DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi
Para 4.7 Decision
MEETING NUMBER : 32/82ALC4/2010 MEETING DATE : 09.11.2010 The Meeting No.32/82 in the year 201011 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 09.11.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri DN Mathur,DY.I.A.,Department of Pharmaceuticals 3. Shri Krishan Kumar, Dy. DGFT 4. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No. 29/82 dated 19.10.2010 were ratified by the Committee. Manual Cases
Case No. B265
M/s Gopinath ChemTech Ltd. N C Meeting No. 32/11 F.No.01/82/50/1215/AM10/DESIII Meeting Date 09.11.2010 Adv. Lic.No.0810087248 dt.11.03.10 Decision: The Committee decided to defer the case for 07.12.2010. comments of D/o C&PC.
Case No. B266
Jt.DGFT, CLA, New Delhi F.No.01/82/162/00583AM11/DESIII The Committee decided to defer the case for 07.12.2010 for comments of D/oPharmaceuticals.
Case No. B267
M/s Jubilant Organosys Ltd. F.No.01/82/50/843/AM07/DESIII Adv. Lic.No.0510189933 dt.31.08.06 Decision:The Committee decided to call for end use of the export product from the firm and to defer the case for04.01.11.
Case No. B268
M/s Metropolitan Exichem Ltd. F.No.01/82/50/1170/AM09/DESIII
Adv. Lic.No.0310491063 dt.20.10.08 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/75/2008/Ch.II dated 22.6.09 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 4,4Diamino 2 Methyl Azo Benzene 1 Kg. 1. Meta Toluidine 0.668 kg 2. Para Amino Acetanilide 0.910 kg RA concerned may take further necessary action as per above decision of NC.
Case No. B269
M/s Jubilant Organosys Ltd. F.No.01/82/50/651/AM07/DESIII Adv. Lic.No.0510187592 dt20.07.06 Decision:The Committee decided to call for following information from the firm and to defer the case for04.01.11: (i) Molecular weight & yield. (ii) Chemical Reaction (iii) Complete set of application. (iv) End use of the export product.
Case No. B270
M/s Kopran Ltd. F.No.01/83/50/00970/AM08 F.No.01/82/50/01346/AM05 Adv. Lic.No.0310439354 dt.13.08.07 Adv. Lic.No.0310299804 dt. 29.10.04 Decision:The Committee considered the case as per agenda and decided to revise quantity of following to import items in the above two licenses as per decision taken in meeting No.47/10 dated 16.02.2010 as under or as applied by the firm whichever is lower: Ceftriaxone Sodium(Non –Sterile) 1.04 kg/ kg of the export product Acetone 1.72 kg/ kg of the export product In NC’s decision for license dated 29.01.04,the word used for one of import item was Ceftriaxone Sodium Sterile. It may be read as Ceftriaxone Sodium(Non –Sterile). Accordingly NC’s decisions for above two licenses taken in meetings No.24/82 dt.16.10.2007 and 45/08 dt.11.03.2008 stand modified. RA may take action accordingly.
Case NoA35
M/s Ruchi Soya Industries Limited F.No.01/82/162/00040/AM11/DESIII Decision:The Committee decided to forward complete set of application to Department of C&PC and to defer the case for 04.01.11..
Case NoA36
M/s Alkyl Amines Chemicals Ltd. F.No.01/82/162/00288/AM11/DESIII Adv. Lic. No.0310417073 dated 07.12.2010 Decision: : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/37/2009/Ch.II dated 15.09.2010 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 2 Ethyl Hexylamine 1 Kg. 1. 2 Ethyl Hexanol 1.06 kg RA concerned may take further necessary action as per above decision of NC..
Case NoC24
M/s Filtra Speciality Catalysts Ltd.,. F.No.01/82162/00006/AM10/DESIII Decision:The Committee decided to make a request to Indian Chemical Council to intimate details of other exporters of the product and to defer the case for 07.12.2010. 1
Case No.:1/5/82ALC4/2009
Party Name:VIVIMED LABS LIMITED Meet No/Date:32/82ALC4/2010 09.11.2010 Status:Case Approved HQ File :01/82/050/00034/AM10/ RLA File :09/24/040/00005/AM10/ Lic.No/Date:0910037716 22.04.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/68/2010/Ch.II dated 26.10.10 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 EHT (Ethyl Hexyl Triazone)/Etone 1 Kg. 1. Para Nitro Benzoic Acid (PNBA) 2.510 kg 2. Perchloro Ethylene (PCE 0.606 kg 3. Methanol 3.324 kg
2 Ethyl Hexano 2.150 kg 5. Aceto Nitrile 2.636 kg 2
Case No.:7/8/82ALC4/2009
Party Name:SHILPA MEDICARE LTD., 09.11.2010 Status:Case Deferred HQ File :01/82/050/00102/AM10/ RLA File :07/24/040/00053/AM10/ Lic.No/Date:0710064718 13.05.2009 Defer Date:07.12.2010 Decision : The Committee noted that the reply to D/L will be sent to D/O Pharmaceuticals as soon as it is received and decided to defer the case for 7.12.10. 3
Case No.:4/14/82ALC4/2009
Party Name:MSN PHARMACHEM PRIVATE LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/00174/AM10/ RLA File :09/24/040/00054/AM10/ Lic.No/Date:0910037983 21.05.2009 Defer Date: Decision :On the basis of recommendations of representative from Department of Pharmaceuticals, the Committee decided to fix adhoc norms as under or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed [R(R*,R*)]2(4 flurophenyl) b,d.dihydroxy5(1 methylethyl)3phenyl4[ (phenyl amino) carbonyl] – 1H prrroh 1 – heptanoic acid] 1 kg 1. (4RCis) 1,1dimethyl ethyl6 cyano methyl2,2 dimethyl 1,3 dioxane4 acetane 1.254 kg 2. Methanol 8.31 kg 3. Cyclohexane 7.35 kg 4. Methyl isobutyryl acetate 1.76 kg 4
Case No.:12/15/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/00241/AM10/ RLA File :09/24/040/00105/AM10/ Lic.No/Date:0910038337 24.06.2009 Defer Date: Decision : The Committee decided to defer the case for 07.12.2010 for comments of D/oC&PC. 5
Case No.:21/15/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 09.11.2010 Status:Case Approved
HQ File :01/82/050/00250/AM10/ RLA File :09/24/040/00104/AM10/ Lic.No/Date:0910038365 26.06.2009 Defer Date: Decision :The Committee decided to defer the case for 07.12.2010 for comments of D/oC&PC. 6
Case No.:29/35/82ALC4/2009
Party Name:BELOOR BAYIR BIOTECH LTD, 09.11.2010 Status:Case Rejected HQ File :01/82/050/00719/AM10/ RLA File :07/24/040/00223/AM10/ Lic.No/Date:0710067058 17.09.2009 Defer Date: Decision : The Committee noted that copy of DML submitted by the firm shows the product as bulk drug while the firm has applied for Capsule/tablet.The firm needs to clarify the position. The Committee deferred the case for04.01.11 . 7
Case No.:14/33/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 09.11.2010 Status:Case Deferred HQ File :01/82/050/00642/AM10/ RLA File :09/24/040/00262/AM10/ Lic.No/Date:0910039756 29.10.2009 Defer Date:07.12.2010 Decision : The Committee deferred the case for 07.12.2010 for comments of D/o Pharmaceuticals . 8
Case No.:27/34/82ALC4/2009
Party Name: VIVIMED LABS LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:07.12.2010 Decision : The Committee deferred the case for 07.12.2010for comments of D/o C&PC. 9
Case No.:7/38/82ALC4/2009
Party Name:PROMED EXPORTS PVT.LTD. 09.11.2010 Status:Case Approved HQ File :01/82/050/00780/AM10/ RLA File :05/24/040/00382/AM10/ Lic.No/Date:0510253729 01.12.2009 Defer Date: Decision :As per decision taken in meeting No.25/82 dated21.09.2010 and on the basis of recommendations of TA from D/o Pharmaceuticals, the Committee decided to fix norms as under or as applied by the firm which ever is lower: S.No. Export item Qty Sl.No. Import item Qty 1. Tropicamide Eye Drops 0.5% (10 ml pack) 1 pack 1 Tropicamide 0.051 gm 2. Tropicamide Eye Drops 1% (10 ml pack) 1 pack 1 Tropicamide 0.102gm RA may take action accordingly. 10
Case No.:4/41/82ALC4/2009
Party Name:BALAJI AMINES LIMITED 09.11.2010 Status:Case Approved
HQ File :01/82/050/00839/AM10/ RLA File :31/24/040/00192/AM10/ Lic.No/Date:3110041170 21.12.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2008/Ch.II dated 26.10.10 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 NMethyl2Pyrrolidone 1 Kg. 1. Methanol 0.377 kg 2. Amonia 0.164 kg 3. 1,4 Butanediol 1.01 kg 4. Methylamine Catalyst 0.00080 kg 5. GBL Catalyst 0.00075 kg 11
Case No.:12/49/82ALC4/2009
Party Name:B. BRAUN MEDICAL (INDIA) PVT. LTD 09.11.2010 Status:Case Deferred HQ File :01/82/050/01147/AM10/ RLA File :04/24/040/00144/AM10/ Lic.No/Date:0410111650 17.02.2010 Defer Date:23.11.2010 Decision : The Committee decided to verify ITC(HS) code of export item ‘catgut’ and defer the case for 23.11.10 12
Case No.:16/49/82ALC4/2009
Party Name:HONEST BIOVET PVT. LTD 09.11.2010 Status:Case Deferred HQ File :01/82/050/01151/AM10/ RLA File :08/24/040/00322/AM10/ Lic.No/Date:0810086636 18.02.2010 Defer Date:04.01.2011 Decision :The committee decided to call for complete specification of the export product, Certificate of Analysis from the foreign suppler for import item and to defer the case for 04.01.2010. 13
Case No.:1/1/82ALC4/2010
Party Name:PARAMOUNT AROMACHEM PVT.LTD., 09.11.2010 Status:Case Deferred HQ File :01/82/050/01232/AM10/ RLA File :05/24/040/00501/AM10/ Lic.No/Date:0510260909 22.03.2010 Defer Date:07.12.2010 Decision : The Committee deferred the case for 07.12.2010for comments of D/o C&PC. 14
Case No.:10/1/82ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/01241/AM10/ RLA File :09/24/040/00531/AM10/ Lic.No/Date:0910041463 Defer Date:
25.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.135011/113/2010PI (Norms) dated 21.10.10 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 (S)2(33(2(7ChloroQuinolin2 YL)Vainyl)Phenyl)3Hydroxy Propyl)Benzoic acid methyl ester monohydrate. 1 Kg. 1. ISOPHALDEHYDE 1.10 2. ()DI ISOPINO CAMPHENYL CHLORO BORANE 1.427 15
Case No.:11/1/82ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/01242/AM10/ RLA File :09/24/040/00537/AM10/ Lic.No/Date:0910041464 25.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.135011/113/2010PI (Norms) dated 21.10.10 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 (S)2(33(2(7ChloroQuinolin2 YL)Vainyl)Phenyl)3Hydroxy Propyl)Benzoic acid methyl ester monohydrate. 1 Kg. 1. ISOPHALDEHYDE 1.10 kg 2. ()DI ISOPINO CAMPHENYL CHLORO BORANE 1.427 kg 16
Case No.:12/1/82ALC4/2010
Party Name: MANTENA LABORATORIES LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/01243/AM10/ RLA File :09/24/040/00538/AM10/ Lic.No/Date:0910041466 25.03.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.135011/113/2010PI (Norms) dated 21.10.10 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 (S)2(33(2(7ChloroQuinolin2 1 Kg. 1. ISOPHALDEHYDE 1.10 kg
YL)Vainyl)Phenyl)3Hydroxy Propyl)Benzoic acid methyl ester monohydrate. 2. ()DI ISOPINO CAMPHENYL CHLORO BORANE 1.427 kg 17
Case No.:47/2/82ALC4/2010
Party Name :MEDREICH LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/01281/AM10/ RLA File :07/24/040/00488/AM10/ Lic.No/Date:0710070729 30.03.2010 Defer Date:07.12.2010 Decision : It was decided to forward a copy of application to D/o Pharmaceuticals and to defer the case for 7.12.2010. 18
Case No.:10/5/82ALC4/2010
Party Name: PARABOLIC DRUGS LTD., 09.11.2010 Status:Case Approved HQ File :01/82/050/00044/AM11/ RLA File :05/24/040/00003/AM11/ Lic.No/Date:0510262859 22.04.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM no. 35011/69/2010 –PI (Norms) dated 05.10.2010 and in consultation with Technical Authorities present in the meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefepime for injection 1 kg 1. Cefepime HCL nonsterile 0.655 kg 2. L arginine 0.37 kg 3. Acetone 1.816 kg 4. Methanol 1.134 kg 5. Activated Carbon 0.034 kg RA may take action accordingly. 19
Case No.:11/5/82ALC4/2010
Party Name: PARABOLIC DRUGS LTD., 09.11.2010 Status: Case Deferred HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 Defer Date:04.01.2011 Decision : The Committee noted that a copy of reply received from the firm has been sent to D/o Pharmaceuticals for examination and decided to defer the case for 4.01.11
20
Case No.:4/8/82ALC4/2010
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 09.11.2010 Status:Case Rejected HQ File :01/82/050/00193/AM11/ RLA File :03/95/040/00054/AM11/ Lic.No/Date:0310573109 06.05.2010 Defer Date: Decision : The Committee noted that the firm did not send reply to queries raised by D/o C&PC vide their letter dt. No.14010/62/2010 dt.30.7.10 and decided to reject the case. 21
Case No.:8/8/82ALC4/2010
Party Name:KAMUD DRUGS PVT.LIMITED., 09.11.2010 Status:Case Approved HQ File :01/82/050/00197/AM11/ RLA File :31/24/040/00017/AM11/ Lic.No/Date:3110043165 10.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.135011/110/2010PI (Norms) dated 18.10.10 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. Qty. allowed Ketamine Hcl 1 kg 1. Cyclo penyl Chloride 1.876 kg 2. O chloro benzonitril 1.684 kg 3. Magnesium turning 0.467 kg 4. Bromoine 1.83 kg 5. Methanol 6.81 kg 6. Toluene 10.32 kg 7. Acetone 0.031 kg 8. ISO Propyl Alcohol 2.71 kg 22
Case No.:11/8/82ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/00200/AM11/ RLA File :03/94/040/00132/AM11/ Lic.No/Date:0310573519 10.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No.1410/83/2006Ch.II dated 11.10.10 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 Menthanol (4Isopropyl 1 kg 1 Cuminique Aldehyde 1.250 kg
Cyclohexyl Menthanol) 1 kg 2 5% Ruthenium on Carbon Catalyst 0.0035 kg 23
Case No.:13/8/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/00202/AM11/ RLA File :09/24/040/00043/AM11/ Lic.No/Date:0910041977 11.05.2010 Defer Date:04.01.2011 Decision : It was decided to forward a copy of Application to Department of Pharmaceuticals and to defer the case for 4.1.11 24
Case No.:14/8/82ALC4/2010
Party Name: HONEST BIOVET PVT. LTD 09.11.2010 Status:Case Approved HQ File :01/82/050/00203/AM11/ RLA File :08/24/040/00048/AM11/ Lic.No/Date:0810088931 12.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.135011/67/2010PI (Norms) dated 1.10.10 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 MENADIONE NICOTINAMIDE BISULPHITE 1 Kg. 1. MENADIONE SODIUM BISULPHITE 94% 0.695 kg 2. NICACINAMIDE 0.40 kg 25
Case No.:15/8/82ALC4/2010
Party Name:HONEST BIOVET PVT. LTD 09.11.2010 Status:Case Approved HQ File :01/82/050/00204/AM11/ RLA File :08/24/040/00049/AM11/ Lic.No/Date:0810088932 12.05.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.135011/67/2010PI (Norms) dated 1.10.10 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 MENADIONE SODIUM BISULPHITE COMPLEX 1 Kg. 1. MENADIONE SODIUM BISULPHITE (Assay NMT 94%) 0.695 kg
(Containing MENADIONE SODIUM BISULPHITE NLT 65%) 26
Case No.:16/8/82ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 09.11.2010 Status:Case Approved HQ File :01/82/050/00205/AM11/ RLA File :05/24/040/00054/AM11/ Lic.No/Date:0510264142 12.05.2010 Defer Date: Decision :As per decision taken in meeting No.25/82 dated21.09.2010 and on the basis of recommendations of TA from D/o Pharmaceuticals, the Committee decided to fix norms as under or as applied by the firm which ever is lower: S.No. Export item Qty Sl.No. Import item Qty 1. Tropicamide Eye Drops 0.5% (10 ml pack) 1 pack 1 Tropicamide 0.051 gm 2. Tropicamide Eye Drops 1% (10 ml pack) 1 pack 1 Tropicamide 0.102gm RA may take action accordingly. 27
Case No.:25/8/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/00214/AM11/ RLA File :09/24/040/00540/AM10/ Lic.No/Date:0910042034 14.05.2010 Defer Date:07.12.2010 Decision : The Committee deferred the case for 07.12.2010 for comments of D/o C&PC. 28
Case No.:34/15/82ALC4/2010
Party Name:S.M. CHEMICALS 09.11.2010 Status:Case Deferred HQ File :01/82/050/00471/AM11/ RLA File :03/95/040/00181/AM11/ Lic.No/Date:0310578751 14.06.2010 Defer Date:07.12.2010 Decision : The Committee deferred the case for 07.12.2010for comments of D/o C&PC. 29
Case No.:6/16/82ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 09.11.2010 Status:Case Approved HQ File :01/82/050/00522/AM11/ RLA File :31/24/040/00065/AM11/ Lic.No/Date:3110043866 06.07.2010 Defer Date: Decision : In consultation with TAs present in the meeting, the Committee decided to fix adhoc norms as under: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Mycophenolate Mofetil (Micofenolato Mofetilo) Bulk Drug 1 Kg. 1. Mycophenolic Acid Chemical 0.941 kg 30
Case No.:7/16/82ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/00523/AM11/ RLA File :03/95/040/00255/AM11/ Lic.No/Date:0310582109 06.07.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No.14010/24/2007/Ch.II dated 26.8..10 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 Calcium Saccharine 1 Kg. 1. Insoluble Saccharine 0.854 kg 31
Case No.:8/16/82ALC4/2010
Party Name:SHIVA PHARMACHEM PVT. LTD, 09.11.2010 Status:Case Approved HQ File :01/82/050/00524/AM11/ RLA File :34/24/040/00076/AM11/ Lic.No/Date:3410027427 06.07.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their UO No.14010/89/2010/Ch.II dated 8.11.10 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 Sodium2Ethylhexanoate/2Ethyl Hexanoic acid sodium salt 1 Kg. 1. 2Ethyl Hexanoic acid 0.963 kg 32
Case No.:11/16/82ALC4/2010
Party Name:ALEMBIC LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/00527/AM11/ RLA File :34/24/040/00077/AM11/ Lic.No/Date:3410027449 07.07.2010 Defer Date:04.01.2011
Decision : The Committee decided to call for copy of DML from the firm and to defer the case for 4..1.2011 33
Case No.:14/16/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 09.11.2010 Status:Case Deferred HQ File :01/82/050/00530/AM11/ RLA File :09/24/040/00109/AM11/ Lic.No/Date:0910042643 08.07.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceutical. 34
Case No.:2/24/82ALC4/2010
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 09.11.2010 Status:Case Deferred HQ File :01/82/050/00802/AM11/ RLA File :03/94/040/00488/AM11/ Lic.No/Date:0310590420 31.08.2010 Defer Date:07.12.2010 Decision : The Committee noted that Chemical Division of D/o C&PC has transferred the case to its Petrochemical Div. vide their UO dated 8.11.10. 35
Case No.:3/24/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 09.11.2010 Status:Deffered and Reindexed HQ File :01/82/050/00803/AM11/ RLA File :03/94/040/00487/AM11/ Lic.No/Date:0310590555 01.09.2010 Defer Date:7.12.2010 Decision : The Committee deferred the case for 7.12.2010for comments of D/o Pharmaceutical. 36
Case No.:6/24/82ALC4/2010
Party Name:AARTI INDUSTRIES LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/00806/AM11/ RLA File :03/94/040/00373/AM11/ Lic.No/Date:0310590944 06.09.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceutical. 37
Case No.:9/24/82ALC4/2010
Party Name:RAMPEX LABS PVT. LTD. 09.11.2010 Status:Case Deferred HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceutical. 38
Case No.:10/24/82ALC4/2010
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 09.11.2010 Status:Case Approved HQ File :01/82/050/00810/AM11/ RLA File :03/94/040/00388/AM11/ Lic.No/Date:0310591331 07.09.2010 Defer Date: Decision: Committee considered case as per agenda and in light of written comments forwarded by
Department of C&PC vide their U.O. No.14010/84/2010/Ch.III dated 8.11.10 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 1,3Dioxolane 1 Kg. 1. Monoethylene Glycol 0.882 kg 1 kg 2. Paraformaldehyde 0.427 kg RA concerned may take further necessary action as per above decision of NC. 16/11 39
Case No.:11/24/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 09.11.2010 Status:Case Deferred HQ File :01/82/050/00811/AM11/ RLA File :03/94/040/00502/AM11/ Lic.No/Date:0310591355 07.09.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceutical. 40
Case No.:12/24/82ALC4/2010
Party Name:VHB MEDISCIENCES LTD. 09.11.2010 Status:Case Deferred HQ File :01/82/050/00812/AM11/ RLA File :03/95/040/00447/AM11/ Lic.No/Date:0310591500 08.09.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceutical. 41
Case No.:1/32/82ALC4/2010
Party Name:ADCOCK INGRAM LTD, 09.11.2010 Status:Case Approved HQ File :01/82/050/00983/AM11/ RLA File :07/24/040/00288/AM11/ Lic.No/Date:0710075018 25.10.2010 Defer Date: Decision : As per SION A412, the Committee on the recommendations of TA from D/o Pharma, decided to fix adhoc norms as given below or as applied by the firm which is lower: Export Product Qty. S.No. Import Items Qty. Mypaid Capsules 1 capsule 1. Paracetamol BP/USP/EP 255 mg 2. Ibuprofen 25 BP/USP/EP 204 mg 3. Sodium Stearyl Fumerate BP/USP/EP 6.5 mg
RA may take necessary action accordingly. 42
Case No.:3/32/82ALC4/2010
Party Name:ANUH PHARMA LTD. 09.11.2010 Status:Case Deferred HQ File :01/82/050/00985/AM11/ RLA File :03/94/040/00649/AM11/ Lic.No/Date:0310598571 25.10.2010 Defer Date:04.01.2011 Decision : It was decided to forward a copy of Application to D/o Pharmaceuticals and to defer the case for 4.01.11. 43
Case No.:2/32/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 09.11.2010 Status:Case Deferred HQ File :01/82/050/00984/AM11/ RLA File :07/24/040/00286/AM11/ Lic.No/Date:0710075068 27.10.2010 Defer Date:04.01.2011 Decision : The Committee decided to call for DML for 1 gm injection from the firm and to defer the case for 4.1.2011. 44
Case No.:4/32/82ALC4/2010
Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:32/82ALC4/2010 09.11.2010 Status:Case Approved HQ File :01/82/050/00986/AM11/ RLA File :08/24/040/00197/AM11/ Lic.No/Date:0810093469 27.10.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/84/2010/Ch.III dated 8.11.10 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. Import items Qty. allowed Citric Acid Antydrous USP 1 Kg. Citric Acid Antydrous 1.01 RA concerned may take further necessary action as per above decision of NC. 16/11 45
Case No.:5/32/82ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 09.11.2010 Status:Case Deferred HQ File :01/82/050/00987/AM11/ RLA File :05/24/040/00265/AM11/ Lic.No/Date:0510275800 27.10.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceuticals.
46
Case No.:6/32/82ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 09.11.2010 Status:Case Deferred HQ File :01/82/050/00988/AM11/ RLA File :05/24/040/00266/AM11/ Lic.No/Date:0510275802 27.10.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceuticals. 47
Case No.:7/32/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 09.11.2010 Status:Case Deferred HQ File :01/82/050/00989/AM11/ RLA File :03/94/040/00657/AM11/ Lic.No/Date:0310599277 28.10.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011for comments of D/o Pharmaceuticasl. 48
Case No.:8/32/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 09.11.2010 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:04.01.2011 Decision : It was decided to forward a copy of Application to D/o C&PC and to defer the case for 04.01.2011. 49
Case No.:9/32/82ALC4/2010
Party Name:HETERO LABS LIMITED 09.11.2010 Status:Case Approved HQ File :01/82/050/00991/AM11/ RLA File :09/24/040/00309/AM11/ Lic.No/Date:0910044089 01.11.2010 Defer Date: Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/87/2007PIIII dated 12.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Lamivudine 1 Kg. 1. Glyoxylic acid 50% 1.80 kg. 2. 1,4dithiane2,5dihydroxy 0.739 kg. 3. Cytosine 0.955 kg. 4. Hexamethyl disilazane 1.89 kg. 5. Salicylic acid 0.79 kg. 6. Sodium borohydride 0.48 kg. 7. Dimethyl formamide 0.83 kg. 8. nHexane 3.75 kg. 9. Methylene dichloride 5.75 kg.
50
Case No.:10/32/82ALC4/2010
Party Name:HONEST BIOVET PVT. LTD 09.11.2010 Status:Case Approved HQ File :01/82/050/00992/AM11/ RLA File :08/24/040/00227/AM11/ Lic.No/Date:0810093579 01.11.2010 Defer Date: Decision :In view of decision taken by NC in its meeting No.28/08 dt.13.11.07 as modified in meeting No. 49/09 dt.24.02.09 and on recommendations of TAs present in the meeting, it was decided to fix adhoc norms as per details below or as applied by the firm whichever is lower: Export Product Qty. S.No. Import Items Qty. 3 Chloroperoxybenzoic Acid 1 kg 1. 3Chloro Benzoychloride (meta chloro benzoyl Acid 1.00 kg 2. Tertiary Butanol 3.50 kg RA may take action accordingly. 51
Case No.:11/32/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 09.11.2010 Status:Case Deferred HQ File :01/82/050/00993/AM11/ RLA File :09/24/040/00312/AM11/ Lic.No/Date:0910044097 02.11.2010 Defer Date:07.12.2010 Decision : : It was decided to to defer the case for 07.12.2010 for comments of D/o Pharmaceuticals. 52
Case No.:12/32/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 09.11.2010 Status:Case Deferred HQ File :01/82/050/00994/AM11/ RLA File :09/24/040/00300/AM11/ Lic.No/Date:0910044098 02.11.2010 Defer Date:04.01.2011 Decision : The Committee deferred the case for 04.01.2011 for comments of D/o C&PC. Outside Agenda M/S Cipla Ltd. The Committee noted that NC in its decision for Adv. Lic No.0310582173 dt. 6.7.10 taken in Meeting No. 22/82 dated 31.8.10 in the description of export product has inter alia used the words ‘cobalt Powder’ which may be replaced by words ‘cobact Powder’ with no other change in earlier NC’s decision.
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