IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2008-04-14

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

MEETING NUMBER : 2/82‐ALC4/2009 MEETING DATE : 14.04.2009 The Mee捀�ng No.2/82 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 14.04.2009 was actually held on 12.05.2009 under the Chairmanship of Jt. DGFT, Shri Anil Aggarwal in his chamber. Following members were present:‐ 1. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 2. Shri Rajinder Pal Singh, Dy. DGFT 3. Shri Shyam Lal, FTDO

Case No.B‐9

M/S Suven Life Science Ltd. Norms Commi掀�ee Mee捀�ng No.2/10 F.No.01/83/050/01017/AM07 Mee捀�ng Date:08.04.2009 RA. F.No.09/24/040/00368/AM07 Adv.Lic.No.0910028637 dated 13.12.2006 Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded byDepartment of Pharmaceu捀�cals vide their U.O. No.35011/73/2009‐PI‐III dated 25.02.2009 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 Exp. Qty. Sl.No. Import items Qty. allowed (2‐Chloro‐5‐Iodo Phenyl)(4‐Fluoro Phenyl) Methanone 1 Kg. 1. 2‐Chloro‐5‐Iodobenzoicacid 0.95 kg 2. Fluoro Benzene 1.49 kg 3. Methyl Ter捀�ary Butyl Ether 0.72 kg 4. Iso Propyl Alcohol 1.425 kg RA concerned may take further necessary ac捀�on as per above decision of NC.

Case No.B‐10

M/S Cipla Ltd F.No.01/82/050/00406/AM08 F.No.01/82/050/00408/AM08 F.No.01/82/050/00110/AM09 RA. F.No.03/94/040/00250/AM08 F.No.03/94/040/00383/AM08 F.No.03/94/040/01099/AM08 Adv.Lic.No.0310432136 dated 08.06.2007

Adv.Lic.No.0310436156 dated 13.07.2008 Adv.Lic.No.0310459961 dated 04.02.2008 Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐11

M/S Cipla Ltd F.No.01/82/050/00443/AM08 RA. F.No.03/94/040/00797/AM08 Adv.Lic.No.0310448512 dated 31.10.2007 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.35011/215/2008‐PI‐III dated 17.03.2009 and in consulta捀�on with technical authority present in mee捀�ng decided to allow import of N‐Heptane to the extent of 3.46 kg/kg of export product without any other change in the decision of NC taken in 3/82 mee捀�ng held on 15.04.2008.

Case No.B‐12

M/S Cipla Ltd F.No.01/82/050/00447/AM08 RA. F.No.03/94/040/00860/AM08 Adv.Lic.No.0310450692dated 19.11.2007 Commi掀�ee decided to forward a copy of applica捀�on along with a copy of representa捀�on to Department of Pharmaceu捀�cals for their comments. Accordingly, case was deferred for 09.06.2009.

Case No.B‐13

M/S Cipla Ltd F.No.01/82/050/00446/AM08 RA. F.No.03/94/040/00857/AM08 Adv.Lic.No.0310450548 dated 16.11.2007 Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐14

M/S Glenmark Pharma Ltd F.No.01/82/050/00627/AM05 RA. F.No.03/24/040/00389/AM05 Adv.Lic.No.0310274399 dated 16.06.2004 Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals.

Case No.B‐15

M/S Glenmark Pharma Ltd. F.No.01/82/050/01531/AM08

RA. F.No.03/94/040/00806/AM08 Adv.Lic.No.0310449259 dated 06.11.2007 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.35011/102/2006‐PI‐III dated 18.04.2007 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 Amiodarone Hcl 1 Kg. 1. 2‐Butyl‐3‐(3,5‐Diiodo‐4‐Hydroxybenzoyl Benzofuran 1.04 kg 2. Iso Propyl Alcohol 0.75 kg 3. Toluene 1.95 kg

Case No.B‐16

M/S Phaarmasia Ltd F.No.01/82/050/00613/AM09 RA. F.No.09/24/040/00041/AM09 Adv.Lic.No.0910034054 dated 23.05.2008 Commi掀�ee considered case as per agenda 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 Oral Contracep捀�ve Pills 1 No. 1. Norgestrel USP 0.3 mg 2. Ethinyl Estradiol USP 0.03 mg

Case No.B‐17

M/S Aar捀� Industries Ltd. F.No.01/82/050/00840/AM09 RA. F.No.03/94/040/00405/AM09 Adv.Lic.No.0310481261 dated 05.08.2008 Commi掀�ee considered case as per agenda and observed that the adhoc norms has been fixed on the basis of yield, molecular weight and compara捀�ve data of other firm as s捀�pulated in Policy Circular No.20. It was, therefore, decided to close the case for enhancement in the quan捀�ty of inputs.

Case No.B‐18

M/S Sterling Auxiliaries Pvt. Ltd. F.No.01/82/050/00449/AM08

RA. F.No.03/95/040/00634/AM08 Adv.Lic.No.0310450751 dated 20.11.2007 Commi掀�ee decided to defer case for 09.06.2009 for comments of C&PC. 1

Case No.:800/24/83‐ALC1/2007

Party Name:RANBAXY LABORATORIES LTD Meet No/Date:2/82‐ALC4/2009 14.04.2009 Status:Case Deferred HQ File :01/83/050/00758/AM08/ RLA File :05/24/040/00285/AM08/ Lic.No/Date:0510206332 16.07.2007 Defer Date:09.06.2009 Decision :Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals. 2

Case No.:6/9/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 14.04.2009 Status:Case Approved HQ File :01/82/050/00239/AM09/ RLA File :09/24/040/00243/AM08/ Lic.No/Date:0910031765 12.10.2007 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.35011/262/2008‐ PI‐III dated 24.03.2009 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 Efavirenz stage‐V ((S)‐5‐Chloro‐ (cyclopropylethynyl)‐2‐amino‐ (trifluoromethyl) Benzenemethanol)MMAA‐1 1 Kg. 1. Tetramethylethylenediamine 0.623 kg 2. Cyclopropyl Acetylene 0.48 kg 3. Sodium Borohydride 0.047 kg 4. Triphosgene 0.433 kg 5. N‐Heptane 0.032 kg 6. Iso Propyl Alcohol 0.065 kg 7. DDQ (2,3‐Dichloro 5,6‐Dicyano 1,4‐ Benzoquinone) 0.175 kg 8. Methanol 0.076 kg 9. Tetrahydrofuran 2.57 kg 10. Acetonitrile 1.26 kg 11. Trifluoroace捀�c acid 0.719 kg 12. N‐Hexane 3.03 kg 13. Methylene Chloride 0.66 kg 3

Case No.:7/45/82‐ALC4/2007

Party Name:METROCHEM API PVT. LTD. 14.04.2009 Status:Case Deferred

HQ File :01/82/050/00470/AM08/ RLA File :09/24/040/00456/AM08/ Lic.No/Date:0910032740 28.01.2008 Defer Date:09.06.2009 Decision :Commi掀�ee decided to forward a copy of applica捀�on alongwith a copy of representa捀�on to Department of Pharmaceu捀�cals for their comments. Accordingly, case was deferred for 09.06.2009. 4

Case No.:17/46/82‐ALC4/2007

Party Name:ARCH PHARMALABS LTD 14.04.2009 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:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals. 5

Case No.:57/6/82‐ALC4/2008

Party Name:CORAL DRUGS PVT. LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/00140/AM09/ RLA File :05/24/040/00884/AM08/ Lic.No/Date:0510217198 28.02.2008 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of MSME. 6

Case No.:6/13/83‐ALC1/2008

Party Name:VASUDHA PHARMA CHEM LTD 14.04.2009 Status:Case Deferred HQ File :01/83/050/00357/AM09/ RLA File :09/24/040/00335/AM08/ Lic.No/Date:0910033373 17.03.2008 Defer Date:09.06.2009 7

Case No.:62/9/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 14.04.2009 Status:Case Deferred HQ File :01/83/050/00234/AM09/ RLA File :03/94/040/01245/AM08/ Lic.No/Date:0310466401 27.03.2008 Defer Date:09.06.2009 8

Case No.:21/13/82‐ALC4/2008

Party Name:CORAL DRUGS PVT. LTD., 14.04.2009 Status:Case Rejected HQ File :01/82/050/00528/AM09/ RLA File :05/24/040/00981/AM08/ Lic.No/Date:0510218739 31.03.2008 Decision :Commi掀�ee considered case as per agenda and observed that firm has failed to furnish informa捀�on called for vide le掀�er dated 17.02.2009. It was decided to close the case.

RA concerned may take ac捀�on accordingly. 9

Case No.:77/11/82‐ALC4/2008

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 14.04.2009 Status:Case Deferred HQ File :01/82/050/00397/AM09/ RLA File :07/24/040/00883/AM08/ Lic.No/Date:0710056843 09.04.2008 Defer Date:09.06.2009 10

Case No.:7/16/82‐ALC4/2008

Party Name:LAFFANS PETROCHEMICALS LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/00700/AM09/ RLA File :03/95/040/00209/AM09/ Lic.No/Date:0310473617 09.06.2008 Decision : Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of C&PC vide their O.M. No.46011/05/2007‐PC.II dated 09.04.2009 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 Polyethylene Glycol 4000 (PEG 4000) 1 MT. 1. Polyethylene Glycol 400 0.102 MT 2. Ethylene Oxide 0.918 MT 11

Case No.:5/15/82‐ALC4/2008

Party Name:LAFFANS PETROCHEMICALS LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/00645/AM09/ RLA File :03/95/040/00276/AM09/ Lic.No/Date:0310475880 23.06.2008 Decision : Commi掀�ee considered case as per agenda and in light of wri掀�en comments forwarded by Department of C&PC vide their O.M. No.46011/05/2007‐PC.II dated 09.04.2009 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 Polyethylene Glycol 1500 (PEG 1500) 1 MT. 1. Polyethylene Glycol 400 0.2545 MT 2. Ethylene Oxide 0.7655 MT 12

Case No.:18/18/82‐ALC4/2008

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 14.04.2009 Status:Case Approved

HQ File :01/82/050/00771/AM09/ RLA File :04/24/040/00090/AM09/ Lic.No/Date:0410097323 21.07.2008 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.35011/217/2008‐ PI‐III dated 16.04.2009 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 Thioridazine Hcl 1 Kg. 1. Pipridine‐2‐Ethanol 0.75 kg 2. 3‐Methyl Mercapto Aniline 2.40 kg 13

Case No.:24/20/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 14.04.2009 Status:Case Approved HQ File :01/82/050/00817/AM09/ RLA File :09/24/040/00140/AM09/ Lic.No/Date:0910034848 30.07.2008 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.35011/192/2008‐ PI‐III dated 08.04.2009 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 Oxacarbazepine 1 Kg. 1. 10‐Methoxy Imino S捀�lbene 1.26 kg 2. DL Mandelic Acid 2.58 kg 3. Methylene dichloride 3.84 kg 4. Iso propyl Alcohol 2.23 kg 5. Methanol 1.70 kg 14

Case No.:38/20/82‐ALC4/2008

Party Name:DR REDDYS LABORATORIES LTD 14.04.2009 Status:Case Approved HQ File :01/82/050/00831/AM09/ RLA File :09/24/040/00166/AM09/ Lic.No/Date:0910034905 01.08.2008 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.35011/173/2008‐ PI‐III dated 16.04.2009 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 Irinotecan Hcl Tryhydrate 1 Kg. 1. Camptothecin 3.20 kg

Case No.:1/21/82‐ALC4/2008

Party Name:AROMA AROMATICS & FLAVOURS 14.04.2009 Status:Case Deferred HQ File :01/82/050/00856/AM09/ RLA File :05/24/040/00274/AM09/ Lic.No/Date:0510225070 07.08.2008 Defer Date:09.06.2009 Decision :Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was deferred for 09.06.2009. It was, therefore, decided to defer the case for 09.06.2009. 16

Case No.:7/22/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/00870/AM09/ RLA File :03/94/040/00393/AM09/ Lic.No/Date:0310481979 08.08.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 17

Case No.:10/39/82‐ALC4/2008

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 14.04.2009 Status:Case Deferred HQ File :01/82/050/01380/AM09/ RLA File :03/94/040/00214/AM09/ Lic.No/Date:0310482603 14.08.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 18

Case No.:23/22/82‐ALC4/2008

Party Name:ALMELO CHEMICALS(P) LTD., 14.04.2009 Status:Case approved HQ File :01/82/050/00886/AM09/ RLA File :09/24/040/00105/AM09/ Lic.No/Date:0910035079 14.08.2008 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.35011/261/2008‐ PI‐III dated 24.03.2009 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 Export Qty. Sl.No. Import item Qty. allowed (S)‐N‐Tert‐1,2,3,4‐ Tetrahydroisouinoline‐3‐ Carboxamide 1 Kg 1. L‐Phenyl Alanine 1.18 kg 2. Hydrobromic Acid 48% in water 2.65 kg 3. Benzyl chloroformate 1.526 kg 4. Tert. Butyl Amine 1.46 kg

Case No.:39/22/82‐ALC4/2008

Party Name:CIPLA LIMITED 14.04.2009 Status Case Deferred HQ File :01/82/050/00902/AM09/ RLA File :03/94/040/00451/AM09/ Lic.No/Date:0310482900 18.08.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 20

Case No.:2/24/82‐ALC4/2008

Party Name:TECKBOND LABORATORIES PVT. LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/00935/AM09/ RLA File :09/24/040/00227/AM09/ Lic.No/Date:0910035160 28.08.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 21

Case No.:11/24/82‐ALC4/2008

Party Name:ASTRIX LABORATORIES LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/00944/AM09/ RLA File :09/24/040/00088/AM09/ Lic.No/Date:0910035174 29.08.2008 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered and approved by NC in its 1/82 mee捀�ng held on 12.05.2009. It was, therefore, decided to withdraw the case. 22

Case No.:15/24/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/00948/AM09/ RLA File :09/24/040/00228/AM09/ Lic.No/Date:0910035181 29.08.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 23

Case No.:22/24/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 14.04.2009 Status:Case Approved HQ File :01/82/050/00955/AM09/ RLA File :03/95/040/00435/AM09/ Lic.No/Date:0310484735 01.09.2008 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered and approved by NC in its 1/82 mee捀�ng held on 12.05.2009. It was, therefore, decided to withdraw the case.

Case No.:5/25/82‐ALC4/2008

Party Name:RAY CHEMICALS PRIVATE LIMITED, 14.04.2009 Status:Case Deferred HQ File :01/82/050/00985/AM09/ RLA File :07/24/040/00301/AM09/ Lic.No/Date:0710059596 08.09.2008 Defer Date: 09.06.2009 25

Case No.:19/26/82‐ALC4/2008

Party Name:R L FINE CHEM 14.04.2009 Status:Case Deferred HQ File :01/82/050/01017/AM09/ RLA File :07/24/040/00297/AM09/ Lic.No/Date:0710059800 15.09.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 26

Case No.:2/27/82‐ALC4/2008

Party Name:AUCTUS PHARMA LIMITED 14.04.2009 Status:Case Approved HQ File :01/82/050/01019/AM09/ RLA File :09/24/040/00216/AM09/ Lic.No/Date:0910035277 16.09.2008 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.35011/233/2008‐ 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 Losartan (2‐Butyl‐4‐Chloro‐1‐ [(2’‐2’‐(2’‐Triphenylmethyl‐2H‐ Tetrazole‐5‐yl)‐1,1’‐Biphenyl‐4‐ yl)Methyl]‐1H‐Imidazole‐5‐ Methanol) 1 Kg. 1. 5‐(4’‐Bromomethyl‐1‐1’ Bephenyl‐2 yl)2‐Triphenylmethyl‐2H‐Tetrazole 1.183 kg 2. 2‐Butyl‐4‐chloro‐5‐Formaldehyde Imidazole 0.42 kg 3. Sodium Borohydride 0.092 kg 4. 1‐Chlorobutane 1.90 kg 27

Case No.:2/28/82‐ALC4/2008

Party Name:VISHNU CHEMICALS LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01051/AM09/ RLA File :09/24/040/00479/AM08/ Lic.No/Date:0910035368 23.09.2008 Defer Date:09.06.2009

Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 28

Case No.:3/28/82‐ALC4/2008

Party Name:VISHNU CHEMICALS LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01052/AM09/ RLA File :09/24/040/00478/AM08/ Lic.No/Date:0910035370 23.09.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 29

Case No.:4/28/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01053/AM09/ RLA File :09/24/040/00245/AM09/ Lic.No/Date:0910035373 23.09.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 30

Case No.:5/28/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01054/AM09/ RLA File :09/24/040/00242/AM09/ Lic.No/Date:0910035376 23.09.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 31

Case No.:13/28/82‐ALC4/2008

Party Name:LUPIN LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01062/AM09/ RLA File :03/95/040/00515/AM09/ Lic.No/Date:0310487728 24.09.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 32

Case No.:15/28/82‐ALC4/2008

Party Name:MEDREICH LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01064/AM09/ RLA File :07/24/040/00340/AM09/ Lic.No/Date:0710060093 24.09.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was

Case No.:30/28/82‐ALC4/2008

Party Name:VINEET LABORATORIES PRIVATE LIMITED 14.04.2009 Status:Case Approved HQ File :01/82/050/01079/AM09/ RLA File :09/24/040/00211/AM09/ Lic.No/Date:0910035468 29.09.2008 Decision : Withdrawn as the case has already approved by NC in its 1/82 mee捀�ng held on 12.05.2009. 34

Case No.:21/29/82‐ALC4/2008

Party Name:MECK PHARMACEUTICALS AND CHEMICALS PVT.LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01103/AM09/ RLA File :08/24/040/00107/AM09/ Lic.No/Date:0810075122 01.10.2008 Defer Date: 09.06.2009 35

Case No.:32/29/82‐ALC4/2008

Party Name:PAUSHAK LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01114/AM09/ RLA File :34/24/040/00115/AM09/ Lic.No/Date:3410022467 06.10.2008 Defer Date:09.06.2009 36

Case No.:50/29/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/01132/AM09/ RLA File :03/94/040/00655/AM09/ Lic.No/Date:0310489368 07.10.2008 Defer Date:23.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and it was decided to call for technical details as per Appendix 33 and defer the case for 23.06.2009. It was, therefore, decided to defer the case for 23.06.2009. 37

Case No.:3/31/82‐ALC4/2008

Party Name:PI INDUSTRIES LTD., 14.04.2009 HQ File :01/82/050/01160/AM09/ RLA File :13/24/040/00012/AM09/ Lic.No/Date:1310027186 16.10.2008 38

Case No.:10/32/82‐ALC4/2008

Party Name:IPCA LABORATORIES LIMITED 14.04.2009 Status:Case Approved Lic.No/Date:0310491361

HQ File :01/82/050/01185/AM09/ RLA File :03/94/040/00592/AM09/ 21.10.2008 Decision : Withdrawn as the case has already been approved by NC in its 1/82 mee捀�ng held on 12.05.2009. 39

Case No.:9/32/82‐ALC4/2008

Party Name:VITAL HEALTHCARE PVT.LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01184/AM09/ RLA File :03/95/040/00523/AM09/ Lic.No/Date:0310491293 21.10.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 40

Case No.:16/32/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 14.04.2009 Status:Case Deferred HQ File :01/82/050/01191/AM09/ RLA File :09/24/040/00368/AM08/ Lic.No/Date:0910035688 22.10.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 41

Case No.:24/32/82‐ALC4/2008

Party Name:R L FINE CHEM 14.04.2009 Status:Case Deferred HQ File :01/82/050/01199/AM09/ RLA File :07/21/040/00724/AM09/ Lic.No/Date:0710060647 23.10.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 42

Case No.:31/32/82‐ALC4/2008

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 14.04.2009 Status:Case Approved HQ File :01/82/050/01206/AM09/ RLA File :03/94/040/00662/AM09/ Lic.No/Date:0310491961 24.10.2008 Decision : Withdrawn as the case has already been approved by NC in its 1/82 mee捀�ng held on 12.05.2009. 43

Case No.:32/32/82‐ALC4/2008

Party Name:PI INDUSTRIES LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01207/AM09/ RLA File :13/24/040/00014/AM09/ Lic.No/Date:1310027220 24.10.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was

Case No.:37/32/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/01212/AM09/ RLA File :05/24/040/00465/AM09/ Lic.No/Date:0510229949 24.10.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 45

Case No.:38/32/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/01213/AM09/ RLA File :05/24/040/00466/AM09/ Lic.No/Date:0510229951 24.10.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 46

Case No.:2/33/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 14.04.2009 HQ File :01/82/050/01218/AM09/ RLA File :09/24/040/00143/AM09/ Lic.No/Date:0910035793 30.10.2008 47

Case No.:10/33/82‐ALC4/2008

Party Name:SI GROUP INDIA LIMITED 14.04.2009 HQ File :01/82/050/01226/AM09/ RLA File :03/95/040/00306/AM08/ Lic.No/Date:0310492305 31.10.2008 48

Case No.:16/33/82‐ALC4/2008

Party Name:GLENMARK GENERICS LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01232/AM09/ RLA File :03/94/040/00686/AM09/ Lic.No/Date:0310492445 31.10.2008 Defer Date:09.06.2009 49

Case No.:9/33/82‐ALC4/2008

Party Name:SI GROUP INDIA LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01225/AM09/ RLA File :03/95/040/00305/AM08/ Lic.No/Date:0310492297 Defer

31.10.2008 Date:09.06.2009 50

Case No.:20/33/82‐ALC4/2008

Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01236/AM09/ RLA File :09/24/040/00305/AM09/ Lic.No/Date:0910035843 05.11.2008 Defer Date:09.06.2009 51

Case No.:26/33/82‐ALC4/2008

Party Name:SMILAX LABORATORIES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01242/AM09/ RLA File :09/24/040/00303/AM09/ Lic.No/Date:0910035860 06.11.2008 Defer Date:09.06.2009 52

Case No.:27/33/82‐ALC4/2008

Party Name:SMILAX LABORATORIES LIMITED 14.04.2009 Status:Case Approved HQ File :01/82/050/01243/AM09/ RLA File :09/24/040/00285/AM09/ Lic.No/Date:0910035861 06.11.2008 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.35011/177/2008‐ PI‐III dated 21.04.2009 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 2‐Butyl‐4‐Chloro‐1[2‐3‐ Triphenylmethyl‐1‐1H‐Tetrazole‐ 2‐YL)[1,1‐Biphenyl‐4‐ YL]Methyl]1H Imidazole‐5‐ Methanol (Trityl Losartan) 1 Kg. 1. 2‐Cyano‐4‐Methyl Bisphenyl 0.57 kg 2. Hyden捀�oin Not directly used in the process. Hence not allowed 3. Methylene dichloride 1.74 kg 4. 2,2‐Azobisisobutyronitrile 0.037 kg 5. 2n‐Butyl‐4‐chloro‐5‐formyl‐1H‐ Imidazole 0.37 kg 6. Toluene 1.65 kg 7. Sodium Borohydride 0.04 kg 8. Methanol 0.28 kg 9. N‐Methyl Pyrrolidine 0.37 kg 10. Sodium Azide 0.248 kg

Trityl chloride 0.59 kg 12. Triethylamine 0.196 kg 53

Case No.:12/34/82‐ALC4/2008

Party Name:HETERO DRUGS LIMITED, 14.04.2009 Status:Case Deferred HQ File :01/82/050/01255/AM09/ RLA File :09/24/040/00319/AM09/ Lic.No/Date:0910035873 07.11.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 54

Case No.:3/34/82‐ALC4/2008

Party Name:ATUL LIMITED, 14.04.2009 Status:Case Deferred HQ File :01/82/050/01246/AM09/ RLA File :08/24/040/00159/AM09/ Lic.No/Date:0810075840 07.11.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 55

Case No.:19/35/82‐ALC4/2008

Party Name:VIJAYASRI ORGANICS LTD 14.04.2009 Status:Case Deferred HQ File :01/82/050/01275/AM09/ RLA File :09/24/040/00287/AM09/ Lic.No/Date:0910035950 17.11.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 56

Case No.:9/36/82‐ALC4/2008

Party Name:SMRUTHI ORGANICS LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01295/AM09/ RLA File :31/24/040/00215/AM09/ Lic.No/Date:3110036143 20.11.2008 Defer Date:09.06.2009 57

Case No.:21/36/82‐ALC4/2008

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 14.04.2009 Status:Case Approved HQ File :01/82/050/01307/AM09/ RLA File :03/94/040/00759/AM09/ Lic.No/Date:0310495213 21.11.2008

Decision : 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.14010/50/2006‐Ch.II dated 13.04.2009 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 DA 2313 An捀�foluant Containing: 10% of Penta (2 Methylene‐4‐ Nonyl Phenol) TEPA adduct 15% of 2,6 diter捀�ary butyl‐4‐ Benzolidene‐2‐5‐dione 25% of 4,4(1,1‐Di ox 0‐1, 10‐ Decanedyl) Bis(2,2,6 tetramethyl‐1‐Piperridine‐N‐ Oxyl) 50 of Aroma捀�c Solvent 1 Kg. 1. Nonyl Phenol 0.0329 kg 2. Tetra ethylene Penta Amine 0.0141 kg 3. Para Formaldehyde 0.00483 kg 4. 2,4 Diter捀�ary Butyl Phenol 0.1031 kg 5. Benzaldehyde 0.0529 kg 6. 4 Hydroxy Tempo (4 Hydroxy 2,2,6,6 Tetramethyl Piperridine‐N‐Oxyl) 0.129 kg 7. Dimethyl Sebacate 0.172 kg 8. Dibutyl 捀�n Oxide 0.0073 kg 9. Methanol 0.456 kg 10. Aroma捀�c Solvent (C10 – C20) 0.500 kg 11. Dipropyl Amine Not Allowed 58

Case No.:25/36/82‐ALC4/2008

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 14.04.2009 Status:Case Deferred HQ File :01/82/050/01311/AM09/ RLA File :31/24/040/00407/AM08/ Lic.No/Date:3110036184 21.11.2008 Defer Date:09.06.2009 59

Case No.:22/37/82‐ALC4/2008

14.04.2009 Status:Case Rejected HQ File :01/82/050/01341/AM09/ RLA File :03/94/040/00796/AM09/ Lic.No/Date:0310496207 02.12.2008 Decision :Commi掀�ee considered case as per agenda and observed that the firm was requested to furnish technical details vide le掀�er dated 01.04.2009, but no reply has been received and norms can not be fixed in absence of required technical details. It was, therefore, decided to close the case. 60

Case No.:4/38/82‐ALC4/2008

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 14.04.2009 Status:Case Deferred

HQ File :01/82/050/01353/AM09/ RLA File :09/24/040/00337/AM09/ Lic.No/Date:0910036194 04.12.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 61

Case No.:6/38/82‐ALC4/2008

Party Name:IPCA LABORATORIES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01355/AM09/ RLA File :03/94/040/00763/AM09/ Lic.No/Date:0310496492 04.12.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 62

Case No.:7/38/82‐ALC4/2008

Party Name:IPCA LABORATORIES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01356/AM09/ RLA File :03/94/040/00762/AM09/ Lic.No/Date:0310496493 04.12.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 63

Case No.:18/38/82‐ALC4/2008

Party Name:UNITED PHOSPHORUS LTD. 14.04.2009 Status:Case Approved HQ File :01/82/050/01367/AM09/ RLA File :03/95/040/00701/AM09/ Lic.No/Date:0310496938 08.12.2008 Decision : Withdrawn as case has already been approved by NC in 1/82 mee捀�ng held on 12.05.2009. 64

Case No.:19/39/82‐ALC4/2008

Party Name:VITAL HEALTHCARE PVT.LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01389/AM09/ RLA File :03/95/040/00662/AM09/ Lic.No/Date:0310497192 10.12.2008 Defer Date:09.06.2009 65

Case No.:13/39/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/01383/AM09/ RLA File :05/24/040/00527/AM09/ Lic.No/Date:0510232365 11.12.2008 Defer Date:09.06.2009

Case No.:23/39/82‐ALC4/2008

Party Name:LUPIN LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01393/AM09/ RLA File :03/95/040/00685/AM09/ Lic.No/Date:0310497268 11.12.2008 Defer Date:09.06.2009 67

Case No.:30/39/82‐ALC4/2008

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/01400/AM09/ RLA File :03/95/040/00722/AM09/ Lic.No/Date:0310497318 11.12.2008 Decision : Withdrawn as case has already been approved by NC in its 1/82 mee捀�ng held on 12.05.2009. 68

Case No.:1/40/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01420/AM09/ RLA File :08/24/040/00187/AM09/ Lic.No/Date:0810076754 16.12.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 69

Case No.:47/39/82‐ALC4/2008

Party Name:DR REDDYS LABORATORIES LTD 14.04.2009 HQ File :01/82/050/01417/AM09/ RLA File :09/24/040/00355/AM09/ Lic.No/Date:0910036324 16.12.2008 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 70

Case No.:10/40/82‐ALC4/2008

14.04.2009 HQ File :01/82/050/01429/AM09/ RLA File :03/94/040/00871/AM09/ Lic.No/Date:0310498562 17.12.2008 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 71

Case No.:11/40/82‐ALC4/2008

14.04.2009 Status:Case Deferred

HQ File :01/82/050/01430/AM09/ RLA File :05/24/040/00568/AM09/ Lic.No/Date:0510232764 17.12.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 72

Case No.:4/40/82‐ALC4/2008

Party Name:TORRENT PHARMACEUTICALS LTD. 14.04.2009 Status:Case Approved HQ File :01/82/050/01423/AM09/ RLA File :08/24/040/00183/AM09/ Lic.No/Date:0810076762 17.12.2008 Decision : Withdrawn as case has already been approved by NC in its 1/82 mee捀�ng held on 12.05.2009. 73

Case No.:8/40/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/01427/AM09/ RLA File :03/94/040/00873/AM09/ Lic.No/Date:0310498344 17.12.2008 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 74

Case No.:16/40/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/01435/AM09/ RLA File :08/24/040/00191/AM09/ Lic.No/Date:0810076822 18.12.2008 Decision : Withdrawn as case has already been approved by NC in its 1/82 mee捀�ng held on 12.05.2009. 75

Case No.:24/41/82‐ALC4/2008

Party Name:LUPIN LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01464/AM09/ RLA File :03/95/040/00773/AM09/ Lic.No/Date:0310499481 23.12.2008 Defer Date:09.06.2009 76

Case No.:21/42/82‐ALC4/2008

Party Name:BIOCHEMICAL & SYNTHETIC PRODUCTS LTD 14.04.2009 Status:Case Deferred HQ File :01/82/050/01499/AM09/ RLA File :09/24/040/00357/AM09/ Lic.No/Date:0910036573 05.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was

Case No.:23/42/82‐ALC4/2008

Party Name:ELDER PHARMACEUTICALS LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01501/AM09/ RLA File :03/94/040/00905/AM09/ Lic.No/Date:0310501128 05.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 78

Case No.:27/42/82‐ALC4/2008

14.04.2009 Status:Case Deferred HQ File :01/82/050/01505/AM09/ RLA File :03/94/040/00904/AM09/ Lic.No/Date:0310501134 05.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 79

Case No.:28/42/82‐ALC4/2008

14.04.2009 HQ File :01/82/050/01506/AM09/ RLA File :03/94/040/00920/AM09/ Lic.No/Date:0310501141 05.01.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 80

Case No.:23/43/82‐ALC4/2008

Party Name:SINGH PLASTICISERS & RESINS (I) PVT.LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01532/AM09/ RLA File :05/24/040/00656/AM09/ Lic.No/Date:0510234079 06.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 81

Case No.:3/43/82‐ALC4/2008

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01512/AM09/ RLA File :03/94/040/00838/AM09/ Lic.No/Date:0310501369 06.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of C&PC. 82

Case No.:7/43/82‐ALC4/2008

Party Name:CIPLA LIMITED Status:Case

14.04.2009 Deferred HQ File :01/82/050/01516/AM09/ RLA File :03/94/040/00928/AM09/ Lic.No/Date:0310501583 06.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee considered case as per agenda and observed that the case has already been considered by NC in its 1/82 mee捀�ng held on 12.05.2009 and was 83

Case No.:25/43/82‐ALC4/2008

Party Name:HALDIA PETROCHEMICALS LTD. 14.04.2009 HQ File :01/82/050/01534/AM09/ RLA File :02/24/040/00248/AM09/ Lic.No/Date:0210122139 13.01.2009 84

Case No.:10/45/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01574/AM09/ RLA File :09/24/040/00363/AM09/ Lic.No/Date:0910036805 22.01.2009 Defer Date:09.06.2009 85

Case No.:5/45/82‐ALC4/2008

Party Name:PADMINI AROMATICS PVT. LTD 14.04.2009 Status:Case Deferred HQ File :01/82/050/01569/AM09/ RLA File :07/24/040/00435/AM09/ Lic.No/Date:0710062501 22.01.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of C&PC. 86

Case No.:8/45/82‐ALC4/2008

Party Name:HETERO LABS LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01572/AM09/ RLA File :09/24/040/00389/AM09/ Lic.No/Date:0910036803 22.01.2009 Defer Date:09.06.2009 87

Case No.:12/45/82‐ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01576/AM09/ RLA File :09/24/040/00372/AM09/ Lic.No/Date:0910036817 23.01.2009 Defer Date:09.06.2009

Case No.:13/45/82‐ALC4/2008

Party Name:MERCK LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01577/AM09/ RLA File :03/95/040/00866/AM09/ Lic.No/Date:0310503731 23.01.2009 Defer Date:09.06.2009 89

Case No.:15/45/82‐ALC4/2008

Party Name:AICO LABORATORIES INDIA LTD. 14.04.2009 Status:Case Rejected HQ File :01/82/050/01579/AM09/ RLA File :08/24/040/00207/AM09/ Lic.No/Date:0810077615 27.01.2009 Decision :Commi掀�ee considered case as per agenda and observed that the firm in another case was requested to furnish Produc捀�on and Consump捀�on data cer捀�fied by Central Excise Authority, but the same has not been received and norms can not be fixed in absence of required data. It was, therefore, decided to reject the case. 90

Case No.:17/45/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01581/AM09/ RLA File :09/24/040/00332/AM09/ Lic.No/Date:0910036834 27.01.2009 Defer Date:09.06.2009 91

Case No.:18/45/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01582/AM09/ RLA File :09/24/040/00368/AM09/ Lic.No/Date:0910036835 27.01.2009 Defer Date:09.06.2009 92

Case No.:3/48/82‐ALC4/2008

Party Name:AARTI INDUSTRIES LIMITED 14.04.2009 Status:Case Approved HQ File :01/82/050/01608/AM09/ RLA File :03/94/040/00962/AM09/ Lic.No/Date:0310505225 03.02.2009 Decision : Commi掀�ee considered case as per agenda and in light of wri掀�en comments of Department of C&PC 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 Meta Nitro Para Toluidine 1 Kg. 1. Para nitro Toluene 1.46 kg

Methylene dichloride 1.10 kg 93

Case No.:8/48/82‐ALC4/2008

Party Name:PAB ORGANICS PVT.LTD, 14.04.2009 Status:Case Deferred HQ File :01/82/050/01613/AM09/ RLA File :34/24/040/00200/AM09/ Lic.No/Date:3410023355 03.02.2009 Defer Date:09.06.2009 94

Case No.:6/48/82‐ALC4/2008

Party Name:MSN LABORATORIES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01611/AM09/ RLA File :09/24/040/00366/AM09/ Lic.No/Date:0910036958 04.02.2009 Defer Date:09.06.2009 95

Case No.:7/48/82‐ALC4/2008

Party Name:ORGANICA AROMATICS PVT LTD 14.04.2009 Status:Case Approved HQ File :01/82/050/01612/AM09/ RLA File :07/24/040/00564/AM09/ Lic.No/Date:0710062745 04.02.2009 Decision : 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.14010/132/2004/Ch.III dated 19.03.2009 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 Alpha Damascone 1 Kg. 1. Citral 1.583 kg 96

Case No.:10/48/82‐ALC4/2008

Party Name:MSN LABORATORIES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01615/AM09/ RLA File :09/24/040/00367/AM09/ Lic.No/Date:0910036968 05.02.2009 Defer Date:09.06.2009 97

Case No.:11/48/82‐ALC4/2008

Party Name:MAITHRI LABORATORIES (P) LTD., 14.04.2009 Status:Case Deferred

HQ File :01/82/050/01616/AM09/ RLA File :09/24/040/00327/AM09/ Lic.No/Date:0910036969 05.02.2009 Defer Date:09.06.2009 98

Case No.:12/48/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01617/AM09/ RLA File :09/24/040/00382/AM09/ Lic.No/Date:0910036970 05.02.2009 Defer Date:09.06.2009 99

Case No.:25/48/82‐ALC4/2008

Party Name:VARUN MEDIMPEX INC. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01630/AM09/ RLA File :05/24/040/00678/AM09/ Lic.No/Date:0510235994 06.02.2009 Defer Date:09.06.2009 100

Case No.:26/48/82‐ALC4/2008

Party Name:T.C. HEALTH CARE PVT.LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01631/AM09/ RLA File :05/24/040/00645/AM09/ Lic.No/Date:0510235995 06.02.2009 Defer Date:09.06.2009 101

Case No.:21/48/82‐ALC4/2008

Party Name:CENTURY PHARMACEUTICALS LTD. 14.04.2009 Status:Case Deferred HQ File :01/82/050/01626/AM09/ RLA File :34/24/040/00153/AM09/ Lic.No/Date:3410023427 09.02.2009 Defer Date:09.06.2009 102

Case No.:23/48/82‐ALC4/2008

Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01628/AM09/ RLA File :03/94/040/01007/AM09/ Lic.No/Date:0310506348 09.02.2009 Defer Date:09.06.2009 103

Case No.:30/48/82‐ALC4/2008

Party Name:PERFECT BIOTECH 14.04.2009 Status:Case

Deferred HQ File :01/82/050/01635/AM09/ RLA File :03/95/040/00881/AM09/ Lic.No/Date:0310506216 09.02.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Ministry of Food Processing Industry. 104

Case No.:33/48/82‐ALC4/2008

Party Name:SURYA PHARMACEUTICAL LTD 14.04.2009 Status:Case Deferred HQ File :01/82/050/01638/AM09/ RLA File :22/24/040/00064/AM09/ Lic.No/Date:2210008634 10.02.2009 Defer Date:09.06.2009 105

Case No.:34/48/82‐ALC4/2008

Party Name:DIVIS LABORATORIES LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01639/AM09/ RLA File :09/24/040/00402/AM09/ Lic.No/Date:0910037046 11.02.2009 Defer Date:09.06.2009 106

Case No.:6/50/82‐ALC4/2008

Party Name:LUPIN LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01673/AM09/ RLA File :03/95/040/00826/AM09/ Lic.No/Date:0310508227 19.02.2009 Defer Date:09.06.2009 107

Case No.:7/50/82‐ALC4/2008

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01674/AM09/ RLA File :09/24/040/00404/AM09/ Lic.No/Date:0910037127 19.02.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of MSME. 108

Case No.:10/50/82‐ALC4/2008

Party Name:SHILPA MEDICARE LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/01677/AM09/ RLA File :07/24/040/00628/AM09/ Lic.No/Date:0710063183 20.02.2009 Decision :Commi掀�ee considered case as per agenda and in light of earlier decision taken in 39/83 mee捀�ng held on 10.01.2007 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

Bicalutamide 1 Kg. 1. N‐(4‐Cyano‐ 3(Trifluoromethyl)Phenyl)‐3‐(4‐ (Fluorophenyl)Thio)‐2‐Hydroxy‐2‐ Methylpropamide 1.25 kg 109

Case No.:12/50/82‐ALC4/2008

Party Name:AVIGNON EXIM PVT.LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/01679/AM09/ RLA File :03/94/040/01303/AM08/ Lic.No/Date:0310508498 20.02.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of C&PC. 110

Case No.:13/50/82‐ALC4/2008

Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01680/AM09/ RLA File :04/24/040/00105/AM09/ Lic.No/Date:0410102480 20.02.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of C&PC. 111

Case No.:18/50/82‐ALC4/2008

Party Name:LIFE LINE INDUSTRIES LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/01685/AM09/ RLA File :03/95/040/00868/AM09/ Lic.No/Date:0310508672 23.02.2009 Defer Date:09.06.2009 112

Case No.:1/2/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/00001/AM10/ RLA File :05/24/040/00762/AM09/ Lic.No/Date:0510239347 01.04.2009 Defer Date:09.06.2009 113

Case No.:2/2/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/00002/AM10/ RLA File :05/24/040/00782/AM09/ Lic.No/Date:0510239348 01.04.2009 Decision : Commi掀�ee considered case as per agenda and in light of earilier decision taken in 28/82 mee捀�ng held on 07.10.2008 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 8‐Chloro‐5,6‐Dihidro‐11‐H‐ Benzo (5,6) Ciclohepta (1,2B) Piridine‐11‐one (L7) 1 kg. 1. 3‐Chlorobenzyl Cyanide 1.80 kg 2. Sodium Methoxide 1.20 kg 3. Hydrazine Hydrate 1.26 kg 4. N N Dimethyl Carbomoyl Chloride 2.20 kg 5. Sodium Cyanide 0.20 kg 6. Potassium Carbonate 0.93 kg 7. NN Dimethyl Formamide 0.05 kg 8. Toluene 7.14 kg 9. Methylene Chloride 4.45 kg 10. Acetonitrile 0.91 kg 11. Isopropyl Alcohol 1.62 kg RA concerned may take further necessary ac捀�on as per above decision of NC. 114

Case No.:3/2/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/00003/AM10/ RLA File :05/24/040/00686/AM09/ Lic.No/Date:0510239349 01.04.2009 Defer Date: 09.06.2009 Decision :Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals. 115

Case No.:4/2/82‐ALC4/2009

Party Name:LUPIN LIMITED 14.04.2009 Status:Case Approved HQ File :01/82/050/00004/AM10/ RLA File :03/95/040/01023/AM09/ Lic.No/Date:0310514019 01.04.2009 Decision :Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 116

Case No.:5/2/82‐ALC4/2009

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 14.04.2009 Status:Case Approved HQ File :01/82/050/00005/AM10/ RLA File :03/94/040/01111/AM09/ Lic.No/Date:0310514113 01.04.2009 Decision : Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 117

Case No.:6/2/82‐ALC4/2009

Party Name:SANDOZ PRIVATE LIMITED 14.04.2009 Status:Case Deferred

HQ File :01/82/050/00006/AM10/ RLA File :03/95/040/01031/AM09/ Lic.No/Date:0310514144 01.04.2009 Defer Date:09.06.2009 Decision :Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Pharmaceu捀�cals. 118

Case No.:7/2/82‐ALC4/2009

Party Name:VETINDIA PHARMACEUTICALS LIMITED Meet No/Date:2/82‐ALC4/2009 14.04.2009 Status:Case Deferred HQ File :01/82/050/00007/AM10/ RLA File :09/24/040/00478/AM09/ Lic.No/Date:0910037612 01.04.2009 Defer Date:23.06.2009 Decision : Commi掀�ee decided to call for a copy of applica捀�on, copy of DML and technical details as per Appendix 33 form RA/firm. Accordingly, case was deferred for 23.06.2009. 119

Case No.:8/2/82‐ALC4/2009

Party Name:LUPIN LIMITED 14.04.2009 Status:Case Deferred HQ File :01/82/050/00008/AM10/ RLA File :03/95/040/01035/AM09/ Lic.No/Date:0310514289 02.04.2009 Defer Date:09.06.2009 120

Case No.:9/2/82‐ALC4/2009

14.04.2009 Status:Case Deferred HQ File :01/82/050/00009/AM10/ RLA File :03/94/040/01131/AM09/ Lic.No/Date:0310514341 02.04.2009 Defer Date:09.06.2009 Decision : Commi掀�ee decided to defer case for 09.06.2009 for comments of Department of Bio‐technology. 121

Case No.:10/2/82‐ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 14.04.2009 Status:Case Approved HQ File :01/82/050/00010/AM10/ RLA File :08/24/040/00260/AM09/ Lic.No/Date:0810079200 08.04.2009 Decision : Commi掀�ee decided to close the case as Advance Authorisa捀�on has been issued under para 4.7.1 of HBP. 122

Case No.:11/2/82‐ALC4/2009

Party Name:SHILPA MEDICARE LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/00011/AM10/ RLA File :07/24/040/00686/AM09/ Lic.No/Date:0710064060 08.04.2009 Defer Date:23.06.2009 Decision :Commi掀�ee decided to call for a copy of applica捀�on, copy of DML and technical details as per Appendix 33 form RA/firm. Accordingly, case was deferred for 23.06.2009.

123

Case No.:12/2/82‐ALC4/2009

Party Name:SHILPA MEDICARE LTD., 14.04.2009 Status:Case Deferred HQ File :01/82/050/00012/AM10/ RLA File :07/24/040/00006/AM10/ Lic.No/Date:0710064061 08.04.2009 Defer Date:23.06.2009 Decision : Commi掀�ee decided to call for a copy of applica捀�on, copy of DML and technical details as per Appendix 33 form RA/firm. Accordingly, case was deferred for 23.06.2009. ******************************

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