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 : 8/82ALC4/2007 MEETING DATE : 28.06.2007 1
Case No.:5/37/82ALC1/2005
Party Name:FDC LTD., Meet No/Date:8/82ALC4/2007 28.06.2007 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:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Econazole Nitrate BP/JP/USP under para 4.7 of HBP. The Committee noted that the RLA had sent the complete three sets of the application in February, 2007, but the same were lying in the DES IV Section. The Committee, therefore, decided to refer the copy of application to the Technical Authority. It was, therefore, decided to defer the case for four weeks. 2
Case No.:9/7/82ALC1/2006
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:8/82ALC4/2007 28.06.2007 Status:Deffered and Reindexed HQ File :01/82/050/01467/AM06/ RLA File :22/24/040/00105/AM06/ Lic.No/Date:2210005323 13.03.2006 Defer Date:10.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Anhydrous 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. Accordingly, the Committee decided to defer the case for two weeks. 3
Case No.:19/6/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00037/AM07/ RLA File :05/24/040/01018/AM06/ Lic.No/Date:0510180636 12.04.2006 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Nesmox Capsules (Amoxycillin Capsules BP) under para 4.7 of HBP. The Committee decided to ratify the norms of the licence as per revised SION at Sl.No.A58 published vide Public Notice No.58 dated 26.09.2006 and SION A54 or as applied by the firm whichever is lower.. RLA may take further necessary action under para 4.7 of the HBP as per above decision of Norms Committee. 4
Case No.:7/8/87ALC1/2006
Party Name:AGIO PHARMACEUTICALS LTD 28.06.2007 Status:Case Rejected HQ File :01/87/050/00063/AM07/ RLA File :03/94/040/00002/AM07/ Lic.No/Date:0310376482 19.04.2006 Defer Date: Decision :The Committee considered the case as per agenda for fixation of I/O Norms for the export product Prednisol Solution for Injection 30mg/1ml under para 4.7 of HBP. The representative of the PI Division present in the meeting informed that the firm has not given the specification of the export product as per their Drug Manufacturing Licence. The Committee noted that the firm was called for personal hearing, but they did not appear for PH. The Committee, therefore, decided to close the case. 5
Case No.:6/11/83ALC1/2006
Party Name:PARABOLIC DRUGS LTD., 28.06.2007 Status:Case Approved HQ File :01/83/050/00148/AM07/ RLA File :22/24/040/00019/AM07/ Lic.No/Date:2210005522 09.05.2006 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Cloxacillin Sodium from Pen G route1kg Import items 1. Penicillin G Potassium first crystal1.43 BOU 2. Penicillin G Amidase (Enzyme)0.732gm 3. Methylene chloride0.407kg 4. Acetone0.1254kg 5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR 5.a) Ochloro Benzaldehyde0.5034kg b) Hydroxy Amine Sulphate0.3192kg c) Methyl Acetoacetate0.410kg d) Chloroform0.270kg e) Methylene chloride0.0542kg 6. Methylene Chloride/Ethyl Acetate0.620kg 7. 2Ethyl Hexanoic acid0.150kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 6
Case No.:49/22/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00518/AM07/ RLA File :05/24/040/00391/AM07/ Lic.No/Date:0510188258 04.08.2006 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Nesmox Capsules (Amoxycillin Capsules BP) and Nesmox (Amoxycillin Oral Suspension BP) under para 4.7 of HBP. The Committee decided to ratify the norms for the export product Nesmox Capsules (Amoxycillin Capsules BP) as per revised SIONs at Sl.No.A58 published vide Public Notice No.58 dated 26.09.2006 and SION A54 or as applied by the firm whichever is lower. As regards second export item viz. Nesmox (Amoxycillin Oral Suspension BP), the Committee in the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the norms as per details below or as applied for whichever is less. Export Product: Amoxycillin Oral Suspension BP/USP, each 5ml containing Amoxycillin Trihydrate equivalent to Amoxycillin 125mg. 100 ml bottle Import items: 1. Amoxycillin Trihydrate3012.83 mg.bottle of 100ml. OR Its relevant raw material as per revised SION Sl.No.A58 on prorata basis. 7
Case No.:12/28/87ALC1/2006
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 28.06.2007 Status:Case Deferred HQ File :01/87/050/00482/AM07/ RLA File :04/24/040/00047/AM07/ Lic.No/Date:0410083795 25.08.2006 Defer Date:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product 2Methyl Mercapto Phenothiazine 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. Accordingly, the Committee decided to defer the case for four weeks. 8
Case No.:46/28/82ALC1/2006
Party Name:BELCO PHARMA 28.06.2007 Status:Case Deferred HQ File :01/82/050/00920/AM07/ RLA File :05/24/040/00343/AM07/ Lic.No/Date:0510190748 13.09.2006 Defer Date:19.07.2007
Decision :Withdrawn as this case has already been considered in the 7/08 meeting held on 20.06.2007 and the Committee had decided to call for the Drug Manufacturing Licence with the list of approved items from the firm. 9
Case No.:11/34/87ALC1/2006
Party Name:ALKALOIDS CORP 28.06.2007 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:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Senega Soft Extract under para 4.7 of HBP. The Committee noted that this case is pending for a long period for want of comments of Department of Ayush. The Committee, therefore, decided to remind Department of Ayush through D.O. letter to the Jt. Secretary, Department of Ayush. The Committee accordingly decided to defer the case for four weeks. 10
Case No.:9/34/82ALC1/2006
Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:8/82ALC4/2007 28.06.2007 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:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Moxifloxacin Hydrochloride under
para 4.7 of HBP.
The representative of PI Division present in the meeting informed that the case is under examination in their Department and he sought deferment of the case for four weeks. Accordingly, the Committee decided to defer the case for four weeks. 11
Case No.:15/34/87ALC1/2006
Party Name:ALKEM LABORATORIES LTD., 28.06.2007 Status:Case Approved HQ File :01/87/050/00577/AM07/ RLA File :03/94/040/00658/AM07/ Lic.No/Date:0310401342 27.09.2006 Defer Date: Decision :Withdrawn as the case has already been approved by the Norms Committee in its 6/08 meeting held on 13.06.2007. 12
Case No.:24/32/82ALC1/2006
Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, 28.06.2007 Status:Case Rejected HQ File :01/82/050/01101/AM07/ RLA File :03/94/040/00703/AM07/ Lic.No/Date:0310402830 06.10.2006 Defer Date: Decision :The Committee considered the case as per agenda and observed that the firm has not furnished technical details in the absence of which it is not possible to compute the requirement of inputs. The Committee decided to reject the case. The RLA concerned may take consequential action accordingly.
13
Case No.:9/34/83ALC1/2006
Party Name:SUVEN LIFE SCIENCES LIMITED 28.06.2007 Status:Case Approved HQ File :01/83/050/00779/AM07/ RLA File :09/24/040/00256/AM07/ Lic.No/Date:0910027846 10.10.2006 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product 2,4Dichloro Pyramidine under
para 4.7 of HBP.
The Committee in the light of written comments forwarded by the PI Division vide their U.O. No.35011/14/2007 PIIII dated 10.04.2007 decided to ratify the Norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: 2,4dichloro pyrimidine1Kg. Import items: 1. Uracil (2,4Dihydroxy Pyrimidine)1.12Kg/Kg. 2. Dichloro methane (Methylene chloride)1.00Kg/Kg. 3. Diethyl aniline1.24Kg/Kg. 4. Triethylamine1.09Kg/Kg. 5. IPA0.50Kg/Kg. The RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 14
Case No.:19/32/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00804/AM07/ RLA File :05/24/040/00559/AM07/ Lic.No/Date:0510192990 18.10.2006 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Amoxycillin Oral Suspension BP/USP/Nesmox under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export Product: Amoxycillin Oral Suspension BP/USP, each 5ml containing Amoxycillin Trihydrate equivalent to Amoxycillin 125mg. 100 ml bottle Import items: 2. Amoxycillin Trihydrate3012.83 mg.bottle of 100ml. OR Its relevant raw material as per revised SION Sl.No.A58 on prorata basis. 15
Case No.:20/32/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00805/AM07/ RLA File :05/24/040/00561/AM07/ Lic.No/Date:0510192992 18.10.2006 Defer Date: 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 the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Metronidazole Granules1Kg. Import item: 1. Metronidazole0.3333Kg/Kg. 2. Povidone/PVPKNot shown in DML 3. Collidal Silicon Dioxide do
16
Case No.:21/32/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00806/AM07/ RLA File :05/24/040/00560/AM07/ Lic.No/Date:0510193028 19.10.2006 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product CoTrimoxazole Granules under
para 4.7 of HBP.
The Committee in the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Cotrimoxazole Granules1Kg. Import item: 1. Trimethoprim0.1414Kg/Kg. 2. Sulphamethoxazole0.707Kg/Kg 17
Case No.:22/32/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00807/AM07/ RLA File :05/24/040/00562/AM07/ Lic.No/Date:0510193029 19.10.2006 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Paracetamol Granules under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Paracetamol Granules1Kg. Import item: 1. Paracetamol0.8686Kg/Kg. 2. Povidone/PVPKNot shown in DML 3. Collidal Silicon Dioxide do 18
Case No.:14/36/87ALC1/2006
Party Name:ALEMBIC LIMITED 28.06.2007 Status:Case Deferred HQ File :01/87/050/00696/AM07/ RLA File :34/24/040/00183/AM07/ Lic.No/Date:3410017311 06.11.2006 Defer Date:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Aza Erythromycin 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. 19
Case No.:24/37/87ALC1/2006
Party Name:ADVY CHEMICAL 28.06.2007 Status:Case Deferred HQ File :01/87/050/00704/AM07/ RLA File :03/94/040/00836/AM07/ Lic.No/Date:0310406891 07.11.2006 Defer Date:10.07.2007 Decision :The case has been wrongly added due to software problem. 20
Case No.:52/36/83ALC1/2006
Party Name:NESTOR PHARMACEUTICALS LTD. 28.06.2007 Status:Case Approved HQ File :01/83/050/00925/AM07/ RLA File :05/24/040/00585/AM07/ Lic.No/Date:0510194529 16.11.2006 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Capsules 250mg (each capsule containing Ampicillin Trihydrate equivalent to Ampicillin 250mg.) under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Ampicillin Capsules 250mg (each capsule containing Ampicillin Trihydrate equivalent to Ampicillin 250mg.)1Capsule Import item: 1. Ampicillin Trihydrate285.32mg/capsule OR Its relevant raw material as per revised SION at Sl.No.A69 on prorata basis. 21
Case No.:8/44/82ALC1/2006
Party Name:M/S.ENAL DRUGS PVT LTD., 28.06.2007 Status:Case Deferred HQ File :01/82/050/01307/AM07/ RLA File :09/24/040/00237/AM07/ Lic.No/Date:0910028243 17.11.2006 Defer Date:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product 2Chloro Methyl3, Methyl 4(2,2,2 Trifluoro Ethoxy) Pyridine HCL(Lansoprazole Chloro Compound) under para 4.7 of HBP. The Committee decided to forward the copy of application to the Technical Authority. Accordingly the case was deferred for four weeks. 22
Case No.:2/39/80ALC2/2006
Party Name:BUILDMET FIBRES PVT LTD., 28.06.2007 Status:Transferred to Different Section HQ File :01/80/050/00932/AM07/ RLA File :07/24/040/00545/AM07/ Lic.No/Date:0710048531 20.11.2006 Defer Date: Decision :The Committee decided to transfer the case to DESVIII Section as the export product pertains to Plastic items.
23
Case No.:12/41/80ALC2/2006
Party Name:BRAWN LABORATORIES LTD 28.06.2007 Status:Case Deferred HQ File :01/80/050/01003/AM07/ RLA File :05/24/040/00737/AM07/ Lic.No/Date:0510195559 04.12.2006 Defer Date:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Cefadroxil Capsule 500mg (each capsule contails Cefadroxil Hemihydrate equivalent to Anhydrous Cefadroxil 500mg) under para 4.7 of HBP. The Committee decided to forward the copy of application alongwith the copy of DML to the Technical Authority. Accordingly the case was deferred for four weeks. 24
Case No.:3/47/80ALC2/2006
Party Name:MANTENA LABORATORIES LIMITED 28.06.2007 Status:Case Deferred HQ File :01/80/050/01016/AM07/ RLA File :09/24/040/00324/AM07/ Lic.No/Date:0910028524 06.12.2006 Defer Date:24.07.2007 Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Benzyl (S)()1,2,3,4Tetrahydro 3Isoquinoline CarboxylateParaToluene Sulfonic Acid Salt under para 4.7 of HBP. The Committee decided to forward the copy of complete set of application to the Technical Authority. Accordingly the case was deferred for four weeks. 25
Case No.:7/47/87ALC1/2006
Party Name:ALKEM LABORATORIES LTD., 28.06.2007 Status:Case Approved HQ File :01/87/050/00855/AM07/ RLA File :03/94/040/01056/AM07/ Lic.No/Date:0310413839 28.12.2006 Defer Date: Decision :Withdrawn as the case has already been approved in the Norms Committee meeting No.6/08 dated 13.06.2007. 26
Case No.:7/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01513/AM07/ RLA File :22/21/040/00108/AM06/ Lic.No/Date:2210006337 02.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007.
27
Case No.:8/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01526/AM07/ RLA File :22/21/040/00099/AM06/ Lic.No/Date:2210006344 03.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate Pen G Route under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007. 28
Case No.:10/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01529/AM07/ RLA File :22/21/040/00052/AM06/ Lic.No/Date:2210006351 04.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007. 29
Case No.:9/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01528/AM07/ RLA File :22/21/040/00096/AM06/ Lic.No/Date:2210006350 04.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007. 30
Case No.:11/8/82ALC4/2007
28.06.2007 Status:Case Approved
HQ File :01/82/050/01537/AM07/ RLA File :22/21/040/00104/AM06/ Lic.No/Date:2210006355 08.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007. 31
Case No.:15/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01538/AM07/ RLA File :22/21/040/00100/AM06/ Lic.No/Date:2210006356 08.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007. 32
Case No.:20/46/87ALC1/2006
Party Name:AARTI DRUGS LIMITED 28.06.2007 Status:Case Deferred HQ File :01/87/050/00921/AM07/ RLA File :03/94/040/01049/AM07/ Lic.No/Date:0310415184 09.01.2007 Defer Date:28.06.2007 33
Case No.:12/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01550/AM07/ RLA File :22/21/040/00117/AM06/ Lic.No/Date:2210006366 10.01.2007 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007. 34
Case No.:2/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01540/AM07/ RLA File :22/24/040/00287/AM07/ Lic.No/Date:2210006358 10.01.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product 6Amino Penicillanic Acid (Pen G Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A33 published vide Public Notice No.58 dated 26.09.2006. 35
Case No.:15/46/82ALC1/2006
Party Name:BALMER LAWRIE & CO LTD 28.06.2007 Status:Transferred to Different Section HQ File :01/82/050/01561/AM07/ RLA File :04/24/040/00387/AM07/ Lic.No/Date:0410086890 12.01.2007 Defer Date: Decision :The Committee decided to transfer the case to DESIV Section as the export product is a Chemical item. 36
Case No.:13/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01588/AM07/ RLA File :22/21/040/00055/AM06/ Lic.No/Date:2210006406 18.01.2007 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items 5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR 37
Case No.:14/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01589/AM07/ RLA File :22/21/040/00073/AM06/ Lic.No/Date:2210006408 19.01.2007 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium (6APA Route) 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 6. 6APA0.490kg 7. Acetone0.0034kg 8. 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 9. Methylene chloride/Ethyl Acetate0.620kg 10. 2Ethyl Hexanoic Acid0.150kg 38
Case No.:3/8/82ALC4/2007
28.06.2007 Status:Case Approved HQ File :01/82/050/01590/AM07/ RLA File :22/21/040/00105/AM06/ Lic.No/Date:2210006409 19.01.2007 Defer Date:
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium (6APA Route) 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 39
Case No.:20/48/87ALC1/2006
Party Name:ALCHEM INTERNATIONAL LTD. 28.06.2007 Status:Case Deferred HQ File :01/87/050/00927/AM07/ RLA File :05/24/040/00765/AM07/ Lic.No/Date:0510198359 24.01.2007 Defer Date:28.06.2007 40
Case No.:23/48/82ALC1/2006
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 28.06.2007 Status:Case Deferred HQ File :01/82/050/01661/AM07/ RLA File :03/94/040/01141/AM07/ Lic.No/Date:0310417197 24.01.2007 Defer Date:28.06.2007
41
Case No.:4/8/82ALC4/2007
Party Name:CIPLA LIMITED 28.06.2007 Status:Case Deferred HQ File :01/82/050/01794/AM07/ RLA File :03/94/040/01221/AM07/ Lic.No/Date:0310418218 02.02.2007 Defer Date:28.06.2007 42
Case No.:5/4/82ALC4/2007
Party Name:KDL BIOTECH LIMITED 28.06.2007 Status:Case Deferred HQ File :01/82/050/00035/AM08/ RLA File :03/94/040/00664/AM07/ Lic.No/Date:0310418079 02.02.2007 Defer Date:28.06.2007 43
Case No.:1/4/82ALC4/2007
Party Name:HITECH ARAI LIMITED 28.06.2007 Status:Case Deferred HQ File :01/82/050/01664/AM07/ RLA File :35/24/040/00060/AM07/ Lic.No/Date:3510020470 20.02.2007 Defer Date:28.06.2007 44
Case No.:2/4/82ALC4/2007
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 28.06.2007 Status:Case Deferred HQ File :01/82/050/01906/AM07/ RLA File :03/94/040/01515/AM07/ Lic.No/Date:0310424944 29.03.2007 Defer Date:28.06.2007 45
Case No.:4/4/82ALC4/2007
Party Name:SANJAY SALES CORPORATION 28.06.2007 Status:Case Deferred HQ File :01/82/050/00021/AM08/ RLA File :03/95/040/01619/AM07/ Lic.No/Date:0310427817 25.04.2007 Defer Date:28.06.2007 46
Case No.:6/4/82ALC4/2007
Party Name:SHALINA LABORATORIES PVT. LTD. 28.06.2007 Status:Case Deferred HQ File :01/82/050/00031/AM08/ RLA File :03/95/040/00095/AM08/ Lic.No/Date:0310428999 10.05.2007 Defer Date:24.07.2007
Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Diproson Lotion 30ml under para 4.7 of HBP. The Committee decided to call for the copy of Drug Manufacturing Licence from the firm. Accordingly the case was deferred for four weeks. 47
Case No.:1/8/82ALC4/2007
Party Name:KDL BIOTECH LIMITED 28.06.2007 Status:Case Approved HQ File :01/82/050/00041/AM08/ RLA File :03/94/040/01418/AM07/ Lic.No/Date:0310429937 21.05.2007 Defer Date: Decision :The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items 5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR 48
Case No.:5/8/82ALC4/2007
Party Name:CIPLA LIMITED 28.06.2007 Status:Case Deferred HQ File :01/82/050/00071/AM08/ RLA File :03/94/040/00254/AM08/ Lic.No/Date:0310432426 12.06.2007 Defer Date:17.07.2007
49
Case No.:6/8/82ALC4/2007
Party Name:CIPLA LIMITED 28.06.2007 Status:Case Deferred HQ File :01/82/050/00072/AM08/ RLA File :03/94/040/00256/AM08/ Lic.No/Date:0310432429 12.06.2007 Defer Date:17.07.2007 Minutes of the Norms Committee Meeting No. 08/08 held on 28.6.07 under the Chairmanship of Shri Sanjay Rastogi, Export Commissioner. The Committee first considered the minutes of the NC Meeting No. 07/08 held on 20.06.07 for confirmation and confirmed and adopted the same.
Case No.A107
M/S KDL Biotech Ltd Meeting No.08/08 File No.01/83/50/54/AM’08/DESIII Date: 28.06.2007 RLA F.No.03/94/40/1377/AM’07 Advance licence No.0310429952 Dated 21.05.2007 The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items
5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A108
M/S KDL Biotech Ltd Meeting No.08/08 File No.01/83/50/53/AM’08/DESIII Date: 28.06.2007 RLA F.No.03/94/40/1419/AM’07 Advance licence No.0310429942 Dated 21.05.2007 The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items
5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A109
M/S Nestor Pharmaceuticals Ltd Meeting No.08/08 File No.01/83/50/1277/AM’07/DESIII Date: 28.06.2007 RLA F.No.05/24/40/960/AM’07 Advance licence No.0510200106 Dated 27.02.2007 The Committee considered the case as per agenda for ratification of Norms for the export product CoTrimoxazole Granules under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Cotrimoxazole Granules1Kg. Import item: 1. Trimethoprim0.1414Kg/Kg. 1. Sulphamethoxazole0.707Kg/Kg
RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A110
M/S Nestor Pharmaceuticals Ltd Meeting No.08/08 File No.01/83/50/1278/AM’07/DESIII Date: 28.06.2007 RLA F.No.05/24/40/961/AM’07 Advance licence No.0510200107 Dated 27.02.2007 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 the light of written comments forwarded by PI Division vide their U.No.35011/29/2007PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Metronidazole Granules1Kg. Import item: 1 Metronidazole0.3333Kg/Kg. 2 Povidone/PVPKNot shown in DML 3 Collidal Silicon Dioxide do
Case No.A111
M/S Mission Pharmaceuticals Ltd. Meeting No.08/08 File No.01/82/50/1614/AM’07/DESIII Date: 28.06.2007 RLA F.No.03/95/40/1249/AM’07 Advance licence No.0310415874 Dated 15.01.2007
of Norms for the export product Erythromycin Ethyl Succinate Caps BP 250mg. under para 4.7 of HBP. The Committee noted that the firm has already been called for personal hearing before the Norms Committee on 17.07.2007 in other two cases of the firm which were considered by the Norms Committee in its 7/08 meeting held on 20.06.2007. It was, therefore, decided to link this case with the cases for personal hearing. Accordingly, this case may be re listed in the Norms Committee meeting to be held on 17.07.2007.
Case No.A112
M/S Merck Ltd. Meeting No.08/08 File No.01/82/50/1618/AM’07/DESIII Date: 28.06.2007 RLA F.No.03/95/40/1258/AM’07 Advance licence No.0310415514 Dated 11.01.2007 of Norms for the export product Thiamine Disulfide under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.No.35011/274/2006PIIII dated 26.06.2007, decided to ratify the the norms as per details below or as applied for whichever is less. Export product: Thiamine Disulfide1Kg. Import items: 1. Thiamine Hcl IP/BP/USP (Vitamin B1 Hcl)1.4199Kg/Kg. 2. Sodium Hydroxide Pellets0.4634Kg/Kg. 3. Potassium Hexacyanoferate (III) GR0.0022Kg/Kg. 4. Hydrochloric Acid Fuming 37%0.3356Kg/Kg. 5. Hydrogen Peroxide Solution 35% extra Pure0.2157Kg/Kg. 6. Acetone0.8702 ltrs/Kg.
Case No.A113
M/S KDL Biotech Ltd Meeting No.08/08 File No.01/82/50/367/AM’08/DESIII Date: 28.06.2007 RLA F.No.03/94/40/1408/AM’07 Advance licence No.0310429935 Dated 21.05.2007 of Norms for the export product Ampicillin Trihydrate IP/BP under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A114
M/S Parabolic Drugs Ltd Meeting No.08/08 File No.01/83/50/1121/AM’07/DESIII Date: 28.06.2007 RLA F.No.22/24/40/283/AM’07 Advance licence No.2210006369 Dated 10.01.2007 of Norms for the export product Ampicillin Trihydrate under para 4.7 of HBP. per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A115
M/S Parabolic Drugs Ltd
Meeting No.08/08 File No.01/83/50/1133/AM’07/DESIII Date: 28.06.2007 RLA F.No.22/24/40/290/AM’07 Advance licence No.2210006385 Dated 16.01.2007 of Norms for the export product Ampicillin Trihydrate under para 4.7 of HBP. per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A116
M/S Parabolic Drugs Ltd Meeting No.08/08 File No.01/83/50/1130/AM’07/DESIII Date: 28.06.2007 RLA F.No.22/24/40/285/AM’07 Advance licence No.2210006378 Dated 11.01.2007 of Norms for the export product Ampicillin Trihydrate under para 4.7 of HBP. per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A117
M/S Lupin Ltd Meeting No.08/08 File No.01/82/50/1851/AM’07/DESIII Date: 28.06.2007 RLA F.No.03/95/40/1581/AM’07 Advance licence No.0310424036 Dated 22.03.2007
of Norms for the export product 7ADCA under para 4.7 of HBP. per revised SION at Sl.No.A35 published vide Public Notice No.2 dated 19.04.2007.
Case No.A118
M/S Aurobindo Pharma Ltd Meeting No.08/08 File No.01/87/50/953/AM’07/DESIII Date: 28.06.2007 RLA F.No.09/24/40/429/AM’07 Advance licence No.0910029197 Dated 05.02.2007 of Norms for the export product Simvastatin under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O. No.35011/22/2007PIIII dated 27.02.2007 decided to ratify the norms of the export product as per details below or as applied for whichever is less. Export Product: Simvastatin1Kg. Import Items: 1. Lavastatin1.736Kg/Kg. 2. Acetic Acid1.116Kg/Kg. 3. Carbon DC Enoaniticromos (activated carbon)0.035Kg/Kg. 4. Cyclohexane5.27Kg/Kg. 5. Methanol13.64Kg/Kg. 6. Methyl Iodide0.61Kg/Kg. 7. Methylene Chloride3.04Kg/Kg. 8. N,NDimethylformamide1.71Kg/Kg. 9. NButylithium in Hexanes0.988Kg/Kg.
10.Pyrrolidine1.208Kg/Kg. 11.Tert Butyldimethylsilyl chloride1.62Kg/Kg. 12.THF8.09Kg/Kg.
Case No.A119
M/S Aurobindo Pharma Ltd. Meeting No.08/08 File No.01/87/50/884/AM’07/DESIII Date: 28.06.2007 RLA F.No.09/24/40386/AM’07 Advance licence No.0910028957 Dated 10.01.2007 of Norms for the export product Cephalexin (Cephalexin Monohydrate) (from Pen G Route) under para 4.7 of HBP. per revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007.
Case No.A120
M/S Aurobindo Pharma Ltd. Meeting No.08/08 File No.01/87/50/985/AM’07/DESIII Date: 28.06.2007 RLA F.No.09/24/40/261/AM’07 Advance licence No.0910029298 Dated 12.02.2007 of Norms for the export product Nelfinavir Mesylate (From PHIQ Route) The Committee decided that the application of the firm may be forwarded to the Technical Authority. The case was, therefore, deferred for four weeks.
Case No.A121
M/S DSM AntiInfectives India Ltd Meeting No.08/08 File No.01/82/50/72/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/310AM’07 Advance licence No.2210006598 Dated 19.03.2007 of Norms for the export product Ampicillin Trihydrate (Pen G Route) under
para 4.7 of HBP.
per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A122
Meeting No.08/08 File No.01/82/50/68/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/307AM’07 Advance licence No.2210006593 Dated 19.03.2007 of Norms for the export product Ampicillin Trihydrate (Pen G Route) under
para 4.7 of HBP.
per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A123
Meeting No.08/08 File No.01/82/50/58/AM’08/DESIII
Date: 28.06.2007 RLA F.No.22/21/42/71/AM’05 Advance licence No.2210006475 Dated 07.02.2007 of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items 5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A124
Meeting No.08/08 File No.01/82/50/253/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/7/AM’08 Advance licence No.2210006705 Dated 03.05.2007 of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items 5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A125
Meeting No.08/08 File No.01/82/50/96/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/2AM’08 Advance licence No.2210006653 Dated 10.04.2007 of Norms for the export product 6Amino Penicillanic Acid (Pen G Route) per revised SION at Sl.No.A33 published vide Public Notice No.58 dated 26.09.2006.
Case No.A126
Meeting No.08/08 File No.01/82/50/70/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/308/AM’07 Advance licence No.2210006595 Dated 19.03.2007 of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items
5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A127
Meeting No.08/08 File No.01/82/50/67/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/306/AM’07 Advance licence No.2210006592 Dated 19.03.2007 of Norms for the export product Cloxacillin Sodium 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 whichever is lower. Export product Import items
5. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)0.62kg OR RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
Case No.A128
Meeting No.08/08 File No.01/82/50/410/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/10AM’08 Advance licence No.2210006746 Dated 28.05.2007 of Norms for the export product Amoxycillin Trihydrate (Pen G Route) per revised SION at Sl.No.A58 published vide Public Notice No.58 dated 26.09.2006.
Case No.A129
Meeting No.08/08 File No.01/82/50/21/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/1AM’08 Advance licence No.2210006652
Dated 10.04.2007 of Norms for the export product 6Amino Penicillanic Acid (Pen G Route) per revised SION at Sl.No.A33 published vide Public Notice No.58 dated 26.09.2006.
Case No.A130
Meeting No.08/08 File No.01/82/50/71/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/305AM’07 Advance licence No.2210006597 Dated 19.03.2007 of Norms for the export product 6Amino Penicillanic Acid (Pencillin G Route) under para 4.7 of HBP. per revised SION at Sl.No.A33 published vide Public Notice No.58 dated 26.09.2006.
Case No.A131
Meeting No.08/08 File No.01/82/50/61/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/24/40/139/AM’06 Advance licence No.2210006480 Dated 08.02.2007 of Norms for the export product Ampicillin Trihydrate Pen G Route under
para 4.7 of HBP.
per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007.
Case No.A132
Meeting No.08/08 File No.01/82/50/59/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/21/42/64/AM’05 Advance licence No.2210006476 Dated 07.02.2007 of Norms for the export product Ampicillin Trihydrate (6APA Route) under
para 4.7 of HBP.
per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007.
Case No.A133
Meeting No.08/08 File No.01/82/50/54/AM’08/DESIII Date: 28.06.2007 RLA F.No.22/21/42/69/AM’05 Advance licence No.2210006461 Dated 02.02.2007 of Norms for the export product Cloxacillin Sodium (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.B107
M/S Medreich Ltd Meeting No.08/08 File No.01/82/50/795/AM’06/DESIII Date: 28.06.2007 RLA F.No.07/24/40/553/AM’06 Advance licence No.0710040930 Dated 18.10.2005 of Norms for the export product Iodine 20Mg+Peptone 75Mg Tablets Iodone Tablets under para 4.7 of HBP. The Committee decided that the application alongwith the reply received from the firm may be forwarded to the Technical Authority. The case was accordingly deferred for four weeks.
Case No.B108
M/S IPCA Laboratories Ltd Meeting No.08/08 File No.01/82/50/661/AM’07/DESIII Date: 28.06.2007 Advance licence No. 0310392753 dated 02.08.2006 0310370771 dated 09.03.2006 0310240505 dated 08.12.2003 0310366791 dated 14.02.2006 The Committee considered the case as per agenda for correction in the specification of item of imports and exports and enhancement in the quantity of the above mentioned Advance licences. The Committee decided to allow corrections in the import and export items as per details below; Advance Licence No. & date Specification of item earlier allowed Corrected item 0310392753 dated 02.08.2006 Pro[rama;jc (export product) Propranolol HCL 0310370771 dated 09.03.2006 Paroxetin HCL (export product) Paroxetine HCL 0310240505 dated 08.12.2003 Nebumelone (export product) Iso Propylalcholoh (import item No.4) Nabumetone Iso Propyl alcohol 0310366791 dated 14.02.2006 Glimepride (export product) Glimepiride As regards enhancement in the quantity of inputs, the Committee decided to maintain status quo.
Case No.B109
M/S Dr. Reddy’s Laboratories Ltd Meeting No.08/08 File No.01/82/50/43/AM’06/DESIII Date: 28.06.2007 RLA F.No.09/24/40/548/AM’06 Advance licence No.0910025936
Dated 13.04.2006 of Norms for the export product Gemcitabine HCL under para 4.7 of HBP. The Committee decided that the application alongwith the reply received from the firm may be forwarded to the Technical Authority. The case was accordingly deferred for four weeks.
Case No.B110
M/S Alco Laboratories India Ltd Meeting No.08/08 File No.01/87/50/663/AM’05/DESIII Date: 28.06.2007 RLA F.No.08/80/40/261/AM’0 Advance licence No.0810041692 Dated 02.09.2004 The Committee considered the case as per agenda for amendment in the item of import against the above mentioned advance licence. The Committee decided to allow amendment in the item of import as per details below; From To Amino Acetic Acid Glycine T Grade (Amino Acetic Acid) Purity not more than 98.5% and Chloride content 0.50%.
Case No.B111
M/S MSN Pharma Pvt. Ltd. Meeting No.08/08 File No.01/82/50/611/AM’07/DESIII Date: 28.06.2007 RLA F.No.09/24/40/110/AM’07 Advance licence No.0910027025 Dated 26.07.2006 of Norms for the export product Moxifloxacin Hydrochloride API 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 sough deferment for four weeks. The Committee accordingly decided to defer the case for four weeks.
Case No.B112
M/S MSN Pharma Pvt. Ltd. Meeting No.08/08 File No.01/82/50/1233/AM’07/DESIII Date: 28.06.2007 RLA F.No.09/24/40/215/AM’07 Advance licence No.0910028088 Dated 03.11.2006 of Norms for the export product Moxifloxacin Hydrochloride API 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 sough deferment for four weeks. The Committee accordingly decided to defer the case for four weeks.
Case No.B113
M/S Glenmark Pharmaceuticals Ltd Meeting No.08/08 File No.01/82/50/2021/AM’05/DESIII Date: 28.06.2007 RLA F.No.03/24/40/2398/AM’05 Advance licence No.0310321344 Dated 15.03.2005 of Norms for the export product Gilimepride 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.35011/127/2006PIIII dated 14.08.2006 or as applied for whichever is less. Export Product: Tenoxicam1Kg.
Import items: 1. Methyl3[Methoxy Carbonyl) [Amino] Sulfonyl]2Thiophene Carboxylate2.70Kg./Kg. 2. Acetone2.40Kg/Kg. 3. Methanol1.60Kg/Kg.
Case No.B114
M/S Glenmark Pharmaceuticals Ltd Meeting No.08/08 File No.01/82/50/3109/AM’05/DESIII Date: 28.06.2007 RLA F.No.03/24/40/2516/AM’04 Advance licence No.0310256280 Dated 04.03.2004 of Norms for the export product Gilimepride 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
RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
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