DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER
: 47/82-ALC4/2007 MEETING DATE : 25.03.2008

The Meeting No.47/08 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 25.03.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi.
At the outset minutes of Norms Committee Meeting No.46/08 dated 18.03.2008 were ratified by the Committee.

Case No.B-592

M/S Brawn Laboratories Ltd. Norms Committee Meeting No.47/08 F.No.01/82/50/154/AM08 Meeting Date: 25.03.2008 RLA F.No.05/24/40/163/AM08 Adv. Lic. No.0510204890 dated 13.06.2007

Committee considered case as per agenda for revision of norms for export product Kanamycin Acid Sulphate Injection BP 1gm under para 4.7 of HBP.

Committee observed that norms in this case were ratified as per written comments of PI Division and therefore, there is no merit for revision of norms. Committee, therefore, decided to maintain status quo.

Case No.B-593

M/S Lupin Ltd. Norms Committee Meeting No.47/08 F.No.01/82/50/533/AM08 Meeting Date: 25.03.2008 RLA F.No.03/95/40/2354/AM08 Adv. Lic. No.0310432279 dated 11.06.2007

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

Committee decided to defer case for four weeks.

Case No.B-594

M/S Lupin Ltd.

Norms Committee Meeting No.47/08 F.No.01/83/50/1458/AM07 Meeting Date: 25.03.2008 RLA F.No.03/95/40/1145/AM07 Adv. Lic. No.0310412637 dated 19.12.2006

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

Committee decided to defer case for four weeks.

Case No.B-595

M/S Lupin Ltd. Norms Committee Meeting No.47/08 F.No.01/83/50/1146/AM08 Meeting Date: 25.03.2008 RLA F.No.03/95/40/570/AM08 Adv. Lic. No.0310442436 dated 11.09.2007

Committee considered case as per agenda for ratification of norms for export product Strile Ceftriaxone Sodium-Non Infringing under para 4.7 of HBP.

Committee decided to defer case for four weeks.

Case No.B-596

M/S Lupin Ltd. Norms Committee Meeting No.47/08 F.No.01/82/50/1721/AM07 Meeting Date: 25.03.2008 RLA F.No.03/95/40/1297/AM07 Adv. Lic. No.0310416716 dated 22.01.2007

Committee considered case as per agenda for ratification of norms for export product Strile Cefriaxone Sodium-Non Infringing under para 4.7 of HBP.

Committee decided to defer case for four weeks.

Case No.B-597

M/Jocil Ltd. Norms Committee Meeting No.47/08 F.No.01/83/50/1557/AM07 Meeting Date: 25.03.2008 RLA F.No.09/24/40/421/AM07 Adv. Lic. No.0910029018 dated 12.01.2007

Committee considered case as per agenda for ratification of norms for export product Pink/Yellow/Green Soap Noodles Sodium Salt of Palmitic acid under para 4.7 of HBP.

Committee in light of written comments dated 25.03.2008 forwarded by DIPP decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product Export Qty. Sl.No. Import items Quanity allowed Pink/Yellow/Green Soap Noodles of 72-75% TFM 35,800 Kgs. 1. Palm Fatty Acid Distillate 21,938 kgs. 2. Crude Palm Kernal Oil 3,607 kgs. 3. Lauric Acid 1,647 kgs.

RA concerned may take further necessary action as per above decision of NC and no repeat licence should be issued on the above norms since the value of Bye-product changes frequently

Case No.C-46

M/S Alkali Metals Ltd Norms Committee Meeting No.47/08 F.No.01/87/162/590/AM08 Meeting Date: 25.03.2008

Committee considered case as per agenda for fixation of SION for export product Phenyl Pyridyl Acetamide (Phenyl-a-(2-Pyridyl) Acetamide.

Committee decided to advise the firm to furnish their application through Pharmexcil alongwith all industry data. Accordingly, case was deferred for six weeks.

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Case No.:109/21/82-ALC4/2007 Party Name:M/S/ SKYLINK

CHEMICALS PVT. LTD., Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00154/AM06/
RLA File :24/80/040/00025/AM06/
Lic.No/Date:2410014098 20.05.2005 Defer Date:
22.04.2008 Decision :Committee considered case as per agenda for ratification of norms for export product 5-Amino Isophthalic Acid (5-AIPA) under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of Chemical Division.

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Case No.:524/24/87-ALC1/2007 Party Name:AMOL

PHARMACEUTICALS PVT. LTD. Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Withdrawn HQ File :01/87/050/00818/AM07/
RLA File :13/24/040/00023/AM07/
Lic.No/Date:1310023360 13.12.2006

Decision : Committee considered case as per agenda for ratification of norms for export product Glucosamine Chondrotin Granules under para 4.7 of HBP.

Committee decided to withdraw case as case has already been approved in its 44/08

meeting held on 04.03.2008.

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Case No.:537/24/87-ALC1/2007 Party Name:ALKALOIDS CORP

Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/87/050/00857/AM07/
RLA File :02/24/040/00272/AM07/
Lic.No/Date:0210096770 29.12.2006 Defer Date: 22.04.2008 product Noscapine BP/Noscapine HCL BP under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

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Case No.:63/42/82-ALC4/2007

Party Name:CADILA HEALTHCARE LTD., Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00399/AM08/
RLA File :08/24/040/00062/AM08/
Lic.No/Date:0810065364 13.06.2007 Defer Date:
22.04.2008 product Amlodipine Besylate 2.5mg Tablets under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

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Case No.:105/39/83-ALC1/2007 Party Name:GEMINI EXPORTS.,

Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/83/050/01684/AM08/
RLA File :03/94/040/00846/AM08/
Lic.No/Date:0310452648 04.12.2007 Defer Date: 06.05.2008 product Ferrous Fumarate under para 4.7 of HBP.

Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from RA. Accordingly, case was deferred for six weeks.

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Case No.:1/47/82-ALC4/2007

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00594/AM08/
RLA File :07/24/040/00669/AM08/
Lic.No/Date:0710055191 01.01.2008 Defer Date: 06.05.2008 product Zinc Pyrithione Fine Particls Suspension under para 4.7 of HBP.

Committee decided to call for a copy of application alongwith a copy of Advance

Authorisation from RA. Accordingly, case was deferred for six weeks.

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Case No.:8/47/82-ALC4/2007

Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00601/AM08/
RLA File :05/24/040/00718/AM08/
Lic.No/Date:0510214784 10.01.2008 Defer Date: 22.04.2008 product Cefpodoxime Proxetil under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

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Case No.:7/47/82-ALC4/2007

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00600/AM08/
RLA File :09/24/040/00438/AM08/
Lic.No/Date:0910032836 30.01.2008 Defer Date: 22.04.2008 product Brosalidox L (Liquid) containing 5-Bromo-5-Nitro-1,3 Dioxane:10% Propylene Glycol 90% under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of Chemical Division.

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Case No.:5/47/82-ALC4/2007

Party Name:SAINOR LABORATORIES PVT LTD Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00598/AM08/
RLA File :09/24/040/00497/AM07/
Lic.No/Date:0910032864 01.02.2008 Defer Date: 22.04.2008 product n-Butyl Lithium (15% WW in Hexane (100% Active basis) under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of Chemical Division.

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Case No.:3/47/82-ALC4/2007

Party Name:VASANT CHEMICALS LIMITED Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00596/AM08/
RLA File :09/24/040/00463/AM08/
Lic.No/Date:0910032874 05.02.2008 Defer Date: 22.04.2008 product 4,4-Dihydrazino Stilben 2,2-Disulphonic Acid (DHS) under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of Chemical Division.

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Case No.:6/47/82-ALC4/2007

Party Name:RANTUS PHARMA PVT LTD Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Approved HQ File :01/82/050/00599/AM08/
RLA File :09/24/040/00370/AM08/
Lic.No/Date:0910032870 05.02.2008

product Tramadol Base under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 36/82 meeting held on 08.01.2008 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 Export Qty. Sl.No. Import items Qty. allowed per unit of export product Tramadol Base 1kg. 1. Cyclohexanone 1.74kg/kg 2. Dimethylamine Hcl 1.16kg/kg 3. Metabromo Anisole 2.03kg/kg 4. IPA 1.65kg/kg 5. THF 1.8926kg/kg 6. Paraformaldehyde 0.35kg/kg

RA concerned may take further necessary action as per above decision of NC.

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Case No.:2/47/82-ALC4/2007

Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Approved HQ File :01/82/050/00595/AM08/
RLA File :09/24/040/00449/AM08/
Lic.No/Date:0910032886 06.02.2008

product Cyproheptadine Hcl under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 24/83 meeting held on 20.09.2006 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 Export Qty. Sl.No. Import items Qty. allowed per unit of export product

Cyproheptadine Hcl 1kg. 1. Methanol 4.80kg/kg 2. Phosphorus Pentaoxide 0.74kg/kg 3. Phosphoric Acid 0.55kg/kg

Tetra Hydro Furan 1.00kg/kg 5. 1,3-Dibromo-5,5- Dimethyl Hydantoin Not recommended earlier. Can be recycled 6. Sodium Methoxide 0.64kg/kg 7. Thionyl Chloride 1.08kg/kg 8. Toluene 2.08kg/kg 9. Chloroform 2.11kg/kg 10. Methyl Acrylate 1.32kg/kg

RA concerned may take further necessary action as per above decision of NC.

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Case No.:9/47/82-ALC4/2007

Party Name:SOMU ORGANO CHEM PVT.LTD., Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00602/AM08/
RLA File :07/24/040/00766/AM08/
Lic.No/Date:0710055880 15.02.2008 Defer Date: 22.04.2008 product 1,3-Cyclohexanedione Dihydro Resorcinol under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

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Case No.:10/47/82-ALC4/2007

Party Name:WEXFORD LABORATORIES P LTD Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00603/AM08/
RLA File :07/24/040/00781/AM08/
Lic.No/Date:0710055893 15.02.2008 Defer Date: 06.05.2008 product Artemether and Lumefantrine Tablets under para 4.7 of HBP.

Committee decided to defer case for six weeks for comments of PI Division.

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Case No.:4/47/82-ALC4/2007

Party Name:SUDERSHAN LABORATORIES LTD. Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00597/AM08/
RLA File :09/24/040/00523/AM08/
Lic.No/Date:0910033012 19.02.2008 Defer Date: 22.04.2008 product N Butyl Lithium (1.6M Solution-As 100%W/W) under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of Chemical Division.

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Case No.:11/47/82-ALC4/2007

Party Name:GRANULES INDIA LIMITED Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Approved HQ File :01/82/050/00604/AM08/
RLA File :09/24/040/00333/AM08/
Lic.No/Date:0910033126 28.02.2008

product Paracetamol Granules DC Grade 96% under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 25/82 meeting held on 23.10.2007 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 Export Qty. Sl.No. Import items Qty. allowed per unit of export product Paracetamol Granules DC Grade 96% 1kg. 1.

Paracetamol Or its raw materials as per SION at A-3488 0.96kg/kg

Povidone (K-30) 0.04kg/kg

RA concerned may take further necessary action as per above decision of NC.

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Case No.:12/47/82-ALC4/2007

Party Name:PI INDUSTRIES LTD., Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00605/AM08/
RLA File :13/24/040/00027/AM08/
Lic.No/Date:1310025892 12.03.2008 Defer Date: 06.05.2008 product MIPD Ketal (1E)-1-(2,5,5-Trimethyl-1,3-Dioxane-2-yl)-Propane-1,2-Dione-1-(O- methyl oxime) under para 4.7 of HBP.

Committee decided to defer case for six weeks for comments of Chemical Division.

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Case No.:13/47/82-ALC4/2007

Party Name:PI INDUSTRIES LTD., Meet No/Date:47/82- ALC4/2007 25.03.2008 Status:Case Deferred HQ File :01/82/050/00606/AM08/
RLA File :13/24/040/00028/AM08/
Lic.No/Date:1310025893 12.03.2008 Defer Date: 06.05.2008 product 2-Cyanimino 1,3 Thiazolidin (CIT) under para 4.7 of HBP.

Committee decided to defer case for six weeks for comments of Chemical Division.