IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-06-08

DGFT Committee Minutes

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

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 10/82‐ALC4/2010 MEETING DATE : 08.06.2010 The MeeƟng No.10/82 in the year 2010‐11 to consider the cases under Duty ExempƟon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 08.06.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri Jasbir Singh, I.A., Department of C&PC 3. Shri D.N. Mathur, Dy. IA, Department of PharmaceuƟcals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO

Case No.B‐102

M/S H.J. Arochem Pvt. Ltd. Norms CommiƩee MeeƟng No.10/11 F.No.01/82/162/543/AM10 MeeƟng Date: 08.06.2010 RA F.No.08/24/040/00126/AM10 Adv.Lic.No.0810082852 dated 14.09.2009 CommiƩee considered the case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority and in consultaƟon with representaƟve of Technical authority present in the meeƟng decided to revise norms under para 4.7 of Handbook of Procedures as per details below or as applied by firm whichever is lower:‐ Export Product Qty. of Export Sl. No. Items of Import Qty. of Import Diphenyl Oxide 1 Kg. 1. Phenol 0.4495 Kg. 2 Monochloro Benzene 0.9888 Kg. 3 CausƟc Soda Flakes 0.4245 Kg. 4 Cuperos Oxide 0.0049 kg RA concerned may take further necessary acƟon as per above decision of NC.

Case No.B‐103

M/S Grand OrganicPvt. Ltd. F.No.01/82/50/1825/AM07 RA F.No. 17/24/040/00084/AM07 Adv.Lic.No.1710001580 dated 15.03.2007 CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to call for the following informaƟon from the firm:‐

1. Chemical name of the export product. 2. Detailed calculaƟon to arrive at the norms applied for. Accordingly, case was deferred for 03.08.2010.

Case No.B‐104

M/S Cipla Ltd. F.No.01/82/162/219/AM11 RA F.No.03/94/040/2548/AM04 Adv.Lic.No.0310258442 dated 15.03.2004 CommiƩee considered case as per agenda and in light of earlier decision taken in 35/82 meeƟng held on 29.12.2004 and in consultaƟon with technical authority present in meeƟng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Tetracip 10% Oral Powder (Pack size 500 gms) 1 pack 1. Tetramisole Hydrochloride 50.50 gm.

Case No.B‐105

M/S Cipla Ltd. F.No.01/82/50/175/AM08 RA F.No.03/94/040/571/AM08 Adv.Lic.No.0310441556 dated 31.08.2007 CommiƩee considered case as per agenda and in light of earlier decision taken in 10/82 meeƟng held on 09.06.2009 and in consultaƟon with technical authority present in meeƟng, 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 Lamivudine and Zidovudine tablet (containing lamivudine 150 mg and zidovudine USP 300 mg.) Zidovudine = 306 mg/tablet 1. 3’‐Azido‐3’‐deoxy‐5’‐O‐trityl thymidine [Trityl Azido Compound (TAZC) 2.38 kg/kg of Zidovudine

Case No.B‐106

M/S Strides Arcolabs Ltd. F.No.01/82/162/727/AM10

RA F.No.07/24/040/405/AM00 Adv.Lic.No.0710001925 dated 02.11.1999 CommiƩee considered case as per agenda and in light of wriƩen comments of Department of C&PC dated 07.06.2010, decided to call for the following informaƟon from the firm. 1. Details of manufacturing process with chemical equaƟon, molecular formula and molecular weight. 2. Yield obtained in each step. 3. Detailed calculaƟon on arriving out the norms as applied for. Accordingly, case was deferred for 03.08.2010.

Case No.B‐107

M/S Vivimed Labs Ltd. F.No.01/82/50/976/AM07 RA F.No.09/24/040/352/AM07 Adv.Lic.No.0910028523 dated 05.12.2006 CommiƩee decided to call the firm for personal hearing on 13.07.2010. Accordingly, case was deferred for 13.07.2010.

Case No.B‐108

M/S Shirdi Chemicals Pvt. Ltd. F.No.01/82/162/1668/AM09 RA F.No.03/95/040/00011/AM10 Adv.Lic.No.0310508181dated 19.02.2009 Adv.Lic.No.0310495847dated 28.11.2008 Adv.Lic.No.0310505059dated 03.02.2009 Adv.Lic.No.0310496757dated 05.12.2008 Adv.Lic.No.0310499973 dated 26.12.2008 CommiƩee considered case as per agenda and in light of wriƩen comments of Department of C&PC dated 07.06.2010, decided to amend the descripƟon of export product to read as “DMBPC or 4,4 Cyclohexylidene bis (2‐ methylphenol) or Dimethylbisphenolcyclohexane” without any other change in the earlier decisions of NC.

Case No. A‐17

M/S Intas Pharma Ltd. F.No.01/82/162/205/AM10 RA F.No.08/24/040/00007/AM10 Adv.Lic.No.0810079232 dated 09.04.2009 CommiƩee considered case as per agenda and observed that the firm was requested to furnish the copy of Master Batch Formula, but they have furnished the copy of Master Batch Record. It was, therefore, decided to call for again the copy of Master Batch Formula from firm. Accordingly, case was deferred for 03.08.2010.

Case No. C‐11

M/S Encee AromaƟcs Pvt. Ltd. F.No.01/82/162/00020/AM10 CommiƩee considered case as per agenda and decided to call for details of advance licences obtained under para 4.7 of HBP for the export product Enamber/Kephalis/Tetrambrone from the firm. Accordingly, case was deferred for 03.08.2010. 1

Case No.:2/21/83‐ALC1/2006

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:10/82‐ALC4/2010 08.06.2010 Status:Case Rejected HQ File :01/83/050/00349/AM07/ RLA File :03/95/040/00266/AM07/ Lic.No/Date:0310387634 29.06.2006 Decision : The commiƩee noted that the firm has not furnished informaƟon w.r.t. D/L already issued and has also not aƩended PH and therefore, decided to reject the case. RA may take acƟon accordingly. 2

Case No.:17/46/82‐ALC4/2007

Party Name:ARCH PHARMALABS LTD 08.06.2010 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:27.07.2010 Decision : The case was deferred for 4 weeks as the firm has been called for PH on 27.07.2010. 3

Case No.:2/17/82‐ALC4/2008

Party Name:SUPREEM PHARMACEUTICALS MYSORE PVT LTD. 08.06.2010 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:03.08.2010 Decision : The commiƩee decided to ask the firm to clarify as to how the product falls under chapter 30 and also to remind DC(MSME) for expediƟng their comments, through a D.O leƩer from chairman NC‐3. 4

Case No.:3/32/82‐ALC4/2008

Party Name:D.TOTLA PLASTIC 08.06.2010 Status:Case Deferred HQ File :01/82/050/01178/AM09/ RLA File :03/94/040/00710/AM09/ Lic.No/Date:0310491145 20.10.2008 Defer Date:06.07.2010 Decision : It was decided to request Shri A.K. Aggarwal, Department of C&PC to give their comments on immediate basis, as the case is pending for long Ɵme. The case was deferred for 06.07.2010.

Case No.:27/42/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 08.06.2010 Status:Case Defered HQ File :01/82/050/01505/AM09/ RLA File :03/94/040/00904/AM09/ Lic.No/Date:0310501134 05.01.2009 Defer Date: 13.07.2010 Decision :CommiƩee decided to defer case for 13.07.2010 for comments of DC (MSME) and decided to remind DC(MSME) through a D.O. from Chairman NC‐3. 6

Case No.:28/42/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 08.06.2010 Status:Case Defered HQ File :01/82/050/01506/AM09/ RLA File :03/94/040/00920/AM09/ Lic.No/Date:0310501141 05.01.2009 Defer Date: 13.07.2010 Decision :CommiƩee decided to defer case for 13.07.2010 for comments of DC (MSME) and decided to remind DC(MSME) through a D.O. from Chairman NC‐3 7

Case No.:13/43/82‐ALC4/2008

Party Name:EMCURE PHARMACEUTICALS LTD. 08.06.2010 Status:Case Approved HQ File :01/82/050/01522/AM09/ RLA File :31/24/040/00273/AM09/ Lic.No/Date:3110036930 07.01.2009 Defer Date: Decision : In view of wriƩen comments furnished by Department of PharmaceuƟcals vide their O.M.. No.35011/376/2009‐PI (Norms) dated 07.06.2010 and in consultaƟon with Technical authority present in the meeƟng , the commiƩee decided to raƟfy the norms 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 Item Qty. allowed 2,6‐Pipecoloxylidide (ROPI II) 1 Kg 1 L‐Pipecolic Acid 1.03 kg RA concerned may take further necessary acƟon as per above decision of NC. 8

Case No.:55/18/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 08.06.2010 Status:Case Defered HQ File :01/82/050/00329/AM10/ RLA File :03/94/040/00949/AM09/ Lic.No/Date:0310503316 21.01.2009 Defer Date: 13.07.2010 Decision :CommiƩee decided to defer case for 13.07.2010 for comments of DC (MSME) and decided to remind DC(MSME) through a D.O. from Chairman NC‐3.

Case No.:8/48/82‐ALC4/2008

Party Name:PAB ORGANICS PVT.LTD, 08.06.2010 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:06.07.2010 Decision :The case was deferred for 06.07.10. 10

Case No.:18/50/82‐ALC4/2008

Party Name:LIFE LINE INDUSTRIES LIMITED 08.06.2010 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:06.07.2010 Decision :The CommiƩee decided to call the firm for PH on 06.07.10 with Excise CerƟfied data . 11

Case No.:17/1/83‐ALC1/2009

Party Name:PRACHI PHARMACEUTICALS PVT LTD 08.06.2010 Status:Case Approved HQ File :01/83/050/01355/AM09/ RLA File :03/95/040/00906/AM09/ Lic.No/Date:0310510030 03.03.2009 Defer Date: In view of wriƩen comments furnished by Department of C & PC, U.O No. 14010/13/2009/Ch.II dated 31.05.2010 and in consultaƟon with Technical authority present in the meeƟng , the commiƩee decided to raƟfy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Sodium Iodide 1 Kg. 1. Potassium Iodide SoluƟon (Iodine Content 25%) 3.42 kg RA may take acƟon accordingly. 12

Case No.:13/1/82‐ALC4/2009

Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. 08.06.2010 Status:Case Approved HQ File :01/82/050/01733/AM09/ RLA File :34/24/040/00232/AM09/ Lic.No/Date:3410023787 20.03.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/ /2010‐Ch.II dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,6‐Diethyl‐4‐Methyl‐ Bromobenzene (2,Bromo‐ 1 Kg. 1. 2,6‐Diethyl‐4‐Methylaniline 0.792 kg

1,3‐Diethyl‐5‐Methyl‐ Benzene) 13

Case No.:9/2/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 08.06.2010 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:27.07.2010 Decision : The case was deferred for 4 weeks as the firm has been called for PH on 27.07.2010. 14

Case No.:22/14/82‐ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 08.06.2010 Status:Case Deferred HQ File :01/82/050/00192/AM10/ RLA File :08/24/040/00007/AM10/ Lic.No/Date:0810079232 09.04.2009 Defer Date:06.07.2010 Decision :CommiƩee considered case as per agenda and observed that the firm was requested to furnish Master Batch Formula, but they have furnished the copy of Master Batch Record. It was, therefore, decided to call the firm for personal hearing alongwith the copy of Master Batch Formula on 27.07.2010. Accordingly, case was deferred for 27.07.2010. 15

Case No.:2/4/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 08.06.2010 Status:Case Approved HQ File :01/82/050/00023/AM10/ RLA File :52/24/040/00032/AM09/ Lic.No/Date:5210026130 15.04.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/6/2005‐Ch.II dated 22.01.2008 and in consultaƟon with technical authority present in meeƟng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Amino 4 Trifluoro Methyl 4 Chloro Diphenyl Ether 1 Kg. 1. 4 Chloro Benzo Trifluoride 1.418 kg 2. Para Chloro Phenol 0.804 kg 16

Case No.:1/5/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00034/AM10/ RLA File :09/24/040/00005/AM10/ Lic.No/Date:0910037716 22.04.2009 Defer Date:13.07.2010

Decision :CommiƩee considered case as per agenda and decided to call from the firm ProducƟon and consumpƟon data cerƟfied by Central Excise Authority. Accordingly, case was deferred for 13.07.2010. 17

Case No.:7/9/82‐ALC4/2009

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 08.06.2010 Status:Case Deferred HQ File :01/82/050/00120/AM10/ RLA File :04/24/040/00040/AM10/ Lic.No/Date:0410104760 21.05.2009 Defer Date:03.08.2010 Decision :CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/226/2009‐PI‐(Norms) dated 27.01.2010, observed that the firm has applied 2% wastage and 2% overage and have applied 41.416 kgs against import of 1 lakh capsules and hence the norms applied by firm are not in line with the DML furnished by them. It was, therefore, decided to seek clarificaƟon from firm. Accordingly, case was deferred for 03.08.2010. 18

Case No.:19/6/82‐ALC4/2010

Party Name:MODERN INSECTICIDES LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00166/AM11/ RLA File :30/24/040/00008/AM10/ Lic.No/Date:3010061426 02.06.2009 Defer Date:03.08.2010 Decision :CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 19

Case No.:16/6/82‐ALC4/2010

Party Name:BEST VALUE CHEM PVT. LTD. 08.06.2010 Status:Case Deferred HQ File :01/82/050/00163/AM11/ RLA File :34/24/040/00037/AM10/ Lic.No/Date:3410024380 05.06.2009 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 20

Case No.:4/18/82‐ALC4/2009

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 08.06.2010 Status:Case Approved HQ File :01/82/050/00278/AM10/ RLA File :03/94/040/00978/AM09/ Lic.No/Date:0310523220 09.06.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/52/2009‐Ch.II dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, 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 Corrosion Inhibitor, Trade Name‐DA 2206/YS DA 2206 (Containing 10% of Cyclohexylamine, 10% of 1 Kg. 1. Cyclohexylamine 0.100 kg 2. Methoxy Propylamine (FCOPA‐M) 0.100 kg 3. Mono Ethanol Amine (99% Minium) 0.700 kg

Methoxy Propylamine and 70% of Mono Ethanol Amine) 21

Case No.:43/18/82‐ALC4/2009

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00317/AM10/ RLA File :03/94/040/00018/AM10/ Lic.No/Date:0310524605 17.06.2009 Defer Date:03.08.2010 Decision :CommiƩee decided to defer case for 03.08.2010 for comments of Department of PharmaceuƟcals. 22

Case No.:35/13/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 08.06.2010 Status:Case Approved HQ File :01/82/050/00225/AM10/ RLA File :03/94/040/00193/AM10/ Lic.No/Date:0310524761 18.06.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/8/2010‐ PI‐(Norms) dated 10.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Hydroxynitrile 1 Kg. 1. Lyophilised Enzyme Powder (CDX403) 0.012 kg 2. Ethyl 4 Chloro Aceto Acetate 1.039 kg 3. D‐Glucose (Dextrose) 0.451 kg 4. Lyophilised Enzyme Powder (CDX014) 0.005 kg 5. Lyophilised Enzyme Powder (CDX‐901) 0.004 kg 6. NNADP‐SP B‐NicoƟnamide‐Adenine DinucleoƟde Phosphate Oxidized Form, Monosodiu M Salt (B‐NADP+,B‐ Tan+,Coenzyme‐II) 0.001 kg 23

Case No.:30/19/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 08.06.2010 Status:Case Deferred HQ File :01/82/050/00408/AM10/ RLA File :22/24/040/00015/AM10/ Lic.No/Date:2210009018 22.06.2009 Defer Date:20.07.2010 Decision :CommiƩee considered case as per agenda and decided to call for technical details as per Appendix 33 from firm. Accordingly, case was deferred for 20.07.2010.

Case No.:13/21/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 08.06.2010 Status:Case Deferred HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Defer Date:20.07.2010 Decision :CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/300/2009‐PI (Norms) dated 11.05.2010, decided to call for the following informaƟon from the firm:‐ 1. Complete and balanced chemical reacƟons for each step of manufacturing process indicaƟng molecular weight of each reactant & output material, % yield on molar basis etc. 2. Material balance for enƟre Process. 3. Requirement & recovery of solvent at each step. Accordingly, case was deferred for 20.07.2010. 25

Case No.:11/15/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 08.06.2010 Status:Case Approved HQ File :01/82/050/00240/AM10/ RLA File :05/24/040/00169/AM10/ Lic.No/Date:0510244336 23.06.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/273/2009‐PI (Norms) dated 30.04.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Cefixime Trihydrate 1 Kg. 1. 7‐Amino 3‐Vinyl Cephalosporanic acid (AVCA) 0.582 kgA 2. AcƟcarbon (TEA) 0.100 kg 3. Acetone 2.528 kg 4. 2‐Mercaptobenzothiazoyl‐(Z)‐2‐(2‐ aminothiazole‐4‐yl)‐2‐ (methoxycarbonymethoxyimino acetate (MICA Easter) 0.82 kg 5. Triethylamine (TEA) 0.30 kg 6. Ethyl Acetate 0.157 kg 7. Methylene Chloride 4.818 kg 26

Case No.:12/15/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00241/AM10/ RLA File :09/24/040/00105/AM10/ Lic.No/Date:0910038337 Defer

24.06.2009 Date:13.07.2010 Decision :CommiƩee decided to call the firm for personal hearing on 13.07.2010. Accordingly, case was deferred for 13.07.2010. 27

Case No.:21/15/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00250/AM10/ RLA File :09/24/040/00104/AM10/ Lic.No/Date:0910038365 26.06.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to call the firm for personal hearing on 13.07.2010. Accordingly, case was deferred for 13.07.2010. 28

Case No.:32/22/82‐ALC4/2009

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 08.06.2010 Status:Case Deferred HQ File :01/82/050/00489/AM10/ RLA File :07/24/040/00165/AM10/ Lic.No/Date:0710066086 21.07.2009 Defer Date:03.08.2010 Decision :CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 29

Case No.:7/36/82‐ALC4/2009

Party Name:IND‐SWIFT LABORATORIES LTD., 08.06.2010 Status:Case Deferred HQ File :01/82/050/00732/AM10/ RLA File :22/24/040/00019/AM10/ Lic.No/Date:2210009119 22.07.2009 Defer Date:06.07.2010 Decision :CommiƩee decided to defer case for 06.07.2010 for comments of Department PharmaceuƟcals 30

Case No.:29/2/82‐ALC4/2010

Party Name:SYNGENTA INDIA LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/01263/AM10/ RLA File :03/95/040/00204/AM10/ Lic.No/Date:0310530294 23.07.2009 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 31

Case No.:4/19/82‐ALC4/2009

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 08.06.2010 Status:Case Deferred HQ File :01/82/050/00382/AM10/ RLA File :03/94/040/00307/AM10/ Lic.No/Date:0310531016 28.07.2009 Defer Date:06.07.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 32

Case No.:2/21/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 08.06.2010 Status:Case Deferred

HQ File :01/82/050/00429/AM10/ RLA File :03/95/040/00224/AM10/ Lic.No/Date:0310532930 07.08.2009 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 33

Case No.:8/24/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 08.06.2010 Status:Case Approved HQ File :01/82/050/00505/AM10/ RLA File :31/24/040/00409/AM08/ Lic.No/Date:3110039743 27.08.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/111/2008‐Ch.II dated 07.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Tetra Methyl Bisphenol F 1 Kg. 1. Phenol 0.986 kg 2. Methanol 0.794 kg 3. Paraformaldehyde 0.140 kg 34

Case No.:16/24/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 08.06.2010 Status:Case Approved HQ File :01/82/050/00513/AM10/ RLA File :09/24/040/00200/AM10/ Lic.No/Date:0910039135 28.08.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/394/2009‐PI (Norms) dated 07.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 FlupirƟne Maleate 1 kg 1. 2,6‐Dichloro Pyridine 1.454 kg 2. Methanol 1.83 kg 3. Iso Propyl Alcohol 9.55 jg 4. 4‐Fluoro Benzyl Amine 0.622 kg 35

Case No.:29/24/82‐ALC4/2009

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00526/AM10/ RLA File :09/24/040/00208/AM10/ Lic.No/Date:0910039223 Defer

01.09.2009 Date:06.07.2010 Decision :CommiƩee decided to defer case for 06.07.2010 for comments of Department of PharmaceuƟcals. 36

Case No.:2/26/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00534/AM10/ RLA File :09/24/040/00185/AM10/ Lic.No/Date:0910039258 09.09.2009 Defer Date:13.07.2010 Decision :CommiƩee decided to call for the firm for personal hearing on 13.07.2010. Accordingly, case was deferred for 13.07.2010. 37

Case No.:5/26/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00537/AM10/ RLA File :03/94/040/00449/AM10/ Lic.No/Date:0310537058 10.09.2009 Defer Date:03.08.2010 Decision :CommiƩee decided to defer case for 03.08.2010 for comments of Department of PharmaceuƟcals. 38

Case No.:4/29/82‐ALC4/2009

Party Name:INDIA GLYCOLS LTD 08.06.2010 Status:Case Deferred HQ File :01/82/050/00574/AM10/ RLA File :05/23/040/00038/AM10/ Lic.No/Date:0510250014 29.09.2009 Defer Date:03.08.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Shri A.K. Agarwal, Jt. IA, Department of C&PC for their comments. Accordingly, case was deferred for 03.08.2010. 39

Case No.:7/29/82‐ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED 08.06.2010 Status:Case Approved HQ File :01/82/050/00577/AM10/ RLA File :07/24/040/00229/AM10/ Lic.No/Date:0710067286 30.09.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/372/2009‐PI (Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Flurazepam Mono Hcl 1 kg 1. 2‐Amino‐5‐Chloro‐2‐Fluro Benzophenone 1.795 kg 40

Case No.:8/29/82‐ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED Status:Case

08.06.2010 Approved HQ File :01/82/050/00578/AM10/ RLA File :07/24/040/00230/AM10/ Lic.No/Date:0710067287 30.09.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/372/2009‐PI (Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Flunitrazepam 1 kg 1. 2‐Amino‐2‐Fluro‐5‐Nitro Benzophenone 2.18 kg 41

Case No.:24/29/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 08.06.2010 Status:Case Approved HQ File :01/82/050/00594/AM10/ RLA File :09/24/040/00247/AM10/ Lic.No/Date:0910039458 05.10.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/271/2009‐PI (Norms) dated 08.03.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Pregabalin 1 kg 1. R‐(‐)‐3‐Carbamolymethyl‐5‐methyl‐hexanoic Acid 2.94 kg 42

Case No.:18/6/82‐ALC4/2010

Party Name:BASE METAL CHLORINATIONS (P) LTD 08.06.2010 Status:Case Approved HQ File :01/82/050/00165/AM11/ RLA File :34/24/040/00102/AM10/ Lic.No/Date:3410025277 06.10.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/48/2010‐Ch.II dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Calcium Butyrate 1 Kg. 1. Butyric Acid 0.788 kg

Case No.:2/33/82‐ALC4/2009

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 08.06.2010 Status:Case Approved HQ File :01/82/050/00630/AM10/ RLA File :03/94/040/00451/AM10/ Lic.No/Date:0310541892 23.10.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/52/2009‐Ch.II dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Organic Mixture, SR 8101 R/YS SR 8101 R/ZF SR 8101 R (Containing condensate of Oleic Acid with Amino Ethyl Ethanol Amine Imidazoline‐ 2.48% and Citric Acid 35%) 1 Kg. 1. Oleic Acid 0.0206 kg 2. Amino Ethyl Ethanol Amine 0.0080 kg 3. Silicone AnƟfoam 0.000003 kg 4. Citric Acid 0.350 kg 44

Case No.:7/33/82‐ALC4/2009

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 08.06.2010 Status:Case Deferred HQ File :01/82/050/00635/AM10/ RLA File :03/94/040/00569/AM10/ Lic.No/Date:0310542418 26.10.2009 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 45

Case No.:9/33/82‐ALC4/2009

Party Name:VISHNU CHEMICALS LTD., 08.06.2010 Status:Case Approved HQ File :01/82/050/00637/AM10/ RLA File :09/24/040/00230/AM10/ Lic.No/Date:0910039712 27.10.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/39/2009‐Ch.II dated 16.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Sodium Saccharin 1 Kg. 1. Ortho Toluene Sulphonamide 0.927 kg 2. Sodium dichromate 0.200 kg

Case No.:16/33/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 08.06.2010 Status:Case Approved HQ File :01/82/050/00644/AM10/ RLA File :09/24/040/00222/AM10/ Lic.No/Date:0910039762 29.10.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/394/2009‐PI (Norms) dated 07.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Baclofen 1 Kg. 1. 3‐(4‐Chloro Phenyl)‐Glutaric Acid Monoamide 1.68 kg 2. Acetone 1.35 kg 47

Case No.:27/34/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:13.07.2010 Decision :CommiƩee decided to call the firm for personal hearing on 13.07.2010. Accordingly, case was deferred for 13.07.2010. 48

Case No.:12/38/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 08.06.2010 Status:Case Approved HQ File :01/82/050/00785/AM10/ RLA File :03/94/040/00711/AM10/ Lic.No/Date:0310548835 03.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/395/2009‐PI‐(Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Paclitaxel 1 gm 1. 10‐Deacety BaccaƟn 1.50gm 2. Pyridine 0.87 gm 3. Trithyl Silyl Chloride 1.67 gm 4. (3R,4S)‐3‐Triethylsilanyloxy‐4‐Phenyl‐N‐ Benzoyl‐2‐AzeƟdinone 1.12 gm

Case No.:5/39/82‐ALC4/2009

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 08.06.2010 Status:Case Deferred HQ File :01/82/050/00808/AM10/ RLA File :05/23/040/00118/AM10/ Lic.No/Date:0510254470 14.12.2009 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of PharmaceuƟcals. 50

Case No.:9/43/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00883/AM10/ RLA File :09/24/040/00354/AM10/ Lic.No/Date:0910040592 12.01.2010 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of PharmaceuƟcals. 51

Case No.:3/10/82‐ALC4/2010

Party Name:POSY PHARMACHEM PVT. LTD. 08.06.2010 Status:Case Deferred HQ File :01/82/050/00356/AM11/ RLA File :08/24/040/00321/AM10/ Lic.No/Date:0810088583 27.04.2010 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of C&PC. 52

Case No.:1/10/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 08.06.2010 Status:Case Approved HQ File :01/82/050/00354/AM11/ RLA File :08/24/040/00051/AM11/ Lic.No/Date:0810088996 14.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of PharmaceuƟcals dated 15.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms 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 Qty. allowed for 25 mg Tablets Qty. allowed for 50 mg Tablets Qty. allowed for 100 mg Tablets Qty. allowed for 200 mg Tablets Topiramate Tablets 1 lakh Nos. each 1. Topiramate 2.55 kg 5.10 kg 10.20 kg 20.40 kg 2. Microcrystalline Cellulose PH 102 0.75 kg 1.50 kg 3.00 kg 6.00 kg 3. Avicel PH 101 0.83 kg 1.65 kg 3.30 kg 6.60 kg 4. Lactose Anhydrous 2.75 kg 5.50 kg 11.00 kg 22.00 kg 5. 500 CC White As per As per As per As per

HDPE Round BoƩle packing policy packing policy packing policy packing policy 6. 225 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 7. 150 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 8. 75 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 9. 60 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 10. 33 MM WHITE PP SCRC with Pulp Liner As per packing policy As per packing policy As per packing policy As per packing policy 11. 33 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy 12. 38 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy 13. 45 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy 14. 53 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy RA concerned may take further necessary acƟon as per above decision of Norms CommiƩee. 53

Case No.:2/10/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 08.06.2010 Status:Case Approved HQ File :01/82/050/00355/AM11/ RLA File :08/24/040/00054/AM11/ Lic.No/Date:0810089022 17.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/287/2009‐PI‐(Norms) dated 03.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy the norms on repeat basis 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 QuanƟty allowed

Tamsulosin Hcl 0.4 mg Capsule 1 No. 1. Tamsulosin Hydrochloride 0.408 mg 2. Methacrylic Acid Copolymer Dispersion NF 170.012 mg 3. Microcrystalline Cellulose (Acicel PH 102) 233 mg 4. Import items at Sl. No.4 to 10 As per packing policy 54

Case No.:4/10/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 08.06.2010 Status:Case Deferred HQ File :01/82/050/00357/AM11/ RLA File :08/24/040/00036/AM11/ Lic.No/Date:0810089052 18.05.2010 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of PharmaceuƟcals. 55

Case No.:5/10/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 08.06.2010 Status:Case Approved HQ File :01/82/050/00358/AM11/ RLA File :08/24/040/00050/AM11/ Lic.No/Date:0810089053 18.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments earlier forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/73/2007‐PI‐III dated 14.08.2007 alongwith enclosures and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Benzonatate 100 mg Capsules 1 Million 1. Benzonanate 102 kg 2. GelaƟn NF 168 kg 3. Glycerin USP 24 kg 4. Noncrystallizing Sorbitol SoluƟon NF 72 kg 5. Triethyl Nitrate NF 75 kg 6. BoƩles and Caps (packing material in finished form a. 60 CC White HDPE Round BoƩle As per packing policy 7. 75 CC White HDPE Round BoƩle ‐do‐ 8. 33 MM White PP Screw Cap ‐do‐ Benzonatate 200 mg Capsules 1 million 1. Benzonanate 204 kg 2. GelaƟn NF 231 kg 3. Glycerin USP 33 kg 4. Noncrystallizing Sorbitol SoluƟon NF 99 kg 5. Triethyl Nitrate NF 75 kg 6. BoƩles and Caps (packing material in finished form a. 60 CC White HDPE As per packing policy

Round BoƩle 7. 75 CC White HDPE Round BoƩle ‐do‐ 8. 33 MM White PP Screw Cap ‐do‐ 56

Case No.:6/10/82‐ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00359/AM11/ RLA File :09/24/040/00057/AM11/ Lic.No/Date:0910042100 20.05.2010 Defer Date:03.08.2010 Decision : CommiƩee decided to defer case for 03.08.2010 for comments of Department of PharmaceuƟcals. 57

Case No.:7/10/82‐ALC4/2010

Party Name:VIVIMED LABS LIMITED 08.06.2010 Status:Case Deferred HQ File :01/82/050/00360/AM11/ RLA File :09/24/040/00063/AM11/ Lic.No/Date:0910042101 20.05.2010 Defer Date:13.07.2010 Decision :CommiƩee decided to call for the firm for personal hearing on 13.07.2010. Accordingly, case was deferred for 13.07.2010. 58

Case No.:8/10/82‐ALC4/2010

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 08.06.2010 Status:Case Deferred HQ File :01/82/050/00361/AM11/ RLA File :05/24/040/00065/AM11/ Lic.No/Date:0510264635 20.05.2010 Defer Date:03.08.2010 Decision :CommiƩee decided to call from firm the ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority. Accordingly, case was deferred for 03.08.2010.

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