IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-11-27

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 : 30/82-ALC4/2007 MEETING DATE : 27.11.2007

Case No.B-414

M/S Kudos Chemie Ltd. NC Meeting No.30/08 F.No.01/82/162/335/AM’08 Meeting Date: 27.11.2007 Committee considered the case as per agenda for clarification as to whether the product Synthetic Caffeine (Anhydrous) is covered under DEPB Schedule against Sl.No.62/19 and SION No.A-97 under the product Head ‘Caffeine’. Shri Jitendra Singh, Managing Director of the company appeared in personal hearing and explained the matter in detail. Committee noted that Natural Caffeine is found in tea and coffee. Thus the export product appearing at SION A-97 appears to be Synthetic Caffeine. They have stated that they are manufacturing and exporting Synthetic Caffeine (Anhydrous) which is Caffeine as per the Indian Pharmacopia. In support, the firm has submitted CA certificate for 2005-06 and 2006-07 supported with copies of shipping bills. The Committee also noted that in SION A-97, the inputs Theophylline and Activated Carbon are allowed which are being used by the applicant. Committee after detailed deliberation and in consultation with the representatives of Deptt. of C&PC present in the meeting came to the conclusion that the synthetic Caffeine (Anhydrous) exported by the firm should be eligible for DEPB benefits. Committee decided to recommend the case to DEPB Committee.

Case No.B-415

M/S Agio Pharmaceuticals Ltd. NC Meeting No.30/08 F.No.01/87/162/287/AM’07 F.No.01/87/50/287/AM07 RLA F.No.03/94/40/294/AM07 RLA F.No.03/94/40/1267/AM07 Adv.Lic.No.0310423444 dated 16.03.2007 Adv.Lic.No.0310385834 dated 21.06.2006 Committee considered case as per agenda for modification of norms for export product Prednisol Sodium Injection 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. Committee, accordingly, decided to defer case for four weeks.

Case No.A-872

M/S Cipla Ltd. NC Meeting No.30/08 F.No.01/82/50/250/AM’08 RLA F.No.03/94/40/749/AM08 Adv.Lic.No.0310447493 dated 23.10.2007 Committee considered case as per agenda for ratification of norms for export product Lamivir HBV Tablets 100mg/Lamivudine 100mg Tablets under para 4.7 of HBP. Committee decided to defer case for 18.12.2007 as firm has been called for personal hearing before Norms Committee on the same date.

Case No.A-873

M/S Cipla Ltd. NC Meeting No.30/08 F.No.01/82/50/251/AM’08 RLA F.No.03/94/40/747/AM08 Adv.Lic.No.0310447486 dated 23.10.2007 product Nevimune 200mg Tablets/Nevirapine 200mg Tablets and Nevirapine Oral Suspension 50mg/5ml Nevimune under para 4.7 of HBP. Committee decided to defer case for 18.12.2007 as firm has been called for personal hearing before Norms Committee on the same date.

Case No.A-874

M/S Gland Pharma Ltd. NC Meeting No.30/08 F.No.01/82/50/254/AM’08 RLA F.No.09/24/40/314/AM08 Adv.Lic.No.0910031800 dated 16.10.2007 product Adenosine Injections USP Prefilled Syringe 3mg/ml, 2ml in a PFS under para 4.7 of HBP.

case is under examination in his Department and he sought deferment for four

Case No.A-875

M/S Aurobindo Pharma Ltd. NC Meeting No.30/08 F.No.01/82/50/253/AM’08 RLA F.No.09/24/40/205/AM08 Adv.Lic.No.0910031156 dated 16.08.2007 product Ceftiofur Sodium Sterile under para 4.7 of HBP.

Case No.A-876

M/S Cipla Ltd. NC Meeting No.30/08 F.No.01/82/50/212/AM’08 RLA F.No.03/94/40/590/AM08 Adv.Lic.No.0310442077 dated 06.09.2007 product Terbinafine Hydrochloride under para 4.7 of HBP.

Case No.A-877

M/S Alembic Ltd. NC Meeting No.30/08 F.No.01/82/50/218/AM’08 RLA F.No.34/24/40/70/AM08 Adv.Lic.No.3410019349 dated 02.08.2007 product Clarithromycin Coated Granules 28 to 31% and 38 to 44% under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting

observed that firm has proposed to export Clarithromycin Coated Granules (26 to 31% and 38 to 44%) while such range of export product is not covered in DML. Committee, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-878

M/S Alembic Ltd. NC Meeting No.30/08 F.No.01/82/50/37/AM’08 RLA F.No.34/24/40/290/AM07 Adv.Lic.No.3410018404 dated 23.03.2007 product Azithromycin Crude under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/227/2006-PI-III dated 12.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Azithromycin Crude Purity NLT 94.5%------------------------------1Kg. Import items: Sl.No. Description of import items Quantity allowed 1. Erythromycin base 1.75kg/kg 2. Acetone 6.45kg/kg 3. Ethyl Alcohol 2.81kg/kg 4. Hydroxylamine Hcl 0.91kg/kg 5. Methane Sulfonyl chloride 0.72kg/kg 6. Methanol 2.72kg/kg 7. Platinum Catalyst with base of activated Carbon (5% Platinum on Carbon) 1.00gm/kg 8. Hyflo Not a raw material. Hence not allowed. Committee also decided to approve on file all the pending cases for the above export product with same inputs with approval of Chairman within the validity period of such adhoc norms. RA Concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-879

M/S Cadila Healthcare Ltd NC Meeting No.30/08 F.No.01/82/50/161/AM’08 RLA F.No.08/24/40/136/AM08 Adv.Lic.No.0810066915 dated 30.08.2007 product 2-(2-Methoxyphenoxy)-Ethylamine Base Pharma Grade under para 4.7 of HBP.

Case No.A-880

M/S Brawn Laboratories Ltd. NC Meeting No.30/08 F.No.01/82/50/154/AM’08 RLA F.No.05/24/40/163/AM08 Adv.Lic.No.0510204890 dated 13.06.2007 product Kanamycin Acid Sulphate Inj. BP 1gm and Lincomycin Capsules 500mg under para 4.7 of HBP. Committee observed that technical information was called for from firm vide letter dated 12.09.2007 followed by reminder dated 16.11.2007, but same has not been received. Committee, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-881

M/S Amoli Organics Pvt. Ltd. NC Meeting No.30/08 F.No.01/87/50/606/AM’07 RLA F.No.03/94/40/411/AM07 Adv.Lic.No.0310380982 dated 24.07.2006 product Noscapine Resin Complex under para 4.7 of HBP. Committee decided to hand over the file to representative of PI Division for examination of case and their comments. Accordingly, case was deferred for four weeks. 1

Case No.:330/24/83-

Party Name:VASUDHA Meet No/Date:30/82- Status:Ca

ALC1/2007 PHARMA CHEM LTD ALC4/2007 27.11.2007 se Approved HQ File : 01/83/050/00676/AM07/ RLA File : 09/21/040/00259/AM07/ Lic.No/Date:09100275 81 15.09.2006

Decision :Committee considered case as per agenda for ratification of norms for export product Amitriptyline Crude under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/210/2005-PI-III dated 27.11.2005 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower. Export product: Amitriptyline Crude-------------------------------------1kg. Import items:

  1. Methanol-----------------------------------------0.423kg/kg
  2. Acetonitrile--------------------------------------0.333kg/kg
  3. Phosphorus Pentaocide-----------------------0.396kg/kg
  4. Phosphoric Acid---------------------------------0.297kg/kg
  5. Tetrahydrofuran--------------------------------0.477kg/kg
  6. 1-bromo-3 chloropropane---------------------0.648kg/kg
  7. Carbon---------------------------------------------0.043kg/kg
  8. Methylene di chloride--------------------------0.288kg/kg
  9. Acetone--------------------------------------------0.072kg/kg Committee also decided to approve on file all the pending cases for the above export product with same inputs with approval of Chairman within the validity period of such adhoc norms. RA 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:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Lopinavir under para 4.7 of HBP.

3

Case No.:654/24/87-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/87/050/00987/AM07/ RLA File : 09/24/040/00451/AM07/ Lic.No/Date:09100293 00 12.02.2007

norms for export product Ampicillin Sodium Sterile under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 26.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ampicillin Sodium Sterile-----------------------------1kg. Import items:

  1. Ampicillin Anhydrous------------------------1.04kg/kg
  2. Diethylamine----------------------------------0.2525kg/kg
  3. Sodium Thiocyanate-------------------------0.3075kg/kg
  4. Acetonitrile------------------------------------1.41kg/kg of Norms Committee. 4

Case No.:756/24/87-

ALC1/2007 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Rejected HQ File : 01/87/050/01102/AM07/ RLA File : 03/94/040/01374/AM07/ Lic.No/Date:03104228 47 13.03.2007

norms for export product Niacinamide BP/USP under para 4.7 of HBP. Committee observed that firm was requested to furnish technical information vide MSME letter No.5(9)/2005-chem dated 15.11.2007, but firm has refused to provide required information vide their letter dated 21.11.2007. Committee, therefore, decided to close the case.

of Norms Committee. 5

Case No.:43/9/82-

ALC4/2007 Party Name:KOPRAN LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Rejected HQ File : 01/82/050/01818/AM07/ RLA File : 03/94/040/01416/AM07/ Lic.No/Date:03104234 86 16.03.2007

norms for export product Clarithromycin EP/USP under para 4.7 of HBP. Committee observed that firm has not submitted technical details as per Appendix 33 alongwith their application for Advance Authorisation. Committee, therefore, decided to close the case. of Norms Committee. 6

Case No.:4/12/82-

ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Rejected HQ File : 01/82/050/01861/AM07/ RLA File : 09/24/040/00500/AM07/ Lic.No/Date:09100297 49 23.03.2007

norms for export product Fluoro Lactone under para 4.7 of HBP. Committee observed that firm was requested to furnish technical information vide letter dated 08.10.2007, but same has not been received. Committee, therefore, decided to close the case. of Norms Committee. 7

Case No.:5/10/82-

ALC4/2007 Party Name:GLAXOSMITHKLINE PHARMACEUTICALS LIMITED, Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/82/050/01887/AM07/ RLA File : 03/94/040/00324/AM06/ Lic.No/Date:03104246 28 27.03.2007

norms for export product Betamethanone Di-Sodium Phosphate BP/USP

under para 4.7 of HBP. their U.O. No.35011/42/2006-PI-III dated 27.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower. Export product: Betamethasone Sodium Phosphate------------------1kg. Import item: 9:11 Epoxide (DBXI or 17-Alpha, 21-Dihydroxy-16-Beta- Methyl-9-Beta-11-Beta-Epoxypregna-1,4-Diene-3,20-Dione)-----0.993kg/kg of Norms Committee. 8

Case No.:474/24/83-

ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007 norms for export product N-[B-D-Ribofuranosyl]-5-Hydroxyimidazole-4- Carboxamide Grade under para 4.7 of HBP. 9

Case No.:508/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product 5-Cyano Phthalide under para 4.7 of HBP.

10

Case No.:530/24/83-

ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Betamethasone Valerate BP/USP under para 4.7 of HBP. 11

Case No.:543/24/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Rejected HQ File : 01/83/050/00169/AM08/ RLA File : 03/94/040/00046/AM08/ Lic.No/Date:03104274 26 20.04.2007

norms for export product Diclofenac Sodium under para 4.7 of HBP. Committee observed that firm and Pharmexcil were requested to furnish Central Excise certified production and consumption data vide letter dated 14.09.2007, but same has not been received. In absence of data, it is not possible for Committee to fix norms. Committee, therefore, decided to close case. of Norms Committee. 12 Case No.:550/24/83- ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Propafenone Hydrochloride under para 4.7 of HBP.

13

Case No.:15/18/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : 01/83/050/00252/AM08/ RLA File : 09/24/040/00023/AM08/ Lic.No/Date:09100301 74 04.05.2007 Defer Date: 26.12.2007 norms for export product Oso Metheptene Mucate under para 4.7 of HBP. Committee observed that firm has been requested to furnish technical information as per Appendix 33 vide letter dated 29.10.2007, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 14 Case No.:627/24/83- ALC1/2007 Party Name:SIRIS IMPEX, Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/00396/AM08/ RLA File : 09/24/040/00562/AM07/ Lic.No/Date:09100303 42 25.05.2007

norms for export product Griffonia Simplicifolia Dry Extract 95% under para 4.7 of HBP. Committee in light of its earlier decision taken in its 2/87meeting held on 13.04.2005 vide Case No.4/19/87 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Griffonia Simplicifolia Extract------------------1kg. Import item: Griffonia Simplicifolia Dried seeds Containing 10% 5HTP by HPLC---------------2.40kg/kg

of Norms Committee. 15

Case No.:636/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Cyclohexyl Ester under para 4.7 of HBP. 16

Case No.:635/24/83-

ALC1/2007 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product N-T-Boc-L-Phenylalanine 99% Purity under para 4.7 of HBP. 17

Case No.:645/24/83-

ALC1/2007 Party Name:AYURSIDDHA INC. Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Blockbuster All Clear Capsules made of Citrolive under para 4.7 of HBP. Representative of MSME 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 case for four weeks. 18 Case No.:647/24/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:30/82- ALC4/2007 Status:Ca se

27.11.2007 Approved HQ File : 01/83/050/00441/AM08/ RLA File : 09/24/040/00015/AM08/ Lic.No/Date:09100304 01 31.05.2007

norms for export product Doxofylline under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 vide Case No.455/24/83 and in consultation with technical authorities 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: Doxofylline---------------------------------------1kg. Import items:

  1. Theophylline---------------------------------------1.17kg/kg
  2. Chloro acetaldehyde dimethyl acetal--------0.81kg/kg
  3. Potassium carbonate----------------------------0.89kg/kg
  4. Methanol-------------------------------------------0.63kg/kg
  5. Dimethyl formamide------------------------------0.56kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 19 Case No.:674/24/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/00512/AM08/ RLA File : 09/24/040/00063/AM08/ Lic.No/Date:09100305 26 13.06.2007

norms for export product Doxofylline under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 vide Case No.455/24/83 and in consultation with technical authorities 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: Doxofylline---------------------------------------1kg. Import items:

  1. Theophylline---------------------------------------1.17kg/kg
  2. Chloro acetaldehyde dimethyl acetal--------0.81kg/kg
  3. Potassium carbonate----------------------------0.89kg/kg
  4. Methanol-------------------------------------------0.63kg/kg
  5. Dimethyl formamide------------------------------0.56kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 20

Case No.:680/24/83-

ALC1/2007 Party Name:DCM SHRIRAM INDUSTRIES LTD, Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product D(-)Para Hydroxy Phenyl Glycine Dane Salt under

para 4.7 of HBP.

21

Case No.:655/24/83-

ALC1/2007 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Methscopolamine Tannete under para 4.7 of HBP.

22

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007 norms for export product (S)-3-Hydroxy-N-Benzyl Pyrrolidineunder para 4.7 of HBP. 23

Case No.:737/24/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Transferr ed HQ File : 01/83/050/00638/AM08/ RLA File : 09/24/040/00004/AM08/ Lic.No/Date:09100307 23 03.07.2007

norms for export product Etocrylene under para 4.7 of HBP. Committee observed that firm has stated about export product being used as Photo anti oxidant. Therefore it pertains to Chemical Sector. It was decided to transfer case to DES-IV. 24

Case No.:19/23/83-

ALC1/2007 Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007 norms for export product L-(+)-Selenomethionine under para 4.7 of HBP. 25 Case No.:798/24/83- ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : RLA File : Lic.No/Date:05102063

01/83/050/00756/AM08/ 05/24/040/00241/AM08/ 28 16.07.2007 norms for export product Mica Ester under para 4.7 of HBP. their U.O. No.35011/67/2007-PI-III dated 23.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Mica Ester--------------------------------------------1kg. Import items:

  1. Mica Acid--------------------------------0.83kg/kg
  2. Triphenyl Phosphine------------------0.911kg/kg
  3. Methanol--------------------------------0.525kg/kg
  4. Triethylamine---------------------------0.322kg/kg
  5. Acetonitrile------------------------------1.44kg/kg
  6. MBTS--------------------------------------1.157kg/kg of Norms Committee. 26 Case No.:799/24/83- ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/00757/AM08/ RLA File : 05/24/040/00240/AM08/ Lic.No/Date:05102063 31 16.07.2007

norms for export product 7AVNA under para 4.7 of HBP. their U.O. No.35011/67/2007-PI-III dated 23.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 7 AVNA---------------------------------------------------1kg.

Import items:

  1. 7-Phenylacetamideo-3-chloromethyl Cephalosporanic Acid Para methoxy Benzyl Ester (GCLE)---------------------------2.672kg/kg
  2. Triphenyl Phospine----------------------------1.26kg/kg
  3. Methanol----------------------------------------8.48kg/kg
  4. Acetone------------------------------------------1.95kg/kg
  5. Acetic acid---------------------------------------0.022kg/kg
  6. Methylene chloride----------------------------8.20kg/kg
  7. Sodium iodide-----------------------------------0.828kg/kg
  8. N,N,Dimethyl Formamide--------------------0.54kg/kg
  9. Phenol--------------------------------------------0.933kg/kg

N-Butyl Acetate---------------------------------5.54kg/kg 11. Carbon--------------------------------------------0.100kg/kg of Norms Committee. 27

Case No.:2/14/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00116/AM08/ RLA File : 22/24/040/00018/AM08/ Lic.No/Date:22100068 97 17.07.2007 Defer Date: 26.12.2007 norms for export product Cefdinir under para 4.7 of HBP. 28 Case No.:851/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/00851/AM08/ RLA File : 05/24/040/00313/AM08/ Lic.No/Date:05102066 70 24.07.2007

norms for export product Midazolam under para 4.7 of HBP.

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: Midazolam----------------------------------------------------------------1Kg. Import items:

  1. 2-Amino-5Chloro2-Fluoro Benzophenone----------------5.223kg/kg
  2. CADMA (Chloro Acetaldehyde Dimethyl Acetal---------3.90kg/kg
  3. Dimethyl Sulphoxide-------------------------------------------6.40kg/kg
  4. Lithium Amide---------------------------------------------------0.85kg/kg
  5. Nitromethane----------------------------------------------------1.88kg/kg
  6. Tetrahydrofuran-------------------------------------------------8.40kg/kg
  7. Triethyl Ortho Acetate-----------------------------------------3.42kg/kg
  8. Activated Carbon------------------------------------------------0.100kg/kg
  9. Isopropyl Alcohol------------------------------------------------4.40kg/kg

Methylene Chloride---------------------------------------------5.26kg/kg 11. Methanol-----------------------------------------------------------5.00kg/kg 12. Toluene-------------------------------------------------------------5.00kg/kg of Norms Committee. 29

Case No.:897/24/83-

ALC1/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007 norms for export product Captothecin under para 4.7 of HBP. Committee observed that application has been forwarded to MSME vide U.O. dated 19.11.2007, but comments have not been received. Committee decided to await comments from MSME. Accordingly, case was deferred for four weeks. 30 Case No.:894/24/83- ALC1/2007 Party Name:DOCTORSORGANIC CHEMICALS LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Clopidogrel Hydrogen Sulfate Solid under para 4.7 of HBP. 31

Case No.:16/25/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Losartan Potassium under para 4.7 of HBP. 32

Case No.:999/24/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01017/AM08/ RLA File : 09/24/040/00154/AM08/ Lic.No/Date:09100312 00 24.08.2007 Defer Date: 26.12.2007 norms for export product [1S,4R]-4-[(2-Amino-6-Chloro-5-Formamido-4- Pyrimidinyl)Amino]-2-Cyclopentene-1-Methanol (An Intermediate of Abacavir) under para 4.7 of HBP. 33 Case No.:8/27/83- ALC1/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007

norms for export product Captothecin under para 4.7 of HBP. Committee observed that application has been forwarded to MSME vide U.O. dated 19.11.2007, but comments have not been received. Committee decided to await comments from MSME. Accordingly, case was deferred for four weeks. 34

Case No.:4/22/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Cefoperazone Sodium Sterile USP/BP under para 4.7 of HBP. 35

Case No.:28/27/83-

ALC1/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Transferr ed HQ File : 01/83/050/01102/AM08/ RLA File : 07/24/040/00172/AM08/ Lic.No/Date:07100531 50 03.09.2007

norms for export product Calcium Levulinate under para 4.7 of HBP. Representative of PI Division present in meeting pointed out that norms for above export product has been fixed in DES-IV Section. Committee, accordingly, decided to transfer this case to DES-IV Section. 36 Case No.:23/27/83- ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/01097/AM08/ RLA File : 09/24/040/00209/AM08/ Lic.No/Date:09100313 82 03.09.2007

norms for export product Amitriptyline Crude under para 4.7 of HBP.

their U.O. No.35011/210/2005-PI-III dated 27.11.2005 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower. Export product: Amitriptyline Crude-------------------------------------1kg. Import items:

  1. Methanol-----------------------------------------0.423kg/kg
  2. Acetonitrile--------------------------------------0.333kg/kg
  3. Phosphorus Pentaocide-----------------------0.396kg/kg
  4. Phosphoric Acid---------------------------------0.297kg/kg
  5. Tetrahydrofuran--------------------------------0.477kg/kg
  6. 1-bromo-3 chloropropane---------------------0.648kg/kg
  7. Carbon---------------------------------------------0.043kg/kg
  8. Methylene di chloride--------------------------0.288kg/kg
  9. Acetone--------------------------------------------0.072kg/kg of Norms Committee. 37

Case No.:32/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007 norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 38 Case No.:31/27/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01105/AM08/ RLA File : 09/24/040/00470/AM07/ Lic.No/Date:09100314 01 05.09.2007 Defer Date: 26.12.2007

norms for export product Pivmecillinam hydrochloride under para 4.7 of HBP. 39

Case No.:39/27/83-

ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/01113/AM08/ RLA File : 22/24/040/00039/AM08/ Lic.No/Date:22100070 31 06.09.2007

norms for export product 6-Amino Penicillinic Acid Pen G Route under para 4.7 of HBP. their U.O. No.35011/165/2006-PI-III dated 27.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 6-Amino Penicillianic acid (6 APA)---------------------1kg. Import items:

  1. Pencillin G Potassium 1st Crystal---------------2.92BOU/kg
  2. Penicillin G Amidase Enzyme--------------------0.096kg/kg
  3. Boric Acid--------------------------------------------0.055kg/kg
  4. Methanol---------------------------------------------0.04kg/kg
  5. Butyl acetate----------------------------------------0.214kg/kg
  6. P.T. Resin---------------------------------------------0.004kg/kg of Norms Committee. 40 Case No.:41/27/83- ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : RLA File : Lic.No/Date:22100070

01/83/050/01115/AM08/ 22/24/040/00036/AM08/ 33 06.09.2007 norms for export product Amoxycillin Trihydrate Pen G Route Through Enzematic Route under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 vide case No.902/24/83 and in consultation with technical authorities 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 RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 41 Case No.:40/27/83- ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/01114/AM08/ RLA File : 22/24/040/00037/AM08/ Lic.No/Date:22100070 32 06.09.2007

norms for export product Amoxycillin Trihhydrate Pen G Route Through Enzematic Route under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 vide case No.902/24/83 and in consultation with technical authorities 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 RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 42 Case No.:82/27/83- ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/01156/AM08/ RLA File : 07/24/040/00422/AM08/ Lic.No/Date:07100532 81 11.09.2007

norms for export product Ambroxol Hcl under para 4.7 of HBP. their U.O. No.35011/231/2006-PI-III dated 27.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ambroxol Hcl------------------------------------1kg. Import items:

  1. Liquid Bromine-------------------------1.32kg/kg

  2. Trans Para Amino Cyclohexanol----0.80kg/kg

  3. Sodium Borohydride------------------0.583kg/kg

  4. Tetra Hydrofuran----------------------2.15kg/kg

  5. Methanol--------------------------------2.58kg/kg

  6. Methylene dichloride-----------------3.225kg/kg of Norms Committee. 43

Case No.:98/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Tenofovie Disoproxil Fumerate under para 4.7 of HBP. 44

Case No.:13/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 08.01.2008 norms for export product Biotin Granules under para 4.7 of HBP. Committee perused file of firm and observed that copy of Advance Authorisation has been furnished for export product Biotin Granules while the application has been furnished for export product Alpha Lipoic Acid Granules 95%. Moreover, copy of DML has not been furnished. Committee, therefore, decided to call for copy of application for export product Biotin Granules alongwith a copy of relevant DML form firm. RA may be asked to furnish reasons for above lapse. Accordingly, case was deferred for six weeks. 45 Case No.:14/22/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:13100250 Defer

01/82/050/00184/AM08/ 13/24/040/00017/AM08/ 52 21.09.2007 Date: 08.01.2008 norms for export product Vitamin B12 Granules under para 4.7 of HBP. Committee decided to call for a copy of relevant DML from firm. Accordingly, case was deferred for six weeks. 46

Case No.:16/22/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 26.12.2007 norms for export product Diproson Lotion (30ml) under para 4.7 of HBP. Committee observed that the export product Diproson Lotion 30ml is based on Betamethasone Dipropionate whereas the firm has applied for import of Betamethasone base. Committee after detailed deliberations decided to call for clarification from firm since import item is not tallying with DML and technical justification has also not been given. Accordingly, case was deferred for four weeks. 47

Case No.:154/27/83-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01228/AM08/ RLA File : 34/24/040/00140/AM08/ Lic.No/Date:34100196 98 25.09.2007 Defer Date: 08.01.2008 norms for export product Venlafaxine Hydrochloride Extended Release Pellets Stage under para 4.7 of HBP. Committee observed that description of export product is not clear. Committee, therefore, decided to call for specific description of export product alongwith copy of relevant DML. Accordingly, case was deferred for six weeks. 48 Case No.:33/29/83- ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:09100317 Defer

01/83/050/01298/AM08/ 09/24/040/00244/AM08/ 13 05.10.2007 Date: 26.12.2007 norms for export product {1R,2S,5R}-Methyl-5S-(Cytosine-1-YL)-1,3- Oxathiolane-2R-Carboxylae/CME Compound under para 4.7 of HBP. 49

Case No.:57/29/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/01322/AM08/ RLA File : 03/95/040/00633/AM08/ Lic.No/Date:03104457 26 09.10.2007

norms for export product Artesunate under para 4.7 of HBP. their U.O. No.35011/182/2006-PI-III dated 27.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Artesunate------------------------------1kg Import item: Artemisinin-----------------------------0.9259kg/kg of Norms Committee. 50 Case No.:2/26/82- ALC4/2007 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., Meet No/Date:30/82- ALC4/2007 27.11.2007 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: 08.01.2008

norms for export product Drugs Formulations Drops Namely Fecistil Drops under para 4.7 of HBP. Committee decided to call for a copy of relevant DML from firm. Accordingly, case was deferred for six weeks. 51

Case No.:3/26/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Case Approved HQ File : 01/82/050/00221/AM08/ RLA File : 03/94/040/00751/AM08/ Lic.No/Date:03104473 34 22.10.2007 Defer Date:27.11.20 07 norms for export product Sulfacox Powder (per pack 1 Kg.) under para 4.7 of HBP. Committee in consultation with technical authorities 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: Sulfacox Powder---------------------------------------------1kg. Each pack of 1kg Sulfacox Powder containing 860 gms Sulphadimerazine and 105 gms. Diaveridine Import items:

  1. Sulphadimerazine----------------------------------868.60gms/kg
  2. Diaveridine-------------------------------------------106.05gms/kg the above export product with same inputs with approval of Chairman of Norms Committee. 52 Case No.:28/30/83- ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se 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: 26.12.2007 norms for export product {1’R,2’S,5’R}-Methyl-5S(Cytosine-1’-YL)-1-3-

Oxathiolane-2R-Carboxylate/CME Compound under para 4.7 of HBP. 53

Case No.:76/32/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved HQ File : 01/83/050/01498/AM08/ RLA File : 09/24/040/00249/AM08/ Lic.No/Date:09100319 43 02.11.2007

norms for export product Methyl-5S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate (Lmuvudine Intermediate Stage-III under para 4.7 of HBP. their U.O. No.35011/108/2007-PI-III dated 30.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Menthyl-5 S-Cytosine-1YL-1,3- Oxathiolane-2R Carboxalate (Lamivudine intermediate State 3)----------------1Kg. Import items:

  1. Menthol----------------------------------------0.87kg/kg
  2. Glyoxalic acid 50%---------------------------0.90kg/kg
  3. 2,5 Dihydroxy-1,4 dithiane-----------------0.37kg/kg
  4. Triethylamine---------------------------------0.67kg/kg
  5. Cytosine----------------------------------------0.475kg/kg
  6. Hexamethyl disilazane----------------------0.75kg/kg
  7. Dimethyl formamide------------------------0.31kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 54 Case No.:1/30/82- ALC4/2007 Party Name:NESTOR PHARMACEUTICALS LTD. Meet No/Date:30/82- ALC4/2007 27.11.2007 Status:Ca se Approved

HQ File : 01/82/050/00249/AM08/ RLA File : 05/24/040/00627/AM08/ Lic.No/Date:05102118 66 08.11.2007

norms for export product Paracetamol Granules under para 4.7 of HBP. Committee in light of its earlier decision taken in its 8/82 meeting held on 28.06.2007 vide case No.22/32/83 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Paracetamol Granules containing Paracetamol 860gms.---------------1Kg. Import items:

  1. Paracetamol-------------------------------------0.8686kg/kg of Norms Committee.

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