DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 5/82ALC4/2011 MEETING DATE : 03.05.2011 The Meeting No.5/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 03.05.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri M. Mitra, Dy. DCGI, Office of DCGI 2. Shri B.K. Tyagi, Dy.I.A, Department of Pharmaceuticals 3. Shri Jasbir Singh, Consultant, Department of C&PC 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.4/82 dated 26.04.2011 were ratified by the Committee and the Chairman, NC3 desired that a list of all cases pending for more than 3 months should be sent to respective TAs with a request to expedite their comments in such cases.
Case No.B41
M/S Granules India Ltd. Norms Committee Meeting No.5/12 F.No.01/82/050/00177/AM06/DESIII Meeting Date:03.05.2011 RA F.No.09/24/040/00243/AM06 Adv.Lic.No.0910030174 dated 04.05.2007 Committee noted that a letter has been written to the firm for explaining reasons for delay on 27.04.2011 in making representation and decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 28.06.2011.
Case No.B42
M/S Parabolic Drugs Ltd. F.No.01/82/050/00802/AM10/DESIII Meeting Date:03.05.2011 RA F.No.05/24/040/00383/AM10 Adv.Lic.No.0510253942 dated 04.12.2009 Committee decided to defer case for 28.06.2011 for comments of Department of Pharmaceuticals.
Case No.B43
M/S Herbochem, Hyderabad F.No.01/82/050/00957/AM11/DESIII F.No.01/82/050/01410/AM11/DESIII F.No.01/82/050/00608/AM11/DESIII F.No.01/82/050/00618/AM11/DESIII Meeting Date: 03.05.2011 RA F.No.09/24/040/00015/AM10 RA.F.No.09/24/040/00077/AM11 RA.F.No.09/24/040/00127/AM11 RA.F.No.09/24/040/00153/AM11 Adv.Lic.No.0910040823 dated 05.02.2010
Adv.Lic.No.0910042303 dated 11.06.2010 Adv.Lic.No.0910042768 dated 20.07.2010 Adv.Lic.No.0910042877 dated 28.07.2010 Committee considered case as per agenda and observed that DC(MSME) vide their U.P. No.23(4)/DGFT/Chem/2010 dated 23.12.2010 has recommended the quantity of Ipecacunha Roots (Dry Roots) or Ipecac Roots Mon. 2% to the extent of 4.80 kg/kg of export product, while the Committee has allowed the quantity of input to the extent of 4.40 kg/kg of export product and the firm has made representation for enhancement in the quantity of inputs. Committee also observed that the firm has given the production and consumption data certified by Central Excise Authority in support of their request. After detailed deliberations, Committee decided to seek comments of DC(MSME) whether the quantity of inputs recommended by them may be allowed to the firm. Accordingly, case was deferred for 28.06.2011.
Case No.B44
M/S Jubilant Organosys Ltd. F.No.01/82/050/00651/AM07/DESIII Meeting Date:03.05.2011 RA F.No.05/24/040/00330/AM07 Adv.Lic.No.0510187592 dated 27.07.2006 Committee decided to defer case for 31.05.2011 for comments of Department of C&PC.
Case No.B45
M/S Laffans Petrochemicals Ltd. F.No.01/83/050/00827/AM08/DESIII Meeting Date:03.05.2011 RA F.No.03/95/040/00219/AM08 Adv.Lic.No.0310437236 dated 24.07.2007 Committee decided to defer case for 31.05.2011 for comments of Department of C&PC, Petrochemicals Division.
Case No.B46
M/S Alembic Ltd. F.No.01/83/050/01725/AM10/DESIII Meeting Date:03.05.2011 RA F.No.34/24/040/00230/AM09 Adv.Lic.No.3410023716 dated 17.03.2009 Committee considered case as per agenda and in light of earlier decision taken in 17/82 meeting held on 21.07.2009 and in consultation with technical authority present in meeting, decided to allow import of Methylene Chloride to the extent of 2.18 kg/kg of export product without any other change in the decision taken in 2/11 meeting held on 13.04.2010. RA concerned may take further necessary action as per above decision of NC.
Case No. A2
M/s Divi’s Laboratories Ltd. Norms Committee Meeting No. 5/12 F.No.01/82/162/01039/AM11/DESIII Meeting Date 03.05.2011
Case No. A3
F.No.01/82/162/01041/AM11/DESIII
Case No. A4
F.No.01/82/162/01029/AM11/DESIII
Case No. A5
F.No.01/82/162/01030/AM11/DESIII
Case No. A6
F.No.01/82/162/01031/AM11/DESIII
Case No. A7
F.No.01/82/162/01036/AM11/DESIII
Case No. A8
F.No.01/82/162/01032/AM11/DESIII
Case No. A9
F.No.01/82/162/01037/AM11/DESIII
Case No. A10
F.No.01/82/162/01040/AM11/DESIII
Case No. A11
F.No.01/82/162/01042/AM11/DESIII
Case No. A12
F.No.01/82/162/01043/AM11/DESIII
Case No. A13
F.No.01/82/162/01044/AM11/DESIII
Case No. A14
Norms Committee Meeting No5/12 F.No.01/82/162/01038/AM11/DESIII
Case No. C9
M/s IndSwift Laboratories Ltd. F.No.01/82/162/00594/AM11/DESIII Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals.
Case No. C10
M/s Alkem Laboratories Ltd. F.No.01/82/162/01131/AM11/DESIII Committee decided to defer case for 17.05.2011 for comments of Department of Pharmaceuticals. 1
Case No.:5/11/82ALC4/2007
Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:5/82ALC4/2011 03.05.2011 Status:Case Approved HQ File :01/82/050/01889/AM07/ RLA File :03/94/040/01289/AM07/ Lic.No/Date:0310424653
27.03.2007 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/63/2008 Ch.II dated 05.04.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Phenoxyethanol (Preservative Grade) 1 KG. 1. Phenol 0.690 kg 2. Ethylene Oxide 0.325 kg 3. HMHDPE Granules As per packing Policy 2
Case No.:76/42/82ALC4/2007
Party Name:CAPLIN POINT LABORATORIES LTD., 03.05.2011 Status:Case Deferred HQ File :01/82/050/00412/AM08/ RLA File :04/24/040/00151/AM08/ Lic.No/Date:0410090415 03.08.2007 Defer Date:31.05.2011 Decision :Committee decided to defer case for 31.05.2011 for comments of Department of Pharmaceuticals. 3
Case No.:29/35/82ALC4/2009
Party Name:BELOOR BAYIR BIOTECH LTD, 03.05.2011 Status:Case Rejected HQ File :01/82/050/00719/AM10/ RLA File :07/24/040/00223/AM10/ Lic.No/Date:0710067058 17.09.2009 Decision :Committee considered case as per agenda and observed that the firm has furnished the copy of Drug Manufacturing Licence for manufacturing of Chondroitin Sulphate Sodium (Bulk Drug), but they have obtained the advance authorization for manufacture and export of Chondroitin Sulphate Sodium USP 200 mg Capsule/tablet which is a formulation. Since the firm is not having DML for manufacturing formulations, Committee decided to reject the case. 4
Case No.:29/38/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 03.05.2011 Status:Case Rejected HQ File :01/82/050/00802/AM10/ RLA File :05/24/040/00383/AM10/ Lic.No/Date:0510253942 04.12.2009 Decision :Withdrawn as the case has already been rejected by NC in 31/82 meeting held on 02.11.2010. 5
Case No.:81/9/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/00296/AM11/ RLA File :09/24/040/00429/AM10/ Lic.No/Date:0910040725 29.01.2010 Defer Date:14.06.2011 Decision :Committee decided to defer case for 14.06.2011 for comments of Department of Pharmaceuticals. 6
Case No.:49/22/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 03.05.2011 Status:Case
Deferred HQ File :01/82/050/00702/AM11/ RLA File :09/24/040/00250/AM10/ Lic.No/Date:0910040873 09.02.2010 Defer Date:28.06.2011 Decision : Committee decided to defer case for 28.06.2011 for comments of Department of Pharmaceuticals. 7
Case No.:53/5/82ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 03.05.2011 Status:Case Deferred HQ File :01/82/050/00087/AM11/ RLA File :08/24/040/00004/AM11/ Lic.No/Date:0810088011 07.04.2010 Defer Date:28.06.2011 Decision : Committee decided to forward a copy of reply received from the firm alongwith the copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 28.06.2011. 8
Case No.:62/15/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 03.05.2011 Status:Case Deferred HQ File :01/82/050/00499/AM11/ RLA File :05/23/040/00041/AM11/ Lic.No/Date:0510265059 31.05.2010 Defer Date:28.06.2011 9
Case No.:20/15/82ALC4/2010
Party Name:MEDREICH LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/00457/AM11/ RLA File :07/24/040/00072/AM11/ Lic.No/Date:0710072323 18.06.2010 Defer Date:28.06.2011 10
Case No.:79/41/82ALC4/2010
Party Name:EXPO FINE CHEMICAL INDUSTRIES 03.05.2011 Status:Case Deferred HQ File :01/82/050/01427/AM11/ RLA File :24/24/040/00004/AM11/ Lic.No/Date:2410028786 22.06.2010 Defer Date:28.06.2011 Decision :Committee considered case as per agenda and decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 28.06.2011. 11
Case No.:5/15/82ALC4/2010
Party Name:SHODHANA LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/00442/AM11/ RLA File :09/24/040/00113/AM11/ Lic.No/Date:0910042470 25.06.2010 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of Pharmaceuticals. 12
Case No.:51/41/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01399/AM11/ RLA File :09/24/040/00091/AM11/ Lic.No/Date:0910042508 25.06.2010 Defer
Date:28.06.2011 13
Case No.:12/15/82ALC4/2010
Party Name:MEDREICH LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date:28.06.2011 14
Case No.:49/41/82ALC4/2010
Party Name:INDIAN IMMUNOLOGICALS LTD., 03.05.2011 Status:Case Deferred HQ File :01/82/050/01397/AM11/ RLA File :09/24/040/00004/AM11/ Lic.No/Date:0910042621 06.07.2010 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of Biotechnology. 15
Case No.:42/41/82ALC4/2010
Party Name:GENEX PHARMA 03.05.2011 Status:Case Deferred HQ File :01/82/050/01390/AM11/ RLA File :03/94/040/00283/AM11/ Lic.No/Date:0310584078 19.07.2010 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of Pharmaceuticals. 16
Case No.:59/41/82ALC4/2010
Party Name:LUPIN LIMITED 03.05.2011 Status:Case Approved HQ File :01/82/050/01407/AM11/ RLA File :03/95/040/00267/AM11/ Lic.No/Date:0310586682 10.08.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/168/2009PI (Norms) dated 22.02.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Quantity Sl.No. Import items Quantity allowed Rifampicin BP/USP 1 kg 1. Sodium RifaS 0.98 kga 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperzine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg 6. Isopropyl Alcohol 0.51 kg 7. Dimethyl Formamide 0.75 kg 8. Tert. Butylamine 0.19 kg 9. Acetone 0.832 kg 10. 1Amino4Methyl Piperazine 0.16 kg
17
Case No.:4/21/82ALC4/2010
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 03.05.2011 Status:Case Deferred HQ File :01/82/050/00642/AM11/ RLA File :03/94/040/00440/AM11/ Lic.No/Date:0310587202 12.08.2010 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of Pharmaceuticals. 18
Case No.:1/22/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/00654/AM11/ RLA File :05/24/040/00171/AM11/ Lic.No/Date:0510270699 17.08.2010 Defer Date:28.06.2011 19
Case No.:57/41/82ALC4/2010
Party Name:LUPIN LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/01405/AM11/ RLA File :03/95/040/00382/AM11/ Lic.No/Date:0310589551 26.08.2010 Defer Date:28.06.2011 20
Case No.:32/23/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date:28.06.2011 21
Case No.:47/26/82ALC4/2010
Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 03.05.2011 Status:Case Approved HQ File :01/82/050/00865/AM11/ RLA File :09/24/040/00120/AM11/ Lic.No/Date:0910043539 17.09.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/197/2010PI(Norms) dated 13.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 7APRA (6R,7R)7Amino8 Oxo3(1Propenyl)5Thia1 Azabicyclo [4,2,0]Oct2Ene 2Carboxylic Acid 1 Kg. 1. Penicillin G Potassium 1st Crystal 17.90 BOU 2. Acetone 7.85 kg 3. Isopropyl Alcohol 7.85 kg 4. Dimethyl Formamide 4.71 kg 5. Methylene Chloride 11.78 kg 6. 2 Mercapto Benzo Thiazole 2.06 kg
Methanol 7.85 kg 8. Triphenyl Phosphine 2.367 kg 9. Sodium Iodide 0.124 kg 22
Case No.:20/39/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 03.05.2011 Status:Case Deferred HQ File :01/82/050/01101/AM11/ RLA File :03/95/040/00321/AM11/ Lic.No/Date:0310593366 22.09.2010 Defer Date:28.06.2011 23
Case No.:54/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/01402/AM11/ RLA File :09/24/040/00289/AM11/ Lic.No/Date:0910043863 08.10.2010 Defer Date:28.06.2011 24
Case No.:55/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/01403/AM11/ RLA File :09/24/040/00298/AM11/ Lic.No/Date:0910043877 11.10.2010 Defer Date:28.06.2011 25
Case No.:80/41/82ALC4/2010
Party Name:CHIRAG ENTERPRISE 03.05.2011 Status:Case Deferred HQ File :01/82/050/01428/AM11/ RLA File :24/24/040/00009/AM11/ Lic.No/Date:2410029974 27.10.2010 Defer Date:28.06.2011 Decision :Committee decided to defer case for 28.06.2011 for comments of Department of C&PC, Petrochemicals Division. 26
Case No.:5/33/82ALC4/2010
Party Name:FORACE POLYMERS (P) LTD. 03.05.2011 Status:Case Approved HQ File :01/82/050/00999/AM11/ RLA File :05/23/040/00201/AM11/ Lic.No/Date:0510276254 03.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC (Petrochemicals Division) vide their O.M. No.46011/18/2011PCII dated 18.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Hardener containing 70% Triacetine (Foundry Grade) and 1 KG. 1. Triacetine (Foundry Grade) 0.713 kg 2. Di Basic Ester 0.307 kg
30% Di Basic Ester 27
Case No.:9/33/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01003/AM11/ RLA File :09/24/040/00321/AM11/ Lic.No/Date:0910044180 04.11.2010 Defer Date:28.06.2011 28
Case No.:11/33/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01005/AM11/ RLA File :05/24/040/00274/AM11/ Lic.No/Date:0510276395 04.11.2010 Defer Date:28.06.2011 29
Case No.:91/41/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 03.05.2011 Status:Case Deferred HQ File :01/82/050/01439/AM11/ RLA File :04/24/040/00206/AM11/ Lic.No/Date:0410118692 08.11.2010 Defer Date:28.06.2011 30
Case No.:83/41/82ALC4/2010
Party Name:CENTURY PHARMACEUTICALS LTD. 03.05.2011 Status:Case Approved HQ File :01/82/050/01431/AM11/ RLA File :34/24/040/00226/AM11/ Lic.No/Date:3410028741 06.12.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/198/2010PI(Norms) dated 15.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Imino Ether 1 Kg. 1. Erythromycin Thiocyanate 1.28 KGA 31
Case No.:76/41/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 03.05.2011 Status:Case Deferred HQ File :01/82/050/01424/AM11/ RLA File :17/24/040/00085/AM09/ Lic.No/Date:1710003597 07.12.2010 Defer Date:31.05.2011 Decision :Committee decided to forward a copy of application to Department of C&PC, Petrochemicals Division for their comments. Accordingly, case was deferred for 31.05.2011. Chairman, NC3 also desired that Jt. Secretary, Deptt. Of C&PC may be requested to send representative of Petrochemicals Division
to NC meeting. 32
Case No.:82/41/82ALC4/2010
Party Name:METROPOLITAN EXIMCHEM LTD. 03.05.2011 Status:Case Deferred HQ File :01/82/050/01430/AM11/ RLA File :03/95/040/00674/AM11/ Lic.No/Date:0310604838 07.12.2010 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 33
Case No.:81/41/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/01429/AM11/ RLA File :03/94/040/00723/AM11/ Lic.No/Date:0310605141 08.12.2010 Defer Date:28.06.2011 34
Case No.:2/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Approved HQ File :01/82/050/01350/AM11/ RLA File :17/24/040/00164/AM08/ Lic.No/Date:1710003636 22.12.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/35/2010 Ch.II dated 20.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Product – AE2454 (Polyoxypropylene Glycol Polyethylene Glycol Lauryl Myristyl Ether 1 KG. 1. Ethyl Oxide (Colourless clear liquid) 0.300 kg 2. Propylene Oxide (colourless liquid) 0.400 kg 3. Lauryl Myristyl Alcohol (colourless clear insoluble liquid) 0.294 kg 35
Case No.:3/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Approved HQ File :01/82/050/01351/AM11/ RLA File :17/24/040/00034/AM10/ Lic.No/Date:1710003639 22.12.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/35/2010 Ch.II dated 20.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Product AFO1002 (Oleyl Cetyl alcohol Polyglycol Ether/Oleyl Cetyl 1 KG. 1. Oleyl Cetyl Alcohol (colourless clear insoluble liquid) 0.197 kg 2. Ethylene Oxide 0.802 kg
Alcohol 25 mole Ethoxylate) 36
Case No.:4/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Approved HQ File :01/82/050/01352/AM11/ RLA File :17/24/040/00014/AM11/ Lic.No/Date:1710003640 22.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/35/2010 Ch.II dated 20.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Product SSC90 (Polyethylene Glycol Stearyl Ether Sulphosuccinate 50% Solution) 1 KG. 1. Ethylene Oxide (Colourless clear liquid) 0.228 kg 37
Case No.:5/41/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01353/AM11/ RLA File :09/24/040/00415/AM11/ Lic.No/Date:0910044855 22.12.2010 Defer Date:28.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/10/2010PI (Norms) dated 10.06.2010, decided to call for the following information/documents from the firm. 1. Molecular weight of each reactant and output product of each step. 2. Molar requirement of input alongwith technical justification. 3. % yield on molar basis for each step of manufacturing process. Accordingly, case was deferred for 28.06.2011. 38
Case No.:18/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Deferred HQ File :01/82/050/01366/AM11/ RLA File :17/24/040/00148/AM08/ Lic.No/Date:1710003645 23.12.2010 Defer Date:31.05.2011 Decision :Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 39
Case No.:10/41/82ALC4/2010
Party Name:AARTI ORGANIC 03.05.2011 Status:Case Deferred HQ File :01/82/050/01358/AM11/ RLA File :08/24/040/00286/AM11/ Lic.No/Date:0810094954 27.12.2010 Defer Date:31.05.2011
Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 40
Case No.:12/41/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01360/AM11/ RLA File :05/24/040/00323/AM11/ Lic.No/Date:0510280422 27.12.2010 Defer Date:28.06.2011 41
Case No.:30/41/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 03.05.2011 Status:Case Deferred HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:28.06.2011 Decision :Committee decided to call for end use of the export product from the firm. Accordingly, case was deferred for 28.06.2011. 42
Case No.:97/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Deferred HQ File :01/82/050/01445/AM11/ RLA File :17/24/040/00020/AM11/ Lic.No/Date:1710003665 30.12.2010 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 43
Case No.:98/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Approved HQ File :01/82/050/01446/AM11/ RLA File :17/24/040/00005/AM09/ Lic.No/Date:1710003673 31.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/35/2010 Ch.II dated 20.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Product AFO1002 (Oleyl Cetyl alcohol Polyglycol Ether/Oleyl Cetyl Alcohol 25 mole Ethoxylate) 1 KG. 1. Oleyl Cetyl Alcohol (colourless clear insoluble liquid) 0.197 kg 2. Ethylene Oxide 0.802 kg 44
Case No.:99/41/82ALC4/2010
LTD, 03.05.2011 Status:Case Approved HQ File :01/82/050/01447/AM11/ RLA File :17/24/040/00093/AM09/ Lic.No/Date:1710003677 31.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/35/2010
Ch.II dated 20.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Esteem – MFA (Polyethylene Glycol Cetostearyl Ether/Cetostearyl Alcohol 23 mole Ethoxylate) 1 KG. 1. Ethylene Oxide (colourless clear liquid) 0.793 kg 2. Ceto Stearyl Alcohol (offwhite flakes) 0.206 kg 45
Case No.:7/45/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/01547/AM11/ RLA File :03/95/040/00836/AM11/ Lic.No/Date:0310612992 28.01.2011 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 46
Case No.:8/45/82ALC4/2010
Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., 03.05.2011 Status:Case Deferred HQ File :01/82/050/01548/AM11/ RLA File :07/24/040/00386/AM11/ Lic.No/Date:0710076995 28.01.2011 Defer Date:28.06.2011 Decision :Committee considered case as per agenda and in light of letter No.14010/10/2006Ch.II dated 10.03.2011 issued by Department of C&PC to the firm, decided to remind the firm to furnish CA certificate certifying the total production of the resultant product and quantity of different items consumed corresponding consumption of different raw materials. Accordingly, case was deferred for 28.06.2011. 47
Case No.:12/45/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01552/AM11/ RLA File :09/24/040/00482/AM11/ Lic.No/Date:0910045338 31.01.2011 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of Pharmaceuticals. 48
Case No.:14/45/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/01554/AM11/ RLA File :05/24/040/00349/AM11/ Lic.No/Date:0510282602 31.01.2011 Defer Date:28.06.2011 49
Case No.:1/5/82ALC4/2011
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/00103/AM12/ RLA File :03/94/040/00029/AM12/ Lic.No/Date:0310626724 Defer
15.04.2011 Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 50
Case No.:2/5/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 03.05.2011 Status:Case Approved HQ File :01/82/050/00104/AM12/ RLA File :09/24/040/00017/AM12/ Lic.No/Date:0910046391 15.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/69/2010PI (Norms) dated 05.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefepime for Injection/Cefepime Hcl Sterile (Buffered with L Arginine) 1 Kg. 1. “(6R.7R)7[(Z)2(2Amino4 Thiazolyl)2Methoxyimino) Acetamido]3[1(1Methylpy4rrolidinyl) Methyl)8oxo5thia1 azabicyclo[4.2.0]oct2en2Carboxylic Acid Hydrochloride Monohydrate” (Cefepime Hcl non sterile) 0.655 kg 2. LArginine 0.37 kg 3. Aluminium Canisters As per packing policy 51
Case No.:3/5/82ALC4/2011
Party Name:MSN PHARMACHEM PRIVATE LIMITED 03.05.2011 Status:Case Approved HQ File :01/82/050/00105/AM12/ RLA File :09/24/040/00621/AM11/ Lic.No/Date:0910046395 15.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/77/2010PI (Norms) dated 01.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Pregabalin 1 Kg. 1. (+) 3(Carbamoylmethyl)5Methylhexanoic Acid 2.94 kg 52
Case No.:4/5/82ALC4/2011
Party Name:HERBOCHEM 03.05.2011 Status:Case Deferred HQ File :01/82/050/00106/AM12/ RLA File :09/24/040/00576/AM11/ Lic.No/Date:0910046396 15.04.2011 Defer Date:28.06.2011 Decision :Committee decided to forward a copy of application to DC(MSME) for their comments. Accordingly, case was deferred for 28.06.2011.
53
Case No.:5/5/82ALC4/2011
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 03.05.2011 Status:Case Deferred HQ File :01/82/050/00107/AM12/ RLA File :03/95/040/00828/AM11/ Lic.No/Date:0310626928 18.04.2011 Defer Date:28.06.2011 54
Case No.:6/5/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 03.05.2011 Status:Case Deferred HQ File :01/82/050/00108/AM12/ RLA File :09/24/040/00004/AM12/ Lic.No/Date:0910046405 18.04.2011 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 55
Case No.:7/5/82ALC4/2011
Party Name:NEULAND LABORATORIES LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/00109/AM12/ RLA File :09/24/040/00561/AM11/ Lic.No/Date:0910046412 19.04.2011 Defer Date:28.06.2011 56
Case No.:8/5/82ALC4/2011
Party Name:PROMED EXPORTS PVT.LTD. 03.05.2011 Status:Case Deferred HQ File :01/82/050/00110/AM12/ RLA File :05/24/040/00003/AM12/ Lic.No/Date:0510288385 20.04.2011 Defer Date:28.06.2011 57
Case No.:9/5/82ALC4/2011
Party Name:KLJ PLASTICIZERS LTD, 03.05.2011 Status:Case Deferred HQ File :01/82/050/00111/AM12/ RLA File :05/23/040/00012/AM12/ Lic.No/Date:0510288426 20.04.2011 Defer Date:31.05.2011 Decision : Committee decided to defer case for 31.05.2011 for comments of Department of C&PC. 58
Case No.:10/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 03.05.2011 Status:Case Deferred HQ File :01/82/050/00112/AM12/ RLA File :05/23/040/00007/AM12/ Lic.No/Date:0510288427 20.04.2011 Defer Date:28.06.2011 Decision :Committee decided to call for end use of the export product from the firm. Accordingly, case was deferred for 28.06.2011. 59
Case No.:11/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 03.05.2011 Status:Case Deferred
HQ File :01/82/050/00113/AM12/ RLA File :05/23/040/00008/AM12/ Lic.No/Date:0510288428 20.04.2011 Defer Date:28.06.2011 Decision : Committee decided to call for end use of the export product from the firm. Accordingly, case was deferred for 28.06.2011. 60
Case No.:12/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 03.05.2011 Status:Case Deferred HQ File :01/82/050/00114/AM12/ RLA File :05/23/040/00026/AM12/ Lic.No/Date:0510288429 20.04.2011 Defer Date:28.06.2011 Decision : Committee decided to call for end use of the export product from the firm. Accordingly, case was deferred for 28.06.2011. 61
Case No.:13/5/82ALC4/2011
Party Name:EMBIO LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/00115/AM12/ RLA File :03/94/040/00009/AM12/ Lic.No/Date:0310627428 20.04.2011 Defer Date:28.06.2011 62
Case No.:14/5/82ALC4/2011
Party Name:EMBIO LTD 03.05.2011 Status:Case Deferred HQ File :01/82/050/00116/AM12/ RLA File :03/94/040/00008/AM12/ Lic.No/Date:0310627429 20.04.2011 Defer Date:28.06.2011 63
Case No.:15/5/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 03.05.2011 Status:Case Approved HQ File :01/82/050/00117/AM12/ RLA File :09/24/040/00025/AM12/ Lic.No/Date:0910046415 20.04.2011 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 51/82 meeting held on 22.03.2011 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 5Cyano Phthalide 1kg. 1. Sulfolane 6.184 kg 2. Sulfamide 1.020 kg 3. Para Formaldehyde 0.53 kg 64
Case No.:16/5/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 03.05.2011 Status:Case Approved HQ File :01/82/050/00118/AM12/ RLA File :09/24/040/00026/AM12/ Lic.No/Date:0910046416
20.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/199/2008PIIII dated 25.02.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Tetrozol Aldehyde 1 Kg. 1. Orthotoluyl Benzonitrile 0.95 kg 2. 1,3Dibromo 5,5Dimethyl Hydantoin 0.57 kg 3. 2NButyl4Chloro5formyl imidazole 0.62 kg 4. Tributyl Tin Chloride 1.65 kg 5. Methyl Isobutyl Ketone 1.43 kg 6. Acetonitrile 1.43 kg 7. Azobis Isobutyronitrile 0.076 kg
Case No.Outside Agenda1
M/S Sarna Chemicals Pvt. Ltd. F.No.01/82/050/00579/AM08/DESIII Meeting Date:03.05.2011 RA F.No.03/95/040/01123/AM08 Adv.Lic.No.0310461411 dated 18.02.2008 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “NHydroxy MethylChloro acetamide/XAW Base” and description of import item to read as “Chloro Acetamide” without any other change in the decision taken in 7/82 meeting held on 13.05.2008.
Case No.Outside Agenda2
M/S Suven Life Sciences Ltd. F.No.01/82/050/01206/AM11/DESIII Meeting Date:03.05.2011 RA F.No.09/24/040/00414/AM11 Adv.Lic.No.0910044683 dated 15.12.2010 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of import item No.1 to read as “2,5Diamino4,6Dihydroxy Pyrimidine Hcl” without any other change in the decision taken in 48/82 meeting held on 01.03.2011.
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