DGFT Committee Minutes

Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi -110011

Para 4.7 Decision

MEETING NUMBER : 44/82-ALC4/2007 MEETING DATE : 04.03.2008 The Meeting No.44/08 for the licensing year 2007-08 to consider the cases under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2004-09 pertaining to Pharma Products was held on 04.03.2008 under the Chairmanship of Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No16/08 dated 21.08.2007, 17/08 dated 28.08.2007, 18/08 dated 06.09.2007, 19/08 dated 11.09.2007 and 20/08 dated 18.09.2007 were ratified by the Committee.

Case No.B-571

M/S Alliance Laboratories Ltd Norms Committee Meeting No.44/08 F.No.01/82/50/424/AM08 F.No.01/83/50/1037/AM08 Meeting Date: 04.03.2008 RLA F.No. Adv.Lic.No.0310430399 dated 23.05.2007 Adv.Lic.No.0310441279 dated 30.08.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Shri Nikunj Kanakia, Director of the company appeared for personal hearing before the Committee and explained the case. He informed the Committee that they will be importing only one item namely Dioxabicyclo Octan. He also informed the Committee that both the firm Alliance Laboratories and Om Shree Pharma are sister concerns and they have obtained advance licences against individual export orders. Committee after hearing representative of firm decided to call the following information/documents within 15 days:- i) Complete chemistry as per Appendix 33. ii) Copy of export orders. iii) An undertaking that they will be exporting only one item. Accordingly, case was deferred for six weeks.

Case No.B-572

M/S Om Shree Pharma Pvt. Ltd.

Norms Committee Meeting No.44/08 F.No.01/83/50/1378/AM07 Meeting Date: 04.03.2008 RLA F.No.03/95/40/1605/AM07 Adv.Lic.No.0310424623 dated 27.03.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Shri Nikunj Kanakia, Director of the company appeared for personal hearing before the Committee and explained the case. He informed the Committee that they will be importing only one item namely Dioxabicyclo Octan. He also informed the Committee that both the firm Alliance Laboratories and Om Shree Pharma are sister concerns and they have obtained advance licences against individual export orders. Committee after hearing representative of firm decided to call the following information/documents within 15 days:-

1. Complete chemistry as per Appendix 33.
2. Copy of export orders.
3. An undertaking that they will be exporting only one item. Accordingly, case was deferred for six weeks.

Case No.B-573

M/S Om Shree Pharma Pvt. Ltd. Norms Committee Meeting No.44/08 F.No.01/83/50/1267/AM07 Meeting Date: 04.03.2008 RLA F.No.03/95/40/1424/AM07 Adv.Lic.No.0310420407 dated 21.02.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Shri Nikunj Kanakia, Director of the company appeared for personal hearing before the Committee and explained the case. He informed the Committee that they will be importing only one item namely Dioxabicyclo Octan. He also informed the Committee that both the firm Alliance Laboratories and Om Shree Pharma are sister concerns and they have obtained advance licences against individual export orders. Committee after hearing representative of firm decided to call the following information/documents within 15 days:-

1. Complete chemistry as per Appendix 33.
2. Copy of export orders.
3. An undertaking that they will be exporting only one item. Accordingly, case was deferred for six weeks.

Case No.B-574

M/S Om Shree Pharma Pvt. Ltd. Norms Committee Meeting No.44/08 F.No.01/83/50/725/AM08 Meeting Date: 04.03.2008 RLA F.No.03/95/40/230/AM08 Adv.Lic.No.0310432141 dated 08.06.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Shri Nikunj Kanakia, Director of the company appeared for personal hearing before the Committee and explained the case. He informed the Committee that they will be importing only one item namely Dioxabicyclo Octan. He also informed the Committee that both the firm Alliance Laboratories and Om Shree Pharma are sister concerns and they have obtained advance licences against individual export orders. Committee after hearing representative of firm decided to call the following information/documents within 15 days:-

1. Complete chemistry as per Appendix 33.
2. Copy of export orders.
3. An undertaking that they will be exporting only one item. Accordingly, case was deferred for six weeks. 1

Case No.:205/21/82-

ALC4/2007 Party Name:IGOR PHARMACHEM LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/82/050/00268/AM06/ RLA File : 09/24/040/00086/AM06/ Lic.No/Date:09100232 19 21.06.2005 Defer Date:08.04.20 08 Decision :Committee considered case as per agenda for ratification of norms for export product 2-Aminomethyl-7-Chloro-2,3-Dihydro-5-(2- Fluorophenyl)-1H-1,4-Benzodiazepine Dimaleate under para 4.7 of HBP. Committee decided to hand over file to representative of PI Division present in meeting for his comments. Accordingly, case was deferred for four weeks. 2

Case No.:304/24/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Approved HQ File : 01/83/050/00338/AM07/ RLA File : 03/95/040/00320/AM07/ Lic.No/Date:03103871 82 28.06.2006

Decision : Committee considered case as per agenda for ratification of norms for export product Artesunate and Artemether under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 09/08 meeting held on 03.07.2007 vide Case No.A-207 and 22/82 meeting held on 04.10.2007 vide case No.242/24/83 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under

para 4.7 of HBP as per details below or as applied by firm whichever is

lower:- Export product Export Quantity Import item Qty. allowed per unit of export product Artemether 1kg. Artemisinin 1.50kg/kg Artesunate 1kg. Artemisinin 0.9259kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 3

Case No.:17/20/83-

ALC1/2006 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Approved HQ File : 01/83/050/00421/AM07/ RLA File : 03/95/040/00391/AM07/ Lic.No/Date:03103890 37 12.07.2006

norms for export product Quinine Hydrochloride under para 4.7 of HBP. Committee in light of DGFT report dated 31.03.2005 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import item Qty. allowed per unit of export product Quinine Hydrochloride 1kg. 1. Cinchona Bark 29kg/kg 2. Toluene 34.30kg/kg of Norms Committee. 4 Case No.:2/34/82- ALC1/2006 Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/82/050/00593/AM07/ RLA File : 08/24/040/00247/AM06/ Lic.No/Date:08100583 23 24.07.2006 Defer Date:22.04.20 08

Decision : Committee considered case as per agenda for ratification of norms for export product 1-Carbethoxy Ethylidene Triphenyl Phosphorane under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division of C&PC for their comments. Accordingly, case was deferred for six weeks. 5

Case No.:327/24/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Approved HQ File : 01/83/050/00639/AM07/ RLA File : 03/95/040/00704/AM07/ Lic.No/Date:03103986 52 07.09.2006 Defer Date: norms for export product Artesunate under para 4.7 of HBP. Committee in light of its earlier decision taken in its 22/82 meeting held on 04.10.2007 vide case No.242/24/83 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Import item Qty. allowed per unit of export product Artesunate 1kg. Artemisinin 0.9259kg/kg of Norms Committee. 6

Case No.:5/39/87-

ALC1/2006 Party Name:AROCHEM INDUSTRIES Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Approved HQ File : 01/87/050/00758/AM07/ RLA File : 03/94/040/00398/AM07/ Lic.No/Date:03104089 39 21.11.2006 Defer Date: norms for export product Choline Bitartrate-FCC-V/USP (with 1% Silicon dioxide) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 01/08 meeting held on 09.05.2007 vide Case No.A-009 in the case of M/S Bajaj Healthcare and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per

details below or as applied by firm whichever is lower. Export product Export Quantity Import item Qty. allowed per unit of export product Choline Bitartrate USP Coated 1kg. L(+)Tartaric Acid 0.775kg/kg of Norms Committee. 7

Case No.:1/42/83-

ALC1/2006 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/00936/AM07/ RLA File : 09/24/040/00218/AM07/ Lic.No/Date:09100282 86 21.11.2006 Defer Date:08.04.20 08 Decision : Committee considered case as per agenda for ratification of norms for export product 1,2-Benzisoxazole-3-methane sulfonic acid sodium salt under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 8

Case No.:524/24/87-

ALC1/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Approved HQ File : 01/87/050/00818/AM07/ RLA File : 13/24/040/00023/AM07/ Lic.No/Date:13100233 60 13.12.2006

norms for export product Glucosamine Chondrotin Granules under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004-PI-III dated 10.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Glucosamine 1kg. 1. Glucosamine 0.538kg/kg

Chondrotin granules 2. Chondrotin Sulphate USP 0.473kg/kg of Norms Committee. 9

Case No.:8/4/83-

ALC1/2007 Party Name:SALVI CHEMICAL INDUSTRIES LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01379/AM07/ RLA File : 03/95/040/01615/AM07/ Lic.No/Date:03104246 38 27.03.2007 Defer Date:22.04.20 08 Decision : Committee considered case as per agenda for ratification of norms for export product 8-Quinolium under para 4.7 of HBP. Committee decided to call for end use of export product alongwith all technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks. 10

Case No.:2/4/85-

ALC3/2007 Party Name:HEINZ INDIA PRIVATE LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Transferr ed to Different Section HQ File : 01/85/050/00259/AM07/ RLA File : 03/94/040/01338/AM07/ Lic.No/Date:0310424 928 29.03.2007

norms for export product Vitamin-Mineral Food Supplement Sprinkle under

para 4.7 of HBP.

Committee decided to transfer case to DES-VI as export product pertains to Food Sector. 11

Case No.:25/14/83-

ALC1/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00016/AM08/ RLA File : 04/24/040/00501/AM07/ Lic.No/Date:04100887 27 02.04.2007

norms for export product Allylestrenol under para 4.7 of HBP. Committee decided to withdraw case as case has already been considered in its 43/08 meeting.

12

Case No.:33/9/82-

ALC4/2007 Party Name:DR. WILLMAR SCHWABE INDIA PVT LTD Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/82/050/00044/AM08/ RLA File : 05/24/040/00826/AM07/ Lic.No/Date:05102039 48 22.05.2007 Defer Date:22.04.20 08 norms for export product White Sugar Globuli (Unarzneiliche Globuli) under

para 4.7 of HBP.

Committee decided to remind Directorate of Sugar for their comments. Accordingly, case was deferred for six weeks. 13

Case No.:1615/26/80-

ALC2/2007 Party Name:GALAXY LABORATORIES PVT LTD., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/80/050/00382/AM08/ RLA File : 03/94/040/00481/AM08/ Lic.No/Date:03104397 94 17.08.2007 Defer Date:22.04.20 08 norms for export product Furfurylamine under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical weeks. 14

Case No.:28/27/83-

ALC1/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01102/AM08/ RLA File : 07/24/040/00172/AM08/ Lic.No/Date:07100531 50 03.09.2007 Defer Date:22.04.20 08 norms for export product Calcium Levulinate under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical weeks. 15 Case No.:21/27/83- ALC1/2007 Party Name:UMA ORGANICS PVT. LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01095/AM08/ RLA File : 09/24/040/00207/AM08/ Lic.No/Date:09100313 80 Defer Date:22.04.20

03.09.2007 08 norms for export product Ethoxy Acetylene 50% WT/WT of Hexanes under

para 4.7 of HBP.

weeks. 16

Case No.:34/27/83-

ALC1/2007 Party Name:ANUS LABORATORIES LTD., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01108/AM08/ RLA File : 09/21/040/00119/AM08/ Lic.No/Date:09100314 04 05.09.2007 Defer Date:22.04.20 08 norms for export product Sodium Methoxide Solution 25% under para 4.7 of HBP. weeks. 17

Case No.:35/27/83-

ALC1/2007 Party Name:SHREE GANESH CHEMICALS Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Deferred HQ File : 01/83/050/01109/AM08/ RLA File : 34/24/040/00089/AM08/ Lic.No/Date:34100195 70 05.09.2007 Defer Date: 22.04.2008 norms for export product Di Ethyl Amino Ethyl Chloride hydrochloride under

para 4.7 of HBP.

Committee decided to refer the case to PC-III for confirmation whether export product is a SCOMET item. Accordingly, case was deferred for six weeks. 18 Case No.:43/27/83- ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Rejected HQ File : 01/83/050/01117/AM08/ RLA File : 34/24/040/00110/AM08/ Lic.No/Date:34100195 73 06.09.2007

norms for export product Venlafaxine Hydrochloride Extended Release

Pellets Stage 1 under para 4.7 of HBP. Committee observed that firm was requested to furnish complete description of export product along with copy of DML vide letter dated 04.02.2008, but same has not been received. Committee, therefore, decided to close the case. of Norms Committee. 19

Case No.:68/27/83-

ALC1/2007 Party Name:AVIK PHARMACEUTICAL LTD., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01142/AM08/ RLA File : 03/94/040/00531/AM08/ Lic.No/Date:03104423 31 10.09.2007 Defer Date:22.04.20 08 norms for export product Ethisterone under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 20

Case No.:73/27/83-

ALC1/2007 Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01147/AM08/ RLA File : 03/95/040/00440/AM08/ Lic.No/Date:03104424 37 11.09.2007 Defer Date:22.04.20 08 norms for export product 2[(Chloro Methyl) Mercapto] Benzo Thiazole (CMBT) under para 4.7 of HBP. weeks. 21 Case No.:72/27/83- ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01146/AM08/ RLA File : 03/95/040/00570/AM08/ Lic.No/Date:03104424 36 11.09.2007

norms for export product Sterile Ceftriaxone Sodium Non Infringing under

para 4.7 of HBP.

Committee decided to withdraw case as case has been considered in its 41/08 meeting held on 03.03.2008. 22

Case No.:101/27/83-

ALC1/2007 Party Name:DOCTORSORGANIC CHEMICALS LTD Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01175/AM08/ RLA File : 26/24/040/00002/AM08/ Lic.No/Date:26100063 81 14.09.2007 Defer Date:18.03.20 08 norms for export product Sertraline Hydrochloride Solid under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 23

Case No.:153/27/83-

ALC1/2007 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01227/AM08/ RLA File : 34/24/040/00139/AM08/ Lic.No/Date:34100196 97 25.09.2007 Defer Date:22.04.20 08 norms for export product Benzyl Acetone (Jastone) under para 4.7 of HBP. weeks. 24

Case No.:162/27/83-

ALC1/2007 Party Name:SRI KRISHNA DRUGS LIMITED., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01236/AM08/ RLA File : 09/24/040/00148/AM08/ Lic.No/Date:09100316 16 26.09.2007 Defer Date:22.04.20 08 norms for export product Frusemide under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 25 Case No.:163/27/83- ALC1/2007 Party Name:SRI KRISHNA DRUGS LIMITED., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred

HQ File : 01/83/050/01237/AM08/ RLA File : 09/24/040/00145/AM08/ Lic.No/Date:09100316 18 26.09.2007 Defer Date:22.04.20 08 norms for export product Folic Acid under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 26

Case No.:14/30/83-

ALC1/2007 Party Name:KAIVAL CHEMICALS P LTD Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01383/AM08/ RLA File : 34/24/040/00157/AM08/ Lic.No/Date:34100198 69 18.10.2007 Defer Date:22.04.20 08 norms for export product L(-)Di-P-Toluoyl Tartaric Acid under para 4.7 of HBP. weeks. 27

Case No.:9/28/82-

ALC4/2007 Party Name:VIVEK PHARMACHEM (INDIA) LTD., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Cas e Rejected HQ File : 01/82/050/00243/AM08/ RLA File : 13/24/040/00022/AM08/ Lic.No/Date:13100252 78 31.10.2007

norms for export product Meropenem Injection USP 1gm Potency 100% (+/- 5%) under para 4.7 of HBP. Committee observed that firm was requested to furnish Actual potency of import item, copy of Bill of Entry, Test Report from Foreign Supplier and Copy of relevant DML vide letter dated 06.02.2008, but same have not been received. Committee, therefore, decided to close the case. of Norms Committee. 28 Case No.:80/32/83- ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : RLA File : Lic.No/Date:05102115 Defer

01/83/050/01502/AM08/ 05/24/040/00562/AM08/ 68 05.11.2007 Date:08.04.20 08 norms for export product (4R-Cis)-1,1-Dimethylethyl-6-Cyanomethyl-2,2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) NLT 99% under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 29

Case No.:8/40/81-

ALC2/2007 Party Name:ULTRA-TECH INDIA LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/81/050/00446/AM08/ RLA File : 03/95/040/00813/AM08/ Lic.No/Date:03104507 07 19.11.2007 Defer Date:22.04.20 08 norms for export product 2-[((3-Methyl-4-(2,2,2-Trifluoro Ethoxy)-2- Pyridinyl)-Methyl)Thio}-1H-Benzimidazole under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 30

Case No.:59/39/83-

ALC1/2007 Party Name:SANJAY SALES CORPORATION Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01638/AM08/ RLA File : 03/95/040/00791/AM08/ Lic.No/Date:03104516 58 27.11.2007 Defer Date:22.04.20 08 norms for export product Sodium Salicylate under para 4.7 of HBP. weeks. 31 Case No.:31/39/83- ALC1/2007 Party Name:VIJAYASRI CHEMICALS Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01610/AM08/ RLA File : 09/24/040/00369/AM08/ Lic.No/Date:09100322 30 27.11.2007 Defer Date:22.04.20 08 norms for export product 2-Butyl-5-Chloro-3H-Imidazole-4-Carbaldehyde (IMAL) (OR) 2-N-Butyl-4-Chloro-5-Formylimidazole (BCFI) under para 4.7 of

HBP. Committee decided to defer case for six weeks for comments of PI Division. 32

Case No.:114/39/83-

ALC1/2007 Party Name:HENKEL ADHESIVES TECHNOLOGIES INDIA PVT.LTD. Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Transferr ed to Different Section HQ File : 01/83/050/01693/AM08/ RLA File : 31/24/040/00293/AM08/ Lic.No/Date:3110031 808 05.12.2007

norms for export product Accuset-M-15 L Part No.46275under para 4.7 of HBP. Committee decided to transfer case to DES-VII as export product pertains to Plastic Sector. 33

Case No.:138/39/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01717/AM08/ RLA File : 03/95/040/00892/AM08/ Lic.No/Date:03104533 32 10.12.2007 Defer Date:22.04.20 08 norms for export product Sterile Ceftriaxone Sodium Non Infringing under

para 4.7 of HBP.

Committee decided to examine the case on file. 34

Case No.:173/39/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01752/AM08/ RLA File : 03/94/040/00853/AM08/ Lic.No/Date:03104537 34 12.12.2007 Defer Date:22.04.20 08 norms for export product Donepezil hydrochloride under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 35 Case No.:164/39/83- ALC1/2007 Party Name:ARCH PHARMALABS LTD Meet No/Date:44/82- ALC4/2007 Status:Cas e Approved

04.03.2008 HQ File : 01/83/050/01743/AM08/ RLA File : 03/94/040/00870/AM08/ Lic.No/Date:03104540 08 14.12.2007 : norms for export product Clopidogrel bisulphate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/192/2006-PI-III dated 24.04.2007 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Clopidogrel Bisulphate 1kg 1. Methanol 4.25kg/kg 2. Methylene Chloride 1.03kg/kg 3. Acetone 1.68kg/kg 4. Formic Acid 0.185kg/kg of Norms Committee. 36

Case No.:8/42/83-

ALC1/2007 Party Name:BODAL CHEMICALS LTD Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/83/050/01784/AM08/ RLA File : 08/24/040/00227/AM08/ Lic.No/Date:08100693 22 02.01.2008 Defer Date:22.04.20 08 norms for export product Sulfo Para Base Ester (Sulfo Vinyl Sulphone Ester) under para 4.7 of HBP. weeks. 37 Case No.:1/44/82- ALC4/2007 Party Name:PARABOLIC DRUGS LTD., Meet No/Date:44/82- ALC4/2007 04.03.2008 Status:Case Deferred HQ File : 01/82/050/00463/AM08/ RLA File : 22/24/040/00056/AM08/ Lic.No/Date:22100074 84 21.02.2008 Defer Date:22.04.20 08

norms for export product Flucloxacillin Sodium Sterile under para 4.7 of HBP. Committee decided to call for production and consumption data certified by Central Excise Authority from firm. Accordingly, case was deferred for six weeks. Date:08.03.2008 Place:New Delhi Shyam Lal Foreign Trade Development Officer