Recommendation the 23Rd SEC (Antimicrobial & Anti-Viral)

Recommendation The 23rd SEC (Antimicrobial & Anti-Viral) meeting deliberated the proposals on 18-01-2016 and recommended the following:

Agend File Name &Drug Firm Name Recommendation a name, Strength No New Drug Division 1 12-01/15-DC(Pt-120) Prof. Rup Lal Dr. Rup Lal presented the details of Rifamycin-B developmental work of Rifamycin-B Analogue analogue done by his team. The Committee opined that preclinical and clinical study should be conducted as per requirements of Schedule-Y of Drugs and Cosmetics Rules, 1945. 2 12-17/15-DC M/s. Astrazeneca The firm applied for permission to Ceftaroline Fosamil Pharma India Pvt. Ltd. Import and Market Ceftaroline Fosamil Injection (ZinfroTM) which is proposed to be indicated for the treatment of adult (≥ 18 years of age) patients with community-acquired pneumonia. The firm presented the Globhal Clinical Trial data on 200 Indian subjects of which 100 subjects were given Ceftaroline Fosamil. Earlier the proposal was deliberated in the SEC held on 22.06.2015 where the firm was asked to present the subset analysis with respect to safety and efficacy of the drug in Indian subjects. Now the firm presented the Indian data on safety and efficacy. Also the Committee noted that the drug is approved in USA since 2010 and also approved in EU, Australia, Asian countries etc. Therefore, the Committee recommended the Import and marketing of the drug Ceftaroline Fosamil indicated for the treatment of adult (≥ 18 years of age) patients with community-acquired pneumonia. GCT Division Proposal 3 CT/48/15 National Institute of Risk Versus Benefit to the Patients: MDR-TB Research in TB In light of the fact that the test drugs are old drugs and already marketed in the country, the safety profile of Page 1 of 5 23rdSEC-Antimicrobial, Antiviral, Antiparasitic, Antifungal, on 18.01.2016

Agend File Name &Drug Firm Name Recommendation a name, Strength No the test drugs justify the conduct of the trial. Innovation vis-a-vis Existing Therapeutic Option: The purpose of the study is the evaluation of a standard treatment regimen of anti- tuberculosis drugs for patients with MDR-TB for shortening of MDR-TB treatment. Unmet Medical Need in the Country: The test drugs may potentially provide alternate treatment regimens/ option in patients with MDR-TB. After detailed deliberation the committee noted that in a previous trial STREAM Stage 1, the applicant was asked to submit the safety data of moxifloxacin 800 mg. The applicant withdrew the proposal ( STREAM Stage 1). Now the applicant presented the protocol for STREAM Stage 2. During the presentation the applicant provided DSMB report which indicated that there is no major safety concern in STREAM Stage 1 trial wherein 154 patients are on 800 mg of moxifloxacin.

After detailed deliberation the committee recommended conduct of the STREAM Stage 2 trial with following condition- 1. The no. of subject randomized to receive dose of 600 and 800 mg moxifloxacin should not exceed 10 for each dose. After 4 weeks of treatment with these doses, the applicant should present the safety data. After reviewing the data by the committee, decision for further enrolment in these doses will be considered while the treatment for already enrolled subject may be continued per

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Agend File Name &Drug Firm Name Recommendation a name, Strength No protocol. 4 CT/51/15 M/s. BJ Medical Risk Versus Benefit to the Patients: Lopinavir/Ritonavir College, Pune. In light of the fact that the test drugs are old drugs and already marketed in the country, the safety profile of the test drugs justify the conduct of the trial. Innovation vis-a-vis Existing Therapeutic Option: The primary objective of the study is to assess HIV remission among HIV-infected neonates who initiate ART within 48 hours of birth. Unmet Medical Need in the Country: The study will provide essential data on whether early combination of antiretroviral therapy for high risk infants would achieve cure.

After detailed deliberation the committee recommended the conduct of the study with the following conditions- 1. Adverse events should be closely monitored. 2. Children permanently discontinued from the study should be provided treatment/ referred to the NACO centre. FDC Division Proposal 5 4-11/2015-DC M/s Macleods The firm made a detailed Rifampicin+Isoniazid Pharmaceuticals presentation before the committee. 75mg+50mg DT The firm also presented the BE study data. The firm also claimed that the proposed formulation is already approved by Expert Review Panel of WHO. Committee was informed that FDC is already approved in other strength. The Committee noted that this FDC in proposed strength was also considered in meeting of Technical Committee for specification held on 13.03.2015.This FDC will be used in daily dosage regimen. The

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Agend File Name &Drug Firm Name Recommendation a name, Strength No committee was informed that RNTCP has taken a policy decision for switching over from intermittent dosage regimen to daily dosage regimen for which this formulation has already been approved. Hence this Committee recommended for manufacturing and marketing for the proposed strength for pediatric and adolescents patients. 6 4-53/2008-DC(Pt. Aqua Vitoe FDC of Meropenem 1gm + Aqua) Laboratories Tazobactam 125mg/250mg injection Meropenam+Tazobact was earlier deliberated by the SEC in am its meeting held on 08.05.2015 1gm+125mg/250mg wherein committee suggested for submitting revised clinical trial protocol with certain modifications. However, instead of presenting revise protocol, the firm requested for waiver of clinical trial and made a presentation in this regard. The Committee noted that the firm did not present any additional data including clinical data on the proposed FDC to merit the trial waiver. Hence, the Committee rejected the request for the clinical trial waiver. 7 04-12/2015-DC M/s Macleods The firm made a detailed Rifampicin BP 75 Pharmaceuticals presentation before the committee. mg+Isoniazid BP The firm also presented the BE study 50mg + data. The firm also claimed that the Pyrazinamide- 150mg proposed formulation is already Dispersible tablets approved by Expert Review Panel of WHO. Committee was informed that FDC is already approved in other strength. The Committee noted that this FDC in proposed strength was also considered in meeting of Technical Committee for specification held on 13.03.2015.This FDC will be used in daily dosage regimen. The committee was informed that RNTCP has taken a policy decision for switching over from intermittent dosage regimen to daily dosage regimen for which this formulation

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Agend File Name &Drug Firm Name Recommendation a name, Strength No has already been approved. Hence this Committee recommended for manufacturing and marketing for the proposed strength for pediatric and adolescents patients. SND Division 8 12-42/2015-DC(Pt- M/s Mylan The firm presented the proposal mylan-SND) before the committee. After Epinephrine deliberation the committee opined 0.3mg/0.3ml & that: epinephrine 1. Storage condition of the 0.15mg/0.3ml solution product is 20-25 degree for injection Celcius. Hence, stability data at 30C/65% RH is required to be submitted. 2. The usual recommended dose in adults is 0.3-0.5ml of 1mg/ml. The proposed strengths are 0.15-0.3ml of 1mg/ml which is on the lower side of the dosage schedule.

Clarifications in this regard may be submitted by the firm.

Medical Device Division

9 31-1405-MD/2013- M/s. Johnson & Firm did not turn up for presentation. DC BIOPATCH Johnson, Mumbai Protective Disc with CHG (Chlorhexidine)

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