sign in sign up
<<
Home , Besifloxacin, Delafloxacin

Recommendations of the SEC (Antimicrobial & Antiviral) made in its 62ndmeetingheld on 30.10.2019at CDSCO, HQ New Delhi:

Agen File Name & Drug Name, Firm Name Recommendations da Strength No Introductory remarks New Drugs Division

1 The applicant presented that the study drug - Hydrochloride gel which is M/s Dr. Neeraj not approved, will be manufactured by a 12-01/19-DC (Pt.101) Kumar, Member, firm for clinical trial. The committee BesifloxacinHydrochloride Secretary Good therefore recommended that the concerned Society of EC manufacturer should submit application to CDSCO. 2 12-01/19-DC (Pt.210) Lady Hardinge The institutional ethics committee has Isoniazid, , Medical College, approved the academic clinical trial and Pyrazinamide and New Delhi submitted the proposal for approval of DCGI. The committee after deliberation opined that the proposal should be deliberated along with two pediatricians. 3 The firm has presented proposal for FDC of + INH for treatment of LTBI along with report of BE study.

F. No. ND/F- The Committee noted that Rifapentine has 44/FF/2019/14701 been approved for LTBI which is to be Rifapentine and Isoniazide M/s Oxalis Labs used concomitantly with INH once weekly Coated Tablets- 300mg/ for RNTCP only. However, the firm 300mg should submit proper justification as to how the recommended dose of individual drug i.e. Rifapentine and INH can be titrated using FDC of the drugs along with documentary evidences. 4 ND/MA/18/000032 M/s. In light of recommendation of the SEC Tafenoquine Tablets 150 mg GlaxoSmithKline dated 25.04.2019, the firm has presented Pharmaceuticals their proposal for manufacture and Ltd. marketing of the drug with local clinical trial waiver. The firm in their submission has mentioned that sales restriction to only the Public sector, hospitals and institutions and country-specific educational materials and training will allow a controlled and safe roll-out of tafenoquine with mandatory quantitative G6PD testing in India. After detailed deliberation and considering the opinion of National Vector Borne Disease Control Programme, the committee recommended that the firm should submit protocol for assessing

62nd SEC (Antimicrobial &Antiviral) _30.10.2019 Agen File Name & Drug Name, Firm Name Recommendations da Strength No feasibility of making the drug available in India in light of concerns relating to G6PD deficiency. 5 ND/MA/19/000040 M/s. Synokem The firm presented their proposal for phase tablets 450 mg III clinical trial protocol and BA-BE protocol before the Committee. After detailed deliberation, committee recommended the following: 1. Grant of permission to conduct proposed BE study 2. For the phase III clinical trial, the firm should submit revised protocol in respect to inclusion/exclusion criteria, primary & secondary end points, comparator, clinical trial sites (geographically distributed) and co-investigators details, etc. Accordingly, the firm should submit revised clinical trial protocol for review by the committee. 6 12-20/18-DC M/s. Gopaldas Firm did not turn up for presentation. Fixed dose combination of “ Visram Co. Ltd Glutaraldehyde, dicecyl dimethyl ammonium chloride and ethylene dioxydimethanol solution (Brand name- Germer TM)” (For external use only 7 12-03/19-DC NITRD The applicant presented the proposal for Anti-tuberculosis Drug Two-month regimens using Novel combinations to Augment Treatment effectiveness for drug-sensitive tuberculosis" and justification in light of earlier SEC recommendation dated 22.05.2019. The committee noted that there is safety data of 35 mg/kg/day of rifampicin. The other anti tubercular drugs used other than the standard regimen drugs are linezolid, clofazamine, bedaquline, levofloxacin are group A or B drugs in terms of efficacy in the treatment of drug resistant tuberculosis as per the recent WHO treatment guideline as well as RNTCP guideline.

However, Rifapentine has been approved for treatment of LTBI and bedaquiline has been approved only for drug resistant TB through the programme. Levofloxacin has not been approved by CDSCO for use in tuberculosis. The representative of Central TB division

62nd SEC (Antimicrobial &Antiviral) _30.10.2019 Agen File Name & Drug Name, Firm Name Recommendations da Strength No expressed the need of such trial. After detailed deliberation, the committee recommended for grant of conduct of clinical Trial subject to the approval of Rifapentine, bedaquiline and levofloxacin by CDSCO for the purpose of the said trial. Dr. Sushil Munjal did not participate in the discussion. 8 Chloroquine – Associated PvPI The committee deliberated the TEN/SJS recommendation of the PvPI. After detailed deliberation the committee recommended that CDSCO to request State Drugs Controllers to instruct the manufactures of the drug Chloroquine to include TEN/SJS as an ADR in the PIL. 9 Lamivudine – Associated PvPI The committee deliberated the Hearing Loss recommendation of the PvPI. After detailed deliberation the committee recommended that CDSCO to request State Drugs Controllers to instruct the manufactures of the drug Lamivudine to include Hearing Loss as an ADR in the PIL. SND Division

10 SND/MA/19/000047 M/s Mecleods The firm presented their proposal for grant Levofloxacin dispersible tablet Pharma Ltd of permission to manufacture and market 100mg (new dosage levofloxacin 100mg dispersible tablet for form/strength/indication) children as an anti-tubercular drug. The committee noted that levofloxacin has not been approved by CDSCO for use in children for any indication including TB. The committee recommended that the proposal may be re-deliberated along with pediatrician and representative from Central TB Division. 11 SND/MA/19/000049 M/s Mecleods The firm presented their proposal for grant dispersible tablet Pharma Ltd of permission to manufacture and market 100mg (new dosage Moxifloxacin 100mg dispersible tablet for form/strength/indication) children as an anti-tubercular drug. The committee noted that Moxifloxacin has not been approved by CDSCO for use in children for any indication including TB. The committee recommended that the proposal may be re-deliberated along with pediatrician and representative from Central TB Division. FDC Division

12 M/s. The firm presented their proposal before FDC/IMP/19/000040 GlaxoSmithKline the committee. Amoxicillin Trihydrate eq. to

62nd SEC (Antimicrobial &Antiviral) _30.10.2019 Agen File Name & Drug Name, Firm Name Recommendations da Strength No Amoxicillin free acid Pharmaceuticals After detailed deliberation, committee 759.04mg Ltd. recommended for grant of permission to (652.78)*+Potassium import and market FDC of Amoxicillin Clavulanate eq. to Clavulanic Trihydrate eq. to Amoxicillin free acid acid 61.48mg (50.41)* powder 759.04mg (652.78)*+Potassium for reconstitution into Clavulanate eq. to Clavulanic acid suspension 61.48mg (50.41)* powder for reconstitution into suspension subject to the condition that Phase IV protocol should be submitted within 3 months of approval.

62nd SEC (Antimicrobial &Antiviral) _30.10.2019

62nd SEC (Antimicrobial &Antiviral) _30.10.2019