DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 13/82ALC4/2011 MEETING DATE : 28.06.2011 The Meeting No.13/82 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 28.06.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri M. Mitra, Dy. DCGI, Office of DCGI 2. Shri V.K. Tyagi, Dy.I.A, Department of Pharmaceuticals 3. Shri Jasbir Singh, Consultant, Department of C&PC 4. Shri S.S. Bose, Sr. D.O., DIPP 5. Shri Promod Bharti, Asstt. Director, Office of DC(MSME) 6. Shri Krishan Kumar, DDG 7. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.12/82 dated 21.06.2011 were ratified by the Committee.
Case No.B120
M/S Cadila Pharmaceuticals Ltd. Norms Committee Meeting No.13/12 F.No.01/82/050/00519/AM11/DESIII Meeting Date:28.06.2011 RA F.No.08/24/040/00069/AM11 Adv.Lic.No.0810089371 dated 02.06.2010 Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals.
Case No.B121
M/S Makson Industries Pvt. Ltd. F.No.01/82/050/00171/AM10/DESIII RA F.No.03/95/040/01025/AM09 Adv.Lic.No.0310515322 dated 13.04.2009 Committee decided to defer case for 12.07.2011 for comments of DC(MSME).
Case No.B122
M/S Jubilant Organosys Ltd. F.No.01/82/050/00843/AM07/DESIII RA F.No.05/24/040/00455/AM07 Adv.Lic.No.0510189933 dated 31.08.2006 Committee considered case as per agenda and decided to forward a copy of application alongwith a copy of reply received from the firm to Department of Pharmaceuticals for their comments. It was also decided to call the firm for personal hearing on 26.07.2011 to explain their case. Accordingly, the case was deferred for 26.07.2011.
Case No.B123
M/S Intas Pharma Ltd. F.No.01/82/050/00947/AM11/DESIII F.No.01/82/050/00470/AM11/DESIII RA F.No.08/24/040/00182/AM11 RA F.No.08/24/040/00073/AM11 Adv.Lic.No.0810092394 dated 22.09.2010 Adv.Lic.No.0810089370 dated 02.06.2010 Committee considered case as per agenda. Shri Ashish Sehgal, Director (Technical) and Shri Keyur Kayasha, Manager of the company appeared before the Committee and explained the case. They explained that the solvent used for manufacturing of Docetaxel is 100% Polysorbate 80 and due to high viscosity, they need to fill 20% extra in 80 mg vial and 30% in 20 mg vial to achieve the minimum extractable labeled volume. After detailed deliberations, the representative of the firm were asked to submit package insert and package insert of Innovator for which the representatives of the firm agreed to submit by 05.07.2011. Accordingly, case was deferred for 05.07.2011.
Case No.B124
M/S Cadila Healthcare Ltd. F.No.01/82/050/01518/AM11/DESIII RA F.No.08/24/040/00304/AM11 Adv.Lic.No.0810095478 dated 12.01.2011 Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals.
Case No.B125
M/S Kaivals Chemicals P. Ltd. F.No.01/83/050/01383/AM08/DESIII RA F.No.34/24/040/00157/AM08 Adv.Lic.No.3410019869 dated 18.10.2007 Committee decided to defer case for 26.07.2011 for comments of Department of C&PC.
Case No.B126
M/S Herbochem, Hyderabad F.No.01/82/050/00957/AM11/DESIII F.No.01/82/050/01410/AM11/DESIII F.No.01/82/050/00608/AM11/DESIII F.No.01/82/050/00618/AM11/DESIII Meeting Date: 28.06.2011 RA F.No.09/24/040/00015/AM10 RA.F.No.09/24/040/00077/AM11 RA.F.No.09/24/040/00127/AM11 RA.F.No.09/24/040/00153/AM11 Adv.Lic.No.0910040823 dated 05.02.2010 Adv.Lic.No.0910042303 dated 11.06.2010 Adv.Lic.No.0910042768 dated 20.07.2010 Adv.Lic.No.0910042877 dated 28.07.2010
Committee decided to defer case for 12.07.2011 for comments of DC(MSME).
Case No.B126A
M/S Panacea Biotec Ltd. F.No.01/82/050/00427/AM10/DESIII F.No.01/82/050/00625/AM10/DESIII F.No.01/82/050/00927/AM11/DESIII RA F.No.05/24/040/00262/AM10 RA F.No.05/24/040/00156/AM10 RA F.No.05/24/040/00235/AM11 Adv.Lic.No.0510247323 dated 06.08.2009 Adv.Lic.No.0510269042 dated 26.07.2010 Adv.Lic.No.0510274701 dated 11.10.2010 The firm was called for personal hearing. From the firm Mr. U.K. Verma, Mr. Manoj Bhatnagar and two others appeared for PH. The firm presented its case with respect to norms fixed by NC in Lf units (which includes batch claim, overfill and overages) for import of Dipththeria Toxid, Tetanus Toxid and Pertussis bulk. The firm’s representative mentioned that NC while fixing norms has not taken into account overages and wastages. After discussions, NC decided to form a SubCommittee comprising of Dr. M. Mitra, representative of DCGI and Dr. Nitin K. Jain, representative of Department of Biotechnology for visiting the plant of the company at Okhla, New Delhi and give their report for further consideration of NC. The case was deferred for 26.07.2011.
Case No.C22
M/S Laffans Petrochemicals Ltd. F.No.01/82/162/00385/AM11/DESIII Committee decided to defer case for 26.07.2011 for comments of Department of C&PC.
Case No.C23
M/S Laffans Petrochemicals Ltd. F.No.01/82/162/00094/AM11/DESIII Committee decided to defer case for 26.07.2011 for comments of Department of C&PC.
Case No.C24
M/S Laffans Petrochemicals Ltd. F.No.01/82/162/01222/AM10/DESIII Meeting Date:26.07.2011 Committee decided to defer case for 26.07.2011 for comments of Department of C&PC.
Case No.C25
M/S Laffans Petrochemicals Ltd. F.No.01/82/162/00093/AM11/DESIII
Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 1
Case No.:76/42/82ALC4/2007
Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:13/82ALC4/2011 28.06.2011 Status:Case Deferred HQ File :01/82/050/00412/AM08/ RLA File :04/24/040/00151/AM08/ Lic.No/Date:0410090415 03.08.2007 Defer Date:23.08.2011 Decision :Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals. 2
Case No.:49/22/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 28.06.2011 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:23.08.2011 Decision : Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals. 3
Case No.:53/5/82ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 28.06.2011 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:23.08.2011 4
Case No.:62/15/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 28.06.2011 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:23.08.2011 5
Case No.:20/15/82ALC4/2010
Party Name:MEDREICH LIMITED 28.06.2011 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:23.08.2011 6
Case No.:79/41/82ALC4/2010
Party Name:EXPO FINE CHEMICAL INDUSTRIES 28.06.2011 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:26.07.2011 Decision : Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 7
Case No.:12/15/82ALC4/2010
Party Name:MEDREICH LIMITED 28.06.2011 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:23.08.2011 8
Case No.:51/41/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 28.06.2011 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:23.08.2011 9
Case No.:1/22/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 28.06.2011 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:23.08.2011 10
Case No.:57/41/82ALC4/2010
Party Name:LUPIN LIMITED 28.06.2011 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:23.08.2011 11
Case No.:20/39/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 28.06.2011 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:23.08.2011 12
Case No.:54/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 28.06.2011 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:23.08.2011
13
Case No.:55/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 28.06.2011 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:23.08.2011 14
Case No.:80/41/82ALC4/2010
Party Name:CHIRAG ENTERPRISE 28.06.2011 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:26.07.2011 Decision :Committee decided to remind the firm to furnish the required technical information. Accordingly, case was deferred for 26.07.2011. 15
Case No.:9/33/82ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 28.06.2011 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:23.08.2011 16
Case No.:11/33/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 28.06.2011 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:23.08.2011 17
Case No.:91/41/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 28.06.2011 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:23.08.2011 18
Case No.:76/41/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 28.06.2011 Status:Case Approved HQ File :01/82/050/01424/AM11/ RLA File :17/24/040/00085/AM09/ Lic.No/Date:1710003597 07.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC, Petrochemicals Division vide their O.M. No.46011/103/2005PCII dated 15.06.2011 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
Product4PP (Ether) 1 KG. 1. Ethylene Oxide 0.9734 kg RA concerned may take further necessary action as per above decision of NC. 19
Case No.:81/41/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 28.06.2011 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:23.08.2011 20
Case No.:5/41/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 28.06.2011 HQ File :01/82/050/01353/AM11/ RLA File :09/24/040/00415/AM11/ Lic.No/Date:0910044855 22.12.2010 Defer Date:23.08.2011 21
Case No.:10/41/82ALC4/2010
Party Name:AARTI ORGANIC 28.06.2011 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:26.07.2011 Decision :Committee decided to remind the firm to furnish the required technical information. Accordingly, case was deferred for 26.07.2011. 22
Case No.:12/41/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 28.06.2011 Status:Case Deferred HQ File :01/82/050/01360/AM11/ RLA File :05/24/040/00323/AM11/ Lic.No/Date:0510280422 27.12.2010 Defer Date:23.08.2011 23
Case No.:30/41/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.06.2011 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:23.08.2011 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 24
Case No.:8/45/82ALC4/2010
Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., 28.06.2011 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:26.07.2011 Decision :Committee considered case as per agenda and noted that Department of C&PC vide their letter No.14010/10/2006Ch.II dated 10.03.2011, have
called from the firm production and consumption data certified by CA, but the same has not been received. It was, therefore, decided to remind the firm to furnish the same. Accordingly, the case was deferred for 26.07.2011. 25
Case No.:14/45/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 28.06.2011 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:23.08.2011 26
Case No.:10/13/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 28.06.2011 Status:Case Approved HQ File :01/82/050/00382/AM12/ RLA File :09/24/040/00531/AM11/ Lic.No/Date:0910045590 18.02.2011 Decision : Committee considered case as per agenda and in light of decision taken in meeting No.31/82 dated 02.11.2010 vide Case No.49/31/82ALC4/2010 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 Fosinopril Sodium 1 Kg. 1. Trans4HydroxyLProline 1.592 kg 2. 4Dimethyl Amino Pyridine 0.114 kg 3. 5% Palladium on Charcoal 0.078 kg 4. 4Phenyl1Butene 3.06 kg 5. Benzyl Bromo Acetate 4.20 kg 6. Cinchonidine 0.2379 kg 7. Trimethyl Silyl Chloride 3.301 kg 8. N,NDicyclohexyl Carbodimide 0.55 kg 9. 2Ethyl Hexanoic Acid Sodium Salt 0.230 kg 10. Propionyl Bromide 1.77 kg 11. Methanol 10.00 kg 12. Pyridine 2.00 kg 13. Acetone 8.00 kg 14. Diisopropyl Ether 4.11 kg 15. Tetrahydrofuran 5.00 kg 27
Case No.:8/13/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 28.06.2011 Status:Case Approved HQ File :01/82/050/00380/AM12/ RLA File :03/94/040/00936/AM11/ Lic.No/Date:0310616888 21.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/84/2010PI (Norms) dated 01.10.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Exp. Qty. Sl.No. Import items Qty. allowed Olmesartan Medoxomill 1 Kg. 1. 4(1Hydroxy1MethylEthyl)2Propyl1H Imidazole 5Carboxylic Acid Ethyl Ester 0.78 kg 2. 5(4Bromomethyl)(1,1Bromomethyl)2YL Triphenyl1H Tetrazole 1.81 kg 3. 4Chloromethyl5Methyl1,3dioxolen2one 0.48 kg 4. Dimethyl Formamide 6.72 kg 5. Tetrahydrofuran 3.43 kg 6. Potassium Carbonate 0.57 kg 7. Toluene 2.41 kg 28
Case No.:12/6/82ALC4/2011
Party Name:VIHITA CHEM PVT.LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00130/AM12/ RLA File :34/24/040/00281/AM11/ Lic.No/Date:3410029404 22.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/11/2008/Ch.II dated 27.06.2011 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 4Methyl Catechol (3,4 Dihydroxy Toluene) 1 Kg. 1. Para Cresol 1.25 kg 2. Hydrobromic Acid 48% 2.00 kg 3. Hydrogen Peroxide 50% 1.00 kg 4. Caustic Soda Flakes 1.510 kg 29
Case No.:13/6/82ALC4/2011
Party Name:VIHITA CHEM PVT.LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00131/AM12/ RLA File :34/24/040/00267/AM11/ Lic.No/Date:3410029409 22.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/11/2008/Ch.II dated 27.06.2011 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 4Methyl Catechol (3,4 Dihydroxy Toluene) 1 Kg. 1. Para Cresol 1.25 kg 2. Hydrobromic Acid 48% 2.00 kg 3. Hydrogen Peroxide 50% 1.00 kg 4. Caustic Soda Flakes 1.510 kg
30
Case No.:68/48/82ALC4/2010
Party Name:VIHITA CHEM PVT.LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/01711/AM11/ RLA File :34/24/040/00294/AM11/ Lic.No/Date:3410029428 24.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/11/2008/Ch.II dated 27.06.2011 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 4Methyl Catechol (3,4 Dihydroxy Toluene) 1 Kg. 1. Para Cresol 1.25 kg 2. Hydrobromic Acid 48% 2.00 kg 3. Hydrogen Peroxide 50% 1.00 kg 4. Caustic Soda Flakes 1.510 kg 31
Case No.:4/52/82ALC4/2010
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 28.06.2011 Status:Case Approved HQ File :01/82/050/01773/AM11/ RLA File :09/24/040/00556/AM11/ Lic.No/Date:0910045892 11.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/34/2011/Ch.II dated 14.06.2011 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 Avobenzone (Butyl Methoxy Dibenzoyl Methane) 1 Kg. 1. Para Tertiary Butyl Benzoic Acid 0.148 kg 2. Para Methoxy Acetyl Phenone 1.00 kg 3. Sodamide 0.480 kg 4. Methanol 0.193 kg 5. Toluene 0.550 kg 32
Case No.:18/52/82ALC4/2010
Party Name:ALKYL AMINES CHEMICALS LTD 28.06.2011 HQ File :01/82/050/01787/AM11/ RLA File :03/94/040/00471/AM11/ Lic.No/Date:0310621836 17.03.2011 Defer Date:26.07.2011 Decision : Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 33
Case No.:1/5/82ALC4/2011
Party Name:HINDUSTAN POLYAMIDES & 28.06.2011 Status:Case
FIBRES LIMITED Approved HQ File :01/82/050/00103/AM12/ RLA File :03/94/040/00029/AM12/ Lic.No/Date:0310626724 15.04.2011 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/14/2005/Ch.II dated 02.06.2011 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 3,3,5Trimethyl Cyclohexyl Salicylate 1 Kg. 1. Isophorone 0.620 kg 2. Methyl Salicylate 0.649 kg 34
Case No.:4/5/82ALC4/2011
Party Name:HERBOCHEM 28.06.2011 HQ File :01/82/050/00106/AM12/ RLA File :09/24/040/00576/AM11/ Lic.No/Date:0910046396 15.04.2011 Defer Date:12.07.2011 Decision : Committee decided to defer case for 12.07.2011 for comments of DC(MSME). 35
Case No.:7/13/82ALC4/2011
Party Name:UNI WORLD PHARMA PVT LTD 28.06.2011 Status:Case Deferred HQ File :01/82/050/00379/AM12/ RLA File :03/95/040/00018/AM12/ Lic.No/Date:0310626694 15.04.2011 Defer Date:23.08.2011 Decision : Committee decided to defer case for 23.08.2011 for comments of Ministry of Environment and Forests. 36
Case No.:5/5/82ALC4/2011
Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00107/AM12/ RLA File :03/95/040/00828/AM11/ Lic.No/Date:0310626928 18.04.2011 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per SION A412. 37
Case No.:6/5/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 28.06.2011 Status:Case Deferred HQ File :01/82/050/00108/AM12/ RLA File :09/24/040/00004/AM12/ Lic.No/Date:0910046405 18.04.2011 Defer Date:23.08.2011 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 38
Case No.:7/5/82ALC4/2011
Party Name:NEULAND LABORATORIES
LTD 28.06.2011 HQ File :01/82/050/00109/AM12/ RLA File :09/24/040/00561/AM11/ Lic.No/Date:0910046412 19.04.2011 Defer Date:23.08.2011 39
Case No.:8/5/82ALC4/2011
Party Name:PROMED EXPORTS PVT.LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00110/AM12/ RLA File :05/24/040/00003/AM12/ Lic.No/Date:0510288385 20.04.2011 : Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/30/2009PIIII dated 26.10.2009 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 Inokain Eye Drops 0.4% Solution, 5 ml Vial 1 No. 1. Benoxinate Hcl 0.021 gm/Vial of 5 ml 40
Case No.:9/5/82ALC4/2011
Party Name:KLJ PLASTICIZERS LTD, 28.06.2011 Status:Case Approved HQ File :01/82/050/00111/AM12/ RLA File :05/23/040/00012/AM12/ Lic.No/Date:0510288426 20.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/36/2011 Ch.II dated 13.06.2011 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 DiIsoNonyl Adipate 1 kg 1. Adipic Acid 0.381 kg 2. Iso Nonanol 0.814 kg 41
Case No.:10/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.06.2011 HQ File :01/82/050/00112/AM12/ RLA File :05/23/040/00007/AM12/ Lic.No/Date:0510288427 20.04.2011 Defer Date:23.08.2011 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 42
Case No.:11/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES
LIMITED (FORMERLY JUBILANT 28.06.2011 HQ File :01/82/050/00113/AM12/ RLA File :05/23/040/00008/AM12/ Lic.No/Date:0510288428 20.04.2011 Defer Date:23.08.2011 Decision : Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 43
Case No.:12/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 28.06.2011 HQ File :01/82/050/00114/AM12/ RLA File :05/23/040/00026/AM12/ Lic.No/Date:0510288429 20.04.2011 Defer Date:23.08.2011 Decision : Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 23.08.2011. 44
Case No.:13/5/82ALC4/2011
Party Name:EMBIO LTD 28.06.2011 HQ File :01/82/050/00115/AM12/ RLA File :03/94/040/00009/AM12/ Lic.No/Date:0310627428 20.04.2011 Defer Date:23.08.2011 45
Case No.:14/5/82ALC4/2011
Party Name:EMBIO LTD 28.06.2011 Status:Case Deferred HQ File :01/82/050/00116/AM12/ RLA File :03/94/040/00008/AM12/ Lic.No/Date:0310627429 20.04.2011 Defer Date:23.08.2011 46
Case No.:16/13/82ALC4/2011
Party Name:ESTEEM INDUSTRIES PVT. LTD, 28.06.2011 Status:Case Deferred HQ File :01/82/050/00388/AM12/ RLA File :17/24/040/00082/AM09/ Lic.No/Date:1710003961 20.04.2011 Defer Date:26.07.2011 Decision : Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 47
Case No.:13/13/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 28.06.2011 Status:Case Approved HQ File :01/82/050/00385/AM12/ RLA File :03/94/040/00039/AM12/ Lic.No/Date:0310629532 04.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 3/82 meeting held on 20.04.2010 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Cilostazol 1 Kg. 1. 6Hydroxy3,4Dihydro 2(1H)Quinolinone 0.59 kg 2. 5(4Chlorobutyl)1Cyclo Hexyl 1HTetrazol 0.88 kg 48
Case No.:9/13/82ALC4/2011
Party Name:RELIANCE INDUSTRIES LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00381/AM12/ RLA File :03/95/040/00103/AM12/ Lic.No/Date:0310630767 11.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC (PC Div.) vide their O.M. No.46011/113/2009PCII dated 11.01.2010 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 Orthoxylene 1 MT. 1. Reformate 1.2565 MT 2. Relevant Catalyst and Chemicals used in manufacture of Orthoxylene CIF value limited to 0.90% of FOB value of exports 49
Case No.:11/13/82ALC4/2011
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 28.06.2011 Status:Case Approved HQ File :01/82/050/00383/AM12/ RLA File :52/24/040/00009/AM12/ Lic.No/Date:5210035140 11.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/45/2010 Ch.III dated 19.05.2011 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 2Carbethoxy Amino5Naphthol 7Sulphonic Acid 1 KG. 1. J Acid 0.904 kg 50
Case No.:12/13/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00384/AM12/ RLA File :31/24/040/00017/AM12/ Lic.No/Date:3110048080 11.05.2011 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per SION A269. Items of import at Sl.No.2 to 4 may be allowed as per packing policy.
51
Case No.:14/13/82ALC4/2011
Party Name:CIPLA LIMITED 28.06.2011 Status:Case Approved HQ File :01/82/050/00386/AM12/ RLA File :03/94/040/00103/AM12/ Lic.No/Date:0310631172 13.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/83/2007PIIII dated 28.01.2008 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. Description of import items Quantity allowed Carvedilol 1kg. 1. 4hydroxy Carbazol 1.06 kg 2. N[2(2methoxy phenoxy)ethyl]benzylamine hcl 1.089 kg 52
Case No.:5/9/82ALC4/2011
Party Name:SUPREET CHEMICALS PVT.LTD. 28.06.2011 Status:Case Deferred HQ File :01/82/050/00256/AM12/ RLA File :03/95/040/00134/AM12/ Lic.No/Date:0310631532 18.05.2011 Defer Date:26.07.2011 Decision : Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 53
Case No.:6/13/82ALC4/2011
Party Name:STERLING AUXILIARIES PVT LTD 28.06.2011 Status:Case Deferred HQ File :01/82/050/00378/AM12/ RLA File :03/95/040/00036/AM12/ Lic.No/Date:0310631606 18.05.2011 Defer Date:26.07.2011 Decision : Committee decided to defer case for 26.07.2011 for comments of Department of C&PC. 54
Case No.:2/13/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:13/82ALC4/2011 28.06.2011 Status:Case Deferred HQ File :01/82/050/00374/AM12/ RLA File :05/23/040/00079/AM12/ Lic.No/Date:0510292751 08.06.2011 Defer Date:23.08.2011 55
Case No.:1/13/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 28.06.2011 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:23.08.2011 Decision :Committee decided to forward a copy of application to Department of Biotechnology for their comments. Accordingly, case was deferred for 23.08.2011. 56
Case No.:4/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES Status:Case
LTD.& MOREPEN INTERNATION 28.06.2011 Deferred HQ File :01/82/050/00376/AM12/ RLA File :05/24/040/00424/AM11/ Lic.No/Date:0510292794 09.06.2011 Defer Date:23.08.2011 57
Case No.:5/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 28.06.2011 Status:Case Deferred HQ File :01/82/050/00377/AM12/ RLA File :05/24/040/00442/AM11/ Lic.No/Date:0510292795 09.06.2011 Defer Date:23.08.2011 58
Case No.:3/13/82ALC4/2011
Party Name:RELIANCE INDUSTRIES LTD. 28.06.2011 Status:Case Approved HQ File :01/82/050/00375/AM12/ RLA File :03/95/040/00188/AM12/ Lic.No/Date:0310635408 10.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their O.M. No.46011/57/2009 PC.II dated 30.11.2009 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 Paraxylene 1 MT 1. Reformate 1.376 MT 2. Relevant Catalyst and Chemicals used in the manufacture of Paraxylene CIF value limited to 0.90% FOB value of exports 59
Case No.:15/13/82ALC4/2011
Party Name:MALLADI SPECIALITIES LTD., 28.06.2011 Status:Case Approved HQ File :01/82/050/00387/AM12/ RLA File :04/24/040/00079/AM12/ Lic.No/Date:0410124886 13.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/241/2009PI(Norms) dated 25.01.2010 and in consultation with technical authority present in meeting decided to fix norms under para 4.7 of HBP on repeat basis as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Piroctone Olamine 1 kg. 1. 3,3Dimethyl Acrylic Acid 0.878 kg 2. Methanol 4.50 kg
60
Case No.:17/13/82ALC4/2011
Party Name:STAR DRUGS & RESEARCH LABS LTD 28.06.2011 Status:Case Approved HQ File :01/82/050/00389/AM12/ RLA File :04/24/040/00081/AM12/ Lic.No/Date:0410124937 14.06.2011 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per packing policy. 61
Case No.:18/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 28.06.2011 Status:Case Deferred HQ File :01/82/050/00390/AM12/ RLA File :05/24/040/00086/AM12/ Lic.No/Date:0510293369 14.06.2011 Defer Date:23.08.2011 62
Case No.:19/13/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 28.06.2011 Status:Case Approved HQ File :01/82/050/00391/AM12/ RLA File :31/83/040/00043/AM12/ Lic.No/Date:3110048676 16.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006 Ch.II dated 10.05.2010 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 Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed.
Case No.Outside Agenda1
M/S Cipla Ltd. F.No.01/82/050/00256/AM11/DESIII F.No.01/82/050/01090/AM11/DESIII RA F.No.03/94/040/00980/AM10 RA F.No.03/94/040/00560/AM11 Adv.Lic.No.0310559358 dated 09.02.2010 Adv.Lic.No.0310594225 dated 28.09.2010 Committee considered case in light of earlier decision taken in 49/11 meeting held on 08.03.2011 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 Agenda2
M/S Yasho Industries Pvt. Ltd. F.No.01/82/050/00566/AM09/DESIII F.No.01/82/050/01305/AM09/DESIII F.No.01/83/050/01431/AM08/DESIII F.No.01/83/050/00292/AM08/DESIII RA F.No.03/95/040/00189/AM09 RA F.No.03/95/040/00688/AM09 RA F.No.03/95/040/00740/AM08 RA F.No.03/95/040/00099/AM08 Adv.Lic.No.0310472525 dated 30.05.2008 Adv.Lic.No.0310495115 dated 21.11.2008 Adv.Lic.No.0310447836 dated 25.10.2007 Adv.Lic.No.0310429016 dated 10.05.2007 Committee considered case and in light of earlier decision taken in 20/11 meeting held on 17.08.2010 and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Aromatic Derivative Diphenylamine (ADA)” without any other change in the earlier decisions of NC.
Case No.Outside Agenda3
M/S Yasho Industries Pvt. Ltd. F.No.01/83/050/01672/AM08/DESIII F.No.01/82/050/00365/AM09/DESIII F.No.01/83/050/00934/AM08/DESIII RA F.No.03/95/040/00854/AM08 RA F.No.03/95/040/00084/AM09 RA F.No.03/95/040/00419/AM08
Adv.Lic.No.0310451958 dated 29.11.2007 Adv.Lic.No.0310470073 dated 30.04.2008 Adv.Lic.No.0310438028 dated 01.08.2007 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Dipentamethylene Thiuram Tetrasulfide (Qureacc DPTT)” without any other change in the earlier decisions of NC.
Case No.Outside Agenda4
M/S Yasho Industries Pvt. Ltd. F.No.01/83/050/00293/AM08/DESIII F.No.01/83/050/00959/AM08/DESIII RA F.No.03/95/040/00097/AM08 RA F.No.03/95/040/00454/AM08 Adv.Lic.No.0310429019 dated 10.05.2007 Adv.Lic.No.03104439189 dated 10.08.2007 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Octylated Diphenylamine (Powder/Flakes)” without any other change in the earlier decisions of NC.
Case No.Outside Agenda5
M/S Auctus Pharma Ltd. F.No.01/82/050/00879/AM10/DESIII RA F.No.09/70/040/00176/AM10 Adv.Lic.No.0910040573 dated 08.01.2010 Committee considered case and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Pentoprazole Sulfide (or) 5(Difluoro Methoxy)2{[(3,4 Dimethoxy2Pyridinyl]thio}1H Benzimidazole” without any other change in the decision taken in 43/82 meeting held on 19.01.2010.
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