DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 49/82ALC4/2010 MEETING DATE : 08.03.2011 The Meeting No.49/82 in the year 201011 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 08.03.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri M. Mitra, Dy. DCGI, Office of DCGI 3. Shri D.N. Mathur, Dy.I.A, Department of Pharmaceuticals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.47/82 dated 22.02.2011 and 48/82 dated 01.03.2011 were ratified by the Committee.
Case No.B410
M/S Yasho Industries Pvt. Ltd. Norms Committee Meeting No.49/11 F.No.01/82/050/01769/AM09/DESIII Meeting Date:08.03.2011 RA F.No.03/95/040/01002/AM09 Adv.Lic.No.0310513238 dated 25.03.2009 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to call for Production and Consumption data certified by Central Excise Authority. Accordingly, case was deferred for 05.04.2011.
Case No.B411
M/S Sandoz Pvt. Ltd. F.No.01/82/050/00547/AM11/DESIII RA F.No.03/95/040/00197/AM11 Adv.Lic.No.0310580896 dated 28.06.2010 Committee considered case as per agenda and observed that the norms has been correctly fixed as per comparison data of all industry. It was, therefore, decided to reject the request of the firm for enhancement in the quantity of inputs.
Case No.B412
M/S Kopran Ltd. F.No.01/82/050/01601/AM09/DESIII RA F.No.03/94/040/00986/AM09 Adv.Lic.No.0310504570 dated 30.01.2009 Committee considered case as per agenda 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 the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Pregabalin 1 Kg. 1. Isovaleraldehyde 5.317 kg 2. Diethyl Malonate 10.767 kg 3. Acetyl Chloride 11.167 kg 4. Ethyl Cyanoacetate 6.336 kg RA concerned may take further necessary action as per above decision of NC.
Case No.B413
M/S Kopran Ltd. F.No.01/82/050/01818/AM07/DESIII RA F.No.03/94/040/01416/AM07 Adv.Lic.No.0310423486 dated 16.03.2007 Committee considered case as per agenda 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 the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin EP/USP 1 Kg. 1. Claritromycin Oxime 1.988 kg
Case No. B414
M/s Laffans Petrochemicals Ltd. Norms Committee Meeting No. 49/11 F.No.01/83/050/00827/AM08/DESIII Meeting Date 08.03.2011 RA F.No. 03/95/040/00219/AM08 Adv. Lic. No.0310437236 dated 24.07.2007 Committee decided to defer case for 03.05.2011 for comments of Petrochemicals Division of Department of C&PC.
Case No. B415
M/s Span Diagnostics Ltd. F.No.01/82/050/01536/AM09/DESIII RA F.No. 52/24/040/00028/AM09 Adv. Lic. No.5210025186 dated 12.01.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of Biotechnology vide their O.M. No.BT/IL/05/308/2009PID dated 26.06.2020 and in consultation with technical authorities present in meeting, decide to revise adhoc norms as per details below or as applied by the firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Parahitf (Device) Test Kit (50 tests per Kit) 56000 Nos. 1. Brij35(NonIonic Detergent ) 1000 gm. 2. Triton X100 (NonIonic Detergent ) 6.791 Liter 3. Anti Mouse 1 gG (Goat) 27.733 gm. 4. Bovine Albumin Powder Standard 2500 gm
Bovine Albumin Protease Free Powder. 666.67 gm. 6. MAB to P. Falciparum for NCM 29 gm. 7. MAB for P. Falciparum Colloidal Gold Rea 28.833 gm 8. Absorbent Pad 30 MM x 500 Ft. 40000 Nos. 9. Conjugate Releasing Pad (2040/2033) Parahit 40000 Nos. 10. Casette Platic for ICT 2800000 Nos. 11. Disposable Lancets Pack each containing25 112000 Nos. 12. Heparinized Capallaries Pack cont25 112000 Nos. 13. Disposable Swab Pack each contain25 112000 Nos. 14. Gold Chloride 91.670 gm RA concerned may take further necessary as per above decision of NC. The earlier decision taken in 30/11 meeting held on 26.10.2010 stands withdrawn.
Case No. B416
M/s Deepak Nitrile Ltd. F.No.01/82/162/00651/AM07/DESIII Committee considered case as per agenda. The representatives of the firm appeared before the Committee for personal hearing and explained the case. The Committee members noted that the case is as under: Export Product (Before issue of P.N. No.32 dated 26.07.2005) Export Product (After issue of P.N. No.32 dated 26.07.2005) Import items (Before issue of P.N. No.32 dated 26.07.2005) Import items (After issue of P.N. No.32 dated 26.07.2005) 2,4 Xylidine/2,6 Xylidine – 1 kg. 2,4 Xylidine thru 4 Nitro Meta Xylene – 1 kg. 1. Meta Xylene – 1 kg 2. Furnance Oil – 1.29 liter/kg 1. Meta Xylene – 1.160 kg OR 4Nitro Meta Xylene – 1.310 kg 2. Catalyst (2% Palladium on Carbon) – 0.05 gm The firm’s representatives also explained that 2,4 Xylidine can be prepared through both Meta Xylene or 4Nitro Meta Xylene. Thus mentioning specifically’ through 4 Nitro Meta Xylene’ in export product is not required. They explained chemical process to Technical Authority present. The Technical Authority noted
requirement of inputs for 2,6 Xylidine also and the Committee in consultation with representative of ‘Department of C&PC, decided to recommend modification of SION A2913 as under for approval of DGFT: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,4 Xylidine OR 2,6 Xylidine 1 Kg. 1. Meta Xylene OR 4Nitro Meta Xylene 1.160 kg 1.310 kg 2. Catalyst (2% Palladium on Carbon 0.05 gm
Case No. B417
M/s Vijaysri Chemicals F.No.01/82/050/00325/AM09/DESIII RA F.No. 09/24/040/00295/AM08 Adv. Lic. No.0910032157 dated 26.11.2007 Committee considered case as per agenda and in light of earlier decision taken in 45/11 meeting held on 08.02.2011 and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “2Butyl5Chloro3HImidazole4Carbaldehyde (IMAL) or 2NButyl4Chloro5 Formylimidazole (BCFI)” without any other change in the decision taken in 11/82 meeting held on 10.06.2008.
Case No. B418
M/s Solaris Chemtech Industries Ltd. F.No.01/82/162/00642/AM10/DESIII Committee decided to defer case for 03.05.2011.
Case No. B419
M/s S.M. Herbal Pvt. Ltd. F.No.01/85/050/00017/AM10/DESIII RA F.No. 05/24/040/00017/AM10 Adv. Lic. No.0510240516 dated 29.04.2009 Committee considered case as per agenda and observed that the quantity of inputs have already been allowed correctly on the basis of comparison data of All Industry and therefore, quantity of inputs can not be enhanced. In case, the firm is not satisfied with the decision of NC, they may appear before the Committee on any Tuesday after prior intimation in this regard to Shri Krishan Kumar, Dy. DGFT & Member Secretary, NC 3 (Tel.No.23061562, Ext. 380, EMail: krishan.kr@nic.in) or Shri Shyam Lal, FTDO (Tel.No.23061562 Ext.269, EMail: shyam.l@nic.in).
Case No. C37
M/s Filtra Speciality Catalysts Ltd. F.No.01/82/162/00006/AM10/DESIII Committee decided to defer case for 05.04.2011 for comments of Department of C&PC.
Case No. C38
M/s IndSwift Laboratories Ltd. F.No.01/82/162/00594/AM11/DESIII Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals.
Case No. C39
M/s Laffans Petrochemicals Ltd. F.No.01/82/162/01223/AM10/DESIII Committee considered case as per agenda and observed that the firm has requested for enhancement in the quantity of inputs against their advance licences issued under para 4.7 of HBP and have requested to allow enhanced quantity of inputs for fixation of SION also. The representative of Department of C&PC informed the Committee that quantity of inputs against their advance licences issued under para 4.7 of HBP has already been allowed correctly on the basis of All Industry data and there is no justification for enhancement in the quantity of inputs. After detailed deliberations and in consultation with technical authority present in meeting, Committee decided to reject the case for fixation of SION.
Case No. A129
M/s Divi’s Laboratories Ltd. F.No.01/82/162/01039/AM11/DESIII
Case No. A130
F.No.01/82/162/01041/AM11/DESIII
Case No. A131
F.No.01/82/162/01029/AM11/DESIII
Case No. A132
F.No.01/82/162/01030/AM11/DESIII
Case No. A133
F.No.01/82/162/01031/AM11/DESIII
Case No. A134
F.No.01/82/162/01036/AM11/DESIII
Case No. A135
F.No.01/82/162/01032/AM11/DESIII
Case No. A136
F.No.01/82/162/01037/AM11/DESIII
Case No. A137
F.No.01/82/162/01040/AM11/DESIII
Case No. A138
F.No.01/82/162/01042/AM11/DESIII Committee decided to defer case for 08.03.2011 for comments of Department of Pharmaceuticals.
Case No. A139
F.No.01/82/162/01018/AM11/DESIII Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
Case No. A140
F.No.01/82/162/01043/AM11/DESIII
Case No. A141
F.No.01/82/162/01044/AM11/DESIII
Case No. A142
F.No.01/82/162/01019/AM11/DESIII Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to fix consumption norms for EOU as per details below. Export product Exp. Qty. Sl.No. Import items Qty. allowed N(2(4Methoxy Phenyl)11 DimethylEthyl) Acetamide (CD 675) 1 Kg. 1. Toluene 0.66 kg 2. nHeptane 1.41 kg 3. Acetonitrile 0.67 kg 4. Methyl Cyclohexane 2.567 kg Development Commissioner concerned may take further necessary action as per above decision of NC.
Case No. A143
F.No.01/82/162/01020/AM11/DESIII Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
Case No. A144
F.No.01/82/162/01046/AM11/DESIII Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
Case No. A145
F.No.01/82/162/01015/AM11/DESIII Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
Case No. A146
F.No.01/82/162/01016/AM11/DESIII
Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
Case No. A147
F.No.01/82/162/01045/AM11/DESIII Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to fix consumption norms for EOU as per details below. Export product Exp. Qty. Sl.No. Import items Qty. allowed (S)tertbutyl 1 (Benzyloxyamino)3 Hydroxy3Methyl1 Oxobutan2yl Carbamate (BAL0030372) 1 Kg. 1. Methanol 6.74 kg 2. DIBOC 3.929 kg 3. 2,2Dimethoxy Propane 3.41 kg 4. Toluene 6.56 kg 5. Citric Acid 8.76 kg 6. Cyclo Hexane 2.95 kg 7. Tetra Hydrofuran 9.86 kg 8. HOBT 1.07 kg 9. Dicyclo Hexylamine 1.16 kg 10. OBenzyl Hydroxylamine Hcl 0.96 kg 11. Potassium Carbonate 1.60 kg 12. 2,2,6,6TetramethylPiperidine 1Oxyl Acetonitrile 0.79 kg Development Commissioner concerned may take further necessary action as per above decision of NC.
Case No. A148
F.No.01/82/162/01017/AM11/DESIII Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
Case No. A149
F.No.01/82/162/01038/AM11/DESIII
Case No. A150
F.No.01/82/162/01014/AM11/DESIII Withdrawn as the case has already been approved by NC in 47/11 meeting held on 22.02.2011.
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Case No.:146/24/87ALC1/2007
Party Name:AQUAPHARM CHEMICALS PVT.LIMITED Meet No/Date:49/82ALC4/2010 08.03.2011 Status:Case Approved HQ File :01/87/050/00191/AM07/ RLA File :31/24/040/00028/AM07/ Lic.No/Date:3110025000 23.05.2006 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/56/2007 Ch.III dated 17.12.2008 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 PM200 Liquid Form 1 KG. 1. Maleic Anhydride 0.355 kg 2
Case No.:55/18/82ALC4/2009
Party Name:ARCH PHARMALABS LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00329/AM10/ RLA File :03/94/040/00949/AM09/ Lic.No/Date:0310503316 21.01.2009 Decision : Committee considered case as per agenda 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 3(3(Benzyloxy)Propoxy)2 (4,4,5,5Tetramethyl1,3,2 Dioxaborolan2YL) Benzaldehyde (AN3728) 1 KG. 1. 2,3Dihydroxy benzaldehyde 1.612 kg 2. Bis (Pinacolato) Diboron 1.88 kg 3. Tetrahydrofuran 4.70 kg 4. Triflic Anhydride 2.015 kg 5. Heptane 5.037 kg 6. 1,1”Bis(Diphenylphosphino) Ferrocene) Dichloropalladium (II) 0.215 kg 3
Case No.:66/18/82ALC4/2009
Party Name:CORVINE CHEMICALS & PHARMACEUTICALS LIMITED, 08.03.2011 Status:Case Approved HQ File :01/82/050/00340/AM10/ RLA File :07/24/040/00009/AM10/ Lic.No/Date:0710064113 13.04.2009 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed 5Methyl1,2,3,4 Tetrazole 1 KG. 1. Hydrazine Hydrate 80% Not shown in reaction/process details. Hence not allowed
Sodium Nitrite do 3. Triethyl Amine 0.540 kg 4. Acetonitrile 0.542 kg 4
Case No.:30/13/82ALC4/2009
Party Name:SHILPA MEDICARE LTD., 08.03.2011 Status:Case Deferred HQ File :01/82/050/00170/AM10/ RLA File :07/24/040/00103/AM10/ Lic.No/Date:0710065349 11.06.2009 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 5
Case No.:7/28/82ALC4/2009
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 08.03.2011 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:26.04.2011 Decision :Committee considered case as per agenda and observed that Production and Consumption data certified by Central Excise Authority has been received from the firm and the same has been forwarded to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 26.04.2011. 6
Case No.:13/21/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:49/82ALC4/2010 08.03.2011 Status:Case Approved HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed 7ATCA 1 KG. 1. 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.70 kg 2. Methylene Chloride 1.907 kg 3. Sodium Bromide 0.62 kg 4. Triphenyl Phosphine 1.82 kg 5. 4Methyl Thiazole5Aldehyde 0.886 kg 6. Iso Propyl Alcohol 2.619 kg 7. Sodium Bisulphite 1.616 kg 8. Sodium Hydroxide 0.218 kg 9. Sodium Sulphate 2.70 kg 10. Sodium Biocarbonate 5.35 kg 11. Phenol 3.65 kg 12. Trifloro Ascetic Acid (TFA) 1.36 kg 13. NButyl Acetate 3.17 kg
Acetic Acid 0.13 kg 15. Eno Carbon 0.100 kg 16. EDTA 0.0044 kg 17. Hydro (Sodium Hydro Sulphide) Not allowed 18. Methanol 5.632 kg 19. Acetone 3.193 kg 20. Dimethyl Formamide 0.80 kg 7
Case No.:4/19/82ALC4/2009
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 08.03.2011 Status:Case Approved HQ File :01/82/050/00382/AM10/ RLA File :03/94/040/00307/AM10/ Lic.No/Date:0310531016 28.07.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/9/2005 Ch.II dated 25.10.2010 and earlier decision taken in 36/82 meeting held on 07.12.2010 and in consultation with technical authorities 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 Astrolide in Dipropylene Glycol Main Astrolide content 62.5% 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Para Formaldehyde 0.088 kg 4. Dipropylene Glycol 0.350 kg 8
Case No.:9/34/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:49/82ALC4/2010 08.03.2011 Status:Case Approved HQ File :01/82/050/00654/AM10/ RLA File :22/24/040/00021/AM10/ Lic.No/Date:2210009180 20.08.2009 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed Cefdinir 1 KG. 1. 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.44 kg 2. Dimethyl Formamide 2.209 kg 3. Triphenyl Phosphine 2.037 kg 4. Sodium Bromide 0.56 kg 5. Methylene Chloride 19.478 kg 6. Methanol 7.031 kg 7. Sodium Hydroxide 0.371 kg
Formaldehyde 2.74 kg 9. Phenol 2.42 kg 10. NButyl Acetate 3.688 kg 11. Sodium Biocarbonate Not allowed 12. Sodium Carbonate 0.018 kg 13. EDTA 0.003 kg 14. Hydro (Sodium Hydro Sulphite Not allowed 15. Eno Carbon 0.100 kg 16. Sulphuric Acid Not allowed 17. Acetone 4.577 kg 18. EHATA 1.07 kg 19. Acetic Anhydride 0.90 kg 20. Potassium Carbonate 0.637 kg 21. MBTS 1.67 kg 22. Triethylamine 0.917 kg 23. Tetrahydrofuran 0.894 kg 9
Case No.:28/24/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00525/AM10/ RLA File :09/24/040/00199/AM10/ Lic.No/Date:0910039222 01.09.2009 Decision : Committee considered the case as per agenda and in consultation with Technical Authority present in the meeting decided ratify 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 N(2Amino4,6 Dichloro5 Pyrimidinyl) Formamide (BAC 2) 1 Kg. 1. Phosphourous Oxy Chloride 4.678 kg 2. (DimethylFormamide 0.44 kg 3. Methanol 0.61kg 4. 2,5Diamino4,6Dihydroxy Pyrimidine (DADHP) 1.37kg 5. Toluene 2.936 kg RA Concerned may take further necessary action as per above decision of NC. 10
Case No.:74/5/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 08.03.2011 Status:Case Deferred HQ File :01/82/050/00108/AM11/ RLA File :09/24/040/00203/AM10/ Lic.No/Date:0910039636 16.10.2009 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 11
Case No.:27/34/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 08.03.2011 Status:Case Deferred
HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:22.03.2011 Decision :Committee considered case as per agenda and observed that production and Consumption data certified by Central Excise Authority has been received from the firm and the same has been sent to Department of C&PC. Accordingly, case was deferred for 22.03.2011. 12
Case No.:34/34/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 08.03.2011 Status:Case Approved HQ File :01/82/050/00679/AM10/ RLA File :05/24/040/00291/AM10/ Lic.No/Date:0510252005 06.11.2009 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed Sulbactam Sodium Sterile 1 KG. 1. Sulbactam Acid 0.9733 kg 2. Activated Carbon 0.0246 kg 3. Iso Propyl Alcohol 2.658 kg 13
Case No.:2/37/82ALC4/2009
Party Name:PADMINI AROMATICS PVT. LTD 08.03.2011 Status:Case Deferred HQ File :01/82/050/00745/AM10/ RLA File :07/24/040/00294/AM10/ Lic.No/Date:0710068389 19.11.2009 Defer Date:22.03.2011 Decision :Committee decided to defer case for 22.03.2011 for comments of Department of C&PC. 14
Case No.:29/38/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 08.03.2011 Status:Case Deferred HQ File :01/82/050/00802/AM10/ RLA File :05/24/040/00383/AM10/ Lic.No/Date:0510253942 04.12.2009 Defer Date:03.05.2011 Decision :Committee decided to defer case for 03.05.2011 for comments of Department of Pharmaceuticals. 15
Case No.:113/46/82ALC4/2009
Party Name:MATRIX LABORATORIES LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/01029/AM10/ RLA File :09/24/040/00216/AM10/ Lic.No/Date:0910040167 04.12.2009 Decision :Committee considered case as per agenda and observed that the firm has surrendered the Advance Authorisation to RA for cancellation. Accordingly, case was closed. 16
Case No.:83/46/82ALC4/2009
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 08.03.2011 Status:Case Deferred HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 Defer
23.12.2009 Date:05.04.2011 Decision :Committee decided to remind the firm to furnish a copy of DML. Accordingly, case was deferred for 05.04.2001. 17
Case No.:67/9/82ALC4/2010
Party Name:HETERO LABS LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/00282/AM11/ RLA File :09/24/040/00393/AM10/ Lic.No/Date:0910040408 23.12.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken 4/82 meeting held on 27.04.2010 and in consultation with technical authority present in meeting, decided to ratify the norms on repeat basis 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 Quantity allowed Zidovudine 1 kg 1. 3Azido3Deoxy Thymidine (total impurities NLT 5%) 1.05 kg 2. Dimethyl Sulfoxide 1.56 kg 3. Methanol 2.19 kg 18
Case No.:63/22/82ALC4/2010
Party Name:INDSWIFT LABORATORIES LTD., 08.03.2011 Status:Case Approved HQ File :01/82/050/00716/AM11/ RLA File :22/24/040/00046/AM10/ Lic.No/Date:2210009581 14.01.2010 Decision : Committee considered the case as per agenda and in consultation with Technical Authority present in the meeting decided ratify 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 1,3Dioxolane,4Acetic Acid,6 [2[2(4Flourophenyl)Methyl]5 (1Methylethyl)3Phenyl4 [(Phenylamino) Carbonyl]1H Pyrrole1YL]Ethyl] 2,2 Dimethyl(1,1 Dimethylethyl)Ester (Atorvastatin Intermediate AT1) 1 Kg. 1. Methyl Isobutyryl Acetate 0.97 kg 2. Benzaldehyde 0.458 kg 3. BAlanine 0.0735 kg 4. 4Fluoro Benzaldehyde 0.556 kg 5. 3Ethyl5 (2Hydroxyethyl)4Methyl Thiozolium Bromide 0.12 kg 6. (4RCis)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl1,3 Dioxane4Acetate (ATS8) 0.635 kg 7. Heptane 4.37 kg 19
Case No.:81/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD Status:Case
08.03.2011 Deferred HQ File :01/82/050/00115/AM11/ RLA File :09/24/040/00390/AM10/ Lic.No/Date:0910040690 28.01.2010 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 20
Case No.:81/9/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 08.03.2011 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:03.05.2011 Decision :Committee decided to defer case for 03.05.2011 for reply from the firm. 21
Case No.:18/48/82ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/01081/AM10/ RLA File :09/24/040/00435/AM10/ Lic.No/Date:0910040860 08.02.2010 Decision : Committee considered the case as per agenda and in consultation with Technical Authority present in the meeting decided ratify 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 3(3Chloro Propyl)2,3 Dihydro 1H Benzimidazol2One (OR) 1 (3Chloro Propyl)1,3 Dihydro 2H Benzimidaxol2One 1 Kg. 1. Ortho Phenylene Diamine 0.917 kg 2. 1Bromo3Chloro Propane 1.07 kg 3. Methyl Aceto Acetate 0.984 kg 22
Case No.:19/48/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/01082/AM10/ RLA File :09/24/040/00454/AM10/ Lic.No/Date:0910040861 08.02.2010 Decision : Committee considered the case as per agenda and in consultation with Technical Authority present in the meeting decided ratify 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 N(2Amino4,6 Dichloro5 Pyrimidinyl) Formamide (BAC 2) 1 Kg. 1. Phosphourous Oxy Chloride 4.678 kg 2. (DimethylFormamide 0.44 kg 3. Methanol 0.61kg 4. 2,5Diamino4,6Dihydroxy Pyrimidine (DADHP) 1.37kg 5. Toluene 2.936 kg RA Concerned may take further necessary action as per above decision of NC.
23
Case No.:25/48/82ALC4/2009
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 08.03.2011 Status:Case Approved HQ File :01/82/050/01088/AM10/ RLA File :03/95/040/00733/AM10/ Lic.No/Date:0310559189 09.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 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 Methyl6Methyl Nicotinate 1 No. 1. 5Ethyl2Methyl Pyridine 0.99 kg 2. Methylene Chloride 0.682 kg 3. Methanol 1.818 kg 23
Case No.:49/22/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 08.03.2011 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:03.05.2011 Decision :Committee decided to defer case for 03.05.2011 for comments of Department of Pharmaceuticals. 25
Case No.:37/50/82ALC4/2009
Party Name:MEDREICH LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/01191/AM10/ RLA File :07/24/040/00455/AM10/ Lic.No/Date:0710070358 04.03.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export product Exp. Qty. Sl.No. Import items Qty. allowed Glucosamine Sulfate Tablet 500 mg 1 No. 1. Glucosamine Sulfate 2KCI (Glucosamine Sulphate Potassium Chloride) 676.60 mg 26
Case No.:4/2/82ALC4/2010
Party Name:HETERO LABS LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/00004/AM11/ RLA File :09/24/040/00568/AM10/ Lic.No/Date:0910041513 01.04.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/96/2010PI (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 Abacavir Sulphate 1 Kg. 1. N(2Amino4,6Dichloro5Pyrimidinyl) Formamide 1.042 kg 2. (1S,4R)4Amino2Cyclopentene 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 27
Case No.:53/5/82ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 08.03.2011 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:03.05.2011 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish Production and Consumption data certified by Central Excise Authority, but the same has not been received. Accordingly, it was decided to remind the firm and defer the case for 03.05.2011. 28
Case No.:48/14/82ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 08.03.2011 Status:Case Deferred HQ File :01/82/050/00410/AM11/ RLA File :03/94/040/00933/AM10/ Lic.No/Date:0310570355 20.04.2010 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 29
Case No.:17/8/82ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 08.03.2011 Status:Case Approved HQ File :01/82/050/00206/AM11/ RLA File :05/24/040/00033/AM11/ Lic.No/Date:0510264144 12.05.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.No.35011/78/2010PI (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 Export Qty. Sl.No. Import items Qty. allowed 2‐(3‐(S)‐(3‐(2‐(7‐Chloro‐2‐ quinolinyl)‐Ethenyl) Phenyl)‐3‐ Hydroxypropyl)Benzoic Acid Methyl Ester Hydrate (MT‐7). 1 kg 1. 7‐Chloroquinaldine 1.22 kg 2. Isophthaldehyde 1.10 kg 3. Methyl‐2‐Iodobenzoate 1.074 kg 4. (‐)‐Diisopinocampheyl chloroborane in Heptane(60‐ 1.427 kga
65% Soluꬅon)(acꬅve)(UOM‐ KGA) 5. Toluene 2.668 kg 6. Tetrahydrofuran 4.84 kg 30
Case No.:137/9/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.03.2011 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:05.04.2011 Decision :Committee decided to defer case for 04.05.2011 for comments of Department of Pharmaceuticals. 31
Case No.:9/22/82ALC4/2010
Party Name:K R R DRUGS & INTERMEDIATES PVT LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00662/AM11/ RLA File :09/24/040/00044/AM11/ Lic.No/Date:0910042151 26.05.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting 15.02.2011 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 Pavest 1 Kg. 1. 7Pheylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 1.274 kg 2. Tri Phenyl Phosphine 0.70 kg 32
Case No.:62/15/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 08.03.2011 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:03.05.2011 Decision :Committee decided to Defer case for 03.05.2011 for comments of Department of Pharmaceuticals. 33
Case No.:71/15/82ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 08.03.2011 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals.
34
Case No.:32/22/82ALC4/2010
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/00685/AM11/ RLA File :03/94/040/00230/AM11/ Lic.No/Date:0310579071 16.06.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/231/2008PIIII dated 01.06.2009 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 Meropenem Injection USP 1 gm 1 mg Vial 1. Meropenem Trihydrate USP 1197.90 mg Meropenem Injection USP 500 mg 500 mg Vial 1. Meropenem Trihydrate USP 598.95 mg 35
Case No.:38/41/82ALC4/2010
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/01386/AM11/ RLA File :09/24/040/00029/AM11/ Lic.No/Date:0910042383 17.06.2010 Defer Date:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 36
Case No.:67/41/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 08.03.2011 Status:Case Deferred HQ File :01/82/050/01415/AM11/ RLA File :09/24/040/00005/AM11/ Lic.No/Date:0910042381 17.06.2010 Defer Date:05.04.2011 Decision : Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 37
Case No.:20/15/82ALC4/2010
Party Name:MEDREICH LIMITED 08.03.2011 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:03.05.2011 Decision : Committee decided to defer case for 03.05.2011 for comments of Department of Pharmaceuticals. 38
Case No.:79/41/82ALC4/2010
Party Name:EXPO FINE CHEMICAL INDUSTRIES 08.03.2011 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:03.05.2011 Decision : Committee decided to defer case for 03.05.2011 for comments of Department of C&PC. 39
Case No.:5/15/82ALC4/2010
Party Name:SHODHANA LABORATORIES LTD 08.03.2011 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:03.05.2011 40
Case No.:51/41/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 08.03.2011 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:03.05.2011 41
Case No.:12/15/82ALC4/2010
Party Name:MEDREICH LIMITED 08.03.2011 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:03.05.2011 42
Case No.:25/15/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00462/AM11/ RLA File :09/24/040/00118/AM11/ Lic.No/Date:0910042554 30.06.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export product Exp. Qty. Sl.No. Import items Qty. allowed Raltegravir Potassium 1 Kg. 1. 2(2AMINO PROPAN2YL)N(4 FLUOROBENZYL)5HYDROXY1METHYL6 OXO1,6DIHYDRO PYRIMIDINE4 CARBOXAMIDE 1.232 kg 2. POTASSIUM 5METHYL1,3,4OXADIAZOLE2 CARBOXYLATE 3.66 kg 3. Acetone 0.487 kg 4. Dimethyl Formamide 0.012 kg 5. Methanol 4.38 kg 6. Methylene Di Chloride 13.11 kg 43
Case No.:78/15/82ALC4/2010
Party Name:ALEMBIC LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/00515/AM11/ RLA File :34/24/040/00070/AM11/ Lic.No/Date:3410027389 30.06.2010 Defer Date:22.03.2011
Decision :Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 44
Case No.:49/41/82ALC4/2010
Party Name:INDIAN IMMUNOLOGICALS LTD., 08.03.2011 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:03.05.2011 Decision : Committee decided to defer case for 03.05.2011 for comments of Department of Biotechnology. 45
Case No.:42/41/82ALC4/2010
Party Name:GENEX PHARMA 08.03.2011 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:03.05.2011 46
Case No.:11/19/82ALC4/2010
Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/00596/AM11/ RLA File :03/94/040/00379/AM11/ Lic.No/Date:0310585032 26.07.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/50/2006 Ch.II dated 07.03.2011 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 Chemical Antifoulant DA 2339/DA2313/DA2316/DA2339 M/DA2394/DA2304C/DA2309 (Containing 30% of Penta (2 Methylene4Nonyl Phenol) TEPA Adduct 13% of 2,6 Ditertiary Butyl4 Benzolidene25Dione 13% of 4,4(1,1Di ox 01,10 Decanedyl) Bis(2,2,6 Tetramethyl 1PiperridineNOxyl) 44% of Aromatic Solvent) 1 KG. 1. 2,6 Ditertiary Butyl Phenol 0.091 kg 2. Dimethyl Sebacate 0.013 kg 3. 4 Hydroxy Tempo (4 Hydroxy 2,2,6,6 Tetramethyl, PiperridineN Oxyl) 0.021 kg 4. Dibutyl Tin Oxide 0.0005 kg 5. Aromatic Solvent (C10C20) 0.44 kg 6. Nonyl Phenol 0.098 kg 7. Tetra Ethylene Penta Amine 0.042 kg 7. Para Formaldehyde 0.01 kg 47
Case No.:68/41/82ALC4/2010
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/01416/AM11/ RLA File :03/94/040/00377/AM11/ Lic.No/Date:0310585474 29.07.2010 Defer Date:
Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/11 meeting held on 22.02.2011 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 Kanamycin Acid Sulphate Injection 1 gm/3 ml Vial 1 Vial 1. Kanamycin Acid Sulphate Sterile BP 2000 1.466 gm. 48
Case No.:37/19/82ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00622/AM11/ RLA File :09/24/040/00147/AM11/ Lic.No/Date:0910042939 30.07.2010 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.14010/112/2010 Ch.II dated 28.02.2011 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 nButyl Magnesium Chloride 24% 1 KG. 1. nButyl Chloride 0.200 kg 2. Tetrahydrofuran 1.00 kg 49
Case No.:59/41/82ALC4/2010
Party Name:LUPIN LIMITED 08.03.2011 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:03.05.2011 Decision :Committee decided to defer case for 03.05.2011 for comments of Department of Pharmaceuticals. 50
Case No.:4/21/82ALC4/2010
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 08.03.2011 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:03.05.2011 51
Case No.:1/22/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.03.2011 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:03.05.2011
52
Case No.:93/41/82ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/01441/AM11/ RLA File :08/24/040/00160/AM11/ Lic.No/Date:0810091363 18.08.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed Amlodipine Besylate 1 KG. 1. Phthalic Anhydride 1.58 kg 2. Ethanol Amine 0.65 kg 3. Xylene 4.80 kg 4. Methylene Aceto Acetate 2.56 kg 5. Ammonia Solution 2.56 kg 6. Methanol 3.75 kg 7. Toluene 4.80 kg 8. Acetic Acid 9.00 kg 9. Sodium Hydride 0.99 kg 10. Tetrahydrofuran 0.50 kg 11. Ethyl4Chloro Aceto Acetate 1.52 kg 12. Iso Propyl Alcohol 7.30 kg 13. Ortho Chloro Benzyl Dehyde 0.92 kg 14. Morpholine 0.11 kg 15. Hexane 6.11 kg 16. Mono Methyl Amine (40%) 8.62 kg 17. Benzene Sulphonic Acid 0.58 kg 18. Activated Charcoal 0.20 kg 53
Case No.:57/41/82ALC4/2010
Party Name:LUPIN LIMITED 08.03.2011 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:03.05.2011 Decision :Committee considered case as per agenda and decided to ask the firm to indicate whether the export product is being manufactured through Non infringing process. Accordingly, the case was deferred for 03.05.2011. 54
Case No.:2/25/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 08.03.2011 Status:Case Deferred HQ File :01/82/050/00816/AM11/ RLA File :08/24/040/00169/AM11/ Lic.No/Date:0810092030 09.09.2010 Defer Date:22.02.2011 Decision :Committee decided to defer case for 22.02.2011 for comments of Department of pharmaceuticals. 55
Case No.:3/25/82ALC4/2010
Party Name:APEX DRUGS & Status:Case
INTERMEDIATES LIMITED 08.03.2011 Deferred HQ File :01/82/050/00817/AM11/ RLA File :09/70/040/00082/AM11/ Lic.No/Date:0910043460 09.09.2010 Defer Date:05.04.2011 Decision : Committee decided to defer case for 05.04.2011 for comments of Department of Pharmaceuticals. 56
Case No.:47/26/82ALC4/2010
Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 08.03.2011 Status:Case Deferred HQ File :01/82/050/00865/AM11/ RLA File :09/24/040/00120/AM11/ Lic.No/Date:0910043539 17.09.2010 Defer Date:03.05.2011 57
Case No.:20/39/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 08.03.2011 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:03.05.2011 58
Case No.:23/28/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/00905/AM11/ RLA File :09/24/040/00233/AM11/ Lic.No/Date:0910043787 01.10.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 59
Case No.:9/29/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 08.03.2011 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:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 60
Case No.:54/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 08.03.2011 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:03.05.2011 Decision :Committee decided to ask the firm to indicate whether the export product is prefilled Injection. Accordingly, case was deferred for 03.05.2011. 61
Case No.:55/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 08.03.2011 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:03.05.2011
Decision : Committee decided to ask the firm to indicate whether the export product is prefilled Injection. Accordingly, case was deferred for 03.05.2011. 62
Case No.:80/41/82ALC4/2010
Party Name:CHIRAG ENTERPRISE 08.03.2011 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:03.05.2011 Decision : Committee decided to defer case for 03.05.2011 for comments of Department of C&PC, Petrochemicals Division. 63
Case No.:3/33/82ALC4/2010
Party Name:MEHTA (API) PVT.LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00997/AM11/ RLA File :03/95/040/00613/AM11/ Lic.No/Date:0310599632 01.11.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authorities 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 Des Azithromycin/Desmethyl Azithromycin CAS Registry No.76801859 1 Kg. 1. Erythromycin Thiocynate 1.640 KGA 2. Hydroxyamine Hydrochloride 0.87 kg 3. Para Toluene Sulfonyl Chloride 0.407 kg 4. Methanol 3.00 kg 5. Methylene Chloride/Acetone 1.27 kg 6. 5% Platinum on Charcoal 0.00105 kg 64
Case No.:4/33/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/00998/AM11/ RLA File :03/94/040/00532/AM11/ Lic.No/Date:0310599921 02.11.2010 Decision :Committee considered case as per agenda and in line with SION A26 and A1146 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as applied by the firm. 65
Case No.:5/33/82ALC4/2010
Party Name:FORACE POLYMERS (P) LTD. 08.03.2011 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:03.05.2011 Decision : Committee decided to defer case for 03.05.2011 for comments of Department of C&PC, Petrochemicals Division. 66
Case No.:7/33/82ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 08.03.2011 Status:Case
Deferred HQ File :01/82/050/01001/AM11/ RLA File :03/94/040/00708/AM11/ Lic.No/Date:0310600070 03.11.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 67
Case No.:9/33/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 08.03.2011 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:03.05.2011 68
Case No.:11/33/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.03.2011 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:03.05.2011 69
Case No.:91/41/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 08.03.2011 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:03.05.2011 70
Case No.:71/41/82ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/01419/AM11/ RLA File :31/24/040/00174/AM11/ Lic.No/Date:3110045645 26.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 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 Fomepizole Injection 1 gm/ml 1.50 ml vial) 1 No. 1. Fomepizole 1.65 gm/1.5 ml vial 71
Case No.:74/41/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 08.03.2011 Status:Case Approved HQ File :01/82/050/01422/AM11/ RLA File :17/24/040/00080/AM09/ Lic.No/Date:1710003593 30.11.2010 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 07.03.2011 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 ASO1315 (Tridecyl Alcohol 15 Mole Ethoxylate) 1 KG. 1. Ethylene Oxide 0.767 kg 2. Tridecyl Alcohol (Iso Tridecanol) 0.232 kg 72
Case No.:75/41/82ALC4/2010
LTD, 08.03.2011 Status:Case Approved HQ File :01/82/050/01423/AM11/ RLA File :17/24/040/00150/AM08/ Lic.No/Date:1710003592 30.11.2010 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 07.03.2011 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 LAP2 (Phosphated Ester of lauryl Alcohol 2 Mole Ethoxylate) 1 KG. 1. Lauryl Alcohol 0.585 kg 2. Ethylene Oxide 0.268 kg 3. Phosphorous Pentoxide 0.148 kg 73
Case No.:83/41/82ALC4/2010
Party Name:CENTURY PHARMACEUTICALS LTD. 08.03.2011 Status:Case Deferred HQ File :01/82/050/01431/AM11/ RLA File :34/24/040/00226/AM11/ Lic.No/Date:3410028741 06.12.2010 Defer Date:03.05.2011 74
Case No.:76/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 75
Case No.:82/41/82ALC4/2010
Party Name:METROPOLITAN EXIMCHEM LTD. 08.03.2011 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:03.05.2011
76
Case No.:87/41/82ALC4/2010
Party Name:DALAS BIOTECH LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/01435/AM11/ RLA File :05/23/040/00245/AM11/ Lic.No/Date:0510278806 07.12.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting held on 15.02.2011 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 Pavest 1 Kg. 1. 7Pheylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 1.274 kg 2. Tri Phenyl Phosphine 0.70 kg 3. Methylene Chloride 2.45 kg 77
Case No.:81/41/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 08.03.2011 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:03.05.2011 Decision :Committee decided to defer case for 03.05.2011 for comments of Department of Pharmaceuticals. 78
Case No.:73/41/82ALC4/2010
Party Name:GOPINATH CHEMTECH LTD., 08.03.2011 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:05.04.2011 Decision :Committee decided to defer case for 05.04.2011 for reply from the firm. 79
Case No.:77/41/82ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 08.03.2011 Status:Case Deferred HQ File :01/82/050/01425/AM11/ RLA File :03/94/040/00836/AM11/ Lic.No/Date:0310605981 13.12.2010 Defer Date:22.03.2011 Decision :Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 80
Case No.:85/41/82ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/01433/AM11/ RLA File :08/24/040/00266/AM11/ Lic.No/Date:0810094593 13.12.2010 Decision :Withdrawn as the case has already been approved by NC in its 40/82 meeting held on 04.01.2011.
81
Case No.:2/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 82
Case No.:3/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 83
Case No.:4/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 84
Case No.:5/41/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 08.03.2011 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:03.05.2011 85
Case No.:6/41/82ALC4/2010
Party Name:SARACA LABORATORIES LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/01354/AM11/ RLA File :09/24/040/00406/AM11/ Lic.No/Date:0910044856 22.12.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting held on 15.02.2011 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 Gabapentin Hcl (Technical Powder) 1 Kg. 1. 1,1 Cyclohexane Di Acetic Acid Monoamide (CAM) 0.988 kg 2. Bromine 0.923 kg 86
Case No.:18/41/82ALC4/2010
LTD, 08.03.2011 Status:Case Deferred HQ File :01/82/050/01366/AM11/ RLA File :17/24/040/00148/AM08/ Lic.No/Date:1710003645 Defer Date:03.05.2011
23.12.2010 87
Case No.:10/41/82ALC4/2010
Party Name:AARTI ORGANIC 08.03.2011 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:03.05.2011 88
Case No.:12/41/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/01360/AM11/ RLA File :05/24/040/00323/AM11/ Lic.No/Date:0510280422 27.12.2010 Defer Date: 89
Case No.:14/41/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/01362/AM11/ RLA File :09/24/040/00405/AM11/ Lic.No/Date:0910044913 27.12.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 90
Case No.:15/41/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/01363/AM11/ RLA File :09/24/040/00379/AM11/ Lic.No/Date:0910044914 27.12.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 91
Case No.:16/41/82ALC4/2010
Party Name:LUPIN LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/01364/AM11/ RLA File :03/95/040/00777/AM11/ Lic.No/Date:0310607934 27.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed Simvastatin 1 KG. 1. Activated Carbon 0.035 kg 2. Caustic Soda Flakes 0.358 kg 3. Cychohexane 3.334 kg 4. Ethyl Acetate 3.414 kg 5. Methyl Ethyl Ketone 0.685 kg 6. Imidazole 0.58 kg
g 7. Methanol 7.374 kg 8. Toluene 2.388 kg 9. Tri Ethyl Amine 0.972 kg 10. Methane Sulphonic Acid 0.060 kg 11. Tertiary Butyl Dimethyl Silyl ChloTBDMS 0.779 kg 12. 2 2 Dimethyl Butyryl Chloride 1.215 kg 13. Lovastatin 1.39 kg 92
Case No.:23/41/82ALC4/2010
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/01371/AM11/ RLA File :04/24/040/00264/AM11/ Lic.No/Date:0410120177 28.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed Pseudoephedrine Hcl 1 KG. 1. 1Ephedrine Hydrochloride Technical Grade 1.20 kg 2. Toluene 0.55 kg 93
Case No.:25/41/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 08.03.2011 Status:Case Approved HQ File :01/82/050/01373/AM11/ RLA File :07/24/040/00385/AM11/ Lic.No/Date:0710076337 29.12.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 44/82 meeting held on 01.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms on prorata basis 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 Ceftazidime for Injection USP 500 mg Vial Size:20 ml 1Vial 1. Ceftazimide USP (As Ceftazidime Pentahydrate) (As Blend of Sterile Ceftazidime Pentahydrate & Sterile Sodium Carbonate) USP 0.565 gram 94
Case No.:27/41/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 08.03.2011 Status:Case Approved
HQ File :01/82/050/01375/AM11/ RLA File :08/24/040/00287/AM11/ Lic.No/Date:0810095085 29.12.2010 Decision : Committee considered case as per agenda 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 Levofloxacin 250 mg Tablets 1 No. 1. Levofloxacin Hemihydrate 261.35 mg 2. Hypermellose 6 CPS, 1910 USP 11.67 mg 3. Microcrystalline Cellulose NF (Avicel PH 102 49.67 mg 4. Crospovidine NF 21.67 mg 5. Magnesium Stearate NF 5.0 mg 6. 60 CC White HDPE bottel As per packing policy 7. CRC White Cap 33MM 8. 100 CC White HDPE Bottle 9. CRC White Cap 38 MM 10. 150 CC White HDPE Bottle 11. 225 CC White HDPE Bottle 12. CRC White Cap 45 MM Levofloxacin 500 mg Tablet 1 No. 1. Levofloxacin Hemihydrate 522.709 mg 2. Hypermellose 6 CPS, 1910 USP 23.33 mg 3. Microcrystalline Cellulose NF (Avicel PH 102 99.33 mg 4. Crospovidine NF 43.33 mg 5. Magnesium Stearate NF 10.00 mg 6. 60 CC White HDPE bottel As per packing policy 7. CRC White Cap 33MM 8. 100 CC White HDPE Bottle 9. CRC White Cap 38 MM 10. 150 CC White HDPE Bottle 11. 225 CC White HDPE Bottle 12. CRC White Cap 45 MM Levofloxacin 750 mg Tablets 1 No. 1. Levofloxacin Hemihydrate 784.06 mg 2. Hypermellose 6 CPS, 1910 USP 35.00 mg 3. Microcrystalline Cellulose NF (Avicel PH 102 149.00 mg 4. Crospovidine NF 65.00 mg 5. Magnesium Stearate NF 15.00 mg 6. 60 CC White HDPE bottel As per packing policy 7. CRC White Cap 33MM 8. 100 CC White HDPE Bottle 9. CRC White Cap 38 MM 10. 150 CC White HDPE Bottle 11. 225 CC White HDPE Bottle 12. CRC White Cap 45 MM
95
Case No.:29/41/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 08.03.2011 Status:Case Approved HQ File :01/82/050/01377/AM11/ RLA File :05/23/040/00267/AM11/ Lic.No/Date:0510280721 30.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export Product Export Qty. Sl.No. Import items Qty. allowed Donepezil Tablets 5 mg 1 No. 1. Donepezil Hcl 1H(US) 5.1 mg Donepezil Tablets 10 mg 1 No. 1. Donepezil Hcl 1H(US) 10.2 mg 96
Case No.:30/41/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 08.03.2011 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:03.05.2011 97
Case No.:97/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 98
Case No.:33/41/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/01381/AM11/ RLA File :09/24/040/00447/AM11/ Lic.No/Date:0910044965 31.12.2010 Defer Date:22.03.2011 Decision :Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 99
Case No.:34/41/82ALC4/2010
Party Name:HETERO LABS LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/01382/AM11/ RLA File :09/24/040/00439/AM11/ Lic.No/Date:0910044966 31.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7
Export Product Export Qty. Sl.No. Import items Qty. allowed Losartan Potassium 1 KG. 1. 2Butyl4Chloro5Formyl Imidazole 0.62 kg 2. 4Bromomethyl2Cyano Biphenyl 1.117 kg 3. Sodium Borohydride 0.048 kg 4. Toluene 3.42 kg 5. Methanol 2.00 kg 6. NMethyl Pyrrolidone 1.20 kg 100
Case No.:98/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 101
Case No.:99/41/82ALC4/2010
LTD, 08.03.2011 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:03.05.2011 102
Case No.:94/41/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 08.03.2011 Status:Case Approved HQ File :01/82/050/01442/AM11/ RLA File :08/24/040/00272/AM11/ Lic.No/Date:0810095163 03.01.2011 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export product Exp. Qty. Sl.No. Import items Qty. allowed Levofloxacin Hemihydrate 1 kg 1. (S)9,10Difluoro2,3dihydro3methyl 7oxo(3S)7Hpyrido[1,2,3de]1,4 benzoxazine6carboxylic Acid (LVF40) 1.01 kg 2. Dimethyl Sulfoxide 4.25 kg 3. NMethylpiperazine 0.432 kg 103 Case No.:95/41/82ALC4/2010 Party Name:RA CHEM PHARMA LIMITED 08.03.2011 Status:Case Deferred HQ File :01/82/050/01443/AM11/ RLA File :09/24/040/00443/AM11/ Lic.No/Date:0910045024 Defer
03.01.2011 Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 104
Case No.:3/45/82ALC4/2010
Party Name:MEDREICH LIMITED 08.03.2011 Status:Case Approved HQ File :01/82/050/01543/AM11/ RLA File :07/24/040/00433/AM11/ Lic.No/Date:0710076954 27.01.2011 Defer Date: Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 105
Case No.:7/45/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 08.03.2011 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:03.05.2011 106
Case No.:8/45/82ALC4/2010
Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., 08.03.2011 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:03.05.2011 107
Case No.:11/45/82ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 08.03.2011 Status:Case Approved HQ File :01/82/050/01551/AM11/ RLA File :31/24/040/00234/AM11/ Lic.No/Date:3110046695 31.01.2011 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 Export product Exp. Qty. Sl.No. Import items Qty. allowed Ciprofloxacin Tablets 250 mg 1 No. 1. Ciprofloxacin Hcl 277.50 mg Ciprofloxacin Tablets 500 mg 1 No. 1. Ciprofloxacin Hcl 555.0 mg 108
Case No.:12/45/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 08.03.2011 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:03.05.2011 Decision :Committee decided to defer case for 03.05.2011 for comments of Department of Pharmaceuticals.
109 Case No.:14/45/82ALC4/2010 Party Name:RANBAXY LABORATORIES LTD 08.03.2011 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:03.05.2011 110
Case No.:13/45/82ALC4/2010
Party Name:SAINOR LABORATORIES PVT LTD 08.03.2011 Status:Case Approved HQ File :01/82/050/01553/AM11/ RLA File :09/24/040/00474/AM11/ Lic.No/Date:0910045353 01.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/112/2010 Ch.II dated 28.02.2011 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 nButyl Magnesium Chloride 24% 1 KG. 1. nButyl Chloride 0.200 kg 2. Tetrahydrofuran 1.00 kg
Case No.Outside Agenda1
M/S Cipla Ltd. F.No.01/82/050/00949/AM11/DESIII RA F.No.03/94/040/00463/AM11 Adv.Lic.No.0310588650 dated 19.08.2010 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 “Artemisinin” without any other change in the decision taken in 40/82 meeting held on 04.01.2011.
Case No.Outside Agenda2
M/S Cipla Ltd. F.No.01/82/050/00936/AM09/DESIII RA F.No.03/94/040/00073/AM09 Adv.Lic.No.0310468658 dated 16.04.2008 Committee considered case and in consultation with technical authority present in meeting, decided to amend the quantity of import item No.5 i.e. “HFA227 Propellant (1,1,1,2,2,2,2Heptafluoropropane Gas)” to read as “21.12 Gram” without any other change in the decision taken in 52/82 meeting dated 17.03.2009 and 38/82 meeting dated 21.12.2010.
Case No.Outside Agenda3
M/S Cipla Ltd. F.No.01/82/050/01109/AM11/DESIII F.No.01/82/050/00421/AM11/DESIII F.No.01/82/050/00967/AM11/DESIII F.No.01/82/050/01003/AM10/DESIII RA F.No.03/94/040/00685/AM10 RA F.No.03/94/040/00186/AM11 RA F.No.03/94/040/00570/AM11 RA F.No.03/94/040/0020/AM10 Adv.Lic.No.0310550099 dated 09.12.2009 Adv.Lic.No.0310575233 dated 20.05.2010 Adv.Lic.No.0310594232 dated 28.09.2010 Adv.Lic.No.0310552364 dated 23.12.2009 Committee considered case and in consultation with technical authority present in meeting, decided to make the following amendments against all the four advance licences: 1. Amendment in the description of export product: Export item No.1: Ipratropium Bromide 20 mcg inhaler (200MD) with 50 mcl Aerosol Valves. Export item No.2: Salbutamol 100 mcg and Ipratropium Bromide 20 mcg inhaler (200MD) with 50 mcl Aerosol valves Export item No.3: Budesonide 100 mcg inhaler (200MD) with 50 mcl Aerosol valves Export item No.4: Budesonide 200 mcg inhaler (200MD) with 50 mcl Aerosol valves 2. Amendment in the description of import item from “63 mcl Aerosol Valve” to “50 mcl Aerosol Valve. 3. Amendment in the quantity of “HFA227 Propellant (1,1,1,2,3,3,3Heptafluoropropane gas)” from 21.12 mg to 16.76 gram.
Case No.Outside Agenda4
M/S Cipla Ltd. F.No.01/82/050/011420/AM11/DESIII F.No.01/82/050/01428/AM11/DESIII F.No.01/82/050/01232/AM11/DESIII RA F.No.03/94/040/00821/AM11 RA F.No.03/94/040/00655/AM11 RA F.No.03/94/040/00740/AM11 Adv.Lic.No.0310605290 dated 09.12.2010 Adv.Lic.No.0310597504 dated 18.10.2010 Adv.Lic.No.0310601558 dated 16.11.2010 Committee considered case and in consultation with technical authority present in meeting, decided to add the uom of import item No.1,2 and 3 to read as ‘gram/relevant pack” without any other change in the earlier decisions of NC.
Case No. Outside Agenda5
M/s Vetindla Pharmaceuticals Ltd., Hyderabad N C Meeting No. 49/11 F.No.01/82/162/00588/AM11/DESIII Committee Considered case for clarification regarding applicability of DEPB for Veterinary Drugs. The representative of DCGI informed that the SIONs are applicable for Human Drugs and therefore, DEPB will not be applicable for export of Veterinary Drugs. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to clarify that DEPB shall not be applicable for export of Veterinary Drugs.
Case No. Outside Agenda6
M/s Mahima Sciences Pvt. Ltd. N C Meeting No. 49/11 F.No.01/82/050/00799/AM11/DESIII RA F.No.05/24/040/00193/AM11 Adv.Lic.No.0510271761 dated 30.08.2010 Committee considered case. The representatives of the firm appeared before the Committee and explained the case. They informed the Committee that their unit has been converted from DTA to EOU and enhancement in the quantity of Betamethasone BP is required for regularization of the case Committee, after detailed deliberations and in light of earlier decision taken in 52/10 meeting held on 23.03.2010 and in consultation with technical authority present in meeting, decided to enhance the quantity of Betamethasone BP to read as “1.19 kg/kg of export product” for regularization purpose without any other change in the decision taken in 31/82 meeting held on 02.11.2010. No repeat licence may be issued on the basis of above decision of NC.
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