IN FORCE

205 Sixth Meeting of the Expert Committee on 27.08.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale i

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----- Start of picture text ----- A s . ’ - - - . Directorate Office of DrugsGeneralController7 of HealthGeneralServices(India) : a ' FDA Bhawan, y * Kotla Road, New Delhi 1 To Dated: 12 AUG 20 , 1, bss * Dr. Y.K.GUPTA, Prof. & Head, Dept. of acolagy, All India Institute of Medical Sciences 2, (AIMS), Main Hospital, Ansari Nagar, tn of Safdurjung Hospital, New Delhi - 110.029, Dr, Shashank V, Parulekar, Prof. & Head, Dept. of Obstetrics & Gynaecology, Seth GS Medical 3, College & KEM Hospital, Parel, Mumbal-400012, 4, Dr. Lakhbir Dhaliwal, Prof & Head, Dept. of Obstetrics ang Gynaecology, PGIMER, Chandigarh, 3. Dr. S.N. Bhattacharya, Prof & Head, Dept. of Dermatology, UCMS, New Dethi. Dr.Udaipur,Asit Mittal,RajasthanProfessor, - 313001,Dept. of Dermatology , Venerology & Leprosy, R N T Medical College, Subject:- Fifth Meeting of the Expen. Commitice on 22.08.2014 at 11:00 a.m, to 6:00 pum. in the Conference Room, |" floor, FOA Bhawan, Kotla Road, Neat National Bal Bhawan, New Delhi-1 10002, to ¢xamine the matters related to approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for manufacture for sule in the country without due approval from office of DCG(I} — regarding, Sir, Reference is invited to this Directorate’s Office Memorandum No.

ions (FDCs) permitted for manufacture for sule in the country without due approval from office of DCG(I} — regarding, Sir, Reference is invited to this Directorate’s Office Memorandum No. 4-01/2013-DC (Misc13-PSC} dated 03.02.2014 on the subject cited ahove, opinion This office in the following proposals for approval of Fixed Dose Combinations seeks your expert approved,of Expert Committee as to whether based on the deta submited by the firm. these proposals can be Laurochem labs |.Octinaxate 7.5% wiv + avobenzone 3.0% wiw + oxybenzone , 3.0% wiw + zinc oxide 2.0 % wiw topical lotion 2.Octinoxate USP 7.5%wiw tAvobenzone USP 2%owi'w 2. Rexcin Pharmaceuticals *Oxybenzone USP 3%/wiw +Processed Zinc Oxide 2%Gwiw 7 el, susemianen aaa CreamAcnfl vineTopic a l Gel HCI (,1gm +Thymol 5.Ddmg +Ceirimide 0.50gm Psychotropies India Lid Allantoin BP 0.25%/wiw +Vitamin-E Acetate 0.25wiw +Tea bee Psychotropies of] 0.50%wiw Medicated Soap India Lad Allantoin BP 0.20%0w/w +Vitamin-E Acetale 0.25%wiw +Tea tree ofl 0.25%%wAw +Titanium Dioxide IP 0.50% w/w Medicated ash Medicare Allantoin 0.2%w/w +Dimethicone 1.0%wiw Urea 10,0%ww *Propylene S.0%wiw +Glycerin 5.0%ew'w +Liquid paraffin _— 8.0% w/w Cream » .Psychosropics India Aloe IP 4%+Vitamin E Acetate IP 0.50% wiw Soap — 2. East West Pharma 2.Aloe L0%ewiy +Vitamin E Acetate 0.5%w/y Lotion = 1 ----- End of picture text -----

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0.50% wiw Soap — 2. East West Pharma 2.Aloe L0%ewiy +Vitamin E Acetate 0.5%w/y Lotion = 1 ----- End of picture text -----

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----- Start of picture text ----- F . * , ay es.: a | a . . my és Lane $ 1,Gelnova Laborntores 1Clindarhycin Phosphate BP eq to Clind +Clotrimazole IP 200mg Vaginal Suppository Ras} 2.Sun Pharmaceuticals | Suppository2.Clotrimazole 200mg +Clindamycin 100mg a Industries bs 3.Akums : 1 Pharmaceuticals drugs & : 4.Gelnova timited J.clindamycin phoasphate [00 mg + chtrimazole 200 mgcapsu . laboratories' 4.clindamycingelatin vaginal phesphatesuppository100 mg + clottimazole 100 mg sofi PP) 5.Zuventus Healthcare S.clotrimazolevapinal tablet 200 me + clindamycin 100 mg Extended Release 6,Glenmark Pharmaceuticals O.Chotrimazole IP 294w/w *Clindamycin Phosphate 2%%w)w Akurms *Benzyl Alcohol IP 2%wAw Gel Drugs & | Clindamycin Phosphate BP Eq. to Clindamycin 100mg Pharmaceuticals Lut Spores+ClotrimazoleSoft GelatinIP Omgveginal +Lactic Acid Bacillus 1,5 Billion . Synokem Pharmaceuticals Cyproteron Acetate 2mg +Ethinylestradiol IP 0.035mg +Folic . “4 | [Synokem][ Pharmaceuticals] CyproterontabletAcid IP Smg acetateFilm Coated Img +Ethinylestradiole Tablets 0.035mg Film coated 1.

proteron Acetate 2mg +Ethinylestradiol IP 0.035mg +Folic . “4 | [Synokem][ Pharmaceuticals] CyproterontabletAcid IP Smg acetateFilm Coated Img +Ethinylestradiole Tablets 0.035mg Film coated 1. Mepromax O.01%wiwI.MiconazoleNitrateCream _2,0°ewiw +Fluocinolone — Acetonide 2.Creatve 2.Miconazole Nitrate IP 2%wiw +Flucinolone Acetonide IP Health Care 0.01 %w/w Cream 3-Helios Pharmaceuticats 3.Miconazole Nitrate [P 2.00% ww *Fluocinolone Acetonide IP 0.01 %ew!w Ointment 4.Miconazole Nitrate |P 2%awi/w *Fluocinolone Acetonide IP 4,Universal Twin Labs 0.01%wiw Cream - S.Curetech [Skincare] 0.01S.Miconazole %swiw nitrate 2.00%w/w +Fluocinolone acetonide . é 7 0.016.Miconazole %wiw *Methy!Nitrate Paryben2%wi/w 0,15%w/w+Fluocinolone Cream — Acetonide Mepromax Fluocinolone Aceionide O.02Sewiw +Miconazole Nitrate Syncom 2.0%wiw +Neomycin Sulp te 0.5% ww Cream Heatlhcare Fluocinolone Acetonide 0,01%*Neomycin sulpahte A 0.5%+Clotimazote 1,0% opical cream mecting has been convened on 22.08.2014 to evaluate the aboveProposals, TAIDA You are requested to kindly make it convenient to attend the sald meeting on the said date. |' a for attending the meeting as well as honorarium will be Paid as per this Directorate’s Office aor Memorandum No, 401/2013-DC (Miscl3-PSC) dated 03,02.2014, If travetied by Air, it should be by Indian Airlines only and the air tickets, if purchased through agent, should be purchased through M/s Balmaer Laurie & Co. who is the authorized Govt, agent for this purpose.

r, it should be by Indian Airlines only and the air tickets, if purchased through agent, should be purchased through M/s Balmaer Laurie & Co. who is the authorized Govt, agent for this purpose. . 2 : | ss j — ye eC; if ----- End of picture text -----

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----- Start of picture text ----- ¥ Y 5 : . . * - - to You are requested kindly to make it convenient to attend attend the said meetingon meetingonon 22.08.2014atat 11:00 a.m. Delhi-1 6200 6200 10002,pum.pum. in the Conference Room, I" floor, FDA Bhawan, Kotla Road, Near National BalBhawan, New You are requested to confirm your participation by e-mail at are requested to confirm your participation by e-mail at to confirm your participation by e-mail at confirm your participation by e-mail at participation by e-mail at by e-mail at e-mail at at fdediviston@)gmail.com. ----- End of picture text -----

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icipation by e-mail at participation by e-mail at by e-mail at e-mail at at fdediviston@)gmail.com. ----- End of picture text -----

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----- Start of picture text ----- 5 : . . : cp. - - ‘ 4 to You are requested kindly to make it convenient to attend attend the said meetingon meetingonon 22.08.2014atat 11:00 a.m. St | Delhi-1 6200 6200 10002,pum.pum. in the Conference Room, I" floor, FDA Bhawan, Kotla Road, Near National BalBhawan, New F You are requested to confirm your participation by e-mail at are requested to confirm your participation by e-mail at to confirm your participation by e-mail at confirm your participation by e-mail at participation by e-mail at by e-mail at e-mail at at fdediviston@)gmail.com. : 7 Yofis faithfully, ! * o,° Drugs Controller/General(Dr. GN, Si e i Copy to: wit |, M/s. Aurochem Laboratories (fF) Pvt Ltd, 133. Gundegha Ind, Comples, Akuly Rd, Kandivall Eugt Mumbai 400 101, 2. DelhiMs, Rexcin~ 110020.Pharmaceuticals Pvt. Lid. Address= D - 5, Okhla Industrial Area, Phase — 1, New 3. Mls, Universal Twin Labs 29, THE MODEL CHS, SAHAKAR NIWAS, 20, TARDEO ROAD, Mumbai - 400034, Maharashtra, 4. Mis.121007,Psychotropics India Limited, A-32, Sector -| 1, Opposite G. E. Motors, Faridabad, Haryana — 5. Mls. Yash Medicare Private Limited, 202, Panch Deep Comples, Hehind Helmet House, Show Roam, 6. Mithakhali Six Road, Mithakhali Six Road, Ahmedabad. Gujarat 380009 7. Mis.

abad, Haryana — 5. Mls. Yash Medicare Private Limited, 202, Panch Deep Comples, Hehind Helmet House, Show Roam, 6. Mithakhali Six Road, Mithakhali Six Road, Ahmedabad. Gujarat 380009 7. Mis. East West Pharma, No, 10, 2nd Cross, Maravaneri, Salem - 636007, Tamil Nadu. Ms, Gelnova Laboratories (1) Pvt. Lid., C-125 TTC Industrial Area,, Mahape (Pawane), Pawane 8. Mide Road Number 7, Electornic Zone, Mahape, Navi Mumbai, Maharashtra400705, 9. M/s. Sun Pharmaceuticals Industries Led, Tandaija, Vadodara-390020, 10. Mls. Akums Drugs & Pharmaceuticals Ltd., 19 to 21, Sector 6-A, IIE, Ranipur, Haridwar. IT. M/s, Zuventus Healthcare Limited, T-184, M.1_D.C., Bhosari, Pune-411026. M/s.Glenmark Pharmaceuticals Lid, 8/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai- 400026. 12, M/s. Synokem Pharmaceuticals Pvt. Lid, Plot No, 35/36, Sector 6A, IIE, SIDCUL, Ranipar, Haridwar-249403, Uttrakhand, 13. Mls. Mepromax Lifesciences Put Lid. Sector , Plot Number 16, 5 SelaquiDetsradun-248197, Uttarakhand,Industrial Area Pharma City 14, M's. Creative Health Care Pyt. Lid,, Plot NO. 25, Kundeshwari Village, kashipur, Udham : 15, Singh Nagar-244713 (Uttarakhand). Mis. Helios Pharmaceuticals, (Div, al PRAT PL Py. Lid.) 6891, Gulbai Tekra, Ind Lune Panchwati, Ahmedubad- 38000, 16. Mis, Curetech Skincare, Plot No.34 Phase-I'V, Bhatoli Kalan, Baddi, Himachal Pradesh 173205. 17, M/s. Syncom Healthcare Ltd. 22] Vyapar Bhawan, P.D.

Ind Lune Panchwati, Ahmedubad- 38000, 16. Mis, Curetech Skincare, Plot No.34 Phase-I'V, Bhatoli Kalan, Baddi, Himachal Pradesh 173205. 17, M/s. Syncom Healthcare Ltd. 22] Vyapar Bhawan, P.D. Mello Road , Mumbal-400 009 Maharashtra. Notefor Firms: - You are requested to depute your technical team for presentation. As application for same FDC have been —— received from multiple applicants, you are requested to be present at COSCO on 22.08.2014 at 11-00 - am. to 6:00 p.m. in the Conference Roam, |" floor, FDA Bhawan, Kotla Road, Near National Bal — - Bhawan, New Delhi - 110 002 to make Presentation as considered necessary by the committee. MeetingAlso requested [date.] to submit the copy of the presentation of the respective proposals before 3 daysof the ----- End of picture text -----

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----- Start of picture text ----- ~ presentation.Also requested to bring Drug Samples in original pack as well as Package insert while coming for : ~ committer.Any other manufacturer who have applied sbove FDC's may also Present their case before the , ‘ ' x ! Yoyts faithfully, s > - be (Dr. 6.N. Singh) Drugs Controtle? General(1) ----- End of picture text -----

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