DGFT Committee Minutes
Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi 110011
Para 4.7 Officewise Statement
MEETING NUMBER : 17/82ALC4/2007 MEETING DATE : 28.08.2007 1
Case No.:31/30/87ALC1/2005
Party Name:ALKALOIDS CORP Meet No/Date:17/82ALC4/2007 28.08.2007 Status:Case Deferred HQ File :01/87/050/00870/AM06/ RLA File :02/24/040/00154/AM06/ Lic.No/Date:0210082777 17.10.2005 Defer Date: 25.09.2007 Decision :The Committee considered the case as per agenda for ratification of norms for the export product Cascara Dry Extract under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but same have not been received so far. Committee, therefore, decided to remind Department of Ayush at an appropriate level. Accordingly, the case was deferred for four weeks. 2
Case No.:39/9/82ALC1/2006
Party Name:KDL BIOTECH LIMITED 28.08.2007 Status:Case Deferred HQ File :01/82/050/00209/AM07/ RLA File :03/94/040/00021/AM07/ Lic.No/Date:0310379882 10.05.2006 Defer Date: 11.09.2007 Decision : Committee considered the case as per agenda for ratification of norms for the export product FluCloxacillin Sodium BP/USP/EP under para 4.7 of HBP. Committee observed that the firm as well as Pharmexcil were requested to furnish data duly certified by Central Excise Authority, but the same has not been received. Committee, therefore, decided to remind the firm as well as Pharmexcil to furnish the data and to defer the case for two weeks. 3
Case No.:2/31/83ALC1/2006
Party Name:PRADEEP SHETYE PVT. LTD. 28.08.2007 Status:Case Deferred HQ File :01/83/050/00707/AM07/ RLA File :03/95/040/00433/AM07/ Lic.No/Date:0310400643 22.09.2006 Defer Date: 25.09.2007 Decision : Committee considered the case as per agenda for ratification of norms for the export product Micronized Rafoxanide under para 4.7 of HBP. Committee observed that the firm was requested to furnish Technical Specification including particle size, analysis for both import and export items vide letter dated 07.08.2007, but same has not been received. The Committee, therefore, decided to remind the firm and to defer
the case for four weeks. 4
Case No.:4/44/82ALC1/2006
Party Name:GULF OIL CORPORATION LIMITED. 28.08.2007 Status:Case Rejected HQ File :01/82/050/01215/AM07/ RLA File :09/24/040/00194/AM07/ Lic.No/Date:0910028005 31.10.2006 Decision : Committee considered the case as per agenda for ratification of norms for the export product Sodium Cromo Glycate under para 4.7 of HBP. Committee observed that the firm was requested to furnish end use of the export product and copy of DML vide letter dated 23.07.2007, but the same has not been received. The Committee, therefore, decided to reject the case since the quantity of inputs can not be computed in absence of the aforesaid information/documents. RLA concerned may take further necessary action including cancellation of Advance Licence under para 4.7 of HBP. 5
Case No.:37/36/83ALC1/2006
Party Name:SRINI PHARMACEUTICALS LTD., 28.08.2007 Status:Case Deferred HQ File :01/83/050/00874/AM07/ RLA File :09/24/040/00307/AM07/ Lic.No/Date:0910028137 07.11.2006 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Lamotrigine under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for two weeks. The Committee accordingly decided to defer the case for two weeks. 6
Case No.:2/41/83ALC1/2006
Party Name:SUVEN LIFE SCIENCES LIMITED 28.08.2007 Status:Case Approved HQ File :01/83/050/00940/AM07/ RLA File :09/24/040/00334/AM07/ Lic.No/Date:0910028290 21.11.2006 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Doxyfylline under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/254/2006PIIII dated 30.08.2007 decided to ratify norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Doxofylline1Kg.
Import items: 1. Theophylline1.17kg/kg 2. Chloro Acetaldehyde dimethyl acetal0.81kg/kg 3. Potassium carbonate0.89kg/kg 4. Methanol0.63kg/kg 5. Dimethyl formamide0.56kg/kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 7
Case No.:4/47/87ALC1/2006
Party Name:ASTRIX LABORATORIES LTD., 28.08.2007 Status:Case Deferred HQ File :01/87/050/00827/AM07/ RLA File :09/24/040/00359/AM07/ Lic.No/Date:0910028661 18.12.2006 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Lopinavir under para 4.7 of HBP. The CommiƩee noted that a case of the firm has been approved earlier. It was decided to link the earlier case and defer the case for re‐lisƟng on 25.09.2007. 8
Case No.:4/9/83ALC1/2007
Party Name:ZANDU CHEMICALS LIMITED 28.08.2007 Status:Case Deferred HQ File :01/83/050/01315/AM07/ RLA File :03/95/040/01260/AM07/ Lic.No/Date:0310422065 06.03.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 2 Methyl 4,6 Bis(Trichloromethyl)1,3,5 Triazine (TAZ) under para 4.7 of HBP. The Committee decided to call from the firm information about end use of the export product and technical details in support of Yield claimed. Accordingly, the case was deferred for four weeks. 9
Case No.:1/17/82ALC4/2007
Party Name:BIOLOGICAL E LTD 28.08.2007 Status:Case Deferred HQ File :01/82/050/01860/AM07/ RLA File :09/24/040/00481/AM07/ Lic.No/Date:0910029748 23.03.2007 Defer Date: 25.09.2007 Decision : Committee considered the case as per agenda for ratification of norms for the export product Noscapine Hcl under para 4.7 of HBP. Committee observed that the comments of Deptt. of Revenue (Narcotics) has been called for, but same has not been received. Committee, therefore, decided to remind Jt. Secretary (Narcotics) demiofficially for their comments. Accordingly, the case was deferred for four weeks. 10
Case No.:2/4/82ALC4/2007
Party Name:HERBERT BROWN Status:Case
PHARMACEUTICAL & RESEARCH LABS 28.08.2007 Withdrawn HQ File :01/82/050/01906/AM07/ RLA File :03/94/040/01515/AM07/ Lic.No/Date:0310424944 29.03.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Unylinker Nittomar Solid Support Loaded Support under para 4.7 of HBP. The Committee decided to withdraw the case as the same has already been transferred to DESIV. 11
Case No.:7/11/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD 28.08.2007 Status:Case Approved HQ File :01/82/050/00029/AM08/ RLA File :09/24/040/00020/AM08/ Lic.No/Date:0910030193 07.05.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Bisacodyl 5mg Tablets under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/209/2005PIIII dated 14.08.2007 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: Bisacodyl tabs. 5mg. Import items: 1. Lactose4.112kg/1 lakh tablets 2. Maize Starch0.9942kg/1 lakh tablets 3. Pregelatinised Starch0.3338kg/1 lakh tablets 4. Bisacodyl0.500kg/1 lakh tablets 5. Magnesium stearate0.060kg/1 lakh tablets 6. Sucrose (PG Sugar)3.5762kg/1 lakh tablets 7. Povidone PVPK250.090kg/1 lakh tablets 8. Purified Talc0.650kg/1 lakh tablets 9. Titanium Dioxide0.0650kg/1 lakh tablets 10. Cellacefate BP0.650kg/1 lakh tablets 11. Diethyl Phthalate BP0.0650kg/1 lakh tablets 12. Methanol BP1.582kg/1 lakh tablets 13. Dichloromethane BP4.746kg/1 lakh tablets 14. Quinoline Yellow Aluminium 0.0750kg/1 lakh tablets Lake E104 RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms committee.
12
Case No.:32/9/82ALC4/2007
Party Name:INDO PHYTOCHEM PHARMACEUTICALS 28.08.2007 Status:Case Deferred HQ File :01/82/050/00043/AM08/ RLA File :05/24/040/00093/AM08/ Lic.No/Date:0510203946 22.05.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Yohimbine Hydrochloride USP under para 4.7 of HBP. The representative of DC(SSI) present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, accordingly, decided to defer the case for four weeks. 13
Case No.:39/9/82ALC4/2007
Party Name:WOCKHARDT LIMITED 28.08.2007 Status:Case Deferred HQ File :01/82/050/00065/AM08/ RLA File :03/95/040/00157/AM08/ Lic.No/Date:0310431490 04.06.2007 Defer Date: 09.10.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Flu Strength Hot Lemon Powders 5 GM Sachet under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for six weeks. The Committee, accordingly, decided to defer the case for six weeks. 14
Case No.:40/9/82ALC4/2007
Party Name:WOCKHARDT LIMITED 28.08.2007 Status:Case Deferred HQ File :01/82/050/00066/AM08/ RLA File :03/95/040/00161/AM08/ Lic.No/Date:0310431494 04.06.2007 Defer Date: 09.10.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Hot Lemon Cold Relief Powers 5GM Sachet under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for six weeks. The Committee, accordingly, decided to defer the case for six weeks. 15
Case No.:2/17/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD 28.08.2007 Status:Case Approved HQ File :01/82/050/00067/AM08/ RLA File :09/24/040/00066/AM08/ Lic.No/Date:0910030528 13.06.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product 2(6Methoxy2 naphthyl)propionic acid (DLAcid) under para 4.7 of HBP.
The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/130/2006PIIII dated 21.08.2007 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: 2(6Methoxy2Naphthyl)Propionic acid (DLAcid)1Kg. Import items: 1. 2Acetyl6Methoxy Naphthalene1.231kg/kg 2. Hydroxylamine Sulphate0.513kg/kg 3. Toluene0.68kg/kg 4. Carbon0.100kg/kg 5. Secondary Butanol1.02kg/kg 6. Mono chloro acetic acid0.492kg/kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 16
Case No.:3/17/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD 28.08.2007 Status:Case Deferred HQ File :01/82/050/00073/AM08/ RLA File :09/24/040/00093/AM08/ Lic.No/Date:0910030626 21.06.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Finasteride under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, accordingly, decided to defer the case for four weeks. 17
Case No.:8/11/82ALC4/2007
Party Name:SHILPA MEDICARE LTD., 28.08.2007 Status:Case Deferred HQ File :01/82/050/00074/AM08/ RLA File :07/24/040/00196/AM08/ Lic.No/Date:0710052106 22.06.2007 Defer Date: 11.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Gemcitabine Hcl under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for two weeks. The Committee, accordingly, decided to defer the case for two weeks. 18
Case No.:4/17/82ALC4/2007
Party Name:NESTOR PHARMACEUTICALS LTD. 28.08.2007 Status:Case Approved
HQ File :01/82/050/00105/AM08/ RLA File :05/24/040/00251/AM08/ Lic.No/Date:0510205698 03.07.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Metronidazole Granules under
para 4.7 of HBP.
The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/29/2007PIIII dated 30.08.2007 decided to ratify norms on repeat basis as per details below or as applied by the firm whichever is lower. Export product: Metronidazole Granules1kg. Import items: 1. Metronidazole0.3333kg/kg 2. Povidone/PVPKNot shown in DML. Hence not allowed. 3. Collidal Silicon DioxideNot shown in DML. Hence not allowed. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 19
Case No.:5/17/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD 28.08.2007 Status:Case Deferred HQ File :01/82/050/00115/AM08/ RLA File :09/24/040/00101/AM08/ Lic.No/Date:0910030910 17.07.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Glimepride under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, accordingly, decided to defer the case for four weeks. 20
Case No.:6/17/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD 28.08.2007 Status:Case Deferred HQ File :01/82/050/00117/AM08/ RLA File :09/24/040/00122/AM08/ Lic.No/Date:0910030946 19.07.2007 Defer Date: 25.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms for the export product Rampril under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, accordingly, decided to defer the case for four weeks.
Date:28.08.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer
Case No.A‐527
M/S Divis Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/695/AM’08/DES‐III MeeƟng Date: 28.08.2007 RLA F.No.09/24/40/141/AM’08 Adv.Lic.No.0910030846 dated 11.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product Cyclopentadecanolide (Recrystallised) under para 4.7 of HBP. The representaƟve of PI Division present in the meeƟng informed the CommiƩee that the case is under examinaƟon in their Department and he sought deferment for six weeks. The CommiƩee accordingly decided to defer the case for six weeks.
Case No.A‐528
M/S Suven Life Sciences Ltd. MeeƟng No.17/08 F.No.01/82/50/308/AM’08/DES‐III RLA F.No.09/24/40/13/AM’08 Adv.Lic.No.0910030250 dated 14.05.2007 Benzhydryl Thioacetamide under para 4.7 of HBP.
Case No.A‐529
M/S Suven Life Sciences Ltd. MeeƟng No.17/08 F.No.01/82/50/804/AM’08/DES‐III RLA F.No.09/24/40/152/AM’08 Adv.Lic.No.0910030953 dated 20.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 2‐ Phenyl‐2‐Dimethyl Amino Butanol under para 4.7 of HBP. The CommiƩee in light of wriƩen comments forwarded by PI Division vide their U.O. No.35011/14/2007‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 2‐Phenyl‐2‐Dimethyl Amino Butanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1kg. Import items: 1. Propiophenone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.10kg/kg 2. Sodium Cyanide‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.768kg/kg 3. IPA‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.38kg/kg 4. Sodium BIS(2‐Methoxy Ethoxy Aluminium Hydride (Synhydrid)‐‐‐‐‐‐2.412kg/kg 5. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.50kg/kg RLA concerned may take further necessary acƟon under para 4.7 of HBP as per above decision of Norms CommiƩee.
Case No.A‐530
M/S Wanbury Limited. MeeƟng No.17/08 F.No.01/82/50/920/AM’08/DES‐III RLA F.No.03/95/40/1516/AM’07 Adv.Lic.No.0310436993 dated 20.07.2007 Ibuprofen DC Granules 65% under para 4.7 of HBP.
Case No.A‐531
M/S Wanbury Limited MeeƟng No.17/08 F.No.01/82/50/919/AM’08/DES‐III RLA F.No.03/95/40/1517/AM’07 Adv.Lic.No.0310436987 dated 20.07.2007 Ibuprofen DC Granules 90% under para 4.7 of HBP.
Case No.A‐532
M/S Wanbury Limited MeeƟng No.17/08 F.No.01/82/50/915/AM’08/DES‐III RLA F.No.03/95/40/1473/AM’07 Adv.Lic.No.0310436839 dated 19.07.2007 Carvedilol BP under para 4.7 of HBP.
Case No.A‐533
M/S Wanbury Limited MeeƟng No.17/08 F.No.01/82/50/916/AM’08/DES‐III RLA F.No.03/95/40/1472/AM’07 Adv.Lic.No.0910030846 dated 11.07.2007
Setralone (Tetralone) under para 4.7 of HBP.
Case No.A‐534
M/S Shodhana Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/389/AM’08/DES‐III RLA F.No.09/24/40/49/AM’08 Adv.Lic.No.0910030335 dated 24.05.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 4‐ (2,3‐Epoxy Propoxy) Carbazole under para 4.7 of HBP.
Case No.A‐535
M/S Shodhana Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/390/AM’08/DES‐III RLA F.No.09/24/40/40/AM’08 Adv.Lic.No.0910030336 dated 24.05.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 3‐ Oxo‐4‐Aza‐5a‐Androstane‐17b‐Carboxylic Acid under para 4.7 of HBP.
Case No.A‐536
M/S Shodhana Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/388/AM’08/DES‐III RLA F.No.09/24/40/48/AM’08 Adv.Lic.No.0910030334 dated 24.05.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 2‐ (2‐Methoxy Phenoxy) Ethylamine under para 4.7 of HBP.
Case No.A‐537
M/S Rashmi Pharma Pvt. Ltd MeeƟng No.17/08 F.No.01/82/50/486/AM’08/DES‐III RLA F.No.09/24/40/88/AM’08 Adv.Lic.No.0910030478 dated 07.06.2007 Orlistat Pellets 50% (Tetrahydro LipstaƟn) under para 4.7 of HBP. The CommiƩee in light of earlier decision taken in its 15/08 meeƟng held on 14.08.2007 vide case No.A‐464 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Orlistat Pellets 50%‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: Olistat‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.505kg/kg Norms CommiƩee.
Case No.A‐538
M/S Rashmi Pharma Pvt. Ltd
MeeƟng No.17/08 F.No.01/82/50/836/AM’08/DES‐III RLA F.No.09/24/40/163/AM’08 Adv.Lic.No.0910030992 dated 24.07.2007 Orlistat Pellets 50% (Tetrahydro LipstaƟn) under para 4.7 of HBP. The CommiƩee in light of earlier decision taken in its 15/08 meeƟng held on 14.08.2007 vide case No.A‐464 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Orlistat Pellets 50%‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: Olistat‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.505kg/kg Norms CommiƩee.
Case No.A‐539
M/S Vasudha Pharma Chem. Ltd MeeƟng No.17/08 F.No.01/82/50/802/AM’08/DES‐III RLA F.No.09/24/40/537/AM’07 Adv.Lic.No.0910030951 dated 20.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 4‐ Piperidone Monohydro Hydrochloride (4‐Piperidone H20 Hcl) under para 4.7 of HBP.
Case No.A‐540
M/S Vasudha Pharma Chem Ltd.
MeeƟng No.17/08 F.No.01/82/50/821/AM’08/DES‐III RLA F.No.09/24/40/42/AM’08 Adv.Lic.No.0910030972 dated 23.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product Cis‐ 4‐Amino‐3‐Methoxy‐Piperidine‐1‐Carboxylic Acid Ethyl Ester Monohydrochloride under para 4.7 of HBP.
Case No.A‐541
M/S Vasudha Pharma Chem Ltd MeeƟng No.17/08 F.No.01/82/50/822/AM’08/DES‐III RLA F.No.09/24/40/68/AM’08 Adv.Lic.No.0910030973 dated 23.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 2‐ Butyl‐4‐Chloro‐5‐Formyl Imidazole (OR) 2(n‐Butyl)‐4‐Chloro‐5‐Formyl Imidazole under para 4.7 of HBP.
Case No.A‐542
M/S Vasudha Pharma Chem Ltd. MeeƟng No.17/08 F.No.01/82/50/803/AM’08/DES‐III RLA F.No.09/24/40/151/AM’08 Adv.Lic.No.0910030952 dated 20.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product N‐ Carbethoxy‐4‐Piperidinol (or) 4‐Hydroxy‐N‐Carbethoxy Piperidine (or) N‐Carbethoxy‐4‐Hydroxy Piperidine under para 4.7 of HBP.
The representaƟve of PI Division present in the meeƟng informed the CommiƩee that the case is
Case No.A‐543
M/S Suven Life Sciences Ltd. MeeƟng No.17/08 F.No.01/82/50/309/AM’08/DES‐III RLA F.No.09/24/40/25/AM’08 Adv.Lic.No.0910030251 dated 14.05.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 2,4‐ Dichloro Pyrimidine under para 4.7 of HBP. The CommiƩee in light of earlier decision taken in its 8/08 meeƟng held on 28.06.2007 vide case No.9/34/83‐ALC1/2006 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 2,4‐dichloro pyrimidine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Uracil (2,4‐Dihydroxy Pyrimidine)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.12kg/kg 2. Dichloro methane (Methylene chloride)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.00kg/kg 3. Diethyl aniline‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.24kg/kg 4. Triethylamine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.09kg/kg 5. IPA‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.50kg/kg Norms CommiƩee.
Case No.A‐544
M/S XL Laboratories Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/50/1151/AM’07/DES‐III RLA F.No.05/24/40/785/AM’07 Adv.Lic.No.0510198209 dated 22.01.2007
Evirose 1000, 100 and 400 Capsules under para 4.7 of HBP. The representaƟve of DC(SSI) present in the meeƟng informed the CommiƩee that the case is under examinaƟon in their Department and he sought deferment for two weeks. The CommiƩee accordingly decided to defer the case for two weeks.
Case No.A‐545
M/S XL Laboratories Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/50/933/AM’07/DES‐III RLA F.No.05/24/40/679/AM’07 Adv.Lic.No.0510194717 dated 20.11.2006 Cipfast‐500 Tablets under para 4.7 of HBP. The CommiƩee in light of wriƩen comments forwarded by PI Division vide their U.O. No.35011/70/2007‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Cipfast 500 tablets Import items: 1. Ciprofloxacin hcl‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐582.20mg/tablet of 500mg. Norms CommiƩee.
Case No.A‐546
M/S Cadila Healthcare Ltd. MeeƟng No.17/08 F.No.01/82/162/1479/AM’07/DES‐III RLA F.No.08/24/40/355/AM’07 Adv.Lic.No.0810063496 dated 09.03.2007
AtorvastaƟn CondensaƟon Product Pharma Grade under para 4.7 of HBP. No.35011/73/2007‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: AtorvastaƟn CondensaƟon Product‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1kg. Import items: Sl.No. DescripƟon of import items QuanƟty allowed 1. Methyl Isobutyryl Acetate 0.970kg/kg 2. 4‐Methy‐5‐Hydroxy ethyl Thiazole 0.120kg/kg 3. (4R,Cis)‐1,1‐dimethyl ethyl‐6‐cyanomethyl‐2,2‐dimethyl‐ 1,3‐Dioxane‐4‐Acetate 0.635kg/kg 4. Methanol 1.09kg/kg 5. Cyclohexane 2.77kg/kg 6. Tetrahydrofuran 0.53kg/kg 7. Isopropyl alcohol 4.49kg/kg 8. Toluene 1.62kg/kg Norms CommiƩee.
Case No.A‐547
M/S Cipla Ltd. MeeƟng No.17/08 F.No.01/82/50/863/AM’07/DES‐III RLA F.No.03/94/40/415/AM’07 Adv.Lic.No.0310390107 dated 19.07.2006 Equine Butazone Granules/Phenylbutazone Granules under para 4.7 of HBP. The CommiƩee taking a cue from SION at Sl.No.A‐1945 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower.
Export product: Equine Butazone Granules/Phenyl Butazone Granules (Each pack of 1 gram)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3,00,000 packs Import item: Phenyl Butazone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐60.60kg/3,00,000 packs Norms CommiƩee.
Case No.A‐548
M/S Cipla Ltd. MeeƟng No.17/08 F.No.01/82/50/168/AM’08/DES‐III RLA F.No.03/94/40/17/AM’07 Adv.Lic.No.0310426065 dated 10.04.2007 Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP.
Case No.A‐549
M/S Ce‐Chem PharmaceuƟcals, Bangalore MeeƟng No.17/08 F.No.01/82/50/46/AM’08/DES‐III RLA F.No.07/24/40/136/AM’08 Adv.Lic.No.0710051761 dated 25.05.2007 Pencillin Potassium 250mg Tablets under para 4.7 of HBP. The CommiƩee observed that the firm was requested to furnish copy of DML alongwith approved list of import items, but the same has not been received. The CommiƩee, therefore, decided to remind the firm and to defer the case for four weeks.
Case No.A‐550
M/S Gracure PharmaceuƟcals Ltd MeeƟng No.17/08 F.No.01/82/162/726/AM’07/DES‐III RLA F.No.05/24/40/112/AM’07 Adv.Lic.No.0510185320 dated 22.06.2006 Doxy‐200 Tabs under para 4.7 of HBP. The CommiƩee decided to call for copy of DML from the firm. The case was accordingly deferred for four weeks.
Case No.A‐551
M/S Arvee Chem Pharma Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/50/297/AM’08/DES‐III RLA F.No.07/24/40/84/AM’08 Adv.Lic.No.0710051589 dated 10.05.2007 Dibenzosuberone Chemical Product under para 4.7 of HBP. under examinaƟon in their Department and he sought deferment for two weeks. The CommiƩee accordingly
Case No.A‐552
M/S IPCA Laboratories Ltd. MeeƟng No.17/08 F.No.01/83/50/589/AM’08/DES‐III RLA F.No.03/94/40/248/AM’08 Adv.Lic.No.0310432927 dated 18.06.2007 Testosterone Propionate under para 4.7 of HBP.
No.35011/116/2005‐PI‐III dated 30.08.2007 in the case of M/S Avik PharmaceuƟcals Ltd decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product; Testosterone Propionate BP/USP‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. 4‐Anrostene 3,17 Dione (Androstenedione)‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.25kg/kg 2. Trimethyl Ortho formate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.57kg/kg Norms CommiƩee.
Case No.A‐553
M/S Intas Pharma Ltd. MeeƟng No.17/08 F.No.01/82/50/168/AM’08/DES‐III RLA F.No.08/24/40/69/AM’08 Adv.Lic.No.0810065436 dated 18.06.2007 Gemcitabine for InjecƟon under para 4.7 of HBP. No.35011/274/2006 PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Gemcitabine for injecƟon USP 200mg/vial, 10ml Vial‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐15,000 Nos. Gemcitabine for injecƟon USP 1000mg/vial, 50ml Vial‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐4,000 Nos. Gemcitabine for injecƟon USP 2000mg/vial, 100ml Vial‐‐‐‐‐‐‐‐‐‐‐‐‐‐1,800 Nos. Import item: Gemcitabine hcl. USP‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐12.85kg. Norms CommiƩee.
Case No.A‐554
M/S Nicholas Piramal India Ltd MeeƟng No.17/08 F.No.01/82/50/2/AM’08/DES‐III RLA F.No.03/95/40/244/AM’08 Adv.Lic.No.Not issued. The case is under para 4.4.2 The CommiƩee considered the case as per agenda for fixaƟon of norms for the export product Oxysept Tablets (9081X) Contact Lens Cleaning Tablets under para 4.4.2 of HBP. The CommiƩee observed that at the Ɵme of making applicaƟon for issue of Advance AuthorizaƟon, it is not clear whether the item of import/export is biotechnology item and on the basis of declaraƟon given by the firm in terms of para 4.7 of HBP (Vol.I), R.As issue authorizaƟons. In this case, the firm has given a declaraƟon that the item of import/export are not biotechnology items. With a view to ascertain the same, the CommiƩee decided to refer a copy of applicaƟon to Department of Biotechnology for their comments and deferred the case for four weeks.
Case No.A‐555
M/S Makson Inds. Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/162/196/AM’08/DES‐III RLA F.No.03/95/40/409/AM’07 Adv.Lic.No.0310390363 dated 20.07.2006 Vicks Vaporub under para 4.7 of HBP. The representaƟve of DC(SSI) present in the meeƟng informed the CommiƩee that the case is under examinaƟon in their Department and he sought deferment for two weeks. The CommiƩee accordingly
Case No.A‐556
M/S Medlay PharmaceuƟcals Ltd. MeeƟng No.17/08 F.No.01/82/50/139/AM’08/DES‐III RLA F.No.03/95/40/380/AM’08 Adv.Lic.No.0310437336 dated 25.07.2007 Ecoflox‐500 Tablet (Ciprofloxacin BP 500mg) under para 4.7 of HBP. No.35011/70/2007‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Cipfast 500 tablets Import items: 1. Ciprofloxacin hcl‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐582.20mg/tablet of 500mg. Norms CommiƩee.
Case No.A‐557
M/S Vivin Laboratories Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/50/871/AM’08/DES‐III RLA F.No.09/24/40/138/AM’08 Adv.Lic.No.0910031028 dated 01.08.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 5‐O Benzoyl‐2,3‐Didehydro‐5‐Methyl Uridine under para 4.7 of HBP.
Case No.A‐558
M/S Suven Life Sciences Ltd. MeeƟng No.17/08 F.No.01/82/50/840/AM’08/DES‐III RLA F.No.09/24/40/165/AM’08 Adv.Lic.No.0910031004 dated 27.07.2007 Doxyfylline under para 4.7 of HBP. No.35011/254/2006‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Doxyphylline‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐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 Norms CommiƩee.
Case No.A‐559
M/S Smilax Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/837/AM’08/DES‐III RLA F.No.09/24/40/155/AM’08 Adv.Lic.No.0910030999 dated 25.07.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product {3‐ 5[Bramo‐1‐(flurophenyl)(1.3‐dihydro isobenzo furanyl)]‐propyl]dimehylamine oxalate under para 4.7 of HBP.
Case No.A‐560
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/608/AM’08/DES‐III RLA F.No.05/24/40/248/AM’08 Adv.Lic.No.0510205474 dated 27.06.2007 PravastaƟn Sodium under para 4.7 of HBP. No.35011/171/2006‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: PravastaƟn Sodium‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1kg. Import item: 1. CompacƟn‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.47kg/kg 2. AnƟ Form SAG‐71‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.05kg/kg 3. Acetonitrile‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐7.17kg/kg 4. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.92kg/kg 5. AcƟvated Carbon‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.100kg/kg 6. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.05kg/kg Norms CommiƩee.
Case No.A‐561
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/758/AM’08/DES‐III RLA F.No.05/24/40/285/AM’08 Adv.Lic.No.0510206332 dated 16.07.2007
AtorvastaƟn Calcium under para 4.7 of HBP. decided to defer the case for two weeks.
Case No.A‐562
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/755/AM’08/DES‐III RLA F.No.05/24/40/286/AM’08 Adv.Lic.No.0510206321 dated 16.07.2007 Citalopram Hydrobromide under para 4.7 of HBP.
Case No.A‐563
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/882/AM’08/DES‐III RLA F.No.05/24/40/354/AM’08 Adv.Lic.No.0510207161 dated 03.08.2007 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product 1‐ benzyl‐3,40dimethyl‐2‐(4‐methoxy benzyl)‐1,2,5,6‐tetrahydropyridine oxalate (Pentazocine Intermediate) under para 4.7 of HBP.
Case No.A‐564
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/700/AM’08/DES‐III RLA F.No.05/24/40/279/AM’08 Adv.Lic.No.0510206048 dated 11.07.2007 Cefpodoxime ProxeƟl under para 4.7 of HBP. decided to defer the case for two weeks.
Case No.A‐565
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/699/AM’08/DES‐III RLA F.No.05/24/40/278/AM’08 Adv.Lic.No.0510206047 dated 11.07.2007 Lisinopril under para 4.7 of HBP.
Case No.A‐566
M/S Ranbaxy Laboratories Ltd. MeeƟng No.17/08 F.No.01/82/50/698/AM’08/DES‐III RLA F.No.05/24/40/274/AM’08 Adv.Lic.No.0510206046 dated 11.07.2007 Fosinopril Sodium under para 4.7 of HBP.
Case No.A‐567
M/S Hetero Labs Ltd. MeeƟng No.17/08 F.No.01/83/50/625/AM’08/DES‐III RLA F.No.09/24/40/126/AM’08 Adv.Lic.No.0910030694 dated 29.06.2007 Irbesartan under para 4.7 of HBP. under examinaƟon in their Department and he sought deferment for four weeks. The CommiƩee accordingly decided to defer the case for four weeks.
Case No.A‐568
M/S Hetero Labs Ltd. MeeƟng No.17/08 F.No.01/83/50/398/AM’08/DES‐III RLA F.No.09/24/40/41/AM’08 Adv.Lic.No.0910030347 dated 25.05.2007 Benazepril Hcl under para 4.7 of HBP.
Case No.A‐569
M/S Hetero Labs Ltd. MeeƟng No.17/08 F.No.01/83/50/83/AM’08/DES‐III
RLA F.No.09/24/40/83/AM’08 Adv.Lic.No.0910030508 dated 11.06.2007 Nelfinavir Mesylate under para 4.7 of HBP.
Case No.A‐570
M/S Hetero Labs Ltd. MeeƟng No.17/08 F.No.01/83/50/499/AM’08/DES‐III RLA F.No.09/24/40/84/AM’08 Adv.Lic.No.0910030506 dated 11.06.2007 Cilostazol under para 4.7 of HBP.
Case No.A‐571
M/S Hetero Labs Ltd. MeeƟng No.17/08 F.No.01/83/50/498/AM’08/DES‐III RLA F.No.09/24/40/85/AM’08 Adv.Lic.No.0910030505 dated 11.06.2007 Didanosine under para 4.7 of HBP.
Case No.A‐572
M/S Hetero Labs Ltd. MeeƟng No.17/08 F.No.01/83/50/626/AM’08/DES‐III RLA F.No.09/24/40/228/AM’07 Adv.Lic.No.0910030695 dated 29.06.2007 Tioconazole under para 4.7 of HBP.
Case No.A‐573
M/S Hetero Drugs Ltd. MeeƟng No.17/08 F.No.01/83/50/501/AM’08/DES‐III RLA F.No.09/24/40/81/AM’08 Adv.Lic.No.0910030509 dated 11.06.2007 Lamivudine under para 4.7 of HBP.
Case No.A‐574
M/S Hetero Drugs Ltd. MeeƟng No.17/08 F.No.01/83/50/489/AM’08/DES‐III RLA F.No.09/24/40/77/AM’08 Adv.Lic.No.0910030483 dated 08.06.2007 Valacyclovir Hydrochloride/Monohydrate under para 4.7 of HBP.
Case No.A‐575
M/S Astrix Laboratories Ltd. MeeƟng No.17/08 F.No.01/83/50/686/AM’08/DES‐III RLA F.No.09/24/40/35/AM’08 Adv.Lic.No.0910030801 dated 06.07.2007 Stavudine under para 4.7 of HBP.
Case No.A‐576
M/S Astrix Laboratories Ltd. MeeƟng No.17/08 F.No.01/83/50/717/AM’08/DES‐III RLA F.No.09/24/40/119/AM’08 Adv.Lic.No.0910030868 dated 12.07.2007 Ritonavir under para 4.7 of HBP. The CommiƩee noted that the firm has been requested to furnish informaƟon vide leƩer dated 14.08.2007 in other case of the firm (F.No.01/87/50/826/AM07) and the same has not been received. The CommiƩee decided to await reply of the firm and to re‐list the case on 18.09.2007.
Case No.A‐577
M/S Astrix Laboratories Ltd. MeeƟng No.17/08 F.No.01/83/50/718/AM’08/DES‐III
RLA F.No.09/24/40/118/AM’08 Adv.Lic.No.0910030869 dated 12.07.2007 Lopinavir under para 4.7 of HBP. The CommiƩee noted that the firm has been requested to furnish informaƟon vide leƩer dated 07.08.2007 in other case of the firm (F.No.01/87/50/827/AM’07) for the same export product. The CommiƩee decided to await reply of the firm. The case may be relisted on 18.09.2007.
Case No.A‐578
M/S Aurobindo Pharma Ltd. MeeƟng No.17/08 F.No.01/83/50/520/AM’08/DES‐III RLA F.No.09/24/40/96/AM’08 Adv.Lic.No.0910030542 dated 13.06.2007 Finasteride under para 4.7 of HBP. under examinaƟon in their Department and he sought deferment for three weeks. The CommiƩee accordingly decided to defer the case for three weeks.
Case No.A‐579
M/S Aurobindo Pharma Ltd. MeeƟng No.17/08 F.No.01/83/50/878/AM’08/DES‐III RLA F.No.09/24/40/182/AM’08 Adv.Lic.No.0910031049 dated 06.08.2007 Benazepril Hcl under para 4.7 of HBP. under examinaƟon in their Department and he sought deferment for three weeks. The CommiƩee accordingly decided to defer the case for three weeks.
Case No.A‐580
M/S Aurobindo Pharma Ltd. MeeƟng No.17/08 F.No.01/83/50/831/AM’08/DES‐III RLA F.No.09/24/40/446/AM’07 Adv.Lic.No.0910030991 dated 24.07.2007 Didanosine under para 4.7 of HBP. under examinaƟon in their Department and he sought deferment for three weeks. The CommiƩee accordingly decided to defer the case for three weeks.
Case No.A‐581
M/S Aurobindo Pharma Ltd. MeeƟng No.17/08 F.No.01/83/50/440/AM’08/DES‐III RLA F.No.09/24/40/50/AM’08 Adv.Lic.No.0910030397 dated 31.05.2007 Meೀ�ormin Hcl under para 4.7 of HBP. The CommiƩee in light of earlier decision taken in its 2/08 meeƟng held on 16.05.2007 vide Case No.5/37/87‐ALC1/2006 decided to raƟfy Norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product Meೀ�ormin Hcl‐‐‐‐‐‐‐‐‐‐‐1kg Import items 1. Dicyanodiamide‐‐‐‐‐0.567kg 2. Iso Amyl Alcohol‐‐‐‐‐0.026kg 3. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.352kg 4. AcƟvated carbon‐‐‐‐‐0.056kg Norms CommiƩee.
Case No.A‐582
M/S Aurobindo Pharma Ltd. MeeƟng No.17/08 F.No.01/83/50/331/AM’08/DES‐III RLA F.No.09/24/40/37/AM’08 Adv.Lic.No.0910030255 dated 16.05.2007 Cloxacillin Sodium From 6‐APA Route under para 4.7 of HBP. The CommiƩee in light of the report of the DepƩ. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Cloxacillin Sodlum from 6 APA Stage‐‐‐‐1kg Import items 1. 6‐APA‐‐‐‐‐‐‐‐0.490kg 2. Acetone‐‐‐‐‐0.0034kg 3. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)‐‐‐‐‐0.62kg OR 3.a) O‐chloro Benzaldehyde‐‐‐‐‐‐‐0.5034kg 3.b) Hydroxyl Amine Sulphate‐‐‐‐‐0.3192kg 3.c) Methyl Acetoacetate‐‐‐‐‐‐‐‐‐‐‐‐0.410kg 3.d) Chloroform‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.270kg 3.e) Methylene chloride‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.0542kg 4. Methylene chloride/Ethyl Acetate‐‐‐‐0.620kg 5. 2‐Ethyl Hexanoic Acid‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.150kg RLA concerned may take further necessary acƟon under para 4.7 of HBP as per above decision of Norms CommiƩee.
Case No.A‐583
M/S Aurobindo Pharma Ltd.
MeeƟng No.17/08 F.No.01/83/50/823/AM’08/DES‐III RLA F.No.09/24/40/159/AM’08 Adv.Lic.No.0910030974 dated 23.05.2007 Efavirenz under para 4.7 of HBP. under examinaƟon in their Department and he sought deferment for three weeks. The CommiƩee accordingly decided to defer the case for three weeks.
Case No.A‐584
M/S Associated Capsules Pvt. Ltd. MeeƟng No.17/08 F.No.01/83/50/805/AM’08/DES‐III RLA F.No.03/94/40/366/AM’08 Adv.Lic.No.0310436155 dated 13.07.2007 Cellulose Capsules under para 4.7 of HBP. No.35011/35/2007‐PI‐III dated 30.08.2007 decided to raƟfy 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: Hydroxy Propyl Methyl Cellulose Capsules‐‐‐‐‐‐‐‐‐‐‐1kg. (unprinted cellulose capsules) Import item: Hydroxy Propyl Methyl Cellulose‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.16kg (Cellulose Ether) Norms CommiƩee.
Case No.A‐585
M/S Granules India Ltd. MeeƟng No.17/08 F.No.01/83/50/393/AM’08/DES‐III RLA F.No.09/24/40/46/AM’08 Adv.Lic.No.0910030337 dated 24.05.2007 Compresso ANG90 (Metamizole Sodium Granules DC Grade 90%) under para 4.7 of HBP.
Case No.B‐237
M/S Alchem InternaƟonal Ltd. MeeƟng No.17/08 F.No.01/87/50/374/AM’06/DES‐III RLA F.No.05/24/40/241/AM’06 Adv.Lic.No.0510160970 dated 29.06.2005 Hyoscinen‐Butyl Bromide or Hyoscine Hydro Bromide under para 4.7 of HBP. The CommiƩee noted that in this case, norms were raƟfied under para 4.7 of HBP as per SION A‐263 and the firm has now sought two addiƟonal import items outside the SION. The CommiƩee aŌer deliberaƟon decided to maintain status quo.
Case No.B‐238
M/S Alchem InternaƟonal MeeƟng No.17/08 F.No.01/87/50/375/AM’06/DES‐III RLA F.No.05/24/40/242/AM’06 Adv.Lic.No.0510160970 dated 29.06.2005 Hyoscinen‐Butyl Bromide or Hyoscine Hydro Bromide under para 4.7 of HBP.
The CommiƩee noted that in this case, norms were raƟfied under para 4.7 of HBP as per SION A‐263 and the firm has now sought two addiƟonal import items outside the SION. The CommiƩee aŌer deliberaƟon decided to maintain status quo.
Case No.B‐239
M/S Cipla Ltd. MeeƟng No.17/08 F.No.01/82/50/1192/AM’04/DES‐III RLA F.No.03/24/40/2009/AM’04 Adv.Lic.No.0310245059 dated 01.01.2004 The CommiƩee considered the case as per agenda for amendment in the unit of quanƟty of import item under para 4.7 of HBP. The CommiƩee observed that the PI Division vide their wriƩen comments conveyed vide their U.O. No.35011/49/2005‐PI‐III has recommended Sulfamethazine @202gm per Kg., but inadvertently in the minutes the quanƟty has been shown as 200mg per pack. The CommiƩee aŌer deliberaƟon decided to amend the quanƟty of import item from 0.202mg/kg to 202gram/kg. Norms CommiƩee.
Case No.B‐240
M/S Cipla Ltd. MeeƟng No.17/08 F.No.01/82/50/1996/AM’05/DES‐III RLA F.No.03/24/40/2713/AM’05 Adv.Lic.No.0310320852 dated 10.03.2005 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for amendment in the descripƟon of import item under para 4.7 of HBP. The CommiƩee in consultaƟon with the representaƟve of PI Division present in the meeƟng decided to amend the descripƟon of import item from Beclomethasone Dipropionate to Budesomide.
Norms CommiƩee.
Case No.B‐241
M/S Adani Pharmachem Pvt. Ltd. MeeƟng No.17/08 F.No.01/87/50/474/AM’06/DES‐III RLA F.No.24/80/40/61/AM’06 Adv.Lic.No.2410014625 dated 26.07.2005 The CommiƩee considered the case as per agenda for amendment in import item under para 4.7 of HBP. The CommiƩee decided to transfer the case to DES‐IV as the export product pertains to Chemical Sector.
Case No.B‐242
M/S AarƟ Drugs Ltd. MeeƟng No.17/08 F.No.01/87/50/238/AM’07/DES‐III RLA F.No.03/94/40/361/AM’07 Adv.Lic.No.0310383220 dated 06.06.2006 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for amendment in the descripƟon of import item under para 4.7 of HBP. The representaƟve of DC(SSI) present in the meeƟng informed the CommiƩee that the case is under examinaƟon in their Department and he sought deferment for four weeks. The CommiƩee accordingly
Case No.B‐243
M/S Ariane Orgachem Pvt. Ltd. MeeƟng No.17/08 F.No.01/87/50/448/AM’07/DES‐III F.No.01/87/50/662/AM’07/DES‐III F.No.01/87/50/873/AM’07/DES‐III
F.No.01/87/50/1025/AM’05/DES‐III Adv.Lic.No.0310278686 dated 02.07.2004 0310300140 dated 10.08.2006 0310394009 dated 13.04.2005 0310405378 dated 24.10.2006 0310414730 dated 05.01.2007 The CommiƩee considered the case as per agenda for enhancement in the quanƟty of inputs under
para 4.7 of HBP.
The CommiƩee observed that the quanƟty of inputs as per all industry data has already been given to the firm, but they are seeking the quanƟty of inputs as per their own data. The CommiƩee aŌer deliberaƟon decided to maintain status quo.
Case No.B‐244
M/S Centaur Chemicals Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/50/875/AM’06/DES‐III RLA F.No.03/94/40/855/AM06 Adv.Lic.No.0310354691 dated 02.11.2005 The CommiƩee considered the case as per agenda for enhancement in the quanƟty of inputs under
para 4.7 of HBP.
The CommiƩee noted that the norms in this case were raƟfied as per SION A‐3358. The CommiƩee, therefore, decided to maintain status quo.
Case No.B‐245
M/S AarƟ Drugs Ltd. MeeƟng No.17/08 F.No.01/87/50/465/AM’07/DES‐III RLA F.No.03/94/40/277/AM06 RLA F.No.03/94/40/999/AM06 RLA F.No.03/94/40/201/AM07
RLA F.No.03/94/40/627/AM06 RLA F.No.03/94/40/933/AM07 Adv.Lic.No.030340050 dated 20.07.2005 Adv.Lic.No.0310365358 dated 01.02.2006 Adv.Lic.No.0310383693 dated 08.06.2006 Adv.Lic.No.0310399630 dated 15.09.2006 Adv.Lic.No.0310415187 dated 09.01.2007 The CommiƩee considered the case as per agenda for correcƟon in the descripƟon of import items under para 4.7 of HBP. The CommiƩee decided to allow amendment in the descripƟon of import items aŌer due verificaƟon as per details below; Sl.No. DescripƟon as per earlier decision of NC Amended descripƟon 1. Methane Sulphonide Chloride Methane Sulphonyl Chloride 2. Methyline dichloride Methylene Dichloride Norms CommiƩee.
Case No.B‐247
M/S Shilpa Medicare Ltd. MeeƟng No.17/08 F.No.01/87/50/1517/AM’06/DES‐III RLA F.No.07/24/40/1025/AM’06 Adv.Lic.No.0710043911 dated 23.03.2006 The CommiƩee considered the case as per agenda for raƟficaƟon of norms for the export product N‐ [B‐D‐Ribofuranosyl]‐5‐Hydroxyimidiazole‐4‐Carbosamide Technical Grade under para 4.7 of HBP.
Case No.B‐248
M/S Sun PharmaceuƟcal Industries MeeƟng No.17/08 F.No.01/87/50/271/AM’06/DES‐III RLA F.No.03/95/40/293/AM’06 Adv.Lic.No.0310333790 dated 09.06.2005 Carbamazepine Pure under para 4.7 of HBP. No.35011/267/2004‐PI‐III dated 30.08.2007 decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Sl.No. DescripƟon of Export Product QuanƟty 1. Carbamazepine BP (assay 98% to 102% by HPLC on anhydrous basis, single impurity not more than 0.1%, total impuriƟes not more than 0.5%) 1Kg. Import item: Sl.No. DescripƟon of import items QuanƟty allowed 1. Carbamazepine Crude (assay 97% to 102% by HPLC on anhydrous basis, single impurity not less than 0.2%, total impuriƟes not less than 1.0%) 1.02kg/kg. Norms CommiƩee.
Case No.B‐249
M/S Makson Industries Pvt. Ltd. MeeƟng No.17/08 F.No.01/82/50/433/AM’07/DES‐III RLA F.No.03/95/40/317/AM’07 Adv.Lic.No.0310386400 dated 23.06.2006 Vicks Veporub under para 4.7 of HBP.
The representaƟve of DC(SSI) present in the meeƟng informed the CommiƩee that the case is under examinaƟon in their Department and he sought deferment for four weeks. The CommiƩee accordingly
Case No.B‐250
Chemexcil, Mumbai MeeƟng No.17/08 F.No.01/82/54/1/AM’08/DES‐III The CommiƩee considered the case as per agenda for fixaƟon of value addiƟon for DEPB rate in respect of export product Menthol. The CommiƩee decided to transfer the case to DES‐IV as the export product pertains to Chemical Sector.
Case No.B‐251
M/S Lupin Ltd. MeeƟng No.17/08 F.No.01/82/162/285/AM’06/DES‐III The CommiƩee considered the case as per agenda for fixaƟon of value addiƟon for DEPB rate in respect of export product ‘3C7ACCA’. The CommiƩee decided to re‐examine the case on file.
Case No.B‐251A
F.No.01/82/50/433/AM’07/DES‐III MeeƟng No.17/08 The CommiƩee considered the case as per agenda for fixaƟon of value addiƟon for revision of DEPB rate in respect of export product ‘Atenolol BP/USP’.
The CommiƩee observed that there are six import items in the SION A‐79, but the cif value of four import items could be collected from the site eximkey.com. The CommiƩee decided that the case may be referred to DEPB CommiƩee as the cif value of two import items may be available with the Department of Revenue.
Case No.B‐251B
F.No.01/82/50/433/AM’07/DES‐III MeeƟng No.17/08 The CommiƩee considered the case as per agenda for fixaƟon of value addiƟon for revision of DEPB rate in respect of export product ‘Aminophylline’. The CommiƩee observed that SION for the above export product has already been deleted. The CommiƩee, therefore, decided to withdraw the case.
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