DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision
MEETING NUMBER : 36/82‐ALC4/2010 MEETING DATE : 07.12.2010 The Meeĕng No.36/82 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 07.12.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri Jasbir Singh, IA, Department of C&PC 3. Shri A.K. Sinha, Assĥ. Director, Pharmexcil 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commiĥee Meeĕng No. 34/82 dated 23.11.2010 and 35/82 dated 30.11.2010 were raĕfied by the Commiĥee.
Case No. B‐298
M/s Prachi Pharmaceuĕcals Pvt. Ltd. Norms Commiĥee Meeĕng No. 36/11 F.No.01/83/050/01323/AM09/DES‐III F.No.01/82/162/01008/AM10/DES‐III Meeĕng Date 07.12.2010 RLA F. No. 03/95/040/00723/AM09 RLA F. No. 03/95/040/00404/AM07 Adv. Lic. No.0310508539 dated 20.02.2009 Adv. Lic. No.0310390437 dated 28.07.2006 Commiĥee considered case as per agenda. The representaĕve of the firm appeared for personal hearing before the Commiĥee and explained the case. He explained that the norms fixed by NC are for the export product Povidone Iodine 20% Soluĕon while their export product is Povidone Iodine 20% Powder. A├er detailed deliberaĕons and in consultaĕon with technical authoriĕes present in meeĕng, Commiĥee decided to forward a copy of representaĕon of the firm to Department of Pharmaceuĕcals for their comments. Accordingly, case was deferred for 01.02.2011.
Case No. B‐299
M/s Cipla Ltd. F.No.01/82/050/00110/AM09/DES‐III RLA F. No. 03/94/040/01099/AM08 Adv. Lic. No.0310459961 dated 04.02.2008 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/255/2008/PI‐III dated 17.03.2009, decided to allow import of 2nd item
namely Butyl Acetate to the extent of 2.09 kg/kg of Stavudine without any other change in the decision taken in 18/82 meeĕng held on 29.07.2008. RA concerned may take further necessary acĕon as per above decision of NC.
Case No. B‐300
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/00398/AM09/DES‐III RLA F. No. 07/24/040/00884/AM08 Adv. Lic. No.0710056844 dated 09.04.2008 Commiĥee considered case as per agenda and in light of earlier decision taken in 20/11 meeĕng held on 17.08.2010 and Producĕon and Consumpĕon data cerĕfied by Central Excise Authority 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 Calcium Gluconate‐ Injectable Grade USP 1 kg 1. Calcium Gluconate (Oral Grade) 1.09 kg Calcium Lactate Gluconate 1 Kg. 1. Calcium Gluconate (Oral Grade) 0.57 kg Calcium Boro Gluconate 1 kg. 1. Calcium Gluconate (Oral Grade) 0.946 kg Calcium Glubionate 1 kg. 1. Calcium Gluconate (Oral Grade) 0.430 kg RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 15/82 meeĕng held on 08.07.2008 may be treated as withdrawn.
Case No. B‐301
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/00397/AM09/DES‐III RLA F. No. 07/24/040/00883/AM08 Adv. Lic. No.0710056843 dated 09.04.2008 Commiĥee considered case as per agenda and in light of Producĕon and Consumpĕon data cerĕfied by Central Excise Authority 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 Sodium Ascorbate 1 Kg. 1. Ascorbic Acid 0.987 kg Zinc Ascorbate 1 Kg. 1. Ascorbic Acid 0.942 kg Calcium Ascorbate 1 Kg. 1. Ascorbic Acid (any grade) 1.229 kg Magnesium Ascorbate 1 Kg. 1. Ascorbic Acid 1.045 kg Potassium Ascorbate 1 Kg. 1. Ascorbic Acid 0.913 kg
RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 54/82 meeĕng held on 31.03.2009 may be treated as withdrawn.
Case No. B‐302
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/00547/AM09/DES‐III RLA F. No. 07/24/040/00108/AM09 Adv. Lic. No.0710057896 dated 13.06.2008 Commiĥee considered case as per agenda and in light of Producĕon and Consumpĕon data cerĕfied by Central Excise Authority and in consultaĕon with technical authority present in meeĕng, decided to enhance the quanĕty of Zinc Gluconate Granular to the extent of 1.03 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‐303
M/s Atul Ltd. F.No.01/82/162/00730/AM11/DES‐III RLA F. No. 08/24/040/00141/AM06 Adv. Lic. No.0810052247 dated 23.11.2005 Commiĥee considered case as per agenda and in light of earlier decision taken in 06/09 meeĕng held on 07.05.2008 and in consultaĕon with technical authoriĕes 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 Reacĕve Diluent Lapox 1 Kg. 1. Epichlorohydrin 0.920 kg 2. Phenol 0.941 kg
Case No. B‐304
Jt. DGFT, CLA, New Delhi F.No.01/82/162/00583/AM11/DES‐III Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals and DCGI.
Case No. B‐305
M/s Grand Organics Pvt. Ltd. F.No.01/82/050/00867/AM07/DES‐III RLA F. No. 17/24/040/00010/AM07
Adv. Lic. No.1710000821 dated 30.07.2004 Commiĥee considered case as per agenda and in light of wriĥen comments of Department of C&PC dated 07.12.2010 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 Grand TCW (Stearic Diethanolamine) 1 Kg. 1. Stearic Acid 0.800 kg 2. Ethylene Oxide Not allowed 3. Di‐Ethanolamine 0.16 kg 4. Sagtex JSA (Foam Control Agent) 0.01 kg
Case No. B‐306
M/s Alembic Ltd. F.No.01/82/050/00410/AM08/DES‐III RLA F. No. 34/24/040/00070/AM08 Adv. Lic. No.3410019349 dated 02.08.2007 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/115/2010‐PI‐(Norms) dated 11.10.2010 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 Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A‐2263 on pro‐rata basis.
Case No. B‐307
M/s Grand Organics Pvt. Ltd. F.No.01/82/050/01044/AM07/DES‐III
RLA F. No. 17/24/040/00046/AM07 Adv. Lic. No.1710001431 dated 26.09.2006 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/114/2007/Ch.II dated 27.07.2010 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 Grand AP05 Colourless Clear Liquid containing 50% of 2 Ethyl Hexyl Phosphate and 10% of Propylene Glycol 1 Kg. 1. 2 Ethyl Hexanol 0.372 kg 2. Phosphorous Pentoxide 0.137 kg 3. Propylene Glycol 0.100 kg
Case No. B‐308
M/s MSN Pharma Pvt. Ltd. F.No.01/82/050/00191/AM11/DES‐III RLA F. No. 09/24/040/00039/AM11 Adv. Lic. No.0910041949 dated 06.05.2009 Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals.
Case No. B‐309
M/s MSN Pharma Pvt. Ltd. F.No.01/82/050/00708/AM10/DES‐III RLA F. No. 09/24/040/00124/AM10 Adv. Lic. No.0910038853 dated 07.08.2009 Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals.
Case No. B‐310
M/s Gopinath Chem‐tech Ltd. F.No.01/82/050/01215/AM10/DES‐III RLA F. No. 08/24/040/00313/AM10 Adv. Lic. No.0810087248 dated 11.03.2010 Commiĥee decided to defer case for 04.01.2011 for comments of Department of C&PC.
1
Case No.:7/8/82‐ALC4/2009
Party Name:SHILPA MEDICARE LTD., Meet No/Date:36/82‐ALC4/2010 07.12.2010 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:01.02.2011 Decision :Commiĥee considered case as per agenda and observed that the technical details called from the firm have been received and the reply received from the firm alongwith a copy of applicaĕon has been forwarded to Department of Pharmaceuĕcals for their comments. Accordingly, the case was deferred for 01.02.2011. 2
Case No.:9/13/82‐ALC4/2009
Party Name:ENCUBE ETHICALS PVT LTD 07.12.2010 Status:Case Approved HQ File :01/82/050/00149/AM10/ RLA File :03/94/040/00063/AM10/ Lic.No/Date:0310522513 03.06.2009 Decision : Commiĥee considered case as per agenda and in light of Producĕon and Consumpĕon data cerĕfied by Central Excise Authority and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Quanĕty allowed Secura Protecĕve Ointment (Product Code 59431500, 59431579 and 59431600) 100 Kg 1. Petrolatum White Fonoline (WF) 98.789 kg 2. Clove Oil (Clove Bud Oil) 0.300 kg 3. Vitamin A & D3 in Corn Oil 0.01 kg 4. D & C Green Colour 6 0.001 kg The above norms have been fixed for regularizaĕon purpose only and no repeat Advance Authorisaĕon may be issued. RLA concerned may take further necessary acĕon as per above decision of NC. 3
Case No.:14/33/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 07.12.2010 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:04.01.2011 Decision :Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals. 4
Case No.:27/34/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 07.12.2010 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:01.02.2011 Decision :Commiĥee decided to remind the firm to furnish Producĕon and Consumpĕon data cerĕfied by Central Excise Authority. Accordingly, case was deferred for 01.02.2011.
5
Case No.:46/48/82‐ALC4/2009
Party Name:CIPLA LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/01109/AM10/ RLA File :03/94/040/00685/AM10/ Lic.No/Date:0310550099 09.12.2009 Defer Date:04.01.2011 Decision :Commiĥee decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 04.01.2011. 6
Case No.:87/46/82‐ALC4/2009
Party Name:CIPLA LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/01003/AM10/ RLA File :03/94/040/00820/AM10/ Lic.No/Date:0310552364 23.12.2009 Defer Date:04.01.2011 Decision : Commiĥee decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 04.01.2011. 7
Case No.:3/43/82‐ALC4/2009
Party Name:ARCH PHARMALABS LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00877/AM10/ RLA File :03/94/040/00784/AM10/ Lic.No/Date:0310554371 08.01.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals. 8
Case No.:16/49/82‐ALC4/2009
Party Name:HONEST BIO‐VET PVT. LTD 07.12.2010 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:01.02.2011 Decision :Commiĥee considered case as per agenda and observed that the firm has been requested to furnish technical informaĕon vide leĥer dated 02.12.2010. It was therefore, decided to defer case for 01.02.2011 for reply from the firm. 9
Case No.:17/50/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/01171/AM10/ RLA File :05/24/040/00486/AM10/ Lic.No/Date:0510259472 25.02.2010 Defer Date:01.02.2011 Decision :Commiĥee decided to remind the firm to furnish technical details as per Appendix 33. Accordingly, case was deferred for 01.02.2011. 10
Case No.:26/50/82‐ALC4/2009
Party Name:CENTURY PHARMACEUTICALS LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/01180/AM10/ RLA File :34/24/040/00208/AM10/ Lic.No/Date:3410026508 02.03.2010 Defer Date:01.02.2011
Decision :Commiĥee considered case as per agenda and observed that the technical informaĕon called from the firm have been received and the same alongwith the copy of applicaĕon have been sent to Department of Pharmaceuĕcals for their comments. Accordingly, case was deferred for 01.02.2011. 11
Case No.:28/50/82‐ALC4/2009
Party Name:SMILAX LABORATORIES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/01182/AM10/ RLA File :09/24/040/00446/AM10/ Lic.No/Date:0910041147 03.03.2010 Defer Date:01.02.2011 Decision : Commiĥee considered case as per agenda and observed that the technical informaĕon called from the firm have been received and the same alongwith the copy of applicaĕon have been sent to Department of Pharmaceuĕcals for their comments. Accordingly, case was deferred for 01.02.2011. 12
Case No.:52/9/82‐ALC4/2010
Party Name:GRANULES INDIA LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00267/AM11/ RLA File :09/24/040/00495/AM10/ Lic.No/Date:0910041156 03.03.2010 Defer Date:01.02.2011 Decision :Commiĥee decided to defer case for 01.02.2011 for comments of Department of Pharmaceuĕcals. 13
Case No.:1/1/82‐ALC4/2010
Party Name:PARAMOUNT AROMACHEM PVT.LTD., 07.12.2010 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:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of C&PC. 14
Case No.:47/2/82‐ALC4/2010
Party Name:MEDREICH LIMITED 07.12.2010 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:01.02.2011 Decision : Commiĥee decided to defer case for 01.02.2011 for comments of Department of Pharmaceuĕcals. 15
Case No.:22/9/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 07.12.2010 Status:Case Approved HQ File :01/82/050/00237/AM11/ RLA File :03/94/040/01136/AM10/ Lic.No/Date:0310567221 30.03.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005‐Ch.II dated 26.11.2010 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 Export Product Export Qty.
p p y Sl.No. Import items Qty. allowed Astrolide in Dipropylene Glycol Main Total Astrolide content 62.5% minimum 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 5. Paraformaldehyde 0.088 kg 4. Dipropylene Glycol 0.350 kg 16
Case No.:35/2/83‐ALC1/2010
Party Name:ADVY CHEMICAL 07.12.2010 Status:Case Deferred HQ File :01/83/050/00035/AM11/ RLA File :03/94/040/01124/AM10/ Lic.No/Date:0310568188 06.04.2010 Defer Date:01.02.2011 Decision : Commiĥee decided to defer case for 01.02.2011 for comments of Department of Bio‐technology. 17
Case No.:25/8/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/00214/AM11/ RLA File :09/24/040/00540/AM10/ Lic.No/Date:0910042034 14.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/68/2010‐Ch.II dated 07.12.2010 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 Export Product Export Qty. Sl.No. Import items Qty. allowed Dantuff‐C (Climbazole) 1 kg 1. Chloro Ether Ketone (1, Chloro,(4‐ Chlorophenoxy 3,3‐Dimethyl 2‐Butanone) 1.12 kg 2. Imidazole 0.291 kg 3. Potassium Carbonate 0.600 kg 18
Case No.:6/22/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/00659/AM11/ RLA File :09/24/040/00070/AM11/ Lic.No/Date:0910042126
25.05.2010 Decision :Withdrawn as the case has already been approved by NC in 30/82 meeĕng held on 26.10.2010. 19
Case No.:7/22/82‐ALC4/2010
Party Name:BIOLOGICAL E LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00660/AM11/ RLA File :09/24/040/00042/AM11/ Lic.No/Date:0910042127 25.05.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals. 20
Case No.:6/26/82‐ALC4/2010
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00824/AM11/ RLA File :09/24/040/00567/AM10/ Lic.No/Date:0910042108 25.05.2010 Defer Date:04.01.2011 Decision : : Commiĥee decided to defer case for 04.1.2011 for comments of Department of Pharmaceuĕcals. 21
Case No.:7/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00825/AM11/ RLA File :09/24/040/00061/AM11/ Lic.No/Date:0910042109 25.05.2010 Defer Date:01.02.2011 22
Case No.:8/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00826/AM11/ RLA File :09/24/040/00060/AM11/ Lic.No/Date:0910042112 25.05.2010 Defer Date:01.02.2011 23
Case No.:21/26/82‐ALC4/2010
Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/00839/AM11/ RLA File :09/24/040/00550/AM10/ Lic.No/Date:0910042135 25.05.2010 Defer Date:01.02.2011 Decision : Commiĥee decided to defer case for 01.02.2011 for Producĕon and Consumpĕon data cerĕfied by Central Excise Authority to be sent by the firm. 24
Case No.:30/14/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 07.12.2010 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:04.01.2011 Decision :Commiĥee decided to call from the firm Producĕon and Consumpĕon data cerĕfied by Central Excise Authority. Accordingly, case was deferred for 04.01.2011. 25
Case No.:31/14/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00393/AM11/ RLA File :07/24/040/00035/AM11/ Lic.No/Date:0710071909 31.05.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to call from the firm Producĕon and Consumpĕon data cerĕfied by Central Excise Authority. Accordingly, case was deferred for 04.01.2011. 26
Case No.:12/22/82‐ALC4/2010
Party Name:AQUAPHARM CHEMICALS PVT.LIMITED 07.12.2010 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 Export Product Export Qty. Sl.No. Import items Qty. allowed Aqueous Soluĕon of Polymaleic Acid (Acĕve content:47‐53%) Modified Polymaleic Acid 1 kg 1. Maleic Anhydride 0.316 kg Note: Acrylic Acid and Hydrogen Peroxide 50% are not recommended as their role in the process is not clear. 27
Case No.:11/26/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/00829/AM11/ RLA File :09/24/040/00080/AM11/ Lic.No/Date:0910042155 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.14010/68/2010‐Ch.II dated 07.12.2010 and in consultaĕon with technical authoriĕes 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 Vivinol (4‐N Butyl Resorcinol or 4‐ Butyl‐1,3‐Dihydroxy Benzene) 1 Kg. 1. Resorcinol 2.42 kg 2. 4 (N) Butyric Acid 2.54 kg 3. Zinc Chloride Anhydrous 1.00 kg 4. Toluene 1.00 kg 5. Hexane 1.00 kg 6. Isopropyl Alcohol 1.00 kg 28
Case No.:6/19/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00591/AM11/ RLA File :09/24/040/00064/AM11/ Lic.No/Date:0910042200 01.06.2010 Defer Date:04.01.2011 29
Case No.:12/18/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 07.12.2010 Status:Case Approved HQ File :01/82/050/00555/AM11/ RLA File :03/94/040/00228/AM11/ Lic.No/Date:0310577783 08.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/127/2010‐PI(Norms) dated 18.10.2010 and in consultaĕon with technical authoriĕes 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 Prasugrel Hcl 1 Kg. 1. Cyclopropyl‐2‐Fluorobenzyl Ketone 2.26 kg 2. 5,6,7,7A‐Tetrahydrothieno(3,2‐C) Pyridine‐2(4H)‐ One Hcl 2.88 kg 30
Case No.:31/22/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/00684/AM11/ RLA File :34/24/040/00021/AM11/ Lic.No/Date:3410027202 10.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/69/2010‐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 Cefepime for Injecĕon 1 Kg. 1. Cefepime Hcl non sterile 0.655 kg 2. L‐Arginine 0.37 kg 3. Acetone 1.816 kg 4. Methanol 1.134 kg 5. Acĕvated Carbon 0.034 kg 31
Case No.:14/18/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 07.12.2010 Status:Case Approved HQ File :01/82/050/00557/AM11/ RLA File :03/94/040/00180/AM11/ Lic.No/Date:0310578576 11.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005‐Ch.II dated 26.11.2010 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 Export Product Export Qty. Sl.No. Import items Qty. allowed Astrolide in Dipropylene Glycol Main Total Astrolide content 62.5% minimum 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 5. Paraformaldehyde 0.088 kg 4. Dipropylene Glycol 0.350 kg 32
Case No.:19/15/82‐ALC4/2010
Party Name:S.M. CHEMICALS 07.12.2010 Status:Case Approved HQ File :01/82/050/00456/AM11/ RLA File :03/95/040/00179/AM11/ Lic.No/Date:0310578621 14.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/64/2010‐Ch.II dated 29.11.2010 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed
Tris (Tridecyl Phosphite) 1 Kg. 1. Phenol 0.0558 kg 2. Tridecyl Alcohol 0.975 kg 3. Phosphorus Trichloride 0.229 kg 33
Case No.:34/15/82‐ALC4/2010
Party Name:S.M. CHEMICALS 07.12.2010 Status:Case Approved HQ File :01/82/050/00471/AM11/ RLA File :03/95/040/00181/AM11/ Lic.No/Date:0310578751 14.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/64/2010‐Ch.II dated 29.11.2010 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 2 Ethyl Hexyl Diphenyl Phosphite 1 Kg. 1. Phenol 0.604 kg 2. Phosphorus Trichloride 0.424 kg 3. Ethyl Hexanol 0.386 kg 34
Case No.:10/18/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00553/AM11/ RLA File :13/24/040/00007/AM11/ Lic.No/Date:1310032417 14.06.2010 Defer Date:01.02.2011 35
Case No.:11/18/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 07.12.2010 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:01.02.2011 36
Case No.:12/26/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00830/AM11/ RLA File :09/24/040/00093/AM11/ Lic.No/Date:0910042310 14.06.2010 Defer Date:01.02.2011
37
Case No.:13/26/82‐ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00831/AM11/ RLA File :09/24/040/00097/AM11/ Lic.No/Date:0910042361 16.06.2010 Defer Date:01.02.2011 38
Case No.:24/18/82‐ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED Meet No/Date:36/82‐ALC4/2010 07.12.2010 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:01.02.2011 39
Case No.:77/22/82‐ALC4/2010
Party Name:AVIGNON EXIM PVT.LTD., 07.12.2010 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 :Withdrawn as the case has already been approved by NC in 34/82 meeĕng held on 23.11.2010. 40
Case No.:14/26/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00832/AM11/ RLA File :09/24/040/00088/AM11/ Lic.No/Date:0910042382 17.06.2010 Defer Date:01.02.2011 41
Case No.:35/22/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 07.12.2010 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 : Withdrawn as the case has already been approved by NC in 34/82 meeĕng held on 23.11.2010. 42
Case No.:59/22/82‐ALC4/2010
Party Name:EUROMED HEALTH PRIVATE LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00712/AM11/ RLA File :35/24/040/00018/AM11/ Lic.No/Date:3510030697 21.06.2010 Defer
Date:01.02.2011 Decision :Commiĥee considered case as per agenda and in light of wriĥen comments of DIPP dated 07.12.2010, decided to call for the following informaĕon from the firm:‐ 1. Details of indigenous input along with their quanĕty. 2. Net quanĕty of inport item in export in weight basis. 3. Manufacturing Process in detail. 4. Technical specificaĕon of import item. Accordingly, case was deferred for 01.02.2011. 43
Case No.:23/18/82‐ALC4/2010
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 07.12.2010 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 Phosphonium Bromide 1 Kg. 1. Triphenyl Phosphine 0.886 kg 44
Case No.:26/31/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00951/AM11/ RLA File :09/24/040/00081/AM11/ Lic.No/Date:0910042501 25.06.2010 Defer Date:01.02.2011 45
Case No.:28/31/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00953/AM11/ RLA File :09/24/040/00083/AM11/ Lic.No/Date:0910042514 25.06.2010 Defer Date:01.02.2011 46
Case No.:56/22/82‐ALC4/2010
Party Name:AARTI INDUSTRIES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00709/AM11/ RLA File :03/94/040/00282/AM11/ Lic.No/Date:0310581151 Defer
29.06.2010 Date:01.02.2011 47
Case No.:64/22/82‐ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 07.12.2010 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:01.02.2011 48
Case No.:24/15/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00461/AM11/ RLA File :09/24/040/00115/AM11/ Lic.No/Date:0910042551 30.06.2010 Defer Date:01.02.2011 49
Case No.:61/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 07.12.2010 Status:Case Deferred HQ File :01/82/050/00714/AM11/ RLA File :03/94/040/00299/AM11/ Lic.No/Date:0310581965 02.07.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of C&PC. 50
Case No.:32/26/82‐ALC4/2010
Party Name:CIPLA LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00850/AM11/ RLA File :03/94/040/00304/AM11/ Lic.No/Date:0310581968 02.07.2010 Defer Date:01.02.2011 51
Case No.:78/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 07.12.2010 Status:Case Approved HQ File :01/82/050/00731/AM11/ RLA File :03/94/040/00285/AM11/ Lic.No/Date:0310582149 06.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005‐Ch.II dated 26.11.2010 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 Export Product Export Qty. Sl.No. Import items Qty. allowed
Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate/Dipropylene Glycol Main Total Astrolide content 62.5% minimum 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Isopropyl Myristrate 0.350 kg 52
Case No.:80/22/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 07.12.2010 Status:Case Approved HQ File :01/82/050/00733/AM11/ RLA File :03/94/040/00310/AM11/ Lic.No/Date:0310582158 06.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/9/2005‐Ch.II dated 26.11.2010 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 Export Product Export Qty. Sl.No. Import items Qty. allowed Astrolide in Diethyl Phthalate/Isopropyl Myristate Main Total Astrolide content 62.5% minimum 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Diethyl Phthalate/Isopropyl Myristrate 0.350 kg 53
Case No.:38/26/82‐ALC4/2010
Party Name:ONEIRO CHEMICALS LTD 07.12.2010 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 :Withdrawn as the case has already been approved by NC in 34/82 meeĕng held on 23.11.2010. 54
Case No.:24/26/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 07.12.2010 Status:Case Approved HQ File :01/82/050/00842/AM11/ RLA File :09/24/040/00099/AM11/ Lic.No/Date:0910042651 08.07.2010 Defer Date:
Decision : Withdrawn as the case has already been approved by NC in 33/82 meeĕng held on 16.11.2010. 55
Case No.:28/26/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00846/AM11/ RLA File :09/24/040/00397/AM10/ Lic.No/Date:0910042652 08.07.2010 Defer Date:01.02.2011 56
Case No.:82/22/82‐ALC4/2010
Party Name:LUPIN LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/00735/AM11/ RLA File :03/95/040/00246/AM11/ Lic.No/Date:0310583088 12.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/152/2010‐PI‐(Norms) dated 25.11.2010 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 Leveĕracetam 1 Kg. 1. Ethyl Acetate 1.49 kg 2. Methanol 0.71 kg 3. Methylene Chloride 3.74 kg 4. Methyl 2 Bromo Butyrate 2.9117 kg 5. Potassium Carbonate 1.0925 kg 6. L(+) Tartaric Acid 0.87 kg 7. Methanol 7.2656 kg 8. Causĕc Soda Lye 0.4892 kg 9. Iso Propyl Alcohol 1.3119 kg 57
Case No.:1/18/82‐ALC4/2010
Party Name:SUPER URECOAT INDUSTRIES 07.12.2010 Status:Case Deferred HQ File :01/82/050/00544/AM11/ RLA File :08/24/040/00112/AM11/ Lic.No/Date:0810090597 19.07.2010 Defer Date:01.02.2011 Decision :Commiĥee decided to forward a copy of applicaĕon to Petrochemicals Division of Department of C&PC for their comments. Accordingly, case was deferred for 01.02.2011. 58
Case No.:33/31/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE 07.12.2010 Status:Case
LIMITED Deferred HQ File :01/82/050/00958/AM11/ RLA File :09/24/040/00144/AM11/ Lic.No/Date:0910042771 20.07.2010 Defer Date:01.02.2011 59
Case No.:32/18/82‐ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 07.12.2010 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:01.02.2011 60
Case No.:34/18/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/00577/AM11/ RLA File :05/24/040/00147/AM11/ Lic.No/Date:0510268636 21.07.2010 Defer Date:21.12.2010 Decision :Commiĥee has already decided to call the firm for personal hearing on 21.12.2010 in 34/82 meeĕng held on 23.11.2010. Accordingly, case was deferred for 21.12.2010. 61
Case No.:35/18/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 07.12.2010 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 has already decided to call the firm for personal hearing on 21.12.2010 in 34/82 meeĕng held on 23.11.2010. Accordingly, case was deferred for 21.12.2010. 62
Case No.:36/18/82‐ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 07.12.2010 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 has already decided to call the firm for personal hearing on 21.12.2010 in 34/82 meeĕng held on 23.11.2010. Accordingly, case was deferred for 21.12.2010. 63
Case No.:39/18/82‐ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 07.12.2010 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:01.02.2011 Decision :Commiĥee decided to defer case for 01.02.2010 for comments of Petrochemicals Division of Department of C&PC.
64
Case No.:40/18/82‐ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/00583/AM11/ RLA File :03/95/040/00278/AM11/ Lic.No/Date:0310584527 22.07.2010 Defer Date:01.02.2011 Decision : Commiĥee decided to defer case for 01.02.2010 for comments of Petrochemicals Division of Department of C&PC. 65
Case No.:19/26/82‐ALC4/2010
Party Name:PRASOL CHEMICALS LIMITED 07.12.2010 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:01.02.2011 Decision :Commiĥee considered case as per agenda and in light of wriĥen comments of Department of C&PC dated 04.12.2010, decided to call for the following informaĕon from the firm:‐ 1. Details of manufacturing process with chemical equaĕons, molecular formula and molecular weight of reacĕons & end product. 2. Yield obtained, supported with authenĕc technical literature. 3. C.A. Cerĕficate about producĕon and consumpĕon for the last 3 years. Accordingly, case was deferred for 01.02.2011. 66
Case No.:40/26/82‐ALC4/2010
Party Name:TIDE INDUSTRIES 07.12.2010 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 firm whichever is lower:‐ 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 67
Case No.:3/28/82‐ALC4/2010
Party Name:FORACE POLYMERS (P) LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/00885/AM11/ RLA File :05/23/040/00111/AM11/ Lic.No/Date:0510269207 28.07.2010 Defer Date:01.02.2011 Decision :Commiĥee decided to forward a copy of applicaĕon to Petrochemical Division of Department of C&PC for their comments. Accordingly, case was deferred for
01.02.2011. 68
Case No.:18/26/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00836/AM11/ RLA File :03/95/040/00269/AM11/ Lic.No/Date:0310585537 30.07.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of C&PC. 69
Case No.:8/20/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 07.12.2010 Status:Case Approved HQ File :01/82/050/00634/AM11/ RLA File :05/24/040/00167/AM11/ Lic.No/Date:0510270032 09.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/140/2010‐PI‐(Norms) dated 25.11.2010 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 Esomeprazole Magnesium Trihydrate 1 Kg. 1. (D‐Det) D‐Diethyl Tartrate 0.164 kg 2. 5‐Methoxy‐2‐Mercaptobenzimidazole (Metmercazole) 0.702 kg 3. Cumene Hydroperoxide 0.669 kg 4. Diisopropyl Ethylamine 0.098 kg 5. Magnesium Sulfate Dried 0.284 kg 6. Methanol 6.00 kg 7. Potassium Methoxide (32% Sol) 0.989 kg 8. Pyramethyl Alcohol 0.633 kg 9. Thionyl Chloride 0.585 kg 10. Titanium‐Isopropoxide 0.109 kg 11. Toluene 8.40 kg 70
Case No.:6/20/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00632/AM11/ RLA File :09/24/040/00167/AM11/ Lic.No/Date:0910043026 10.08.2010 Defer Date:01.02.2011
71
Case No.:9/21/82‐ALC4/2010
Party Name:S.M. CHEMICALS 07.12.2010 Status:Case Approved HQ File :01/82/050/00647/AM11/ RLA File :03/95/040/00321/AM10/ Lic.No/Date:0310587339 12.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/64/2010‐Ch.II dated 29.11.2010 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 2 Ethyl Hexyl Diphenyl Phosphite 1 Kg. 1. Phenol 0.604 kg 2. Phosphorus Trichloride 0.424 kg 3. Ethyl Hexanol 0.386 kg 72
Case No.:44/22/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00697/AM11/ RLA File :08/24/040/00158/AM11/ Lic.No/Date:0810091380 18.08.2010 Defer Date:01.02.2011 73
Case No.:2/24/82‐ALC4/2010
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 07.12.2010 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:01.02.2011 Decision :Commiĥee decided to forward a copy of applicaĕon to Petrochemical Division of Department of C&PC for their comments. Accordingly, case was deferred for 01.02.2011. 74
Case No.:2/28/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00884/AM11/ RLA File :34/24/040/00112/AM11/ Lic.No/Date:3410028120 28.09.2010 Defer Date:01.02.2011 75
Case No.:5/28/82‐ALC4/2010
Party Name:ANUS LABORATORIES LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00887/AM11/ RLA File :09/24/040/00137/AM11/ Lic.No/Date:0910043673 Defer
28.09.2010 Date:01.02.2011 76
Case No.:6/28/82‐ALC4/2010
Party Name:PORUS LABORATORIES PVT LTD. 07.12.2010 Status:Case Approved HQ File :01/82/050/00888/AM11/ RLA File :09/24/040/00274/AM11/ Lic.No/Date:0910043692 28.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/3/2010‐Ch.II dated 17.05.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Phenyl‐3,3Bis(4 hydroxy phenyl)phthalimidine (PPPBP) 1 Kg. 1. Phthalic Anhydride 0.550 kg 2. Phenol 0.850 kg 3. Zinc Chloride 0.350 kg 4. Aniline 0.420 kg 5. Methanol 1.35 kg 77
Case No.:7/28/82‐ALC4/2010
Party Name:UNIMARK REMEDIES LIMITED., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00889/AM11/ RLA File :03/95/040/00403/AM11/ Lic.No/Date:0310594441 29.09.2010 Defer Date:01.02.2011 78
Case No.:8/28/82‐ALC4/2010
Party Name:UNIMARK REMEDIES LIMITED., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00890/AM11/ RLA File :03/95/040/00466/AM11/ Lic.No/Date:0310594450 29.09.2010 Defer Date:01.02.2011 79
Case No.:9/28/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00891/AM11/ RLA File :09/24/040/00256/AM11/ Lic.No/Date:0910043740 29.09.2010 Defer Date:01.02.2011
80
Case No.:10/28/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:01.02.2011 81
Case No.:11/28/82‐ALC4/2010
Party Name:S M S PHARMACEUTICALS LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00893/AM11/ RLA File :09/24/040/00271/AM11/ Lic.No/Date:0910043759 30.09.2010 Defer Date:01.02.2011 82
Case No.:12/28/82‐ALC4/2010
Party Name:S M S PHARMACEUTICALS LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00894/AM11/ RLA File :09/24/040/00278/AM11/ Lic.No/Date:0910043760 30.09.2010 Defer Date:01.02.2011 83
Case No.:13/28/82‐ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 07.12.2010 Status:Case Approved HQ File :01/82/050/00895/AM11/ RLA File :05/24/040/00224/AM11/ Lic.No/Date:0510274077 01.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/131/2010‐PI‐(Norms) dated 25.11.2010 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 8‐Chloro‐6,11‐Dihydro‐11‐ (1‐Methyl‐4‐ Piperidinylidene)‐5H‐ Benzo(5,6)Cyclohepta(1,2‐ B)Pyridine (LH09) 1 Kg. 1. 3‐Chlorobenzyl Cyanide 1.82 kg 2. Sodium Methoxide 1.218 kg 3. Toluene 10.173 kg 4. N,N‐Dimethyl Carbamoyl Chloride 2.233 kg 5. Methanol 0.822 kg 6. Tetrahydrofuran 3.205 kg
84
Case No.:14/28/82‐ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 07.12.2010 Status:Case Deferred HQ File :01/82/050/00896/AM11/ RLA File :09/24/040/00272/AM11/ Lic.No/Date:0910043780 01.10.2010 Defer Date:01.02.2011 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/10/2010‐PI (Norms) dated 10.06.2010, decided to call for the following informaĕon/documents from the firm. 1. Molecular weight of each reactant and output product of each step. 2. Molar requirement of input alongwith technical jusĕficaĕon. 3. % yield on molar basis for each step of manufacturing process. Accordingly, case was deferred for 01.02.2011. 85
Case No.:15/28/82‐ALC4/2010
Party Name:VIC INDUSTRIES, 07.12.2010 Status:Case Approved HQ File :01/82/050/00897/AM11/ RLA File :17/24/040/00011/AM09/ Lic.No/Date:1710003517 01.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/115/2007/Ch.II dated 06.05.2008 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 Product AP‐05 Containing 50% of Phosphated Ester of 2 Ethyl Hexanol (50%) 10%of Propylene Glycol 40% in water 1 Kg. 1. 2 Ethyl Hexanol 0.365 kg 2. Phosphorous Pentoxide 0.135 kg 3. Propylene Glycol 0.100 kg 86
Case No.:17/28/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00899/AM11/ RLA File :07/24/040/00257/AM11/ Lic.No/Date:0710074553 01.10.2010 Defer Date:01.02.2011 87
Case No.:20/28/82‐ALC4/2010
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/00902/AM11/ RLA File :03/94/040/00567/AM11/ Lic.No/Date:0310594816 01.10.2010 Defer
Date:01.02.2011 88
Case No.:25/28/82‐ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 07.12.2010 Status:Case Deferred HQ File :01/82/050/00907/AM11/ RLA File :03/94/040/00593/AM11/ Lic.No/Date:0310594844 01.10.2010 Defer Date:01.02.2011 89
Case No.:26/28/82‐ALC4/2010
Party Name:NEW ALLIANCE DYE‐CHEM PVT. LTD., 07.12.2010 Status:Case Approved HQ File :01/82/050/00908/AM11/ RLA File :03/95/040/00526/AM11/ Lic.No/Date:0310594864 01.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/83/2010/Ch.II dated 29.11.2010 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 Zinc Diammonium EDTA‐ Liquid Zinc content 9%( +1) 1 kg 1. Ethylene Diamine Tetra Aceĕc Acid (EDTA) 0.422 kg 90
Case No.:27/28/82‐ALC4/2010
Party Name:NEW ALLIANCE DYE‐CHEM PVT. LTD., 07.12.2010 Status:Case Approved HQ File :01/82/050/00909/AM11/ RLA File :03/95/040/00528/AM11/ Lic.No/Date:0310594867 01.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/83/2010/Ch.II dated 29.11.2010 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 Disodium EDTA Zinc [Zn content 15% (+0.5%] 1 kg 1. Ethylene Diamine Tetra Aceĕc Acid (EDTA) 0.690 kg 91
Case No.:28/28/82‐ALC4/2010
Party Name:NEW ALLIANCE DYE‐CHEM PVT. LTD., 07.12.2010 Status:Case Approved
HQ File :01/82/050/00910/AM11/ RLA File :03/95/040/00527/AM11/ Lic.No/Date:0310594869 01.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/83/2010/Ch.II dated 29.11.2010 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 Copper Diammonium EDTA‐ Liquid Copper content 9% (+1) 1 kg 1. Ethylene Diamine Tetra Aceĕc Acid (EDTA) 0.436 kg 92
Case No.:18/28/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00900/AM11/ RLA File :07/24/040/00263/AM11/ Lic.No/Date:0710074559 04.10.2010 Defer Date:01.02.2011 93
Case No.:21/28/82‐ALC4/2010
Party Name:PRAVEEN LABORATORIES PVT LTD, 07.12.2010 Status:Case Deferred HQ File :01/82/050/00903/AM11/ RLA File :52/24/040/00021/AM11/ Lic.No/Date:5210032090 04.10.2010 Defer Date:01.02.2011 94
Case No.:24/28/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00906/AM11/ RLA File :07/24/040/00264/AM11/ Lic.No/Date:0710074577 04.10.2010 Defer Date:01.02.2011 95
Case No.:16/31/82‐ALC4/2010
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/00941/AM11/ RLA File :09/24/040/00444/AM10/ Lic.No/Date:0910043815 06.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/161/2009‐PI‐(Norms) dated 09.01.2010 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 7‐Amino 3‐Vinyl Cephalospornic Acid 1 Kg. 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporonic Acid Para Methoxybenzyl Ester 2.672 kg 2. Acetone 10.11 kg 3. Methylene Chloride 7.59 kg 4. Methanol 7.78 kg 96
Case No.:4/31/82‐ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 07.12.2010 Status:Case Approved HQ File :01/82/050/00929/AM11/ RLA File :52/24/040/00020/AM11/ Lic.No/Date:5210032206 13.10.2010 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 firm whichever is lower:‐ 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 97
Case No.:8/31/82‐ALC4/2010
Party Name:GLAND PHARMA LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00933/AM11/ RLA File :09/24/040/00290/AM11/ Lic.No/Date:0910043914 14.10.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals. 98
Case No.:13/31/82‐ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 07.12.2010 Status:Case Deferred HQ File :01/82/050/00938/AM11/ RLA File :09/24/040/00303/AM11/ Lic.No/Date:0910043939 15.10.2010 Defer Date:01.02.2011 99
Case No.:48/31/82‐ALC4/2010
Party Name:GLAND PHARMA LIMITED Status:Case
07.12.2010 Deferred HQ File :01/82/050/00973/AM11/ RLA File :09/24/040/00297/AM11/ Lic.No/Date:0910043978 20.10.2010 Defer Date:04.01.2011 Decision : Commiĥee decided to defer case for 04.01.2011 for comments of Department of Pharmaceuĕcals. 100
Case No.:57/31/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/00982/AM11/ RLA File :09/24/040/00296/AM11/ Lic.No/Date:0910044017 22.10.2010 Defer Date:01.02.2011 101
Case No.:1/36/82‐ALC4/2010
Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 07.12.2010 Status:Case Approved HQ File :01/82/050/01039/AM11/ RLA File :09/24/040/00337/AM11/ Lic.No/Date:0910044393 23.11.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/53/2010‐PI‐(Norms) dated 29.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 N‐((2‐Cyano Biphenyl‐4‐YL)‐ Methyl)‐(L)‐Valine Methyl Ester Hydrochloride 1 Kg. 1. 2‐Cyno‐4‐Methyl Biphenyl 0.84 kg 2. L‐Valine 0.51 kg 3. Catalyst (2,2‐Azo Bis Isobutyronitrile 0.0336 kg 4. Ethyl Acetate 1.653 kg 5. N‐Bromosuccinamide 0.28 kg 6. IPA 1.00 kg 7. Methanol 1.16 kg 102
Case No.:2/36/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 07.12.2010 Status:Case Approved HQ File :01/82/050/01040/AM11/ RLA File :05/24/040/00284/AM11/ Lic.No/Date:0510277691 23.11.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/75/2010‐PI‐(Norms) dated 1.10.2010 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 Cilazapril 1 kg 1. (‐) R‐hydoxy‐4‐phenylbutyric Acid Ethyl Este 1.20 kg 2. 1,2‐Dimethoxy Ethane (Monoglyme) 9.90 kg 3. 5‐ Bromo Valeric Acid 13.60 kg 4. Acetone 32.29 kg 5. Acĕvated Carbon 0.100 kg 6. BF3 Etherate 7.51 kg 7. Dicyclohexyl Carbodimide (DCC) 15.49 kg 8. Diisopropyl Ether 6.77 kg 9. DMAP(4‐Dimtyyl Aminopyridine) 0.91 kg 10. Liquid Bromine 24.20 kg 11. Methanol 12.87 kg 12. Palladium 0.005 kg 13. P‐ Nitrobenzene Sulfonyl Chloride 1.29 kg 14. Pyridine 6.54 kg 15. Tetrahydrofuran 13.94 kg 16. Triethylamine 5.22 kg RA concerned may take further necessary acĕon as per above decision of NC 103
Case No.:3/36/82‐ALC4/2010
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 07.12.2010 Status:Case Approved HQ File :01/82/050/01041/AM11/ RLA File :03/95/040/00612/AM11/ Lic.No/Date:0310602552 23.11.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/5/2009‐Ch.II dated 06.12.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Sorbitan Mono Oleate 1 Kg. 1. Sorbitol 70% Soluĕon 0.470 kg 2. Oleic Acid 0.770 kg 104
Case No.:4/36/82‐ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 07.12.2010 Status:Case Approved HQ File :01/82/050/01042/AM11/ RLA File :05/23/040/00218/AM11/ Lic.No/Date:0510277734 24.11.2010 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//2/2010/Ch.II
dated 01.11.2010 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 2,3,5 Trichloropyridine 1 Kg. 1. Denatured Ethyl Alcohol 2.39 kg 2. Methanol 1.44 kg 3. Alumino Silicate Catalyst 0.0197 kg 4. Dimethyl Formamide 0.350 kg 5. Toluene 0.126 kg 6. Thionyl Chloride 0.960 kg 7. Sodium Nitrite 0.566 kg 8. Styrene 0.001 kg 9. Causĕc Soda Lye (46%) 2.00 kg 105
Case No.:5/36/82‐ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 07.12.2010 Status:Case Deferred HQ File :01/82/050/01043/AM11/ RLA File :05/23/040/00219/AM11/ Lic.No/Date:0510277735 24.11.2010 Defer Date:04.01.2011 106
Case No.:6/36/82‐ALC4/2010
Party Name:GALPHA LABORATORIES LIMITED, 07.12.2010 Status:Case Deferred HQ File :01/82/050/01044/AM11/ RLA File :03/94/040/00747/AM11/ Lic.No/Date:0310602797 24.11.2010 Defer Date:01.02.2011 107
Case No.:7/36/82‐ALC4/2010
Party Name:ALKALOIDS CORPORATION 07.12.2010 Status:Case Deferred HQ File :01/82/050/01045/AM11/ RLA File :02/24/040/00152/AM11/ Lic.No/Date:0210151006 24.11.2010 Defer Date:01.02.2011 108
Case No.:8/36/82‐ALC4/2010
Party Name:ALKALOIDS CORPORATION 07.12.2010 Status:Case Deferred HQ File :01/82/050/01046/AM11/ RLA File :02/24/040/00149/AM11/ Lic.No/Date:0210151007 Defer
24.11.2010 Date:01.02.2011 109
Case No.:9/36/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 07.12.2010 Status:Case Deferred HQ File :01/82/050/01047/AM11/ RLA File :09/24/040/00311/AM11/ Lic.No/Date:0910044459 25.11.2010 Defer Date:01.02.2011 110
Case No.:10/36/82‐ALC4/2010
Party Name:FDC LTD 07.12.2010 Status:Case Approved HQ File :01/82/050/01048/AM11/ RLA File :03/94/040/00195/AM11/ Lic.No/Date:0310603035 25.11.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 7/11 meeĕng held on 18.05.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed Chloramphenicol Eye Drops 0.5% w/v 10 ml Vial made out of LDPE 1 No. 1. Chloramphenicol 0.05 gram 2. LDPE Granules As per packing policy
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