Recommendations of thesec (Dermatology & Allergy) made in its 23 rd meeting held on at CDSCO HQ New Delhi: New Drugs Division

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1 Recommetions of thesec (Dermatology & Allergy) made in its 23 rd meeting held on at CDSCO HQ New Delhi: File /Drug Name Recommetions New Drugs Division /15-DC (Pt-B) Apremilast 10/20/30 mgtablets /15-DC (Pt-C) Apremilast 10/20/30 mg tablets M/s. Dr. Reddy s M/s. Hetero Labs The firm has proposed to conduct Phase-III clinical trial entitled A Phase III, multicentre, randomized, doubleblind, placebo controlled parallel study to evaluate the efficacy and safety of Apremilast in patients with moderate to severe plaque psoriasis in240 subjectswith treatment duration of 16 weeks. Firm has also presented the Bioequivalence study protocol foran open label, balanced, randomized, twotreatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Apremilast Tablet 30 mg of Dr. Reddy s Laboratories Limited, India Comparing with OTEZLA (Apremilast) Tablets 30 mg of Celgene Corporation Summit, NJ in adult, human subjects under fasting condition. After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III Clinical Trial and Bio-Equivalence study. However, in clinical trial the patients withdrawn from the study from either arm should be provided the stard of care treatment. The firm shall complete the bio-equivalence study before initiation of clinical trial. The firm has proposed to conduct Phase-III clinical trial entitled A Phase III, Multi-Center, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Apremilast in Adult Patients with Moderate to Severe Plaque Psoriasisin 228 subjects withtreatment duration of 16 weeks. The firm has also presented Bioequivalence study protocol for An open label, balanced, randomized, two treatment, two period, two sequence, single oral dose, crossover

2 File /Drug Name Recommetions bioequivalence study comparing Apremilast 30 mg tablets of Hetero Labs Limited, India with OTEZLA (Apremilast) 30 mg tablets manufactured for Celgene Corporation summit, NJ inhealthy adult male human subjects under fasting conditions. After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III Clinical Trial and Bio-Equivalence study. However, in clinical trial the patients withdrawn from the study from either arm should be provided the stard of care treatment. The firm shall complete the bio-equivalence study before initiation of clinical trial. Fixed Dose Combination Division /2016-DC(Misc. 57) Clotrimazole+Hydroc ortisone (1%w/w + 1%w/w) /2017-DC Ethanol IP+Hydrogen Peroxide IP+Glycerol IP ( 80%v/v %v/v %v/v per 100ml) M/s. Encube Ethicals M/s. Alliance Formulations The firm presented therapeutic equivalencestudy protocol. The representative of the firm submitted before the committee that the proposed study is exclusively for export purpose. After detail deliberation, the committee recommended for the proposed study subject to addressing the following issues: The Laboratory outcome will not be available at the time of completion of 10 days treatment period, which is also inadequate as per current treatment guidelines for Dermatophytosis. Therefore, it will be inconclusive as to whether at the end of study the patients have been adequately treated or need further treatment. Accordingly, the firm should submit the revised protocol for consideration of the committee. The firm presented the data on formulation including efficacy study results before the Committee. The Committee also noted that the proposed formulation is recommended by WHO. After detail deliberation, the committee recommended for granting permission for manufacturing and marketing, subject to condition that the patients with hand Eczema and Atopic Dermatitis should use with caution. This should be mentioned on the label of the

3 File /Drug Name Recommetions product /2017-DC Iso Propyl Alcohol IP+Hydrogen Peroxide IP+Glycerol IP ( 75%v/v %v/v +1.45%v/v per 100ml) /2017-DC Luliconazole+Beclom ethasone Dipropionate IP+Methylparaben IP+Propylparaben IP+Benzyl Alcohol IP (As preservative) (1.0%w/w+0.025%w/ w+0.2%w/w+0.02%w /w+1.0%w/w) M/s. Alliance Formulations M/s. Glenmark Pharmaceuticals Subsequent New Drugs Division The firm presented the data on formulation including efficacy study results before the Committee. The Committee also noted that the proposed formulation is recommended by WHO. After detail deliberation, the committee recommended for granting permission for manufacturing and marketing, subject to condition that the patients with hand Eczema and Atopic Dermatitis should use with caution. This should be mentioned on the label of the product. The firm presented the data before the Committee. After detail deliberation the Committee recommended that the rationality and the need for this combination against Luliconazole alone needs to be established through Clinical Trial. The firm may be asked to submit Clinical Trial Protocol accordingly before the Committee /2017-DC (Pt- Ajanta-snd) Ivermectin topical lotion 0.5% w/w /2013-DC(Pt- Intas-SND) Tacrolimus ointment 0.1% M/s. Ajanta The firm presented the proposal along with clinical trial protocol before the Committee. After detail deliberation the Committee recommended for grant of permission to conduct the clinical trial. However, the firm may increase the study site from northern India. M/s. Intas Ltd The firm presented the proposal along with phase II clinical report before the Committee. After detailed deliberation the Committee recommended for phase III clinical trial in accordance with the recommetion of SEC (Dermatology) meeting held on Medical Device Division 9 29/Misc./03/2016-DC (258) Applicat ion for import of product Twak-M (Skin M/s. Polyskin Lifesciences pvt. Ltd. Kerala The firm did not turn up for the presentation.

4 File /Drug Name Recommetions regeneration scaffold) under the provisions of Drugs & Cosmetics Act and Rules MD/2015- DC(End.01) Application for the registration of medical device for the products : 1. INTEGRA Dermal Regeneration Template 2. INTEGRA Meshed Dermal Regeneration Template. 3. INTEGRA Dermal Regeneration Template Single Layer 4. INTEGRA Wound Matrix (Thin). M/s. Emergo (India) Consulting Private Ltd, Hyderabad The firm presented the adequate data establishing the safety and efficacy of the products. The proposed products are approved for marketing in Europe, USA, Australia and Canada. The committee after detailed deliberation recommended that the import permission may be granted to the firm for these products with the condition that the firm shall submit PMS data after every six months up to two years for further review.

5 S.No SEC Experts Name & Designation 1. Dr. V. K. Sharma, Professor & Head, Dept. of Dermatology, AIIMS, New Delhi Signature 2. Dr. Binod Khaitan, Professor & Head, Dept. of Dermatology, AIIMS,New Delhi 3. Dr. D.M Thappa, Professor & Head, Dept. of Dermatology, JIPMER, Pondicherry Dr. S.N. Bhattacharya, Professor & Head, Dept. of Dermatology, University College of Medical Sciences, New Delhi 5. Dr. Sanjeev Ha, Professor & Head, Dept. of Dermatology, PGIMER, Sector 12, Chandigarh 6. Dr. P. K. Singh, Professor & Head, Dept. of Dermatology, Sarojini Naidu Medical College, Agra 7. Dr. V. Ramesh, Professor & Head, Dept. of Dermatology, VMMC &Safdarjung Hospital, New Delhi 8. Dr. Shalini Chawla, Director-Professor, Dept. of Pharmacology, MAMC, Delhi