IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2009-11-24

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

MEETING NUMBER : 35/82‐ALC4/2009 MEETING DATE : 24.11.2009 The Meeting No.35/82 in the year 2009‐10 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 24.11.2009 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuticals 2. Shri Rajinder Pal Singh, Dy. DGFT 3. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.32/82 dated 03.11.2009 were ratified by the Committee.

Case No.B‐343

M/S Alembic Ltd. Norms Committee Meeting No.35/10 F.No. 01/87/050/00568/AM07 F.No.01/87/050/00569/AM07 Meeting Date:24.11.2009 RA F.No.34/24/040/00154/AM07 RA F.No.34/24/040/00155/AM07 Adv.Lic.No.3410016993 dated 25.09.2006 Adv.Lic.No.3410016999 dated 25.09.2006 Committee considered case as per agenda and observed that there are two written comments dated 18.04.2007 and 20.08.2007 of Department of Pharmaceutical for two different export products. It appears that there is some mix up during making the minutes of NC meeting. It was, therefore, decided to trace out both the written comments of Department of Pharmaceuticals and to examine the case on file. Accordingly, case was deferred for 22.12.2009.

Case No.B‐344

M/S Biostadt India Ltd. F.No. 01/83/050/00189/AM06 Adv.Lic.No.0310331549 dated 26.05.2005 Committee considered case as per agenda and perused the decision of NC meeting No.42/08 dated 23.01.2008 wherein it has been mentioned that it was decided with the approval of DGFT that the case may be placed before the Norms Committee. NC desired to confirm whether the case was shown to DGFT. Accordingly, it was decided to examine the case on file and defer the case for 22.12.2009.

Case No.B‐345

M/S Anuh Pharma Ltd. F.No. 01/82/050/00114/AM0o RA F.No.03/94/040/01081/AM08 Adv.Lic.No.0310459813 dated 01.02.2008

Adv.Lic.No.0310459813 dated 01.02.2008 Committee considered case as per agenda. Shri Bipin Shah, Managing Director and Shri G.C. Sharda, CEO of the company appeared before the Committee and explained the case. They informed that the item of import is Azithromycin Amine Crude while the export product is Azithromycin Amine Purified. Committee observed that in the application, description of export product has been given as “Azithromycin Amine Purified’ while in the shipping bills, the description of export product has been given as Azithromycin Amine. The representative of the firm further informed that they have got brand rate fixed on 28.07.2009 and 22.09.2009. They also informed that the Zonal Jt. DGFT, Mumbai has included the name of the firm in the DEL and they are facing problem for ge܂ng new advance authorization and hence their export are badly effected. They also informed that they are Export House Certificate holder and have fulfilled the export obligation against the instant advance licence. A䬀er detailed deliberations, Committee decided that a letter may be issued to Zonal Jt. DGFT, Mumbai advising them not to take any action against the firm in respect of instant advance licence 奱�ll the decision is taken by NC. It was also decided to call for Production and Consumption data certified by Central Excise Authority from firm. Accordingly, case was deferred for 05.01.2010.

Case No.B‐346

M/S Policy Division F.No. 01/82/162/00775/AM10 Committee considered case as per agenda and in compliance to DGFT order, it was decided to form sub groups in which Shri R.P. Singh, DDG, Shri Shyam Lal, FTDO and concerned technical authority will be included. Every sub‐group shall meet once in a week and will find out the SIONs which can be merged . As regards chemical export product, the products are common. Shri Shaish Kumar, IA, DIPP, Shri Jasbir Singh, IA, C&PC and Shri A.K. Agarwal, Jt. IA, C&PC were not present in the meeting. It was, therefore, decided to inform them to attend the meeting.

Case No.A‐164

M/S Sandoz Pvt. Ltd. F.No. 01/82/162/00859/AM09 RA F.NO.03/95/040/00518/AM09 Adv.Lic.No.0310485890 dated 10.09.2008 Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals.

Case No.A‐165

M/S Adcock Ingram Ltd F.No. 01/82/162/01219/AM09 RA F.NO.07/24/040/00619/AM09 Adv.Lic.No.0710063396 dated 03.03.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/82/2009‐PI‐III dated 26.10.2009 and in consultation with technical authority present in meeting 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

Export product Exp. Qty. Sl.No. Import items Qty. allowed Paracetamol 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Colour Yellow Amstead 14037 1.632 mg Paracetamol 450 mg + Caffeine 45 mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Colour Quiolin Yellow Lake 4.56 mg 3. Colour Quilolin Yellow WS 2.43 mg Paracetamol 450 mg + Caffeine 50 mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Colour Yellow Amstead 14037 Do not tally with master batch formula and hence not allowed Paracetamol 450 mg + Caffeine 45 mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Colour Green Appble Deep F 1569 2.00 mg RA concerned may take further necessary action as per above decision of NC.

Case No.A‐166

M/S Cipla Ltd F.No. 01/82/162/00107/AM10 RA F.NO.03/94/040/00994/AM09 Adv.Lic.No.0310505514 dated 04.02.2009 Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals.

Case No.A‐167

M/S Fleming Labs. Ltd. F.No. 01/82/162/01125/AM09 RA F.NO.09/24/040/00030/AM09 Adv.Lic.No.0910033923 dated 15.05.2008 Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals.

Case No.A‐168

M/S Cipla Ltd. F.No. 01/82/162/00110/AM10 RA F.NO.03/94/040/01006/AM09 Adv.Lic.No.0310505855 dated 05.02.2009 Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals.

Case No.A‐169

M/S Srini Pharmaceuticals Ltd.�

F.No. 01/82/162/01222/AM09 RA F.NO.03/95/040/00442/AM09 Adv.Lic.No.0910037267 dated 03.03.2009 Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals.

Case No.A‐170

M/S Unimark Remedies Ltd. F.No. 01/82/162/00859/AM09 RA F.NO.03/95/040/00095/AM09 Adv.Lic.No.0310494004 dated 12.11.2008 Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals. 1

Case No.:723/24/87‐ALC1/2007

Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:35/82‐ALC4/2009 24.11.2009 Status:Case Approved HQ File :01/87/050/01066/AM05/ RLA File :04/24/040/00038/AM05/ Lic.No/Date:0410057482 26.05.2004 Decision : Committee considered case as per agenda and in light of earlier decision taken in 25/06 meeting held on 27.09.2005 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 Exp. Qty. Sl.No. Import items Qty. allowed Phenyl Methyl Amino Propanol (PMAP) 1 Kg. 1. 5% Palladium on Carbon 0.06 kg 2. Paraformaldehyde 0.578 kg 3. Acetone 2.90 kg 4. Hexane 5.42 kg 5. DP2052 Tote bags As per packing policy 2

Case No.:17/19/83‐ALC1/2006

Party Name:SHASUN CHEMICALS & DRUGS LIMITED 24.11.2009 Status:Case Deferred HQ File :01/83/050/00438/AM07/ RLA File :04/24/040/00138/AM07/ Lic.No/Date:0410082941 19.07.2006 Defer Date:22.12.2009 Decision :Committee considered case as per agenda. The representative of Department of Pharmaceuticals informed the Committee that the advance licence is old one and they are searching out the written comments furnished during the relevant period. It was, therefore, decided to defer the case for 22.12.2009.

Case No.:165/39/83‐ALC1/2007

Party Name:ARCH PHARMALABS LTD 24.11.2009 Status:Case Approved HQ File :01/83/050/01744/AM08/ RLA File :03/94/040/00872/AM08/ Lic.No/Date:0310454009 14.12.2007 Decision : The Committee considered the case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U O

3 Decision : The Committee considered the case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/207/2006‐PI‐III dated 07.04.2008 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 Clopidogrel bisulphate 1 kg. 1. Couple amine Hcl 1.05 kg 2. Methanol 4.25 kg 3. Methylene dichloride 1.03 kg 4. Acetone 1.68 kg 5. Formic acid 0.185 kg 4

Case No.:10/28/82‐ALC4/2008

Party Name:LUPIN LIMITED 24.11.2009 HQ File :01/82/050/01059/AM09/ RLA File :03/95/040/00374/AM09/ Lic.No/Date:0310487704 24.09.2008 Defer Date:05.01.2010 Decision :Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 5

Case No.:54/1/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 24.11.2009 HQ File :01/82/050/01774/AM09/ RLA File :09/24/040/00460/AM09/ Lic.No/Date:0910037582 31.03.2009 Defer Date:22.12.2009 Decision :Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals. 6

Case No.:6/22/82‐ALC4/2009

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 24.11.2009 HQ File :01/82/050/00463/AM10/ RLA File :22/24/040/00076/AM09/ Lic.No/Date:2210008911 11.05.2009 Defer Date:22.12.2009 Decision : Committee decided to defer case for 22.12.2009 for comments of Department of Pharmaceuticals. 7

Case No.:13/21/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 24.11.2009 HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Defer Date:05.01.2010 Decision :Committee considered case as per agenda and decided to call for complete description of export product from firm. Accordingly, case was deferred for 05.01.2010. 8

Case No.:19/35/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 24.11.2009 HQ File :01/82/050/00709/AM10/ RLA File :09/24/040/00133/AM10/ Lic No/Date:0910038696 Defer

8 HQ File :01/82/050/00709/AM10/ RLA File :09/24/040/00133/AM10/ Lic.No/Date:0910038696 24.07.2009 Defer Date:22.12.2009 9

Case No.:21/35/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 24.11.2009 HQ File :01/82/050/00711/AM10/ RLA File :09/24/040/00127/AM10/ Lic.No/Date:0910038698 24.07.2009 Defer Date:22.12.2009 10

Case No.:22/35/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 24.11.2009 HQ File :01/82/050/00712/AM10/ RLA File :09/24/040/00130/AM10/ Lic.No/Date:0910038699 24.07.2009 Defer Date:22.12.2009 11

Case No.:16/35/82‐ALC4/2009

Party Name:HETERO LABS LTD. 24.11.2009 HQ File :01/82/050/00706/AM10/ RLA File :09/24/040/00158/AM10/ Lic.No/Date:0910038722 29.07.2009 Defer Date:22.12.2009 12

Case No.:24/35/82‐ALC4/2009

Party Name:CLARIANT CHEMICALS [INDIA] LTD 24.11.2009 Status:Case Approved HQ File :01/82/050/00714/AM10/ RLA File :03/94/040/00379/AM10/ Lic.No/Date:0310531791 31.07.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/32/2009‐Ch.II dated 23.11.2009, 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 Para Methoxy Benzoic Acid 1 kg. 1. P‐Hydroxy Benzoic Acid (PHBA) 1.01 kg 13

Case No.:13/35/82‐ALC4/2009

Party Name:HETERO LABS LTD. 24.11.2009 HQ File :01/82/050/00703/AM10/ RLA File :09/24/040/00162/AM10/ Lic.No/Date:0910038777 03.08.2009 Defer Date:22.12.2009

Case No.:14/35/82‐ALC4/2009

Party Name:HETERO LABS LTD. 24.11.2009 HQ File :01/82/050/00704/AM10/ RLA File :09/24/040/00173/AM10/ Lic.No/Date:0910038796 04.08.2009 Defer Date:22.12.2009 15

Case No.:17/35/82‐ALC4 / 2009

Party Name: MSN LABORATORIES LIMITED 24.11.2009 HQ File :01/82/050/00707/AM10/ RLA File :09/24/040/00123/AM10/ Lic.No/Date:0910038850 07.08.2009 Defer Date:22.12.2009 16

Case No.:18/35/82‐ALC4/2009

Party Name:MSN PHARMACHEM PRIVATE LIMITED 24.11.2009 HQ File :01/82/050/00708/AM10/ RLA File :09/24/040/00124/AM10/ Lic.No/Date:0910038853 07.08.2009 Defer Date:22.12.2009 17

Case No.:23/35/82‐ALC4/2009

Party Name:GURUDEV DYESTUFF INDIA PVT.LTD. 24.11.2009 Status:Case Approved HQ File :01/82/050/00713/AM10/ RLA File :08/24/040/00122/AM10/ Lic.No/Date:0810082309 13.08.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/9/2008‐Ch.II dated 30.06.2009, decided to reatify 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 4,4 Diamino Sulphanilide 1 kg. 1. Aniline Oil 0.458 kg 2. Acetic Acid 0.317 kg 3. Para nitro Aniline 0.728 kg 4. Caustic Soda Flakes 0.545 kg 5. Soda Ash 0.350 kg 18

Case No.:15/35/82‐ALC4/2009

Party Name:HETERO LABS LTD. 24.11.2009 HQ File :01/82/050/00705/AM10/ RLA File :09/24/040/00191/AM10/ Lic.No/Date:0910039017 18.08.2009 Defer Date:22.12.2009

Case No.:20/35/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 24.11.2009

19 HQ File :01/82/050/00710/AM10/ RLA File :09/24/040/00194/AM10/ Lic.No/Date:0910039023 18.08.2009 Defer Date:20.12.2009 20

Case No.:12/35/82‐ALC4/2009

Party Name:HETERO DRUGS LIMITED, 24.11.2009 HQ File :01/82/050/00702/AM10/ RLA File :09/24/040/00204/AM10/ Lic.No/Date:0910039063 24.08.2009 Defer Date:22.12.2009 21

Case No.:26/35/82‐ALC4/2009

Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD 24.11.2009 HQ File :01/82/050/00716/AM10/ RLA File :03/94/040/00366/AM10/ Lic.No/Date:0310535746 28.08.2009 Defer Date:22.12.2009 Decision : Committee decided to defer case for 22.12.2009 for comments of Department of C&PC. 22

Case No.:25/35/82‐ALC4/2009

Party Name:ENALTEC LABS PVT.LTD. 24.11.2009 HQ File :01/82/050/00715/AM10/ RLA File :03/94/040/00433/AM10/ Lic.No/Date:0310535974 01.09.2009 Defer Date:22.12.2009 23

Case No.:7/35/82‐ALC4/2009

Party Name:CIPLA LIMITED 24.11.2009 Status:Case Approved HQ File :01/82/050/00697/AM10/ RLA File :03/94/040/00479/AM10/ Lic.No/Date:0310536220 03.09.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 37/82 meeting held on 09.12.2008 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 per unit of export product Fluticasone Propionate Nasal Spray/Flomist Aqueous Nasal Spray/Flomist Nasal Spray (per pack 50 mcg/120 MD) 1 No. 1. Fluticasone Propionate 0.005 gm 2. 15 ml PP Transparent Vial As per packing policy 3. 100 mclNasal Pump As per packing policy 4. Nasal Acquator/Adeptor Wider Wing As per packing policy

Case No.:27/35/82‐ALC4/2009

Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 24 11 2009

24 24.11.2009 HQ File :01/82/050/00717/AM10/ RLA File :03/94/040/00477/AM10/ Lic.No/Date:0310537552 14.09.2009 Defer Date:22.12.2009 Decision : Committee decided to defer case for 22.12.2009 for comments of Department of C&PC. 25

Case No.:28/35/82‐ALC4/2009

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 24.11.2009 Status:Case Approved HQ File :01/82/050/00718/AM10/ RLA File :05/23/040/00015/AM10/ Lic.No/Date:0510249405 16.09.2009 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as applied by the firm with nil wastage. 26

Case No.:29/35/82‐ALC4/2009

Party Name:BELOOR BAYIR BIOTECH LTD, 24.11.2009 HQ File :01/82/050/00719/AM10/ RLA File :07/24/040/00223/AM10/ Lic.No/Date:0710067058 17.09.2009 Defer Date:22.12.2009 27

Case No.:8/35/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 24.11.2009 HQ File :01/82/050/00698/AM10/ RLA File :03/94/040/00510/AM10/ Lic.No/Date:0310538824 22.09.2009 Defer Date:22.12.2009 28

Case No.:1/35/82‐ALC4/2009

Party Name:NEON LABORATORIES LTD. 24.11.2009 HQ File :01/82/050/00691/AM10/ RLA File :03/95/040/00495/AM10/ Lic.No/Date:0310544646 09.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 29

Case No.:33/35/82‐ALC4/2009

Party Name:MADAUS PHARMACEUTICALS PRIVATE LIMITED 24.11.2009 HQ File :01/82/050/00723/AM10/ RLA File :17/24/040/00031/AM10/ Lic.No/Date:1710002843 09.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm.

Case No.:2/35/82‐ALC4/2009

Party Name:VDH INTERNATIONAL 24 11 2009

30 24.11.2009 HQ File :01/82/050/00692/AM10/ RLA File :05/24/040/00280/AM10/ Lic.No/Date:0510252129 10.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 31

Case No.:3/35/82‐ALC4/2009

Party Name:V.D.H. ORGANICS PVT. LTD 24.11.2009 HQ File :01/82/050/00693/AM10/ RLA File :05/24/040/00350/AM10/ Lic.No/Date:0510252131 10.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 32

Case No.:4/35/82‐ALC4/2009

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 24.11.2009 HQ File :01/82/050/00694/AM10/ RLA File :03/95/040/00365/AM10/ Lic.No/Date:0310544960 11.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 33

Case No.:5/35/82‐ALC4/2009

Party Name:GOPINATH CHEM‐TECH LTD., 24.11.2009 Status:Case Approved HQ File :01/82/050/00695/AM10/ RLA File :08/24/040/00103/AM10/ Lic.No/Date:0810084084 11.11.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/123/2005‐Ch.II dated 03.07.2007, decided to reatify 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 4,4‐Diamino diphenyl Amine 2‐Sulphonic Acid 1 kg. 1. Para Nitro Aniline 0.840 kg 2. Para Nitro Chloro Benzene 1.150 kg 3. Caustic Soda Lye (100% basis) OR Caustic Soda Flakes 2.300 kg 4. Soda Ash 0.500 kg 34

Case No.:6/35/82‐ALC4/2009

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:35/82‐ALC4/2009 24.11.2009 HQ File :01/82/050/00696/AM10/ RLA File :05/24/040/00339/AM10/ Lic.No/Date:0510252282 11.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm.

Case No.:9/35/82‐ALC4/2009

Party Name:SHILPA MEDICARE LTD., 24.11.2009 HQ File :01/82/050/00699/AM10/ RLA File :07/24/040/00298/AM10/ Lic.No/Date:0710068187 11.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 36

Case No.:10/35/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 24.11.2009 Status:Case Approved HQ File :01/82/050/00700/AM10/ RLA File :09/24/040/00245/AM10/ Lic.No/Date:0910039881 12.11.2009 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 37

Case No.:11/35/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 24.11.2009 Status:Case Approved HQ File :01/82/050/00701/AM10/ RLA File :09/24/040/00313/AM10/ Lic.No/Date:0910039882 12.11.2009 Decision : Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 38

Case No.:30/35/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 24.11.2009 Status:Case Approved HQ File :01/82/050/00720/AM10/ RLA File :09/24/040/00220/AM10/ Lic.No/Date:0910039890 12.11.2009 Decision : Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 39

Case No.:31/35/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 24.11.2009 HQ File :01/82/050/00721/AM10/ RLA File :09/24/040/00306/AM10/ Lic.No/Date:0910039891 12.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. 40

Case No.:32/35/82‐ALC4/2009

Party Name:SMILAX LABORATORIES LIMITED 24.11.2009 HQ File :01/82/050/00722/AM10/ RLA File :09/24/040/00299/AM10/ Lic.No/Date:0910039896 12.11.2009 Defer Date: 05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm.

Case No.:34/35/82‐ALC4/2009

Party Name:WOCKHARDT LIMITED 24.11.2009 HQ File :01/82/050/00724/AM10/ RLA File :03/95/040/00448/AM10/ Lic.No/Date:0310545253 12.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 05.01.2010. 42

Case No.:35/35/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 24.11.2009 HQ File :01/82/050/00725/AM10/ RLA File :03/94/040/00587/AM10/ Lic.No/Date:0310545337 12.11.2009 Defer Date:05.01.2010 Decision : Committee decided to call for a copy of application, copy of Advance Authorisation, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 05.01.2010. ****************************

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