outs from the study M/s Enzene Biosciences In light of the earlier Ltd recommendation of SEC held on 22.12.2020, the firm presented the causality assessment report before the committee. BIO/CT21/BO/2 After detailed deliberation, the 4. 020/21500-Denosumab committee recommended for grant 60 mg/ml of approval for marketing authorisation of Denosumab 60mg in the treatment of osteoporosis in postmenopausal women, subject to the condition that the firm should submit Phase IV clinical trial protocol within three months of grant of marketing authorization. M/s Roche Products The firm presented the proposal for (India) Pvt ltd addition of indication. The committee noted that firm did 4-59/Roche/PAC- not present clinical evidence in R/Tocilizumab/2020- 5. support of their claim. BD-Tocilizumab Injection 162mg/0.9ml After detailed deliberation, the committee did not recommend for approval of the proposed additional indication. Virchow Biotech In light of the SEC BIO/CT04/FF/2020/234 6. recommendations dated 23.03.2021 58- Rituximab & 24.03.2021, the firm presented SEC (Analgesic & Rheumatology) made in its 72stmeeting held on 24.06.2021 & 25.06.2021 at CDSCO HQ New Delhi the revised Phase III protocol with amendments. After detailed deliberation, the committee recommended for the grant of permission to conduct the Phase III clinical trial subject to following conditions - 1. The PI should be Rheumatologist or Physician having experience in Rheumatology 2. Patients with low IgG levels shall be excluded from the trial. Accordingly, the firm shall submit revised protocol to CDSCO for approval. SND Division The firm presented their proposal for manufacturing and marketing of Tofacitinib Extended-Release Tablet 11 mg requesting clinical SND/MA/21/000087 trial waiver and presented the BE Tofacitinib 11 mg M/s Dr. Reddy’s study protocol before committee. 7. Extended-Release Laboratories After detailed deliberation, the Tablet committee recommended for the grant of permission to conduct the BE study subject to condition that Lipid profile assessment should be included at Screening level. The firm presented their proposal of manufacturing and marketing of Teriperatide Injection, Solution for injection in a pre-filled pen 600mcg/2.4ml (Synthetic Origin) along with the BE study report and SND/MA/21/000091 requested for clinical trial waiver Teriperatide Injection, before the committee. Solution for injection 8. M/s Sun The committee noted that in a pre-filled pen 600mcg/2.4ml internationally the product is (Synthetic Origin) already approved in countries such as UK, Spain & France etc. After detailed deliberation the committee recommended for grant of permission for manufacturing and marketing of Teriperatide Injection, Solution for injection in a pre-filled SEC (Analgesic & Rheumatology) made in its 72stmeeting held on 24.06.2021 & 25.06.2021 at CDSCO HQ New Delhi pen 600mcg/2.4ml (Synthetic Origin) subject to condition that the firm should conduct Phase IV CT study. Accordingly, protocol should be submitted to CDSCO within three months of approval. However, before final approval CDSCO should ensure chemical and pharmaceutical comparability of the test and reference product along with testing the product in IPC accredited lab in regard to quality. The firm presented their proposal for manufacturing and marketing of Tapentadol Nasal Spray 225mg/ml for additional indication along with the Phase III Clinical Trial protocol before the committee. After detailed deliberation committee recommended to revise the Phase III CT protocol as follows: 1. Subject population included patients from 3 different clinical indications. All these sub-group SND/CT/21/000001- patients should be clearly defined in MS Torrent 9. Tapentadol Nasal terms of clinical presentation/pain Pharmaceuticals Spray 225mg/ml scores. 2. Sample size should be recalculated based on statistical calculation & justifiable in this 3 sub-group. 3. Study design should be modified & it should preferably be blinded. 4. The rescue medications should be changed as test products are opioids (Tapentadol & Tramadol) Accordingly, the firm should submit revised Phase III Clinical Trial protocol before the Committee. SND/MA/19/000154- In light of earlier recommendation Acetylsalicylic acid of SEC meeting held on 11.02.2020, 10. M/s Reckitt Benckiser effervescent Tablets the firm presented clinical data in 500 mg support of Acetyl Salicylic acid as SEC (Analgesic & Rheumatology) made in its 72stmeeting held on 24.06.2021 & 25.06.2021 at CDSCO HQ New Delhi per proposed indication. After detailed deliberation, the committee recommended for grant of permission to manufacture and market Acetylsalicylic acid Effervescent tablets 500 mg indicated as Analgesic and anti- pyretic. FDC Division FDC/CT/21/000006- M/s. Biotehnos Pvt. Ltd. The firm presented their proposal Bioactive concentrate before the committee. The from small Marine committee noted that the firm needs Fish (Active) + Water to present the full text of published for injection articles in support of proposed FDC. (Inactive) (Indication: On the request of the firm, the 1. Degenerative proposal was deferred for the next rheumatic diseases of meeting. the joints:osteoarthrosis with diverse localization 11. coxathrosis, gonarthrosis, small joints arthrosis; spondylosis, osteochonodrosis; 2. The period of convalescence (as adjuvant) after traumas and joint surgery) (0.1ml + 1.0ml) Solution for injection FDC/MA/20/000147- M/s. Aeon Formulations The firm presented the proposal Serratiopeptidase Pvt. Ltd. before the committee. After detailed 10mg + Zaltoprofen deliberation, the committee opined 80mg tablets that, the firm has not submitted any additional data. Further, the 12. committee also opined that there is no role of Serratiopeptidase in the proposed indication. Therefore the committee reiterated its earlier recommendation. 4-46/2018-DC- M/s. Neon Laboratories The firm presented their Phase III RopivacaineHCl eq. Clinical trial report before the 13. to Anhydrous committee. After detailed RopivacaineHCl+Dex deliberation, the committee opined trose (7.5mg+80mg) that the firm should do the statistical SEC (Analgesic & Rheumatology) made in its 72stmeeting held on 24.06.2021 & 25.06.2021 at CDSCO HQ New Delhi Injection analysis and make the presentation before the committee for further consideration. FDC/IMP/19/000011- M/s. Septodont The firm presented their proposal Articaine Healthcare India Pvt. before the committee and requested Hydrochloride + Ltd. for Phase-III clinical trial waiver. Epinephrine Bitartrate The committee opined that firm did (40mg + 0.018mg) not present any data for justification 14. injection of waiver. In view of above, the committee reiterated its earlier recommendation dated 22.12.2020. FDC/MA/21/000084- M/s. Akums Drugs & The firm presented their proposal Alcohol IP 36.8% v/w Pharmaceuticals Ltd. before the committee. Committee + Ketoprofen IP opined that firm could not present 2.5%w/w Gel any rationality/ therapeutic 15. justification for use of Alcohol as 36.8% as active ingredient in the proposed FDC. Hence the committee did not recommend for approval. GCT Division CT/66/19 Online M/s. Eli Lilly The firm presented their proposal Submission for protocol amendment before the committee. After detailed deliberation, the committee recommended for approval of protocol amendment subject to condition that opinion 16. from Rheumatologist should be taken for addition of imaging procedures
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