IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-09-30

DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER : 27/82‐ALC4/2008 MEETING DATE : 30.09.2008 The Meeting No.27/09 in the year 2008‐09 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 was held on 30.09.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. Following members were present:‐ 1. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 2. Shri A. Malik, Dy. Director, Department of MSME 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.25/09 dated 16.09.2008 were ratified by the Committee.

Case No.B‐212

M/S Omkar Specilaity Chemicals Pvt. Ltd. Norms Committee Meeting No.27/09 F.No.01/83/50/1295/AM08 Meeting Date: 30.09.2008 RA Fo.03/95/040/00611/AM08 Adv.Lic.No.0310445277 dated 05.10.2007 Committee decided to defer case for 28.10.2008 for comments of Chemical Division.

Case No.B‐213

M/S Metropolitan Overseas Ltd. F.No.01/83/50/516/AM08 RA Fo.03/95/040/01030/AM08 Adv.Lic.No.0310458166 dated 18.01.2008 Committee considered case as per agenda and observed that the firm was requested to furnish technical justification along with calculations for working out the quantative requirement, but the firm has neither submitted the required information at the 奱�me of ratification of norms in its 7/09 meeting held on 13.05.2008 nor have they submitted the required information now. It was, therefore, decided to maintain the decision taken by committee in its 7/09 meeting held on 13.05.2008.

Case No.B‐214

M/S Metropolitan Overseas Ltd.

F.No.01/82/50/933/AM08 RA Fo.03/95/040/00301/AM08 Adv.Lic.No.0310458008 dated 01.08.2007 Committee considered case as per agenda and observed that the firm was requested to furnish technical justification along with calculations for working out the quantative requirement, but the firm has neither submitted the required information at the 奱�me of ratification of norms in its 7/09 meeting held on 13.05.2008 nor have they submitted the required information now. It was, therefore, decided to maintain the decision taken by committee in its 7/09 meeting held on 13.05.2008.

Case No.B‐215

M/S Cipla Ltd., Mumbai F.No.01/82/50/250/AM08 RA Fo.03/94/040/00749/AM08 Adv.Lic.No.0310447493 dated 23.10.2007 Committee considered the case as per agenda and observed that the firm has obtained Advance Authorization for export of 9 items, out of which committee has fixed the norms for 8 items in its 2/09 meeting held on 08.04.2008 and the norms for 1 export product namely Triomune 30 was not fixed due to non submission of DML by the firm. Now, the firm has submitted DML for the said export product. Committee in light of written comments forwarded by PI Division vide O.M. No. 35011/83/2008‐PI‐III dated 27.08.2008 and in consultation with technical authority present in the meeting decided to fix norms for export product Triomune 30 Tablets 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 Quantity Allowed Triomune 30 Tablets [Lamivudine‐153mg/Tablet of Triomune 30] 1 No. 1 (1’R, 2’S, 5’R)‐Menthyl – 5S‐ (Cytosine‐1”‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate/Cme Compound 2.19 Kg/kg of Lamivudine 2 Sodium Borohydride 0.48 Kg/kg of Lamivudine RA concerned may take further necessary action as per above decision of NC.

Case No.B‐216

M/S Cipla Ltd., Mumbai

F.No.01/82/50/215/AM08 RA Fo.03/94/040/00621/AM08 Adv.Lic.No.0310443538 dated 18.09.2007 Committee considered the case as per agenda and observed that the firm has obtained Advance Authorization for export of 9 items, out of which committee has fixed the norms for 8 items in its 2/09 meeting held on 08.04.2008 and the norms for 1 export product namely Triomune 30 was not fixed due to non submission of DML by the firm. Now, the firm has submitted DML for the said export product. Committee in light of written comments forwarded by PI Division vide O.M. No. 35011/83/2008‐PI‐III dated 27.08.2008 and in consultation with technical authority present in the meeting decided to fix norms for export product Triomune 30 Tablets 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 Quantity Allowed Triomune 30 Tablets [Lamivudine‐153mg/Tablet of Triomune 30] 1 No. 1 (1’R, 2’S, 5’R)‐Menthyl – 5S‐ (Cytosine‐1”‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate/Cme Compound 2.19 Kg/kg of Lamivudine 2 Sodium Borohydride 0.48 Kg/kg of Lamivudine

Case No.B‐217

M/S Cipla Ltd., Mumbai F.No.01/82/50/255/AM08 RA Fo.03/94/040/00798/AM08 Adv.Lic.No.0310448930 dated 02.11.2007 Committee considered the case as per agenda and observed that the firm has obtained Advance Authorization for export of 9 items, out of which committee has fixed the norms for 8 items in its 2/09 meeting held on 08.04.2008 and the norms for 1 export product namely Triomune 30 was not fixed due to non submission of DML by the firm. Now, the firm has submitted DML for the said export product.

Committee in light of written comments forwarded by PI Division vide O.M. No. 35011/83/2008‐PI‐III dated 27.08.2008 and in consultation with technical authority present in the meeting decided to fix norms for export product Triomune 30 Tablets 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 Quantity Allowed Triomune 30 Tablets [Lamivudine‐153mg/Tablet of Triomune 30] 1 No. 1 (1’R, 2’S, 5’R)‐Menthyl – 5S‐ (Cytosine‐1”‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate/Cme Compound 2.19 Kg/kg of Lamivudine 2 Sodium Borohydride 0.48 Kg/kg of Lamivudine

Case No.B‐218

M/S Shilpa Medicare Ltd. F.No.01/87/50/1517/AM06 RA Fo.07/24/040/01025/AM06 Adv.Lic.No.0710043911 dated 23.03.2006 Committee considered the case as per agenda for amendment in the description of import and export items and in consultation with technical authority present in meeting decided to allow amendment in the description of export product to read as “N‐[B‐D‐RIBOFURANOSYL]‐5‐HYDROXYIMIDIAZOLE‐4‐ CARBOXAMIDE TECHNICAL GRADE” and amendment in the Import Item No.1 to read as “N((2,3,5‐TRI‐O‐ BENZOYL)B‐D‐RIBOFURANOSYL)‐5‐HYDROXYMIDAZOLE‐4 CARBOXAMIDE CRUDE” without any change in quantity and description of other items.

Case No.B‐219

M/S Suven Life Sciences F.No.01/82/50/627/AM09 RA Fo.09/24/040/00044/AM09 Adv.Lic.No.0910034059 dated 26.05.2008

Committee decided to defer the case for 28.10.2008 for comments of PI Division.

Case No.B‐220

M/S Divis Laboratories Ltd. F.No.01/82/050/00463/AM09 RA Fo.09/24/040/00043/AM09 Adv.Lic.No.0910033814 dated 02.05.2008 Committee considered the case as per agenda for amendment in the description and quantity of Import Item No. 1 and amendment in the quantity of Import Item No. 2 and in consultation with Technical Authority present in the meeting decided to revise the norms as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Cyclopentadecanolide (Recrystallised) 1 Kg. 1. Cyclopentadecanolide (technical grade) (purity NMT 98.5%) 1.075 kg 2. Methanol 2.00 kg RA Concerned may take further necessary action as per above decision of NC.

Case No.B‐221

M/S Avignon Exim Pvt. Ltd. F.No.01/82/050/00273/AM09 RA Fo.03/94/040/01006/AM08 Adv.Lic.No.0310467005 dated 02.04.2008 Committee decided to defer the case for 28.10.2008 for comments of Department of MSME.

Case No.B‐222

M/S Mission Pharma Ltd. F.No.01/82/050/00606/AM07 RA Fo.03/65/040/00318/AM04 Adv.Lic.No.0310247155 dated 13.01.2004 Committee decided to defer the case for 14.10.2008 for comments of PI Division.

Case No.A‐82

M/S Cipla Ltd. F.No.01/82/050/00482/AM05 RA Fo.03/24/040/00340/AM05 Adv.Lic.No.0310269066 dated 17.05.2004 Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 14/08 meeting held on 07.08.2007 vide Case No.A‐429 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Maxima Powder (per pack 4.54 kgs) 1 No. 1 Glucosamine Hydrochloride 2.497 kg/pack of 4.54 kg 2. Sodium Chondroitin Sulphate 0.8172 kg/pack of 4.54 kg 1

Case No.:52/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:27/82‐ALC4/2008 30.09.2008 Status:Case Deferred HQ File :01/82/050/00388/AM08/ RLA File :07/24/040/00005/AM08/ Lic.No/Date:0710051374 23.04.2007 Defer Date:14.10.2008 Decision :Committee decided to defer case for 14.10.2008 for comments of Chemical/PI Division. 2

Case No.:28/27/83‐ALC1/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 30.09.2008 Status:Case Deferred HQ File :01/83/050/01102/AM08/ RLA File :07/24/040/00172/AM08/ Lic.No/Date:0710053150 03.09.2007 Defer Date:14.10.2008 Decision : Committee decided to defer case for 14.10.2008 for comments of Chemical/PI Division. 3

Case No.:102/32/83‐ALC1/2007

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 30.09.2008 Status:Case Approved HQ File :01/83/050/01524/AM08/ RLA File :05/24/040/00508/AM08/ Lic.No/Date:0510211703 06.11.2007

Decision :Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/62/2004/Ch.II dated 29.01.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed 2‐Hydroxymethyl Pyridine (Pyridine‐2‐Methanol) 1 Kg. 1. Alpha Picoline 1.8 kg 2. Acetic Acid Glacial 1.98 kg 3. Hydrogen Peroxide 50% 2.51 kg 4. Hydrochloric Acid 0.285 kg 5. Methylene Di Chloride 0.980 kg 4

Case No.:51/9/82‐ALC4/2008

Party Name:GLENMARK PHARMACEUTICALS LTD., 30.09.2008 Status:Case Deferred HQ File :01/82/050/00284/AM09/ RLA File :03/94/040/00989/AM08/ Lic.No/Date:0310455413 27.12.2007 Defer Date:29.10.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 29.10.2008. 5

Case No.:17/46/82‐ALC4/2007

Party Name:ARCH PHARMALABS LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00571/AM08/ RLA File :03/94/040/01117/AM08/ Lic.No/Date:0310461019 14.02.2008 Defer Date:29.10.2008 Decision :Committee decided to defer case for 29.10.2008 for comments of PI Division. 6

Case No.:86/11/82‐ALC4/2008

Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 30.09.2008 Status:Case Approved HQ File :01/82/050/00406/AM09/ RLA File :03/94/040/01111/AM08/ Lic.No/Date:0310460975 14.02.2008 Decision :Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/73/2008‐PI‐III dated 30.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Bio‐Heparin Injection 5000 IU/ML‐5 ML of Vial (Net Bulk Drug content 2.398 kgs.) 1 No. 1. Heparin Sodium EP V (Injectable Grade) 183.33 mg/5ml Vial RA concerned may take further necessary action asa per above decision of NC.

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Case No.:18/46/82‐ALC4/2007

Party Name:GITANJALI CHEMICALS PVT LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00572/AM08/ RLA File :03/94/040/01120/AM08/ Lic.No/Date:0310461653 19.02.2008 Defer Date:29.10.2008 Decision : Committee decided to defer case for 29.10.2008 for comments of Chemical Division. 8

Case No.:113/11/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 30.09.2008 Status:Case Approved HQ File :01/82/050/00433/AM09/ RLA File :09/24/040/00518/AM08/ Lic.No/Date:0910033067 25.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/71/2008‐PI‐III dated 30.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Tolmetin Sodium Dihydrate 1 Kg. 1. p‐Toluoyl Chloride 0.958 kg 2. Toluene 3.10 kg 3. N‐Hexane 1.94 kg 4. Methanol 2.43 kg 5. Dichloromethane 4.37 kg 6. Methyl‐1‐Methyl Pyrrole 2 Acetate 0.784 kg 7. Morpholine 0.54 kg RA concerned may take further necessary action asa per above decision of NC. 9

Case No.:40/11/82‐ALC4/2008

Party Name:RA CHEM PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/00360/AM09/ RLA File :09/24/040/00520/AM08/ Lic.No/Date:0910033434 24.03.2008 Defer Date:29.10.2008 Decision : Committee decided to defer case for 29.10.2008 for comments of PI Division. 10

Case No.:39/9/82‐ALC4/2008

Party Name:CIPLA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/00272/AM09/ RLA File :03/94/040/01345/AM08/ Lic.No/Date:0310466954 01.04.2008 Defer Date:29.10.2008

Case No.:47/9/82‐ALC4/2008

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00280/AM09/ RLA File :03/94/040/00446/AM08/ Lic.No/Date:0310467448 04.04.2008 Defer Date:11.11.2008 Decision :Committee decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for 11.11.2008. 12

Case No.:50/6/82‐ALC4/2008

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 30.09.2008 Status:Case Approved HQ File :01/82/050/00133/AM09/ RLA File :04/24/040/00419/AM08/ Lic.No/Date:0410095125 07.04.2008 Decision :Case has already been approved by NC in its 18/09 meeting held on 29.07.2008. 13

Case No.:119/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 30.09.2008 Status:Case Deferred HQ File :01/82/050/00202/AM09/ RLA File :08/24/040/00002/AM09/ Lic.No/Date:0810071149 08.04.2008 Defer Date:29.10.2008 14

Case No.:69/11/82‐ALC4/2008

Party Name:AVENTIS PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/00389/AM09/ RLA File :03/94/040/01144/AM08/ Lic.No/Date:0310471796 22.05.2008 Defer Date:29.10.2008 15

Case No.:18/13/82‐ALC4/2008

Party Name:RESONANCE LABORATORIES PVT LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00525/AM09/ RLA File :07/24/040/00081/AM09/ Lic.No/Date:0710057574 26.05.2008 Defer Date:29.10.2008 Decision : Committee decided to defer case for 29.10.2008 for comments of Chemical Division. 16

Case No.:28/11/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 30.09.2008 Status:Case Deferred HQ File :01/82/050/00348/AM09/ RLA File :08/24/040/00016/AM09/ Lic.No/Date:0810072185 29.05.2008 Defer Date:29.10.2008

Case No.:71/11/82‐ALC4/2008

Party Name:CIPLA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/00391/AM09/ RLA File :03/94/040/00177/AM09/ Lic.No/Date:0310472457 29.05.2008 Defer Date:29.10.2008 18

Case No.:76/14/82‐ALC4/2008

Party Name:ONEIRO CHEMICALS LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00628/AM09/ RLA File :34/24/040/00041/AM09/ Lic.No/Date:3410021533 05.06.2008 Defer Date:29.10.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 29.10.2008. 19

Case No.:38/15/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 30.09.2008 Status:Case Approved HQ File :01/82/050/00678/AM09/ RLA File :09/24/040/00094/AM09/ Lic.No/Date:0910034169 05.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/138/2008‐PI‐III dated 08.09.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Emtricitabine 1 Kg. 1. Glyoxylic Acid (as 50%) 2.234 kg 2. 5‐Fluorocytosine 1.348 kg 3. Triethyl amine 2.23 kg 4. Traimethyl Chlorosilane 2.654 kg 5. 2,5‐Dihydroxy,1,4‐Dithiane 0.90 kg 6. Sodium Borohydride 0.510 kg 7. Activated Carbon 0.100 kg 8. Cyclohexane 3.12 kg 9. Methylene Chloride 13.32 kg 10. n‐Hexane 6.871 kg RA concerned may take further necessary action asa per above decision of NC. 20

Case No.:35/14/82‐ALC4/2008

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00587/AM09/ RLA File :03/94/040/00278/AM09/ Lic.No/Date:0310474948

16.06.2008 Defer Date:11.11.2008 Decision :Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 11.11.2008. 21

Case No.:43/13/82‐ALC4/2008

Party Name:ANUPAM RASAYAN (INDIA) LTD 30.09.2008 Status:Case Approved HQ File :01/82/050/00550/AM09/ RLA File :52/24/040/00005/AM09/ Lic.No/Date:5210023726 16.06.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 22

Case No.:1/14/82‐ALC4/2008

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 30.09.2008 Status:Case Approved HQ File :01/82/050/00553/AM09/ RLA File :31/24/040/00070/AM09/ Lic.No/Date:3110034059 17.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/59/2003/Ch.III dated 22.05.2005 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Trigonox‐423C70 1,1,3,3 tetra methyl butyl 2‐ peroxyneodecanoate (70%) containing 23% Isododecene 1 Kg. 1. Neodecanoyl Chloride 0.516 kg 2. Tetra‐methyl butyl hydro peroxide 90% 0.472 kg 3. Isododecane 0.230 kg 4. Magnesium Sulphate 0.021 kg 5. Container HDPE Ltr. Loose with 2 labels 30 Ltr. CR Cans From HDPE, Natural with K‐60 Opening & Red K‐29 Screwcap, 6 Pieces in Plastic Bag, including Caps. As per packing policy 6. Screwcap K60 with pregasket As per packing policy 23

Case No.:49/14/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00601/AM09/ RLA File :03/95/040/00245/AM09/ Lic.No/Date:0310475408 19.06.2008 Defer Date:29.10.2008

Case No.:29/16/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00722/AM09/ RLA File :05/24/040/00237/AM09/ Lic.No/Date:0510223637 09.07.2008 Defer Date:29.10.2008 25

Case No.:2/17/82‐ALC4/2008

Party Name:SUPREEM PHARMACEUTICALS MYSORE PVT LTD. 30.09.2008 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:29.10.2008 Decision :Committee decided to forward a copy of application to Department of MSME for their comments and defer case for 29.10.2008. 26

Case No.:12/17/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 30.09.2008 Status:Case Deferred HQ File :01/82/050/00736/AM09/ RLA File :09/24/040/00552/AM08/ Lic.No/Date:0910034576 11.07.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 27

Case No.:20/17/82‐ALC4/2008

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00744/AM09/ RLA File :31/24/040/00110/AM09/ Lic.No/Date:3110034371 14.07.2008 Defer Date:29.10.2008 Decision : Committee decided to defer case for 29.10.2008 for comments of Chemical Division. 28

Case No.:21/17/82‐ALC4/2008

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00745/AM09/ RLA File :31/24/040/00105/AM09/ Lic.No/Date:3110034376 14.07.2008 Defer Date:29.10.2008 Decision : Committee decided to defer case for 29.10.2008 for comments of Chemical Division. 29

Case No.:29/17/82‐ALC4/2008

Party Name:EMCURE PHARMACEUTICALS LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00753/AM09/ RLA File :31/24/040/00103/AM09/ Lic.No/Date:3110034394 15.07.2008 Defer Date:29.10.2008

Case No.:2/23/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/00906/AM09/ RLA File :09/24/040/00212/AM09/ Lic.No/Date:0910035106 21.08.2008 Defer Date:29.10.2008 Decision : Committee decided to defer case for 29.10.2008 for comments of Chemical Division. 31

Case No.:4/23/82‐ALC4/2008

Party Name:RA CHEM PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/00908/AM09/ RLA File :09/24/040/00177/AM09/ Lic.No/Date:0910035108 21.08.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 32

Case No.:19/23/82‐ALC4/2008

Party Name:HETERO LABS LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/00923/AM09/ RLA File :09/24/040/00215/AM09/ Lic.No/Date:0910035123 25.08.2008 Defer Date:29.10.2008 33

Case No.:21/23/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00925/AM09/ RLA File :05/24/040/00341/AM09/ Lic.No/Date:0510226181 26.08.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 34

Case No.:24/23/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/00928/AM09/ RLA File :03/94/040/00512/AM09/ Lic.No/Date:0310483819 26.08.2008 Defer Date:29.10.2008 35

Case No.:5/27/82‐ALC4/2008

Party Name:IND‐SWIFT LABORATORIES LTD., 30.09.2008 Status:Case Deferred

HQ File :01/82/050/01022/AM09/ RLA File :22/24/040/00039/AM09/ Lic.No/Date:2210008171 15.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 36

Case No.:1/27/82‐ALC4/2008

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01018/AM09/ RLA File :03/95/040/00561/AM09/ Lic.No/Date:0310486605 16.09.2008 Defer Date:29.10.2008 37

Case No.:2/27/82‐ALC4/2008

Party Name:AUCTUS PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01019/AM09/ RLA File :09/24/040/00216/AM09/ Lic.No/Date:0910035277 16.09.2008 Defer Date:29.10.2008 38

Case No.:3/27/82‐ALC4/2008

Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 30.09.2008 Status:Case Approved HQ File :01/82/050/01020/AM09/ RLA File :05/24/040/00372/AM09/ Lic.No/Date:0510227613 16.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐PI‐III dated 24.03.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐1,3‐ dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl (R)‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg 3. Tertiary Butyl Acetate 2.11 kg 4. Tetra Hydro Furan 5.63 kg 5. 2,2‐Dimethoxy propane 2.79 kg 6. Ketroreducatse YDH/KRED 0.013 kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 Gram

Case No.:4/27/82‐ALC4/2008

Party Name:BEST VALUE CHEM PVT. LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01021/AM09/ RLA File :34/24/040/00109/AM09/ Lic.No/Date:3410022305 16.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 40

Case No.:6/27/82‐ALC4/2008

Party Name:CIPLA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01023/AM09/ RLA File :03/94/040/00586/AM09/ Lic.No/Date:0310486822 17.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 41

Case No.:7/27/82‐ALC4/2008

Party Name:GURUDEV DYESTUFF INDIA PVT.LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01024/AM09/ RLA File :08/24/040/00131/AM09/ Lic.No/Date:0810074790 17.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 42

Case No.:8/27/82‐ALC4/2008

Party Name:VIJAYASRI ORGANICS LTD 30.09.2008 Status:Case Approved HQ File :01/82/050/01025/AM09/ RLA File :09/24/040/00031/AM09/ Lic.No/Date:0910035304 18.09.2008 Decision :Committee considered case as per agenda and in light of its earlier decision taken in its 1/09 meeting held on 01.04.2008 vide Case No.A‐17 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed 2‐Butyl‐5‐Chloro‐3H‐Imidazole‐ 4‐Carbaldehyde (IMAL) 1 Kg. 1. Valeronitrile 1.19 kg 2. Methanol 1.08 kg 3. Glycine 0.80 kg 4. Toluene 1.50 kg 5. Dimethyl Formamide 1.16 kg 6. Methyl Cyclohexane 2.00 kg

Case No.:9/27/82‐ALC4/2008

Party Name:HETERO DRUGS LIMITED, 30.09.2008 Status:Case Deferred HQ File :01/82/050/01026/AM09/ RLA File :09/24/040/00260/AM09/ Lic.No/Date:0910035312 18.09.2008 Defer Date:29.10.2008 44

Case No.:10/27/82‐ALC4/2008

Party Name:SAINOR LABORATORIES PVT LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/01027/AM09/ RLA File :09/24/040/00251/AM09/ Lic.No/Date:0910035319 18.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 45

Case No.:11/27/82‐ALC4/2008

Party Name:NEULAND LABORATORIES LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/01028/AM09/ RLA File :09/24/040/00256/AM09/ Lic.No/Date:0910035320 18.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 46

Case No.:12/27/82‐ALC4/2008

Party Name:CIPLA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01029/AM09/ RLA File :03/94/040/00619/AM09/ Lic.No/Date:0310486904 18.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 47

Case No.:14/27/82‐ALC4/2008

Party Name:MADAUS PHARMACEUTICALS PRIVATE LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01031/AM09/ RLA File :17/24/040/00070/AM09/ Lic.No/Date:1710002175 19.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm.

Case No.:17/27/82‐ALC4/2008

Party Name:ORGANICA AROMATICS PVT LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/01034/AM09/ RLA File :07/24/040/00280/AM09/ Lic.No/Date:0710059944 19.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 49

Case No.:20/27/82‐ALC4/2008

Party Name:CIPLA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01037/AM09/ RLA File :03/94/040/00620/AM09/ Lic.No/Date:0310487080 19.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 50

Case No.:21/27/82‐ALC4/2008

Party Name:AVIK PHARMACEUTICAL LTD., 30.09.2008 Status:Case Approved HQ File :01/82/050/01038/AM09/ RLA File :03/94/040/00346/AM09/ Lic.No/Date:0310487169 19.09.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/16/2008‐PI‐III dated 17.07.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Ethisterone 1 Kg 1. 4‐Androstene 3,17 Dione 1.072 kg RA concerned may take further necessary action asa per above decision of NC. 51

Case No.:22/27/82‐ALC4/2008

Party Name:AVIK PHARMACEUTICAL LTD., 30.09.2008 Status:Case Approved HQ File :01/82/050/01039/AM09/ RLA File :03/94/040/00224/AM09/ Lic.No/Date:0310487171 19.09.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/16/2008‐PI‐III dated 17.07.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Ethisterone 1 Kg 1. 4‐Androstene 3,17 Dione 1.072 kg

RA concerned may take further necessary action asa per above decision of NC. 52

Case No.:13/27/82‐ALC4/2008

Party Name:AICO LABORATORIES INDIA LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01030/AM09/ RLA File :08/24/040/00136/AM09/ Lic.No/Date:0810074855 22.09.2008 Defer Date:11.11.2008 Decision :Committee decided to call for Production and Consumption data certified by Central Excise Authority from firm. Accordingly, case was deferred for 11.11.2008. 53

Case No.:15/27/82‐ALC4/2008

Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 30.09.2008 Status:Case Approved HQ File :01/82/050/01032/AM09/ RLA File :05/24/040/00345/AM09/ Lic.No/Date:0510227905 22.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐PI‐III dated 24.03.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐1,3‐ dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl (R)‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg 3. Tertiary Butyl Acetate 2.11 kg 4. Tetra Hydro Furan 5.63 kg 5. 2,2‐Dimethoxy propane 2.79 kg 6. Ketroreducatse YDH/KRED 0.013 kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 Gram 54

Case No.:16/27/82‐ALC4/2008

Party Name:PROMED EXPORTS PVT.LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01033/AM09/ RLA File :05/24/040/00413/AM09/ Lic.No/Date:0510227907 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm.

Case No.:18/27/82‐ALC4/2008

Party Name:CONCORD BIOTECH LTD 30.09.2008 Status:Case Deferred HQ File :01/82/050/01035/AM09/ RLA File :08/24/040/00138/AM09/ Lic.No/Date:0810074890 22.09.2008 Defer Date:11.11.2008 Decision :Committee decided to call for complete specification of import and export items from firm. Accordingly, case was deferred for 11.11.2008. 56

Case No.:19/27/82‐ALC4/2008

Party Name:BALAJI AMINES LIMITED 30.09.2008 Status:Case Approved HQ File :01/82/050/01036/AM09/ RLA File :31/24/040/00031/AM09/ Lic.No/Date:3110035472 22.09.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/51/2004/Ch.III dated 27.10.2005 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Diethyl Amino Ethanol 1 Kg. 1. Denatured Ethyl Alcohol 0.834 kg 2. Ammonia Anhydrous 0.154 kg 3. Ethylene Oxide 0.395 kg 57

Case No.:23/27/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01040/AM09/ RLA File :09/24/040/00240/AM09/ Lic.No/Date:0910035350 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 58

Case No.:24/27/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01041/AM09/ RLA File :09/24/040/00241/AM09/ Lic.No/Date:0910035351 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 59

Case No.:25/27/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED Status:Case

30.09.2008 Deferred HQ File :01/82/050/01042/AM09/ RLA File :09/24/040/00243/AM09/ Lic.No/Date:0910035352 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 60

Case No.:26/27/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01043/AM09/ RLA File :09/24/040/00236/AM09/ Lic.No/Date:0910035355 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 61

Case No.:27/27/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 30.09.2008 Status:Case Deferred HQ File :01/82/050/01044/AM09/ RLA File :09/24/040/00197/AM09/ Lic.No/Date:0910035356 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 62

Case No.:28/27/82‐ALC4/2008

Party Name:HETERO LABS LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01045/AM09/ RLA File :09/24/040/00249/AM09/ Lic.No/Date:0910035357 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 63

Case No.:29/27/82‐ALC4/2008

Party Name:HETERO LABS LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01046/AM09/ RLA File :09/24/040/00248/AM09/ Lic.No/Date:0910035358 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 64

Case No.:30/27/82‐ALC4/2008

Party Name:HETERO LABS LTD. 30.09.2008 Status:Case Deferred

HQ File :01/82/050/01047/AM09/ RLA File :09/24/040/00250/AM09/ Lic.No/Date:0910035359 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 65

Case No.:31/27/82‐ALC4/2008

Party Name:KAMUD DRUGS PVT.LIMITED., 30.09.2008 Status:Case Deferred HQ File :01/82/050/01048/AM09/ RLA File :31/24/040/00163/AM09/ Lic.No/Date:3110035487 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. 66

Case No.:32/27/82‐ALC4/2008

Party Name:DALAS BIOTECH LTD. 30.09.2008 Status:Case Deferred HQ File :01/82/050/01049/AM09/ RLA File :05/24/040/00386/AM09/ Lic.No/Date:0510227965 22.09.2008 Defer Date:11.11.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Date:01.10.2008 Place:New Delhi Shyam Lal Foreign Trade Development Officer

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