Recommendations:
I approve the minutes of 23rd SEC Pulmonary meeting held on 07.04.2017 at CDSCO HQ New Delhi and recommended the following:
Agenda File no./Drug Name Name of firm/ Institute Recommendations no.
New Drugs Division
1 12-193/10-DC (Pt-C/Phase Firm did not turn up for the IV) Roflumilast 500mcg M/s. MSN Labs presentation. Tablets 2 12-193/10-DC (Pt-J/Phase Firm did not turn up for the IV) Roflumilast 500mcg M/s. Takeda Pharmaceuticals presentation. Tablets 3 12-206/10-DC (Pt-A) Firm did not turn up for the M/s. Zuventus Healthcare Fenspiride hydrochloride presentation. Ltd 80 mg tablets Fixed Dose Combination Division
4 04-14/2016-DC(Pt. Cipla) The firm presented revised Glycopyrronium (As Clinical trial protocol before Glycopyrronium USP) + the Committee. After detailed deliberations the Formoterol Fumarate Cipla Ltd. Dihydrate( 25mcg+12mcg) Committee recommended for grant of approval for conduct of phase III clinical trial with revised protocol. Global Clinical Trial Division
5 CT/55/16 IndacaterolMaleate Novartis Risk versus Benefit:- and MometasoneFuroate The safety and efficacy of the individual ingredients of FDC QMF149 as well as in combination in preclinical and clinical studies justify the conduct of the study. Innovation vis-à-vis Existing Therapeutic Option:- The proposed study will evaluate once daily LABA/ICS (QMF149- Mometasone+Indacaterol) fix dose combination for asthma patients Unmet Medical Need in the Country:- Development of once daily FDC QMF149 may provide Page 1 of 3 23rd SEC Pulmonary 07.04.2017 Agenda File no./Drug Name Name of firm/ Institute Recommendations no.
convenience to the patients as compared to twice daily dosing. At present twice daily dosage long-acting beta 2-agonists are approved for treatment of Asthma. After detailed deliberation the committee recommended the conduct of the study. Subsequent New Drugs Division
6 12-66/2015-DC (Pt-Cipla- M/s Cipla The 27th Apex committee SND) Tiotropium bromide meeting held on 06-04-2016 inhaler 9 mcg & rota caps 18 noted that no evidence is mcg (additional indication) available regarding approval of the drug in Asthma and
keeping this in view did not approve the waiver of local clinical trial and suggested to re-examination of the proposal.
The same was re - deliberated with 37th technical committee meeting held on 26-04-2016 and noted that Tiotropium bromide inhalation spray 2.5mcg/1.25mcg approved for asthma in USA and UK. The proposed inhaler Rota- caps (9mcg & 18mcg respectively) are not approved anywhere in the world for Asthma. Hence, the committee did not recommend for wavier of Local clinical trial. Firm has presented the published literature and requested for wavier of local clinical trial for the proposed indication. The committee noted that
1. The comparator
Page 2 of 3 23rd SEC Pulmonary 07.04.2017 Agenda File no./Drug Name Name of firm/ Institute Recommendations no.
device technology and strengths approved for asthma in other countries are different when compared to the proposed product. Therefore the committee after detailed deliberation reiterated the recommendations of the Apex committee and recommended for the conduct of local clinical trial in the country. Accordingly firm should submit CT protocol and requisite document to O/o DCG(I) for approval .
Page 3 of 3 23rd SEC Pulmonary 07.04.2017