IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-12-27

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

MEETING NUMBER : 34/82-ALC4/2007 MEETING DATE : 27.12.2007 The Meeting No.34/08 for the licensing year 2007-08 to consider the cases under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2004-09 pertaining to Pharma Products was held on 27.12.2007 under the Chairmanship of Shri S.K. Prasad, Addl. Director General of Foreign Trade in his chamber.

Case No.B-449

M/S Shalina Laboratories Pvt. Ltd. Norms Committee Meeting No.34/08 F.No.01/83/50/1084/AM’07/ Meeting Date: 26.12.2007 RLA F.No.03/95/40/1163/AM07 Advance Licence No.0310414239 dated 02.01.2007 Committee considered case as per agenda for ratification of norms for export product Betasol Lotion 30ml under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for two weeks. Accordingly, Committee decided to defer the case for two weeks.

Case No.B-450

M/S Shalina Laboratories Pvt. Ltd. F.No.01/83/50/1083/AM’07/ RLA F.No.03/95/40/1164/AM07 Advance Licence No.0310414237 dated 02.01.2007 Committee considered case as per agenda for ratification of norms for export product Epiderm Lotion 30ml under para 4.7 of HBP.

Case No.B-451

M/S SMS Pharmaceutical Ltd.

F.No.01/83/162/424/AM’07/ RLA F.No.09/24/40/02/AM06 Advance Licence No.0910023407 dated 05.07.2005 Committee considered case as per agenda for revision of norms for export product D-erythro.d-threo-2-Deoxy-2,2-difluro penta furanos-1 ulose-3,5-dibenzoate under para 4.7 of HBP. case is under examination in his Department and he sought deferment for four weeks. Accordingly, Committee decided to defer the case for four weeks.

Case No.B-452

M/S SMS Pharmaceuticals Ltd. F.No.01/83/162/425/AM’07/ RLA F.No.09/24/40/377/AM06 Advance Licence No.0910025027 dated 28.11.2005 product D-erythro.d-threo-2-Deoxy-2,2-difluro penta furanos-1 ulose-3, 5-dibenzoate under para 4.7 of HBP.

Case No.B-453

M/S Ranbaxy Laboratories Ltd. F.No.01/83/50/617/AM’07/ RLA F.No.05/24/40/400/AM07 Advance Licence No.0510189882 dated 31.08.2006 product Pravastatin Sodium under para 4.7 of HBP.

Case No.B-454

M/S Ranbaxy Laboratories Ltd F.No.01/82/50/608/AM’08/ RLA F.No.05/24/40/248/AM08

Advance Licence No.0510205474 dated 27.06.2007 product Pravastatin Sodium under para 4.7 of HBP.

Case No.B-455

M/S Ranbaxy Laboratories Ltd. F.No.01/83/50/167/AM’08/ RLA F.No.05/24/40/49/AM08 Advance Licence No.0510202775 dated 20.04.2007 product Pravastatin Sodium under para 4.7 of HBP.

Case No.B-456

M/S Wockhardt Ltd. F.No.01/82/162/548/AM’07/

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product D-Oxypehne Base (Powder), SION at Sl.No.A- 166. Committee decided to defer the case for two weeks.

Case No.B-457

M/S Mega Fine Pharma Pvt. Ltd. F.No.01/82/50/557/AM’04/ RLA F.No.03/24/40/1002/AM04 Advance Licence No.0310224423 dated 12.09.2003 product 4-Amino-1,24-Triazole Powder under para 4.7 of HBP. Committee observed that initially the written comments were received from Ch-III, Department of C&PC. Committee, therefore, decided to transfer the case to

NC-IV (DES-IV).

Case No.B-458

M/S Lupin Ltd. F.No.01/82/162/285/AM’05/

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product 3C7ACCA, SION at Sl.No.A-2119. Committee decided to defer the case for two weeks.

Case No.B-459

M/S Kopran Ltd. F.No.01/83/50/896/AM’07/ RLA F.No.03/94/40/362/AM07 Advance Licence No.0310391067 dated 24.07.2006 product Clarithromycin Granules 40% under para 4.7 of HBP. Committee observed that initially the norms were fixed by NC in line with SION. Committee, therefore, decided to maintain status quo.

Case No.B-460

M/S Kopran Ltd. F.No.01/83/50/1372/AM’07/ RLA F.No.03/94/40/951/AM07 Advance Licence No.0310410420 dated 01.12.2006 product Ceftriaxone Sodium Sterile under para 4.7 of HBP. Committee observed that the quantity of import item No.1 was allowed as per firm’s own material balance (STOICHIOMETRIC) submitted by the firm alongwith their application. Committee, therefore, decided to maintain status quo.

Case No.B-461

M/S Penam Laboratories Ltd. F.No.01/82/162/450/AM’08/

Committee considered case as per agenda for fixation of value addition for

DEPB rate in respect of export product 6-Amino Penicillanic Acid, SION at Sl.No.A-33. Committee decided to defer the case for two weeks.

Case No.B-462

M/S Wockhardt Ltd. F.No.01/83/162/428/AM07 Meeting Dated: 26.12.2007 Committee considered case as per agenda for fixation of value addition for revision of DEPB rate in respect of Dextromethorphan Hydrobromide SION at Sl.No.A-173. Committee decided to defer the case for two weeks.

Case No.B-463

M/S Suven Life Science Ltd. F.No.01/83/50/823/AM06/DES-III RLA F.No.09/24/040/219/AM06 Advance Licence No.0910024206 dated 07.10.2005 Committee considered case as per agenda for ratification of norms for export product 1,2-Benzisoxazole-3-Methane Sulphonic Acid Sodium Salt Monohydrate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/254/2006-PI-III dated 27.12.2007 and in consultation of the representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 1,2 benzisoxazole-3-methane Sulphonic acid sodium salt monohydrate-------1kg. Import items:

  1. 2,hydroxyl Acetophenone--------------------------2.855kg/kg
  2. Dimethyl carbonate----------------------------------7.55kg/kg
  3. Pyridine--------------------------------------------------1.765kg/kg
  4. Hydroxylamine Hcl------------------------------------1.00kg/kg
  5. Bromine--------------------------------------------------1.73kg/kg
  6. Toluene---------------------------------------------------2.45kg/kg
  7. Methanol-------------------------------------------------1.92kg/kg
  8. Acetone---------------------------------------------------1.12kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.C-28

M/S DCM Shriram Industries Ltd. F.No.01/83/162/286/AM’08/

Committee considered case as per agenda for fixation of SION in respect of export product D(-) Para Hydroxy Phenyl Glycine Methyl Potassium Dane Salt.

Case No.A-947

M/S Vamshi Chemicals Ltd. F.No.01/83/162/150/AM’08/ RLA F.No.06/24/40/07/AM08 Advance Licence No.0610012062 dated 20.06.2007 Committee considered case as per agenda for ratification of norms for export product Iso-Longifolene and Longifolene Acetate Main under para 4.7 of HBP. Committee observed that export product is Chiral Hydroborating Agent i.e. Chemical item. Committee, therefore, decided to transfer the case to NC-IV (DES- IV).

Case No.A-948

M/S Gland Pharma Ltd. F.No.01/82/50/254/AM’08/ RLA F.No.09/24/40/314/AM08 Advance Licence No.0910031800 dated 16.10.2007 Committee considered case as per agenda for ratification of norms for export product Adenosine Injection USP USP Prefilled Syringe 30mg/ml, 2ml in a PFS and Adenosine Injection USP Prefilled Syringe 3mg/ml, 4ml in a PFS under para 4.7 of HBP.

Case No.A-949

M/S Aurobindo Pharma Ltd. F.No.01/82/50/253/AM’07/ RLA F.No.09/24/40/205/AM08 Advance Licence No.0910031156 dated 16.08.2007

Committee considered case as per agenda for ratification of norms for export product Ceftiofur Sodium Strile under para 4.7 of HBP.

Case No.A-950

M/S Cadila healthcare Ltd. F.No.01/82/50/161/AM’08/ RLA F.No.08/24/40/136/AM08 Advance Licence No.0810066915 dated 30.08.2007 Committee considered case as per agenda for ratification of norms for export product 2-(2-Methoxyphenoxy)-Ethylamine Base Pharma Grade under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/73/2007-PI-III dated 27.12.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 2-(2-Methoxyphenoxy)-Ethylamine--------------------1kg. Import items:

  1. Guaiacol-------------------------------------------0.707kg/kg
  2. Di methyl formamide---------------------------1.989kg/kg
  3. Toluene---------------------------------------------1.321kg/kg
  4. Methylene chloride------------------------------2.00kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 1

Case No.:801/21/82-

ALC4/2007 Party Name:IGOR PHARMACHEM LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/82/050/01543/AM05/ RLA File : 09/24/040/00289/AM05/ Lic.No/Date:09100210 62 09.12.2004

Decision :Committee considered case as per agenda for ratification norms for export product 2,3-Dichloro Benzoyl Cyanide under para p.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/66/2007-PI-III dated 06.08.2007 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: 2,3 Dichloro benzoyl cyanide-------------------1Kg. Import items:

  1. 2,3 dichloro benzoyl chloride-------------1.50kg/kg
  2. Cuprous Cyanide--------------------------0.70kg/kg
  3. Hexane-------------------------------------1.00kg/kg
  4. Ortho dichloro benzene-------------------Not allowed RLA concerned may take further necessary action as per above decision of Norms Committee. 2

Case No.:4/47/87-

ALC1/2006 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/87/050/00827/AM07/ RLA File : 09/24/040/00359/AM07/ Lic.No/Date:09100286 61 18.12.2006

Decision : Committee considered case as per agenda for ratification norms for export product Lopinavir under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/58/2007-PI-III dated 04.12.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Lopinavir----------------------------------------------1kg. Import items:

  1. L-Phenyl Alanine--------------------------1.36kg/kg
  2. L-Valine--------------------------------------1.58kg/kg
  3. Triphosgene--------------------------------0.715kg/kg
  4. 2,6 Dimethy Phenol----------------------0.73kg/kg
  5. (L)-Pyroglutamic acid---------------------0.57kg/kg
  6. Sodium Borohydride----------------------0.89kg/kg
  7. Phenyl chloro formate--------------------2.21kg/kg
  8. 1,2 Dimethyl Ethane----------------------29.38kg/kg
  9. Methanol------------------------------------10.59kg/kg 10.Tetrahydrofuran---------------------------12.20kg/kg 11.N-Heptane------------------------------------2.91kg/kg 12.Iso Propyl Alcohol---------------------------2.43kg/kg 13.Methyl Tertiary Butyl Ether--------------14.92kg/kg 14.Methylene chloride-------------------------7.75kg/kg 15.Acetomitrile-----------------------------------0.58kg/kg 16.Dimethyl formamide------------------------1.82kg/kg RA concerned may take further necessary action as per above decision

of Norms Committee. 3

Case No.:3/9/83-ALC1/2007 Party Name:VITAL

HEALTHCARE PVT.LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01284/AM07/ RLA File : 03/95/040/01405/AM07/ Lic.No/Date:03104210 71 27.02.2007

for export product Dihydroartemisinin under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/245/2006-PI-III dated 26.11.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Dihydro Artemisinin-----------------------------1kg. Import item: Artemisinin-----------------------------------------1.12kg/kg of Norms Committee. 4

Case No.:6/9/82-ALC4/2007 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Withdrawn HQ File : 01/82/050/01728/AM07/ RLA File : 09/24/040/00488/AM07/ Lic.No/Date:09100295 04 01.03.2007

for export product Cefdinir under para p.7 of HBP. Committee decided to withdraw the case as same has been approved by NS in its 33/08 meeting held on 18.12.2007. 5

Case No.:467/24/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/01334/AM07/ RLA File : 09/24/040/00519/AM07/ Lic.No/Date:09100296 57 14.03.2007 Defer Date: 05.02.2008

for export product 2-Aminomethyl 7-Chloro-2,3 Dihydro-5(2- Fluorophenyl)1H-4-Benzodiazepine Dimaleate under para p.7 of HBP. Committee decided to call for a copy of application along with a copy of Advance Authorisation from RA/firm. Accordingly, case was deferred for six weeks. 6

Case No.:474/24/83-

ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 22.01.2008 for export product

N-[B-D-Ribofuranosyl]-5-Hydroxyimidazole-4- Carboxamide Technical Grade under para p.7 of HBP. 7

Case No.:508/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/00084/AM08/ RLA File : 09/24/040/00541/AM07/ Lic.No/Date:09100299 35 10.04.2007

for export product 5-Cyano Phthalide under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/226/2006-PI-III dated 27.12.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 5-Cyano Phthalide-----------------------------1kg. Import items:

  1. Sulfolane-------------------------------6.184kg/kg
  2. Sulfamide------------------------------1.020kg/kg
  3. Para Formaldehyde------------------0.53kg/kg

of Norms Committee. 8

Case No.:9/21/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/82/050/00009/AM08/ RLA File : 09/24/040/00543/AM07/ Lic.No/Date:09100299 31 10.04.2007 Defer Date: 22.01.2008 for export product 7-Amino-3[(Z/E)—Propen-1-YL]-3-Cepham-4-Carboxylic Acid (APRA) under para p.7 of HBP. 9

Case No.:530/24/83-

ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 08.01.2008 for export product Betamethasone Valerate BP/USP under para p.7 of HBP. 10

Case No.:550/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 08.01.2008 for export product Propafenone Hydrochloride under para p.7 of HBP. 11 Case No.:15/18/83- ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:34/82- ALC4/2007 Status:Cas e Rejected

26.12.2007 HQ File : 01/83/050/00252/AM08/ RLA File : 09/24/040/00023/AM08/ Lic.No/Date:09100301 74 04.05.2007

for export Product Iso Metheptene Mucate under para p.7 of HBP. Committee observed that the firm was requested to furnish technical details as per Appendix 33 vide letter dated 29.10.2007, but the same has not been received. In the absence of technical details, it is not possible for the Committee to fix adhoc norms. Committee, therefore, decided to reject the case. of Norms Committee. 12

Case No.:636/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 08.01.2008 for export product Cyclohexyl Ester under para p.7 of HBP. 13

Case No.:635/24/83-

ALC1/2007 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 22.01.2008 for export Product N-T-Boc-L-Phenylalanine 99% Purity under para p.7 of HBP. 14 Case No.:645/24/83- ALC1/2007 Party Name:AYURSIDDHA INC. Meet No/Date:34/82- ALC4/2007 Status:Cas e Deferred

26.12.2007 HQ File : 01/83/050/00438/AM08/ RLA File : 05/24/040/00105/AM08/ Lic.No/Date:05102042 54 30.05.2007 Defer Date: 22.01.2008 for export product Blockbuster All Clear Capsules made of Citrolive (Olive Leaf Citrus) under para p.7 of HBP. Committee decided to defer the case for four weeks for comments of Department of MSME. 15

Case No.:680/24/83-

ALC1/2007 Party Name:DCM SHRIRAM INDUSTRIES LTD, Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 22.01.2008 for export product D(-)Para Hydroxy Phenyl Glycine Dane Salt under para p.7 of HBP. 16

Case No.:655/24/83-

ALC1/2007 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 22.01.2008 for export product Methscopolamine Tannate under para p.7 of HBP. 17 Case No.:83/19/83- ALC1/2007 Party Name:SUMITOMO CHEMICAL INDIA PRIVATE LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/00643/AM08/ RLA File : 03/95/040/01529/AM07/ Lic.No/Date:03104338 38 25.06.2007 Defer Date: 22.01.2008

for export product 1,2-Methylenedioxybenzene under para p.7 of HBP. Committee decided to call for following information from the firm.

  1. End use of the export product.
  2. Technical literature in support of above. Accordingly, case was deferred for four weeks. 18

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/00623/AM08/ RLA File : 09/24/040/00120/AM08/ Lic.No/Date:09100306 86 29.06.2007 Defer Date: 22.01.2008 for export product (S)03-Hydroxy-N-Benzyl Pyrrolidine under para p.7 of HBP. 19

Case No.:19/23/83-

ALC1/2007 Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/00655/AM08/ RLA File : 07/24/040/00234/AM08/ Lic.No/Date:07100523 01 04.07.2007 Defer Date: 22.01.2008 for export product L-(+)-Selenomethionine under para p.7 of HBP. Committee decided to call for following information from the firm. 3. End use of the export product. 4. Technical literature in support of above. Accordingly, case was deferred for four weeks. 20 Case No.:2/14/82- ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/82/050/00116/AM08/ RLA File : 22/24/040/00018/AM08/ Lic.No/Date:22100068 97 17.07.2007

for export product Cefdinir under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/159/2006-PI-III dated 27.12.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Cefdinir--------------------------------------------------------------1kg. Import items:

  1. 7-Phenylacetamideo-3-Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE)------------------------------------2.44kg/kg
  2. Triphenyl Phosphine-----------------------------------2.429kg/kg
  3. Sodium Iodide-------------------------------------------0.76kg/kg
  4. Formaldehyde 37%-------------------------------------2.74kg/kg
  5. Dimethyl formamide-----------------------------------1.84kg/kg
  6. Methanol--------------------------------------------------3.93kg/kg
  7. Methylene Dichloride----------------------------------18.90kg/kg
  8. N-butyl acetate-------------------------------------------3.91kg/kg
  9. Phenol------------------------------------------------------2.42kg/kg

Acetone----------------------------------------------------4.77kg/kg 11. Eno Carbon------------------------------------------------0.1kg/kg 12. Triethylamine---------------------------------------------1.132kg/kg 13. Tetrahydrofuran------------------------------------------2.45kg/kg 14. Sulphuric Acid------------------------------------Not an importable item. Hence not allowed. 15. Dicyclo Hexylamine--------------------------------------0.56kg/kg 16. Ethyl-(z)-2-Hydroxylamine-2- (2-Aminothiazol-4yl) Acetate--------------------------1.097kg/kg 17. Mercapto Benzo Thiazole Disulphide----------------1.67kg/kg 18. Ethyl Alcohol-----------------------------------------------1.74kg/kg 19. Sodium Hydroxide----------------------------------------0.371kg/kg 20. Acetic Anhydride------------------------------------------0.90kg/kg 21. Pen. G Amidase (Enzyme)-------------------------------0.032kg/kg of Norms Committee. 21 Case No.:850/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved

HQ File : 01/83/050/00850/AM08/ RLA File : 05/24/040/00312/AM08/ Lic.No/Date:05102066 55 24.07.2007

for export product Isotretinoin under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/85/2007-PI-III dated 20.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Isotretinoin----------------------------------1kg. Import items:

  1. Acetone---------------------------------0.48kg/kg
  2. Activated Carbon---------------------0.100kg/kg
  3. Beta lonone----------------------------3.20kg/kg
  4. Dimethy Acrylic Acid-----------------2.37kg/kg
  5. Hexane----------------------------------9.69kg/kg
  6. Lithium Aluminium Hydride---------0.40kg/kg
  7. Methanol---------------------------------8.56kg/kg
  8. Methylene chloride--------------------9.36kg/kg
  9. N-Butyl Lithium 30%-------------------0.89kg/kg 10.Tetrahydrofuran-------------------------6.59kg/kg 11.Toluene------------------------------------7.53kg/kg 12.Triethylphosphone Acetate------------4.10kg/kg of Norms Committee. 22

Case No.:897/24/83-

ALC1/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/00905/AM08/ RLA File : 05/24/040/00287/AM08/ Lic.No/Date:05102073 00 07.08.2007 Defer Date: 22.01.2008 for export product Camptothecin under para p.7 of HBP. Committee observed that Department of MSME has called for technical information from the firm vide their letter No.5(9)/2005-Chem dated 26.11.2007, but the same has not been received. Committee, therefore, decided to await reply of the firm. Accordingly, case was deferred for four weeks. 23 Case No.:16/25/83- ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:34/82- ALC4/2007 Status:Cas e Deferred

26.12.2007 HQ File : 01/83/050/01041/AM08/ RLA File : 03/94/040/00516/AM08/ Lic.No/Date:03104397 36 16.08.2007 Defer Date: 22.01.2008 for export product Losartan Potassium under para p.7 of HBP. 24

Case No.:30/25/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01055/AM08/ RLA File : 05/24/040/00425/AM08/ Lic.No/Date:05102083 17 30.08.2007

for export product Sertraline Hcl under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/85/2007-PI-III dated 20.11.2007 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: Sertraline--------------------------------------------------1kg. Import items:

  1. 4-(3’,4’-Dichlorophenyl)-1-Tetralone-----3.27kg/kg
  2. Mandelic Acid ®-------------------------------0.392kg/kg
  3. Activated Carbon------------------------------0.100kg/kg
  4. Toluene------------------------------------------2.50kg/kg
  5. Methanol----------------------------------------2.50kg/kg
  6. Palladium----------------------------------------0.80gm/kg of Norms Committee. 25 Case No.:7/27/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01081/AM08/ RLA File : 05/24/040/00442/AM08/ Lic.No/Date:05102084 07 31.08.2007

for export product ATS 4-Nitrobenzyl (2S,4S)-4-acetylthio-2-(N-sulpfmolyl- tert-butoxycarboxamidomethyl)pyrrolidine-1-carboxylate under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/101/2006-PI-III dated 27.12.2007 and in consultation with the representative of PI Division present in the meeting 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: ATS 4-Nitrobenzyl (2S,4S)-4-acetytlthio-2- (N-sulfamolyl-tert-Butoxycarboxamidomethyl) pyrrolidine-1-carboxylate-------------------------------------1kg. Import items:

  1. Trans-4-hydroxy-L-Proline------------------------------0.44kg/kg
  2. P-Nitrobenzyl chloroformate--------------------------0.79kg/kg
  3. Toluene-----------------------------------------------------3.74kg/kg
  4. Methylene chloride--------------------------------------4.10kg/kg
  5. Triethylamine----------------------------------------------0.36kg/kg
  6. Methanol----------------------------------------------------1.57kg/kg
  7. Sodium borohydride--------------------------------------0.22kg/kg
  8. Dimethyl formamide-------------------------------------0.47kg/kg
  9. Potassium thioacetate-----------------------------------0.45kg/kg

Di isopropyl azodicarboxylate--------------------------0.48kg/kg 11. Triphenyl phosphine--------------------------------------0.64kg/kg 12. Chlorosulfonyl isocyanate-------------------------------0.61kg/kg 13. Pyridine------------------------------------------------------0.74kg/kg 14. Activated Carbon------------------------------------------0.098kg/kg of Norms Committee. 26 Case No.:4/27/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01078/AM08/ RLA File : 09/24/040/00230/AM08/ Lic.No/Date:09100313 27 31.08.2007

for export product 1,2-Benzisoxazole-3-Methane Sulphonic Acid Sodium Salt Monohydrate under para p.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/254/2006-PI-III dated 27.12.2007 and in consultation of the representative of PI Division present in meeting decided to ratify norms under

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

Export product: 1,2 benzisoxazole-3-methane Sulphonic acid sodium salt monohydrate-------1kg. Import items:

  1. 2,hydroxyl Acetophenone--------------------------2.855kg/kg
  2. Dimethyl carbonate----------------------------------7.55kg/kg
  3. Pyridine--------------------------------------------------1.765kg/kg
  4. Hydroxylamine Hcl------------------------------------1.00kg/kg
  5. Bromine--------------------------------------------------1.73kg/kg
  6. Toluene---------------------------------------------------2.45kg/kg
  7. Methanol-------------------------------------------------1.92kg/kg
  8. Acetone---------------------------------------------------1.12kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 27

Case No.:6/27/83-

ALC1/2007 Party Name:VANI CHEMICALS & INTERMEDIATES LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/01080/AM08/ RLA File : 09/24/040/00009/AM08/ Lic.No/Date:09100313 30 31.08.2007 Defer Date: 22.01.2008 for export product 4-(3,4-Dichlorophenyl)-Tetralone under para p.7 of HBP. 28 Case No.:8/27/83- ALC1/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/01082/AM08/ RLA File : 05/24/040/00439/AM08/ Lic.No/Date:05102084 08 31.08.2007 Defer Date: 22.01.2008 for export product Camptothecin under para p.7 of HBP. Committee observed that Department of MSME has called for technical information from the firm vide their letter No.5(9)/2005-Chem dated 26.11.2007, but the same has not been received. Committee, therefore,

decided to await reply of the firm. Accordingly, case was deferred for four weeks. 29

Case No.:4/22/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 22.01.2008 for export product Cefoperazone Sodium Sterile USP/BP under para p.7 of HBP. 30

Case No.:33/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/01107/AM08/ RLA File : 09/24/040/00192/AM07/ Lic.No/Date:09100314 03 05.09.2007 Defer Date: 22.01.2008 for export product GCLE Stage I under para p.7 of HBP. 31

Case No.:32/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/01106/AM08/ RLA File : 09/24/040/00388/AM07/ Lic.No/Date:09100314 02 05.09.2007 Defer Date: 22.01.2008 for export product Cefpodoxime Proxetil under para p.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. Accordingly, Committee decided to defer the case for four weeks. 32 Case No.:31/27/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:34/82- ALC4/2007 Status:Cas e Deferred

26.12.2007 HQ File : 01/83/050/01105/AM08/ RLA File : 09/24/040/00470/AM07/ Lic.No/Date:09100314 01 05.09.2007 Defer Date: 22.01.2008 for export product Pivmecillinam Hydrochloride under para p.7 of HBP. 33

Case No.:98/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 22.01.2008 for export product Tenofovir Disoproxil Fumerate under para p.7 of HBP. 34

Case No.:13/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 08.01.2008 for export product Biotin Granules under para p.7 of HBP. Committee observed that the copy of DML furnished by the firm does not contain the list of approved items. Committee, therefore, decided to call for again complete set of DML form firm. Accordingly, case was deferred for two weeks. 35 Case No.:14/22/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 08.01.2008

for export product Vitamin B12 Granules under para p.7 of HBP. Committee observed that the firm was requested to furnish a copy of DML, but the same has not been received. Committee, therefore, decided to remind the firm for furnishing the copy of DML. Accordingly, case was deferred for two weeks. 36

Case No.:16/22/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e 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: 08.01.2008 for export product Diproson Lotion (30ml) under para p.7 of HBP. 37 Case No.:1/29/83- ALC1/2007 Party Name:DALAS BIOTECH LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01266/AM08/ RLA File : 05/24/040/00512/AM08/ Lic.No/Date:05102097 81 28.09.2007

for export product 7 Amino Acid-3-Vinyl-3 Cephem-4 Carboxylic Acid Diphenyl Ester Hcl (7 AVCA) under para p.7 of HBP. The Committee in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 vide Case No.898/24/83-ALC1/2007 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: 7AVCA (7Amino-3-vinyl-cephalosporanic acid------------1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 7-Phenylacetamido-3-chloromethyl cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene Chloride 10.31kg/kg

RLA concerned may take further necessary action as per above decision of Norms Committee. 38

Case No.:28/30/83-

ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/83/050/01397/AM08/ RLA File : 09/24/040/00291/AM08/ Lic.No/Date:09100318 44 23.10.2007 Defer Date: 22.01.2008 for export product {1’R,2’S,5’R}-Methyl-5S (Cytosine-1’-YL)-1-3- Oxathiolane-2R-Carboxylate/CME Compound under para p.7 of HBP. 39

Case No.:5/32/83-

ALC1/2007 Party Name:R L FINE CHEM Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01427/AM08/ RLA File : 07/24/040/00512/AM08/ Lic.No/Date:07100540 35 25.10.2007

for export product Nortriptyline HCL/BP/USP under para p.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/49/2006-PI-III dated 27.12.2007 and in consultation with the representative of PI Division present in the meeting 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: Nortriptyline hcl BP/USP--------------------------1kg. Import items:

  1. 1-Bromo-3-Chloro Propane-------------0.96kg/kg
  2. Tetrahydrofuran---------------------------0.71kg/kg
  3. Ethyl chloro formate----------------------0.46kg/kg of Norms Committee.

40

Case No.:7/32/83-

ALC1/2007 Party Name:DALAS BIOTECH LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01429/AM08/ RLA File : 05/24/040/00584/AM08/ Lic.No/Date:05102111 29 25.10.2007

for export product 7 AVCA under para p.7 of HBP. The Committee in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 vide Case No.898/24/83-ALC1/2007 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: 7AVCA (7Amino-3-vinyl-cephalosporanic acid------------1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 7-Phenylacetamido-3-chloromethyl cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene Chloride 10.31kg/kg RLA concerned may take further necessary action as per above decision of Norms Committee. 41 Case No.:8/32/83- ALC1/2007 Party Name:DALAS BIOTECH LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01430/AM08/ RLA File : 05/24/040/00576/AM08/ Lic.No/Date:05102111 31 25.10.2007

for export product 7 AVCA under para p.7 of HBP. The Committee in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 vide Case No.898/24/83-ALC1/2007 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: 7AVCA (7Amino-3-vinyl-cephalosporanic acid------------1Kg. Import items: Sl.No. Description of import item Quantity allowed

7-Phenylacetamido-3-chloromethyl cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene Chloride 10.31kg/kg RLA concerned may take further necessary action as per above decision of Norms Committee. 42

Case No.:18/32/83-

ALC1/2007 Party Name:DALAS BIOTECH LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01440/AM08/ RLA File : 05/24/040/00568/AM08/ Lic.No/Date:05102111 82 26.10.2007

for export product 7 AVCA under para p.7 of HBP. The Committee in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 vide Case No.898/24/83-ALC1/2007 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: 7AVCA (7Amino-3-vinyl-cephalosporanic acid------------1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 7-Phenylacetamido-3-chloromethyl cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene Chloride 10.31kg/kg RLA concerned may take further necessary action as per above decision of Norms Committee. 43 Case No.:2/28/82- ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/82/050/00236/AM08/ RLA File : 05/24/040/00592/AM08/ Lic.No/Date:05102111 95 26.10.2007 Defer Date: 08.01.2008 for export product Cefuroxime Axetil Amorphous under para p.7 of HBP.

44

Case No.:7/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/82/050/00241/AM08/ RLA File : 03/94/040/00783/AM08/ Lic.No/Date:03104481 15 26.10.2007 Defer Date: 22.01.2008 for export product Toltrazuril Oral solution 2.5%/Cipcox 2.5% Solution under para p.7 of HBP. 45

Case No.:35/32/83-

ALC1/2007 Party Name:DALAS BIOTECH LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01457/AM08/ RLA File : 05/24/040/00575/AM08/ Lic.No/Date:05102112 73 31.10.2007

for export product 7 AVCA under para p.7 of HBP. The Committee in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 vide Case No.898/24/83-ALC1/2007 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: 7AVCA (7Amino-3-vinyl-cephalosporanic acid------------1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 7-Phenylacetamido-3-chloromethyl cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene Chloride 10.31kg/kg RLA concerned may take further necessary action as per above decision of Norms Committee.

46

Case No.:4/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/82/050/00238/AM08/ RLA File : 03/94/040/00792/AM08/ Lic.No/Date:03104485 19 31.10.2007 Defer Date: 22.01.2008 for export product Lamivudine and Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para p.7 of HBP. 47

Case No.:9/28/82-

ALC4/2007 Party Name:VIVEK PHARMACHEM (INDIA) LTD., Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/82/050/00243/AM08/ RLA File : 13/24/040/00022/AM08/ Lic.No/Date:13100252 78 31.10.2007 Defer Date: 22.01.2008 for export product Meropenem Injection USP 1gm under para p.7 of HBP. 48

Case No.:10/28/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Deferred HQ File : 01/82/050/00244/AM08/ RLA File : 13/24/040/00020/AM08/ Lic.No/Date:13100252 80 01.11.2007 Defer Date: 22.01.2008 for export product Ascorbyl Palmitate Granule 95% under para p.7 of HBP. Committee decided to call for a copy of application along with a copy Advance Authorisation and copy of complete DML from concerned RA/firm. Accordingly, case was deferred for four weeks. 49 Case No.:72/32/83- ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Approved HQ File : 01/83/050/01494/AM08/ RLA File : 22/24/040/00048/AM08/ Lic.No/Date:22100072 17

02.11.2007 for export product Amoxycillin Trihydrate Pen G Route Through Enzamatic Route under para p.7 of HBP. Committee in light of its earlier decision taken in its 30/82 meeting held on 27.11.2007 vide case No.41/27/83 and in consultation with representative of PI Division present in meeting decided to ratify 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: Amoxycillin Trihydrate enzymatic route-----------------1kg. Import items: 1. Penicillin G Pot. 1st crystal-----------------------------------1.664 BOU/Kg 2. D(-) Para hydroxy phenyl glycine methyl ester------------0.608Kg 3. Oxilasa enzyme-------------------------------------------------5.0gm. 4. Penicillin G Amidase enzyme---------------------------------0.852gm. 5. Methanol---------------------------------------------------------0.0215Kg 6. Butyl Acetate----------------------------------------------------0.122Kg 7. Boric acid---------------------------------------------------------0.032Kg of Norms Committee. 50

Case No.:13/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Withdrawn HQ File : 01/82/050/00247/AM08/ RLA File : 03/94/040/00784/AM08/ Lic.No/Date:03104492 11 05.11.2007

for export product Advocip Powder/Danofloxacin Soluble Powder/ (75gm/Sachet) (pack size 300gm) under para p.7 of HBP. Committee decided to withdraw the case as the same has already been approved by NC in its 28/08 meeting held on 13.11.2007. 51 Case No.:1/34/82- ALC4/2007 Party Name:WOCKHARDT LIMITED Meet No/Date:34/82- ALC4/2007 26.12.2007 Status:Cas e Withdrawn HQ File : 01/82/050/00279/AM08/ RLA File : 03/95/040/00810/AM08/ Lic.No/Date:03104504 00 15.11.2007

for export product Flu Strength Hot Lemon Powder 5gm Sachet under para p.7 of HBP. Committee decided to withdraw the case as the same has already been approved by NC in its 33/08 meeting held on 18.12.2007. Date:22.12.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.

Citation copied