DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 48/82ALC4/2011 MEETING DATE : 28.02.2012 The Meeting No.46/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 28.02.2012 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri S.S. Bose, Senior Development Officer, Department of Industrial Policy and Promotion. 2. Shri Jasbir Singh, Consultant, Department of C&PC 3. Shri V.K. Tyagi, Dy. Industrial Adviser, Department of Pharmaceuticals 4. Shri R.C. Meena, Dy. Director General of Foreign Trade 5. Ms.Lalita Maini, FTDO At the outset, minutes of Norms Committee Meeting No.47/82 dated 21.2.2012 were ratified by the Committee.
Case No.B 494
M/s. Elfa Laboratories Norms Committee Meeting No.48/AM12 F.No. 01/82/050/003530/AM 12/DES III Meeting Date:28.02.2012 Adv. Lic. No 0510215792 dated 4.2.2008 R.A F.NO 05/25/40/00483/AM 08 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed that in original application, applicant has requested import of bulk drug without taking into account the molecular weight of sale being imported. Accordingly, the application was rectified as applied. The company has now represented that the entire export obligation could not be met due to shortage of raw material on account of higher consumption due to molecular weight difference. The Committee deliberated the issue and agreed to make necessary amendment in the quanity of Ceftraxone Sodium Sterile from 500 kg to 505.96gm/vial. RA may take appropriate action as per the decision of Norms Committee.
Case No.B 495
M/s. Ultratech India Limited Pt. F.No. 01/82/050/00446/AM 08 Pt. F.No.01/82/050/00119/AM 09 Pt F. No. 01/82/050/00259/Am 12
Adv. Lic. No 0310450707 dated 19.11.2007 Adv. Lic. No 0310459552 dated 30.01.2008 Adv. Lic. No 0310631866 dated 19.05.2011 R.A F.NO 03/95/040/00813/AM 08 R.A F.No 03/95/040/01080/AM 08 R.A F.No 03/95/040/00078/AM 12 authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.B 496
M/s Zenith Dyeintermediates Limited . F.No. 01/82/050/00563/AM 12 DES III Adv. Lic. No 031645518 dated 1.08.2011 R.A F.NO 03/95/040/00310/AM 12 authorities present in the meeting decided to call from the firm Certificate of Analysis for import and export products. Accordingly, the case has been deferred for 27.3.2012.
Case No.B 497
M/s. DSM AntiInfectives India Limited F.No. 01/82/050/01305/AM 11/DES III F.No.01/82/050/01440/AM 11/DES III F.No. 01/82/050/01309/AM 11/DES III F. No. 01/82/050/01109/AM 11/DES III Adv. Lic. No 2210010237 dated 4.8.2010 Adv. Lic. No 2210010247 dated 5.8.2010 Adv. Lic. No 2210010202 dated 21.07.2010 Adv. Lic. No. 2210010203 dated 21.07.2010 R.A F.NO 22/24/040/00021/Am 11 R.A F.No 22/24/040/00024/AM 11 R.A F.No 22/24/040/00016/AM 11 R.A F.No. 22/24/040/00017/AM 11 authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.B 498
M/s. Siddhi Vinayaka Spechem Pvt. Ltd. F.No 01/82/050/01548/AM 11/DES III
Adv. Lic. No 0710076995 dated 28.01.2011 R.A F.NO 07/24/040/00386/Am 11 Decision: The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.o No. 14010/154/2011 dated 27.2.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity Item of Import Quantity allowed Dithiothreitol/DTT 1 kg CIS2Butene 1,4 Diol 3.038 kg Thioacetic Acid 2.581 kg .RA may take appropriate action as per the decision of Norms Committee.
Case No.B 499
M/s. Vivimed Labs Limited F.No 01/83/050/00443/AM 07/DES III Adv. Lic. No 0910026921 dated 20.07.2006 R.A F.NO 09/24/040/00103/AM 07 authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.B 500
M/s. Divis Laboratories Limited F.No 01/82/162/00153/AM 12/DES III F.No 01/82/162/00158/AM 12/DES III F.No 01/82/162/00159/AM 12/DES III F.No 01/82/162/00160/AM 12/DES III F.No 01/82/162/00161/AM 12/DES III F.No 01/82/162/00162/AM 12/DES III F.No 01/82/162/00163/AM 12/DES III F.No 01/82/162/00165/AM 12/DES III F.No 01/82/162/00166/AM 12/DES III
Decision: In respect of F.No. 01/82/162/00153/Am 12/DES III The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals forwarded vide OM No. 35011/204/2011PI(Norms) dated 22.2.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under
Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less.
Export Product Exp. Qty. S.No Import Item Qty. allowed/kg (Benzofuran2carboxylic acid{(s)1[(3s,4s,7r)3 hydroxy7methyl1 1(pytidine2sulfonyl) azepan4ylcarbamoyl]3 methylbutyl}AMI*(2s)2 [(2 benzofuranylcarbonyl)amino] n[(3s,4s,7r)hexahydro3 hydroxy7methyl1(2 pyridinylsulfonyl)1hazepin 4yl]4methylpentanamide 1 kg 1 GSK 922777A (TOSYLATE SM) 1.47 2 TOLUENE 8.015 3 DBU 0.57 4 CITRIC ACID 0.15 5 IPA 1.875 6 BTPP 0.18 7 TETRAKIS (HYDROXYL METHYL) PHOSPHONIUM CHLORIDE 1.03 8 SODIUM BICARBONATE 0.15 9 CYCLOHEXANE 3.00 10 THF 3.40 11 EDAC HCL 0.44 In respect of other File numbers mentioned above, the Committee decided to remind the firm to furnish following technical details within 15 days failing which the case will be closed: Copy of valid Drug Manufacturing License showing composition of the export product. Copy of Master Batch Formula duly certified by Quality Control Incharge.
The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.B 501
M/s DSM AntiInfectives India Limited F.No 01/82/050/01319/AM 11/DES III F.No 01/82/050/01106/AM 11/DES III Adv. Lic. No 2210010536 dated 18.10.2010 Adv. Lic. No. 2210010163 dated 9.7.2010 R.A F.NO 22/24/040/00048/AM 11 R.A F.No 22/24/040/00020/AM 11 authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.B 502
M/s. Balaji Amines Limited F.No 01/82/050/00458/AM 12/DES III Adv. Lic. No 3110048921 dated 28.06.2011 R.A F.No 31/83/040/00053/AM 12 Decision: The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals forwarded vide U.O No. 14010/51/2004/Ch. II dated 10.2.2006 and in consultation with the technical authorities present in the meeting observed that due to inadvertence, item no. 3 was indicated as Alumina Silica Catalyst in place of “Gamma Butyrolactone”. Accordingly, norms has been refixed under Para 4.7 of HBP v 1 as per details below: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg N/Methyl2Pyrrolidone 1 kg 1 Methanol 0.377 kg 2. Ammonia 0.164 kg 3. Gamma Butyrolactone 0.965
Case No.C96
M/s. Shasun Pharmaceuticals Limited F.No 01/82/162/00267/AM 12/DES III
authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.C 95
M/s. Shasun Pharmaceuticals Limited F.No 01/82/162/00261/AM 12/DES III authorities present in the meeting decided to defer the case for 27.3.2012.
Case No.C97
M/s. Shasun Pharmaceuticals Limited F.No 01/82/162/01146/AM 12/DES III authorities present in the meeting decided to defer the case for 27.3.2012. 1
Case No.:12/15/82ALC4/2010
Party Name:MEDREICH LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Approved HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date: Decision : The Committee considered the case as per agenda and in light of earlier decision taken in meeting 50/82 dated 9.3.2010 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less Export product Exp. Qty. Sl.No. Import items Qty. allowed Vitamin C Chewable tablet 500 mg 1 No. 1. Sodium Ascorbate 357 mg 2. Ascorbic Acid 192.78 mg 3. Sodium Cyclamate 17.20 mg 4. Trusil organe flavor 171063 4.40 mg 5. Trusil nature identical orange flavor 173126 4.40 mg 6. Jaffa orange oil 510154 M 1.20 mg
2
Case No.:67/22/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 28.02.2012 Status:Case Approved HQ File :01/82/050/00720/AM11/ RLA File :03/95/040/00210/AM11/ Lic.No/Date:0310581119 29.06.2010 Defer Date: Decision : The Committee considered the case as per agenda and noted that the firm has not provided technical details despite reminder. In the absence of the details and considering single stage reaction and 90% yield, the Committee in consultation with the technical authorities present in the meeting ratify norms under Para 4.7 of HBP v1 as per details below: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg Nandrolone Decanoate 100 kg 1 Nandrolone Base 71 2. Decanoyl Chloride 45 3
Case No.:122/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/01321/AM11/ RLA File :22/24/040/00025/AM11/ Lic.No/Date:2210010236 03.08.2010 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish production and consumption data duly certified by Central Excise authority. Accordingly, the case has been deferred for 27.3.2012. 4
Case No.:15/31/82ALC4/2010
Party Name:R L FINE CHEM 28.02.2012 Status:Case Deferred HQ File :01/82/050/00940/AM11/ RLA File :07/24/040/00156/AM11/ Lic.No/Date:0710073569 12.08.2010 Defer Date: 27.3.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 5
Case No.:5/28/82ALC4/2010
Party Name:ANUS LABORATORIES LTD., 28.02.2012 Status:Case Deferred HQ File :01/82/050/00887/AM11/ RLA File :09/24/040/00137/AM11/ Lic.No/Date:0910043673 28.09.2010 Defer Date:27.03.2012 Decision : Tthe Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to remind the firm to furnish the following information within 15 days failing which the case will be closed: Stepwise chemical reaction showing Mol. Weight of each reactant and output product. % yield on molar basis for each step.
Material balance for entire process. Requirement and recovery of solvents of each step of manufacturing process. End use of the export product. Accordingly, the case has been deferred for 27.03.2012. 6
Case No.:10/28/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 7
Case No.:14/28/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 28.02.2012 Status:Case Approved HQ File :01/82/050/00896/AM11/ RLA File :09/24/040/00272/AM11/ Lic.No/Date:0910043780 01.10.2010 Defer Date: Decision : Committee considered case as per agenda and in consultation with the technical authorities present in the 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 (1S,4R)4(2Amino6Chloro5 Formamido4Pyrimidinyl) Amino2Cyclopentene1 Methanol (AFC) 1kg. 1. (+)2Azabicyclo (2.2.1) Hept Ene3One (Vancelactam) 100% 1.832kg/kg 2. N(2Amino4,6Dichloro5 Pyrimidinyl) Formamide 0.764kg/kg 3. Pyridine 2.872 kg/kg 4. Sodium Borohydride (SBH) 0.266 kg/kg 5. Methanol 6.058 kg/kg 6. DTartaric Acid 1.06kg/kg 7. Iso Propyl Alcohol 3.530 kg/kg 8. Dichloro Methane 2.817 kg/kg The written comments of Department of Pharmaceuticals will follow. RA concerned may take further necessary action as per above decision of NC. 8
Case No.:6/30/82ALC4/2010
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00925/AM11/ RLA File :03/94/040/00472/AM11/ Lic.No/Date:0310595543 06.10.2010 Defer Date:27.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish requisite information within 15 days failing which the case would be closed. Accordingly, the case has been deferred for 27.3.2012. 9
Case No.:3/35/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 28.02.2012 Status:Case Approved HQ File :01/82/050/01019/AM11/ RLA File :04/24/040/00215/AM11/ Lic.No/Date:0410118914 16.11.2010 Defer Date: Decision : The Committee considered the case as per agenda and in line with the SION A 412 and in consultation with the technical authorities present in the meeting, decided to ratify norms under 4.7 of HBP v1 as applied by the firm. However, it is noted that in the export product, tuna fish lipid oil is not mentioned. RA may take appropriate action as per the decision of Norms Committee. 10
Case No.:28/46/82ALC4/2010
28.02.2012 Status:Case Deferred HQ File :01/82/050/01583/AM11/ RLA File :09/24/040/00295/AM11/ Lic.No/Date:0910044520 01.12.2010 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 11
Case No.:5/41/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 28.02.2012 Status:Case Approved HQ File :01/82/050/01353/AM11/ RLA File :09/24/040/00415/AM11/ Lic.No/Date:0910044855 22.12.2010 Defer Date: 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 (1S,4R)4(2Amino6Chloro5 Formamido4Pyrimidinyl) Amino2Cyclopentene1 Methanol (AFC) 1kg. 1. (+)2Azabicyclo (2.2.1) Hept Ene3One (Vancelactam) 100% 1.832kg/kg 2. N(2Amino4,6Dichloro5 Pyrimidinyl) Formamide 0.764kg/kg 3. Pyridine 2.872 kg/kg 4. Sodium Borohydride (SBH) 0.226 kg/kg 5. Methanol 6.058 kg/kg 6. DTartaric Acid 1.06 kg/kg 7. Iso Propyl Alcohol 3.530 kg/kg 8. Dichloro Methane 2.817 kg/kg
The written comments of Department of Pharmaceuticals will follow. RA concerned may take further necessary action as per above decision of NC. 12
Case No.:30/41/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.02.2012 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:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 13
Case No.:14/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 14
Case No.:23/6/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 15
Case No.:31/47/82ALC4/2010
28.02.2012 Status:Case Deferred HQ File :01/82/050/01621/AM11/ RLA File :09/24/040/00510/AM11/ Lic.No/Date:0910045498 09.02.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals 16
Case No.:36/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/01626/AM11/ RLA File :09/24/040/00509/AM11/ Lic.No/Date:0910045516 11.02.2011 Defer Date:20.03.2012 Decision : The firm has requested for personal hearing in the 2nd and 3rd week of the March 2012. The Committee decided to call the firm for Personal Hearing on 20.3.2012. Accordingly, the case has been deferred for 20.3.2012.
17
Case No.:53/47/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 18
Case No.:17/10/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 28.02.2012 Status:Case Approved HQ File :01/82/050/00276/AM12/ RLA File :09/24/040/00521/AM11/ Lic.No/Date:0910045939 16.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/194/2011PI(Norms) dated 22.2.2012 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 Irbesartan 1 kg 1 4‐BROMOMETHYL BIPHENYL‐2‐ CARBONITRILE(BMCP) 1.04 2 2‐N‐BUTYL‐4‐ SPIROCYCLOPENTANE‐2‐ IMIDAZOLIN‐5‐ONE‐ HYDROCHLORIDE(BSI HCL 0.88 3 TOLUENE 2.86 19
Case No.:5/2/82ALC4/2011
Party Name:SMRUTHI ORGANICS LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/01795/AM11/ RLA File :31/24/040/00281/AM11/ Lic.No/Date:3110047488 22.03.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 20
Case No.:12/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 28.02.2012 Status:Case Approved
HQ File :01/82/050/01802/AM11/ RLA File :09/24/040/00589/AM11/ Lic.No/Date:0910046080 25.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/205/2011PI(Norms) dated 22.2.2012 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 (kg/kg) 2‐CHLOROMETHYL‐3‐ METHYL‐4‐(3‐METHOXY PROPOXY)PYRIDINE HYDEROCHLORIDE. 1 kg 1. 2,3‐Lu솗dine 1.00 2 ISO PROPYL ALCOHOL 0.75 3 3‐METHOXY‐1‐PROPANOL 1.187 4 ACETONE 0.67 5 METHYLENE CHLORIDE 1.07 21
Case No.:19/4/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.02.2012 Status:Case Approved HQ File :01/82/050/00070/AM12/ RLA File :05/23/040/00381/AM11/ Lic.No/Date:0510287719 07.04.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 10.2.2012 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. S.No Import Item Qty. allowed/kg 2Chloro6 Trichloromethyl Pyridine 1 kg 1 2 3 4 Alpha Picoline 1,2,4Trichlorobenzene Heptane Stergene 0.658 kg 0.220 kg 0.280 kg 0.006 kg
5 Carbon 0.005 kg RA may take appropriate action as per the decision of Norms Committee 22
Case No.:32/8/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00232/AM12/ RLA File :03/94/040/01167/AM11/ Lic.No/Date:0310625603 07.04.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals 23
Case No.:41/8/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00241/AM12/ RLA File :03/94/040/01171/AM11/ Lic.No/Date:0310625608 07.04.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of DC(MSME). 24
Case No.:48/4/82ALC4/2011
28.02.2012 Status:Case Deferred HQ File :01/82/050/00099/AM12/ RLA File :09/24/040/00003/AM12/ Lic.No/Date:0910046368 12.04.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 25
Case No.:15/12/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00348/AM12/ RLA File :03/94/040/00052/AM12/ Lic.No/Date:0310627904 25.04.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of DC(MSME). 26
Case No.:44/6/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00163/AM12/ RLA File :09/24/040/00038/AM12/ Lic.No/Date:0910046559 28.04.2011 Defer Date:27.03.2012 Decision : The Committee decided to remind the firm to furnish copy of production and consumption data duly certified by Central Excise
Authority. Accordingly, the case has been deferred for 27.3.2012. 27
Case No.:4/8/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00204/AM12/ RLA File :09/24/040/00606/AM11/ Lic.No/Date:0910046587 02.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/361/2011PI(Norms) dated 27.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Amisulpride 1 kg 1 4‐AMINO‐5‐ (ETHYLSULFONYL)‐2‐ METHOXYBENZOIC ACID 0.892 2 [(2RS)‐1‐ ETHYLPYRROLIDINE‐2‐YL]‐ METHANAMINE 0.528 3 METHYLENE CHLORIDE 6.49 4 TRIETHYLAMINE 0.417 5 ETHYL CHLOROFORMATE 0.411 6 ACETONE 2.684 7 ACTIVATED CARBON 0.076 28
Case No.:6/8/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:20.03.2012 Decision : The firm has been called for Personal Hearing on 20.3.2012 as requested by them. Accordingly, the case has been deferred for 20.3.2012.
29
Case No.:28/7/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00194/AM12/ RLA File :03/94/040/01026/AM11/ Lic.No/Date:0310629152 03.05.2011 Defer Date:27.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 27.3.2012.. 30
Case No.:29/7/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00195/AM12/ RLA File :03/94/040/01027/AM11/ Lic.No/Date:0310629153 03.05.2011 Defer Date:27.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 27.03.2012 31
Case No.:9/14/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00400/AM12/ RLA File :03/94/040/00091/AM12/ Lic.No/Date:0310629729 05.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 12/82 dated 22.6.2010 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 Artesunate 1 Kg. 1. Artemisinin 0.9259 kg 2. Sodium Boro Hydride 0.150 kg 3. Methanol 1.429 kg 4. S.B. Toluene 0.974 kg RA concerned may take further necessary action as per above decision of NC. 32
Case No.:15/16/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00473/AM12/ RLA File :09/24/040/00035/AM12/ Lic.No/Date:0910046677 Defer
09.05.2011 Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals 33
Case No.:5/12/82ALC4/2011
Party Name:LUPIN LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00338/AM12/ RLA File :03/95/040/00067/AM12/ Lic.No/Date:0310630428 10.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in the meeting No. 44/82 dated 31.1.2012 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 Cefprozil 1 Kg. 1. 7Phenylacetamido3Chloromethyl Cephalosporanic Acid PMethoxybenzyl Ester (GCLE) 3.238 kg 2 D() Alpha Parahydroxy Phenylglycine Methyl Potassium Dane Salt (M.K.) 1.050 kg 3. Acetone 2.41 kg 4. Dimethylaniline 0.25 kg 5. Methanol 0.68 kg 6. Methylene Chloride 21.74 kg 7. Dimethyl Formamide 4.91 kg 8. Hexamethyl Disilazane 0.42 kg 9. Trimethyl Chlorosilane 0.273 kg 10. Ethyl Acetate 1.92 kg 11. N,OBis (Trimethyl Silyl) Acetamide 0.004 kg 12. Ethyl Chloro Formate 0.398 kg 13. Trifluoro Acetic Acid 2.986 kg 14. Isopropyl Alcohol 7.38 kg 15. Triphenyl Phosphine 1.851 kg 16. Phosphorous Pentachloride (PCL5) 1.571 kg 17 Activated Carbon 0.100 kg 18. Caustic Soda 1.63 kg 19. Sodium Hydrosulphite 0.004 kg
RA concerned may take further necessary action as per above decision of NC. 34
Case No.:50/8/82ALC4/2011
Party Name:VIJAYASRI ORGANICS LTD 28.02.2012 Status:Case Approved HQ File :01/82/050/00250/AM12/ RLA File :09/24/040/00592/AM11/ Lic.No/Date:0910046744 12.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/317/2011PI(Norms) dated 27.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) 4FluoroA2Methyl1 Oxopropyl)GOxoNB Diphenyl Benzene Butaneamide (Diketone Intermediate for Atorvastatin/DKT3) 1 kg 1 FLUOROBENZENE 0.609 2 METHYLENE DICHLORIDE (MDC) 2.00 3 METHYL ISO BUTYRYL ACETATE (MIBA) 0.80 4 METHANOL 0.50 35
Case No.:17/16/82ALC4/2011
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Deferred HQ File :01/82/050/00475/AM12/ RLA File :09/24/040/00501/AM11/ Lic.No/Date:0910046743 12.05.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 36
Case No.:3/9/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00254/AM12/ RLA File :03/94/040/00120/AM12/ Lic.No/Date:0310631346 16.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as
some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 27.3.2012.. 37
Case No.:4/9/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00255/AM12/ RLA File :03/94/040/00121/AM12/ Lic.No/Date:0310631350 16.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 27.3.2012.. 38
Case No.:2/9/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Deferred HQ File :01/82/050/00253/AM12/ RLA File :09/24/040/00012/AM12/ Lic.No/Date:0910046777 18.05.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 39
Case No.:2/10/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00261/AM12/ RLA File :03/94/040/00151/AM12/ Lic.No/Date:0310631883 19.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 27.3.2012.. 40
Case No.:41/10/82ALC4/2011
Party Name:HETERO LABS LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00300/AM12/ RLA File :09/24/040/00111/AM12/ Lic.No/Date:0910046916 26.05.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals 41
Case No.:43/10/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LTD Status:Case
28.02.2012 Approved HQ File :01/82/050/00302/AM12/ RLA File :09/24/040/00093/AM12/ Lic.No/Date:0910046918 26.05.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/379/2011PI(Norms) dated 27.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Sulfaturamide (or) NXL104SU(OR) Tetra Butyl Ammonium (2S, 5R)2 Carbamoyl7oxo1,6 Diazabicyclo[3.2.1]Octan6 ylsulfate 1 kg 1 OXAMINE OXALATE OR OXYAMINE OXALATE(PURE TRANS) 1.42 2 FLUORENYLMETHYL OXYCARBONYL CHLORIDE (FMOC‐CI) (OR) 9‐ FLUORENYLMETHYL CHLOROFORMATE 0.80 3 1,1’‐CARBONYLDIIMIDAZOLE (CDI) (OR) N,N’,CARBONYLDIIMIDAZOLE 0.63 RA may take appropriate action as per the decision of Norms Committee. 42
Case No.:51/10/82ALC4/2011
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 28.02.2012 Status:Case Approved HQ File :01/82/050/00310/AM12/ RLA File :09/24/040/00095/AM12/ Lic.No/Date:0910046934 27.05.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals 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 (1S,4R)4(2Amino6Chloro5 Formamido4Pyrimidinyl) Amino2Cyclopentene1 Methanol (AFC) 1kg. 1. (+)2Azabicyclo (2.2.1) Hept Ene3One (Vancelactam) 100% 1.832kg/kg 2. N(2Amino4,6Dichloro5 Pyrimidinyl) Formamide 1.534kg/kg 3. Pyridine 2.872 kg/kg 4. Sodium Borohydride (SBH) 0.266 kg/kg
Methanol 22.855 kg/kg 6. DTartaric Acid 1.557kg/kg 7. Iso Propyl Alcohol 13.31 kg/kg 8. Dichloro Methane 10.63 kg/kg RA concerned may take further necessary action as per above decision of NC. 43
Case No.:1/14/82ALC4/2011
Party Name:STERLING AUXILIARIES PVT LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00392/AM12/ RLA File :03/95/040/00138/AM12/ Lic.No/Date:0310633159 27.05.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 44
Case No.:18/11/82ALC4/2011
28.02.2012 Status:Case Deferred HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals 45
Case No.:19/11/82ALC4/2011
28.02.2012 Status:Case Deferred HQ File :01/82/050/00333/AM12/ RLA File :09/24/040/00079/AM12/ Lic.No/Date:0910046974 02.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals 46
Case No.:27/19/82ALC4/2011
28.02.2012 Status:Case Deferred HQ File :01/82/050/00541/AM12/ RLA File :09/24/040/00086/AM12/ Lic.No/Date:0910046997 06.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals 47
Case No.:34/12/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS Status:Case
PRIVATE LIMITED 28.02.2012 Deferred HQ File :01/82/050/00367/AM12/ RLA File :03/94/040/01112/AM11/ Lic.No/Date:0310634571 06.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals. 48
Case No.:6/18/82ALC4/2011
28.02.2012 Status:Case Deferred HQ File :01/82/050/00510/AM12/ RLA File :09/24/040/00094/AM12/ Lic.No/Date:0910047017 06.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals 49
Case No.:10/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00524/AM12/ RLA File :09/24/040/00128/AM12/ Lic.No/Date:0910047036 07.06.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/409/2011PI(Norms) dated 22.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Ceftibuten 1 kg 1 3‐METHYL‐2‐BUTEN‐1‐OL 3.30 2 ACETONE 1.51 3 ACETONITRILE 10.62 4 ACTIVATED CARBON 0.200 5 DIMETHYL FORMAMIDE 4.38 6 GHYH[7‐PHENYLACETAMIDE‐3‐HYDROXY‐ 3‐CEPHEM‐4‐CARBOXYLIC ACID DIPHENYLMETHYL ESTER] 3.73 7 ISO PROPYL ALCOHOL 14.16
8 METHANE SULFONYL CHLORIDE 1.228 9 METHANESULFONIC ACID 0.971 10 METHANOL 24.81 11 METHYL 4‐CHLORO ACETOACETATE 1.88 12 METHYL‐3‐METHOXYACRYLATE 1.73 13 METHYLENE CHLORIDE 108.00 14 POTASSIUM CARBONATE(ANHYDROUS) 1.125 15 PYRIDINE 1.061 16 SODIUM BOROHYDRIDE 0.425 17 TRIETHYLAMINE [TEA] 4.091 50
Case No.:19/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00533/AM12/ RLA File :09/24/040/00107/AM12/ Lic.No/Date:0910047035 07.06.2011 Defer Date:20.03.2012 Decision : The firm has requested for personal hearing in the 2nd and 3rd week of the March 2012. The Committee decided to call the firm for Personal Hearing on 20.3.2012. Accordingly, the case has been deferred for 20.3.2012 51
Case No.:1/13/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00373/AM12/ RLA File :03/94/040/01111/AM11/ Lic.No/Date:0310635238 09.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
52
Case No.:4/16/82ALC4/2011
Party Name:BOSTIK INDIA PRIVATE LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Petrochemicals. 53
Case No.:21/19/82ALC4/2011
28.02.2012 Status:Case Deferred HQ File :01/82/050/00535/AM12/ RLA File :09/24/040/00138/AM12/ Lic.No/Date:0910047112 14.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 54
Case No.:23/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00537/AM12/ RLA File :09/24/040/00105/AM12/ Lic.No/Date:0910047123 15.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/412/2011PI(Norms) dated 22.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Olmesartan Medoxomil 1 kg 1 (IMIDAZOLE DERIVATIVE)[4‐(HYDROXY‐1‐ METHYLETHYL)‐2‐PROPYLIMIDAZOLE‐5‐ CARBOXYLIC ACID, ETHYL ESTER 0.78 2 4‐CHLOROMETHYL‐5‐METHYL‐1,3‐ DIOXOL‐2‐ONE 0.48 3 5‐[4’‐(BROMOMETHYL)[1,1’‐ BIPHENYL]‐2‐YL]‐N‐(TRIPHENYL‐ METHYL)TETRAZOLE(BROMOMETHYL BIPHENYL TRITYL TETRAZOLE) 1.786 4 ACETONE 5.678 5 DIISOPROPYL ETHER 1.668 6 METHYLENE CHLORIDE 5.044 N,N‐DIMETHYLACETAMIDE 1.755
7 8 POWDERED ANHYDROUS POTASSIUM CARBONATE 0.564 9 TETRAHYDROFURAN 2.036 10 STEAM/THERMAL COAL AS PER FUEL POLICY 55
Case No.:24/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00538/AM12/ RLA File :09/24/040/00125/AM12/ Lic.No/Date:0910047121 15.06.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/411/2011PI(Norms) dated 22.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Ritonavir 1 kg 1 RITANOVIR INTERMEDIATE A THIOZOLE [CARBONIC ACID‐4‐NITROPHENYL‐5‐ THIAZOLYLMETHYLESTSER (NCT)] 0.72 2 RITONAVIR INTERMEDIATE –B(BDH PURE) [(2S,3S,5S)‐5(TERT‐BUTYLOXYCARBONYL)‐ AMINO‐2‐AMINO‐3‐HYDROXY‐1,6‐ DIPHENYLHEXANE.] 0.989 3 THIONYL CHLORIDE 0.768 4 4‐DIMETHYL AMINO PYRIDINE 0.068 5 N‐HEPTANE 2.85 6 TRIETHYLAMINE 0.341 7 L‐VALINE 0.376 8 ANHYDROUS POTASSIUM CARBONATE 1.776 9 ACTIVATED CARBON 0.0368
10 ACETONE 0.698 11 HEXANES 0.488 12 ISOPROPYL ALCOHOL 0.76 13 METHANOL 3.33 14 METHYLENE CHLORIDE 12.76 15 TETRAHYDROFURAN [THF] 1.86 56
Case No.:34/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Approved HQ File :01/82/050/00616/AM12/ RLA File :09/24/040/00089/AM12/ Lic.No/Date:0910047213 21.06.2011 Defer Date: Decision : The Commi컦�ee considered case as per agenda and in light of earlier decision taken in mee솗ng No. 4/82 dated 28.4.2009 and in consulta솗on with technical authority present in mee솗ng, decided to ra솗fy 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 (R,E)‐Methyl‐2‐(3‐Chloro‐3‐(3‐((2‐ (7‐Chloroquinolin‐2‐ yl)vinyl)phenyl)propyl)benzoate 1 Kg. 1. 2‐[3‐(S)‐[3‐Chloro‐2‐ quiolinyl)Ethenyl]phenyl]‐3‐hydroxy Propyl]‐ Benzoic acid methyl ester Hydrate (Hydroxy compound 1.25 kg 2. Thionyl Chloride 0.84 kg 3. Dimethyl formamide 0.74 kg 4. Methylene Chloride 5.81 kg 5. Methanol 0.88 kg 6. Toluene 8.14 kg 7. Acetonitrile 8.44 kg RA concerned may take further necessary ac솗on as per above decision of NC. 57
Case No.:41/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD Status:Case
28.02.2012 Deferred HQ File :01/82/050/00623/AM12/ RLA File :09/24/040/00040/AM12/ Lic.No/Date:0910047212 21.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 58
Case No.:47/14/82ALC4/2011
Party Name:FDC LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 59
Case No.:31/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Deferred HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic.No/Date:0910047366 29.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 60
Case No.:25/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Deferred HQ File :01/82/050/00607/AM12/ RLA File :09/24/040/00039/AM12/ Lic.No/Date:0910047386 30.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 61
Case No.:32/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Deferred HQ File :01/82/050/00614/AM12/ RLA File :09/24/040/00041/AM12/ Lic.No/Date:0910047385 30.06.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 62
Case No.:18/21/82ALC4/2011
Party Name:SHREE JAYA LABORATORIES PVT LTD. 28.02.2012 Status:Case Deferred Lic.No/Date:0910047446
HQ File :01/82/050/00600/AM12/ RLA File :09/24/040/00623/AM11/ 01.07.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 63
Case No.:16/20/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00578/AM12/ RLA File :22/24/040/00024/AM12/ Lic.No/Date:2210011568 01.07.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 64
Case No.:16/21/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 28.02.2012 Status:Case Approved HQ File :01/82/050/00598/AM12/ RLA File :09/24/040/00165/AM12/ Lic.No/Date:0910047474 05.07.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/394/2011PI(Norms) dated 22.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Sertraline HCL 1 kg 1 4‐(3,4‐ DICHLOROPHENYL)‐1,2,3,4‐ TETRAHYDRO‐N‐METHYL‐1‐ NAPHTHALENIMINE 3.27 2 SODIUM BOROHYDRIDE 0.331 3 METHANOL 5.493 4 D(‐) MANDELIC ACID 0.392 5 N‐BUTANOL 0.632 6 DIISOPROPYL ETHER 0.696
65
Case No.:17/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Approved HQ File :01/82/050/00599/AM12/ RLA File :09/24/040/00153/AM12/ Lic.No/Date:0910047476 05.07.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/394/2011PI(Norms) dated 22.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Oxacarbazepine 1 kg 1 10‐METHOXY IMINO STILBENE 1.26 2 DL MANDELIC ACID 2.58 3 METHYLENEDICHLORIDE 3.84 4 ISO PROPYL ALCOHOL 2.23 5 METHANOL 1.70 RA may take appropriate action as per the decision of Norms Committee 66
Case No.:60/21/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 28.02.2012 Status:Case Approved HQ File :01/82/050/00642/AM12/ RLA File :22/24/040/00026/AM12/ Lic.No/Date:2210011604 06.07.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/393/2011PI(Norms) dated 27.2.2012 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed (kg/kg) Atorvastatin Calcium 1 kg 1 4‐FULORO BENZALDEHYDE 0.70 2 TRIETHYLAMINE 0.516 3 3‐ETHYL‐5‐(2‐HYDROXY ETHYL)‐4‐METHYL 0.262
THIAZOLIUM BROMIDE 4 ISOPROPYL ALCOHOL 5.00 67
Case No.:34/16/82ALC4/2011
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 28.02.2012 Status:Case Deferred HQ File :01/82/050/00492/AM12/ RLA File :03/95/040/01038/AM11/ Lic.No/Date:0310641073 07.07.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 68
Case No.:5/21/82ALC4/2011
Party Name:CIPLA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00587/AM12/ RLA File :03/94/040/00319/AM12/ Lic.No/Date:0310641299 08.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and observed that this case has already been approved in Meeting No. 45/82 dated 7.2.2012. 69
Case No.:3/17/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00498/AM12/ RLA File :05/24/040/00124/AM12/ Lic.No/Date:0510296379 12.07.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 70
Case No.:6/17/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.02.2012 Status:Case Approved HQ File :01/82/050/00501/AM12/ RLA File :05/23/040/00137/AM12/ Lic.No/Date:0510296623 14.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and observed that this case has already been approved in Meeting No. 45/82 dated 7.2.2012 71
Case No.:58/21/82ALC4/2011
Party Name:ESSIX BIOSCIENCES LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00640/AM12/ RLA File :22/24/040/00028/AM12/ Lic.No/Date:2210011653 Defer Date:
14.07.2011 27.3.2012 Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM NO. 35011/392/2011PI(Norms) dated 27.2.2012 and in consultation with technical authority present in meeting decided to call from the firm the complete technical details as per Appendix 33. Accordingly, the case has been deferred for 27.3.2012. 72
Case No.:9/17/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00504/AM12/ RLA File :03/94/040/00318/AM12/ Lic.No/Date:0310642597 15.07.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 73
Case No.:17/26/82ALC4/2011
Party Name:CTX LIFESCIENCES PVT LTD, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00700/AM12/ RLA File :03/94/040/00302/AM12/ Lic.No/Date:0310642596 15.07.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 74
Case No.:1/35/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 28.02.2012 Status:Case Deferred HQ File :01/82/050/00928/AM12/ RLA File :03/95/040/00278/AM12/ Lic.No/Date:0310642739 18.07.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Biotechnology. 75
Case No.:19/21/82ALC4/2011
Party Name:SAIRAM ORGANICS PVT. LTD., 28.02.2012 Status:Case Approved HQ File :01/82/050/00601/AM12/ RLA File :09/24/040/00174/AM12/ Lic.No/Date:0910047733 19.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and observed that this case already been approved in 45/82 meeting held on 7.2.2012. 76
Case No.:11/26/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00694/AM12/ RLA File :03/94/040/00317/AM12/ Lic.No/Date:0310642955 19.07.2011 Defer Date:27.03.2012
Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 77
Case No.:28/21/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00610/AM12/ RLA File :09/24/040/00178/AM12/ Lic.No/Date:0910047796 21.07.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 78
Case No.:4/26/82ALC4/2011
Party Name:GALENTIC PHARMA (INDIA) PVT.LTD. 28.02.2012 Status:Case Approved HQ File :01/82/050/00687/AM12/ RLA File :03/94/040/00352/AM12/ Lic.No/Date:0310643997 22.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 , in line with SION A412 as applied by the firm. RA may take appropriate action as per the decision of Norms Committee. 79
Case No.:12/26/82ALC4/2011
Party Name:CTX LIFESCIENCES PVT LTD, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00695/AM12/ RLA File :03/94/040/00244/AM12/ Lic.No/Date:0310644247 25.07.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 80
Case No.:55/26/82ALC4/2011
Party Name:TIDE INDUSTRIES 28.02.2012 Status:Case Deferred HQ File :01/82/050/00738/AM12/ RLA File :34/24/040/00075/AM12/ Lic.No/Date:3410031091 28.07.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish following information within 15 days else their case will be closed: Authentic/printed technical literature in support of % yield or norms applied for import. Chemical composition and specification of export item and import item. Production of export item for the past two years up to September, 2011 and corresponding consumption of each input duly certified by CA. Details of byproducts/coproduces formed and their recovery in quantity and value.
Accordingly, the case has been deferred for 27.3.2012. 81
Case No.:19/20/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 28.02.2012 Status:Case Deferred HQ File :01/82/050/00581/AM12/ RLA File :04/24/040/00363/AM11/ Lic.No/Date:0410126761 03.08.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of pharmaceuticals 82
Case No.:14/27/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00764/AM12/ RLA File :03/94/040/00395/AM12/ Lic.No/Date:0310646407 04.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and decided to remind the firm to furnish details as per Appendix 33. The case has been deferred for 27.3.2012. 83
Case No.:25/26/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:27.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of DC(MSME) 84
Case No.:34/31/82ALC4/2011
Party Name:HETERO LABS LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00860/AM12/ RLA File :09/24/040/00189/AM12/ Lic.No/Date:0910048117 08.08.2011 Defer Date: Decision : The Committee observed that this case has already been approved in 45/82 meeting held on 7.2.2012. 85
Case No.:50/26/82ALC4/2011
Party Name:PAB ORGANICS PVT.LTD, 28.02.2012 Status:Case Approved HQ File :01/82/050/00733/AM12/ RLA File :34/24/040/00090/AM12/ Lic.No/Date:3410031224 08.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 48/82 meeting held on 23.02.3012 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 item Qty. allowed 5Bromo Phthalide 1 Kg. 1. Hydrobromic Acid 48% 5.00 kg 2. 5Amino Phthalide 0.87 kg RA concerned may take further necessary action as per above decision of NC. 86
Case No.:9/26/82ALC4/2011
Party Name:CIPLA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00692/AM12/ RLA File :03/94/040/00409/AM12/ Lic.No/Date:0310647117 09.08.2011 Defer Date: Decision : The Committee observed that this case has already been approved in 45/82 meeting held on 7.2.2012. 87
Case No.:43/26/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00726/AM12/ RLA File :22/24/040/00036/AM12/ Lic.No/Date:2210011760 09.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 88
Case No.:41/31/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00867/AM12/ RLA File :09/24/040/00196/AM12/ Lic.No/Date:0910048207 10.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 89
Case No.:45/31/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00871/AM12/ RLA File :09/24/040/00220/AM12/ Lic.No/Date:0910048208 10.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 90
Case No.:28/26/82ALC4/2011
Party Name:INTAS PHARMACEUTICALS LTD., 28.02.2012 Status:Case Deferred HQ File :01/82/050/00711/AM12/ RLA File :08/24/040/00114/AM12/ Lic.No/Date:0810102412 Defer
11.08.2011 Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 91
Case No.:16/25/82ALC4/2011
Party Name:STERICAT GUTSTRINGS PVT. LTD. Meet No/Date:48/82ALC4/2011 28.02.2012 Status:Case Approved HQ File :01/82/050/00683/AM12/ RLA File :05/24/040/00154/AM12/ Lic.No/Date:0510299727 17.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their OM No. 46011/103/2011PC.II dated 22.2.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm whichever is less: Export product Export Qty. Sl.No. Import item Qty. allowed Monofilament Polypropylene Mesh in various sizes 1 Sq meter 1 NonSterile Monofilament Polypropylene Mesh (Size 30 cm x30 cm) 1.02 Sq. Mtr. 92
Case No.:64/26/82ALC4/2011
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/00747/AM12/ RLA File :03/95/040/00396/AM12/ Lic.No/Date:0310649795 23.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals 93
Case No.:11/27/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/00761/AM12/ RLA File :03/94/040/00465/AM12/ Lic.No/Date:0310650141 24.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 94
Case No.:9/27/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/00759/AM12/ RLA File :03/94/040/00464/AM12/ Lic.No/Date:0310650335 25.08.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals 95
Case No.:10/27/82ALC4/2011
Party Name:CIPLA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00760/AM12/ RLA File :03/94/040/00480/AM12/ Lic.No/Date:0310650724 26.08.2011 Defer Date: Decision : The Committee observed that this case has already been approved in 45/12 meeting held on 7.2.2012. 96
Case No.:19/31/82ALC4/2011
Party Name:MICRO LABS LTD 28.02.2012 Status:Case Approved HQ File :01/82/050/00845/AM12/ RLA File :07/24/040/00199/AM12/ Lic.No/Date:0710081875 29.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify the norms under Para 4.7 of HBP v 1 as applied by the firm. RA may take appropriate action as per the decision of Norms Committee. 97
Case No.:39/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 98
Case No.:38/31/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00864/AM12/ RLA File :22/24/040/00041/AM12/ Lic.No/Date:2210011844 01.09.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 99
Case No.:6/27/82ALC4/2011
Party Name:CIPLA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00756/AM12/ RLA File :03/94/040/00489/AM12/ Lic.No/Date:0310651351 02.09.2011 Defer Date: Decision : The Committee observed that this case has already been approved in 45/82 meeting held on 7.2.2012. 100 Case No.:16/29/82ALC4/2011 Party Name:CIPLA LIMITED Status:Case
28.02.2012 Approved HQ File :01/82/050/00815/AM12/ RLA File :03/94/040/00501/AM12/ Lic.No/Date:0310651860 06.09.2011 Defer Date: Decision : The Committee observed that this case has already been approved in 44/82 meeting held on 31.01.2012. 101
Case No.:11/31/82ALC4/2011
Party Name:ESTEEM INDUSTRIES PVT. LTD, 28.02.2012 Status:Case Approved HQ File :01/82/050/00837/AM12/ RLA File :17/24/040/00044/AM12/ Lic.No/Date:1710004498 08.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/35/2010Ch. II dated 20.4.2011 and in consultation with the technical authorities present in the meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export product Export Qty. Sl.No. Import item Qty. allowed ProductOC 3200(Castor Oil Polyether) 1 kg 1 Ethylene Oxide (colourless clear liquid) 0.640 kg 102
Case No.:50/31/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00876/AM12/ RLA File :04/24/040/00165/AM12/ Lic.No/Date:0410127861 08.09.2011 Defer Date:27.03.2012 Decision : Committee decided to remind the firm to furnish the Master Batch Formula along with Drug Manufacturing License. Accordingly, the case has been deferred for 27.3.2012. 103 Case No.:15/31/82ALC4/2011 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.02.2012 Status:Approved HQ File :01/82/050/00841/AM12/ RLA File :05/23/040/00197/AM12/ Lic.No/Date:0510302069 13.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 10.2.2012 2012and 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. S.No Import Item Qty. allowed/kg 2Chloro6 Trichloromethyl Pyridine 1 kg 1 2 Alpha Picoline 1,2,4Trichlorobenzene 0.658 kg 0.220 kg
3 4 5 Heptane Stergene Carbon 0.280 kg 0.006 kg 0.005 kg RA may take appropriate action as per the decision of Norms Committee 104
Case No.:28/31/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 28.02.2012 Status:Case Deferred HQ File :01/82/050/00854/AM12/ RLA File :22/24/040/00044/AM12/ Lic.No/Date:2210011894 14.09.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 105
Case No.:7/29/82ALC4/2011
Party Name:MEDICAMEN BIOTECH LTD., 28.02.2012 Status:Case Deferred HQ File :01/82/050/00806/AM12/ RLA File :05/24/040/00208/AM12/ Lic.No/Date:0510302892 19.09.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 106
Case No.:19/27/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/00769/AM12/ RLA File :03/95/040/00407/AM12/ Lic.No/Date:0310654860 20.09.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 107 Case No.:20/31/82ALC4/2011 Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.02.2012 Status:Case Approved HQ File :01/82/050/00846/AM12/ RLA File :05/23/040/00218/AM12/ Lic.No/Date:0510303152 20.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and considering the molecular weight of the salt and also in line with the SION 412 decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Sildenafil Citrate Tablets 50 mg 6 lakhs tablets 1 Sildenafile Citrate 1H 70.25 gm /1000 tablets Sildenafil Citrate Tablets 100 mg 1 Sildenafil Citrate 1 H 140.50 /1000 tablets. 108
Case No.:12/29/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00811/AM12/ RLA File :03/94/040/00530/AM12/ Lic.No/Date:0310655109 21.09.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 109 Case No.:4/31/82ALC4/2011 Party Name:CIPLA LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00830/AM12/ RLA File :03/94/040/00540/AM12/ Lic.No/Date:0310655386 22.09.2011 Defer Date: Decision : Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/419/2011PI (Norms) dated 22.2.2012 and consultation with the technical authorities present in the meeting decided to ratify the norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed ( in Kgs) Triomune Junior Tablets/Lamivudine, Stavudine and Nevirapine Tablets Each uncoated tablet contains: Stavudine 12 mg, Lamivudine 60 mg, Nevirapine 100 mg 1 Number 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 61.2 102.0 24.48 Lamivir S‐30 Tablets/Lamivudine and Stavudine Tablets Each film coated tablet contains: Lamivudine 1 Number 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 153.0 ‐ 61.2
150 mg Stavudine 30 mg Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contain: Stavudine 30 mg, Lamivudine 150 mg, Nevirapine 200 mg 1 Number 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 153.0 204.0 61.2 Triomune Baby Tablets/Triomune Baby Dispersible Tablets/Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contains: Stavudine 6 mg Lamivudine 30 mg, Nevirapine 50 mg 1 Number 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 30.6 51.0 12.24 Lamivir‐S Junior Tablets/Lamivudine, Stavudine Dispersible Tablets Each Tablet contains: Lamivudine 60 mg, Stavudine 12 mg 1 Number 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 61.2 ‐ 24.48 Lamivir‐S Baby Tablets/Lamivudine, Stavudine Dispersible Tables Each tablet contains: Lamivudine 30 mg, Stavudine 6 mg 1 number 1. 2 3 Lamivudine Nevirapine 2,3‐Didehydro,5‐O‐benzoyl, 5‐methyl uridine (Z‐4 Compound) 30.6 ‐ 12.24 110
Case No.:49/31/82ALC4/2011
Party Name:ASCENT FINECHEM PVT. LTD., 28.02.2012 Status:Case Deferred HQ File :01/82/050/00875/AM12/ RLA File :08/24/040/00147/AM12/ Lic.No/Date:0810103865 Defer
22.09.2011 Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Chemicals and Petrochemicals. 111
Case No.:1/29/82ALC4/2011
Party Name:SANDOZ PRIVATE LIMITED 28.02.2012 Status:Case Deferred HQ File :01/82/050/00800/AM12/ RLA File :03/95/040/00325/AM12/ Lic.No/Date:0310657295 30.09.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals. 112
Case No.:6/31/82ALC4/2011
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 28.02.2012 Status:Case Approved HQ File :01/82/050/00832/AM12/ RLA File :03/95/040/00513/AM12/ Lic.No/Date:0310659452 13.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/143/2011Ch. II dated 22.2.3012 and in consultation with the technical authorities present in the meeting decided to to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Methyl Idodide 1 kg 1 Potassium Iodide 1.210 kg 113
Case No.:7/31/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00833/AM12/ RLA File :03/94/040/00612/AM12/ Lic.No/Date:0310659475 13.10.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.03.2012 114
Case No.:8/31/82ALC4/2011
Party Name:EMBIO LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00834/AM12/ RLA File :03/94/040/00611/AM12/ Lic.No/Date:0310659491 Defer
13.10.2011 Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.03.2012. 115
Case No.:54/31/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/00880/AM12/ RLA File :03/94/040/00647/AM12/ Lic.No/Date:0310660797 19.10.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 27.3.2012 for comments of Department of Pharmaceuticals 116
Case No.:124/42/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 28.02.2012 Status:Case Approved HQ File :01/82/050/01159/AM12/ RLA File :09/24/040/00371/AM12/ Lic.No/Date:0910049646 09.11.2011 Defer Date: Decision : This case has already been approved in 45/82 meeting held on 7.2.2012. 117
Case No.:22/41/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/01023/AM12/ RLA File :05/24/040/00267/AM12/ Lic.No/Date:0510308239 17.11.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 118
Case No.:1/37/82ALC4/2011
Party Name:THERMAX LTD., 28.02.2012 Status:Case Deferred HQ File :01/82/050/00983/AM12/ RLA File :31/83/040/00157/AM12/ Lic.No/Date:3110051627 28.11.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and noted that the firm has been requested to furnish following information by Department of Chemicals and Petrochemicals vide their letter No. 14010/78/2010Ch.II dated 24.2.2012: 2. The norms of import items applied in respect to each export item speartely for Water Corrosion inhibitor (Brand name Corrosion 3159), Biocide2 (Brand Name:Biomin 4020), Scale Inhibitor (Brand name: Scalemin 3640) and Biocide 1 (Brand name: Biomin 2750). 3. Justification for 3% wastage claimed in formulation supported with technical literature.
4. Prodcution of each export item for the past 2 years and corresponding consumption of each input duly certified by C.A separately for each export item. 5. Photocopy of the norms already fixed for the same export item in the recent past. Accordingly the case has been deferred for 27.3.2012. 119
Case No.:2/37/82ALC4/2011
Party Name:POLYDRUG LABORATORIES PVT.LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/00984/AM12/ RLA File :03/95/040/00667/AM12/ Lic.No/Date:0310667832 29.11.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 120
Case No.:3/37/82ALC4/2011
Party Name:RELIANCE LIFE SCIENCES PVT. LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/00985/AM12/ RLA File :03/95/040/00538/AM12/ Lic.No/Date:0310668193 30.11.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 121
Case No.:5/44/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.02.2012 Status:Case Deferred HQ File :01/82/050/01177/AM12/ RLA File :05/23/040/00349/AM12/ Lic.No/Date:0510311823 20.12.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 122
Case No.:2/44/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/01174/AM12/ RLA File :05/23/040/00346/AM12/ Lic.No/Date:0510312327 26.12.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 123 Case No.:4/44/82ALC4/2011 Party Name:DHANUKA LABORATORIES LTD. Status:Case
28.02.2012 Deferred HQ File :01/82/050/01176/AM12/ RLA File :05/23/040/00365/AM12/ Lic.No/Date:0510312325 26.12.2011 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 124
Case No.:1/44/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. 28.02.2012 Status:Case Deferred HQ File :01/82/050/01173/AM12/ RLA File :31/83/040/00213/AM12/ Lic.No/Date:3110052544 20.01.2012 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 125
Case No.:1/48/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/01308/AM12/ RLA File :03/94/040/01013/AM12/ Lic.No/Date:0310682488 17.02.2012 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 126
Case No.:2/48/82ALC4/2011
Party Name:SOHAN HEALTHCARE PVT. LTD 28.02.2012 Status:Case Deferred HQ File :01/82/050/01309/AM12/ RLA File :31/83/040/00228/AM12/ Lic.No/Date:3110053067 21.02.2012 Defer Date:27.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to Outside No. 1 M/s. Laffans Petrochemicals Limited F.No. 01/82/050/00244/AM 09/DES III F.No 01/82/050/00565/Am 08/DES III F.No01/82/050/00561/Am 08/DES III F.No 01/82/050/00508/AM 08/DES III Adv. Lic. No 0310464757 dated 17.1.2006
Adv. Lic. No. 0310455622 dated 28.12.2007 Adv. Lic. No. 0310461500 dated 18.2.2008 Adv. Lic. No. 0310457833 dated 16.01.2008 Adv. Lic. No. 0310406439 dated 3.11.2006 Adv. Lic. No. 0310434050 dated 26.06.07 Adv. Lic. No.0310434642 dated 2.07.07 Decision: The firm’s Managing Director came for personal hearing before the Committee and explained that there manufacturing process involves chemical reaction followed by distillation and maximum yield obtained is 93.5% and so he requested that higher yield is not achievable in their process. The Committee after deliberations decided to recommend the following norms: Export Product Export Qty S.No Import Items Qty allowed per unit of export product Lasffsolve MEB Ethylene Glycol Mono Butyl Ether 1 kg 1 nButanol Ethylene Oxide 0.673 kg/kg 0.400 kg/kg Outside agenda No.2 Sandoz Private Limited F.No. 01/82/050/00328/Am 08/DES III F.No. 01/82/050/00330/AM 08/DES III Adv. Lic. No 0310374310 dated 31.3.2006 Adv. Lic. No. 0310374312 dated 31.3.2006 Decision: The Committee considered the case and observed that the norms were fixed on the basis of comparative data and hence decided to maintain status quo. RA may take necessary action as per the decision of Norms Committee. Date:01.03.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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