DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision
MEETING NUMBER : 34/82‐ALC4/2010 MEETING DATE : 23.11.2010 The Meeĕng No.34/82 in the year 2010‐11 to consider the cases under Duty Exempĕon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 23.11.2010 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 D.N. Mathur, Dy. IA, Department of Pharmaceuĕcals 3. Shri M. Mitra, Dy. DCGI, DCGI 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO
Case No. B‐280
M/s Cipla Ltd, Mumbai Norms Commiĥee Meeĕng No. 34/11 F.No.01/82/050/00561/AM11/DES‐III F.No.01/82/050/00493/AM11/DES‐III Meeĕng Date 23.11.2010 RLA F. No. 03/94/040/00224/AM11 RLA F. No. 03/94/040/00203/AM11 Adv. Lic. No.0310576657 dated 01.06.2010 Adv. Lic. No.0310576091 dated 26.05.2010 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/111/2010‐PI (Norms) dated 11.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to revise 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 Amoxicillin & Clavulanate Potassium for Suspension USP 600mg/42.90mg (Pack size 75 ml) 75 ml pack 1. Amoxycillin Trihydrate 10.080 gm/pack 2. Clavulanate Potassium Syloid 1.6081 gm/pack 3. Silicon Dioxide (Syloid AL‐1FP)NF 1.500 gm/pack 4. 150 CC N/M Pen Nat 31 GR As per packing policy 5. 185 CC N/M Pen RD Natural 36 GRSN 6. 250 CC N/M Pen RD NAT 7. Cap 28/400 WHT CRC W/FS M‐1 Amoxicillin & Clavulanate Potassium for Suspension USP 125 ml pack 1. Amoxycillin Trihydrate 16.695 gm 2. Clavulanate Potassium Syloid 2.6802 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 2.50 gm
600mg/42.90mg (125 ml) 4. 150 CC N/M Pen Nat 31 GR 5. 185 CC N/M Pen RD Natural 36 GRSN 6. 250 CC N/M Pen RD NAT 7. Cap 28/400 WHT CRC W/FS M‐1 Amoxicillin & Clavulanate Potassium for Suspension USP 600mg/42.90mg (200 ml) 150 ml pack 1. Amoxycillin Trihydrate 26.145 gm 2. Clavulanate Potassium Syloid 4.2883 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 4.00 gm 4. 150 CC N/M Pen Nat 31 GR 5. 185 CC N/M Pen RD Natural 36 GRSN 6. 250 CC N/M Pen RD NAT 7. Cap 28/400 WHT CRC W/FS M‐1 The earlier decision taken in 15/82 meeĕng held on 13.07.2010 and 18/82 meeĕng held on 03.08.2010 stands withdrawn. RA concerned may take further necessary acĕon as per above decision of NC.
Case No. B‐281
M/s Shasun Chemicals & Drugs Ltd. F.No.01/82/050/00142/AM09/DES‐III RLA F. No. 04/24/040/00388/AM08 Adv. Lic. No.0410094353 dated 12.03.2008 Commiĥee considered case as per agenda and a├er considering 50% recovery and in consultaĕon with technical authority present in meeĕng, decided to enhance the quanĕty of import item namely Methyl Cyclohexane to the extent of 107 kg/kg of export product without any other change in the decision taken in 18/82 meeĕng held on 29.07.2008.
Case No. B‐282
M/s Kopran Ltd. F.No.01/82/050/01601/AM09/DES‐III RLA F. No. 03/94/040/00986/AM09 Adv. Lic. No.0310504570 dated 30.01.2009 Commiĥee decided to forward a copy of applicaĕon to Department of Pharmaceuĕcals for their comments. Accordingly, the case was deferred for 21.12.2010.
Case No. B‐283
M/s Jubilant Organosys Ltd.
F.No.01/82/050/01715/AM09/DES‐III RLA F. No. 05/24/040/00744/AM09 Adv. Lic. No.0510238238 dated 18.03.2009 Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC.
Case No. B‐284
M/s GVS Ltd. F.No.01/82/050/001367/AM07/DES‐III F.No.01/82/050/001368/AM07/DES‐III RLA F. No. 03/94/040/00842/AM07 RLA F. No. 03/94/040/00843/AM07 Adv. Lic. No.0310410371 dated 30.11.2006 Adv. Lic. No.0310410389 dated 30.11.2006 Commiĥee decided to send a copy of applicaĕon to Department of Pharmaceuĕcals and to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals.
Case No. B‐285
M/s Solaris Chemical Industries Ltd. F.No.01/82/162/00642/AM10/DES‐III Commiĥee considered case as per agenda and observed that as per data submiĥed by the firm, the value addiĕon works out to 35.71%, whereas as per import data furnish by DGCIS, Kolkata and export data submiĥed by the firm, the value addiĕon works out to 185%. It was further observed that DGCIS has informed that they were not having the export data of Tetra Bromo Bisophenol A. A├er detailed deliberaĕon, Commiĥee decided to recommend value addiĕon to the extent of 225% to DEPB Commiĥee for fixaĕon of DEPB rate.
Case No. B‐286
M/s Hetero Labs Ltd. F.No.01/82/050/01100/AM08/DES‐III RLA F. No. 09/24/040/00227/AM08 Adv. Lic. No.0910031385 dated 03.09.2007 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/68/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to delete first import item namely “1‐2‐Cyanobiophenyl‐4‐yl)‐2‐n‐butyl‐4‐ Spirocyclopentane‐2‐Imidazoloin‐5‐one” and to allow import of 2‐n‐butyl‐1,3‐diazaspiro(4,4)non‐1‐en‐4‐one Hcl to the extent of 0.88 kg/kg of export product and to reduce the quanĕty of Methylene Chloride as 4.44 kg/kg of export product. Quanĕty of Acetone shall remain 2.83 kg/kg of export product, as allowed in NC’s meeĕng No.31/82 dated 04.12.2007.
Case No. B‐287
M/s Star Orechem Internaĕonal Pvt. Ltd. F.No.01/82/050/001052/AM10/DES‐III F.No.01/82/050/00651/AM10/DES‐III RLA F. No. 50/24/040/00004/AM10 RLA F. No. 50/24/040/00006/AM10 Adv. Lic. No.5010000149 dated 25.09.2009 Adv. Lic. No.5010000150 dated 25.09.2010 Commiĥee noted that the firm has submiĥed the Central Excise cerĕfied producĕon and consumpĕon data and decided to defer case for 21.12.2010 for comments of Department of C&PC.
Case No. B‐288
M/s Vivimed Labs Ltd. F.No.01/85/050/00236/AM10/DES‐III RLA F. No. 09/24/040/00504/AM10 Adv. Lic. No.0910041262 dated 11.03.2010 Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC.
Case No. B‐289
M/s Deepak Novachem Technologies Ltd. F.No.01/82/050/01311/AM09/DES‐III F.No.01/82/050/00176/AM10/DES‐III F.No.01/82/050/01274/AM09/DES‐III RLA F. No. 31/24/040/00407/AM08 RLA F. No. 31/24/040/00332/AM09 RLA F. No. 31/24/040/00205/AM09 Adv. Lic. No.3110036184 dated 21.11.2008 Adv. Lic. No.3110038123 dated 17.04.2009 Adv. Lic. No.3110036117 dated 17.11.2008 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/111/2008‐Ch.II dated 02.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Advance licence No.3110036184 dated 21.11.2008 Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,6 Xylidine 1 kg 1. Phenol 1.770 kg 2. Methanol 1.345 kg Advance licence No. 3110038123 dated 17.04.2009
Advance licence No. 3110036117 dated 17.11.2008 Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,6 Xylidine 1 kg 1. 2,6 Xylenol 1.946 kg The earlier decision taken in 15/82 meeĕng held on 07.07.2009, 14/82 meeĕng held on 30.06.2009 and 12/82 meeĕng held on 16.06.2009 stands withdrawn.
Case No. B‐290
M/s Shilpa Medicare Ltd. F.No.01/83/050/01382/AM07/DES‐III RLA F. No. 07/24/040/00879/AM07 Adv. Lic. No.0710050972 dated 29.03.2007 Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals.
Case No. B‐291
M/s Shilpa Medicare Ltd. F.No.01/82/050/00102/AM10/DES‐III RLA F. No. 07/24/040/00053/AM10 Adv. Lic. No.0710064718 dated 13.05.2009 Commiĥee considered case as per agenda and observed that the case has been considered on‐line in 32/82 meeĕng held on 09.11.2010 and the same has been deferred for 07.12.2010 for reply from firm. It was, therefore, decided to merge the representaĕon in the main file.
Case No. B‐292
M/s Shilpa Medicare Ltd. F.No.01/83/050/00095/AM07/DES‐III RLA F. No. 07/24/040/00046/AM07 Adv. Lic. No.0710044550 dated 26.04.2006 Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals.
Case No. B‐293
M/s Shilpa Medicare Ltd. F.No.01/83/050/01418/AM08/DES‐III F.No.01/83/050/00469/AM07/DES‐III RLA F. No. 07/24/040/00420/AM08 RLA F. No. 07/24/040/00270/AM07
Adv. Lic. No.0710054000 dated 24.10.2007 Adv. Lic. No.0710046357 dated 27.07.2006 Commiĥee considered case as per agenda and observed that the norms for the same export product were fixed by NC in 24/87 meeĕng held on 21.09.2005 against advance licence No.0710037468 dated 27.04.2005. It was further observed that in the said meeĕng, Commiĥee decided to revise the SION A‐3467, but the decision for revision of SION could not be implemented. A├er detailed deliberaĕons, Commiĥee in light of decision taken in 24/87 meeĕng held on 21.09.2005 and in consultaĕon with technical authority present in meeĕng, decided to revise 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 3a, 7b Dioxy Cholanic Acid 1 Kg. 1. 3a 7a Dihydroxy 5B Cholan‐24‐OIC Acid Technical Grade 1.90 kg/kg 2. Sodium Metal 1.33 kg/kg 3. Sodium Bromate 0.80 kg/kg 4. Secondary Butanol 9.70 kg/kg 5. Methylene Chloride 1.82 kg/kg It was also decided that firm shall immediately be asked to make an applicaĕon for revision of SION A‐3467. If firm does not make applicaĕon, in future, it shall be allowed import items for the export product in quesĕon, as per exisĕng SION.
Case No. B‐294
M/s Divis Laboratories Ltd F.No.01/82/050/01489/AM09/DES‐III RLA F. No. 09/24/040/00356/AM09 Adv. Lic. No.0910036547 dated 01.01.2009 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/121/2009‐PI‐III dated 01.05.2009 and in consultaĕon with technical authority present in meeĕng, decided to allow import of C‐10 Dialdehyde to the extent of 0.42 kg/kg of export product without any other change in the decision taken in 42/82 meeĕng held on 13.01.2009.
Case No. C‐25
M/s Bliss GVS Pharma Ltd. F.No.01/82/162/01192/AM10/DES‐III
Commiĥee decided to call for All Industry producĕon and consumpĕon data in respect of export product “Suppositories/Pessaires from Pharmexcil. Accordingly, case was deferred for 18.01.2011. 1
Case No.:12/49/82‐ALC4/2009
Party Name:B. BRAUN MEDICAL (INDIA) PVT. LTD Meet No/Date:34/82‐ALC4/2010 23.11.2010 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:18.01.2011 Decision :Commiĥee considered case as per agenda and observed that inspite of reminder, Department of Animal Husbandary has not inĕmated whether the item Catgut is sensiĕve one. It was, therefore, decided to remind the concerned Joint Secretary/Director in Department of Animal Husbandary to expedite their comments. Accordingly, case was deferred for 18.01.2011. 2
Case No.:5/52/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/01198/AM10/ RLA File :09/24/040/00496/AM10/ Lic.No/Date:0910041237 09.03.2010 Defer Date:21.12.2010 Decision :Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 3
Case No.:14/52/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/01207/AM10/ RLA File :05/24/040/00507/AM10/ Lic.No/Date:0510260189 10.03.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 4
Case No.:29/52/82‐ALC4/2009
Party Name:AARTI INDUSTRIES LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/01222/AM10/ RLA File :03/94/040/01071/AM10/ Lic.No/Date:0310564649 12.03.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 5
Case No.:14/6/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00161/AM11/ RLA File :34/24/040/00229/AM10/ Lic.No/Date:3410026592 12.03.2010 Defer Date:18.01.2011 Decision : Commiĥee decided to defer case for 18.01.2011 for comments of Department of Pharmaceuĕcals.
6
Case No.:34/14/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00396/AM11/ RLA File :09/24/040/00527/AM10/ Lic.No/Date:0910041331 18.03.2010 Defer Date:18.01.2011 7
Case No.:69/22/82‐ALC4/2010
Party Name:BIOLOGICAL E LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/00722/AM11/ RLA File :09/24/040/00481/AM10/ Lic.No/Date:0910041328 18.03.2010 Defer Date:18.01.2011 8
Case No.:1/6/82‐ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 23.11.2010 Status:Case Approved HQ File :01/82/050/00148/AM11/ RLA File :52/24/040/00032/AM10/ Lic.No/Date:5210030126 24.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/187/2001‐Ch.III dated 02.08.2005 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Naphthyl Amine‐6‐Sulfonamide N‐Methyl 1 Kg. 1. Beta Naphthol 1.243 kg 2. Mono Methyl Amine 1.902 kg 3. Causĕc Soda Flakes 1.502 kg 9
Case No.:15/2/82‐ALC4/2010
Party Name:COMBITIC GLOBAL CAPLET PVT. LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/01249/AM10/ RLA File :33/24/040/00016/AM10/ Lic.No/Date:3310015180 26.03.2010 Defer Date:18.01.2011 Decision :Commiĥee decided to forward a copy of applicaĕon to Directorate of Vanaspaĕ, Vegetable Oil and Fats for their comments. Accordingly, case was deferred for 18.01.2011. 10
Case No.:12/14/82‐ALC4/2010
Party Name:VDH INTERNATIONAL 23.11.2010 Status:Case Deferred
HQ File :01/82/050/00374/AM11/ RLA File :05/24/040/00514/AM10/ Lic.No/Date:0510261659 01.04.2010 Defer Date:21.12.2010 Decision : :Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 11
Case No.:2/3/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00013/AM11/ RLA File :09/24/040/00549/AM10/ Lic.No/Date:0910041571 07.04.2010 Defer Date:21.12.2010 Decision : :Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 12
Case No.:29/18/82‐ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00572/AM11/ RLA File :31/24/040/00001/AM11/ Lic.No/Date:3110042802 08.04.2010 Defer Date:21.12.2010 Decision : :Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 13
Case No.:5/3/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00016/AM11/ RLA File :03/94/040/01138/AM10/ Lic.No/Date:0310568958 09.04.2010 Defer Date:21.12.2010 Decision : :Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 14
Case No.:28/14/82‐ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00390/AM11/ RLA File :07/24/040/00005/AM11/ Lic.No/Date:0710070972 16.04.2010 Defer Date:18.01.2011 Decision : :Commiĥee decided to forward a copy of applicaĕon to Department of Pharmaceuĕcals for their comments. Accordingly, case was deferred for 18.01.2011. 15
Case No.:73/22/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 23.11.2010 Status:Case Deferred HQ File :01/82/050/00726/AM11/ RLA File :09/24/040/00015/AM11/ Lic.No/Date:0910041826 27.04.2010 Defer Date:18.01.2011 Decision : :Commiĥee decided to defer case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 16
Case No.:99/22/82‐ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 23.11.2010 Status:Case Approved
HQ File :01/82/050/00752/AM11/ RLA File :09/24/040/00011/AM11/ Lic.No/Date:0910041827 27.04.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM. No.35011/109/2010PI(Norms) dated 18.10.2010 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 (2S,5R)‐5‐Fluorocytosine‐1‐YL‐ [1,3]‐Oxathiolane‐2 Carboxylic Acid Menthyl Ester (FCME) 1 kg 1. Glyoxalic Acid 0.34 kg 2. Cyclohexane 1.27 kg 3. 2,5‐Dihyroxy‐1,4‐Diethane 0.28 kg 4. 5‐Fluorocystone 0.531 kg 5. Methylene Chloride 8.54 kg RA may take further necessary action as per above decision of NC. 17
Case No.:20/6/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 23.11.2010 Status:Case Deferred HQ File :01/82/050/00167/AM11/ RLA File :07/24/040/00002/AM11/ Lic.No/Date:0710071273 28.04.2010 Defer Date:18.01.2011 18
Case No.:100/22/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 23.11.2010 Status:Case Deferred HQ File :01/82/050/00753/AM11/ RLA File :09/24/040/00562/AM10/ Lic.No/Date:0910041845 28.04.2010 Defer Date:18.01.2011 19
Case No.:30/6/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00177/AM11/ RLA File :34/24/040/00020/AM11/ Lic.No/Date:3410026932 29.04.2010 Defer Date:18.01.2011 Decision :Commiĥee decided to defer case for 18.01.2011 for reply from the firm. 20
Case No.:33/6/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/00180/AM11/ RLA File :03/94/040/00030/AM11/ Lic.No/Date:0310572376 Defer
30.04.2010 Date:18.01.2011 21
Case No.:36/6/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00183/AM11/ RLA File :09/24/040/00033/AM11/ Lic.No/Date:0910041861 03.05.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 22
Case No.:56/14/82‐ALC4/2010
Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/00418/AM11/ RLA File :03/95/040/00081/AM11/ Lic.No/Date:0310573993 12.05.2010 Defer Date:18.01.2011 Decision :Commiĥee considered case as per agenda and decided to call for technical literature and copy of DML from the firm. Accordingly, case was deferred for 18.01.2011. 23
Case No.:60/14/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00422/AM11/ RLA File :03/94/040/00108/AM11/ Lic.No/Date:0310573861 12.05.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 24
Case No.:61/14/82‐ALC4/2010
Party Name:JAYANT AGRO ORGANICS LTD., 23.11.2010 Status:Case Approved HQ File :01/82/050/00423/AM11/ RLA File :03/94/040/00059/AM11/ Lic.No/Date:0310573847 12.05.2010 Decision :Withdrawn as the case has already been approved by NC in 30/82 meeĕng held on 26.10.2010. 25
Case No.:83/22/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 23.11.2010 Status:Case Approved HQ File :01/82/050/00736/AM11/ RLA File :08/24/040/00046/AM11/ Lic.No/Date:0810089011 14.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product: Venlafaxine Tablets ‐ 25 MG/37.5 MG/ 50 MG /75 MG
Imports Items: Quanĕty Allowed per tablet(in MG) 25 MG 37.5 MG 50 MG 75 MG 100MG 1. Venlafaxine HCL 28.855 43.283 57.71 86.565 115.42 2. Lactose Monohydrate 30.0 45.0 60.0 90.0 120.0 3. Microcrystalline Cellulose (Avicel PH 101) 16.863 24.994 33.325 49.988 66.650 4. Microcrystalline Cellulose (Avicel PH 102) 16.463 24.694 32.925 49.388 65.85 5. Other 4 Items As per packing policy (relevant) 26
Case No.:54/14/82‐ALC4/2010
Party Name:NAPROD LIFE SCIENCES PVT. LTD. 23.11.2010 Status:Case Approved HQ File :01/82/050/00416/AM11/ RLA File :03/95/040/00098/AM11/ Lic.No/Date:0310574607 17.05.2010 Decision : Commiĥee considered case as per agenda and in line with DML and as per SION A‐205 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Ifosfamide for Inecĕon 1 gm. 18200 Vials 1. Ifosfamide 19.11 kg 27
Case No.:57/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00710/AM11/ RLA File :03/94/040/00118/AM11/ Lic.No/Date:0310574865 18.05.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 28
Case No.:59/14/82‐ALC4/2010
Party Name:CIPLA LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00421/AM11/ RLA File :03/94/040/00186/AM11/ Lic.No/Date:0310575233 20.05.2010 Defer Date:21.12.2010 Decision :Commiĥee decided to remind Ministry of Environment and Forests for NOC for import of Gas (1,1,1,2,3,3,3 Heptafluoropropane)(HFA 227 Propellant). Accordingly case was deferred for 21.12.2010. Ministry of Environment and Forests is to be reminded through D.O. leĥer. 29
Case No.:7/22/82‐ALC4/2010
Party Name:BIOLOGICAL E LTD
23.11.2010 HQ File :01/82/050/00660/AM11/ RLA File :09/24/040/00042/AM11/ Lic.No/Date:0910042127 25.05.2010 Decision : Commiĥee decided to defer the case for 21.12.10 for comments of Department Pharmaceuĕcals 30
Case No.:7/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 23.11.2010 HQ File :01/82/050/00825/AM11/ RLA File :09/24/040/00061/AM11/ Lic.No/Date:0910042109 25.05.2010 Defer Date:18.01.2011 31
Case No.:8/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 23.11.2010 HQ File :01/82/050/00826/AM11/ RLA File :09/24/040/00060/AM11/ Lic.No/Date:0910042112 25.05.2010 Defer Date:18.01.2011 Decision: Commiĥee decided to defer case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 32
Case No.:30/14/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/00392/AM11/ RLA File :07/24/040/00037/AM11/ Lic.No/Date:0710071792 26.05.2010 Defer Date:18.01.2011 Decision : Commiĥee decided to forward a copy of applicaĕon to Department of C&PC for their comments. Accordingly, case was deferred for 18.01.2011. 33
Case No.:10/22/82‐ALC4/2010
Party Name:FDC LTD 23.11.2010 HQ File :01/82/050/00663/AM11/ RLA File :03/94/040/00954/AM10/ Lic.No/Date:0310576214 26.05.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 34
Case No.:31/14/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 23.11.2010 HQ File :01/82/050/00393/AM11/ RLA File :07/24/040/00035/AM11/ Lic.No/Date:0710071909 31.05.2010 Decision : Commiĥee decided to defer the case for 21.12.10 for comments of Department of C&PC.
35
Case No.:12/22/82‐ALC4/2010
Party Name:AQUAPHARM CHEMICALS PVT.LIMITED 23.11.2010 Status:Case Approved HQ File :01/82/050/00665/AM11/ RLA File :31/24/040/00026/AM11/ Lic.No/Date:3110043418 31.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/56/2007‐Ch.II dated 03.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Aqueous Soluĕon of Polymaleic Acid (Acĕve Content: 47‐53%) 1 Kg. 1. Maleic Anhydride 0.316 kg 36
Case No.:15/22/82‐ALC4/2010
Party Name:SUNWAYS LABORATORIES PVT. LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00668/AM11/ RLA File :03/95/040/00140/AM11/ Lic.No/Date:0310576643 31.05.2010 Defer Date:18.01.2011 37
Case No.:10/26/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 23.11.2010 HQ File :01/82/050/00828/AM11/ RLA File :09/24/040/00058/AM11/ Lic.No/Date:0910042154 31.05.2010 Defer Date:18.01.2011 Decision :Commiĥee considered case as per agenda and decided to advise the firm to get the descripĕon of export product amended from RA indicaĕng the percentage content of API in the export product. Accordingly, case was deferred for 18.01.2011. 38
Case No.:11/26/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 23.11.2010 HQ File :01/82/050/00829/AM11/ RLA File :09/24/040/00080/AM11/ Lic.No/Date:0910042155 31.05.2010 Decision : Commiĥee decided to defer the case for 21.12.10 for comments of Department of C&PC. 39
Case No.:33/26/82‐ALC4/2010
Party Name:CIPLA LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00851/AM11/ RLA File :03/94/040/00216/AM11/ Lic.No/Date:0310576655 01.06.2010 Defer Date:18.01.2011
40
Case No.:28/22/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 23.11.2010 Status:Case Approved HQ File :01/82/050/00681/AM11/ RLA File :03/94/040/00922/AM10/ Lic.No/Date:0310577746 07.06.2010 Decision :Withdrawn as the case has already been approved by NC in 31/82 meeĕng held on 02.11.2010. 41
Case No.:14/18/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 HQ File :01/82/050/00557/AM11/ RLA File :03/94/040/00180/AM11/ Lic.No/Date:0310578576 11.06.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of C&PC. 42
Case No.:10/18/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 23.11.2010 HQ File :01/82/050/00553/AM11/ RLA File :13/24/040/00007/AM11/ Lic.No/Date:1310032417 14.06.2010 Defer Date:18.01.2011 Decision : Commiĥee decided to defer case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 43
Case No.:11/18/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 23.11.2010 Status:Case Deferred HQ File :01/82/050/00554/AM11/ RLA File :13/24/040/00012/AM11/ Lic.No/Date:1310032416 14.06.2010 Defer Date:18.01.2011 44
Case No.:12/26/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 23.11.2010 HQ File :01/82/050/00830/AM11/ RLA File :09/24/040/00093/AM11/ Lic.No/Date:0910042310 14.06.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 45
Case No.:13/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:34/82‐ALC4/2010 23.11.2010 HQ File :01/82/050/00831/AM11/ RLA File :09/24/040/00097/AM11/ Lic.NoDate:0910042361 16.06.2010 Defer Date:18.01.2011
46
Case No.:24/18/82‐ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED Meet No/Date:34/82‐ALC4/2010 23.11.2010 Status:Case Deferred HQ File :01/82/050/00567/AM11/ RLA File :03/95/040/00196/AM11/ Lic.No/Date:0310579194 17.06.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 47
Case No.:34/22/82‐ALC4/2010
Party Name:WEXFORD LABORATORIES P LTD 23.11.2010 HQ File :01/82/050/00687/AM11/ RLA File :07/24/040/00074/AM11/ Lic.No/Date:0710072310 17.06.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 48
Case No.:77/22/82‐ALC4/2010
Party Name:AVIGNON EXIM PVT.LTD., 23.11.2010 Status:Case Approved HQ File :01/82/050/00730/AM11/ RLA File :03/94/040/00254/AM11/ Lic.No/Date:0310579381 17.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/1/2009‐Ch.II dated 19.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Alpha Picolinic Acid 1 Kg. 1. 2‐Cyanopyridine 1.34 kg 49
Case No.:14/26/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 23.11.2010 HQ File :01/82/050/00832/AM11/ RLA File :09/24/040/00088/AM11/ Lic.No/Date:0910042382 17.06.2010 Defer Date:18.01.2011 50
Case No.:35/22/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 23.11.2010 Status:Case Approved HQ File :01/82/050/00688/AM11/ RLA File :08/24/040/00071/AM11/ Lic.No/Date:0810089869
21.06.2010 Decision : Commiĥee considered case as per agenda and taking cue from SION at Sl.No.A‐412 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Propafenone Tablet 150 mg Propafenone 150 Heumann 1 No. 1. Propafenone Hcl 153 mg Propafenone Tablet 300 mg Propafenone 300 Heumann 1 No. 1. Propafenone Hcl 306 mg 51
Case No.:36/22/82‐ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00689/AM11/ RLA File :31/24/040/00052/AM11/ Lic.No/Date:3110043681 21.06.2010 Defer Date:21.12.2010 Decision Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 52
Case No.:59/22/82‐ALC4/2010
Party Name:EUROMED HEALTH PRIVATE LIMITED Meet No/Date:34/82‐ALC4/2010 23.11.2010 HQ File :01/82/050/00712/AM11/ RLA File :35/24/040/00018/AM11/ Lic.No/Date:3510030697 21.06.2010 Decision : : Commiĥee decided to defer the case for 21.12.10 for comments of DIPP. 53
Case No.:1/15/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 23.11.2010 Status:Case Approved HQ File :01/82/050/00438/AM11/ RLA File :08/24/040/00088/AM11/ Lic.No/Date:0810089940 23.06.2010 Decision : Withdrawn as the case has already been approved by NC in 31/82 meeĕng held on 02.11.2010. 54
Case No.:23/18/82‐ALC4/2010
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 23.11.2010 Status:Case Approved HQ File :01/82/050/00566/AM11/ RLA File :34/24/040/00066/AM11/ Lic.No/Date:3410027335 24.06.2010 Decision: Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/79/2010‐Ch.II dated 23.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Methyl Triphenyl PhosphoniumBromide 1 kg. 1. Triphenyl Phosphine 0.886 kg 55
Case No.:56/22/82‐ALC4/2010
Party Name:AARTI INDUSTRIES LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00709/AM11/ RLA File :03/94/040/00282/AM11/ Lic.No/Date:0310581151 29.06.2010 Defer Date:18.01.2011 Decision Commiĥee decided to defer case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 56
Case No.:64/22/82‐ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00717/AM11/ RLA File :03/94/040/00287/AM11/ Lic.No/Date:0310581185 29.06.2010 Defer Date:18.01.2011 Decision Commiĥee decided to defer the case for 18.01.2011 for comments of D/o Pharmaceuĕcals. 57
Case No.:67/22/82‐ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 23.11.2010 HQ File :01/82/050/00720/AM11/ RLA File :03/95/040/00210/AM11/ Lic.No/Date:0310581119 29.06.2010 Defer Date:18.01.2011 Decision : Commiĥee decided to call for technical details as per Appendix 33 from the firm and to defer case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 58
Case No.:61/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 HQ File :01/82/050/00714/AM11/ RLA File :03/94/040/00299/AM11/ Lic.No/Date:0310581965 02.07.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of C&PC. 59
Case No.:32/26/82‐ALC4/2010
Party Name:CIPLA LIMITED 23.11.2010 HQ File :01/82/050/00850/AM11/ RLA File :03/94/040/00304/AM11/ Lic.No/Date:0310581968 02.07.2010
Decision Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 60
Case No.:78/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00731/AM11/ RLA File :03/94/040/00285/AM11/ Lic.No/Date:0310582149 06.07.2010 Defer Date:21.12.2010 Decision Commiĥee decided to defer the case for 21.12.2010 for comments of Department of C&PC. 61
Case No.:80/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.11.2010 HQ File :01/82/050/00733/AM11/ RLA File :03/94/040/00310/AM11/ Lic.No/Date:0310582158 06.07.2010 Defer Date:23.11.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of C&PC. 62
Case No.:38/26/82‐ALC4/2010
Party Name:ONEIRO CHEMICALS LTD 23.11.2010 Status:Case Approved HQ File :01/82/050/00856/AM11/ RLA File :34/24/040/00068/AM11/ Lic.No/Date:3410027426 06.07.2010 Decision Commiĥee considered case as per agenda and in light of earlier decision taken in 14/82 meeĕng held on 06.07.2010 and 33/11 meeĕng held on 16.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis (NC decision dated 17.11.2009):‐ Export product Export Qty. Sl.No. Import items Qty. allowed 2‐Chloromethyl‐3,5‐ Dimethyl‐4‐Methoxy Pyridine Hydrochloride 1 Kg. 1. 3,5 Luĕdine 1.77 kg 2. Toluene 5.20 kg 3. Methanol 4.14 kg 4. Acetone 2.07 kg 5. Acĕvated Carbon 0.100 kg 6. Ammonium Persulphates 6.00 kg 63
Case No.:28/26/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 23.11.2010 HQ File :01/82/050/00846/AM11/ RLA File :09/24/040/00397/AM10/ Lic.No/Date:0910042652 08.07.2010 Defer Date:18.01.2011
Decision : Commiĥee decided to defer the case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 64
Case No.:82/22/82‐ALC4/2010
Party Name:LUPIN LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00735/AM11/ RLA File :03/95/040/00246/AM11/ Lic.No/Date:0310583088 12.07.2010 Defer Date:18.01.2011 65
Case No.:31/26/82‐ALC4/2010
Party Name:LAFFANS PETROCHEMICALS LTD., 23.11.2010 HQ File :01/82/050/00849/AM11/ RLA File :03/95/040/00085/AM11/ Lic.No/Date:0310583874 16.07.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of P.C. Division of Department of C&PC. 66
Case No.:32/18/82‐ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 23.11.2010 Status:Case Deferred HQ File :01/82/050/00575/AM11/ RLA File :05/24/040/00465/AM10/ Lic.No/Date:0510268627 21.07.2010 Defer Date:18.01.2011 Decision Commiĥee decided to defer the case for 18.01.2011 for comments of Department of Pharmaceuĕcals. 67
Case No.:34/18/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 23.11.2010 HQ File :01/82/050/00577/AM11/ RLA File :05/24/040/00147/AM11/ Lic.No/Date:0510268636 21.07.2010 Decision :Commiĥee considered case as per agenda and decided to call the firm for personal hearing in its meeĕng to be held on 21.12.2010. Accordingly, case was deferred for 21.12.2010. 68
Case No.:35/18/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00578/AM11/ RLA File :05/24/040/00151/AM11/ Lic.No/Date:0510268639 21.07.2010 Defer Date:21.12.2010 Decision: Commiĥee considered case as per agenda and decided to call the firm for personal hearing in its meeĕng to be held on 21.12.2010. Accordingly, case was deferred for 21.12.2010. 69
Case No.:36/18/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 23.11.2010 Status:Case Deferred
HQ File :01/82/050/00579/AM11/ RLA File :05/24/040/00152/AM11/ Lic.No/Date:0510268642 21.07.2010 Defer Date:21.12.2010 Decision: Commiĥee considered case as per agenda and decided to call the firm for personal hearing in its meeĕng to be held on 21.12.2010. Accordingly, case was deferred for 21.12.2010. 70
Case No.:39/18/82‐ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00582/AM11/ RLA File :03/95/040/00277/AM11/ Lic.No/Date:0310584525 22.07.2010 Defer Date:21.12.2010 Decision: Commiĥee decided to defer the case for 21.12.2010 for comments of P.C. Division of Department of C&PC. It was also decided to remind TA for comments. 71
Case No.:40/18/82‐ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 23.11.2010 HQ File :01/82/050/00583/AM11/ RLA File :03/95/040/00278/AM11/ Lic.No/Date:0310584527 22.07.2010 Defer Date:23.11.2010 Decision: Commiĥee decided to defer the case for 21.12.2010.10 for comments of D/o C&PC, Petro Chemicals Division. It was also decided to remind TA for comments. 72
Case No.:19/26/82‐ALC4/2010
Party Name:PRASOL CHEMICALS LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00837/AM11/ RLA File :03/95/040/00156/AM11/ Lic.No/Date:0310584802 23.07.2010 Defer Date:18.01.2011 Decision: Commiĥee decided to defer the case for 18.01.2011 for comments of Department of C&PC. 73
Case No.:40/26/82‐ALC4/2010
Party Name:TIDE INDUSTRIES 23.11.2010 Status:Case Approved HQ File :01/82/050/00858/AM11/ RLA File :34/24/040/00079/AM11/ Lic.No/Date:3410027586 28.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/85/2010‐Ch.II dated 03.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Aldehyde C‐12 Lauric 1 Kg. 1. C‐12 Faĥy Alcohol (Lauryl Alcohol) 1.123 kg 74
Case No.:18/26/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL Status:Case
LIMITED 23.11.2010 Deferred HQ File :01/82/050/00836/AM11/ RLA File :03/95/040/00269/AM11/ Lic.No/Date:0310585537 30.07.2010 Defer Date:18.01.2011 Decision: Commiĥee decided to defer the case for 18.01.2011 for comments of Department of C&PC. 75
Case No.:29/26/82‐ALC4/2010
Party Name:SARACA LABORATORIES LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/00847/AM11/ RLA File :09/24/040/00163/AM11/ Lic.No/Date:0910042998 06.08.2010 Defer Date:21.12.2010 Decision: Commiĥee decided to defer the case for 21.12.10 for comments of Department of Pharmaceuĕcals. 76
Case No.:39/26/82‐ALC4/2010
Party Name:TIDE INDUSTRIES 23.11.2010 Status:Case Approved HQ File :01/82/050/00857/AM11/ RLA File :34/24/040/00080/AM11/ Lic.No/Date:3410027663 09.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/5/2005‐Ch.II dated 10.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Lauryl Nitrile 1 Kg. 1. Lauric Acid 1.228 kg 77
Case No.:22/26/82‐ALC4/2010
Party Name:RATNAGIRI CHEMICALS PVT. LTD. 23.11.2010 Status:Case Approved HQ File :01/82/050/00840/AM11/ RLA File :03/95/040/00337/AM11/ Lic.No/Date:0310586676 10.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/97/2006/Ch.II dated 20.11.09 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Guaiacol 2 Methoxy Phenol (purity min: 99%) 1 Kg. 1. Catechol 1.00 kg
78
Case No.:34/26/82‐ALC4/2010
Party Name:DALAS BIOTECH LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00852/AM11/ RLA File :05/23/040/00122/AM11/ Lic.No/Date:0510270364 11.08.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 79
Case No.:46/22/82‐ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 23.11.2010 Status:Case Approved HQ File :01/82/050/00699/AM11/ RLA File :52/24/040/00005/AM11/ Lic.No/Date:5210031651 18.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/45/2010‐Ch.II dated 27.09.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Sulpho Gamma Acid (7‐Amino‐1‐Naphthol‐3,6‐ Disulfonic Acid) 1 Kg. 1. K Acid 2.500 kg 80
Case No.:43/26/82‐ALC4/2010
Party Name:ONEIRO CHEMICALS LTD 23.11.2010 Status:Case Approved HQ File :01/82/050/00861/AM11/ RLA File :34/24/040/00118/AM11/ Lic.No/Date:3410027750 19.08.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 14/82 meeĕng held on 06.07.2010 and 33/11 meeĕng held on 16.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis (NC decision dated 17.11.2009):‐ Export product Export Qty. Sl.No. Import items Qty. allowed 2‐Chloromethyl‐3,5‐ Dimethyl‐4‐Methoxy Pyridine Hydrochloride 1 Kg. 1. 3,5 Luĕdine 1.77 kg 2. Toluene 5.20 kg 3. Methanol 4.14 kg 4. Acetone 2.07 kg 5. Acĕvated Carbon 0.100 kg 6. Ammonium Persulphates 6.00 kg
81
Case No.:23/26/82‐ALC4/2010
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 23.11.2010 Status:Case Deferred HQ File :01/82/050/00841/AM11/ RLA File :03/95/040/00350/AM11/ Lic.No/Date:0310588666 20.08.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 82
Case No.:35/26/82‐ALC4/2010
Party Name:DHANUKA LABORATORIES LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00853/AM11/ RLA File :05/23/040/00085/AM11/ Lic.No/Date:0510271131 20.08.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 83
Case No.:36/26/82‐ALC4/2010
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 23.11.2010 Status:Case Approved HQ File :01/82/050/00854/AM11/ RLA File :04/24/040/00325/AM10/ Lic.No/Date:0410116556 23.08.2010 Decision : Commiĥee considered case as per agenda and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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‐Methyl Mercapto Phenothiazine 1 Kg. 1. 3‐Methyl Mercapto Aniline 2.36 kg 84
Case No.:26/26/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00844/AM11/ RLA File :22/24/040/00035/AM11/ Lic.No/Date:2210010327 24.08.2010 Defer Date:21.12.2010. Decision :Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 85
Case No.:44/26/82‐ALC4/2010
Party Name:SODIUM METAL (P) LTD 23.11.2010 Status:Case Approved HQ File :01/82/050/00862/AM11/ RLA File :34/24/040/00028/AM11/ Lic.No/Date:3410027804 27.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/112/2005/Ch.II dated 16.01.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by
Export product Exp. Qty. Sl.No. Import items Qty. allowed Verdyl Propionate 1 kg 1. Dicylopentadiene 0.712 kg 2. Propionic Acid 0.400 kg 86
Case No.:1/26/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 23.11.2010 Status:Case Approved HQ File :01/82/050/00819/AM11/ RLA File :09/24/040/00227/AM11/ Lic.No/Date:0910043502 14.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/88/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Nevirapine Anhydrous/Nevirapine 1 Kg. 1. 2‐Chloro Nicoĕnic Acid 0.902 kg 2. Acetone 1.513 kg 3. Carbon Enoanĕcromos (Acĕvated Carbon) 0.100 kg 4. Cyclohexane 1.109 kg 5. Cyclo Propylamine 0.57 kg 6. Diethylene Glycol Dimethyl Ether (Diglyme) 2.16 kg 7. Malano Nitrile 0.84 kg 8. Methanol 8.43 kg 9. Methylene Chloride 1.30 kg 10. Phosphorous Oxychloride 2.884 kg 11. Phosphorous Pentachloride 0.392 kg 12. Pyridine 0.47 kg 13. Steam/Thermal As per packing policy 87
Case No.:2/26/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00820/AM11/ RLA File :09/24/040/00226/AM11/ Lic.No/Date:0910043503 14.09.2010 Defer Date:21.12.2010 Decision :Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals.
88
Case No.:3/26/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/00821/AM11/ RLA File :05/24/040/00222/AM11/ Lic.No/Date:0510272765 14.09.2010 Defer Date:21.12.2010 Decision :Commiĥee decided to call for the firm for personal hearing on 21.12.2010. Accordingly, case was deferred for 21.12.2010. 89
Case No.:4/26/82‐ALC4/2010
Party Name:RATNAGIRI CHEMICALS PVT. LTD. 23.11.2010 Status:Case Approved HQ File :01/82/050/00822/AM11/ RLA File :03/95/040/00467/AM11/ Lic.No/Date:0310592325 14.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/97/2006/Ch.II dated 20.11.09 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Guaiacol 2 Methoxy Phenol (purity min: 99%) 1 Kg. 1. Catechol 1.00 kg 90
Case No.:37/26/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00855/AM11/ RLA File :09/24/040/00252/AM11/ Lic.No/Date:0910043534 16.09.2010 Defer Date:18.01.2011 91
Case No.:45/26/82‐ALC4/2010
Party Name:MEDREICH LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00863/AM11/ RLA File :07/24/040/00222/AM11/ Lic.No/Date:0710074194 16.09.2010 Defer Date:18.01.2011 92
Case No.:48/26/82‐ALC4/2010
Party Name:GODAVARI BIOREFINERIES LTD. 23.11.2010 Status:Case Approved HQ File :01/82/050/00866/AM11/ RLA File :03/94/040/00486/AM11/ Lic.No/Date:0310592897 17.09.2010
Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/52/2010‐Ch.II dated 20.09.10 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Crotonaldehyde Min. 99% 1 KG. 1. Denatured Ethyl Alcohol 1.70 kg 93
Case No.:49/26/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/00867/AM11/ RLA File :09/24/040/00245/AM11/ Lic.No/Date:0910043540 17.09.2010 Defer Date:21.12.2010 Decision :Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 94
Case No.:5/30/82‐ALC4/2010
Party Name:VIC INDUSTRIES, 23.11.2010 Status:Case Deferred HQ File :01/82/050/00924/AM11/ RLA File :17/24/040/00064/AM09/ Lic.No/Date:1710003530 07.10.2010 Defer Date:18.01.2011 Decision : Commiĥee decided to defer the case for 18.01.2011 for comments of Department of C&PC. 95
Case No.:3/30/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 23.11.2010 Status:Case Deferred HQ File :01/82/050/00922/AM11/ RLA File :05/24/040/00233/AM11/ Lic.No/Date:0510274511 08.10.2010 Defer Date:21.12.2010 Decision : Commiĥee decided to defer the case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 96
Case No.:2/34/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/01008/AM11/ RLA File :34/24/040/00207/AM11/ Lic.No/Date:3410028544 09.11.2010 Defer Date:18.01.2011 97
Case No.:3/34/82‐ALC4/2010
Party Name:GALPHA LABORATORIES LIMITED, 23.11.2010 Status:Case Deferred HQ File :01/82/050/01009/AM11/ RLA File :03/94/040/00638/AM11/ Lic.No/Date:0310600646 Defer
09.11.2010 Date:21.12.2010 Decision : Commiĥee decided to defer case for 21.12.2010 for comments of Department of Pharmaceuĕcals. 98
Case No.:1/34/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 23.11.2010 Status:Case Deferred HQ File :01/82/050/01007/AM11/ RLA File :09/24/040/00335/AM11/ Lic.No/Date:0910044198 10.11.2010 Defer Date:18.01.2011 99
Case No.:4/34/82‐ALC4/2010
Party Name:AMINES & PLASTICIZERS LIMITED 23.11.2010 Status:Case Approved HQ File :01/82/050/01010/AM11/ RLA File :03/94/040/00669/AM11/ Lic.No/Date:0310600869 10.11.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/23/2007‐Ch.II dated 05.03.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed N Methyl Morpholine Oxide 50% 1 Kg. 1. Morpholine 0.391 kg 100
Case No.:5/34/82‐ALC4/2010
Party Name:AKTINOS PHARMA PVT LTD, 23.11.2010 Status:Case Approved HQ File :01/82/050/01011/AM11/ RLA File :09/70/040/00123/AM11/ Lic.No/Date:0910044214 10.11.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 18/11 meeĕng held on 03.08.2008 and in consultaĕon with technical authority present in meeĕng, decided to revise 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 CBZ‐L‐Valine (N‐Benzyloxy Valine) 1 Kg. 1. L‐Valine 0.63 kg 2. Benzyl Chloroformate 0.92 kg 101
Case No.:6/34/82‐ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 23.11.2010 Status:Case Approved
HQ File :01/82/050/01012/AM11/ RLA File :09/24/040/00328/AM11/ Lic.No/Date:0910044225 10.11.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments earlier forwarded by Department of Pharmaceuĕcals vide their U.O.. No.35011/98/2007‐PI‐III dated 31.03.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Mebeverine Hcl 1 Kg. 1. Methyl‐2‐Chloromethyl Propionate 0.66 kg 2. Veraĕc Acid 0.56 kg 3. Methanol 0.45 kg 4. Toluene 0.57 kg 5. 1,4‐Dibromobutane 0.84 kg 102
Case No.:7/34/82‐ALC4/2010
Party Name:SUPREET CHEMICALS PVT.LTD. 23.11.2010 Status:Case Deferred HQ File :01/82/050/01013/AM11/ RLA File :03/95/040/00643/AM11/ Lic.No/Date:0310600876 11.11.2010 Defer Date:18.01.2011 Decision : Commiĥee decided to defer the case for 18.01.2011 for comments of Department of C&PC. 103
Case No.:8/34/82‐ALC4/2010
Party Name:RASULA PHARMACEUTICALS & FINE CHEMICALS 23.11.2010 Status:Case Deferred HQ File :01/82/050/01014/AM11/ RLA File :09/24/040/00293/AM11/ Lic.No/Date:0910044229 11.11.2010 Defer Date:18.01.2011 104
Case No.:9/34/82‐ALC4/2010
Party Name:ALKALOIDS CORPORATION 23.11.2010 Status:Case Deferred HQ File :01/82/050/01015/AM11/ RLA File :02/24/040/00140/AM11/ Lic.No/Date:0210150395 11.11.2010 Defer Date:18.01.2011 105
Case No.:10/34/82‐ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 23.11.2010 Status:Case Approved HQ File :01/82/050/01016/AM11/ RLA File :03/95/040/00600/AM11/ Lic.No/Date:0310601007 11.11.2010
Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/10/2010‐Ch.II dated 23.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Stero MDEA (PIP) (Blends of 37% of Piperazine & 48% of Methyl Di Ethanol Amine) 1 Kg. 1. Monomethyl Ethanolamine 0.309 kg 2. Ethylene Oxide 0.181 kg 3. Pipierazine Chips (Pure) 0.370 kg Outside Agenda ‐ 1 M/s Avenĕs Pharma Ltd. F.No.01/82/050/00381/AM10/DES‐III RLA F. No. 03/94/040/00134/AM10 Adv. Lic. No.0310530972 dated 28.07.2009 Commiĥee considered case and in consultaĕon with technical authority present in meeĕng, decided to amend the UOM of export item No.1 to read as “packs of 60s” UOM for export item No.2 to read as “packs of 20s” without any other change in the decision taken in 11/82 meeĕng held on 15.06.2010. Outside Agenda ‐ 2 M/s Shree Ganesh Remedies Pvt. Ltd. F.No.01/82/050/01075/AM10/DES‐III RLA F. No. 34/24/040/00193/AM10 Adv. Lic. No.3410026297 dated 05.02.2010 Commiĥee considered case and in consultaĕon with technical authority present in meeĕng, decided to amend the descripĕon of export product to read as “Di Methyl Amino Propyl Chloride Hydrochloride 65% Soluĕon in water” without any other change in the decision taken in 48/82 meeĕng held on 23.02.2010. Outside Agenda ‐ 3 M/s Enaltek Labs Ltd. F.No.01/82/162/00166/AM10/DES‐III RLA F. No03/94/040/01133/AM09 Adv. Lic. No.0310514629 dated 03.04.2009 Commiĥee considered case and in light of wriĥen comments forwarded by Department of Pharmaceuĕcal vide their O.M. No.35011/238/2009 PI(Norms) dated 28.01.2010 and in consultaĕon with technical authority present
in meeĕng, decided to amend the descripĕon of import items at Sl.No.1,2 and 5 as per details below without any other change in the decision taken in 46/10 meeĕng held on 09.02.2010. Sl.No. of import items Descripĕon 1. Para Fluoro Benzaldehyde 2. Debal‐H 5. Diethyl Methoxy Borane (DEMB) Outside Agenda ‐ 4 M/s Enaltek Labs Ltd. F.No.01/82/050/01001/AM10/DES‐III RLA F. No03/94/040/00789/AM10 Adv. Lic. No.0310551405 dated 17.12.2009 Commiĥee considered case and in light of wriĥen comments forwarded by Department of Pharmaceuĕcal vide their O.M. No.35011/238/2009 PI(Norms) dated 28.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to amend the descripĕon of import items at Sl.No.1 to read as (S)‐4‐Chloro‐3‐Hydroxy Butyronitrile without any other change in the decision taken in 46/82 meeĕng held on 09.02.2010. Outside Agenda ‐ 5 M/s Enaltek Labs Ltd. F.No.01/82/050/00948/AM10/DES‐III RLA F. No03/94/040/00491/AM10 Adv. Lic. No.0310537347 dated 11.09.2009 Commiĥee considered case and in light of wriĥen comments forwarded by Department of Pharmaceuĕcal vide their O.M. No.35011/238/2009 PI(Norms) dated 28.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to amend the descripĕon of import items at Sl.No.1 to read as “2[3(S)‐[3‐[2‐(7‐Chloroquinoline‐ 2‐YL) Ethenyl]Phenyl]‐3‐Hydroxypropyl] Benzene‐2‐Propanol” and import item No.2 to read as “2‐(1‐ Meracaptomethyl) Cyclopropyl) Aceĕc acid” without any other change in the decision taken in 46/82 meeĕng held on 09.02.2010. Outside Agenda ‐ 6 M/s Alembic Ltd.
F.No.01/82/050/01290/AM10/DES‐III RLA F. No.34/24/040/00164/AM10 Adv. Lic. No.3410025977 dated 23.12.2009 Commiĥee considered case and in consultaĕon with technical authority present in meeĕng, decided to amend the descripĕon and UOM of export product to read as “Azithromycin Step‐3 – 1 KGA” and amendment in the descripĕon of import item No.2 and 7 to read as “Hydroxylamine Hydrochloride” and “Plaĕnum Catalyst with Base of Acĕvated Carbon” repecĕvely without any other change in the decision taken in 2/82 meeĕng held on 13.04.2010. Outside Agenda ‐ 7 M/s Rossari Biotech Ltd., Mumbai N C Meeĕng No. 34/11 F.No.01/82/50/01139/AM09/DES‐III F.No.01/82/50/01139/AM09/DES‐III Adv. Lic. No.0310489633 dated 08.10.2008 Commiĥee considered case and observed that there was a typographical error in recording the advance licence No. and date in 26/11 meeĕng held on 28.09.2010 and decided to amend the advance licence No. and date to read as “0310489633 dated 08.10.2008” without any other change in the above said decision of NC.
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