Recommendations: Agend a no. Recommendations. Institute. New Drugs Division /12-DC ArbekacinSulphate Injection 200mg/4ml

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1 : I approve the minutes of 32 nd SEC (Antimicrobial, Antiviral, Antiparasitic and Antifungal) held on at CDSCO HQ New Delhi and recommended the following: Agend New Drugs Division /12-DC ArbekacinSulphate Injection 200mg/4ml M/s. Alkem Fixed Dose Combination Division The firm did not turn up for presentation /2016-DC(Pt. Maneesh) Rifampicin IP+Isoniazid IP (450mg+225mg) Maneesh The firm presented the BE protocol for the FDC of Pyridoxine (vit B6) 10 mg with Rifampicin 450mg, Isoniazid 225mg, Pyrazinamide 1200 mg and Ethambutol Hcl 825mg Sachet with the Reference product Rimstar (3 tablets) of Sandoz Denmark (Each tab. containing Rifampicin 150mg, Isoniazid 75mg, Pyrazinamide 400mg and Ethambutol Hcl 275mg).The firm also informed that the BE data for the proposed 4 drug FDCs will be extrapolated to 2 drugs and 3 drugs FDCs. The Committee deliberated and recommended for conduct of proposed BE study. After the submission of BE report the proposal for Phase III Clinical trial will be considered as already recommended in the previous meeting held on Page 1 of 6

2 /2016-DC Daclatasvir+Sofosbuvir ( 60mg+400mg) /2000-DC(Pt.Cipla) Lopinavir+Ritonavir ( 40mg+10mg) M/s NATCO Pharma M/s. Cipla Ltd., Page 2 of 6 The firm presented the BE study data conducted for export purpose as recommended by the Committee in the previous meeting held on The committee reviewed and found the BE data satisfactory. Further the firm also requested for the CT waiver based on the recent circular issued by DCG(I) on The Committee did not recommended for the CT waiver as the proposed drug does not fall under the category of extreme urgency. The firm was directed by the Committee to conduct the acceptability and feasibility study in Indian pediatric population in its meeting held on However the firm expressed its inability to conduct such study. Further the firm also requested for the study waiver based on the recent circular issued by DCG(I) on The Committee opined that the above circular is not applicable for the proposed study and has insisted to do

3 /2009-DC(Pt. EM) DarunavirEthanolateeq.to Darunavir+Ritonavir IP (600mg+100mg) /2016-DC Each Combikit contains: Part A: two film coated tablets of darunavirethanolate eq. to Darunavir 600mg and Part B: two film coated tablets of Ritonavir IP100mg M/s. Emcure M/s. Emcure Page 3 of 6 the study as proposed in earlier meeting held on The Firm presented the Pharmacokinetic Interaction Study report before the Committee. The Committee recommended for the approval of manufacturing and marketing of FDC of Darunavir Ethanolate eq. to Darunavir + Ritonavir IP (600mg+100mg) for the indication for the treatment of Human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor and with other antiretroviral agents. The Firm presented the Pharmacokinetic Interaction Study report for FDC of Darunavir Ethanolate eq. to Darunavir + Ritonavir IP (600mg+100mg) before the Committee. The Committee recommended for the approval of manufacturing and marketing of proposed combikit of Part A: two film coated tablets of Darunavir Ethanolate eq. to Darunavir 600mg and Part B: two film

4 /2017-DC Part A: One film coated tablets of EmtricitabineIP+TenofovirDisoproxilFumara te IP & Part B: One Uncoated tablets of Nevirapine Extended release tablets (Nevirapine USP)(200mg+300mg & 400mg)Combikit Medical Devices M/s. Emcure coated tablets of Ritonavir IP 100mg Combikit for the indication for the treatment of Human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor and with other antiretroviral agents. The firm presented the proposal for the proposed combikit of Part A: One film coated tablets of Emtricitabine IP + Tenofovir Disoproxil Fumarate IP & Part B: One Uncoated tablets of Nevirapine Extended release tablets (Nevirapine USP) (200mg+300mg & 400mg). The committee after detailed deliberation did not recommend the proposed combikit as it will not provide any additional benefit. 8 4-MD/CT-105/2013-DC (Part-2) Application in Form 44 for permission to conduct Clinical Trial titled of product i.e., Hinglact Prime (Absorbable, antibacterialchlorhexidineacetate surgical PGA-PLAsuture) M/s. HLL Lifecare Ltd,Trivandrum , Kerala The firm could not present the adequate safety and efficacy data of the product. However the firm presented protocol for conducting clinical trial in India. The committee observed that the protocol has many limitations/inadequacy Page 4 of 6

5 . a) Sample size not calculated scientifically. b) Trial sites selected are inappropriate (small nursing homes) and without Institutional Ethics Committee. c) Inclusion criteria were not defined. d) The study methodology lacks clarity. Hence,the protocol in the present form is not acceptable. Page 5 of 6

6 S.No SEC Experts Name & Designation 1. Dr.Archna Thakur, Dir. Prof. Department of Microbiology, G. B Pant Hospital, New Delhi. Signature 2. Dr. B. Gupta Prof & Head Dept of Medicine, NDMC Medical college & Hindu Rao Hospital, New Delhi 3. Dr.Subhash C. Parija, Sr. Prof & HOD, Microbiology, JIPMER, Puducherry 4. Dr.Varsha Gupta, Prof. Department of Microbiology, Govt. medical college and Hospital (GMCH), Chandigarh 5. Dr.Amita Jain, Prof. Department of Microbiology, KGMU, Lucknow 6. Dr. C.D. Tripathi, Department of Pharmacology VMMC &Safdarjung Hospital, New Delhi 7. DrPratipKundu, MD Professor of Microbiology & Medical Superintendent cum Vice Principal, School of Tropical Medicine ChittaRanjan Avenue Kolkata 8. Dr. AbhishekAgrawal (Associate Professor) Dept. of Medicine SMS Medical College, Jaipur Page 6 of 6