Second Meeting of the Expert Committee on 23.04.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale in the country without due approval from office of DCG(I)

F.No. 4-01/2013-DC (Mise. 13-PSC -Pt-Meeting) Directorate General of Health Services Office of Drugs Controller General (India) FDC Division FDA Bhawan, ; - Kotla Road, New Delhi Dated: 7": To / 1. Dr. Santanu Tripathi, Prof. & Head, Dept. of Clinical & Experimental Pharmacology, School of Tropical Medicine, Chittaranjan Avenue, Kolkata - 700 012. 2. Dr. Surendra K, Sharma, Prof. & Head, Dept. of Medicine, AITIMS, Main Hospital, Ansari Nagar, Infront of Safdarjung Hospital, New Delhi - 110 029 3, Dr, Rajender Prasad, Prof. & Head, Dept. of Pulmonary Medicine, Vallabh Bhai Pate] Chest Institute, Guru Tegh Bahadur Road, University Enclave, New Delhi — 110 007 4, Dr. A.U. Athavale, Professor & Head of Chest Medicine & Chief of E.P.R.C, Seth GS Medical College & KEM Hospital, Mumbai 5, Dr, Usha Acharya, Prof. & Head, Dept. of Paediatrics, SMS Medical College, Jaipur Subject:- Second Meeting of the Expert Committee on 23.04.2014 at 11:00 a.m. to 6:00 p.m. in the Conference Room, 1" floor, FDA Bhawan, Kotla Road, Near National Bal Bhawan, New Delhi-110002, to examine the matters related to approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for manufacture for sale in the country without due approval from office of DCG(1) — 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 above. This office in the following proposals for approval of Fixed Dose Combinations seeks your expert _ opinion of Expert Committee as to whether based on the data submitted by the firm, these proposals can be approved. S.No. | Name of firi/ Institute Drug 1 Restech pharma chlorpheniramine maleate 2.5 mg + dextromethophan 5mg + dextromethophan HBr 50 mg + guaiphenesin 60 mg + ammonium chloride + menthol 1 mg Syrup 2 Naxpar pharma dextromethorphan hydrobromide 5 mg + phenylephrine HCI 5 mg + ammonium chloride $0 mg + menthol 2.5 mg syrup 3 1.DM pharma I.levocetrizine HC! 2.5 mg. + ambroxol HC] 60 mg +. phenylepherineHCi 5 mg + paracetamol 325 mg tablets 2,LevoCetrizine Dihydrochloride IP Smg +Phenylephrine HCI IP 2.BRD Medilabs Smg +Ambroxol IP 30mg +Paracetamol IP 325mg Tablets 3,LevoCetrizine Dihydrochloride 2.5mg +Phenylephrine HCL Sing +Paracetamol 325mg +Ambroxol 60mg Uncoated Tablet 3.Tee & TEE Health care 4.LevoCetrizine HCl IP Smg +Ambroxel HC! IP 30mg +Phenylephrine HCL IP Smg +Paracetamol IP 325mg Tablets 4.Rivpra Formulations 5.LevoCetrizine HC] IP 2.5mg/Smg +Paracetamol — IP 325mg/S00mg +Ambroxol Help IP 30mg/60mg +Phenylephrine 5.Arion Healthcare HC] IP Smg Uncoated tablet :6.LevoCetrizine HCl IP 2.5mg/2.5mg +Phenylephrine HCl IP Smg/l0mg +Ambroxol HCI IP 60mg/60mg +Paracetamol IP 6.Akums Drugs & 500mg/325mg Tablets Pharmaceuticals 7.LevoCetrizine HCl IP Smg +Phenylephrine HCl IP Smg 7.Noel Pharma +Ambroxol HCI IP 30mg +Paracetamol IP 325mg Uncoated Tablets 8.LevoCetrizine HCl IP 5mg +Phenylephrine HCl IP Smg 8.Unix Biotech +Ambroxol HCI IP 60mg +Paracetamol IP 325mg Tablets 9.Windlas Biotech 9.LevoCetrizine HC! 2.5mg +Paracetamo! 325mg +Phenylephrine HCI 10mg +Ambroxol HC! 30mg Tablets 10.LevoCetrizine HC! 5Smg +Phenylephrine HCI smg 10.Cipla Ltd., +Ambroxol HCI 30mg +Paracetamol 325mg Tablets 11.Logos Pharma 11.LevoCetrizine IP 2.5mg +Phenylephrine IP Smg +Ambroxol IP 60mg +Paracetamol IP 325mg Uncoated Tablets 12.Paracetamol IP 500mg/325mg +Levocetrizine HCl IP 12.Akums Drugs & | 2 IP. 5 6m 0g m/ gS /m 3g 0 m+ gPh Te an by ll ee tp shrine HCL IP S5mg/Smg +Ambroxol HCl Pharmaceuticals Ltd - 4 PA hk au rm mas c euticalsD r Ltu dg s .& | +L Pev ho eC ne yt lr pi hz ei rn ie n e H He el l II PP Sm2 g.5 m +Pg a ra+ cA em tb ar mo ox l ol IP 2H 5cl 0 mgI P p er3 0 Sm mig Suspension 5 P1 h. aA rk mu acm es u ticals Drugs & | +1 P. hP ea nr yac le et pa hm ro il n eI HP CI3 I2 P5 m Sg m g+ TC ah bl lo er tp sheniramine Maleate IP 2mg 2.Suncare Formulations 2.Paracetamol IP 325mg +Phenylephrine HCi IP 5mg +Chlorpheniramine Maleate IP 2mg Solid Oral/Tablets 3.phenylephrine hydrochloride 5 mg + chlorpheniramine maleate 3.Ravian life science 4 mg + paracetamol 325 mg uncoated tablet 4, Wallace Pharmaceuticals 4.Paracetamol 325mg +Phenylephrine HCL 10mg +Chlorampheniramine Maleate 2mg Tablet 5.Swiss Garnier 5.Paracetamol 250mg +Phenylephrine HCL 2.5mg +Chlorampheniramine Maleate Img Tablet 6 P1 h. aA rk mu acm es u ticals D Lr tu d gs & | S1 u. lA pc he ab tr eo p Ih Py l 1l ,i 2n 5e m g5 0 pem rg S m+ lG u Sa yi rp uh penesin [P 50mg +Terbutaline 2.Aeon Formulations 2.Terbutaline — Sulphate {25mg +Acebrophyiline 50mg +Guaiphenesin 50mg Syrup 7 Phoenix Biologicals Acebrophylline 200mg +Montelukast Sodium IP 10mg 8 Sun Pharmaceuticals Industries A+ cD ee bs rl oo pr ha yt la ld li in ne e S m 2g 0 F 0i ml gm Co +a Mt oe nd t eB li ul ka ay se tre d ST oab dl ie ut ms IP eq. to Montelukast 10mg Tablets 9 Psychotropics India Acetaminophen 125mg +Guaiphenesin 25mg +Dexttomethorphan Hydrobromide 7.5mg +Chlorpheniramine Maleate Smg/Img Syrup 10 i.RPG life science 1.Acetaminophen 500mg +Phenylephrine HCL 10mg +Chlorpheniramine Maleate 2mg +Caffeine 30mg Tablet 2.Caffeine (Anhydrous) IP 30mg +Paracetamol IP 35mg 2.Pro Laboratories +Phenylephrine HCI IP 2.5mg +Chlorpheniramine Maleate [P2mg Uncoated tablet 3.Acme Lifesciences 3.Caffeine IP 30mg +Chlorpheniramine Maleate IP amg +Paracetamol JP 500mg +Phenylephrine HCl IP S5mg Uncoated Tablets 4.CIAN Healthcare 4.Chlorpheniramine Maleate IP 2mg +Phenylephrine HCI IP Smg +Paracetamol IP 325mg +Caffeine Anhydrous IP 30mg Uncoated Tablets 5.Micro labs Itd 5.paracetamol 325mg + phenylephrine HCL 10 mgt chlorpheniramine Maleate 2 mg + caffeine 30 mg tablets 6.AGIO pharmaceuticals 6.paracetamol 500 mg + phenylephrine hydrochloride 10 mg + 7,.Alembic Pharmaceuticals caffeine 30 mg + chlorpheniramine maleate 2mg uncoated tablet 7.Paracetamol IP 500mg/500mg +Chlorpheniramine Maleate IP 2mg/2mg +Phenylephrine HCl IP 10mg/Smg +Caffeine IP 30mg/30mg Uncoated Tablets 8.Akums Drugs Pharmaceuticals 8.Paracetamol IP S500mg/S00mg +Phenylephrine HC! IP 10mg/10mg +Caffeine IP 32mg +Chlorpheniramine Maleate IP 2mg Combikit (Film Coated Tablets) 9.Kaizen Pharmaceuticals 9.Paracetamol IP 325mg +Phenylephrine HCI IP 5mg +Caffeine IP 16mg +Chlorpheniramine Maleate IP 2mg Uncoated Tablets 10.BRD Medilabs- | 10.Paracetamol IP 325mg +Phenylephrine HCl IP 10mg +Chlorpheniramine Maleate IP 2mg +Caffeine anhydrous IP 30mg Tablets 11.Sain Medicaments 11.Paracetamol IP 325mg +Phenylephrine HCI IP Smg +Chiorpheniramine Maleate IP 2mg++Caffeine anhydrous IP 30mg Film Coated Tablets ; 12.Swiss Garnier 12.Paracetamol IP 325mg +Phenylephrine HCL. IP 10mg +Chlorpheniramine Maleate IP 2mg +Caffeine IP 30mg Uncoated tablets 13.GENPHARMA 13.paracetamol 325mg + phenylephrine hydrochloride 10 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg uncoated tablet 14.Noel Pharma +1 C4 h. lP oar ra pc he et na im ro al m ine 32 Ma5 lm eg a te + 2P mh gen y +l Ce ap fh fe er ii nn ee 30mH gC ! Unco1 a0 tm eg d tablet 15,Paracetamol 500mg +Phenylepherine HCI 5mg 15.Agron Remedies +Chlorpheniramine Maleate 2mg +Caffeine 30mg Tablets 16.Akums drugs & 16.Paracetamol 500mg/S00mg/325mg +Phenylephrine HCL pharmaceuticals 10mg/10mg/10mg +Chlorpheniramine Maleate 2.5ng/Smg/Smg + caffeine 30mg/30mg/30mg Film coated tablet 17.Paracetamol 500/500/325/325/325/325/325me 17.Akums Drugs & +Phenylephrine HCL 5/5/5/10/10/10mg —+Chlorpheniramine Pharmaceuticals Maleate 2/2/2/4/2/4mg + caffeine 15/20/30/16/30/15mg Tablet{S.RIVPRA Formulations 18.Paracetamol 325mg +Phenylphrine HC! {[P 10mg +Chlorpheniramine Maleate IP 4mg +Caffeine 20mg Uncoated Tabiets 19.Shiva Biogenetic 19,Phenylephrine HC] IP 5mg +Chlorpheniramine Maleate IP Pharmaceutica 2mg +Cafteine IP 20mg/30mg +Paracetamol [P 325mg Tablets ‘LL.MDC Pharmaceuticals L.Acetyl Cysteine BP 300mg +Ambroxol HCl IP 30mg Film Coated Tablets 2.Ambroxol HCI IP 30mg +Acetyl-Cysteine USP 300mg Film 2,Symbiotic Drugs & Diabetic Coated Tablets : 3.Akums Drugs & 3.Ambroxol Hydrochloride IP 30mg +N-Acetyl L-Cysteine USP Pharmaceuticals Ltd 300mg Tablets 4.Healer's Lab 4.Acetyicysteine BP 300mg +Ambroxol HCI IP 30mg Uncoated Tablets 12 swiss garnier Acetylcysteine 300mg + ambroxol hydrochloride 60 mg hard ; gelatin capsules : 13 1.Prim research laboratories Montelukast sodium 10 mg + levocetrizine dihydrochloride Smg + ambroxol hydrochloride 60 mg film coated tablet : Montelukast Sodium IP 10mg +LevoCetrizine Dihydrochtoride 2.Safetab Life Science IP Smg +Ambroxol HC! IP 75mg Uncoated Bilayered Tablets 3.GKM New Pharma ‘Montelukast Sodium 10mg +LevoCetrizine HCl IP Smg +Ambroxol HCL IP 75mg Uncoated Tablets LevoCetrizine HCI 5mg +Montelukast Sodium IP eq. to 4.Sozin Flora Pharma Montelukast 10mg +Ambroxol HCI IP 75mg Tablets . A meeting has been convened on 23.04.2014 to evaluate thé above proposals, You are requested to kindly make it convenient to attend'the said meeting on the said date. TA/DA for attending the meeting as well as honorarium will be paid as per this Directorate’s Office Memorandum No. 4-01/2013-DC (Misc13-PSC) dated 03.02.2014. If travelled 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 are the authorized Govt. agent for this purpose. You are requested kindly to make it convenient to attend the said meeting on 23.04.2014 at 1 1:00 a.m. to 6:00 p.m. in the Conference Room, 1* floor, FDA Bhawan, Kotla Road, Near National BaiBhawan, New Delhi-110002. You are requested to confirm your participation by e-mail at fdedivision@gmail.com. Yours faithfully, : (Dr. G.N. Singh) Drugs Controller, eneral (I)Copy to: M/s. Restech Pharma, B- 184/185, PIPDIC Industrial Estate, Mettupalayam, Pondicherry. P.C. - 605009.Pondicherry. M/s. Naxpar Pharma Pvt. Ltd. 104-107, Bldg. No.8, Jogani Industrial" Complex, Chunabhatti, Sion, Mumbai- 400 022. M/s. DM Pharma, NH 21-A, Bhud, Baddi, Soian (H.P.) 173205. M/s. BRD MediLabs, Mr. Rahul Bansal, No. 23, DIC Industrial Area, Baddi, Himachal Pradesh - 173 205. M/s Rivpra Formulation Pvt Ltd, Plot No. 08, Sec- 6A, ITE SIDCUL, BHEL Industrial Area, Ranipur, Haridwar - 249403, Uttranchal. M/s. Arion Healthcare Private Limited, Mr. Abhay Jain, SCO 907, 2nd Floor, N.A.C., Manimajra, Chandigarh - 160017, Chandigarh. M/s, Akums Drugs & Pharmaceuticals Ltd., 19 to 21, Sector 6-A, IIE, Ranipur, Haridwar. M/s, NOEL Pharma, 24- 85/7, Laxminarayana Nagar Colony, New I.D.A., Uppal, Hyderabad — 500 039, M/s. Unix Biotech,Mr. Asif Ali, Plot No. 27, Phase No. 1, E. P. I. P., Jharmajari, Baddi District, Solan - 173205, Himachal Pradesh. . M/s. Windlas Healthcare (P) Ltd., Plot No. 183 & 192, Mohabewala Industrial Area, Dehradun- 248110, Uttarakhand. . M/s. Cipla Limited, Mumbai Central, Mumbai-400008, . M/s. Logos Pharma Village Maissa Tibba, Tehsil Nalgarh, District-Solan -174 101, Himachal Pradesh. M/s. Suncare Formulations Pvt. Ltd., E-20, UPSIDC Industrial Area, Selakai, Dehradun - 248007, Uttarakhand. . M/s, Ravian Life Science Pvt. Ltd. Vivek Anand Shahi, Plot No. — 34, Sector 8a, SIDCUL, LIE, Haridwar — 249403, Uttarakhand . M/s. Wallace Pharmaceuticals Ltd. B-307/312, Floral Deck Plaza, Off. Central MIDC Road, Andheri (East), Mumbai - 400 093. . M/s. Swiss Garnier Life Sciences, No, 21-23 Industrial Area Mehatpur, Dist. UNA, H.P. 174315. . M/s. Aeon Formulations Pvt. Ltd., R.S. No. 515/2 & $15/2 & 514, no, 152/7, Vinayagar Koil Stret, Thirubuvanaipalayam, Mannadipet Commune, Puducherry-605107. . M/s. Phoenix Biologicals Pvt Ltd., R.S No. 135/2B, Kotha Puri, Natham Road, Thiruvondar Koil, - Puducherri, 605107. 19, M/s. Psychotropics India Limited, A-32; Sector -11, Opposite G. E, Motors, Faridabad, Haryana — 121007. 20, M/s, Sun Pharmaceuticals Industries Ltd., Tandalja, Vadodara-390020. 21. M/s. RPG Lifesciences Ltd., 25, MIDC Land, thane Belapur Road, Navi Mumbai-400705. 22. M/s. Pro Laboratories Pvt. Pvt. Ltd., 140-141, Makkanpur, Bhagwanpur, Roorkee Dist Haridwar, Haridwar Uttrakhand, Haridwar — 249401. 23, M/s Rivpra Formulation Pvt Ltd, Plot No. 08, Sec- 6A, HE SIDCUL, BHEL Industrial Area, Ranipur, Haridwar - 249403, Uttranchal. 24, M/s. Shiva Biogenetic Pharmaceuticals Pvt. Ltd., Village Manpura, Nalagarh, District Solan, Near Le Meriot Hotel, Baddi - 174101, Himachal Pradesh. 25. M/s. MDC Pharmacueticals Pvt. Limited, Plot No. 213, Industrial Area, Phase I, Chandigarh- 160002. 26. M/s. Symbiotic Drugs & Diabetic Care Pvt. Lid., Jharmajri Baddi, Dist. Solan, Himachal Pradesh-173205. 27, M/s. Healers Lab, Plot No. 112, HPSIDC, Baddi - 173205, Himachal Pradesh. 28. Safetab Life Sciences, Plot No. A-67 & 68, Electronic Park, Thirubuvanai, Tamil Nadu. 29. Prim Research Laboratories, Sujam Formulations Pvt Ltd, No 68/137,2nd floor, Kundrathur Road, Porur, Chennai - 600 116, Tamil nadu, Sozin Flora, Nr. Govt. School , Nahan Road 30. , Village Moginand, Kala Amb, Distt. Sirmour,- 173030 , Himachal Pradesh.31. M/s. GKM New Pharma, Spl. Type Plot No. 5, 6, 7 and 8; PIPDIC Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry-605 107. , Note for 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 CDSCO on 23.04.2014 at 11:00 a.m. to 6:00 p.m. in the Conference Room, I* floor, FDA Bhawan, Kotla Road, Near National Bal Bhawan, - NAleswo Dreeqluheis -t e1d1 0t o0 s0u2b tmoi tm atkhee cporpeyse ontfa tthieo np raess cenotnastiidoenr eodf ntehcee rsessapreyc tbiyv et hper coopmosmailtst eeb.efore 3 days of the meeting date. - Also requested to bring Drug Samples in original pack as well as package insert while coming for presentation. - Any oe wawwopachinens tka Anete. appls¢cl alee FRCL ttey aloe prercesl . Yours faithfully, (Dr. GN. Singh) . Drugs Controlley/General (D