IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-10-30

DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER : 26/82-ALC4/2007 MEETING DATE : 30.10.2007

Case No.B-364

M/s H.E.F. (I) Pvt.Ltd. M.No.26/08 F.No.01/82/162/481/AM 08 Meeting Date 30.10.2007 RLA F. No. 04/24/40/112/AM01 Adv. Lic. No. 04100009466 dt. 09.10.2000 The Committee considered the case as per agenda for ratification of norms for the export product (1) CR 4 Base Salt (2) Oxynit 1-2 Base Salt (3) CR 8 Base Salt under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to Chemical Sector.

Case No.B-365

M/s Glenmark Pharmaceuticals Ltd. M.No.26/08 F.No.01/82/50/1484/AM 06 RLA F. No. 03/94/40/1347/AM06 Adv. Lic. No. 0310372003 dt. 17.03.2006 for the export product Cilazapil under para 4.7 of HBP. Committee decided to defer case for six weeks for want of comments of PI Division.

Case No.B-366

M/s Glenmark Pharmaceutical Ltd. M.No.26/08 F.No.01/82/162/285/AM 08 RLA F. No. 09/24/40/178/AM03 Adv. Lic. No. 0310295800 dt. 07.10.2004 for the export product Cilazapil under para 4.7 of HBP. Committee decided to defer case for six weeks for want of comments of PI Division.

Case No.B-367

M/s Shree Ganesh Remedies Pvt. Ltd. M.No.26/08 F.No.01/82/50/243/AM 08 RLA F. No. 34/24/40/166/AM07 Adv. Lic. No. 3410018711 dt. 03.05.2007

for the export product Di Methyl Amino ISO Propyl Chloride Hydrochloride 65% Solution in water (DMIPC 65%) under para 4.7 of HBP. Committee decided to withdraw case since issue whether export product falls under SCOMET list has not been decided.

Case No.B-368

M/s Shree Ganesh Remedies Pvt. Ltd. M.No.26/08 F.No.01/82/50/1051/AM 07 RLA F. No. 34/24/40/216/AM07 Adv. Lic. No. 3410017694 dt. 22.12.2006 for the export product Di Methyl Amino ISO Propyl Chloride Hydrochloride 65% Solution in water (DMIPC 65%) under para 4.7 of HBP. Committee observed that export product falls under SCOME list. Committee, therefore, decided to maintain status quo. It was also decided to seek clarification from RA as to why Advance Authorisation has been issued without an Export Authorisation for export product appearing in SCOMET list.

Case No.B-369

M/s M.J.Biopharma Pvt. Ltd. M.No.26/08 F.No.01/82/50/17/AM 08 RLA F. No. 03/95/40/21/AM08 Adv. Lic. No. 0310427662 dt. 23.04.2007 for the export product Prednilolone Sodium Phosphate Inj. 30mg/ml under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in their Department and he sought deferment for two weeks. Committee, accordingly, decided to defer case for two weeks.

Case No.B-370

M/s Miles International
M.No.26/08 F.No.01/82/50/1002/AM 07 RLA F. No. 03/95/40/314/AM07 Adv. Lic. No. 0310386250 dt. 22.06.2007 for the export product Dithranol BP/EP/Dithranol under para 4.7 of HBP.

Case No.B-371

M/s Process Chemicals Co. M.No.26/08 F.No.01/83/50/485/AM 07

RLA F. No. 03/95/40/1320/AM06 Adv. Lic. No. 0210092098 dt.1.8.2006 Adv. Lic. No. 0210083908 dt.1.12.2005 Adv. Lic. No. 0210083906 dt.1.12.2005 for the export product calcium D- Saccharate & Monopotassium Glucarate 99% Purity under para 4.7 of HBP.

Case No.B-372

M/s KDL Biotech Ltd. M.No.26/08 F.No.01/82/50/1415/AM 05 RLA F. No. 03/24/40/1364/AM05 Adv. Lic. No. 0310301988 dt. 11.11.2004 for the export product Immobilized Penicillin G Amidase Enzyme under para 4.7 of HBP. Committee decided to remind Department of Bio-technology to furnish technical comments. Committee also decided to call for No Objection Certification issued by DBT to the firm. Accordingly, case was deferred for four weeks.

Case No.B-373

M/s Agio Pharmaceuticals Ltd. M.No.26/08 F.No.01/87/50/287/AM 07 F.No.01/87/50/1118/AM 07 Adv. Lic. No. 0310423444 dt. 16.03.2007 RLA F. No. 03/94/40/294/AM07 Adv. Lic. No. 0310385834 dt. 21.06.2006 RLA F. No. 03/94/40/1267/AM07 for the export product PrednisolSodium for Injection 30mg/1ml(Prednisolone Sodium Phosphate Injection B.P) under para 4.7 of HBP. Shri Madhusudan Ruia, Chairman and Managing Director of company appeared before Committee for personal hearing and explained the case. After detailed deliberations, Committee in consultation with representative of technical authority present in meeting decided to call for details of working and size of Injection from firm. Accordingly, case was deferred for four weeks.

Case No.B-374

M/s Sandoz Pvt.Ltd. M.No.26/08 F.No.01/82/162/1266/AM 01 RLA F. No. 03/95/40/1320/AM06 Adv. Lic. No. 0310002380 dt.

27.07.1999 for the export product under para 4.7 of HBP. Committee observed that a report regarding development of case has been called for from RA, but same has not been received. Committee, therefore, decided to await report from RA and defer the case for four weeks.

Case No.A-801

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/212/AM 08 RLA F. No. 03/94/40/590/AM08 Adv. Lic. No.0310442077 dt.06.09.2007 for the export product 62/0 Terbinafine Hydrochloride under para 4.7 of HBP. case is under examination in their Department and he sought deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-802

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/211/AM 08 RLA F. No. 03/94/40/553/AM08 Adv. Lic. No.0310440694 dt.27.08.2007 for the export product 62/0 Lamivir 150MG Tablets/Lamivudine Tablet 150 MG under para 4.7 of HBP. Committee decided to call representative of firm for personal hearing to explain their case on 20.11.2007. Accordingly, case was deferred for three weeks.

Case No.A-803

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/210/AM 08 RLA F. No. 03/94/40/578/AM08 Adv. Lic. No.0310441906 dt.05.09.2007 for the export product 62/0 Lamivir 150MG Tablets/Lamivudine Tablet 150 MG under para 4.7 of HBP.

Case No.A-804

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/213/AM 08

RLA F. No. 03/94/40/534/AM08 Adv. Lic. No.0310440647 dt.23.08.2007 for the export product 62/0 Efavir Capsules 200MG/Efavirenz 200 Capsules (2) Efavir 600 MG Tablets/Efavirenz 600 MG Tablets under para 4.7 of HBP.

Case No.A-805

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/216/AM 08 RLA F. No. 03/94/40/688/AM08 Adv. Lic. No.0310445044 dt.03.10.2007 for the export product 62/0 Nevimune Tablets /Nevirapine Oral Suspension under

para 4.7 of HBP.

Case No.A-806

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/215/AM 08 RLA F. No. 03/94/40/621/AM08 Adv. Lic. No.0310443538 dt.18.09.2007 for the export product 62/0 Lamivir Tablets under para 4.7 of HBP.

Case No.A-807

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/214/AM 08 RLA F. No. 03/94/40/674/AM08 Adv. Lic. No.0310445040 dt.03.10.2007 for the export product 62/0 Telmisartan and Amlodipin Tablets under para 4.7 of HBP.

Case No.A-808

M/s Alembic Ltd. M.No.26/08 F.No.01/82/50/218/AM 08 RLA F. No. 34/24/40/70/AM08 Adv. Lic. No.3410019349

dt.02.08.2007 for the export product Clarithromycin Coated Granules under para 4.7 of HBP.

Case No.A-809

M/s Amoli Organices Pvt. Ltd. M.No.26/08 F.No.01/87/50/606/AM 07 RLA F. No. 03/94/40/411/AM07 Adv. Lic. No.0310380982 dt.24.07.2007 for the export product Noscapine Resin Complex under para 4.7 of HBP. Committee decided to forward a copy of application alongwith a copy of reply of firm to PI Division for their comments. Accordingly, case was deferred for four weeks.

Case No.A-810

M/s Brawn Laboratories Ltd. M.No.26/08 F.No.01/82/50/154/AM 08 RLA F. No. 05/24/40/163/AM08 Adv. Lic. No.0510204890 dt.13.06.2007 for the export product Kanamycin Acid Sulphate Inj.B.P.IGM. under para 4.7 of HBP. Committee observed that DML furnished by firm does not contain list of approved items. Committee, therefore, decided to call for a copy of complete DML from firm. Accordingly, case was deferred for four weeks.

Case No.A-811

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/158/AM 08 RLA F. No. 03/94/40/535/AM08 Adv. Lic. No.0310440429 dt.22.08.2007 for the export product 62/0 Budccort 200 Inhaler (200 MD) Aerobud Inhaler (200 MD)/Budesonide Generis 200 Inhaler (200MD) under para 4.7 of HBP.

Case No.A-812

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/102/AM 08 RLA F. No. 03/24/40/2622/AM04 Adv. Lic. No.0310257978

dt.12.03.2004 for the export product Finpecia 1mg Tablets under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Finasteride tablets 1mg Import item: Finastride-----------------------1.02mg/1mg tablet Export product: Finasteride tablets 5mg. Import item: Finasteride ----------------------5.10mg/5mg tablet RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-813

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/136/AM 08 RLA F. No. 03/94/40/383/AM08 Adv. Lic. No.0310436156 dt.13.07.2007 for the export product Stavir 15 MG Capsules /Stavudine Capsules 15 MG under

para 4.7 of HBP.

Case No.A-814

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/169/AM 08 RLA F. No. 03/94/40/250/AM08 Adv. Lic. No.0310432136 dt.08.06.2007

for the export product Stavir 15 MG Capsules under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to call for following information from firm.

  1. There are six export products involving Stavudine at various strengths and multi component tablets. The firm has not shown import requirement for each export product separately.
  2. The firm has applied for import of intermediate for Stavudine and the wastage shown is 36.63%. It is not understood whether this wastage is for tablet manufacturing or for the manufacture of Stavudine.
  3. The yields indicated by the firm at various places are not matching and the firm has not indicated the requirement of imported intermediate per Kg. of Stavudine. Committee also decided to call representative of firm for personal hearing in its meeting to be held on 20.11.2007. Accordingly, case was deferred for three weeks.

Case No.A-815

M/s Cipla Ltd. M.No.26/08 F.No.01/82/50/160/AM 08 RLA F. No. 03/94/40/524/AM08 Adv. Lic. No.0310440273 dt.21.08.2007 for the export product Irinotecan Hydrochloride Injection 40MG/(Each Vial 2ML) Irinotecan Hydrochloride Injection 100MG/5Ml (Each Vial 5Ml) under para 4.7 of HBP.

Case No.A-816

M/s Alembic Ltd. M.No.26/08 F.No.01/82/50/37/AM 08 RLA F. No. 34/24/40/290/AM07 Adv. Lic. No.3410018404 dt.23.03.2007 for the export product Azhhromycin Crude under para 4.7 of HBP.

Case No.A-817

M/s Cadila Healthcare Ltd. M.No.26/08 F.No.01/82/50/161/AM 08 RLA F. No. 08/24/40/136/AM08

Adv. Lic. No.0810066915 dt.30.08.2007 for the export product 62/0 2(2-Methoxyphenoxy)-Ethylamine Base Pharma Grade under para 4.7 of HBP.

Case No.A-818

M/s Gracure Pharmaceuticals Ltd. M.No.26/08 F.No.01/82/162/726/AM 07 RLA F. No. 05/24/40/112/AM07 Adv. Lic. No.0510185320 dt.22.06.2006 for the export product Daxy 200 Tabs under para 4.7 of HBP. Committee observed that firm was requested to furnish a copy of DML vide letter dated 12.09.2007, but same has not been received and in absence of copy of DML, it is not possible to fix norms. Committee, therefore, decided to reject the case. RA concerned may take further necessary action including cancellation of Advance Authorisation under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-819

M/s Gulf Oil Corporation. M.No.26/08 F.No.01/82/50/47/AM 08 RLA F. No. 09/24/40/538/AM07 Adv. Lic. No.0910028240 dt.17.11.2006

for the export product Fexafenadine Hydrochloride under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/95/2007-PI-III dated 18.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Fexofenadine Hcl-------------------------------1Kg. Import items:

  1. Methacryclic acid-------------------1.462kg/kg
  2. Dimethoxy Ethane------------------1.12kg/kg
  3. Tetrahydrofuran---------------------3.00kg/kg
  4. Sodium Borohydride----------------0.332kg/kg
  5. Azacyclonol---------------------------1.035kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-820

M/s Nicholas Piramal India Ltd. M.No.26/08 F.No.01/82/50/261/AM 08 RLA F. No. 03/95/40/1401/AM07 for the export product Vitamin A Palmitate 1.7 MIU/gm under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 1

Case No.:1/6/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00389/AM04/ RLA File : 09/24/040/00068/AM04/ Lic.No/Date:09100152 88 05.08.2003 Defer Date: 13.11.2007 Decision :Committee considered case as per agenda for ratification of norms for export product N.N-Dimethyl Amino Ethoxy Benzyl Amino (DEBA) under para 4.7 of HBP.

2

Case No.:5/37/82-

ALC1/2005 Party Name:FDC LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/82/050/00946/AM06/ RLA File : 03/94/040/00798/AM06/ Lic.No/Date:03103562 18 22.11.2005

Decision:Committee considered case as per agenda for ratification of norms for export product Econaxole Nitrate BP/JP/USP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006-PI-III dated 01.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Econazole Nitrate BP/USP----------------------------1Kg. Import items:

  1. 2,2,4-Trichloro Acetophenone------------------0.98kg/kg
  2. Sodium Borohydride------------------------------0.085kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 3

Case No.:355/24/83-

ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00815/AM07/ RLA File : 09/24/040/00275/AM07/ Lic.No/Date:09100279 66 27.10.2006

Decision:Committee considered case as per agenda for ratification of norms for export product 1-(3-Hydroxymethyl-Pyridin-2-YL)-4-Methyl-2- Phenyl Piperaxine (M Alcohol) (Drug Intermediate of Mirtazapine) under

para 4.7 of HBP.

their U.O. No.35011/86/2007-PI-III dated 26.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 1-(3-hydroxymethyl-pyridine-2-YL)-4-Methyl-2-Phenyl Piperazine (M Alcohol) (Drug intermediate of Mirtazapine)------------------1Kg.

Import items:

  1. 1-Methyl 3 Phenyl Piperazine---------------------------------1.35 Kg/Kg
  2. 2-chloro Nicotinonitrile-----------------------------------------1.06 Kg/Kg
  3. Chloroform---------------------------------------------------------6.37 Kg/Kg
  4. Dimethyl formamide---------------------------------------------5.38 Kg/Kg
  5. Sodium Bis(2-methoxyethoxy aluminiumhydride --------2.44 Kg /Kg (Vitride) 4

Case No.:4/47/87-

ALC1/2006 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00827/AM07/ RLA File : 09/24/040/00359/AM07/ Lic.No/Date:09100286 61 18.12.2006 Defer Date: 27.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Lopinavir under para 4.7 of HBP. 5

Case No.:426/24/83-

ALC1/2007 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/01206/AM07/ RLA File : 03/95/040/00502/AM07/ Lic.No/Date:03104169 18 23.01.2007

norms for export product Cefprozil under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 01.11.2007 decided to ratify whichever is lower. Export product: Cefproozil-----------------------------------------------------------------1Kg. Import items:

  1. 7-Phenylacetamideo-3-chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester-----------3.649kg/kg

  2. Methylene chloride------------------------------------------------19.52kg/kg

  3. Sodium iodide--------------------------------------------------------1.20kg/kg

  4. Triphenyl phosphine------------------------------------------------2.065kg/kg

  5. Sodium thiosulphate------------------------------------------------3.65kg/kg

  6. Methanol---------------------------------------------------------------2.87kg/kg

  7. Phenol------------------------------------------------------------------4.43kg/kg

  8. N-Butyl Acetate-------------------------------------------------------5.60kg/kg

  9. Activated carbon----------------------------------------------------0.100kg/kg

Acetone-----------------------------------------------------------------3.09kg/kg 11. D(-)Alpha Para Hydroxy Phenyl Glycine Methyl Potassium Dane Salt--------------------------------------1.05kg/kg 12. Ethyl chloroformate--------------------------------------------------0.406kg/kg 13. Dimethyl formamide-------------------------------------------------4.92kg/kg 6

Case No.:427/24/83-

ALC1/2007 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/01207/AM07/ RLA File : 03/95/040/00934/AM07/ Lic.No/Date:03104169 45 23.01.2007

norms for export product Ethyl-1, 4 Dihydro-7-Methyl-4-one-1,8- Napthyridine-3-Carboxylate under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 25.10.2007 decided to ratify whichever is lower. Export product: Ethyl-1,4 Dihydro-7-Methyl-4-one-1,8-Nepthyridine-3-carboxylate------1Kg. Import items:

  1. Sodium Metal-----------------------------0.421kg/kg
  2. Alpha Picoline-----------------------------1.116kg/kg
  3. Ethoxy Methylene Malonic ester-----1.86kg/kg
  4. Diphenyl oxide----------------------------0.47kg/kg
  5. Dimethyl formamide--------------------1.08kg/kg 7

Case No.:435/24/83-

ALC1/2007 Party Name:SATYA DEEPTHA Meet No/Date:26/82- ALC4/2007 Status:Ca se

PHARMACEUTICALS LTD 30.10.2007 Approved HQ File : 01/83/050/01234/AM07/ RLA File : 09/24/040/00430/AM07/ Lic.No/Date:09100293 03 12.02.2007

norms for export product 1,1-Cyclohexane Diacetic Acid Anhydride under

para 4.7 of HBP.

their U.O. No.35011/274/2006-PI-III dated 25.10.2007 decided to ratify whichever is lower. Export product: 1,1-Cyclohexane Diacetic Anhydride------------------1Kg. Import items:

  1. 1,1-Cyclohexane Diacetic Acid---------------1.20kg/kg 8

Case No.:654/24/87-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00987/AM07/ RLA File : 09/24/040/00451/AM07/ Lic.No/Date:09100293 00 12.02.2007 Defer Date: 27.11.2007 norms for export product Ampicillin Sodium Sterile under para 4.7 of HBP. 9

Case No.:8/2/83-

ALC1/2007 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01256/AM07/ RLA File : 34/24/040/00259/AM07/ Lic.No/Date:34100181 08 19.02.2007 Defer Date: 11.12.2007 norms for export product 5-Bromo Phthalide under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for

their comments. Accordingly, case was deferred for six weeks. 10

Case No.:3/10/83-

ALC1/2007 Party Name:WANKSONS CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01262/AM07/ RLA File : 03/95/040/01284/AM07/ Lic.No/Date:03104202 13 20.02.2007 Defer Date: 13.11.2007 norms for export product Metacholoropropiophenone under para 4.7 of HBP. 11 Case No.:7/2/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01804/AM07/ RLA File : 03/94/040/01443/AM07/ Lic.No/Date:03104229 72 13.03.2007 Defer Date: 20.11.2007 norms for export product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/ Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to call for following information from firm.

  1. The case has been examined and it is noted that the export product is a combination tablet of Lamivudine + Stavudine and Nevirapine bulk drugs. The firm have applied import of intermediates for the manufacture of Lamivudine and Nevirapine. The firm have neither shown import of third ingredient i.e. Stavudine nor as the indigenous input.
  2. For working out the requirement of inputs for Lamivudine and Nevirapine, all the technical details as required under Appendix should be made available by the firm. The firm have not given the chemistry, molecular weight, percentage yield on molar basis and other relevant details for working out the required inputs. Committee also decided to call representative of firm for personal hearing in its meeting to be held on 20.11.07 to explain the case alongwith

above details. Accordingly, case was deferred for three weeks. 12

Case No.:43/9/82-

ALC4/2007 Party Name:KOPRAN LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01818/AM07/ RLA File : 03/94/040/01416/AM07/ Lic.No/Date:03104234 86 16.03.2007 Defer Date: 27.11.2007 norms for export product Clarithromycin EP/USP under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for four weeks. 13

Case No.:4/12/82-

ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01861/AM07/ RLA File : 09/24/040/00500/AM07/ Lic.No/Date:09100297 49 23.03.2007 Defer Date: 27.11.2007 norms for export product Fluoro Lactone under para 4.7 of HBP. Committee observed that firm has been has been requested to furnish certain technical information vide letter dated 08.10.2007, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 14

Case No.:5/10/82-

ALC4/2007 Party Name:GLAXOSMITHKLINE PHARMACEUTICALS LIMITED, Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01887/AM07/ RLA File : 03/94/040/00324/AM06/ Lic.No/Date:03104246 28 27.03.2007 Defer Date: 27.11.2007 norms for export product Betamethasone Di-Sodium Phosphate BP/USP Drug under para 4.7 of HBP. 15 Case No.:474/24/83- ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:26/82- ALC4/2007 Status:Ca se

30.10.2007 Deferred HQ File : 01/83/050/01382/AM07/ RLA File : 07/24/040/00879/AM07/ Lic.No/Date:07100509 72 29.03.2007 Defer Date: 27.11.2007 norms for export product N-[B-D-Ribofuranosyl]-5-Hydroxyimidazole-4- Carboxamide Technical Grade under para 4.7 of HBP. 16

Case No.:508/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00084/AM08/ RLA File : 09/24/040/00541/AM07/ Lic.No/Date:09100299 35 10.04.2007 Defer Date: 27.11.2007 norms for export product 5-Cyano Phthalide under para 4.7 of HBP. 17

Case No.:530/24/83-

ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00143/AM08/ RLA File : 34/24/040/00296/AM07/ Lic.No/Date:34100186 01 18.04.2007 Defer Date: 27.11.2007 norms for export product Betamethasone Valerate BP/USP under para 4.7 of HBP. 18 Case No.:543/24/83- ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00169/AM08/ RLA File : 03/94/040/00046/AM08/ Lic.No/Date:03104274 26 20.04.2007 Defer Date: 27.11.2007

norms for export product Diclofenac Sodium under para 4.7 of HBP. Committee observed that firm has been requested to furnish Central Excise Data vide letter dated 14.09.2007, but same has not been received. Committee, therefore, decided to await data from firm. Accordingly, case was deferred for four weeks. 19

Case No.:550/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00188/AM08/ RLA File : 09/24/040/00526/AM07/ Lic.No/Date:09100301 04 25.04.2007 Defer Date: 27.11.2007 norms for export product Propafenone Hydrochloride under para 4.7 of HBP. 20 Case No.:8/12/83- ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00205/AM08/ RLA File : 22/24/040/00005/AM08/ Lic.No/Date:22100066 83 26.04.2007

norms for export product Clopidogrel Hydrogen Sulphate under para 4.7 of HBP. The file from representative of PI was received back. their U.O. No.35011/77/2004-PI-III dated 25.10.2007 decided to ratify whichever is lower. Export product: Clopidogrel Hydrogen sulfate----------------------1kg. Import items:

  1. Alpha Bromo (20chloro Phenyl) Acetic Acid----1.18kg/kg
  2. Methylene chloride-----------------------------------2.41kg/kg
  3. Dimethyl formamide---------------------------------3.39kg/kg
  4. Acetone--------------------------------------------------3.91kg/kg
  5. Thiophene-2-Ethanol----------------------------------1.00kg/kg
  6. L(-)Camphor Sulphonic Acid--------------------------0.70kg/kg

21

Case No.:643/24/83-

ALC1/2007 Party Name:ALLIANCE LABORATORIES PVT.LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Rejected HQ File : 01/83/050/00424/AM08/ RLA File : 03/94/040/00160/AM08/ Lic.No/Date:03104303 99 23.05.2007

norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee observed that firm was requested to furnish certain technical information vide letter dated 16.10.2007, but same has not been received. In absence of technical information, it is not possible to fix I/O norms. Committee, therefore, decided to close the case. RA concerned may take further necessary action including cancellation of Advance Authorisation under para 4.7 of HBP as per above decision of Norms Committee. 22 Case No.:627/24/83- ALC1/2007 Party Name:SIRIS IMPEX, Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00396/AM08/ RLA File : 09/24/040/00562/AM07/ Lic.No/Date:09100303 42 25.05.2007 Defer Date: 27.11.2007 norms for export product Griffonia Simplicifolia Dry Extract 95% under para 4.7 of HBP. Committee observed that Deptt. of Ayush vide their O.M. No.K.11025/5/2007-DCC(Ayush) dated 08.10.2007 has stated that while considering the cases pertaining to input and output norms fixation, plants like Artemisinin, Griffonia, Simplicifolia, Podophyllum, Cpecacuanha, Mappia Foetida, many of the plants are not mentioned in Ayurveda, Siddha, Unani and Homeopathy systems of medicine. They have further stated that in other cases the product manufacturing technology, resultant product or extractions are not according to the Ayush systems of medicine manufacturing and hence their Department can not suggest the input output norms. Committee observed that the unit being an SSI Unit, DC(MSME) can examine the case with reference to input output norms. It was, therefore,

decided to forward a copy of application to DC(MSME) for their comments. Accordingly, case was deferred for four weeks. 23

Case No.:636/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00412/AM08/ RLA File : 09/24/040/00531/AM07/ Lic.No/Date:09100303 65 28.05.2007 Defer Date: 27.11.2007 norms for export product Cyclohexyl Ester under para 4.7 of HBP. 24

Case No.:635/24/83-

ALC1/2007 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00411/AM08/ RLA File : 09/24/040/00045/AM08/ Lic.No/Date:09100303 62 28.05.2007 Defer Date: 27.11.2007 norms for export product N-T-Box-L-Phenylalanine 99% Purity under para 4.7 of HBP. 25 Case No.:645/24/83- ALC1/2007 Party Name:AYURSIDDHA INC. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00438/AM08/ RLA File : 05/24/040/00105/AM08/ Lic.No/Date:05102042 54 30.05.2007 Defer Date: 27.11.2007 norms for export product Blockbuster All Clear Capsules under para 4.7 of HBP. Committee observed that Deptt. of Ayush vide their O.M. No.K.11025/5/2007-DCC(Ayush) dated 08.10.2007 has stated that while considering the cases pertaining to input and output norms fixation, plants like Artemisinin, Griffonia, Simplicifolia, Podophyllum, Cpecacuanha, Mappia Foetida, many of the plants are not mentioned in Ayurveda, Siddha,

Unani and Homeopathy systems of medicine. They have further stated that in other cases the product manufacturing technology, resultant product or extractions are not according to the Ayush systems of medicine manufacturing and hence their Department can not suggest the input output norms. Committee observed that the unit being an SSI Unit, DC(MSME) can examine the case with reference to input output norms. It was, therefore, decided to forward a copy of application to DC(MSME) for their comments. Accordingly, case was deferred for four weeks. 26

Case No.:680/24/83-

ALC1/2007 Party Name:DCM SHRIRAM INDUSTRIES LTD, Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00524/AM08/ RLA File : 05/24/040/00166/AM08/ Lic.No/Date:05102049 18 14.06.2007 Defer Date: 27.11.2007 norms for export product D(-)Para Hydroxy Phenyl Glycine Dane Salt under

para 4.7 of HBP.

27

Case No.:655/24/83-

ALC1/2007 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00530/AM08/ RLA File : 08/24/040/00066/AM08/ Lic.No/Date:08100654 23 15.06.2007 Defer Date: 27.11.2007 norms for export product Methscopolamine Tannate under para 4.7 of HBP. 28 Case No.:2/18/82- ALC4/2007 Party Name:HARMAN FINOCHEM LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/82/050/00114/AM08/ RLA File : 03/94/040/00273/AM08/ Lic.No/Date:03104333 97 21.06.2007

norms for export product Phenob Arbital (Phenobarbitone) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/141/2005-PI-III dated 01.11.2007 decided to ratify the norms under

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

Export Product: Phenobarbitone--------------------------1Kg. Import item:

  1. Benzyl cyanide----------------0.77kg/kg
  2. Dimethyl carbonate---------0.59kg/kg
  3. Sodium metal------------------0.31kg/kg
  4. Methanol------------------------1.09kg/kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 29

Case No.:736/24/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00634/AM08/ RLA File : 09/24/040/00129/AM08/ Lic.No/Date:09100307 09 29.06.2007

norms for export product Drotaverine Hcl under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 10/82 meeting held on 10.07.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Export Product: Drotaverine -------------------------------------1Kg. Import item:

  1. Ortho Diethoxy Benzene ------------------1.86kg/kg
  2. Iso Propyl Alcohol -------------------------1.63kg/kg
  3. Sodium Cyanide ----------------------------0.48kg/kg.
  4. Para Formaldehyde -------------------------0.30kg/kg.
  5. Methanol -------------------------------------3.26kg/kg. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 30 Case No.:737/24/83- ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:26/82- ALC4/2007 Status:Ca se

30.10.2007 Deferred HQ File : 01/83/050/00638/AM08/ RLA File : 09/24/040/00004/AM08/ Lic.No/Date:09100307 23 03.07.2007 Defer Date: 27.11.2007 norms for export product Etocrylene under para 4.7 of HBP. 31

Case No.:738/24/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00639/AM08/ RLA File : 09/24/040/00087/AM08/ Lic.No/Date:09100307 24 03.07.2007

norms for export product Fexofenadine Hcl under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 9/08 meeting held on 03.07.2007 vide Case No.A-205 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:- Export Product: Fexofenadine Hcl--------------------------------1Kg. Import items Sl.No. Description of item Quantity allowed 1. Sodium boro hydride 0.332Kg/Kg. 2. 4-chloro butryl chloride 1.216Kg/Kg. 3. Dimethyl sulfoxide 1.12Kg/Kg. 4. Methylene dichloride 3.00Kg/Kg. 5. Methanol 4.00Kg/Kg. 6. Potassium permanganate 1.905Kg/Kg. 7. Tetrahydrofuran Not shown in the process 8. Toluene 6.80Kg/Kg. 9. Gamma picolene 0.76Kg/Kg. 10. IPA 1.93Kg/Kg. 11. Methyl Isobutyl ketone 3.12Kg/Kg. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

32

Case No.:742/24/83-

ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00662/AM08/ RLA File : 09/24/040/00132/AM08/ Lic.No/Date:09100307 43 04.07.2007

norms for export product 1-(3-Hydroxymethyl-Pyridin-2-YL)-4-Methyl-2- Phenyl Piperaxine (M Alcohol) (Drug Intermediate of Mirtazapine) under

para 4.7 of HBP.

their U.O. No.35011/86/2007-PI-III dated 26.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 1-(3-hydroxymethyl-pyridine-2-YL)-4-Methyl-2-Phenyl Piperazine (M Alcohol) (Drug intermediate of Mirtazapine)------------------1Kg. Import items:

  1. 1-Methyl 3 Phenyl Piperazine---------------------------------1.35 Kg/Kg
  2. 2-chloro Nicotinonitrile-----------------------------------------1.06 Kg/Kg
  3. Chloroform---------------------------------------------------------6.37 Kg/Kg
  4. Dimethyl formamide---------------------------------------------5.38 Kg/Kg
  5. Sodium Bis(2-methoxyethoxy aluminiumhydride --------2.44 Kg /Kg (Vitride) RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
    33 Case No.:745/24/83- ALC1/2007 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00667/AM08/ RLA File : 09/24/040/00133/AM08/ Lic.No/Date:09100307 59 05.07.2007

norms for export product 2-(1-H-Tetrazole-5-YL)Phenyl Boronic Acid Dihydrate under para 4.7 of HBP. their U.O. No.35011/190/2006-PI-III dated 01.11.2007 decided to ratify whichever is lower.

Export product: 2-(1-H-Tetrazol-5-YL) Phenyl boronic acid dehydrate-----1kg. Import items:

  1. 5-Phenyl-1H-Tetrazole----------------------------------1.60kg/kg
  2. Tetrahydrofuran-------------------------------------------0.92kg/kg
  3. Trimethyl Borate-------------------------------------------2.75kg/kg 34

Case No.:760/24/83-

ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00693/AM08/ RLA File : 09/24/040/00099/AM08/ Lic.No/Date:09100308 44 11.07.2007

norms for export product Cefdinir under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 30.10.2007 decided to ratify whichever is lower. Export product: Cefdinir---------------------------------------------------------------------------1Kg. Import items:

  1. 7-Phenylacetamideo-3-Chloromethyl Cephalosporanic Acid Para Methoxy benzyl Ester (GCLE)-------------------------2.44kg/kg
  2. Ethyl-(Z)-2-Hydroxyimino-2-(2-Aminothiazole-4-YL) Acetone (EHATA)-------------------------------------------------------1.896kg/kg 35 Case No.:821/24/83- ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Rejected HQ File : 01/83/050/00807/AM08/ RLA File : 03/94/040/00375/AM08/ Lic.No/Date:03104361 63 13.07.2007

norms for export product 2-Dimethyl Amino Isopropyl Chloride Hydrochloride Or DMAIPC Or 2 Chloro-1-Dimethylamino Propane Hydrochloride under para 4.7 of HBP. Committee observed that export product falls under SCOMET list. Committee, therefore, decided to advise firm to first obtain Export Authorisation. Accordingly, it was decided to close the case. 36

Case No.:798/24/83-

ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00756/AM08/ RLA File : 05/24/040/00241/AM08/ Lic.No/Date:05102063 28 16.07.2007 Defer Date: 27.11.2007 norms for export product Mica Ester under para 4.7 of HBP. 37

Case No.:799/24/83-

ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00757/AM08/ RLA File : 05/24/040/00240/AM08/ Lic.No/Date:05102063 31 16.07.2007 Defer Date: 27.11.2007 norms for export product 7 AVNA under para 4.7 of HBP. 38

Case No.:838/24/83-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00834/AM08/ RLA File : 34/24/040/00061/AM08/ Lic.No/Date:34100192 69 24.07.2007 Defer Date: 13.11.2007 norms for export product Fenofibrate under para 4.7 of HBP.

39

Case No.:851/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00851/AM08/ RLA File : 05/24/040/00313/AM08/ Lic.No/Date:05102066 70 24.07.2007 Defer Date: 27.11.2007 norms for export product Midazolam under para 4.7 of HBP. 40 Case No.:853/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00853/AM08/ RLA File : 05/24/040/00324/AM08/ Lic.No/Date:05102066 95 24.07.2007

norms for export product Candesartan Cilexetil under para 4.7 of HBP. their U.O. No.35011/9/2005-PI-III dated 01.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Candesartan Cilexetil-----------------------------------1kg. Import items:

  1. 1-chloro ethyl chloroformate---------------0.45kg/kg
  2. 4-(bromomethyl)-2-cyanobiphenyl---------1.66kg/kg
  3. Acetic acid----------------------------------------4.07kg/kg
  4. Formic Acid---------------------------------------1.30kg/kg
  5. Pyridine--------------------------------------------0.922kg/kg
  6. Stannous chloride dehydrate------------------3.62kg/kg
  7. Tetrabutyl Ammonium Bromide--------------0.18kg/kg
  8. Triethylamine--------------------------------------0.31kg/kg
  9. Moleculral Sieve 3a powdered-----------------0.05kg/kg

Tetraethyl orthocarbonate----------------------1.19kg/kg 11. Acetonitrile------------------------------------------2.50kg/kg 12. Dimethyl formamide------------------------------1.52kg/kg 13. Cyclohexane-----------------------------------------5.88kg/kg 14. Ethylacetate-----------------------------------------10.00kg/kg

Isopropyl Alcohol------------------------------------0.50kg/kg 16. Methanol--------------------------------------------10.00kg/kg 17. Methylene chloride---------------------------------5.00kg/kg 18. Tert. Butanol------------------------------------------2.00kg/kg 19. Toluene-------------------------------------------------5.00kg/kg 20. Acetone-------------------------------------------------3.45kg/kg 21. Activated carbon--------------------------------------0.100kg/kg 41

Case No.:918/24/83-

ALC1/2007 Party Name:AROCHEM INDUSTRIES Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00931/AM08/ RLA File : 03/94/040/00371/AM08/ Lic.No/Date:03104375 27 26.07.2007

norms for export product Choline Bitartrate – FCC-V/USP under para 4.7 of HBP. their U.O. No.35011/57/2007-PI-III dated 01.11.2007 decided to ratify whichever is lower. Export product: Choline Bitartrate-FCC-V/USP-------------------------1kg. Import items:

  1. Tartaric Acid------------------------------------0.775kg/kg 42 Case No.:894/24/83- ALC1/2007 Party Name:DOCTORSORGANIC CHEMICALS LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00902/AM08/ RLA File : 26/24/040/00001/AM08/ Lic.No/Date:26100063 18 07.08.2007 Defer Date: 27.11.2007 norms for export product Clopidogrel Hydrogen Sulfate Solid under para 4.7 of HBP.

43

Case No.:900/24/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00910/AM08/ RLA File : 22/24/040/00031/AM08/ Lic.No/Date:22100069 47 07.08.2007

norms for export product 1,3-Dioxolane,4-acetic acid, 6-[2-[2-(4- flourophenyl)methyl]-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-p under para 4.7 of HBP. their U.O. No.35011/77/2004A-PI-III dated 25.10.2007 decided to ratify whichever is lower. Export product: Atorvastatin Intermediate AT-1-----------------------------1Kg. Import items: 1.Methyl Isobutyryl Acetate ----------------------------0.970kg/kg 2. Benzaldehyde-------------------------------------------0.458kg/kg 3. B-alanine--------------------------------------------------0.0735kg/kg 4. 4-fluoro benzaldehyde---------------------------------0.69kg/kg 5. 3-Ethyl-5-(2-Hydroxyethyl)-4-methyl thiozolium-0.120kg/kg 6. (4R-CIS)-1,1 Dimethylethyl6-Cyanomethyl-2-2- dimethyl-1,3-Dioxane-4-Acetate(ATS-8)------------0.635kg/kg 7. Heptane----------------------------------------------------4.37kg/kg 44 Case No.:901/24/83- ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00911/AM08/ RLA File : 22/24/040/00032/AM08/ Lic.No/Date:22100069 48 07.08.2007

norms for export product Fexofenadine Hydrochloride under para 4.7 of HBP.

their U.O. No.35011/77/2004A-PI-III dated 25.10.2007 decided to ratify whichever is lower. Export product: Fexofenadine Hcl------------------------------1kg. Import items:

  1. 4-chloro Butyryl chloride----------1.216kg/kg
  2. Azacyclonol----------------------------1.035kg/kg
  3. Potassium Permanganate----------1.905kg/kg
  4. Dimethyl sulphoxide-----------------1.12kg/kg
  5. Toluene---------------------------------6.80kg/kg
  6. Monoethylene Glycol----------------1.24kg/kg
  7. Methanol--------------------------------4.00kg/kg
  8. 1,2 Dimethoxyethane-----------------1.12kg/kg
  9. Sodium Borohydride powder--------0.332kg/kg

Methylene chloride--------------------3.00kg/kg 11. Acetone-----------------------------------2.21kg/kg 12. Methyl Isobutyl Ketone----------------3.12kg/kg 13. Isopropyl Alcohol------------------------1.93kg/kg 14. Tetrahydrofuran-------------------------Not allowed as not shown in process 45 Case No.:943/24/83- ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/83/050/00957/AM08/ RLA File : 09/24/040/00186/AM08/ Lic.No/Date:09100311 19 13.08.2007

Decision : Committee considered case as per agenda for ratification of norms for export product 3-Acetoxymethyl-4-Acetoxyacetophenone (Diacetate) (Drug Intermediate of Salbutamol Sulphate) under para 4.7 of HBP. their U.O. No.35011/5/2005-PI-III dated 01.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product: 3-Acetoxymethyl-4-Acetoxy Acetophenone(Diacetate) (Drug intermediate of Salbutamol Sulphate--------------------------------1kg. Import items:

  1. Para Hydroxy Aceto Phenone-----------------------0.91kg/kg
  2. Toluene--------------------------------------------------0.525kg/kg 46

Case No.:5/20/82-

ALC4/2007 Party Name:RICHY GOLD INTERNATIONAL Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00162/AM08/ RLA File : 03/95/040/00461/AM08/ Lic.No/Date:03104394 44 14.08.2007 Defer Date: 11.12.2007 norms for export product Oral Rehydration Salt BP under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 47

Case No.:16/25/83-

ALC1/2007 ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01041/AM08/ RLA File : 03/94/040/00516/AM08/ Lic.No/Date:03104397 36 16.08.2007 Defer Date: 27.11.2007 norms for export product Losartan Potassium under para 4.7 of HBP. 48 Case No.:972/24/83- ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00988/AM08/ RLA File : 09/24/040/00554/AM07/ Lic.No/Date:09100311 78 21.08.2007 Defer Date: 11.12.2007 norms for export product 1,2-Epoxy-2-(2,4-Difluorophenyl)-3(1(H)-Triazole-

1-YL) Propane Methane Sulphonate under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 49

Case No.:973/24/83-

ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00990/AM08/ RLA File : 09/24/040/00139/AM08/ Lic.No/Date:09100311 79 21.08.2007 Defer Date: 11.12.2007 norms for export product 1,2-Epoxy-2-(2,4-Difluorophenyl)-3(1(H)-Triazole- 1-YL) Propane Methane Sulphonate under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 50

Case No.:1000/24/83-

ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01018/AM08/ RLA File : 09/24/040/00185/AM08/ Lic.No/Date:09100312 01 24.08.2007 Defer Date: 27.11.2007 norms

for

export

product

8-Chloro-5,6-Dihydro-11h- benzo(5,6)cyclohepta(1,2-b)pyridine-11-one under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 51 Case No.:41/25/83- ALC1/2007 Party Name:INVENTIS DRUG DELIVERY SYSTEMS PVT LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Rejected HQ File : 01/83/050/01066/AM08/ RLA File : 09/24/040/00213/AM08/ Lic.No/Date:09100313 20 30.08.2007

norms for export product Orlistat Pellets 50% under para 4.7 of HBP. Committee observed that firm has not submitted copy of DML and therefore it is not possible to ratify norms. Committee, therefore, decided to reject the case.

RA concerned may take further necessary action including cancellation of Advance Authorisation under para 4.7 of HBP as per above decision of Norms Committee. 52

Case No.:4/22/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00174/AM08/ RLA File : 09/24/040/00207/AM07/ Lic.No/Date:09100313 28 31.08.2007 Defer Date: 27.11.2007 norms for export product Cefoperazone Sodium Sterile USP/BP under para 4.7 of HBP. 53

Case No.:5/22/82-

ALC4/2007 ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00175/AM08/ RLA File : 03/94/040/00571/AM08/ Lic.No/Date:03104415 56 31.08.2007 Defer Date: 20.11.2007 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. Committee decided to call representative of firm for personal hearing to 54 Case No.:6/22/82- ALC4/2007 Party Name:SKM PHARMA(P)LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/82/050/00176/AM08/ RLA File : 07/24/040/00339/AM08/ Lic.No/Date:07100531 23 31.08.2007

norms for export product Fortified Procaine Penicillin 4 Mega Injection 20ml under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 16/82 meeting held on 21.08.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product: Fortified Procaine Penicillin 4 Mega Injection 20ml-------------------------1No. Procaine penicillin and benzyl penicillin sodium 3:1) Import item: Fortified Procaine Penicillin (Procaine Penicillin /Benzyl Penicillin Sodium-3:1)—-----------------------0.00346 BOU with 4% wastage RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 55

Case No.:27/27/83-

ALC1/2007 Party Name:SHARP STATIONERY PRODUCTS Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Transferr ed HQ File : 01/83/050/01101/AM08/ RLA File : 08/24/040/00141/AM08/ Lic.No/Date:08100669 64 03.09.2007

norms for export product Carbon Paper Black under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to Chemical Sector. 56

Case No.:7/22/82-

ALC4/2007 ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/82/050/00177/AM08/ RLA File : 03/94/040/00586/AM08/ Lic.No/Date:03104418 20 05.09.2007

norms for export product Lamotrigine under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-3208. 57 Case No.:36/27/83- ALC1/2007 Party Name:BAJAJ HEALTHCARE LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01110/AM08/ RLA File : 03/94/040/00486/AM08/ Lic.No/Date:03104419 14 05.09.2007 Defer Date: 11.12.2007

norms for export product Carbamazepine BP (Micronized) under para 4.7 of HBP. Committee decided to call for specification of import and export product showing purity and particle size from firm. Accordingly, case was deferred for six weeks. 58

Case No.:54/27/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01128/AM08/ RLA File : 03/94/040/00525/AM08/ Lic.No/Date:03104419 78 06.09.2007 Defer Date: 11.12.2007 norms for export product Aprepitant under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 59

Case No.:10/22/82-

ALC4/2007 ALC4/2007 30.10.2007 Status:Case Deferred HQ File : 01/82/050/00180/AM08/ RLA File : 03/94/040/00615/AM08/ Lic.No/Date:03104428 78 12.09.2007 Defer Date:20.11.20 07 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Committee decided to call representative of firm for personal hearing to 60 Case No.:98/27/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01172/AM08/ RLA File : 09/24/040/00258/AM08/ Lic.No/Date:09100315 11 14.09.2007 Defer Date: 27.11.2007 norms for export product Tenofovir Disoproxil Fumerate under para 4.7 of HBP.

61

Case No.:11/22/82-

ALC4/2007 Party Name:HARMAN FINOCHEM LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/82/050/00181/AM08/ RLA File : 03/94/040/00591/AM08/ Lic.No/Date:03104434 68 18.09.2007

norms for export product Phenobarbital (Phenobarbitone) under para 4.7 of HBP. their U.O. No.35011/99/2007-PI-III dated 18.10.2007 decided to ratify whichever is lower. Export product: Phenobarbitone-----------------------------------1kg. Import items:

  1. Benzyl cyanide----------------------------0.662kg/kg
  2. Dimethyl carbonate---------------------0.59kg/kg
  3. Sodium Metal-----------------------------0.31kg/kg
  4. Methanol-----------------------------------1.09kg/kg 62

Case No.:12/22/82-

ALC4/2007 ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00182/AM08/ RLA File : 03/94/040/00638/AM08/ Lic.No/Date:03104436 98 19.09.2007 Defer Date: 11.12.2007 norms for export product Carvedilol under para 4.7 of HBP. case is under examination in their Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 63 Case No.:15/22/82- Status:Ca

ALC4/2007 ALC4/2007 30.10.2007 se Approved HQ File : 01/82/050/00185/AM08/ RLA File : 03/94/040/00633/AM08/ Lic.No/Date:03104438 47 20.09.2007

norms for export product GCS Max Powder (per pack 500 grams under para 4.7 of HBP. Committee in the light of its earlier decision taken in its 11/82 meeting held on 17.07.2007 vide Case No.5/8/82 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is lower. Export Product: GCS Max Powder (Pack size 500gm) Import items: Glucosamine hcl------------------------------0.275kg/pack of 500gm. Sodium chondroitin sulphate--------------0.09kg/pack of 500gm. Manganese-------------------------------------0.00122/pack of 500gm. Ascorbic acid-----------------------------------0.0159kg/pack of 500gm. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 64

Case No.:13/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00183/AM08/ RLA File : 13/24/040/00018/AM08/ Lic.No/Date:13100250 51 21.09.2007 Defer Date: 27.11.2007 norms for export product Biotin Granules under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for four weeks. 65 Case No.:14/22/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00184/AM08/ RLA File : 13/24/040/00017/AM08/ Lic.No/Date:13100250 52 21.09.2007 Defer Date: 27.11.2007 norms for export product Vitamin B12 Granules under para 4.7 of HBP.

Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for four weeks. 66

Case No.:16/22/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00186/AM08/ RLA File : 03/95/040/00574/AM08/ Lic.No/Date:03104440 49 24.09.2007 Defer Date: 27.11.2007 norms for export product Diproson Lotion (30ml) under para 4.7 of HBP. 67

Case No.:17/22/82-

ALC4/2007 ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00187/AM08/ RLA File : 03/94/040/00650/AM08/ Lic.No/Date:03104442 04 25.09.2007 Defer Date: 20.11.2007 norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. Committee decided to call representative of firm for personal hearing to 68 Case No.:1/26/82- ALC4/2007 Party Name:ALKEM LABORATORIES LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Approved HQ File : 01/82/050/00219/AM08/ RLA File : 03/94/040/00716/AM08/ Lic.No/Date:03104471 59 19.10.2007

norms for export product Ceftazidime Injection 1gm under para 4.7 of HBP. their U.O. No.35011/6/2007-PI-III dated 01.11.2007 in case of M/S Karnataka Antibiotics Ltd. decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ceftazidime 1gm. Injection

Import item: Sterile Ceftazidime USP as Pentahydrate With minimum8.33% Sodium Carbonate---------------1.32gm/Vial 69

Case No.:2/26/82-

ALC4/2007 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., Meet No/Date:26/82- ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00220/AM08/ RLA File : 03/94/040/00755/AM08/ Lic.No/Date:03104473 19 22.10.2007 Defer Date: 27.11.2007 norms for export product Drug Formulations Drops namely Fecistil Drops under para 4.7 of HBP. Committee decided to call for a copy of application alongwith copy of Advance Authorisation from RA. Accordingly, case was deferred for four weeks. 70

Case No.:3/26/82-

ALC4/2007 ALC4/2007 30.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00221/AM08/ RLA File : 03/94/040/00751/AM08/ Lic.No/Date:03104473 34 22.10.2007 Defer Date: 27.11.2007 norms for export product Sulfacox Powder under para 4.7 of HBP. Committee decided to call for a copy of application alongwith copy of Advance Authorisation from RA. Accordingly, case was deferred for four weeks. Date:25.10.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

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