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 : 14/82ALC4/2007 MEETING DATE : 07.08.2007 1
Case No.:1/6/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:14/82ALC4/2007 07.08.2007 Status:Case Deferred HQ File :01/82/050/00389/AM04/ RLA File :09/24/040/00068/AM04/ Lic.No/Date:0910015288 05.08.2003 Defer Date:18.09.2007 Decision :The Committee considered the case as per agenda for ratification of norms of the export product under para 4.7 of HBP. The Committee decided to call for complete set of application alongwith technical details as per annexure, copy of DML and copy of Advance licence from the firm. The Case was accordingly deferred for six weeks. 2
Case No.:2/6/82ALC4/2007
Party Name:HINDUSTAN ANTIBIOTICS LTD 07.08.2007 Status:Case Deferred HQ File :01/82/050/00432/AM04/ RLA File :31/80/040/00163/AM04/ Lic.No/Date:3110012090 08.08.2003 Defer Date:18.09.2007 Decision :The Committee considered the case as per agenda for ratification of norms of the export product ‘Tables I.E. Potassium Phenoxymethyl Pencillin Tablets BP 250mg under para 4.7 of HBP. The Committee to call for complete set of application alongwith technical details as per annexure and copy of DML from the firm. The case was accordingly deferred for six weeks. 3
Case No.:2/35/82ALC1/2004
Party Name:MADHUR PHARMA & RESEARCH LABORATORIES PVT.LTD., 07.08.2007 Status:Case Deferred HQ File :01/82/050/01467/AM05/ RLA File :07/24/040/00492/AM05/ Lic.No/Date:0710034246 23.11.2004 Defer Date:18.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms of the export product Herpasil Capsules and Stimmune Capsules under para 4.7 of HBP. The Committee decided to remind Department of Ayush demi officially and to call for the complete set of application alongwith technical details as per annexure, copy of DML and copy of advance licence from the firm. The case was accordingly deferred for six weeks.
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Case No.:5/37/82ALC1/2005
Party Name:FDC LTD., 07.08.2007 Status:Case Deferred HQ File :01/82/050/00946/AM06/ RLA File :03/94/040/00798/AM06/ Lic.No/Date:0310356218 22.11.2005 Defer Date:18.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms of the export product Econazole Nitrate BP/JP/USP under para 4.7 of HBP. The Committee decided to call for complete set of application alongwith the technical details as per annexure and copy of DML from the firm. After receipt of the documents from the firm, the case may be put up in NC after six weeks. 5
Case No.:10/47/83ALC1/2005
Party Name:UNIMARK REMEDIES LIMITED., 07.08.2007 Status:Case Approved HQ File :01/83/050/00648/AM06/ RLA File :03/95/040/01126/AM06/ Lic.No/Date:0310365523 02.02.2006 Decision : The Committee considered the case as per agenda for ratification of norms of the export product Cefadroxil under para 4.7 of HBP. The Committee in light of Report forwarded by PI Division vide their U.O.35011/165/2006/PIIII dated 30.07.2007 decided to ratify the norms as per details below or as applied for by the firm whichever is lower. Export Product: Cefadroxil Monohydrate from Pen G Route1Kg. Import items: 1. Penicillin G Potassium 1st Crystal2.34BOU/Kg 2. Pyridine Hydrobromide0.320kg/kg OR Hydrobromic acid 48%0.375kg/kg 3. Hydrogen Peroxide 60%0.363kg/kg 4. Acetic Acid0.933kg/kg 5. Trimethyl chloro silane2.7027kg/kg OR 5(a). Bis trimethyl silyl urea1.543kg/kg 5(b). Hexamethyl disilazane0.3284kg/kg 6. Trimethyl chloro silane0.2180kg/kg 7. D()para hydroxy Phenyl glycine0.959kg/kg Methyl/etyl potassium dane salt
OR 7(a). D() para hydroxyl Phenyl glycine base0.5402kg/kg 7(b). Methyl Aceto acetate0.4113kg/kg 7©. Methanol0.3370kg/kg 8. Dimethyl formamide2.051kg/kg 9. Toluene0.583kg/kg 10. Acetone1.1498kg/kg 11. Methylene chloride0.407kg/kg 12. Potassium carbonate0.2418kg/kg 13. Activated Carbon0.0839kg/kg 14. Ethyl Chloro formate0.357kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 6
Case No.:1/35/83ALC1/2006
Party Name:SRINI PHARMACEUTICALS LTD., 07.08.2007 Status:Case Deferred HQ File :01/83/050/00557/AM07/ RLA File :09/24/040/00190/AM07/ Lic.No/Date:0910027254 22.08.2006 Defer Date:18.09.2007 Decision : The Committee considered the case as per agenda for ratification of norms of the export product Cefadroxil under para 4.7 of HBP. The Committee decided to forward the complete set of application to the Technical Authority for their comments. The case was accordingly deferred for six weeks. 7
Case No.:12/28/87ALC1/2006
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 07.08.2007 Status:Case Approved HQ File :01/87/050/00482/AM07/ RLA File :04/24/040/00047/AM07/ Lic.No/Date:0410083795 25.08.2006 Defer Date: Decision : The Committee considered the case as per agenda for ratification of norms of the export product 2Methyl Mercapto Phenothiazine under
para 4.7 of HBP.
The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006PIIII dated 07.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 2methyl Mercapto Phenothiazene1Kg. Import item: 3methyl Mercapto Aniline2.36kg/kg
RLA concerned may take further necessary action as per the above decision of Norms Committee. 8
Case No.:2/33/83ALC1/2006
Party Name:SRINI PHARMACEUTICALS LTD., 07.08.2007 Status:Case Approved HQ File :01/83/050/00646/AM07/ RLA File :09/24/040/00220/AM07/ Lic.No/Date:0910027505 11.09.2006 Decision : The Committee considered the case as per agenda for ratification of norms of the export product Methyl Alpha(4,5,6,7Tetrahydro5Thieno) 3,2C) Pyridyl)(2 Chlorophenyl) Acetate Hcl (CPG20) under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/125/2006PIIII dated 15.09.2006 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Methyl Alpha(4,5,6,7Tetrahydro5Thieno) 3,2C) Pyridyl)(2 Chlorophenyl) Acetate Hcl (CPG20) 1Kg. Import item: 1. Nbromo succinamide0.81kg/kg 2. 4,5,6,7 Tetrahydro theino) 3,2C Pyridine Hcl0.985kg/kg 3. MIBK3.75kg/kg 4. IPA0.50kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 9
Case No.:17/31/82ALC1/2006
Party Name:GLENMARK PHARMACEUTICALS LTD., 07.08.2007 Status:Case Deferred HQ File :01/82/050/00911/AM07/ RLA File :03/94/040/00615/AM07/ Lic.No/Date:0310399069 12.09.2006 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Terbinafine Hydrochloride Tablets 250mg 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, therefore, decided to defer the case for four weeks.
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Case No.:11/34/87ALC1/2006
Party Name:ALKALOIDS CORP 07.08.2007 Status:Case Deferred HQ File :01/87/050/00566/AM07/ RLA File :02/24/040/00189/AM07/ Lic.No/Date:0210094006 25.09.2006 Defer Date:18.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Senega Soft Extract under para 4.7 of HBP. The Committee decided to remind Department of Ayush demi officially for their comments. The case was accordingly deferred for six weeks. 11
Case No.:8/34/82ALC1/2006
Party Name:MAITHRI LABORATORIES (P) LTD., 07.08.2007 Status:Case Deferred HQ File :01/82/050/00998/AM07/ RLA File :09/24/040/00214/AM07/ Lic.No/Date:0910027658 25.09.2006 Defer Date:21.08.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Moxifloxacin 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, therefore, decided to defer the case for two weeks. 12
Case No.:9/34/82ALC1/2006
Party Name:MAITHRI LABORATORIES (P) LTD., 07.08.2007 Status:Case Deferred HQ File :01/82/050/00999/AM07/ RLA File :09/24/040/00177/AM07/ Lic.No/Date:0910027659 25.09.2006 Defer Date:21.08.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Moxifloxacin 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, therefore, decided to defer the case for two weeks. 13
Case No.:23/32/82ALC1/2006
Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, 07.08.2007 Status:Case Deferred HQ File :01/82/050/01100/AM07/ RLA File :03/94/040/00702/AM07/ Lic.No/Date:0310402829 06.10.2006 Defer Date:18.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product 1Phenyl Proponolamine Hcl (L Norephedrine Hcl under para 4.7 of HBP. The Committee decided to call for the technical details as per annexure from the firm. The Case was accordingly deferred for six weeks.
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Case No.:24/32/82ALC1/2006
Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, 07.08.2007 Status:Case Deferred HQ File :01/82/050/01101/AM07/ RLA File :03/94/040/00703/AM07/ Lic.No/Date:0310402830 06.10.2006 Defer Date:18.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product LNorephedrine Base under para 4.7 of HBP. The Committee decided to call for the technical details as per annexure from the firm. The Case was accordingly deferred for six weeks. 15
Case No.:27/30/83ALC1/2006
Party Name:SHILPA MEDICARE LTD., 07.08.2007 Status:Case Approved HQ File :01/83/050/00769/AM07/ RLA File :07/24/040/00428/AM07/ Lic.No/Date:0710047728 06.10.2006 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Aceclofenac EP under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/264/2006PIIII dated 18.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Aceclofenac BP1Kg. Import items: 1. Diclofenec Sodium1.11kg/kg 2. Tertiary Butanol0.61kg/kg 3. IPA3.77kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 16
Case No.:29/36/83ALC1/2006
Party Name:SHALINA LABORATORIES PVT. LTD. 07.08.2007 Status:Case Deferred HQ File :01/83/050/00841/AM07/ RLA File :03/95/040/00897/AM07/ Lic.No/Date:0310406100 31.10.2006 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Moxifloxacin 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 four weeks. The Committee, therefore, decided to defer the case for four weeks.
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Case No.:31/36/83ALC1/2006
Party Name:SRINI PHARMACEUTICALS LTD., 07.08.2007 Status:Case Approved HQ File :01/83/050/00857/AM07/ RLA File :09/24/040/00291/AM07/ Lic.No/Date:0910028095 03.11.2006 Defer Date: Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Clonazepam under para 4.7 of HBP. The Committee decided to ratify the norms under para 4.7 of HBP as per SION at Sl.No.A3358 or as applied by the firm whichever is lower. RLA concerned may take further necessary action as per the above decision of Norms Committee. 18
Case No.:4/43/83ALC1/2006
Party Name:SREENIVASA PHRAMA PVT LTD. 07.08.2007 Status:Case Deferred HQ File :01/83/050/00942/AM07/ RLA File :09/24/040/00163/AM07/ Lic.No/Date:0910028292 21.11.2006 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Cis2Bromo Methyl)2(2,4Dichloro Phenyl)4Methane Sulphonyl methyl1, 3dioxalane (CisBromo mesylate) 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, therefore, decided to defer the case for four weeks. 19
Case No.:12/41/80ALC2/2006
Party Name:BRAWN LABORATORIES LTD Meet No/Date:14/82ALC4/2007 07.08.2007 Status:Case Withdrawn HQ File :01/80/050/01003/AM07/ RLA File :05/24/040/00737/AM07/ Lic.No/Date:0510195559 04.12.2006 Decision :Withdrawn as the case has already been approved in the NC Meeting No.12/08 dated 27.07.2007. 20
Case No.:11/46/82ALC1/2006
Party Name:BIOLOGICAL E LTD 07.08.2007 Status:Case Approved HQ File :01/82/050/01533/AM07/ RLA File :09/24/040/00409/AM07/ Lic.No/Date:0910028883 04.01.2007 Defer Date: Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Noscapine Bulk under para 4.7 of HBP. The Committee perused the details furnished by the firm in their letter dated 6.6.07 and in consultation with the representative of PI present in the meeting decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower.
Export Product: Noscapine Bulk1Kg. ‘ Import item: Noscapine Crude1.01kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 21
Case No.:7/47/83ALC1/2006
Party Name:SURYA PHARMACEUTICAL LTD 07.08.2007 Status:Case Rejected HQ File :01/83/050/01170/AM07/ RLA File :05/24/040/00848/AM07/ Lic.No/Date:0510198449 25.01.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Cefpodoxime Proxetil under para 4.7 of HBP. The Committee noted that the firm has not submitted the technical details alongwith the application and therefore, it is not possible for the Committee to ratify the norms without technical details. The Committee, accordingly, decided to reject the case. RLA concerned may take further necessary action including cancellation of advance licence under para 4.7 of HBP. 22
Case No.:6/50/87ALC1/2006
Party Name:ALKEM LABORATORIES LTD., 07.08.2007 Status:Case Deferred HQ File :01/87/050/00967/AM07/ RLA File :03/94/040/01200/AM07/ Lic.No/Date:0310418737 07.02.2007 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Amoxycillin Clavulanate Potassium Tablet 375mg, 625mg and 1000mg 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, therefore, decided to defer the case for four weeks. 23
Case No.:4/1/83ALC1/2007
Party Name:VIJAY PERFUMES PVT.LTD. 07.08.2007 Status:Case Deferred HQ File :01/83/050/01214/AM07/ RLA File :03/95/040/01118/AM07/ Lic.No/Date:0310418795 08.02.2007 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product NMethyl Benzothiazene Methyl Ester 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, therefore, decided to defer the case for four weeks. 24
Case No.:1/10/82ALC4/2007
Party Name:HAFFKINE BIO PHARMACEUTICAL CORPN LTD 07.08.2007 Status:Case Deferred HQ File :01/82/050/01645/AM07/ RLA File :03/94/040/01208/AM07/ Lic.No/Date:0310419601 14.02.2007 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Oral Polio Vaccine (OPV) under para 4.7 of HBP. The Committee decided to forward complete set of application to Department of Biotechnology for their comments. Accordingly, the case was deferred for four weeks. 25
Case No.:3/2/82ALC4/2007
Party Name:DR REDDYS LABORATORIES LTD 07.08.2007 Status:Case Deferred HQ File :01/82/050/01756/AM07/ RLA File :09/24/040/00382/AM07/ Lic.No/Date:0910029552 06.03.2007 Defer Date:04.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product 2(6Methoxy2naphthyl)propionie acid (DLAcid) 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, therefore, decided to defer the case for four weeks. 26
Case No.:7/2/82ALC4/2007
Party Name:CIPLA LIMITED 07.08.2007 Status:Case Deferred HQ File :01/82/050/01804/AM07/ RLA File :03/94/040/01443/AM07/ Lic.No/Date:0310422972 13.03.2007 Defer Date:21.08.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets 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, therefore, decided to defer the case for two weeks. 27
Case No.:4/10/82ALC4/2007
Party Name:MSN PHARMACHEM 07.08.2007 Status:Case
PRIVATE LIMITED Deferred HQ File :01/82/050/01807/AM07/ RLA File :09/24/040/00422/AM07/ Lic.No/Date:0910029669 14.03.2007 Defer Date:21.08.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Moxifloxacin 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, therefore, decided to defer the case for two weeks. 28
Case No.:5/10/82ALC4/2007
Party Name:GLAXOSMITHKLINE PHARMACEUTICALS LIMITED, 07.08.2007 Status:Case Deferred HQ File :01/82/050/01887/AM07/ RLA File :03/94/040/00324/AM06/ Lic.No/Date:0310424628 27.03.2007 Defer Date:18.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Betamethasone DiSodium Phosphate BP/USP 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, therefore, decided to defer the case for six weeks. 29
Case No.:1/14/82ALC4/2007
Party Name:TTK LIG LIMITED 07.08.2007 Status:Transferred to Different Section HQ File :01/82/050/00108/AM08/ RLA File :04/24/040/00107/AM08/ Lic.No/Date:0410090218 09.07.2007 Defer Date: Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Durex Play Longer under para 4.7 of HBP. The Committee decided to transfer the case to DESVIII as the exports product pertains to Plastic Sector. 30
Case No.:2/14/82ALC4/2007
Party Name:NECTAR LIFESCIENCES LIMITED, 07.08.2007 Status:Case Deferred HQ File :01/82/050/00116/AM08/ RLA File :22/24/040/00018/AM08/ Lic.No/Date:2210006897 17.07.2007 Defer Date:18.09.2007 Decision : The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product Cefdinir 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, therefore, decided to defer the case for six weeks.
Date:08.08.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer Minutes of the Norms Committee Meeting No.14/08 held on 07.08.2007 under the Chairmanship of Shri Sanjay Rastogi, Export Commissioner. The Committee first considered the minutes of the NC Meeting No.13/08 held on 31.07.2007 for confirmation and confirmed and adopted the same. The Committee considered each case as per agenda.
Case No.A409
M/S Prachi Pharmaceuticals Pvt. Ltd, Mumbai N.C. Meeting No.14/08 F.No.01/83/50/709/AM’08/DESIII Meeting date: 07.08.2007 RLA F.No.03/95/40/308/AM08 Adv.Lic.No.0310435714 dated 11.07.2007 The Committee considered the case as per agenda for ratification of norms for the export product Thiamine Hcl BP/USP 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, therefore, decided to defer the case for six weeks.
Case No.A410
M/S Merck Ltd F.No.01/82/50/1/AM’08/DESIII RLA F.No.03/95/40/152/AM08 Adv.Lic.No. Under para 4.4.2 of HBP The Committee considered the case as per agenda for fixation of norms for the export product DLAlpha Tocopheryl Acetate USP (Vitamin E Acetate USP) under para 4.4.2 of HBP. The Committee in light of its earlier decision taken in its 30/82 meeting held on 08.11.2006 vide case no.10/27/82, decided to ratify the norms under para 4.7 of HBP as applied by the firm. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A411
M/S Nicholas Piramal India Ltd F.No.01/83/50/249/AM’07/DESIII RLA F.No.03/95/40/1474/AM06 Adv.Lic.No.0310382972 dated 02.06.2006 The Committee considered the case as per agenda for correction in the import item under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/226/2005PIIII dated 28.02.2007 decided to allow amendment in the import item at Sl.No.3 from Citral to Betaionone under para 4.7 of HBP. All other norms fixed by the Norms Committee shall remain the same. RLA concerned may take further necessary action as per above decision of Norms Committee.
Case No.A412
M/S Neuland Laboratories Ltd F.No.01/83/50/1047/AM’07/DESIII RLA F.No.09/24/40/361/AM07 Adv.Lic.No.0910028737 dated 11.07.2007 the export product Levetiracetam under para 4.7 of HBP.
Case No.A413
M/S Lupin Ltd F.No.01/82/50/119/AM’08/DESIII RLA F.No.03/95/40/293/AM08 Adv.Lic.No.0310433980 dated 26.06.2007 the export product Sterile Ceftriaxone Sodium 1MG/2MG/250MG Injection under para 4.7 of HBP.
Case No.A414
M/S Matrix Ltd F.No.01/82/50/125/AM’08/DESIII
RLA F.No.09/24/40/455/AM08 Adv.Lic.No.0910030195 dated 07.05.2007 the export product Nelfinavir Mesylate under para 4.7 of HBP.
Case No.A415
M/S IndSwift Laboratories Ltd F.No.01/83/50/466/AM’08/DESIII RLA F.No.22/24/40/11/AM08 Adv.Lic.No.2210006765 dated 05.06.2007 the export product Clarithromycin Granules 33% (Suspension Grade) under para 4.7 of HBP. The Committee in light of earlier decision taken by the Norms Committee in its 8/82ALC1/2006 held on 24.05.2006 vide case No.1/8/82ALC1/2006, decided to ratify the norms for the export product under para 4.7 of HBP as per details below or as applied by the firm which ever is lower. Export product Clarithromycin Granules 33% (Suspension Grade)1kg Import items 1. Clarithromycin0.3333kg OR its raw material as per SION A2263 on prorata basis. 2. Carbopol0.25kg 3. HPMC Phthalate0.44kg
RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A416
M/S Nicholas Piramal India Ltd F.No.01/82/50/2/AM’08/DESIII RLA F.No.03/95/40/244/AM08 Adv.Lic.No.Under para 4.4.2 of HBP The Committee considered the case as per agenda for fixation of norms for the export product Thiamine Hcl BP/USP under para 4.4.2 of HBP. The Committee decided to forward the complete set of application to Department of BioTechnology for their comments. Accordingly, the case was deferred for six weeks.
Case No.A417
M/S Ranbaxy Lab. Ltd. F.No.01/82/50/97/AM’08/DESIII RLA F.No.05/24/40/36/AM08 Adv.Lic.No.0510202774 dated 20.04.2007 the export product Ciprofloxacin Tablet under para 4.7 of HBP. that the case is under examination in their Department and he sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.
Case No.A418
M/S Shantha Biotech Ltd. F.No.01/82/50/30/AM’08/DESIII RLA F.No.09/24/40/366/AM07 Adv.Lic.No.0910028896 dated 05.01.2007 the export product Hepatitis BVaccine Human Bodies under para 4.7 of HBP. The Committee in light of written comments forwarded by Department of Bio Technology vide their letter No.BT/IL/05/165/2004PIDdated 11.07.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Hepatitis B Vaccine Human Bodies1Kg. Import items: ConsumablesAs per policy Packing materialAs per packing policy. Testing KitsNet to Net with accountability clause Balance itemswith 5% wastage
Case No.A419
M/S Sheetal Pharma F.No.01/82/50/2525/AM’08/DESIII RLA F.No.03/95/40/408/AM07 Adv.Lic.No.0310390246 dated 19.07.2006 the export product Paracetamol 500mg under para 4.7 of HBP.
The Committee noted that the firm was requested to furnish the copy of DML and Master Batch Formula duly certified by Quality Control Incharge vide letter dated 26.06.2007, but the firm has not responded so far. In view of the decision taken in Senior Officers Meeting held on 31.07.07, it was decided not to reject the case and on the basis of information available, the Committee, therefore, decided to ratify the norms under para 4.7 of HBP allowing only one item as per details below; Export Product: Paracetamol Tablet 500 mg1No. Import item: Paracetamol510mg/tablet
Case No.A420
M/S Shiva Pharmachem Pvt. Ltd. F.No.01/82/50/1302AM’07/DESIII RLA F.No.34/24/40/257/AM07 Adv.Lic.No.3410018220 dated 01.03.2007 the export product nValeryl Chloride under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.
Case No.A421
M/S Wockhardt Ltd F.No.01/82/50/155/AM’08/DESIII RLA F.No.03/95/40/44/AM08 Adv.Lic.No.0310427335 dated 19.04.2007 the export product Hydroxocobalamin Acetate Hcl under para 4.7 of HBP.
Case No.A422
M/S Ranbaxy Laboratories Ltd. F.No.01/82/50/1134/AM’07/DESIII RLA F.No.05/24/40/819/AM07 Adv.Lic.No.0510197930 dated 16.01.2007 the export product Ciprofloxacin Tablet USP 250mg, 500mg and 750mg under para 4.7 of HBP. four weeks. The Committee, therefore, decided to defer the case for four weeks.
Case No.A423
M/S Ranbaxy Laboratories Ltd. F.No.01/82/50/107/AM’08/DESIII RLA F.No.05/24/40/17/AM08 Adv.Lic.No.0310435714 dated 11.07.2007 the export product Isotretinoin under para 4.7 of HBP.
Case No.A424
M/S RA Chem Pharma Ltd. F.No.01/82/50/1238/AM’07/DESIII RLA F.No.09/24/40/404/AM07 Adv.Lic.No.0910029307 dated 12.02.2007 the export product 2,3Di Chloro Benzoyl Cyanide under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/66/2007PIIII dated07.08.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 2,3 Dichloro benzoyl cyanide1Kg. Import items: 1. 2,3 dichloro benzoyl chloride1.50kg/kg 2. Cuprous Cyanide0.70kg/kg 3. Hexane1.00kg/kg 4. Ortho dichloro benzeneNot allowed
Case No.A425
M/S Cadila Healthcare Ltd. F.No.01/82/50/123/AM’08/DESIII RLA F.No.08/24/40/90/AM08 Adv.Lic.No.0810065759 dated 04.07.2007 the export product Atenolol 25mg, 50mg and 100mg Tablet under para 4.7 of HBP.
Case No.A426
M/S Cadila Health Care Ltd. F.No.01/82/50/122/AM’08/DESIII RLA F.No.08/24/40/91/AM08 Adv.Lic.No.0810065758 dated 04.07.2007 the export product Carvedilol Tablets under para 4.7 of HBP.
Case No.A427
M/S Glenmark Pharmaceutical Ltd F.No.01/82/50/120/AM’08/DESIII RLA F.No.03/94/40/270/AM08 Adv.Lic.No.0310435339 dated 06.07.2007 the export product Glimepirid under para 4.7 of HBP. The Committee on the recommendation of the representative of PI Division present in the meeting decided to ratify the Norms under para 4.7 of HBP as per written comments forwarded by PI Division vide their U.O. No.35011/378/2003PIIII dated 08.12.2003 or as applied for whichever is less.
Export Product: Gilimepride1Kg. Import items: 1. 4(23Ethyl4Methyl2 Oxo3Pyrroline1Carboxamido Ethyl Phenyl Sulfonamide)0.96Kg/Kg. 2. Trans4Methyl Cyclohexyl Isocyanate0.39Kg/Kg. 3. Acetone2.50Kg/Kg. 4. Methanol2.50Kg/Kg. 5. TolueneNot required in the process(Not allowed)
Case No.A428
M/S Cipla Ltd. F.No.01/82/50/121/AM’08/DESIII RLA F.No.03/94/40/355/AM08 Adv.Lic.No.0310435675 dated 10.07.2007 the export product Sulfacox Powder under para 4.7 of HBP. The Committee decided to call for the copy of DML from the firm and also to forward the copy of application alongwith copy of DML to the technical authority for their comments. Accordingly, the case was deferred for six weeks.
Case No.A429
M/S Cipla Ltd. F.No.01/82/50/128/AM’08/DESIII RLA F.No.03/94/40/166/AM08 Adv.Lic.No.0310432617 dated 14.06.2007
the export product Maxima Powder under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O. No.35011/49/2005PIIII dated 21.11.2006 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is lower. Export Product: Maxima Powder (Pack size 10Lbs=4.54kgs) Containing Glucosamine Hydrochloride Net wt. 247.636kgs Sodium Chondroitin Sulphate Net wt. 82.545kgs Manganese (as Manganese Sulphate) net wt. 2.201kgs Ascorbic Acid (as Calcium Ascorbate) Net wt. 14.308kgs. Import items: 1. Glucosamine hcl2.497kg/pack of 4.54kg 2. Sodium chondroitin sulphate0.8172kg/pack of 4.54kg 3. Manganese0.0110kg/pack of 4.54kg 4. Ascorbic acid0.1443kg/pack of 4.54kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A430
M/S Aurobindo Pharma Ltd. F.No.01/82/50/127/AM’08/DESIII RLA F.No.09/24/40/469/AM08 Adv.Lic.No.0910030086dated 24.04.2007 the export product Sterile Ampicillin Sodium under para 4.7 of HBP.
Case No.A431
M/S Granules India Ltd. F.No.01/82/50/125/AM’08/DESIII RLA F.No.09/24/40/456/AM07 Adv.Lic.No.0910029318 dated 13.02.2007 the export product Phenazopyridine Hydrochloride Dc Grade 68% (Compresso PPY 68) under para 4.7 of HBP. The Committee in light of the earlier decision taken by the Norms Committee in its 7/82ALC1/2006 held on 17.05.2006 case No.4/40/82ALC1/2005 decided to ratify the nors under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Phenazopyridine Hcl DC Grade 68% (Compresso PPY 68)1Kg. Import items: 1. Phenazopyridine Hcl0.68kg/kg 2. Starch Pregelatinised0.083kg/kg 3. Maize Starch0.0428kg/kg 4. Povidone K300.0098kg/kg 5. Croscarmellose Sodium0.0244kg/kg 6. Microcrystalline Cellulose0.0977kg/kg 7. Magnesium Stearate0.0049kg/kg
Case No.A432
M/S Cadila Healthcare Ltd. F.No.01/82/50/126/AM’08/DESIII RLA F.No.08/24/40/87/AM08
Adv.Lic.No.0810065592 dated 26.06.2007 the export product Benzonatate 100 mg Capsules under para 4.7 of HBP. two weeks. The Committee, therefore, decided to defer the case for two weeks.
Case No.A433
M/S Camphor & Allied Products Ltd. F.No.01/83/50/747/AM’08/DESIII RLA F.No.03/94/40/274/AM08 Adv.Lic.No.0310433529 dated 22.06.2007 the export product Camphor USP under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.
Case No.A434
F.No.01/87/50/882/AM’07/DESIII RLA F.No.09/24/40/412/AM06 Adv.Lic.No.0810065592 dated 26.06.2007 the export product Cloxacillin Sodium (From 6APA Route) under para 4.7 of HBP. The Committee in light of the report of the Deptt. of C&PC forwarded vide their U.O.No.35011/165/2006/PIIII(PartIV) 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 Stage1kg Import items 1. 6APA0.490kg 2. Acetone0.0034kg 3. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CKIC Chloride)0.62kg OR 3.a) Ochloro Benzaldehyde0.5034kg 3.b) Hydroxyl Amine Sulphate0.3192kg 3.c) Methyl Acetoacetate0.410kg 3.d) Chloroform0.270kg 3.e) Methylene chloride0.0542kg 4. Methylene chloride/Ethyl Acetate0.620kg 5. 2Ethyl Hexanoic Acid0.150kg
Case No.A435
F.No.01/82/50/1082/AM’07/DESIII RLA F.No.09/24/40/510/AM07 Adv.Lic.No.0910029551 dated 06.03.2007 the export product Nevirapine (From DMF Route) under para 4.7 of HBP.
Case No.A436
M/S Alembic Ltd. F.No.01/82/50/48/AM’08/DESIII RLA F.No.34/24/40/1/AM08 Adv.Lic.No.3410018493 dated 05.04.2007 the export product Leflunomide under para 4.7 of HBP.
Case No.A437
M/S Anuh Pharma Ltd. F.No.01/82/50/1122/AM’07/DESIII RLA F.No.03/94/40/1299/AM07 Adv.Lic.No.0310423834 dated 21.03.2007 the export product Clobetasol Propionate BP under para 4.7 of HBP. The Committee in light of its earlier decision in the meeting No.06/AM07 held on 10.05.2006 vide Case No.A70 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Clobetasol Propionate BP1Kg. Import item: Betamethasone base BP1.19kg/kg
Case No.A438
M/S Envee Drugs Pvt. Ltd. F.No.01/82/50/143/AM’08/DESIII RLA F.No.34/24/40/296/AM07 Adv.Lic.No.3410018601 dated 18.04.2007 the export product Betamethasone Valerate BP/USP under para 4.7 of HBP. weeks. The Committee, therefore, decided to defer the case for six weeks.
Case No.A439
F.No.01/82/50/986/AM’07/DESIII RLA F.No.09/24/40/302/AM07 Adv.Lic.No.0910029299 dated 12.02.2007 the export product Stavudine under para 4.7 of HBP.
Case No.A440
M/S Aarti Drugs Ltd. F.No.01/82/50/169/AM’08/DESIII RLA F.No.03/94/40/46/AM08 Adv.Lic.No.0310427426 dated 20.04.2007 the export product Diclofenac Sodium under para 4.7 of HBP.
Case No.A441
F.No.01/82/50/1135/AM’07/DESIII RLA F.No.09/24/40/522/AM07 Adv.Lic.No.0910029746 dated 23.03.2007 the export product Citalopram Hydrobromide (From DMF Route) under para 4.7 of HBP.
Case No.A442
F.No.01/82/50/141/AM’08/DESIII RLA F.No.09/24/40/1/AM08 Adv.Lic.No.0910030047 dated 18.04.2007
the export product Abacavir Sulfate (From DMF Route) under para 4.7 of HBP.
Case No.A443
F.No.01/82/50/987/AM’07/DESIII RLA F.No.09/24/40/451/AM07 Adv.Lic.No.0910029300 dated 12.02.2007 the export product Ampicillin Sodium Sterile under para 4.7 of HBP.
Case No.A444
F.No.01/82/50/1000/AM’07/DESIII RLA F.No.09/24/40/355/AM07 Adv.Lic.No.0910029746 dated 23.03.2007 the export product Quetiapine Fumerate under para 4.7 of HBP.
Case No.A445
M/S Alembic Ltd. F.No.01/82/50/37/AM’08/DESIII RLA F.No.34/24/40/290/AM07 Adv.Lic.No.3410018404 dated 23.03.2007 the export product Azithromycin Crude under para 4.7 of HBP.
Case No.A446
M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/108/AM’08/DESIII RLA F.No.03/94/40/16/AM08 Adv.Lic.No.0310426673 dated 13.04.2007 the export product Nateglinide under para 4.7 of HBP. two weeks. The Committee, therefore, decided to defer the case for two weeks.
Case No.A447
M/S Alembic Ltd.
F.No.01/82/50/244/AM’08/DESIII RLA F.No.34/24/40/22/AM08 Adv.Lic.No.3410018712 dated 03.05.2007 the export product Venlafaxine Hcl under para 4.7 of HBP.
Case No.A448
M/S Alliance Laboratories Pvt. Ltd. F.No.01/82/50/424/AM’08/DESIII RLA F.No.03/94/40/160/AM08 Adv.Lic.No.0310430399 dated 23.05.2007 the export product Iso Sorbide5Mononitrate under para 4.7 of HBP.
Case No.A449
M/S Acacia Life Science Pvt. Ltd. F.No.01/82/50/1086/AM’07/DESIII RLA F.No.09/24/40/492/AM07 Adv.Lic.No.0910029581 dated 08.03.2007 the export product (3Z)4(Aminomethyl)3PyrrolidinoneOMethyloxime
Hydrochloride under para 4.7 of HBP.
Case No.A450
M/S Astrix Laboratories Ltd. F.No.01/82/50/792/AM’07/DESIII RLA F.No.09/24/40/440/AM07 Adv.Lic.No.0910029251 dated 08.02.2007 the export product Lamivudine (Cyclohexyl Ester Route) under para 4.7 of HBP.
Case No.A451
M/S Vivin Laboratories Pvt. Ltd. F.No.01/82/50/275/AM’08/DESIII RLA F.No.09/24/40/39/AM08 Adv.Lic.No.0910029746 dated 23.03.2007 the export product 5OBenzoyl3Mesyl2,2 Anhydro5Methyl Uridine under para 4.7 of HBP.
Case No.A452
M/S Vivin Laboratories Pvt. Ltd. F.No.01/82/50/273/AM’08/DESIII RLA F.No.09/24/40/444/AM07 Adv.Lic.No.0910030207 dated 08.05.2007 the export product Menthyl5SCytosine1YL1,3Oxathiolane2R Carboxalate (Lamuvudine Intermediate StateIII) under para 4.7 of HBP.
Case No.A453
M/S Vivin Laboratories Pvt. Ltd. F.No.01/82/50/274/AM’08/DESIII RLA F.No.09/24/40/43/AM08 Adv.Lic.No.0910030208 dated 08.05.2007 the export product Menthyl5SCytosine1YL1,3Oxathiolane2R Carboxalate (Lamuvudine Intermediate StateIII) under para 4.7 of HBP.
Case No.A454
M/S Vivimed Labs Ltd. F.No.01/82/50/1192/AM’07/DESIII RLA F.No.09/24/40/449/AM07 Adv.Lic.No.0910030207 dated 08.05.2007 the export product Avis (Avo Benzone)under para 4.7 of HBP. that the export product is used in the Cosmetics and therefore it can not be treated as Pharma Product. The Committee, therefore, decided to transfer the case to DESIV.
Case No.A455
M/S Vivimed Labs Ltd. F.No.01/82/50/387/AM’08/DESIII RLA F.No.09/24/40/60/AM08 Adv.Lic.No.0910030333 dated 24.05.2007 the export product Avis (Avo Benzone) under para 4.7 of HBP. that the export product is used in the Cosmetics and therefore it can not be treated as Pharma Product. The Committee, therefore, decided to transfer the case to DESIV.
Case No.A456
M/S Smilax Laboratories Ltd. F.No.01/82/50/1268/AM’07/DESIII RLA F.No.09/24/40/478/AM07 Adv.Lic.No.0910029428 dated 22.02.2007 the export product {35[Bromo1(Flurophenyl)(1,3dihydro
isobenzofuranyl)]propyl}dimehylamine Oxalate under para 4.7 of HBP.
Case No.A457
M/S RA Chem Pharma Ltd F.No.01/82/50/1366/AM’07/DESIII RLA F.No.09/24/40/521/AM07 Adv.Lic.No.0910029766 dated 23.03.2007 the export product Mebeverine Hcl under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/206/2005PIIII dated 07.08.2007 decided to ratify the norms under
para 4.7 of HBP as per details below or as applied by the firm whichever is lower.
Export product: Mebeverine Hcl1Kg. Import item: 1. 2chloromethyl Propionate0.66kg/kg 2. Veratric acid0.56kg/kg 3. Methyl Isobytyl ketone0.51Lts/kg 4. 1,4dibromo Butane0.84kg/kg
Case No.A458
M/S Smilax Laboratories Ltd.
F.No.01/82/50/1203/AM’07/DESIII RLA F.No.09/24/40/466/AM07 Adv.Lic.No.0910029229dated 07.02.2007 the export product 5Methoxy2((4Methoxy3,5Dimethyl2Pyridinyl)Methyl]ThioIH Benzimidazole under para 4.7 of HBP.
Case No.A459
M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/102/AM’08/DESIII RLA F.No.03/94/40/12/AM’08 Adv.Lic.No.0310426504 dated 12.04.2007 the export product Avis Imiquimod under para 4.7 of HBP. two weeks. The Committee, therefore, decided to defer the case for two weeks.
Case No.B199
M/S IPCA Labs Ltd. F.No.01/82/50/1327/AM’07/DESIII RLA F.No.03/94/40/924/AM07 Adv.Lic.No.0310409045 dated 22.11.2006
The Committee considered the case as per agenda for correction in the description of item of import from Seasamol to Sesamol under para 4.7 of HBP. The Committee decided to allow correction in the description of import item from Seasamol to Sesamol after due verification. The Committee also decided to reject the request of the firm for enhancement in the quantity of inputs as the norms were ratified on the basis of written comments forwarded by PI Division.
Case No.B200
M/S IPCA Labs Ltd. F.No.01/82/50/966/AM’07/DESIII RLA F.No.03/94/40/662/AM07 Adv.Lic.No.0310400231 dated 20.09.2006 The Committee considered the case as per agenda for correction in the description of item of import No.1 from Diclosenec Sodium to Diclofenac Sodium and in the description of item of import No.2 from Tertiary butyl chloro acetate to Tertery butyl chloro acetate under para 4.7 of HBP. The Committee decided to allow correction in the description of import item No.1 from Diclofenec Sodium to Diclofenac Sodium after due verification. The Committee also decided to reject the request for correction in the import item No.2 as the correct chemical name of the item is Tertiary butyl chloro acetate which has been given by the firm in their chemistry.
Case No.B201
M/S IPCA Labs Ltd. F.No.01/82/50/1073/AM’07/DESIII
RLA F.No.03/94/40/537/AM07 Adv.Lic.No.0310396795 dated 28.08.2006 The Committee considered the case as per agenda for amendment in the description of export product from Morantel Citrate to Aceclofenac under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/264/2006PIIII dated 18.04.2007 decided to ratify the norms under
para 4.7 of HBP as per details below or as applied by the firm whichever is lower.
Export product: Aceclofenac BP1Kg. Import items: 1. Diclofenec Sodium1.11kg/kg 2. Tertiary butyl chloro acetate0.52kg/kg 3. Dimethyl formamide0.60kg/kg 4. Toluene3.17kg/kg
Case No.B202
M/S IndSwift Laboratories Ltd. F.No.01/82/50/1131/AM’07/DESIII RLA F.No.22/24/40/261/AM07 Adv.Lic.No.2210006123 dated 11.10.2006 The Committee considered the case as per agenda for allowing input ‘L(+)Tartaric Acid’ under para 4.7 of HBP.
Case No.B203
M/S Shilpa Medicare Ltd. F.No.01/83/162/570/AM’07/DESIII RLA F.No.07/24/40/146/AM03 Adv.Lic.No.0710014440 dated 20.06.2002 The Committee considered the case as per agenda for enhancement in the quantity of input under para 4.7 of HBP. The Committee noted that the licence is old one issued on 20.06.2002 and therefore it is not possible for the Committee to allow any amendment against such licence. The Committee, therefore, decided to maintain status quo.
Case No.B204
M/S Sandoz (P) Ltd F.No.01/83/50/820/AM’07/DESIII RLA F.No.03/95/40/735/AM07 Adv.Lic.No.0310405563 dated 26.10.2006 The Committee considered the case as per agenda for enhancement in the quantity of input and allowing the 2nd input under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/238/2006PIIII dated 08.01.2007 decided to allow import of additional item as per details below; 1Amino4methyl Piperazine0.16kg/kg
Case No.B205
M/S Shalina Laboratories Ltd. F.No.01/83/50/1083/AM’07/DESIII RLA F.No.03/95/40/1164/AM’07 Adv.Lic.No.0310414237 dated 02.01.2007 the export product Epiderm Lotion 30ml under para 4.7 of HBP.
Case No.B206
M/S Shalina Laboratories Ltd. F.No.01/83/50/1084/AM’07/DESIII RLA F.No.03/95/40/1163/AM’07 Adv.Lic.No.0310414239 dated 02.01.2007 the export product Bitasol Lotion 30ml under para 4.7 of HBP.
Case No.B207
M/S Aarti Drugs Ltd. F.No.01/87/50/767/AM’06/DESIII RLA F.No.03/94/40/414/AM’04 Adv.Lic.No.0310347752 dated 16.09.2005
The Committee considered the case as per agenda for allowing the input Potassium Hydroxide under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/178/2006PIIII dated 20.07.2007 decided to allow one additional import item as per details below; Potassium Hydroxide0.400kg/kg
Case No.B208
M/S Glenmark Pharmaceuticals Ltd. F.No.01/83/162/207/AM’08/DESIII RLA F.No.03/94/40/789/AM’04 Adv.Lic.No.0310217859 dated 11.08.2003 the export product Cilostazol under para 4.7 of HBP. The Committee decided to call for the copy of application alongwith the decision of NC, if any from RLA. Accordingly, the case was deferred for six weeks.
Case No.B209
M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/162/154/AM’08/DESIII RLA F.No.03/94/40/1857/AM’04 Adv.Lic.No.0310414237 dated 02.01.2007 the export product Amiodrone under para 4.7 of HBP.
The Committee decided to call for the copy of application alongwith the decision of NC, if any from RLA. Accordingly, the case was deferred for six weeks.
Case No.B210
M/S Lupin Ltd. F.No.01/83/50/1604/AM’07/DESIII RLA F.No.03/95/40/1237/AM’07 Adv.Lic.No.0310415404 dated 10.01.2007 The Committee considered the case as per agenda for correction in the description of import item No.2 and 9 under para 4.7 of HBP.
Case No.B211
M/S Lupin Ltd. F.No.01/83/50/1458/AM’07/DESIII RLA F.No.03/95/40/1145/AM’07 Adv.Lic.No.0310414237 dated 02.01.2007 The Committee considered the case as per agenda for correction in the description of import item No.12 under para 4.7 of HBP.
Case No.B212
M/S Savers Impex, Thane F.No.01/85/162/102/AM’08/DESIII RLA F.No.03/95/40/41/AM’08 Adv.Lic.No.0310428179 dated 27.04.2007 the export product Vitamin Mineral Premix Savit for Flour Fortification under para 4.7 of HBP. The Committee noted that no DML has been issued to the firm and therefore the export product is not a pharmaceutical product. The Committee, therefore, decided to transfer the case to DESVI.
Case No.B213
M/S IndSwift Laboratories Ltd F.No.01/82/50/882/AM’06/DESIII RLA F.No.22/24/40/16/AM’06 Adv.Lic.No.2210004954 dated 27.10.2005 The Committee considered the case as per agenda for correction in the item of import from 2Acetyloxy Benzoic acid (Asprin) to Acetyloxy Benezoic acid (Asprin). The Committee noted that the norms was fixed in this case as per Chemistry. The Committee, therefore, decided to reject the case.
Case No.B214
M/S IndSwift Laboratories Ltd. F.No.01/82/50/119/AM’07/DESIII RLA F.No.22/24/40/09/AM07 Adv.Lic.No.2210005475 dated 26.04.2006 The Committee considered the case as per agenda for correction in the item of import from 2Acetyloxy Benzoic acid (Asprin) to Acetyloxy Benezoic acid (Asprin).
The Committee noted that the norms was fixed in this case as per Chemistry. The Committee, therefore, decided to reject the case.
Case No.B215
M/S IndSwift Laboratories Ltd. F.No.01/82/50/179/AM’07/DESIII RLA F.No.22/24/40/18/AM07 Adv.Lic.No.2210005501 dated 04.05.2006 The Committee considered the case as per agenda for modification of norms for the export product Clopidogrel Hydrogen Sulphate under para 4.7 of HBP. The Committee decided to forward a copy of application to the technical authority for their comments. The case was accordingly deferred for six weeks.
Case No.B216
M/S IndSwift Laboratories Ltd. F.No.01/82/50/1130/AM’07/DESIII RLA F.No.22/24/40/262/AM07 Adv.Lic.No.2210006122 dated 11.10.2006 The Committee considered the case as per agenda for correction in the items of import under para 4.7 of HBP. The Committee decided to allow corrections in the imports items after due verification as per details below; Sl.No. Earlier Description Amended Description 1. 4chloro bytyryl 4Chloro butyryl Chloride 2. Tonuene Toluene 3. Methylene dichloride Methylene chloride
RLA concerned may take further necessary action as per above decision of Norms Committee. Norms Committee Meeting No.14/08 dated 07.08.2007 Outside Agenda: The Committee also considered the report forwarded by PI Division vide their U.O. No.35011/274/2006 PIIII dated 20.07.2007 in which PI Division have recommended the following norms in respect of the export product “Ampicillin Anhydrous from Pen G route. Export Product: Ampicillin Anhydrous from Pen G Route1Kg. Import items: 1. Penicillin G Potassium 1st Crystal2.088BOU/kg 2. Pivaloyl chloride0.42kg/kg 3. Triethylamine0.0239kg/kg 4. Methylene chloride1.50kg/kg 5. D()Alpha Phenyl glycine Base0.500kg/kg 6. Pen. G Amidase (Enzyme)1.078gm/kg 7. Ethyl Aceto acetate0.45kg/kg 8. Isopropyl Alcohol1.21kg/kg 9. Pot. Carbonate0.235kg/kg The Committee decided to accept the recommendation of PI Division and to fix the SION in respect of the above export product.
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