DGFT Committee Minutes
Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi 110011
Para 4.7 Officewise Statement
MEETING NUMBER : 15/82ALC4/2007 MEETING DATE : 14.08.2007 1
Case No.:10/20/87ALC1/2005
Party Name:ALKALOIDS CORP Meet No/Date:15/82ALC4/2007 14.08.2007 Status:Case Deferred HQ File :01/87/050/00429/AM06/ RLA File :02/24/040/00081/AM06/ Lic.No/Date:0210080076 15.07.2005 Defer Date:11.09.2007 Decision :The Committee considered the case as per agenda for ratification of norms for the export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. The Committee decided to defer the case for four weeks for want of comments from the Department of Ayush. 2
Case No.:39/38/82ALC1/2005
Party Name:LUPIN LIMITED 14.08.2007 Status:Case Withdrawn HQ File :01/82/050/01028/AM06/ RLA File :03/95/040/01052/AM06/ Lic.No/Date:0310358437 06.12.2005 Decision : Withdrawn as the case has already been approved by NC in its 13/08 meeting held on 31.07.2007. 3
Case No.:8/39/87ALC1/2005
Party Name:SURYA PHARMACEUTICAL LIMITED 14.08.2007 Status:Case Withdrawn HQ File :01/87/050/01083/AM06/ RLA File :22/24/040/00045/AM06/ Lic.No/Date:2210005064 12.12.2005 Decision : Withdrawn as the case has already been approved by NC in its 13/08 meeting held on 31.07.2007. 4
Case No.:7/47/83ALC1/2005
Party Name:UNIMARK REMEDIES LIMITED., 14.08.2007 Status:Case Withdrawn HQ File :01/83/050/00639/AM06/ RLA File :03/95/040/01284/AM06/ Lic.No/Date:0310365479 01.02.2006 Decision : Withdrawn as the case has already been approved by NC in its 13/08 meeting held on 31.07.2007.
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Case No.:31/47/82ALC1/2005
Party Name:CALYX CHEMICALS & PHARMACEUTICALS PVT.LTD. 14.08.2007 Status:Case Deferred HQ File :01/82/050/01335/AM06/ RLA File :03/94/040/01210/AM06/ Lic.No/Date:0310365692 03.02.2006 Defer Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Coenzyme Q10 under para 4.7 of HBP. The Committee was informed by Department of BioTechnology vide their letter No.BT/IL/05/231/06/2006PID dated 20.07.2007 that the export product is chemical product and not biotech product. The Committee, therefore decided to forward copy of the application alongwith copy of letter received from Department of Biotechnology to PI Division. The Committee also decided to call for production and consumption data certified by the Central Excise Authority from the firm. Accordingly, the case was deferred for six weeks. 6
Case No.:8/10/87ALC1/2006
Party Name:ALKALOIDS CORP 14.08.2007 Status:Case Deferred HQ File :01/87/050/00096/AM07/ RLA File :02/24/040/00020/AM07/ Lic.No/Date:0210088734 28.04.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Aescin (Horse Chestnut Extract) The Committee decided to remind Department of Department of Ayush and defer the case for four weeks. 7
Case No.:39/9/82ALC1/2006
Party Name:KDL BIOTECH LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/00209/AM07/ RLA File :03/94/040/00021/AM07/ Lic.No/Date:0310379882 10.05.2006 Defer Date:28.08.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product FluCloxacillin Sodium BP/USP/EP under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, accordingly decided to defer the case for two weeks. 8
Case No.:4/14/82ALC1/2006
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:15/82ALC4/2007 14.08.2007 Status:Case Approved HQ File :01/82/050/00215/AM07/ RLA File :09/24/040/00511/AM06/ Lic.No/Date:0910026249 11.05.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product (4RCis)1, 1Dimethylethyl6(2 amino ethyl)2,2dimethyl1,3dioxane4acetate under para 4.7 of HBP.
The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/49/2007PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: (4Rcis)1,1dimethyl ethyl6(2amino ethyl) 2,2 dimethyl1,3 dioxane4acetate1Kg. Import items: 1. (4Rcis)1,1dimethylethyl6cyno methyl2,2 dimethyl1,3 dioxane4acetate1.05kg/kg 2. Raney nickel0.510kg/kg 3. Methanol2.99kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 9
Case No.:25/14/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 14.08.2007 Status:Case Approved HQ File :01/83/050/00268/AM07/ RLA File :05/24/040/00021/AM07/ Lic.No/Date:0510183618 29.05.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Cloxacillin Sodium BP (Pen G Route) under para 4.7 of HBP. The Committee in light of the report of the Deptt. of C&PC forwarded vide their U.O.No.35011/165/2006/PIIII(PartIV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm whichever is lower. Export product Cloxacillin Sodium from Pen G route1kg Import items 1. Penicillin G Potassium first crystal1.43 BOU 2. Penicillin G Amidase (Enzyme)0.732gm 3. Methylene chloride0.407kg 4. Acetone0.1254kg 5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR 5.a) Ochloro Benzaldehyde0.5034kg b) Hydroxy Amine Sulphate0.3192kg c) Methyl Acetoacetate0.410kg d) Chloroform0.270kg e) Methylene chloride0.0542kg
6. Methylene Chloride/Ethyl Acetate0.620kg 7. 2Ethyl Hexanoic acid0.150kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 10
Case No.:1/23/87ALC1/2006
Party Name:ALCHEM INTERNATIONAL LTD. 14.08.2007 Status:Case Deferred HQ File :01/87/050/00336/AM07/ RLA File :05/24/040/00255/AM07/ Lic.No/Date:0510185276 21.06.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Silymarin Extract under para 4.7 of HBP. The Committee decided to defer the case for four weeks for want of comments from Department of Ayush. 11
Case No.:24/20/82ALC1/2006
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.08.2007 Status:Case Transferred HQ File :01/82/050/00533/AM07/ RLA File :07/24/040/00220/AM07/ Lic.No/Date:0710045973 11.07.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Magnesium Orotate (Dihydrate) The Committee noted that the export product is a Calcium Nutrient but not a bulk drug. Moreover, the copy of DML has not been received. The Committee, therefore, decided to transfer the case to DESIV. 12
Case No.:25/20/82ALC1/2006
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.08.2007 Status:Case Transferred HQ File :01/82/050/00534/AM07/ RLA File :07/24/040/00145/AM07/ Lic.No/Date:0710045974 11.07.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Potassium Citrate, Calcium Citrate and Zinc Citrate under para 4.7 of HBP. The Committee noted that the export product is Nutrient but not a bulk drug. Moreover, the copy of DML has not been received. The Committee, therefore, decided to transfer the case to DESIV. 13
Case No.:2/34/82ALC1/2006
Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 14.08.2007 Status:Case Deferred
HQ File :01/82/050/00593/AM07/ RLA File :08/24/040/00247/AM06/ Lic.No/Date:0810058323 24.07.2006 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 1Carbethoxy Ethylidene Triphenyl Phosphorance under para 4.7 of HBP. The Committee decided to call for the End Use of the export product alongwith supporting technical literature from the firm. Accordingly, it was decided to defer the case for four weeks. 14
Case No.:16/27/87ALC1/2006
Party Name:ALKALOIDS CORP 14.08.2007 Status:Case Deferred HQ File :01/87/050/00419/AM07/ RLA File :02/24/040/00123/AM07/ Lic.No/Date:0210092125 02.08.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Kola Extract under para 4.7 of HBP. The Committee decided to remind Deptt. of Ayush and defer the case for four weeks. 15
Case No.:17/31/82ALC1/2006
Party Name:GLENMARK PHARMACEUTICALS LTD., 14.08.2007 Status:Case Deferred HQ File :01/82/050/00911/AM07/ RLA File :03/94/040/00615/AM07/ Lic.No/Date:0310399069 12.09.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Terbinafine Hcl Tablets 250mg (Terbinafine Hcl equivalent qty. 1873Kgs30s Packs) and Terbinafine Hcl Tablets 250mg (Terbinafine Hcl equi. Qty. 312Kgs100s Packs) The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, therefore, decided to defer the case for four weeks. 16
Case No.:5/32/82ALC1/2006
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.08.2007 Status:Case Transferred HQ File :01/82/050/01096/AM07/ RLA File :07/24/040/00412/AM07/ Lic.No/Date:0710047697 05.10.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Calcium Levulinate under para 4.7 of HBP. The Committee observed that the firm themselves has declared that the export product can be used for the preparation of various organic mineral Salts and can be used as Mineral supplements. Hence the export product is not a bulk drug. Moreover, the copy of DML has not been received. The Committee, therefore, decided to transfer the case to DESIV.
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Case No.:24/32/82ALC1/2006
Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, 14.08.2007 Status:Case Withdrawn HQ File :01/82/050/01101/AM07/ RLA File :03/94/040/00703/AM07/ Lic.No/Date:0310402830 06.10.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product LNorephedrine Base under para 4.7 of HBP. Withdrawn as the case has already been rejected by NC in its 8/08 meeting held on 28.06.2007. 18
Case No.:10/32/82ALC1/2006
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.08.2007 Status:Case Transferred HQ File :01/82/050/01118/AM07/ RLA File :07/24/040/00413/AM07/ Lic.No/Date:0710047772 09.10.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Zinc Gluconate etc. under para 4.7 of HBP. The Committee noted that the export product is a Gluconate and Minerals but not a bulk drug. Moreover, the copy of DML has not been received. The Committee, therefore, decided to transfer the case to DESIV. 19
Case No.:31/34/87ALC1/2006
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 14.08.2007 Status:Case Deferred HQ File :01/87/050/00637/AM07/ RLA File :04/24/040/00252/AM07/ Lic.No/Date:0410084952 17.10.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 10Methoxy Imino Stilbene under
para 4.7 of HBP.
The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, therefore, decided to defer the case for four weeks. 20
Case No.:2/46/87ALC1/2006
Party Name:AVON ORGANICS LTD., 14.08.2007 Status:Case Deferred HQ File :01/87/050/00663/AM07/ RLA File :09/24/040/00271/AM07/ Lic.No/Date:0910027981 30.10.2006 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 5Acetyl Amino Benzimidazolone (AABZ) or 5Aceto Acetyl Amino Benzimidazolone2 (AABI) under para 4.7 of HBP.
The Committee observed that NCI has forwarded the copy of application to Department of Chemicals & Petrochem, while the export product is Pharmaceutical item. The application should have been forwarded to PI Division. The Committee, therefore decided to forward the application to PI Division for their comments. It was accordingly decided to defer the case for four weeks. 21
Case No.:3/44/82ALC1/2006
Party Name:GULF OIL CORPORATION LIMITED. 14.08.2007 Status:Case Deferred HQ File :01/82/050/01214/AM07/ RLA File :09/24/040/00174/AM07/ Lic.No/Date:0910028004 31.10.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Fexofenadine Hcl under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, therefore, decided to defer the case for four weeks. 22
Case No.:4/44/82ALC1/2006
Party Name:GULF OIL CORPORATION LIMITED. 14.08.2007 Status:Case Deferred HQ File :01/82/050/01215/AM07/ RLA File :09/24/040/00194/AM07/ Lic.No/Date:0910028005 31.10.2006 Defer Date:28.08.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Sodium Cromo Glycate under para 4.7 of HBP. The Committee observed that the firm was requested to furnish End Use of the export product and copy of DML, but the same has not been received. The Committee therefore decided to await the reply and defer the case for two weeks. 23
Case No.:17/37/87ALC1/2006
Party Name:AVENTIS PHARMA LIMITED 14.08.2007 Status:Case Deferred HQ File :01/87/050/00684/AM07/ RLA File :03/94/040/00824/AM07/ Lic.No/Date:0310406387 02.11.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Articaine Hcl under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, therefore, decided to defer the case for four weeks. 24
Case No.:12/45/87ALC1/2006
Party Name:AUROBINDO PHARMA LIMITED 14.08.2007 Status:Case Deferred HQ File :01/87/050/00747/AM07/ RLA File :09/24/040/00128/AM07/ Lic.No/Date:0910028249 17.11.2006 Defer Date:11.09.2007
Decision : The Committee considered the case as per agenda for ratification of norms for the export product Sterile Ampmicillin Sodium+Salbactam Sodium (2:1) under para 4.7 of HBP. The Committee decided to call for the production and consumption date certified by the Central Excise Authority from firm and Pharmexcil for revision of SION at Sl.No.A2114 and A2121. The Committee also decided to defer this case for four weeks. 25
Case No.:8/44/82ALC1/2006
Party Name:M/S.ENAL DRUGS PVT LTD., 14.08.2007 Status:Case Deferred HQ File :01/82/050/01307/AM07/ RLA File :09/24/040/00237/AM07/ Lic.No/Date:0910028243 17.11.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 2Chloro Methyl3, Methyl 4(2,2,2 Trifluoro Ethoxy) Pyridine Hcl (Lansoprazole Chloro Compound) Powder under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, therefore, decided to defer the case for four weeks. 26
Case No.:2/38/82ALC1/2006
Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED 14.08.2007 Status:Case Transferred HQ File :01/82/050/01322/AM07/ RLA File :03/94/040/00923/AM07/ Lic.No/Date:0310408850 21.11.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Fluazinam echnical Min 98% The Committee decided to transfer the case to DESIV as the export product is from Chemical Sector. 27
Case No.:23/36/82ALC1/2006
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.08.2007 Status:Case Transferred HQ File :01/82/050/01314/AM07/ RLA File :07/24/040/00565/AM07/ Lic.No/Date:0710048577 22.11.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Magnesium Orottate Dihtdrate, Calcium Orotate Dihydrate, Potassium Orotate and Zinc Orotate Dihydrate under para 4.7 of HBP. The Committee noted that the export product is a Gluconate and Minerals but not a bulk drug. Moreover, the copy of DML has not been received. The Committee, therefore, decided to transfer the case to DESIV. 28
Case No.:2/46/82ALC1/2006
Party Name:MATRIX LABORATORIES LTD Status:Case
14.08.2007 Deferred HQ File :01/82/050/01441/AM07/ RLA File :09/24/040/00390/AM07/ Lic.No/Date:0910028634 13.12.2006 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product NTrifluoro AcetylNLysine Praline (Lyspro (Isolated) under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department. The Committee, therefore, decided to defer the case for four weeks. 29
Case No.:4/47/87ALC1/2006
Party Name:ASTRIX LABORATORIES LTD., 14.08.2007 Status:Case Deferred HQ File :01/87/050/00827/AM07/ RLA File :09/24/040/00359/AM07/ Lic.No/Date:0910028661 18.12.2006 Defer Date:28.08.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Lopinavir under para 4.7 of HBP. The Committee observed that the firm was requested to furnish some information, but the same has not been received. The Committee therefore decided to await the reply and defer the case for two weeks. 30
Case No.:14/43/82ALC1/2006
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.08.2007 Status:Case Transferred HQ File :01/82/050/01502/AM07/ RLA File :07/24/040/00655/AM07/ Lic.No/Date:0710049235 27.12.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Calcium Levulinate under para 4.7 of HBP. The Committee noted that the export product is used as Minerals and Nutrients but not a bulk drug. Moreover, the copy of DML has not been received. The Committee, therefore, decided to transfer the case to DESIV. 31
Case No.:18/46/82ALC1/2006
Party Name:FLORALE (INDIA) PVT. LTD., 14.08.2007 Status:Case Transferred HQ File :01/82/050/01580/AM07/ RLA File :07/24/040/00695/AM07/ Lic.No/Date:0710049625 18.01.2007 Decision : The Committee decided to transfer the case to DESVI as the export product pertains to Food Product sector. 32
Case No.:16/49/82ALC1/2006
Party Name:LUPIN LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/01721/AM07/ RLA File :03/95/040/01297/AM07/ Lic.No/Date:0310416716 Defer
22.01.2007 Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Sterile Ceftriazone SodiumNon Infringing under para 4.7 of HBP. The Committee decided to call for the production and consumption data duly certified by the Central Excise Authority from the firm as firm has stated that it is prepared using non infringing process. Accordingly, the case was deferred for six weeks. 33
Case No.:2/14/83ALC1/2007
Party Name:SRI GAYATHRI DRUGS PVT LTD. 14.08.2007 Status:Case Approved HQ File :01/83/050/01204/AM07/ RLA File :09/24/040/00447/AM07/ Lic.No/Date:0910029230 07.02.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 4(3,4Dichlorophenyl)3,4 dihydro1(2H)Naphthalenone (PID) under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that earlier the firm was allowed input @0.95kg/kg, while in the present application, the firm has applied the input @0.943kg/kg. The Committee, therefore, decided to ratify the norms under para 4.7 of HBP as applied by the firm. RLA Concerned may take further necessary action as per above decision of NC. 34
Case No.:3/4/82ALC1/2007
Party Name:HETERO LABS LTD. 14.08.2007 Status:Case Deferred HQ File :01/82/050/01648/AM07/ RLA File :09/24/040/00482/AM07/ Lic.No/Date:0910029348 15.02.2007 Defer Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Osel Tamivir Phosphate under
para 4.7 of HBP.
The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for six weeks. The Committee, therefore, decided to defer the case for six weeks. 35
Case No.:1/11/83ALC1/2007
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 14.08.2007 Status:Case Deferred HQ File :01/83/050/01270/AM07/ RLA File :03/95/040/01095/AM07/ Lic.No/Date:0310420522 22.02.2007 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Sertraline Hcl under para 4.7 of HBP.
The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/221/20060PIIII dated 14.08.2007 decided to call for the following information from the firm and also decided to defer the case for four weeks: 1. The firm have applied Alpha Naphthol @0.80kg/kg whereas the consumption coefficient of Tetralone indicated @3.73 kg/kg. Technical justification alongwith complete working for the above may be furnished. 2. The firm has given chemical reactions. However molecular weight of each input and output, % yield on molar basis for each step is not given. The same may be furnished. 3. Requirement and recovery of solvents may be given for each step. 4. Molecular weight of Sertraline Hcl is shown as 341 whereas it is indicated as 342.70 in the literature. The discrepancy may be explained. 36
Case No.:6/16/83ALC1/2007
Party Name:SODIUM METAL (P) LTD 14.08.2007 Status:Case Approved HQ File :01/83/050/01275/AM07/ RLA File :34/24/040/00268/AM07/ Lic.No/Date:3410018173 26.02.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 1,1Cyclohexane Diacetic Acid Monoamide under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/187/2006PIIII dated 08.08.2006 in the case of M/S Rampex Labs Pvt. Ltd, decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 1,1Cyclohexane Diacetic Acid Monoamide1Kg. Import items: 1,1 Cyclohexane Diacetic Acid1.12kg/kg RLA concerned may take further necessary action as per above decision of NC. 37
Case No.:22/50/83ALC1/2006
Party Name:SEQUENT SCIENTIFIC LIMITED 14.08.2007 Status:Case Approved HQ File :01/83/050/01286/AM07/ RLA File :03/95/040/01482/AM07/ Lic.No/Date:0310421169 27.02.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Chloropropiophenone under para 4.7 of HBP. The Committee observed that the complete description of the export is 3Chloropropiophenone and SION for this product has been fixed at Sl.No.A3405. The Committee, therefore decided to ratify the norms under para 4.7 of HBP as per SION at Sl.No.A3405.
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Case No.:3/1/87ALC1/2007
Party Name:AVON ORGANICS LTD., 14.08.2007 Status:Case Deferred HQ File :01/87/050/01107/AM07/ RLA File :09/24/040/00487/AM07/ Lic.No/Date:0910029668 14.03.2007 Defer Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 5Aceto Acetyl Amino Benzimidazo under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department 39
Case No.:43/9/82ALC4/2007
Party Name:KOPRAN LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/01818/AM07/ RLA File :03/94/040/01416/AM07/ Lic.No/Date:0310423486 16.03.2007 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Clarithromycin EP/USP under
para 4.7 of HBP.
The Committee decided to defer the case for four weeks. 40
Case No.:1/15/82ALC4/2007
Party Name:CHEMSHEL ENTERPRISES PVT.LTD., 14.08.2007 Status:Case Transferred HQ File :01/82/050/01841/AM07/ RLA File :02/24/040/00357/AM07/ Lic.No/Date:0210099250 21.03.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Aleuritic Acid under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector. 41
Case No.:17/9/82ALC4/2007
Party Name:CIPLA LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/01837/AM07/ RLA File :03/94/040/01468/AM07/ Lic.No/Date:0310423777 21.03.2007 Defer Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Exemestane under para 4.7 of HBP.
The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department 42
Case No.:19/9/82ALC4/2007
Party Name:DIVIS LABORATORIES LTD., 14.08.2007 Status:Case Deferred HQ File :01/82/050/01846/AM07/ RLA File :09/24/040/00523/AM07/ Lic.No/Date:0910029739 22.03.2007 Defer Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Carvedilol under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department 43
Case No.:20/9/82ALC4/2007
Party Name:CONCORD BIOTECH LTD 14.08.2007 Status:Case Deferred HQ File :01/82/050/01863/AM07/ RLA File :08/24/040/00356/AM07/ Lic.No/Date:0810063862 26.03.2007 Defer Date:25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Vamcomycin Hcl under para 4.7 of HBP. The Committee observed that the firm intends to import only consumables and not raw material. The Committee, therefore, decided to seek the comments of Policy Division. Accordingly, the case was deferred for six weeks. 44
Case No.:8/4/83ALC1/2007
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 14.08.2007 Status:Case Transferred HQ File :01/83/050/01379/AM07/ RLA File :03/95/040/01615/AM07/ Lic.No/Date:0310424638 27.03.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 8Quinolium under para 4.7 of HBP. The Committee observed that the application of the firm has been forwarded to Chemical Division by Norms Committee1. The Committee, therefore, decided to transfer the case to DESIV. 45
Case No.:9/4/83ALC1/2007
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 14.08.2007 Status:Case Approved HQ File :01/83/050/01380/AM07/ RLA File :03/95/040/01614/AM07/ Lic.No/Date:0310424641 27.03.2007
Decision : The Committee considered the case as per agenda for ratification of norms for the export product Ferrous Fumarate USP under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Ferrous Fumerate USP, Purity not less than 97%1Kg. Import items: 1. Furmeric Acid0.856kg/kg 2. Soda Ash0.944kg/kg 3. Ferrous Sulphate1.98kg/kg 46
Case No.:22/9/82ALC4/2007
Party Name:CIPLA LIMITED 14.08.2007 Status:Case Approved HQ File :01/82/050/01894/AM07/ RLA File :03/94/040/01500/AM07/ Lic.No/Date:0310424681 28.03.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Tylocip Powder 20%/Tylosin Soluble Powder 20% w/w under para 4.7 of HBP. The Committee decided to ratify the norms under para 4.7 of HBP as per details below; Export product: 1. Tylocip Powder 20%/Tylosin Soluble Powder 20% w/w (Pack size of 100GM) Each 10gm contains Tylosin Tartarate BP (Vet) 2.00gm560 Packs 2. Tylocip Powder 50%/Tylosin Soluble Powder 50% w/w (Pack Size of 100GM) Each 10gm contains Tylosin Tartarate BP(Vet) 5.00gm200 Packs Import item: Tylosin Tartarate BP (Vet)21.41kg
47
Case No.:2/4/82ALC4/2007
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 14.08.2007 Status:Case Transferred HQ File :01/82/050/01906/AM07/ RLA File :03/94/040/01515/AM07/ Lic.No/Date:0310424944 29.03.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Unylinker Nittomar Solid Support Loaded Support under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export product is a Polymer item and not Pharmaceutical product. 48
Case No.:23/9/82ALC4/2007
Party Name:LUPIN LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/01901/AM07/ RLA File :03/95/040/01622/AM07/ Lic.No/Date:0310424915 29.03.2007 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Cefpodoxime Proxetil under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks. 49
Case No.:6/11/82ALC4/2007
Party Name:DIVIS LABORATORIES LTD., 14.08.2007 Status:Case Deferred HQ File :01/82/050/01897/AM07/ RLA File :09/24/040/00529/AM07/ Lic.No/Date:0910029839 29.03.2007 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Cyclopentadecanolide (Recrystallised) under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks. 50
Case No.:2/3/82ALC4/2007
Party Name:ALEMBIC LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/00005/AM08/ RLA File :34/24/040/00301/AM07/ Lic.No/Date:3410018454 30.03.2007 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Azithromycin Crude under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.
51
Case No.:25/14/83ALC1/2007
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 14.08.2007 Status:Case Deferred HQ File :01/83/050/00016/AM08/ RLA File :04/24/040/00501/AM07/ Lic.No/Date:0410088727 02.04.2007 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Allylestrenol under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks. 52
Case No.:6/11/83ALC1/2007
Party Name:ALCHEM INTERNATIONAL LTD. 14.08.2007 Status:Case Approved HQ File :01/83/050/00049/AM08/ RLA File :05/24/040/01067/AM07/ Lic.No/Date:0510202037 02.04.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product HyoscineNButyl Bromide or Hyoscine Hydro Bromide under para 4.7 of HBP. The Committee in light of written comments forwarded by DC(SSI) vide their U.O. No.5(9)/2005chem dated 18.12.2006 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: HyoscineNButyl Bromide or Hyoscine Hydro Bromide1Kg. Import items: 1. Dubosia Leaves85Kg 2. Methylene Chloride68.55Kg 3. Methanol26.34Kg 53
Case No.:9/9/83ALC1/2007
Party Name:LACTOSE (INDIA) LTD., 14.08.2007 Status:Case Transferred HQ File :01/83/050/00024/AM08/ RLA File :03/95/040/01500/AM07/ Lic.No/Date:0310425398 02.04.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Lactose Monohydrate BP under
para 4.7 of HBP.
The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.
54
Case No.:13/7/83ALC1/2007
Party Name:NEULAND LABORATORIES LTD 14.08.2007 Status:Case Deferred HQ File :01/83/050/00086/AM08/ RLA File :09/24/040/00544/AM07/ Lic.No/Date:0910029937 10.04.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Ranitidine Hcl under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department 55
Case No.:9/13/83ALC1/2007
Party Name:KUMAR ORGANIC PRODUCTS LIMITED, 14.08.2007 Status:Case Deferred HQ File :01/83/050/00105/AM08/ RLA File :07/24/040/00020/AM08/ Lic.No/Date:0710051216 13.04.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Minoxidil under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department 56
Case No.:21/16/83ALC1/2007
Party Name:SURYA PHARMACEUTICAL LTD 14.08.2007 Status:Case Approved HQ File :01/83/050/00144/AM08/ RLA File :22/24/040/00004/AM08/ Lic.No/Date:2210006675 17.04.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Cefadroxil under para 4.7 of HBP. The Committee in light of Report forwarded by PI Division vide their U.O.35011/165/2006/PIIII dated 30.07.2007 decided to ratify the norms as per details below or as applied for by the firm whichever is lower. Export Product: Cefadroxil Monohydrate from Pen G Route1Kg. Import items: 1. Penicillin G Potassium 1st Crystal2.34BOU/Kg 2. Pyridine Hydrobromide0.320kg/kg OR Hydrobromic acid 48%0.375kg/kg
3. Hydrogen Peroxide 60%0.363kg/kg 4. Acetic Acid0.933kg/kg 5. Trimethyl chloro silane2.7027kg/kg OR 5(a). Bis trimethyl silyl urea1.543kg/kg 5(b). Hexamethyl disilazane0.3284kg/kg 6. Trimethyl chloro silane0.2180kg/kg 7. D()para hydroxy Phenyl glycine0.959kg/kg Methyl/etyl potassium dane salt OR 7(a). D() para hydroxyl Phenyl glycine base0.5402kg/kg 7(b). Methyl Aceto acetate0.4113kg/kg 7©. Methanol0.3370kg/kg 8. Dimethyl formamide2.051kg/kg 9. Toluene0.583kg/kg 10. Acetone1.1498kg/kg 11. Methylene chloride0.407kg/kg 12. Potassium carbonate0.2418kg/kg 13. Activated Carbon0.0839kg/kg 14. Ethyl Chloro formate0.357kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 57
Case No.:8/6/83ALC1/2007
Party Name:R L FINE CHEM 14.08.2007 Status:Case Approved HQ File :01/83/050/00123/AM08/ RLA File :07/24/040/00021/AM08/ Lic.No/Date:0710051273 17.04.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Methane Sulfonate of 10,11,DihydroN,N Betatrimethyl 5HDibenzo (B,F)Azepine5 Propanamine under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/49/2006PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower; Export product:
Methane Sulfonate of 10,11DihydroN,N, Betarimethyul5H Dibenz(B,F) Azepine5Propanamine1Kg. Import items: 1. 1 Bramo 3 chloro 2 methyl propane0.55kg/kg 2. Iminodibenzyl0.56kg/kg 58
Case No.:18/7/83ALC1/2007
Party Name:RESONANCE LABORATORIES PVT LTD 14.08.2007 Status:Case Deferred HQ File :01/83/050/00171/AM08/ RLA File :07/24/040/00048/AM08/ Lic.No/Date:0710051363 23.04.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 1[2,6 Dichloro 4(Trifluoromethyl) Phenyl]5[Pyridine2YL Methylene)Amino] 1HPyrazole3Carbonitrile (C6900) under para 4.7 of HBP. The Committee decided to forward copy of application to PI Division for their comments. The Committee also decided to defer the case for six weeks. 59
Case No.:9/11/83ALC1/2007
Party Name:RICHY GOLD INTERNATIONAL 14.08.2007 Status:Case Deferred HQ File :01/83/050/00341/AM08/ RLA File :03/95/040/00069/AM08/ Lic.No/Date:0310429618 16.05.2007 Defer Date: 28.08.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Methyl Dopa Tablet 250MG under
para 4.7 of HBP.
The Committee decided to defer the case for two weeks for want of comments of PI Division. 60
Case No.:34/9/82ALC4/2007
Party Name:AGIO PHARMACEUTICALS LTD 14.08.2007 Status:Case Deferred HQ File :01/82/050/00045/AM08/ RLA File :03/94/040/00082/AM08/ Lic.No/Date:0310430135 22.05.2007 Defer Date:11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Prednisolone Solution for Injection 30mg/1ml under para 4.7 of HBP. The Committee decided to remind the firm to get the export product amended from RLA and to furnish documentary evidence in this regard. The Committee also decided to defer the case for four weeks.
61
Case No.:37/16/83ALC1/2007
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 14.08.2007 Status:Case Deferred HQ File :01/83/050/00385/AM08/ RLA File :03/94/040/00170/AM08/ Lic.No/Date:0310430424 23.05.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Niclosamide Piperazine Salt under
para 4.7 of HBP.
The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department 62
Case No.:35/9/82ALC4/2007
Party Name:ALEMBIC LIMITED 14.08.2007 Status:Case Deferred HQ File :01/82/050/00051/AM08/ RLA File :34/24/040/00035/AM08/ Lic.No/Date:3410018854 28.05.2007 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Azithromycin Step3 under para 4.7 of HBP. The Committee observed that the firm has been requested to furnish complete chemical description of the export product which has not been received. The Committee, therefore, decided to await the reply of the firm and to defer the case for four weeks. 63
Case No.:2/15/82ALC4/2007
Party Name:NICHIPLAST INDIA PVT LTD. 14.08.2007 Status:Case Transferred HQ File :01/82/050/00063/AM08/ RLA File :05/24/040/00140/AM08/ Lic.No/Date:0510204505 05.06.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Dettol Medicated Fabric Plaster The Committee decided to transfer the case to DESVIII as the export product pertains to Plastic Sector. 64
Case No.:3/15/82ALC4/2007
Party Name:HARMAN FINOCHEM LTD. 14.08.2007 Status:Case Deferred HQ File :01/82/050/00103/AM08/ RLA File :03/94/040/00179/AM08/ Lic.No/Date:0310431949 07.06.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Phenobarbital (Phenobarbitone) The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department
Date:13.08.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer Minutes of the Norms Committee Meeting No.15/08 held on 14.08.2007 under the Chairmanship of Shri Sanjay Rastogi, Export Commissioner. The Committee first considered the minutes of the NC Meeting No.14/08 held on 07.08.2007 for confirmation and confirmed and adopted the same. The Committee considered each case as per agenda.
Case No.A460
M/S RA Chem Pharma Ltd. N.C. Meeting No.15/08 F.No.01/82/50/1335/AM’07/DESIII Meeting date: 14.08.2007 RLA F.No.09/24/40/463/AM07 Adv.Lic.No.0910029658 dated 14.03.2007 The Committee considered the case as per agenda for ratification of norms for the export product 2,3,Dichloro Benzoyl Cyanide under para 4.7 of HBP. The Committee in light of earlier decision of Norms Committee in its 14/08 meeting held on 07.08.2007 vide Case No.A424 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 2,3 Dichloro benzoyl cyanide1Kg. Import items: 1. 2,3 dichloro benzoyl chloride1.50kg/kg
2. Cuprous Cyanide0.70kg/kg 3. Hexane1.00kg/kg 4. Ortho dichloro benzeneNot allowed RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A461
M/S Unimark Remedies Ltd F.No.01/82/50/1206/AM07/DESIII RLA F.No.03/95/40/502/AM07 Adv.Lic.No.0310416918 dated 23.01.2007 the export product Cefprozil under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for six weeks. The Committee, therefore, decided to defer the case for six weeks.
Case No.A462
M/S Unimark Remedies Ltd F.No.01/82/50/1207/AM07/DESIII RLA F.No.03/95/40/934/AM07 Adv.Lic.No.0310416945 dated 23.01.2007 the export product Ethyl1,4 Dihydro7Methyl4one1,8Napthyridine3Carboxylate
Case No.A463
M/S R.L. Fine Chem F.No.01/82/50/176/AM08/DESIII RLA F.No.07/24/40/18/AM08 Adv.Lic.No.0710051369 dated 23.04.2007 the export product Oxo6,11Dihydro Dibenzo (BE) Thiepine under para 4.7 of HBP.
Case No.A464
M/S Rashmi Pharma Pvt. Ltd F.No.01/82/50/1327/AM07/DESIII RLA F.No.09/24/40/506/AM07 Adv.Lic.No.0910029625 dated 09.03.2007 the export product Orlistat Pellets 50% (Tetrahydro Lipstatin Pellets 50%) Pellets (Anti Obesity) under para 4.7 of HBP. The Committee in light of earlier decision taken in its 39/2006 meeting held on 10.01.2007 vide Case No.47/31/82 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is lower. Export Product: Orlistat Pellets 50%1Kg.
Import item: Olistat0.505kg/kg RLA concerned may take further necessary action as per above decision of Norms Committee.
Case No.A465
M/S Rantus Pharma Ltd F.No.01/82/50/1235/AM07/DESIII RLA F.No.09/24/40/401/AM07 Adv.Lic.No.0910029304 dated 12.02.2007 the export product Tramadol Crude under para 4.7 of HBP. The Committee decided to call for complete specification of the export product from the firm. The case was accordingly deferred for six weeks.
Case No.A466
M/S Unichem Laboratories Ltd. F.No.01/82/50/453/AM08/DESIII RLA F.No.03/95/40/143/AM08 Adv.Lic.No.0310431069 dated 30.05.2007 the export product Amlodipine Maleatate under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/232/2005PIIII dated 14.08.2007 decided to ratify the norms under
para 4.7 of HBP as per details below or as applied by the firm whichever is lower.
Export Product:
Amlodipine Maleate1Kg. Import items: 1. Phthaloyl Amlodipine1.08kg/kg 2. Methylene chloride4.50kg/kg 3. Isopropyl alcohol2.40kg/kg
Case No.A467
M/S Unichem Laboratories Ltd. F.No.01/82/50/1388/AM07/DESIII RLA F.No.03/95/40/1488/AM07 Adv.Lic.No.0310424905 dated 29.03.2007 the export product Amlodipine Maleatate under para 4.7 of HBP. U.O. No.35011/232/2005PIIII dated 14.08.2007 decided to ratify the norms under
para 4.7 of HBP as per details below or as applied by the firm whichever is lower.
Export Product: Amlodipine Maleate1Kg. Import items: 4. Phthaloyl Amlodipine1.08kg/kg 5. Methylene chloride4.50kg/kg 6. Isopropyl alcohol2.40kg/kg
Case No.A468
M/S Suven Life Science Ltd. F.No.01/82/50/84/AM08/DESIII RLA F.No.09/24/40/541/AM07 Adv.Lic.No.0910029935 dated 10.04.2007 the export product 5Cyano Phthalide under para 4.7 of HBP.
Case No.A469
M/S R.L. Fine Chem F.No.01/83/50/365/AM08/DESIII RLA F.No.07/24/40/16/AM08 Adv.Lic.No.0710051274 dated 17.04.2007 the export product Nortriptyline Hcl BP/USP under para 4.7 of HBP.
Case No.A470
M/S Satya Deeptha Pharmaceuticals Ltd F.No.01/82/50/1234/AM07/DESIII RLA F.No.09/24/40/430/AM07 Adv.Lic.No.0910029303 dated 12.02.2007
the export product 1,1Cyclohexane Diacetic Acid under para 4.7 of HBP.
Case No.A471
M/S Shilpa Medicare Ltd. F.No.01/83/50/1382/AM07/DESIII RLA F.No.07/24/40/879/AM07 Adv.Lic.No.0710050972 dated 29.03.2007 the export product N[BDRibofuranosyl]5Hydroxyimidazole4Carboxamide Technical Grade under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O. No.35011/159/2006PIIII dated 14.08.2007 decided to call for the following information from the firm and also decided to defer the case for six weeks: 1. Percentage yield on molar basis. 2. Material balance for the entire process. 3. Requirement & recovery of solvents of each step.
Case No.A472
M/S Dalas Biotech Ltd. F.No.01/82/50/223/AM08/DESIII RLA F.No.05/24/40/1078/AM07 Adv.Lic.No.0510203062 dated 27.04.2007
the export product 7Amino3Vinyl3Cephem4Carboxylic Acid Diphenyl Ester HCL (7AVCA) under para 4.7 of HBP. U.O. No.35011/18/2007PIIII dated 26.06.2007 in another case decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: 7AVCA (7Amino3vinylcephalosporanic acid1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 7Phenylacetamido3chloromethyl cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene Chloride 10.31kg/kg
Case No.A473
M/S DCM Shriram Industries Ltd. F.No.01/82/50/524/AM08/DESIII RLA F.No.05/24/40/166/AM08 Adv.Lic.No.0510204918 dated 14.06.2007 the export product D() Para Hydroxy Phenyl Glycine Dane Salt under para 4.7 of HBP.
Case No.A474
M/S Surya Pharmaceuticals Ltd F.No.01/82/50/90/AM08/DESIII RLA F.No.21/24/40/291/AM07 Adv.Lic.No.2210006400 dated 17.01.2007 the export product Sultamicillin Tosylate under para 4.7 of HBP.
Case No.A475
M/S PAB Organics Pvt. Ltd. F.No.01/83/50/1782/AM’07/DESIII RLA F.No.34/24/40/299/AM07 Adv.Lic.No.3410018452 dated 30.03.2007 the export product 2,3,Dichloro Benzoyl Cyanide under para 4.7 of HBP. The Committee in light of earlier decision of Norms Committee in its 14/08 meeting held on 07.08.2007 vide Case No.A424 decided to ratify the norms under para 4.7 of HBP as applied by the firm, only 1 item of import is allowed. Export product: 2,3 Dichloro benzoyl cyanide1Kg. Import items: 1. 2,3 dichloro benzoyl chloride1.50kg/kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A476
M/S Medreich Ltd. F.No.01/82/50/48/AM08/DESIII RLA F.No.07/24/40/810/AM07 Adv.Lic.No0710050467 dated 06.03.2007 the export product Paracetamol 450mg + Doxylamine Succinate 5mg + Caffeine 45mg + Codeine Phosphate 10mg Tablets under para 4.7 of HBP.
Case No.A477
M/S Neuland Laboratories Ltd. F.No.01/83/50/1337/AM07/DESIII RLA F.No.09/24/40/513/AM07 Adv.Lic.No.0910029660 dated 14.03.2007 the export product Moxifloxacin Hcl under para 4.7 of HBP. that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.
Case No.A478
M/S KDL Biotech Ltd. F.No.01/82/50/77/AM08/DESIII RLA F.No.03/94/40/1430/AM07 Adv.Lic.No.0310429938 dated 21.05.2007 the export product Cefadroxil under para 4.7 of HBP. The Committee in light of Report forwarded by PI Division vide their U.O.35011/165/2006/PIIII dated 30.07.2007 decided to ratify the norms as per details below or as applied for by the firm whichever is lower. Export Product: Cefadroxil Monohydrate from Pen G Route1Kg. Import items: 1. Penicillin G Potassium 1st Crystal2.34BOU/Kg 2. Pyridine Hydrobromide0.320kg/kg OR Hydrobromic acid 48%0.375kg/kg 3. Hydrogen Peroxide 60%0.363kg/kg 4. Acetic Acid0.933kg/kg 5. Trimethyl chloro silane2.7027kg/kg OR 5(a). Bis trimethyl silyl urea1.543kg/kg 5(b). Hexamethyl disilazane0.3284kg/kg 6. Trimethyl chloro silane0.2180kg/kg 7. D()para hydroxy Phenyl glycine0.959kg/kg Methyl/etyl potassium dane salt OR 7(a). D() para hydroxyl Phenyl glycine base0.5402kg/kg 7(b). Methyl Aceto acetate0.4113kg/kg 7©. Methanol0.3370kg/kg
8. Dimethyl formamide2.051kg/kg 9. Toluene0.583kg/kg 10. Acetone1.1498kg/kg 11. Methylene chloride0.407kg/kg 12. Potassium carbonate0.2418kg/kg 13. Activated Carbon0.0839kg/kg 14. Ethyl Chloro formate0.357kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee.
Case No.A479
M/S Nexuz Pharma Ltd. F.No.01/82/50/76/AM08/DESIII RLA F.No.08/24/40/317/AM07 Adv.Lic.No.0810062842 dated 09.02.2007 the export product Dexamethasone IP/BP/USP under para 4.7 of HBP.
Case No.A480
M/S Lyka BDR Intl. Ltd. F.No.01/82/50/89/AM08/DESIII RLA F.No.03/95/40/1309/AM07 Adv.Lic.No.0310419266 dated 12.02.2007
the export product Clobetasole Propionate Cream 10mg under para 4.7 of HBP.
Case No.A481
M/S IndSwift Laboratories Ltd. F.No.01/82/50/2/AM08/DESIII RLA F.No.22/24/40/297/AM07 Adv.Lic.No.2210006382dated 13.02.2007 the export product Ezethimibe under para 4.7 of HBP. that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.
Case No.A482
M/S Neuland Laboratories Ltd. F.No.01/83/50/170/AM08/DESIII RLA F.No.09/24/40/378/AM07 Adv.Lic.No.0910029084 dated 18.01.2007 the export product Levetiracetam under para 4.7 of HBP. that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.
Case No.A483
M/S Lepro Herbals Pvt. Ltd. F.No.01/83/50/469/AM08/DESIII RLA F.No.05/24/40/155/AM08 Adv.Lic.No.0510204504 dated 05.06.2007 the export product Griffonia Dry Extract under para 4.7 of HBP. The Committee decided to forward the copy of application to Department of Ayush for their comments. The case was accordingly deferred for six weeks.
Case No.A484
M/S Lupin Ltd. F.No.01/83/50/742/AM08/DESIII RLA F.No.03/95/40/276/AM08 Adv.Lic.No.0310433502 dated 22.06.2007 the export product Levetiracetam under para 4.7 of HBP.
Case No.A485
M/S Parabolic Drugs Ltd
F.No.01/83/50/1120/AM07/DESIII RLA F.No.22/24/40/284/AM07 Adv.Lic.No.2210006368 dated 10.01.2007 the export product Ampicillin Trihydrate under para 4.7 of HBP. The Committee decided to ratify the norms of the export product under para 4.7 of HBP. as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower. above decision of Norms Committee.
Case No.A486
M/S IndSwift Laboratories Ltd. F.No.01/83/50/675/AM08/DESIII RLA F.No.22/24/40/23/AM08 Adv.Lic.No.2210006857 dated 05.07.2007 the export product Atorvastatin Calcium under para 4.7 of HBP.
Case No.A487
M/S Ponalab F.No.01/83/50/640/AM08/DESIII RLA F.No.07/24/40/223/AM08 Adv.Lic.No.0710052285 dated 03.07.2007
the export product 8Hydroxyquinoline under para 4.7 of HBP.
Case No.A488
M/KDL Biotech Ltd. F.No.01/83/50/426/AM08/DESIII RLA F.No.03/94/40/1431/AM07 Adv.Lic.No.0310430868 dated 29.05.2007 the export product Cefadroxil under para 4.7 of HBP. The Committee in light of Report forwarded by PI Division vide their U.O.35011/165/2006/PIIII dated 30.07.2007 decided to ratify the norms as per details below or as applied for by the firm whichever is lower. Export Product: Cefadroxil Monohydrate from Pen G Route1Kg. Import items: 1. Penicillin G Potassium 1st Crystal2.34BOU/Kg 2. Pyridine Hydrobromide0.320kg/kg OR Hydrobromic acid 48%0.375kg/kg 3. Hydrogen Peroxide 60%0.363kg/kg 4. Acetic Acid0.933kg/kg 5. Trimethyl chloro silane2.7027kg/kg OR
5(a). Bis trimethyl silyl urea1.543kg/kg 5(b). Hexamethyl disilazane0.3284kg/kg 6. Trimethyl chloro silane0.2180kg/kg 7. D()para hydroxy Phenyl glycine0.959kg/kg Methyl/etyl potassium dane salt OR 7(a). D() para hydroxyl Phenyl glycine base0.5402kg/kg 7(b). Methyl Aceto acetate0.4113kg/kg 7©. Methanol0.3370kg/kg 8. Dimethyl formamide2.051kg/kg 9. Toluene0.583kg/kg 10. Acetone1.1498kg/kg 11. Methylene chloride0.407kg/kg 12. Potassium carbonate0.2418kg/kg 13. Activated Carbon0.0839kg/kg 14. Ethyl Chloro formate0.357kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee.
Case No.A489
M/S Lepro Herbals Pvt. Ltd. F.No.01/83/50/468/AM08/DESIII RLA F.No.05/24/40/131/AM08 Adv.Lic.No.0510204503 dated 05.06.2007 the export product Glycyrrhetinic Acid (18 Beta Glycyrrhetinic Acid) under para 4.7 of HBP. The Committee in light of the written comments of the Deptt. of C&PC forwarded vide their U.O.No.35011/163/2006PIIII dated 23.5.2007 decided to fix I/O Norms for
the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product: Glycyrrhetinic acid (18 Beta Glycyrrhetinic acid1kg Import item Glycyrrhizic acid2.70kg/kg above decision of Norms Committee.
Case No.A490
M/Lupin Ltd. F.No.01/83/50/743/AM08/DESIII RLA F.No.03/95/40/254/AM08 Adv.Lic.No.0310433506 dated 22.06.2007 the export product Cefadroxil under para 4.7 of HBP. The Committee in light of Report forwarded by PI Division vide their U.O.35011/165/2006/PIIII dated 30.07.2007 decided to ratify the norms as per details below or as applied for by the firm whichever is lower. Export Product: Cefadroxil Monohydrate from Pen G Route1Kg. Import items: 1. Penicillin G Potassium 1st Crystal2.34BOU/Kg 2. Pyridine Hydrobromide0.320kg/kg OR Hydrobromic acid 48%0.375kg/kg
3. Hydrogen Peroxide 60%0.363kg/kg 4. Acetic Acid0.933kg/kg 5. Trimethyl chloro silane2.7027kg/kg OR 5(a). Bis trimethyl silyl urea1.543kg/kg 5(b). Hexamethyl disilazane0.3284kg/kg 6. Trimethyl chloro silane0.2180kg/kg 7. D()para hydroxy Phenyl glycine0.959kg/kg Methyl/etyl potassium dane salt OR 7(a). D() para hydroxyl Phenyl glycine base0.5402kg/kg 7(b). Methyl Aceto acetate0.4113kg/kg 7©. Methanol0.3370kg/kg 8. Dimethyl formamide2.051kg/kg 9. Toluene0.583kg/kg 10. Acetone1.1498kg/kg 11. Methylene chloride0.407kg/kg 12. Potassium carbonate0.2418kg/kg 13. Activated Carbon0.0839kg/kg 14. Ethyl Chloro formate0.357kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee.
Case No.A491
M/S Cipla Ltd. F.No.01/82/162/169/AM08/DESIII RLA F.No.03/94/40/250/AM08 Adv.Lic.No.0310432136 dated 08.06.2007
the export product Stavir 15mg, 20mg, 30mg, 40mg Capsules and Lamvir S30, S40 Tablets under para 4.7 of HBP.
Case No.A492
M/S Honest Bio Pvt. Ltd. F.No.01/82/50/1761/AM07/DESIII RLA F.No.08/24/40/304/AM07 Adv.Lic.No.0810062375 dated 12.01.2007 the export product Chloroperoxybenzoic under para 4.7 of HBP. The Committee decided to forward the copy of application to PI Division for their comments. The case was accordingly deferred for four weeks.
Case No.A493
M/S Gulf Oil corporation. F.No.01/82/50/47/AM08/DESIII RLA F.No.09/24/40/538/AM07 Adv.Lic.No.0910028240 dated 17.11.2006 the export product Fexafenadine Hcl under para 4.7 of HBP.
Case No.A494
M/S Cadila Healthcare Ltd. F.No.01/82/162/182/AM08/DESIII RLA F.No.08/24/40/54/AM08 Adv.Lic.No.0810065287 dated 08.06.2007 the export product Simvastatin 5mg, 10mg, 20mg, 40mg and 80mg Tablets under para 4.7 of HBP. U.O. No.35011/73/2007PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Sl.No. Description of Export Product Quantity 1. Simvastatin 5mg tablets 94,95,640 Nos. 2. Simvastatin 10mg tablets 4,03,58,000 Nos. 3. Simvastatin 20mg tablets 13,30,98,000 Nos. 4. Simvastatin 40mg tablets 11,98,87,000 Nos. 5. Simvastatin 80mg tablets 3,19,42,250 Nos. Import items: Sl.No. Description of import item Quantity allowed 1. Simvastatin 10,673.15kg 2. Lactose anhydrous 76,530.69kg 3. Citric acid Anhydrous 1,472.54kg 4. Magnesium Stearate 999.05kg 5. Bottles & Caps (a to c) Relevant, As per packing policy. above decision of NC.
Case No.A495
M/S Cadila Healthcare Ltd. F.No.01/82/162/181/AM08/DESIII RLA F.No.08/24/40/53/AM08 Adv.Lic.No.0810065288 dated 08.06.2007 the export product Paroxetine 10mg, 20mg, 30mg and 40mg Tablets under para 4.7 of HBP. U.O. No.35011/73/2007PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Sl.No. Description of Export Product Quantity 1. Paroxetine 10mg tablets 4,62,25,000 Nos. 2. Paroxetine 20mg tablets 11,55,00,000 Nos. 3. Paroxetine 30mg tablets 3,39,35,000 Nos. 4. Paroxetine 40mg tablets 4,72,00,000 Nos. Import items: Sl.No. Description of import item Quantity allowed 1. Paroxetine hcl. Hemihydrate 5,740.76 Kg. 2. Lactose anhydrous NF 37,439.85 3. Diabasic calcium phosphate anhydrous USP 13,163.80 Kg. 4. Povidone K 30 2,495.97 Kg. 5. Magnesium Stearate 623.94Kg. 6. Bottles & Caps (a to c) Relevant, As per packing policy above decision of NC.
Case No.A496
M/S Cadila Healthcare Ltd. F.No.01/82/162/187/AM08/DESIII RLA F.No.08/24/40/355/AM07 Adv.Lic.No.0810063496 dated 09.03.2007 the export product Atorvastatin Condensation Product under para 4.7 of HBP. U.O. No.35011/73/2007PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Sl.No. Description of Export Product Quantity 1. Atorvastatin Condensation product 1 Kg. Import items: Sl.No. Description of import item Quantity allowed 1. Methyl Isobutyryl Acetate 0.970kg/kg 2. 4Methy5Hydroxy ethyl Thiazole 0.120kg/kg 3. (4R,Cis)1,1dimethyl ethyl6cyanomethyl2,2 dimethyl1,3Dioxane4Acetate 0.635kg/kg 4. Methanol 1.09kg/kg 5. Cyclohexane 2.77kg/kg 6. Tetrahydrofuran 0.53kg/kg 7. Isopropyl alcohol 4.49kg/kg 8. Toluene 1.62kg/kg above decision of NC.
Case No.A497
M/S Cadila Healthcare Ltd. F.No.01/82/162/186/AM08/DESIII RLA F.No.08/24/40/269/AM07 Adv.Lic.No.0810064986 dated 22.05.2007 the export product Lamivudine under para 4.7 of HBP. U.O. No.35011/73/2007PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Sl.No. Description of Export Product Quantity 1. Lamivudine 1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. (1R,2S,5R)Methyl5(S)Cytosin1YL1,3 Oxathiolane,2RCarboxylate 2.19kg/kg 2. Sodium Borohydride 0.48kg/kg 3. Salicylic Acid 0.8169kg/kg 4. Methanol 3.23kg/kg above decision of NC.
Case No.A498
M/S Cadila Healthcare Ltd. F.No.01/82/162/183/AM08/DESIII RLA F.No.08/24/40/62/AM08 Adv.Lic.No.0810065364 dated 13.06.2007 the export product Amlodipine Besylate 2.5mg, 5mg. & 10mg tablets under para 4.7 of HBP.
U.O. No.35011/73/2007PIIII dated 14.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Sl.No. Description of Export Product Quantity 1. Amlodipine Besylate 2.5 mg. tablets 1,74,46,570 Nos. 2. Amlodipine Besylate 5 mg. tablets 12,97,30,200 Nos. 3. Amlodipine Besylate 10 mg. tablets 11,70,79,490 Nos. Import items: Sl.No. Description of import item Quantity allowed 1. Amlodipine Besylate 2,635.74kg/kg 2. Microcrystalline cellulose 33,186.661kg/kg 3. Magnesium starch 372.106kg/kg 4. Bottles & Caps (a to e) Relevant as per packing policy above decision of NC.
Case No.A499
M/S Ellpe Chemicals Pvt. Ltd. F.No.01/82/50/388/AM07/DESIII RLA F.No.03/94/40/1062/AM07 Adv.Lic.No.0310418988 dated 09.02.2007 the export product Niclosamide Paperazine Salt under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in his Department and he sought deferment for six weeks. The Committee, accordingly, decided to defer the case for six weeks.
Case No.A500
M/S Cadila Pharmaceuticals Ltd F.No.01/82/162/185/AM08/DESIII RLA F.No.08/24/40/27/AM07 Adv.Lic.No.0810064612 dated 04.05.2007 the export product Carbetapentane Tannate under para 4.7 of HBP. U.O. No.35011/21/2005PIIII dated 14.08.2007 in the case of M/S Malladi Drugs & Pharma Pvt. Ltd. decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Carbetapentane Tannate1Kg. Import items: 1. Carbetapentane Citrate0.86kg/kg 2. Tanic Acid0.73kg/kg above decision of NC.
CASE NO. B217
M/S MEDRIECH LTD M. No. 11/08 F.NO. 01/82/50/795/AM06 DATED 17.7.2007 RLA NO.07/24/40/553/AM06
ADV. LIC.NO. 0710040930 DT. 18.10.05 The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product IODINE 20 MG+ PEPTONE 75 MG + RUTIN 1 MG TABLETS under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.
CASE NO. B218
M/S AGIO PHARMACEUTICAL LTD M. No. 15/08 F.NO. 01/87/50/925/AM06 DATED 14.08.2007 F.NO. 01/87/50/182/AM07 F.NO. 01/87/50/1118/AM07 F.NO. 01/87/50/63/AM07 F.NO. 01/87/50/267/AM07 ADV. LIC.NO. 0310353471 DT. 25.10.05 ADV. LIC.NO. 0310381026 DT. 19.05.06 ADV. LIC.NO. 0310423444 DT. 16.03.07 ADV. LIC.NO. 0310376482 DT. 19.04 06 ADV. LIC.NO. 0310385834 DT. 21.06.06 The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product PREDNISOLONE SODIUM PHOSPHATE INJECTION 30MG/ML VAIL under para 4.7 of HBP. The Committee decided to remind the firm to furnish the documents regarding amendment in the export product as per their DML from the office of Jt. DGFT, Mumbai. The case was accordingly deferred for four weeks.
CASE NO. B219
M/S Aarti Drugs Ltd. M. No. 15/08 F.NO. 01/87/50/630/AM06
DATED 14.08.2007 RLA F.No.03/94/40/598/AM’06 Adv.Lic.No.0310345259 dated 30.08.2005 The Committee considered this case as per agenda for modification of I/O Norms for the Export Product Diphenyl Methyl(4ISO Propyl Pyridine) Boronate The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.
CASE NO. B220
M/S Cipla Ltd. M. No. 15/08 F.NO. 01/82/50/722/AM07 DATED 14.08.2007 RLA F.No.03/94/40/519/AM’07 Adv.Lic.No.0310394029 dated 10.08.2006 The Committee considered this case as per agenda for amendment in the item of imports under para 4.7 of HBP. The Committee decided to defer the case for four weeks and link the earlier file.
CASE NO. B221
M/S CADILA PHARMA LTD M. No. 15/08 F.NO. 01/82/50/1433/AM05 DATED 14.08.2007 RLA NO.08/24/40/95/AM05 ADV. LIC.NO. 0810041718 DT. 6.09.2004 ADV.LIC NO. 0810036678 DT. 05.03.2004 The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product CARBINOXAMINE under para 4.7 of HBP.
The Committee decided to examine the case on file.
CASE NO. C08
M/S WOCKHARDT M. No. 15/08 F.NO. 01/82/162/262/AM08 DATED 14.08.2007 The Committee considered this case as per agenda for fixation of SION for vitamin B12 (Cyanocobalamin ) USP (Micronised ) Non Feed Grade. The Case was discussed in detail and it was noted that the SION for Vitamin B12 are already fixed from the basic stage. The Committee observed that in the present case, there is only minor operations for which Advance Authorisation can be considered under para 4.7 of HBP. The firm may be advised accordingly. Norms Committee Mee韫�ng No.15/08 dated 14.08.2007 Outside Agenda: The Committee observed that as per para 4.7.1 of Current Hand Book of Procedures Vol.I, in cases where Norms Committee has already ratified norms for same export and import product in respect of an Authorisation obtained under para 4.7, such norms shall be valid for a period of six months reckoned from date of ratification. The RAs are authorized to issue Authorisations under “Adhoc Norms Fixed” Catagory and application copies need not be forwarded to NC for fixation/ratification of Norms. It is observed that the RAs are not strictly adhering to the above provision with the result that the work load on Norms Committee has increased enormously. The Committee deliberated the issue and decided to issue instructions to all the RAs to strictly adhere to the provisions of
para 4.7.1 of Current HBP.
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