IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2009-06-09

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision

MEETING NUMBER : 6/82‐ALC4/2009 MEETING DATE : 12.05.2009 The Mee捀�ng No.6/82 in the year 2009‐10 to consider the cases under Duty Exemp捀�on Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 12.05.2009 was actually held on 09.06.2009 under the Chairmanship of Jt. DGFT, Shri Anil Aggarwal 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 Pharmaceu捀�cals 3. Shri P.P. Srivastava, Dy. IA, Department of C&PC 4. Shri Rajinder Pal Singh, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commi掀�ee Mee捀�ng No.3/82 dated 19.05.2009 and 4/82 dated 19.05.2009 were ra捀�fied by the Commi掀�ee.

Case No.B‐60

M/S Sterling Biotech Ltd. Norms Commi掀�ee Mee捀�ng No.6/10 F.No.01/82/050/00655/AM09 Mee捀�ng Date: 12.05.2009 RA F.No.34/24/040/00055/AM09 Adv.Lic.No.3410021673 dated 23.06.2008 Commi掀�ee considered case as per agenda and decided to call from firm Produc捀�on and Consump捀�on data cer捀�fied by Central Excise Authority. Accordingly, case was deferred for 21.07.2009.

Case No.B‐61

M/S Vasudha Pharma Chem Ltd. F.No.01/82/050/01276/AM09 RA F.No.09/24/040/00522/AM08 Adv.Lic.No.0910035953 dated 17.11.2008 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐62

M/S Ambuja Intermediates Pvt. Ltd. F.No.01/82/050/00614/AM08 RA F.No.03/94/040/01106/AM08 Adv.Lic.No.0510229796 dated 22.10.2008 Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of C&PC vide their U.O. No.14010/1/2008/Ch.II dated 23.02.2009 and in consulta捀�on with technical authority present in mee捀�ng, 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 2‐Carbethoxyamino‐5‐ Naphthol Sulfonic Acid (2‐CNS Acid) 1 Kg. 1. J Acid 1.322 kg RA concerned may take further necessary ac捀�on as per above decision of NC. The earlier decision taken in 5/82 mee捀�ng held on 29.04.2008 is withdrawn.

Case No.B‐63

M/S Jubilant Organosys Ltd. F.No.01/82/050/01195/AM09 RA F.No.05/24/040/00026/AM09 Adv.Lic.No.3410021673 dated 23.06.2008 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC.

Case No.B‐64

M/S Aquapharm Chemicals Pvt. Ltd. F.No.01/83/050/00651/AM08 RA F.No.31/24/040/00103/AM08 Adv.Lic.No.3110029727 dated 03.07.2007 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC.

Case No.B‐65

M/S Vijayasri Organics Ltd. Norms Commi掀�ee Mee捀�ng No. 6/10 F.No.01/82/050/01434/AM09 RA F.No.09/24/040/00354/AM09 Adv.Lic.No.0910036390 dated 18.12.2008 Commi掀�ee considered case as per agenda and in light of decision taken in 25/09 mee捀�ng held on 16.09.2008 and in consulta捀�on with technical authority present in mee捀�ng decided to allow import of Phosphorus Oxy Chloride to the extent of 2.60 kg per kg of export product without any other change in the decision taken in 40/82 mee捀�ng held on 30.12.2008. RA concerned may take further necessary ac捀�on as per above decision of NC.

Case No.B‐66

M/S Acacia Sciences Pvt. Ltd. F.No.01/87/050/01086/AM07 RA F.No.09/24/040/00492/AM07 Adv.Lic.No.0910029581 dated 08.03.2007 Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of Pharmaceu捀�cals vide their U.O. No.35011/170/2008‐PI‐III dated 23.04.2009 and in consulta捀�on with technical authority

present in mee捀�ng, decided to ra捀�fy 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 (3Z)‐4‐(Aminomethyl)‐3‐ Pyrrolidinone‐O‐Methyloxime Hcl 1 Kg. 1. BOC Anhydride 99% min. (Di‐Tert‐Butyl Doacarbonate) 4.63 kg 2. O‐Methyoxy Hydroxylamine Hcl 0.521 kg

Case No.B‐67

M/S Aurolab F.No.01/85/050/00075/AM08 RA F.No.35/24/040/00029/AM08 Adv.Lic.No.3510021598 dated 04.09.2007 Commi掀�ee considered case as per agenda and in consulta捀�on with technical authority present in mee捀�ng, decided to amend measurement of the quan捀�ty of export product from KG to numbers without any other change in the decision taken in 39/82 mee捀�ng held on 31.12.2008.

Case No.B‐68

M/S Kamud Drugs Pvt. Ltd. F.No.01/82/050/00839/AM09 RA F.No.31/24/040/00119/AM09 Adv.Lic.No.3110034700 dated 04.08.2008 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐69

M/S Kamud Drugs Pvt. Ltd. F.No.01/82/050/00136/AM09 RA F.No.31/24/040/00394/AM08 Adv.Lic.No.3110033090 dated 14.03.2008 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐70

M/S Benzo Chem Industries Pvt. Ltd. F.No.01/82/050/00882/AM09 RA F.No.03/94/040/00204/AM09 Adv.Lic.No.0310482608 dated 14.08.2008 Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of C&PC

vide their U.O. No.14010/11/2008/Ch.II dated 27.04.2009 and in consulta捀�on with technical authority present in mee捀�ng, 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 2‐Coumaranone 30% in Ace捀�c Anhydride 70% 1 Kg. 1. Ortho Chloro Benzyl Cyanide 0.666 kg 2. Caus捀�c Soda Flakes 1.150 kg 3. Toluene 0.266 kg RA concerned may take further necessary ac捀�on as per above decision of NC. The earlier decision taken in 30/82 mee捀�ng held on 21.02.2008 is withdrawn.

Case No.B‐71

M/S Hetero Labs Ltd. F.No.01/82/050/01403/AM09 RA F.No.09/24/040/00342/AM09 Adv.Lic.No.0910036287 dated 12.12.2008 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐72

M/S Avignon Exim Pvt. Ltd. F.No.01/82/050/00273/AM09 Mee捀�ng Date:12.05.2009 RA F.No.03/94/040/01006/AM08 Adv.Lic.No.0310467005 dated 02.04.2008 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of MSME.

Case No.B‐73

M/S Medchl Chemicals & Pharmaceu捀�cals Pvt. Ltd. F.No.01/82/050/00435/AM09 RA F.No.09/24/040/00289/AM08 Adv.Lic.No.0910033007 dated 15.02.2008 Commi掀�ee considered case as per agenda and in consulta捀�on with technical authority present in mee捀�ng, decided to maintain the decision taken in 11/82 mee捀�ng held on 10.06.2008 as there is no jus捀�fica捀�on for enhancement in he quan捀�ty of inputs.

Case No.B‐74

M/S Strides Arcolab Ltd. F.No.01/82/162/00660/AM09 RA F.No.03/24/040/01015/AM02 Adv.Lic.No.0310110666 dated 19.11.2000 Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of MSME.

Case No.B‐75

M/S Nestor Pharmaceu捀�cals Ltd F.No.01/82/050/01401/AM09 RA F.No.05/24/040/00542/AM09 Adv.Lic.No.0510232404 dated 11.12.2008 Commi掀�ee considered case as per agenda and in consulta捀�on with technical authority present in mee捀�ng, 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 item Qty. allowed Co‐Trimoxazole Granules Each gram Granules contains: Trimethoprim BP 140 mg Sulphamethoxazile BP 700 mg 1 Kg. 1. Trimethoprim BP/USP/IP 141.4 gram 2. Sulphamethoxazole IP/BP/USP 707 gram RA concerned may take further necessary ac捀�on as per above decision of NC. The earlier decision taken in 39/82 mee捀�ng held on 23.12.2008 is withdrawn. 1

Case No.:1/35/82‐ALC4/2007

Party Name:FDC LTD Meet No/Date:6/82‐ALC4/2009 12.05.2009 Status:Case Approved HQ File :01/82/050/00280/AM08/ RLA File :03/94/040/00771/AM08/ Lic.No/Date:0310450616 19.11.2007 Decision : Commi掀�ee considered case as per agenda and in light of earlier decision taken in its 34/82 mee捀�ng held on 18.11.2008 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy norms on repeat basis 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 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 RA concerned may take further necessary ac捀�on as per above decision of NC. 2

Case No.:2/17/82‐ALC4/2008

Party Name:SUPREEM PHARMACEUTICALS MYSORE PVT LTD. 12.05.2009 Status:Case Deferred HQ File :01/82/050/00726/AM09/ RLA File :07/24/040/00173/AM09/ Lic.No/Date:0710058403 09.07.2008 Defer Date:07.07.2009 Decision :Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of MSME. 3

Case No.:17/27/82‐ALC4/2008

Party Name:ORGANICA AROMATICS PVT LTD Status:Case

12.05.2009 Deferred HQ File :01/82/050/01034/AM09/ RLA File :07/24/040/00280/AM09/ Lic.No/Date:0710059944 19.09.2008 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC. 4

Case No.:28/32/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 12.05.2009 Status:Case Approved HQ File :01/82/050/01203/AM09/ RLA File :09/24/040/00103/AM09/ Lic.No/Date:0910035733 24.10.2008 Decision : Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/28/2007‐Ch.II dated 15.04.2009 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 Potassium Methoxide 5% Solu捀�on w/w in Methanol 1 Kg. 1. Caus捀�c Potash Flakes 0.024 kg 2. Methanol 0.961 kg 5

Case No.:2/36/82‐ALC4/2008

Party Name:SI GROUP INDIA LIMITED 12.05.2009 Status:Case Deferred HQ File :01/82/050/01288/AM09/ RLA File :03/95/040/00674/AM09/ Lic.No/Date:0310494806 19.11.2008 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC. 6

Case No.:13/36/82‐ALC4/2008

Party Name:CIPLA LIMITED 12.05.2009 Status:Case Approved HQ File :01/82/050/01299/AM09/ RLA File :03/94/040/00012/AM09/ Lic.No/Date:0310495022 20.11.2008 Decision :Withdrawn as the case has already been approved by NC in its 32/09 mee捀�ng held on 04.11.2008. 7

Case No.:20/37/82‐ALC4/2008

Party Name:VASUDHA PHARMA CHEM LTD 12.05.2009 Status:Case Deferred HQ File :01/82/050/01339/AM09/ RLA File :09/24/040/00312/AM09/ Lic.No/Date:0910036146 02.12.2008 Defer Date:07.07.2009 Decision :Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals.

Case No.:28/37/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 12.05.2009 Status:Case Deferred HQ File :01/82/050/01347/AM09/ RLA File :05/24/040/00562/AM09/ Lic.No/Date:0510231994 02.12.2008 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 9

Case No.:29/37/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 12.05.2009 Status:Case Deferred HQ File :01/82/050/01348/AM09/ RLA File :05/24/040/00566/AM09/ Lic.No/Date:0510231995 02.12.2008 Defer Date:07.07.2009 Decision :Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 10

Case No.:30/37/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 12.05.2009 Status:Case Approved HQ File :01/82/050/01349/AM09/ RLA File :08/24/040/00178/AM09/ Lic.No/Date:0810076463 03.12.2008 Decision : Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 11

Case No.:17/43/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 12.05.2009 Status:Case Deferred HQ File :01/82/050/01526/AM09/ RLA File :03/94/040/00899/AM09/ Lic.No/Date:0310501723 07.01.2009 Defer Date:07.07.2009 Decision :Commi掀�ee decided to forward a copy of applica捀�on to Department of Pharmaceu捀�cals for their comments. Accordingly, case was deferred for 07.07.2009. 12

Case No.:17/48/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 12.05.2009 Status:Case Approved HQ File :01/82/050/01622/AM09/ RLA File :05/24/040/00703/AM09/ Lic.No/Date:0510235842 05.02.2009 Decision : Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 13

Case No.:5/54/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 12.05.2009 Status:Case Deferred HQ File :01/82/050/01707/AM09/ RLA File :05/24/040/00746/AM09/ Lic.No/Date:0510237937 16.03.2009 Defer Date:07.07.2009 Decision :Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals.

Case No.:7/54/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 12.05.2009 Status:Case Deferred HQ File :01/82/050/01709/AM09/ RLA File :08/24/040/00233/AM09/ Lic.No/Date:0810078677 16.03.2009 Defer Date:07.07.2009 Decision :Commi掀�ee considered case as per agenda and observed that RA has been requested to furnish the details of calcula捀�on of inputs for the export products rela捀�ng to Advance Authorisa捀�on issued under para 4.7.1 of HBP, but no reply has been received. It was, therefore, decided to await reply from RA and defer the case for 07.07.2009. 15

Case No.:10/54/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 12.05.2009 Status:Case Deferred HQ File :01/82/050/01712/AM09/ RLA File :05/24/040/00769/AM09/ Lic.No/Date:0510238138 17.03.2009 Defer Date:21.07.2009 Decision :Commi掀�ee decided to call for a copy of applica捀�on, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 21.07.2009. 16

Case No.:11/54/82‐ALC4/2008

Party Name:SWISS PARENTERALS PVT.LTD. 12.05.2009 Status:Case Deferred HQ File :01/82/050/01713/AM09/ RLA File :08/24/040/00235/AM09/ Lic.No/Date:0810078764 18.03.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 17

Case No.:12/54/82‐ALC4/2008

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 12.05.2009 Status:Case Deferred HQ File :01/82/050/01714/AM09/ RLA File :05/24/040/00712/AM09/ Lic.No/Date:0510238226 18.03.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 18

Case No.:16/54/82‐ALC4/2008

Party Name:MOREPEN LABORATORIES LTD., 12.05.2009 Status:Case Deferred HQ File :01/82/050/01718/AM09/ RLA File :05/24/040/00615/AM09/ Lic.No/Date:0510238452 20.03.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 19

Case No.:1/6/82‐ALC4/2009

Party Name:SUNSHIELD CHEMICALS LTD. 12.05.2009 Status:Case Deferred

HQ File :01/82/050/00056/AM10/ RLA File :03/95/040/00011/AM10/ Lic.No/Date:0310517490 27.04.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC. 20

Case No.:2/6/82‐ALC4/2009

Party Name:CIPLA LIMITED 12.05.2009 Status:Case Approved HQ File :01/82/050/00057/AM10/ RLA File :03/94/040/00031/AM10/ Lic.No/Date:0310517566 28.04.2009 Decision : Commi掀�ee considered case as per agenda and in light of its earlier decision taken in its 22/82 mee捀�ng held on 26.08.2008 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 per unit of export product GCS Dog (Powder) 1 Pack of 150 gram 1. Glucosamine Hcl 82.635gm/pack 2. Sodium Chondro捀�n sulphate 27.54gm/pack 3. Manganese sulphate 0.732gm/pack 4. Ascorbic acid (calcium ascorbate) 4.776gm/pack GCS Dog Powder 1 pack of 500 gram 1. Glucosamine Hcl 0.2754 kg/pack 2. Sodium Chondro捀�n Sulphate 0.0918 kg/pack 3. Manganese Sulphate 0.00244 kg/pack 4. Ascorbic acid (calcium ascorbate 0.01592 kg/pack GCS Dog Powder 1 Pack of 4.54 kgs 1. Glucosamine Hcl 2.501 kg/pack 2. Sodium Chondro捀�n Sulphate 0.833 kg/pack 3. Manganese Sulphate 0.022 kg/pack 4. Ascorbic acid (calcium ascorbate 0.144 kg/pack 21

Case No.:3/6/82‐ALC4/2009

Party Name:UNIMARK REMEDIES LIMITED., 12.05.2009 Status:Case Deferred HQ File :01/82/050/00058/AM10/ RLA File :03/95/040/00091/AM09/ Lic.No/Date:0310517620 28.04.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 22

Case No.:4/6/82‐ALC4/2009

Party Name:ADCOCK INGRAM LTD, 12.05.2009 Status:Case Deferred HQ File :01/82/050/00059/AM10/ RLA File :07/24/040/00033/AM10/ Lic.No/Date:0710064390 Defer

28.04.2009 Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of Pharmaceu捀�cals. 23

Case No.:8/6/82‐ALC4/2009

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 12.05.2009 Status:Case Approved HQ File :01/82/050/00063/AM10/ RLA File :22/24/040/00069/AM09/ Lic.No/Date:2210008873 28.04.2009 Decision : Commi掀�ee considered case as per agenda and in light of earlier decision taken in 51/82 mee捀�ng held on 10.03.2009 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 6‐Amino Penicillianic Acid (6‐ APA) 1 Kg. 1. Pencillin G Potassium Ist Crystal 2.92 BOU 2. Penicillin G Amidase Enzyme 0.096 gm 3. Boric Acid 0.055 kg 4. Methanol 0.04 kg 5. Butyl Acetate 0.214 kg 6. P.T. Resin 0.004 Ltr. 24

Case No.:5/6/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 12.05.2009 Status:Case Approved HQ File :01/82/050/00060/AM10/ RLA File :05/24/040/00020/AM10/ Lic.No/Date:0510240520 29.04.2009 Decision :Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 25

Case No.:6/6/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 12.05.2009 Status:Case Approved HQ File :01/82/050/00061/AM10/ RLA File :09/24/040/00476/AM09/ Lic.No/Date:0910037809 30.04.2009 Decision : Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of Pharmaceu捀�cals vide their O.M. No.35011/61/2008‐ PI‐III dated 30.08.2008 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 2‐Butyl‐5‐Chloro‐3H‐ Imidazol‐4‐Carbaldehyde (IMAL) 1. Sodium Cyanide 1.08 kg 2. Phosphorous Oxychloride 2.60 kg 3. Dimethyl Formamide 1.16 kg

Case No.:7/6/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 12.05.2009 Status:Case Approved HQ File :01/82/050/00062/AM10/ RLA File :09/24/040/00011/AM10/ Lic.No/Date:0910037810 30.04.2009 Decision : Commi掀�ee considered case as per agenda and in light of earlier decision taken in 10/82 mee捀�ng held on 10.07.2007 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 Iminoguanidyl‐2,3‐ Dichlorobenzoyl Cyanide Phosphate 1 kg 1. 2,3‐Dichloro Benzoyal Chloride 1.20 kg 2. 1‐Amino Guanidine Bicarbonate 0.80 kg 3. Poly Phosphoric Acid 4.00 kg 4. Acetonitrile 1.00 kg 5. Cuprous Cyanide 0.56 kg 27

Case No.:9/6/82‐ALC4/2009

Party Name:RASHMI PHARMA PVT LTD., 12.05.2009 Status:Case Deferred HQ File :01/82/050/00064/AM10/ RLA File :09/24/040/00012/AM10/ Lic.No/Date:0910037811 30.04.2009 Defer Date:21.07.2009 Decision : Commi掀�ee decided to call for a copy of applica捀�on, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 21.07.2009. 28

Case No.:10/6/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 12.05.2009 Status:Case Approved HQ File :01/82/050/00065/AM10/ RLA File :09/24/040/00030/AM10/ Lic.No/Date:0910037818 01.05.2009 Decision : Commi掀�ee considered case as per agenda for ra捀�fica捀�on of norms and in light of wri掀�en comments forwarded by Chemical Division vide their U.O. No.14010/96/2008‐Ch.II dated 09.02.2009 and in consulta捀�on with Technical Authority present in mee捀�ng, decided to ra捀�fy 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 product (on 100% basis) Dimethyl Phenidone/Dimethyl Phenyl Pyrazolidone 1 Kg. 1. Hydroxy Pivalinic Acid 0.933 kg 2. Phenyl Hydrazine 0.760 kg

Sodium Methoxide 0.400 kg 4. Methanol 0.400 kg 29

Case No.:11/6/82‐ALC4/2009

Party Name:NAWAL PRAKASH AVIKEM PVT.LTD., 12.05.2009 Status:Case Deferred HQ File :01/82/050/00066/AM10/ RLA File :03/95/040/00041/AM10/ Lic.No/Date:0310517953 01.05.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of DIPP. 30

Case No.:12/6/82‐ALC4/2009

Party Name:LUPIN LIMITED 12.05.2009 Status:Case Approved HQ File :01/82/050/00067/AM10/ RLA File :03/95/040/00021/AM10/ Lic.No/Date:0310518142 04.05.2009 Decision :Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 31

Case No.:13/6/82‐ALC4/2009

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 12.05.2009 Status:Case Approved HQ File :01/82/050/00068/AM10/ RLA File :07/24/040/00035/AM10/ Lic.No/Date:0710064490 04.05.2009 Decision : Commi掀�ee considered case as per agenda and in light of earlier decision taken in 02/08 mee捀�ng held on 16.05.2007 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 CeŌazidime for Injec捀�on 1 gm Vial 1 Vial 1. CeŌazidime Pentahydrae 1.32 gm/vial 32

Case No.:14/6/82‐ALC4/2009

Party Name:INTERMED LABS PVT. LTD., 12.05.2009 Status:Case Approved HQ File :01/82/050/00069/AM10/ RLA File :07/24/040/00028/AM10/ Lic.No/Date:0710064491 04.05.2009 Decision : Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of Pharmaceu捀�cals vide their U.O. No.35011/256/2008‐ PI‐III dated 17.03.2009 and in consulta捀�on with technical authority present in mee捀�ng, decided to ra捀�fy 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 Capecitabine 1 Kg. 1. 1,2,3‐Triacetoxy‐5‐Deoxy‐Ribose 1.11 kg 2. 5‐Fluorocytosine 0.553 kg 33

Case No.:15/6/82‐ALC4/2009

Party Name:PASCHIM CHEMICALS PVT.LTD. 12.05.2009 Status:Case Deferred HQ File :01/82/050/00070/AM10/ RLA File :03/95/040/01006/AM09/ Lic.No/Date:0310518330 04.05.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC. 34

Case No.:16/6/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 12.05.2009 Status:Case Deferred HQ File :01/82/050/00071/AM10/ RLA File :03/95/040/00020/AM10/ Lic.No/Date:0310518335 04.05.2009 Defer Date:07.07.2009 Decision : Commi掀�ee decided to defer case for 07.07.2009 for comments of Department of C&PC. ***************************

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.