DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 45/82‐ALC4/2010 MEETING DATE : 08.02.2011 The Meeng No.45/82 in the year 2010‐11 to consider the cases under Duty Exempon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 08.02.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, I.A., Department of C&PC 2. Shri Shaish Kumar, IA, DIPP 3. Shri D.N. Mathur, Dy.I.A, Department of Pharmaceucals 4. Shri K.C. Kumar, Pharmexcil 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commi쏧ee Meeng No.43/82 dated 25.01.2011 were rafied by the Commi쏧ee.
Case No. B‐375
M/s Kopran Ltd. Norms Commi쏧ee Meeng No. 45/11 F.No.01/82/050/01818/AM07/DES‐III Meeng Date 08.02.2011 RA F.No. 03/94/040/01416/AM07 Adv. Lic. No.0310423486 dated 16.03.2007 Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of Pharmaceucals.
Case No. B‐376
M/s Kopran Ltd. F.No.01/82/050/01601/AM09/DES‐III RA F.No. 03/94/040/00986/AM09 Adv. Lic. No.0310504570 dated 30.01.2009 Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of Pharmaceucals.
Case No. B‐377
M/s Merit Healthcare Pvt. Ltd. F.No.01/82/050/01690/AM09/DES‐III RA F.No. 03/95/040/00909/AM09 Adv. Lic. No.0310509173 dated 25.02.2009 Commi쏧ee considered case as per agenda and observed that the representave of the firm appeared before the Commi쏧ee for personal hearing in 35/11 meeng held on 30.11.2010 and he was asked to furnish copy of DML duly amended from the Drug Authority, but the same has not been received and in absence of revised DML, norm can not be revised. It was, therefore, decided to reject the case.
Case No. B‐378
M/s Deepak Nitrile Ltd. F.No.01/82/162/00651/AM07/DES‐III Commi쏧ee considered case as per agenda and decided to call the firm for personal hearing on 08.03.2011. Accordingly, case was deferred for 08.03.2011.
Case No. B‐379
M/s Srini Pharmaceucals Ltd. F.No.01/83/050/01679/AM04/DES‐III RA F.No. 09/24/040/00376/AM04 Adv. Lic. No.0910017292 dated 30.01.2004 Commi쏧ee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of PH for 22.02.2011. It was, therefore, decided to call the firm for personal hearing on 22.02.2011. Accordingly, case was deferred for 22.02.2011.
Case No. B‐380
M/s Divi’s Laboratories Ltd. F.No.01/82/050/00553/AM08/DES‐III F.No.01/82/050/00553/AM08/DES‐III RA F.No. 03/94/040/01106/AM09 Adv. Lic. No.0910032640 dated 10.01.2008 Adv. Lic. No.0910035511 dated 01.10.2008 Commi쏧ee considered the case as per agenda and in light of earlier decision taken in 14/82 meeng held on 06.07.2010 and in consultaon with Technical Authority present in the meeng decided to revise the norms as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Cyclopentadecanolide (Recrystallised) 1 Kg. 1. Cyclopentadecanolide (technical grade) (purity NMT 98.5%) 1.075 kg 2. Methanol 2.00 kg RA Concerned may take further necessary acon as per above decision of NC.
Case No. B‐381
M/s Morepen Laboratories Ltd. F.No.01/82/050/00207/AM11/DES‐III RA F.No. 05/24/040/00052/AM11 Adv. Lic. No.0510264145 dated 12.05.2010 The Commi쏧ee considered the case as per agenda. The representaves of the firm appeared for personal
hearing before the Commi쏧ee and explained the case. They informed the Commi쏧ee that they have manufactured Atorvastan Calcium through other route but NC has fixed the norms taking different route. A챦er detailed deliberaons and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/78/2010‐PI (Norms) dated 01.10.2010 and in consultaon with technical authority present in meeng, decided to revise the norms as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Atorvastan Calcium 1 Kg. 1. 4‐Fluoro‐(Alpha)‐(2‐Methyl‐1‐Oxopropyl)‐ Gamma‐oxo‐N‐(Beta)‐Diphenyl Benzene Butanamide 1.15 kg 2. (4R‐Cis)‐1,1‐Dimethylethyl‐6‐Cyanomethyl‐ 2,2‐Dimethyl‐1,3‐dioxane‐4‐Acetate 1.003 kg 3. Methylene Chloride 8.55 kg 3. Diisopropyl ether 7.44 kg RA concerned may take further necessary acon as per above decision of NC.
Case No. B‐382
M/s Benzo Petro Internaonal Ltd. F.No.01/82/050/00381/AM01/DES‐III RA F.No. 03/24/040/00428/AM01 Adv. Lic. No.0310046243 dated 21.07.2000 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O.14010/11/2008/Ch.II dated 22.09.2009 and in consultaon with technical authority present in meeng, decided to rafy norms as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Ortho Chloro Benzo Nitrile/2 Chloro Benzo Nitrile 1 kg 1. Ortho Chloro Toluene 1.258 kg Note: The role of Sulfamic Acid in the reacon is not clear and hence not allowed. RA concerned may take further necessary acon as per above decision of NC.
Case No. B‐383
M/s Vijayasri Chemicals F.No.01/82/050/01610/AM08/DES‐III F.No.01/82/050/00552/AM08/DES‐III RA F.No. 09/24/040/00369/AM08 RA F.No. 09/24/040/00470/AM08 Adv. Lic. No.0910032230 dated 27.11.2007
Adv. Lic. No.0910032689 dated 21.01.2008 Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng, decided to amend the descripon of export product to read as “2‐Butyl‐5‐Chloro‐3H‐Imidazole‐4‐Carbaldehyde (IMAL) or 2‐N‐Butyl‐4‐Chloro‐5‐Formylimidazole (BCFI)” without any other change in the decision taken in 5/82 meeng held on 29.04.2008. RA concerned may take further necessary acon as per above decision of NC.
Case No. B‐384
M/s Malladi Drugs & Pharma Ltd. F.No.01/82/050/00613/AM08/DES‐III F.No.01/82/050/01647/AM08/DES‐III RA F.No. 04/24/040/00113/AM08 RA F.No. 04/24/040/00289/AM08 Adv. Lic. No.0410090130 dated 28.06.2007 Adv. Lic. No.0410092451 dated 30.11.2007 Commi쏧ee decided to call from the firm Producon and Consumpon data cerfied by Central Excise Authority. Accordingly, case was deferred for 08.03.2011.
Case No. B‐385
M/s GVS Ltd. F.No.01/82/050/01401/AM07/DES‐III RA F.No. 03/94/040/00917/AM07 Adv. Lic. No.0310411112 dated 06.12.2006 Commi쏧ee considered case as per agenda and in line with SION and in consultaon with technical authority present in meeng, decided to rafy norms as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Clavumoxin 457 Oral Suspension in 70 ml Bo쏧le 70 ml bo쏧le 1. Amoxiciline Trihydrate 87.53% and Clavulanate Potassium 12.47% in mixed form 7.536 gm/70 ml Bo쏧le RA concerned may take further necessary acon as per above decision of NC.
Case No. B‐386
M/s Laffans Petrochemicals Ltd. F.No.01/83/050/00827/AM08/DES‐III RA F.No. 03/95/040/00219/AM08 Adv. Lic. No.0310437236 dated 24.07.2007 Commi쏧ee decided to defer case for 08.03.2011 for comments of Petrochemicals Division of Department of C&PC.
Case No. B‐387
M/s Privi Organics Ltd. F.No.01/83/050/01580/AM08/DES‐III RA F.No. 03/95/040/00770/AM08 Adv. Lic. No.0310450598 dated 19.11.2007 Commi쏧ee considered case as per agenda and in light of wri쏧en comments of Department of C&PC and in light of Producon and Consumpon data cerfied by CA and in consultaon with technical authority present in meeng, decided to enhance the quanty of Propanaldehyde to the extent of 0.800 kg/kg of export product and quanty of Sodium Borohydride to the extent of 0.100 kg/kg of export product without any other change in the decision taken 8/82 meeng held on 20.05.2008.
Case No. B‐388
M/s Aqua Pharma Ltd. F.No.01/87/050/00575/AM11/DES‐III RA F.No. 31/24/040/00219/AM07 Adv. Lic. No.3110026642 dated 26.09.2006 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/85/2002‐Ch.III dated 01.06.2009 and in consultaon with technical authority present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Paral Sodium Salt of Phosphino Poyacrylic Acid (Acve content:50+3%) (Maxinol 5160) 1 Kg. 1. Acrylic Acid 0.300 kg 2. Causc Soda Lye (48%) 0.095 kg RA concerned may take further necessary acon as per above decision of NC.
Case No. C‐32
M/s Transpek Industry Ltd. F.No.01/83/162/01179/AM10/DES‐III Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of C&PC.
Case No. C‐33
M/s Filtra Speciality Catalyst Ltd. F.No.01/82/162/00006/AM10/DES‐III
Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of C&PC. 1
Case No.:40/39/82‐ALC4/2008
Party Name:CIPLA LIMITED Meet No/Date:45/82‐ALC4/2010 08.02.2011 Status:Case Approved HQ File :01/82/050/01410/AM09/ RLA File :03/94/040/01198/AM08/ Lic.No/Date:0310497955 15.12.2008 Decision :Commi쏧ee decided to close the case as the firm has surrendered Advance Authorisaon to RA for cancellaon. 2
Case No.:55/18/82‐ALC4/2009
Party Name:ARCH PHARMALABS LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00329/AM10/ RLA File :03/94/040/00949/AM09/ Lic.No/Date:0310503316 21.01.2009 Defer Date:08.03.2011 Decision :Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of Pharmaceucals. 3
Case No.:66/18/82‐ALC4/2009
Party Name:CORVINE CHEMICALS & PHARMACEUTICALS LIMITED, 08.02.2011 Status:Case Deferred HQ File :01/82/050/00340/AM10/ RLA File :07/24/040/00009/AM10/ Lic.No/Date:0710064113 13.04.2009 Defer Date:08.03.2011 Decision :Commi쏧ee decided to forward a copy of reply received from the firm alongwith the copy of applicaon to Department of Pharmaceucals for their comments. Accordingly, case was deferred for 08.03.2011. 4
Case No.:7/28/82‐ALC4/2009
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 08.02.2011 Status:Case Deferred HQ File :01/82/050/00567/AM10/ RLA File :03/94/040/01121/AM09/ Lic.No/Date:0310524602 17.06.2009 Defer Date:08.03.2011 Decision :Commi쏧ee considered case as per agenda and observed that the firm have sought more me to submit Producon and Consumpon data cerfied by the firm. Accordingly, it was decided to forward a copy of applicaon to Department of Pharmaceucals and defer the case for 08.03.2011. 5
Case No.:13/21/82‐ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Defer Date:08.03.2011 Decision : Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of Pharmaceucals. 6
Case No.:16/20/82‐ALC4/2009
Party Name:PANACEA BIOTEC LTD., Status:Case
08.02.2011 Approved HQ File :01/82/050/00427/AM10/ RLA File :05/24/040/00262/AM10/ Lic.No/Date:0510247323 06.08.2009 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Bio‐technology vide O.M. No.BT/IL/05/316/2010‐ PID dated 31.12.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 DTwP‐HepB‐Hib Pentavalent Vaccine (Easyfive) 1 Unit (One unit dose Vial) 1. Diphtheria Bulk 27.2 Lf (includes label claim, overfill & overages 2. Tetanus Bulk 10.2 Lf (includes label claim, overfill & overages 3. Pertussis Bulk 16.32 OU (includes label claim, overfill & overages 7
Case No.:9/34/82‐ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00654/AM10/ RLA File :22/24/040/00021/AM10/ Lic.No/Date:2210009180 20.08.2009 Defer Date:08.03.2011 8
Case No.:28/24/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00525/AM10/ RLA File :09/24/040/00199/AM10/ Lic.No/Date:0910039222 01.09.2009 Defer Date:08.03.2011 9
Case No.:34/34/82‐ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 08.02.2011 Status:Case Deferred HQ File :01/82/050/00679/AM10/ RLA File :05/24/040/00291/AM10/ Lic.No/Date:0510252005 06.11.2009 Defer Date:08.03.2011 10
Case No.:2/37/82‐ALC4/2009
Party Name:PADMINI AROMATICS PVT. LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00745/AM10/ RLA File :07/24/040/00294/AM10/ Lic.No/Date:0710068389 Defer
19.11.2009 Date:08.03.2011 Decision : Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of C&PC. 11
Case No.:113/46/82‐ALC4/2009
Party Name:MATRIX LABORATORIES LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/01029/AM10/ RLA File :09/24/040/00216/AM10/ Lic.No/Date:0910040167 04.12.2009 Defer Date:08.03.2011 Decision :Commi쏧ee decided to call the firm alongwith revised applicaon for personal hearing on 08.03.2011. Accordingly, case was deferred for 08.03.2011. 12
Case No.:83/46/82‐ALC4/2009
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 08.02.2011 Status:Case Deferred HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 23.12.2009 Defer Date:08.03.2011 Decision :Commi쏧ee decided to defer case for 08.03.2011 for reply from the firm. 13
Case No.:67/9/82‐ALC4/2010
Party Name:HETERO LABS LTD. 08.02.2011 Status:Case Deferred HQ File :01/82/050/00282/AM11/ RLA File :09/24/040/00393/AM10/ Lic.No/Date:0910040408 23.12.2009 Defer Date:08.03.2011 14
Case No.:81/5/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00115/AM11/ RLA File :09/24/040/00390/AM10/ Lic.No/Date:0910040690 28.01.2010 Defer Date:08.03.2011 15
Case No.:81/9/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 08.02.2011 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:08.03.2011 Decision :Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/70/2010‐PI (Norms) dated 25.10.2010, decided to call for the following informaon from the firm. 1. Mol. Weight and molar requirement of each input and out product. 2. Requirement & recovery of solvents of each step.
3. Copy of technical literature in support of the yields claimed by the firm. 4. Producon and Actual consumpon data of the firm for the export product Sitaglipn Phosphate Monohydrate duly cerfied by Central Excise Authority. Accordingly, case was deferred for 08.03.2011. 16
Case No.:18/48/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/01081/AM10/ RLA File :09/24/040/00435/AM10/ Lic.No/Date:0910040860 08.02.2010 Defer Date:08.03.2011 17
Case No.:19/48/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/01082/AM10/ RLA File :09/24/040/00454/AM10/ Lic.No/Date:0910040861 08.02.2010 Defer Date:08.03.2011 18
Case No.:25/48/82‐ALC4/2009
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 08.02.2011 Status:Case Deferred HQ File :01/82/050/01088/AM10/ RLA File :03/95/040/00733/AM10/ Lic.No/Date:0310559189 09.02.2010 Defer Date:08.03.2011 19
Case No.:1/1/82‐ALC4/2010
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:45/82‐ALC4/2010 08.02.2011 Status:Case Approved HQ File :01/82/050/01232/AM10/ RLA File :05/24/040/00501/AM10/ Lic.No/Date:0510260909 22.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O.No.14010/61/2010‐Ch.II dated 24.01.2011 and in consultaon with technical authority present in meeng, decided to rafy 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 L‐Carvone 1 kg 1. D‐Limonene (Citrus‐Terpene) 3.25 kg 20
Case No.:1/8/82‐ALC4/2010
Party Name:MSN LABORATORIES LIMITED Status:Case
08.02.2011 Approved HQ File :01/82/050/00190/AM11/ RLA File :09/24/040/00035/AM11/ Lic.No/Date:0910041947 06.05.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/82/2010‐PI (Norms) dated 01.10.2011 and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy 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 Rosuvastan Calcium 1 kg 1. (4R‐Cis)‐6‐((Acetyloxy)‐Methyl)‐2,2‐Dimethyl‐ 1,3‐Dioxane‐4‐Acec Acid‐1,1‐Dimethylethyl Ester 1.871 kg 2. 4‐(4‐Fluorophenyl)‐6‐Isopropyl‐2‐[(N‐Methyl‐ N‐Methylsulphonyl)Amino]Pyrimidine‐5‐YL‐ Methanol 1.871 kg 21
Case No.:24/8/82‐ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/00213/AM11/ RLA File :03/94/040/00111/AM11/ Lic.No/Date:0310574367 14.05.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/83/2006‐Ch.II dated 04.08.2008 and in consultaon with technical authories present in meeng, decided to rafy 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 Para Terary Butyl Cyclohexyl Acetate 1 Kg. 1. Para Terary Butyl Phenol 0.820 kg 2. 5% Ruthenium on Carbon Catalyst 0.000003 kg 3. Acec Acid 0.300 kg 4. Methanol 0.330 kg 22
Case No.:137/9/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00352/AM11/ RLA File :05/24/040/00048/AM11/ Lic.No/Date:0510264575 19.05.2010 Defer Date:08.03.2011 Decision :Commi쏧ee decided to defer the case for 08.03.2011 for reply from the firm.
23
Case No.:79/41/82‐ALC4/2010
Party Name:EXPO FINE CHEMICAL INDUSTRIES 08.02.2011 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:08.03.2011 24
Case No.:25/15/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00462/AM11/ RLA File :09/24/040/00118/AM11/ Lic.No/Date:0910042554 30.06.2010 Defer Date:08.03.2011 25
Case No.:8/17/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/00542/AM11/ RLA File :09/24/040/00148/AM11/ Lic.No/Date:0910042685 14.07.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy 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 Queapine Hemifumarate 1 kg 1. 1‐[2‐(2‐Hydroxyethoxy)Ethyl]Piperazine 0.714 kg 2. Toluene 1.40 kg 3. Methanol 1.06 kg 26
Case No.:67/39/82‐ALC4/2010
Party Name:KREATIVE ORGANICS (P) LTD., 08.02.2011 Status:Case Approved HQ File :01/82/050/01148/AM11/ RLA File :09/24/040/00067/AM11/ Lic.No/Date:0910042698 16.07.2010 Decision :Withdrawn as the case has already been approved by NC in 43/82 meeng held on 25.01.2011. 27
Case No.:19/19/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/00604/AM11/ RLA File :03/94/040/00374/AM11/ Lic.No/Date:0310585384 29.07.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy
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 (1R,2S,5S)‐6,6‐Dimethyl‐3‐ Azabicyclo[3.1.0]Hexane‐2‐ Carboxylic Acid methyl Ester hydrochloride (BPVR503034‐ T) 1 kg 1. Caronic Anhydrate 3.029 kg 2. Vitride [Sodium Bis(2‐Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX‐616) 0.076 kg 28
Case No.:39/19/82‐ALC4/2010
Party Name:NEULAND LABORATORIES LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/00624/AM11/ RLA File :09/24/040/00158/AM11/ Lic.No/Date:0910042941 30.07.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy 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 (1‐(3‐Hydroxy Methyl‐ Pyridine‐2‐YL)‐4‐Methyl‐2‐ Phenyl Piperazine (M Alcohol) (Drug Intermediate of Mirtazapine) 1 kg 1. 1‐Methyl 3 Phenyl Piperazine 1.082 kg 2. 2‐Chloro Nicononitrile 0.852 kg 3. Chloroform 6.37 kg 4. Dimethyl Formamide 5.38 kg 5. Sodium Bis(2‐Methoxyethoxy) Alluminium Hydride (Vitride) 1.96 kg 29
Case No.:59/41/82‐ALC4/2010
Party Name:LUPIN LIMITED 08.02.2011 Status:Case Deferred HQ File :01/82/050/01407/AM11/ RLA File :03/95/040/00267/AM11/ Lic.No/Date:0310586682 10.08.2010 Defer Date:08.03.2011 Decision :Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of Pharmaceucals. 30
Case No.:4/21/82‐ALC4/2010
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 08.02.2011 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:08.03.2011
31
Case No.:1/22/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.02.2011 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:08.03.2011 Decision :Commi쏧ee decided to forward a copy of applicaon to Department of Pharmaceucals for their comments. Accordingly, case was deferred for 08.03.2011. 32
Case No.:58/41/82‐ALC4/2010
Party Name:HERANBA INDUSTRIES LTD. 08.02.2011 Status:Case Approved HQ File :01/82/050/01406/AM11/ RLA File :03/94/040/00346/AM11/ Lic.No/Date:0310588323 18.08.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC and in consultaon with technical authority present in meeng, decided to rafy 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 Methamidophos Technical 73% 1 kg 1. O,O Dimethyl Phosphoroamido Thioate (95%) 0.952 kg 2. Dimethyl Sulphate 0.034 kg 33
Case No.:113/22/82‐ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/00766/AM11/ RLA File :09/24/040/00180/AM11/ Lic.No/Date:0910043180 20.08.2010 Defer Date: 34
Case No.:31/31/82‐ALC4/2010
Party Name:CIPLA LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/00956/AM11/ RLA File :03/94/040/00475/AM11/ Lic.No/Date:0310589085 23.08.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 44/82 meeng held on 01.02.2011 and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy 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 Levofloxacin Hemihydrate 1 kg 1. (S)9,10‐Difluoro‐3‐Methyl‐7‐oxo‐2,3‐ 1.265 kg
Dihydro‐7H‐Pyrido[1,2,3‐de] [1,4]benzoxazine‐6‐carboxylic acid ethyl ester (LVF‐3) 2. N‐Methyl Piperazine 0.432 kg 35
Case No.:56/41/82‐ALC4/2010
Party Name:LUPIN LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01404/AM11/ RLA File :03/95/040/00392/AM11/ Lic.No/Date:0310589566 26.08.2010 Defer Date: 36
Case No.:57/41/82‐ALC4/2010
Party Name:LUPIN LIMITED 08.02.2011 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:08.03.2011 37
Case No.:16/24/83‐ALC1/2010
Party Name:VIJAYASRI ORGANICS LTD 08.02.2011 Status:Case Approved HQ File :01/83/050/00423/AM11/ RLA File :09/24/040/00214/AM11/ Lic.No/Date:0910043388 07.09.2010 Decision : The Commi쏧ee consider the case in view of wri쏧en comments forwarded by O/o DC(MSME) vide teir UO No. 23(2)/DGFT/2010 dt.5.10.10 and a챦er deliberaons on the recommendaons of TAs present in the meeng decided to fix ad‐hoc norms as under:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Chenedeoxycholic Acid 1 kg 1. Pure Cholic Acid 1.579 kg 2. Triethyl Amine 0.529 kg 3. Dimethyl Amino Pyridine 0.007 kg 38
Case No.:1/25/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 08.02.2011 Status:Case Approved HQ File :01/82/050/00815/AM11/ RLA File :08/24/040/00170/AM11/ Lic.No/Date:0810092029 09.09.2010
Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments of Department of Pharmaceucals and in consultaon with technical authority present in meeng, decided to rafy norms as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Azelasne Nasal Spray 137 MCG (Acve Ingredient: Azelasne Hcl: 15.75 kg) 30 ml bo쏧le 500000 Nos 1. Azelasne Hcl 15.30 kg 2. 30 C HDPE 18 mm Bo쏧le NS As per packing policy 3. Pump + Actuator (Clip) As per packing policy RA concerned may take further necessary acon as per above decision of NC. 39
Case No.:44/41/82‐ALC4/2010
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 08.02.2011 Status:Case Approved HQ File :01/82/050/01392/AM11/ RLA File :03/94/040/00516/AM11/ Lic.No/Date:0310592885 17.09.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/106/2004/Ch.II dated 02.01.2006 and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed 2,4 Dichloro Benzyl Alcohol (Protectol DA) 1 Kg 1 2,4 Dichloro Benzyl Chloride 1.412 kg 2 Causc Soda 0.730 kg 40
Case No.:115/40/82‐ALC4/2010
Party Name:DSM ANTI‐INFECTIVES INDIA LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/01314/AM11/ RLA File :22/24/040/00041/AM11/ Lic.No/Date:2210010432 20.09.2010 Decision : Commi쏧ee considered case as per agenda and in light of its earlier decision taken in 42/82 meeng held on 19.02.2008 and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate enzymac route (ITC(HS)No.29411030) 1kg. 1. Penicillin G Pot. 1st crystal 1.664 BOU 2. D(‐) Para hydroxy phenyl glycine methyl ester 0.608 kg 3. Oxilasa enzyme 5.0 gm
Methanol 0.0215 kg 5. Boric acid 0.032 kg RA concerned may take further necessary acon as per above decision of Norms. 41
Case No.:119/40/82‐ALC4/2010
Party Name:DSM ANTI‐INFECTIVES INDIA LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/01318/AM11/ RLA File :22/24/040/00039/AM11/ Lic.No/Date:2210010433 20.09.2010 Decision : Commi쏧ee considered case as per agenda and in light of its earlier decision taken in 42/82 meeng held on 19.02.2008 and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate enzymac route (ITC(HS)No.29411030) 1kg. 1. Penicillin G Pot. 1st crystal 1.664 BOU 2. D(‐) Para hydroxy phenyl glycine methyl ester 0.608 kg 3. Oxilasa enzyme 5.0 gm 4. Methanol 0.0215 kg 5. Boric acid 0.032 kg RA concerned may take further necessary acon as per above decision of Norms. 42
Case No.:6/27/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/00873/AM11/ RLA File :03/94/040/00561/AM11/ Lic.No/Date:0310593686 23.09.2010 Decision : Commi쏧ee considered case as per agenda and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy 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 (1R,2S,5S)‐6,6‐Dimethyl‐3‐ Azabicyclo[3.1.0]Hexane‐2‐ Carboxylic Acid methyl Ester hydrochloride (BPVR503034‐ T) 1 kg 1. Caronic Anhydrate 3.029 kg 2. Vitride [Sodium Bis(2‐Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX‐616) 0.076 kg
43
Case No.:9/29/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 08.02.2011 Status:Case Deferred HQ File :01/82/050/00919/AM11/ RLA File :09/24/040/00255/AM11/ Lic.No/Date:0910043812 06.10.2010 Defer Date:08.03.2011 44
Case No.:63/41/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01411/AM11/ RLA File :09/24/040/00286/AM11/ Lic.No/Date:0910043864 08.10.2010 Defer Date: Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 31/82 meeng held on 02.11.2010 and as per SION A‐3520 and in consultaon with technical authority present in meeng, decided to rafy 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 Moxifloxacin Hcl 1 Kg. 1. 1‐Cyclopropyl‐6,7‐difluoro‐1,4‐ Dihydro‐8‐Methoxy‐4‐Oxo‐3‐ Quinoline Carboxylic Acid Ethyl Ester 1.51 kg 2. (S,S)‐2,8‐Diazabicyclo (4,3,0) Nonane 0.55 kg 45
Case No.:40/41/82‐ALC4/2010
Party Name:CIPLA LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01388/AM11/ RLA File :03/94/040/00640/AM11/ Lic.No/Date:0310596948 14.10.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 44/82 meeng held on 01.02.2011 and in consultaon with representave of Department of Pharmaceucals present in meeng, decided to rafy 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 Levofloxacin Hemihydrate 1 kg 1. (S)9,10‐Difluoro‐3‐Methyl‐7‐oxo‐2,3‐ Dihydro‐7H‐Pyrido[1,2,3‐de] [1,4]benzoxazine‐6‐carboxylic acid ethyl ester (LVF‐3) 1.265 kg 2. N‐Methyl Piperazine 0.432 kg
46
Case No.:3/33/82‐ALC4/2010
Party Name:MEHTA (API) PVT.LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/00997/AM11/ RLA File :03/95/040/00613/AM11/ Lic.No/Date:0310599632 01.11.2010 Defer Date:08.03.2011 47
Case No.:1/33/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 08.02.2011 Status:Case Deferred HQ File :01/82/050/00995/AM11/ RLA File :09/24/040/00121/AM11/ Lic.No/Date:0910044100 02.11.2010 Defer Date:08.03.2011 48
Case No.:5/33/82‐ALC4/2010
Party Name:FORACE POLYMERS (P) LTD. 08.02.2011 Status:Case Deferred HQ File :01/82/050/00999/AM11/ RLA File :05/23/040/00201/AM11/ Lic.No/Date:0510276254 03.11.2010 Defer Date:08.03.2011 Decision : Commi쏧ee decided to defer case for 08.03.2011 for comments of Department of C&PC, Petrochemicals Division. 49
Case No.:98/40/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 08.02.2011 Status:Case Approved HQ File :01/82/050/01297/AM11/ RLA File :11/24/040/00039/AM11/ Lic.No/Date:1110023537 15.11.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their U.O. No.35011/96/2009‐PI‐III dated 17.03.2009 and in consultaon with technical authority present in meeng, decided to rafy 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 Hydrocorsone Sodium Succinate for Injecon (Hydrocorsone Sodium Succinate buffered 5% Sterile )Organical Chemicals 1 Kg. 1. Hydrocorsone Base 1.00 kg 50
Case No.:74/41/82‐ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 08.02.2011 Status:Case Deferred HQ File :01/82/050/01422/AM11/ RLA File :17/24/040/00080/AM09/ Lic.No/Date:1710003593 Defer
30.11.2010 Date:08.03.2011 51
Case No.:75/41/82‐ALC4/2010
08.02.2011 Status:Case Deferred HQ File :01/82/050/01423/AM11/ RLA File :17/24/040/00150/AM08/ Lic.No/Date:1710003592 30.11.2010 Defer Date:08.03.2011 52
Case No.:84/41/82‐ALC4/2010
Party Name:SODIUM METAL (P) LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/01432/AM11/ RLA File :34/24/040/00223/AM11/ Lic.No/Date:3410028737 06.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/112/2005/Ch.II dated 16.01.2009 and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed Verdyl Propionate 1 Kg 1 Dicylopentadiene 0.712 kg 2. Propionic Acid 0.400 kg 53
Case No.:76/41/82‐ALC4/2010
08.02.2011 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:08.03.2011 54
Case No.:82/41/82‐ALC4/2010
Party Name:METROPOLITAN EXIMCHEM LTD. 08.02.2011 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:08.03.2011 55
Case No.:87/41/82‐ALC4/2010
Party Name:DALAS BIOTECH LTD. 08.02.2011 Status:Case Deferred
HQ File :01/82/050/01435/AM11/ RLA File :05/23/040/00245/AM11/ Lic.No/Date:0510278806 07.12.2010 Defer Date:08.03.2011 56
Case No.:73/41/82‐ALC4/2010
Party Name:GOPINATH CHEM‐TECH LTD., 08.02.2011 Status:Case Deferred HQ File :01/82/050/01421/AM11/ RLA File :08/24/040/00270/AM11/ Lic.No/Date:0810094594 13.12.2010 Defer Date:08.03.2011 Decision :Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their le쏧er No.14010/67/2008‐Ch.II, decided to remind the firm to furnish the following informaon:‐ 1. Authenc/printed technical literature in support of percentage yield or norms applied for import. 2. Producon of export item ll date and corresponding consumpon of each input duly cerfied by CA. 3. The norms for Farmazan Base is already printed at Sl.No.A‐2989 and A‐3018 of Hand Book of Procedures, Vol.II. Jusficaon for the requirement of quanty taking into the consideraon the printed norms of Ortho Notro Toluene at Sl.No.A‐1437 and Benzaldehyde at Sl.No.A‐1886 of the Hand book. 4. Jusficaon for the requirement of 8 kg Causc Soda Flakes/Lye (100% basis) per kg of export item as alongwith technical literature. 5. Jusficaon for the requirement of 1 kg of Polyol for per kg of export item along with the details of quanty charged, recovered and loss in process for per kg of export item. Accordingly, case was deferred for 08.03.2011. 57
Case No.:1/41/82‐ALC4/2010
Party Name:KEDIA ORGANIC CHEMICALS PVT.LTD. 08.02.2011 Status:Case Approved HQ File :01/82/050/01349/AM11/ RLA File :03/94/040/00792/AM11/ Lic.No/Date:0310607421 22.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/105/2010/Ch.II dated 07.02.2011 and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed Mixture of Methyl Esters derived from Acid Oil (RE‐100) 1 Kg 1 Acid Oil 0.970 kg 58
Case No.:2/41/82‐ALC4/2010
08.02.2011 Status:Case Deferred HQ File :01/82/050/01350/AM11/ RLA File :17/24/040/00164/AM08/ Lic.No/Date:1710003636 22.12.2010 Defer Date:08.03.2011
59
Case No.:3/41/82‐ALC4/2010
08.02.2011 Status:Case Deferred HQ File :01/82/050/01351/AM11/ RLA File :17/24/040/00034/AM10/ Lic.No/Date:1710003639 22.12.2010 Defer Date:08.03.2011 60
Case No.:4/41/82‐ALC4/2010
08.02.2011 Status:Case Deferred HQ File :01/82/050/01352/AM11/ RLA File :17/24/040/00014/AM11/ Lic.No/Date:1710003640 22.12.2010 Defer Date:08.03.2011 61
Case No.:6/41/82‐ALC4/2010
Party Name:SARACA LABORATORIES LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/01354/AM11/ RLA File :09/24/040/00406/AM11/ Lic.No/Date:0910044856 22.12.2010 Defer Date:08.03.2011 62
Case No.:18/41/82‐ALC4/2010
08.02.2011 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:08.03.2011 63
Case No.:7/41/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 08.02.2011 Status:Case Approved HQ File :01/82/050/01355/AM11/ RLA File :08/24/040/00277/AM11/ Lic.No/Date:0810094940 24.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments of Department of Pharmaceucals and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed Isosorbide Mononitrate Extended Release Tablets USP 30 mg 34640000 Nos. 1 Isosorbnide‐5‐ Mononitrate 50% in Lactose 50% (Short 4577.209 kg Isosorbide Mononitrate Extended 20075500 Nos.
Release Tablets USP 60 mg form:IS5MN 50%‐ Lactose 200 50%) 64
Case No.:9/41/82‐ALC4/2010
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01357/AM11/ RLA File :09/24/040/00431/AM11/ Lic.No/Date:0910044904 27.12.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/24/200/Ch.II dated 08.02.2011 and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed Dimethyl Dimethylol Hydantoin (assay 52‐53% min.) 1 Kg 1 5,5‐Dimethyl Hydantoin 0.387 kg 65
Case No.:10/41/82‐ALC4/2010
Party Name:AARTI ORGANIC 08.02.2011 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:08.03.2011 66
Case No.:97/41/82‐ALC4/2010
08.02.2011 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:08.03.2011 67
Case No.:98/41/82‐ALC4/2010
08.02.2011 Status:Case Deferred HQ File :01/82/050/01446/AM11/ RLA File :17/24/040/00005/AM09/ Lic.No/Date:1710003673 31.12.2010 Defer Date:08.03.2011
68
Case No.:99/41/82‐ALC4/2010
08.02.2011 Status:Case Deferred HQ File :01/82/050/01447/AM11/ RLA File :17/24/040/00093/AM09/ Lic.No/Date:1710003677 31.12.2010 Defer Date:08.03.2011 69
Case No.:95/41/82‐ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 08.02.2011 Status:Case Deferred HQ File :01/82/050/01443/AM11/ RLA File :09/24/040/00443/AM11/ Lic.No/Date:0910045024 03.01.2011 Defer Date:08.03.2011 Decision :Commi쏧ee decided to call for a copy of applicaon, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 08.03.2011. 70
Case No.:1/45/82‐ALC4/2010
Party Name:HETERO DRUGS LIMITED, 08.02.2011 Status:Case Approved HQ File :01/82/050/01541/AM11/ RLA File :09/24/040/00475/AM11/ Lic.No/Date:0910045231 27.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by PI Division vide their O.M. No.35011/160/2008‐PI‐III dated 19.09.2008 and in consultaon with technical authority present in meeng decided to rafy 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 Cefixime USP 1 kg. 1. G.C.L.E. 1.555 kg 2. Mica Ester 1.112 kg 3. Triethylamine 0.416 kg 4. Thriphenyl Phosphine 1.22 kg 5. Dimethyl Formamide 5.61 kg 6. Methylene Chloride 16.25 kg 7. Acetonitrile 3.84 kg RA concerned may take further necessary acon as per above decision of NC. 71
Case No.:2/45/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01542/AM11/ RLA File :09/24/040/00486/AM11/ Lic.No/Date:0910045265 27.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/96/2010‐PI (Norms) dated 05.10.2010 and in consultaon with technical authority present in meeng, decided to rafy 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
Abacavir Sulphate 1 Kg. 1. N‐(2‐Amino‐4,6‐Dichloro‐5‐Pyrimidinyl) Formamide 1.042 kg 2. (1S,4R)‐4‐Amino‐2‐Cyclopentene 1‐Methanol Tartaric Acid Salt 1.331 kg 3. Triethyl Amine 0.503kg 4. Triethyl Ortho Formate 1.50 kg 5. Tetrahydrofuran 14.28 kg 6. Cyclopropylamine 0.19 kg 7. Gluataric Acid 0.65 kg 72
Case No.:3/45/82‐ALC4/2010
Party Name:MEDREICH LIMITED 08.02.2011 Status:Case Deferred HQ File :01/82/050/01543/AM11/ RLA File :07/24/040/00433/AM11/ Lic.No/Date:0710076954 27.01.2011 Defer Date:08.03.2011 Decision :Commi쏧ee decided to call for a copy of applicaon, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 08.03.2011. 73
Case No.:4/45/82‐ALC4/2010
Party Name:ONEIRO CHEMICALS LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/01544/AM11/ RLA File :34/24/040/00265/AM11/ Lic.No/Date:3410029174 27.01.2011 Decision :Commi쏧ee considered case as per agenda and observed that the instant Advance Authorisaon has been issued on repeat basis on the basis of norms fixed in 34/82 meeng held on 23.11.2010. The representave of Department of Pharmaceucals informed the Commi쏧ee that they have recommended import of Ammonium Persulphates to the extent of 2.43 kg/kg of export product. Commi쏧ee also observed that the enhanced quanty of said input was allowed against old advance licences for regularizaon purpose only, on the basis of Central Excise data for the cases considered in NC Meeng No.33/11 dated 16.11.2010. No repeat licence should be issued on the basis to enhanced norms of NC Meeng No.33/11 dated 16.11.2010. A챦er detailed deliberaons and in consultaon with technical authories present in meeng, Commi쏧ee decided to direct RA to reduce the quanty of Ammonium Persulphates to the extent of 2.43 kg/kg of export product against both the advance authorizaons Nos. 3410029174 dated 27.01.2011 and 3410027426 dated 06.07.2010 and in future repeat licence may be issued to the firm on the basis of the quanty of 2.43 kg/kg of export product in respect of import item Ammonium Persulphates. Commi쏧ee also decided to call for the data from Pharmexcil for revision of SION A‐321 for Omeprazole, A‐322 for Omeprazole Pellets 8.5%, A‐323 for Omeprozole Pellets 8.5%, A‐2407 for 2‐(Hydroxy Methyl) 3,5,Dimethyl‐4‐Methoxy Pyridine (Omeprazole Intermediate) and A‐2684 for 2‐Chloromethyl‐3,5‐Dimethyl‐4‐Methoxy Pyridine Hydrochloride.
74
Case No.:5/45/82‐ALC4/2010
Party Name:ARCATA TRADE LINKS PVT. LTD. 08.02.2011 Status:Case Approved HQ File :01/82/050/01545/AM11/ RLA File :08/24/040/00325/AM11/ Lic.No/Date:0810095803 27.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/42/2005/Ch.II dated 10.01.2011 and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed 3,5 Di Amino Benzoic Acid 1 Kg 1 3,5 Di Nitro Benzoic Acid 2.00 kg 75
Case No.:6/45/82‐ALC4/2010
Party Name:BALAJI AMINES LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01546/AM11/ RLA File :31/24/040/00076/AM11/ Lic.No/Date:3110046649 28.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006‐Ch.II dated 10.05.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed. 76
Case No.:7/45/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 08.02.2011 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:08.03.2011 77
Case No.:8/45/82‐ALC4/2010
Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., Meet No/Date:45/82‐ALC4/2010 08.02.2011 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:08.03.2011
Decision :Commi쏧ee decided to call from firm Producon and Consumpon data cerfied by CA/ICWA/Jurisdiconal Central Excise Authority. Accordingly, the case was deferred for 08.03.2011. 78
Case No.:9/45/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 08.02.2011 Status:Case Approved HQ File :01/82/050/01549/AM11/ RLA File :03/95/040/00837/AM11/ Lic.No/Date:0310613304 31.01.2011 Defer Date: Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/81/2005/Ch.II dated 27.12.2010 and in consultaon with technical authority present in meeng, decided to rafy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import Item Qty. allowed Para Fluoro Bromo Benzene (4 Fluoro Bromo Benzene) 1 Kg 1 Fluoro Benzene 0.685 kg 2. Bromine 1.200 kg 79
Case No.:10/45/82‐ALC4/2010
Party Name:POSY PHARMACHEM PVT. LTD. 08.02.2011 Status:Case Approved HQ File :01/82/050/01550/AM11/ RLA File :08/24/040/00294/AM11/ Lic.No/Date:0810095886 31.01.2011 Defer Date: Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/84/2010/Ch.III dated 8.11.10 and in consultaon with technical authority present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Import items Qty. allowed Citric Acid Antydrous USP 1 Kg. Citric Acid Antydrous 1.01 80
Case No.:11/45/82‐ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 08.02.2011 Status:Case Deferred HQ File :01/82/050/01551/AM11/ RLA File :31/24/040/00234/AM11/ Lic.No/Date:3110046695 31.01.2011 Defer Date:08.03.2011 81
Case No.:12/45/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 08.02.2011 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:08.03.2011 82
Case No.:14/45/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.02.2011 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:08.03.2011 83
Case No.:15/45/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.02.2011 Status:Case Approved HQ File :01/82/050/01555/AM11/ RLA File :05/24/040/00352/AM11/ Lic.No/Date:0510282606 31.01.2011 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/89/2008‐PI‐III dated 11.06.2009 and in consultaon with technical authority present in meeng, decided to rafy 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 Atorvastan Calcium 1 Kg. 1. (4R‐CIS)‐1,1‐Dimethylethyl‐6‐Cyanomethyl‐2,2‐ Dimethyl‐1,3‐Dioxane‐4‐Acetate 1.003kg 2. Acvated Carbon 0.047 kg 3. Cyclohexane 0.235 kg 4. Diketone(+/‐)4‐Fluro‐Alfa(2‐methyl‐1‐ Oxopropyl)Fama‐OX O‐N Beta‐ Diphenylbenzenebutaneamide) 1.15 kg 5. Heptane 1.60kg 6. Isopropyl Alcohol 1.128 kg 7. Methanol 5.45 kg 8. Methyl‐T‐Butyl‐Ether 2.63 kg 9. Tetrahydrofuran 2.12 kg 10. Toluene 2.826 kg 84
Case No.:13/45/82‐ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD 08.02.2011 Status:Case Deferred HQ File :01/82/050/01553/AM11/ RLA File :09/24/040/00474/AM11/ Lic.No/Date:0910045353 Defer
01.02.2011 Date:08.03.2011
Case No. Outside Agenda‐1
M/s Hindustan Polyamides & Fibres Ltd. F.No.01/82/050/01343/AM07/DES‐III F.No.01/82/050/01661/AM07/DES‐III F.No.01/83/050/01490/AM08/DES‐III F.No.01/82/050/01141/AM08/DES‐III F.No.01/82/050/00241/AM09/DES‐III F.No.01/82/050/01149/AM09/DES‐III F.No.01/82/050/00417/AM09/DES‐III F.No.01/82/050/00981/AM10/DES‐III F.No.01/82/050/00402/AM11/DES‐III RA F.No. 03/94/040/00915/AM07 RA F.No. 03/94/040/01141/AM07 RA F.No. 03/94/040/00807/AM07 RA F.No. 03/94/040/00580/AM08 RA F.No. 03/94/040/00937/AM08 RA F.No. 03/94/040/00338/AM09 RA F.No. 03/94/040/00031/AM09 RA F.No. 03/94/040/00489/AM10 RA F.No. 03/94/040/00098/AM11 Adv. Lic. No.0310409452 dated 24.11.2006 Adv. Lic. No.0310417197 dated 24.01.2007 Adv. Lic. No.0310448910 dated 02.11.2007 Adv. Lic. No.0310442329 dated 10.09.2007 Adv. Lic. No.0310454666 dated 19.12.2007 Adv. Lic. No.0310490082 dated 13.10.2008 Adv. Lic. No.0310467654 dated 08.04.2008 Adv. Lic. No.0310543250dated 29.10.2009 Adv. Lic. No.0310572124 dated 29.04.2010 Commi쏧ee considered case and in consultaon with technical authority present in meeng, decided to amend the descripon of import item to read as “Pentyl Endo (2‐Pentyl‐2‐Cyclopentene‐1‐one” without any other change in the earlier decisions of NC.
Case No. Outside Agenda‐2
M/s Alembic Ltd. F.No.01/87/050/00771/AM06/DES‐III RA F.No. 34/24/040/00148/AM06 Adv. Lic. No.3410014451 dated 28.09.2005 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their U.O. No.35011/115/2010‐PI‐(Norms) dated 11.10.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A‐2263 on pro‐rata basis.
Case No. Outside Agenda‐3
M/s Alembic Ltd. F.No.01/82/050/00161/AM11/DES‐III RA F.No. 34/24/040/00229/AM10 Adv. Lic. No.3410026592 dated 12.03.2010 Commi쏧ee considered case as per agenda and in light of earlier decision taken in 3/82 meeng held on 23.05.2007 and in consultaon with technical authority present in meeng, decided to rafy 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 Azithromycin Monohydrate 1 KG 1. Erythromycin Thiocyanate 2.24 KGA 2. Hydroxylamine Hcl 1.03 kg 3. Acetone/Acetonitrile 7.24 kg 4. Methanol/IPA 3.06 kg 5. Planum Oxide 2.50 gram 6. Triethylamine 0.51 kg 7. Methylene Chloride 3.16 kg 8. Acvated Carbon 0.0227 kg
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