IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-07-10

DGFT Committee Minutes

Document text

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

Para 4.7 Officewise Statement

MEETING NUMBER : 10/82‐ALC4/2007 MEETING DATE : 10.07.2007 1

Case No.:1/6/82‐ALC4/2007

Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:10/82‐ALC4/2007 10.07.2007 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:07.08.2007 Decision :The case was considered by the Commi찄ee as per agenda for ra䈆fica䈆on of Norm under para 4.7 of HBP. The Commi찄ee noted that the Jt. DGFT, Hyderabad was requested to furnish complete set of applica䈆on vide le찄er dated 27.06.2007, but the same has not been received so far. The Commi찄ee, therefore, decided to remind the RLA through D.O. le찄er from the appropriate level. Accordingly, the case was deferred for four weeks. 2

Case No.:2/6/82‐ALC4/2007

Party Name:HINDUSTAN ANTIBIOTICS LTD 10.07.2007 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:07.08.2007 Decision :The case was considered by the Commi찄ee as per agenda for ra䈆fica䈆on of Norm for the export product Tables i.e. Potassium Phenoxymethyl Pencillin Tables BP 250 Mg. under para 4.7 of HBP. The Commi찄ee noted that the instant licence was issued on 08.08.2003, while the applica䈆on of the firm has been forwarded now. The Commi찄ee, therefore, decided to write a D.O. le찄er to RLA from the appropriate level asking them the reasons for forwarding the applica䈆on too late. Accordingly, the case was deferred for four weeks. 3

Case No.:2/35/82‐ALC1/2004

Party Name:MADHUR PHARMA & RESEARCH LABORATORIES PVT.LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Herpasil Capsules and S䈆mmune Capsules under para 4.7 of HBP. The Commi찄ee decided to remind Department of Ayush demi‐officially at the appropriate level to expedite the comments. The Commi찄ee also decided to defer the case for four week. 4

Case No.:4/19/83‐ALC1/2005

Party Name:RANBAXY LABORATORIES LTD 10.07.2007 Status:Case Approved HQ File :01/83/050/00221/AM06/ RLA File :05/24/040/00294/AM06/ Lic.No/Date:0510162630 25.07.2005 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tablets 375mg, 625mg and 1000mg. under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/171/2006‐PI‐III dated 16.04.2007 decided to ra䈆fy the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: 1. Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tabs. 375mg.‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 5904000 Nos. tablets OR 2. Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tabs. 625mg.‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐5904000 Nos. Tablets 3. Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tabs. 1000mg.‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐5904000 Nos. Tablets

4. Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tabs. 156mg.‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐23616160 Nos. Tablets 5. Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tabs. 228.5mg.mg.‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐25894810 Nos. Tablets 6. Amoxycillin Trihydrate & Potassium Clavulanate & Microcrystalline Cellulose 1:1 Tabs. 457mg.‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐12947406 Nos. Tablets Import items: 1. Amoxycillin Trihydrate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐23361.96 Kg. OR Its raw materials as per revised SION A‐57 on pro‐rata basis 2. Potassium Clavulanate & Microcrystalline Cellulose 1:1‐‐‐‐‐‐10749.41 Kg. RLA concerned may take further necessary ac䈆on under para 4.7 of HBP as per above decision of Norms Commi찄ee. 5

Case No.:5/37/82‐ALC1/2005

Party Name:FDC LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Econazole Nitrate BP/JP/USP under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for four weeks. The Commi찄ee, therefore, decided to defer the case for four weeks. 6

Case No.:25/39/83‐ALC1/2005

Party Name:PARABOLIC DRUGS LTD., 10.07.2007 Status:Case Approved HQ File :01/83/050/00503/AM06/ RLA File :22/24/040/00038/AM06/ Lic.No/Date:2210005029 30.11.2005 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm whichever is lower. Export product Cloxacillin Sodium from Pen G route‐‐‐‐1kg Import items 1. Penicillin G Potassium first crystal‐‐‐‐‐1.43 BOU 2. Penicillin G Amidase (Enzyme)‐‐‐‐‐‐0.732gm 3. Methylene chloride‐‐‐‐0.407kg 4. Acetone‐‐‐‐‐0.1254kg 5. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)‐‐‐‐‐‐‐‐0.62kg OR 5.a) O‐chloro Benzaldehyde‐‐‐‐‐0.5034kg b) Hydroxy Amine Sulphate‐‐‐‐‐0.3192kg c) Methyl Acetoacetate‐‐‐‐‐0.410kg d) Chloroform‐‐‐‐‐0.270kg e) Methylene chloride‐‐‐‐‐‐‐0.0542kg 6. Methylene Chloride/Ethyl Acetate‐‐‐‐‐0.620kg 7. 2‐Ethyl Hexanoic acid‐‐‐‐‐0.150kg The Commi찄ee also decided to fix SION of the export product as per above comments of PI Division.

Case No.:10/47/83‐ALC1/2005

Party Name:UNIMARK REMEDIES LIMITED., 10.07.2007 Status:Case Deferred HQ File :01/83/050/00648/AM06/ RLA File :03/95/040/01126/AM06/ Lic.No/Date:0310365523 02.02.2006 Defer Date:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cefadroxil under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks. 8

Case No.:3/9/82‐ALC1/2006

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 10.07.2007 Status:Case Deferred HQ File :01/82/050/01314/AM06/ RLA File :22/24/040/00080/AM06/ Lic.No/Date:2210005220 02.02.2006 Defer Date:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Ampicillin Anhydrous under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks. 9

Case No.:5/49/83‐ALC1/2005

Party Name:NESTOR PHARMACEUTICALS LTD. 10.07.2007 Status:Case Deferred HQ File :01/83/050/00661/AM06/ RLA File :05/24/040/00875/AM06/ Lic.No/Date:0510176456 15.02.2006 Defer Date:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Ampicillin Anhydrous under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks. 10

Case No.:1/7/83‐ALC1/2006

10.07.2007 Status:Case Approved

HQ File :01/83/050/00712/AM06/ RLA File :22/24/040/00125/AM06/ Lic.No/Date:2210005314 10.03.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Cloxacillin Sodlum from 6 APA Stage‐‐‐‐1kg Import items 1. 6‐APA‐‐‐‐‐‐‐‐0.490kg 2. Acetone‐‐‐‐‐0.0034kg 3. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CKIC Chloride)‐‐‐‐‐0.62kg OR 3.a) O‐chloro Benzaldehyde‐‐‐‐‐‐‐0.5034kg 3.b) Hydroxyl Amine Sulphate‐‐‐‐‐0.3192kg 3.c) Methyl Acetoacetate‐‐‐‐‐‐‐‐‐‐‐‐0.410kg 3.d) Chloroform‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.270kg 3.e) Methylene chloride‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.0542kg 4. Methylene chloride/Ethyl Acetate‐‐‐‐0.620kg 5. 2‐Ethyl Hexanoic Acid‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.150kg 11

Case No.:9/7/82‐ALC1/2006

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 10.07.2007 Status:Case Deferred HQ File :01/82/050/01467/AM06/ RLA File :22/24/040/00105/AM06/ Lic.No/Date:2210005323 13.03.2006 Defer Date: 24.07.2007 Decision :The commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Ampicillin Anhydrous under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks

Case No.:19/6/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00037/AM07/ RLA File :05/24/040/01018/AM06/ Lic.No/Date:0510180636 12.04.2006 Decision :Withdrawn as the case has already been approved in NC 8/08 dated 28.06.2007. 13

Case No.:9/8/82‐ALC1/2006

Party Name:BAADER SCHULZ LABORATORIES, 10.07.2007 Status:Case Approved HQ File :01/82/050/00091/AM07/ RLA File :03/94/040/01450/AM06/ Lic.No/Date:0310377084 24.04.2006

Decision : The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Salconil under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by DC(SSI) vide their U.O. No.5(9)/2005‐chem dated 02.07.2007 decided to ra䈆fy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Salconil ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐60000Kgs. Net content: i) Salinomycin Sodium 12% Feed Grade:59880 Kg. ii) B.H.A. (Indigenous 60 Kg.) iii) Calcium Carbonate (indigenous 60 Kg.) Import item: i) Salinomycin Sodium 12% Feed Grade‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐60478.8Kg. 14

Case No.:1/22/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00122/AM07/ RLA File :22/24/040/00012/AM07/ Lic.No/Date:2210005500 04.05.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (From 6‐APA Route) under

para 4.7 of HBP

The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items 6. 6‐APA‐‐‐‐‐‐‐‐0.490kg 7. Acetone‐‐‐‐‐0.0034kg 8. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CKIC Chloride)‐‐‐‐‐0.62kg OR 9. Methylene chloride/Ethyl Acetate‐‐‐‐0.620kg 10. 2‐Ethyl Hexanoic Acid‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.150kg The Commi찄ee also decided to fix the SION as per above report of Department of C&PC. 15

Case No.:6/11/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00148/AM07/ RLA File :22/24/040/00019/AM07/ Lic.No/Date:2210005522 09.05.2006 Decision :Withdrawn as the case has already been approved in NC Mee䈆ng No.8/08 dated 28.06.2007. 16

Case No.:7/11/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00149/AM07/ RLA File :22/24/040/00011/AM07/ Lic.No/Date:2210005523 09.05.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items: OR The Commi찄ee also decided to fix SION as per above report of Dep찄. Of C&PC. 17

Case No.:9/11/83‐ALC1/2006

Party Name:SURYA PHARMACEUTICAL LTD 10.07.2007 Status:Case Deferred HQ File :01/83/050/00165/AM07/ RLA File :22/24/040/00035/AM07/ Lic.No/Date:2210005538 15.05.2006 Defer Date:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Ampicillin Anhydrous under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks. 18

Case No.:9/13/83‐ALC1/2006

Party Name:UNIMARK REMEDIES LIMITED., 10.07.2007 Status:Case Approved

HQ File :01/83/050/00191/AM07/ RLA File :03/95/040/01559/AM06/ Lic.No/Date:0310381029 19.05.2006 Decision :The Commi찄ee considered this case as per agenda for fixa䈆on of I/O Norms for the Export Product CEPHALEXIN MONOHYDRATE (FROM PEN G ROUTE) under para 4.7 of HBP. The Commi찄ee decided to ra䈆fy the norms under para 4.7 of HBP as per revised SION at Sl.No.A‐116 published vide Public No䈆ce No.2 dated 19.04.2007 or as applied by the firm whichever is lower. 19

Case No.:14/22/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00304/AM07/ RLA File :22/24/040/00068/AM07/ Lic.No/Date:2210005662 16.06.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items OR

Case No.:18/18/83‐ALC1/2006

Party Name:PENAM LABORATORIES LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00365/AM07/ RLA File :05/24/040/00062/AM07/ Lic.No/Date:0510185515 29.06.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items OR The Commi찄ee also decided to no䈆fy the SION as per above report. 21

Case No.:21/22/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00372/AM07/ RLA File :22/24/040/00095/AM07/ Lic.No/Date:2210005727 04.07.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm whichever is lower. Export product Cloxacillin Sodium from Pen G route‐‐‐‐1kg Import items 1. Penicillin G Potassium first crystal‐‐‐‐‐1.43 BOU 2. Penicillin G Amidase (Enzyme)‐‐‐‐‐‐0.732gm 3. Methylene chloride‐‐‐‐0.407kg 4. Acetone‐‐‐‐‐0.1254kg 5. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)‐‐‐‐‐‐‐‐0.62kg OR 5.a) O‐chloro Benzaldehyde‐‐‐‐‐0.5034kg b) Hydroxy Amine Sulphate‐‐‐‐‐0.3192kg c) Methyl Acetoacetate‐‐‐‐‐0.410kg d) Chloroform‐‐‐‐‐0.270kg e) Methylene chloride‐‐‐‐‐‐‐0.0542kg 6. Methylene Chloride/Ethyl Acetate‐‐‐‐‐0.620kg 7. 2‐Ethyl Hexanoic acid‐‐‐‐‐0.150kg The Commi찄ee also decided to fix SION of the export product as per above comments of PI Division. 22

Case No.:13/19/83‐ALC1/2006

Party Name:SHASUN CHEMICALS & DRUGS LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00425/AM07/ RLA File :04/24/040/00133/AM07/ Lic.No/Date:0410082841 13.07.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 4‐(2‐Chloroethyl)‐1‐Trityl‐1H‐Imidazole under

para 4.7 of HBP.

The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/225/2006‐PI‐III dated 03.05.2007 decided to ra䈆fy the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 4‐(2‐Chloroethyl)‐1‐Trityl‐1H‐Imidazole ‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 2‐(1H‐Imidazole‐4yl)‐Ethylamine Hcl ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. 23

Case No.:10/23/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00432/AM07/ RLA File :22/24/040/00124/AM07/ Lic.No/Date:2210005783 17.07.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items OR The Commi찄ee also decided to no䈆fy the SION as per above report. 24

Case No.:12/23/83‐ALC1/2006

Party Name:SURYA PHARMACEUTICAL LTD 10.07.2007 Status:Case Rejected HQ File :01/83/050/00434/AM07/ RLA File :22/24/040/00134/AM07/ Lic.No/Date:2210005788 17.07.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Fexofenadine Hcl under para 4.7 of HBP. The Commi찄ee noted that the firm was asked tetails of manufacturing process wastage and chemical reac䈆on. The firm has not responded. The case is lingering since long only for want of firms response. It was, therefore, decided to reject the case. 25

Case No.:9/23/83‐ALC1/2006

10.07.2007 Status:Case Approved

HQ File :01/83/050/00431/AM07/ RLA File :22/24/040/00113/AM07/ Lic.No/Date:2210005782 17.07.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items OR 26

Case No.:16/19/83‐ALC1/2006

Party Name:SHASUN CHEMICALS & DRUGS LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00437/AM07/ RLA File :04/24/040/00137/AM07/ Lic.No/Date:0410082940 19.07.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product (Z)‐5‐[(4‐Fluorophenyl)Methylene]‐2‐4‐ Thiazolidinedione under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/229/2006‐PI‐III dated 03.05.2007 decided to ra䈆fy the (Z)‐5‐[(4‐Fluorophenyl)Methylene]‐2‐4‐Thiazolidinedione‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. 2,4‐thiazolidinedione‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 0.77Kg/Kg. 2. 4‐fluorobenzaldehyde ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.82Kg/Kg. 27

Case No.:16/23/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00455/AM07/ RLA File :22/24/040/00141/AM07/ Lic.No/Date:2210005805 21.07.2006

Case No.:21/21/83‐ALC1/2006

Party Name:SUVEN LIFE SCIENCES LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00452/AM07/ RLA File :09/24/040/00143/AM07/ Lic.No/Date:0910026940 21.07.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 3,5‐Diacetoxy Acetophenone under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/254/2006‐PI‐III dated 16.04.2007 decided to ra䈆fy the Export Product: 3,5‐Diacetoxy Acetophenone 1Kg. Import item: 3,5‐dihydroxy acetophenone 0.89Kg/Kg. 29

Case No.:39/22/83‐ALC1/2006

Party Name:SAI LIFE SCIENCES LIMITED 10.07.2007 Status:Transferred to Different Sec䈆on HQ File :01/83/050/00484/AM07/ RLA File :09/24/040/00152/AM07/ Lic.No/Date:0910027096 01.08.2006 Defer Date: Decision :The Commi찄ee decided to transfer the case to DES‐IV as the export product pertains to Chemical Sector. 30

Case No.:31/23/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00506/AM07/ RLA File :22/24/040/00148/AM07/ Lic.No/Date:2210005843 02.08.2006

Case No.:49/22/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00518/AM07/ RLA File :05/24/040/00391/AM07/ Lic.No/Date:0510188258 04.08.2006 Decision :Withdrawn as the case has already been approved in the NC Mee䈆ng No.08/08 dated 28.06.2007. 32

Case No.:55/22/83‐ALC1/2006

Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., 10.07.2007 Status:Case Approved HQ File :01/83/050/00545/AM07/ RLA File :03/95/040/00554/AM07/ Lic.No/Date:0310394656 14.08.2006 Defer Date:

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Pure 5‐amino salicylic acid (Pure Mesalamine) (Assay not less than 99.5% by HPLC) under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/269/2006‐PI‐III dated 28.04.2007 decided to ra䈆fy the Export Product: Pure 5‐amino salicylic acid (Pure Mesalamine) (Assay not less than 99.5% by HPLC) ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: Crude 5‐amino salicylic acid (Assay not more than 97.5% by HPLC)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1.02Kg./Kg. 33

Case No.:1/35/83‐ALC1/2006

Party Name:SRINI PHARMACEUTICALS LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Bicalutamide under para 4.7 of HBP. The Commi찄ee decided to forward the complete set of applica䈆on again to the Technical Authority and defer the case for four weeks. 34

Case No.:12/28/87‐ALC1/2006

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 10.07.2007 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:07.08.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 2‐Methyl Mercapto Phenothiazine under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 35

Case No.:21/27/83‐ALC1/2006

Party Name:SURYA PHARMACEUTICAL LTD 10.07.2007 Status:Case Approved HQ File :01/83/050/00629/AM07/ RLA File :22/21/040/00041/AM07/ Lic.No/Date:2210005954 04.09.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items OR 36

Case No.:34/28/82‐ALC1/2006

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 10.07.2007 Status:Case Deferred HQ File :01/82/050/00849/AM07/ RLA File :22/24/040/00203/AM07/ Lic.No/Date:2210005950 04.09.2006 Defer Date:24.07.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Ampicillin Anhydrous under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks. 37

Case No.:3/32/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/00631/AM07/ RLA File :22/24/040/00188/AM07/ Lic.No/Date:2210005959 05.09.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm whichever is lower. Export product Cloxacillin Sodium from Pen G route‐‐‐‐1kg Import items 1. Penicillin G Potassium first crystal‐‐‐‐‐1.43 BOU 2. Penicillin G Amidase (Enzyme)‐‐‐‐‐‐0.732gm 3. Methylene chloride‐‐‐‐0.407kg 4. Acetone‐‐‐‐‐0.1254kg 5. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)‐‐‐‐‐‐‐‐0.62kg OR 5.a) O‐chloro Benzaldehyde‐‐‐‐‐0.5034kg b) Hydroxy Amine Sulphate‐‐‐‐‐0.3192kg c) Methyl Acetoacetate‐‐‐‐‐0.410kg d) Chloroform‐‐‐‐‐0.270kg e) Methylene chloride‐‐‐‐‐‐‐0.0542kg 6. Methylene Chloride/Ethyl Acetate‐‐‐‐‐0.620kg 7. 2‐Ethyl Hexanoic acid‐‐‐‐‐0.150kg The Commi찄ee also decided to fix SION of the export product as per above comments of PI Division.

Case No.:10/30/83‐ALC1/2006

Party Name:PENAM LABORATORIES LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00655/AM07/ RLA File :05/24/040/00418/AM07/ Lic.No/Date:0510190573 11.09.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium (6‐APA Route) under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Import items OR 39

Case No.:2/33/83‐ALC1/2006

Party Name:SRINI PHARMACEUTICALS LTD., 10.07.2007 Status:Case Deferred HQ File :01/83/050/00646/AM07/ RLA File :09/24/040/00220/AM07/ Lic.No/Date:0910027505 11.09.2006 Defer Date:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Methyl Alpha‐(4,5,6,7‐Tetrahydra‐5‐ Thieno(3,2‐c) Pyridyl)(2‐Chlorophenyl) Acetate Hyderochloride (CPG‐20) under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought

Case No.:3/33/83‐ALC1/2006

Party Name:SRINI PHARMACEUTICALS LTD., 10.07.2007 Status:Case Approved HQ File :01/83/050/00647/AM07/ RLA File :09/24/040/00221/AM07/ Lic.No/Date:0910027506 11.09.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Lansoprazole under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/8/2007‐PI‐III dated 28.04.2007 decided to ra䈆fy the Export Product: Lansoprazole 1Kg. Import item: 1. 2‐chloro methyl‐3‐methyl‐4‐(2,2,2 trifluoro ethoxy) pyridine hcl‐‐ 1.35Kg/Kg. 2. 2‐mercapto banzimidazol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.80Kg/Kg. 3. Methy Tert. Butyl ether ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.05Kg/Kg. 4. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 2.85Kg/Kg. 5. Acetonitrile ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.87Kg/Kg. 41

Case No.:17/31/82‐ALC1/2006

Party Name:GLENMARK PHARMACEUTICALS LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Terbinafine Hydrochloride Tablets 250Mg. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 42

Case No.:29/27/83‐ALC1/2006

10.07.2007 Status:Case Approved

HQ File :01/83/050/00658/AM07/ RLA File :22/24/040/00210/AM07/ Lic.No/Date:2210005985 12.09.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm whichever is lower. Export product Cloxacillin Sodium from Pen G route‐‐‐‐1kg Import items 1. Penicillin G Potassium first crystal‐‐‐‐‐1.43 BOU 2. Penicillin G Amidase (Enzyme)‐‐‐‐‐‐0.732gm 3. Methylene chloride‐‐‐‐0.407kg 4. Acetone‐‐‐‐‐0.1254kg 5. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)‐‐‐‐‐‐‐‐0.62kg OR 5.a) O‐chloro Benzaldehyde‐‐‐‐‐0.5034kg b) Hydroxy Amine Sulphate‐‐‐‐‐0.3192kg c) Methyl Acetoacetate‐‐‐‐‐0.410kg d) Chloroform‐‐‐‐‐0.270kg e) Methylene chloride‐‐‐‐‐‐‐0.0542kg 6. Methylene Chloride/Ethyl Acetate‐‐‐‐‐0.620kg 7. 2‐Ethyl Hexanoic acid‐‐‐‐‐0.150kg The Commi찄ee also decided to fix SION of the export product as per above comments of PI Division. 43

Case No.:1/34/83‐ALC1/2006

Party Name:RA CHEM PHARMA LIMITED. 10.07.2007 Status:Case Approved HQ File :01/83/050/00677/AM07/ RLA File :09/24/040/00178/AM07/ Lic.No/Date:0910027582 15.09.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Fexofenadine Hcl under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 17.05.2007 decided to ra䈆fy the Export Product: 1. Fexofenadine Hcl ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Sodium boro hydride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 0.332Kg/Kg. 2. 4‐chloro butryl chloride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1.216Kg/Kg. 3. Dimethyl Sulfoxide ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.12Kg/Kg. 4. Methylene dichloride ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.00Kg/Kg. 5. Methanol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐4.00kg/kg. 6. Potassium Permanganate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1.905kg/kg. 7. Tetrahydrofuran ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐Not shown in the process 8. Toluene ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6.80kg/kg. 9. Gamma picolene‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 0.76kg/kg. 10. IPA ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.93kg/kg. 11. Methyl Isobutyl ketone ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.12kg/kg 44

Case No.:44/36/82‐ALC1/2006

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 10.07.2007 Status:Case Approved HQ File :01/82/050/00954/AM07/ RLA File :22/24/040/00233/AM07/ Lic.No/Date:2210006017 18.09.2006

Case No.:11/34/87‐ALC1/2006

Party Name:ALKALOIDS CORP 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Senega So頄 Extract under para 4.7 of HBP. The Commi찄ee decided that the report received from Central council for Research in Ayurveda and Siddhs, New Delhi vide their le찄er No.9‐4/2006‐ CCRAS/Admn. Dated 24.01.2007 may be forwarded to Department of Ayush for their comments. The case was accordingly deferred for four weeks. 46

Case No.:8/34/82‐ALC1/2006

Party Name:MAITHRI LABORATORIES (P) LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Moxifloxacin Hcl under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 47

Case No.:9/34/82‐ALC1/2006

Party Name:MAITHRI LABORATORIES (P) LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Moxifloxacin Hcl under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 48

Case No.:5/33/83‐ALC1/2006

Party Name:SRINI PHARMACEUTICALS LTD., 10.07.2007 Status:Case Approved HQ File :01/83/050/00719/AM07/ RLA File :09/24/040/00254/AM07/ Lic.No/Date:0910027672 26.09.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product N‐(1,4‐Benzodioxan‐2‐Carbonyl)Piperazine The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/8/2007‐PI‐III dated 28.04.2007 decided to ra䈆fy the Export Product: N‐(1,4‐Benzodioxan‐2‐Carbonyl)Piperazine ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Catechol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.07kg/kg. 2. Piperazine anhydrous ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.50kg/kg. 3. Acetone ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.57kg/kg. 4. IPA ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.06kg/kg. 49

Case No.:19/28/83‐ALC1/2006

Party Name:RANBAXY LABORATORIES LTD 10.07.2007 Status:Case Approved HQ File :01/83/050/00738/AM07/ RLA File :05/24/040/00551/AM07/ Lic.No/Date:0510191994 29.09.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Valacyclovir Hcl under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 17.05.2007 decided to ra䈆fy the Export Procuct: Valacyclovir Hcl ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Acyclovir ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.78Kg/kg. 2. CBZ‐L‐Valine ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.60kg/kg 3. Dicyclohexyl Carbodimide ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.47kg/kg 4. Dimethylamino Pyridine ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.028kg/kg 5. Dimethyl formamide ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.05kg/kg 6. Methanol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.47kg/kg 7. Acetone ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.69kg/kg 8. Ac䈆vated Carbon ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.0242kg/kg 50

Case No.:23/32/82‐ALC1/2006

Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 1‐Phenyl Propanolamine HCL (L‐Norephedrine Hcl) under para 4.7 of HBP. The Commi찄ee decided to call for technical details as per annexure of the applica䈆on from the firm and decided to defer the case for four weeks. 51

Case No.:24/32/82‐ALC1/2006

Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, 10.07.2007 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:07.08.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product L‐Norephedrine Base under para 4.7 of HBP. The Commi찄ee decided to call for technical details as per annexure of the applica䈆on from the firm and decided to defer the case for four weeks. 52

Case No.:1/43/83‐ALC1/2006

Party Name:SUVEN LIFE SCIENCES LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00781/AM07/ RLA File :09/24/040/00223/AM07/ Lic.No/Date:0910027848 10.10.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Doxofylline under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/254/2006‐PI‐III dated 16.04.2007 decided to ra䈆fy the Export Product: Doxofylline ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Theophylline ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.17kg/kg 2. Chloro acetaldehyde dimethyl acetal ‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.81kg/kg 3. Potassium carbonate ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.89kg/kg 4. Methanol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.63kg/kg. 5. Dimethyl formamide ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.56kg/kg 53

Case No.:20/31/83‐ALC1/2006

Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 10.07.2007 Status:Transferred to Different Sec䈆on HQ File :01/83/050/00782/AM07/ RLA File :03/95/040/00681/AM07/ Lic.No/Date:0310403341 10.10.2006 Defer Date: Decision :The Commi찄ee decided to transfer the case to DEC‐IV as the export product pertains to Chemical Sector.

Case No.:13/34/83‐ALC1/2006

Party Name:RA CHEM PHARMA LIMITED. 10.07.2007 Status:Case Approved HQ File :01/83/050/00802/AM07/ RLA File :09/24/040/00278/AM07/ Lic.No/Date:0910027867 18.10.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Drotaverine Hcl under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 17.05.2007 decided to ra䈆fy the Export Product: Drotaverine ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Ortho Diethoxy Benzene ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.86kg/kg 2. Iso Propyl Alcohol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.63kg/kg 3. Sodium Cyanide ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.48kg/kg. 4. Para Formaldehyde ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.30kg/kg. 5. Methanol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.26kg/kg. 55

Case No.:19/32/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00804/AM07/ RLA File :05/24/040/00559/AM07/ Lic.No/Date:0510192990 18.10.2006 : Decision :Withdrawn as the case has already been approved in NC mee䈆ng No.8 dated 28.06.2007. 56

Case No.:20/32/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00805/AM07/ RLA File :05/24/040/00561/AM07/ Lic.No/Date:0510192992 18.10.2006 Decision :Withdrawn as the case has already been approved in NC mee䈆ng No.8 dated 28.06.2007.

Case No.:21/32/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00806/AM07/ RLA File :05/24/040/00560/AM07/ Lic.No/Date:0510193028 19.10.2006 Decision : Withdrawn as the case has already been approved in NC mee䈆ng No.8 dated 28.06.2007. 58

Case No.:22/32/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00807/AM07/ RLA File :05/24/040/00562/AM07/ Lic.No/Date:0510193029 19.10.2006 Decision :Withdrawn as the case has already been approved in NC mee䈆ng No.8 dated 28.06.2007. 59

Case No.:29/36/83‐ALC1/2006

Party Name:SHALINA LABORATORIES PVT. LTD. 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Epiderm Lo䈆on 30ml under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 60

Case No.:31/36/83‐ALC1/2006

Party Name:SRINI PHARMACEUTICALS LTD., 10.07.2007 Status:Case Deferred HQ File :01/83/050/00857/AM07/ RLA File :09/24/040/00291/AM07/ Lic.No/Date:0910028095 03.11.2006 Defer Date:07.08.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Clonazepam under para 4.7 of HBP. The Commi찄ee decided to forward the complete set of applica䈆on to the Technical Authority. It was, therefore, decided to defer the case for four weeks. 61

Case No.:24/37/87‐ALC1/2006

Party Name:ADVY CHEMICAL 10.07.2007 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:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product C. Reac䈆ve Protein under para 4.7 of HBP. The Commi찄ee decided to defer the case for two weeks for want of comments from DBT. 62

Case No.:52/36/83‐ALC1/2006

10.07.2007 Status:Case Withdrawn HQ File :01/83/050/00925/AM07/ RLA File :05/24/040/00585/AM07/ Lic.No/Date:0510194529 16.11.2006 Decision :Withdrawn as the case has already been approved in NC Mee䈆ng No.8 dated 28.06.2007. 63

Case No.:4/43/83‐ALC1/2006

Party Name:SREENIVASA PHRAMA PVT LTD. 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 64

Case No.:34/40/82‐ALC1/2006

Party Name:KOPRAN LIMITED 10.07.2007 Status:Case Approved

HQ File :01/82/050/01372/AM07/ RLA File :03/94/040/00951/AM07/ Lic.No/Date:0310410420 01.12.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Ce頄riaxone Sodium Sterile under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/65/2007‐PI‐III dated 07.07.2007 decided to ra䈆fy the Export Product: Ce頄riaxone Sodium Sterile ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Ce頄riaxone Sodium Sterile‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.00kg/kg. 2. Acetone ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.08kg/kg 65

Case No.:8/38/83‐ALC1/2006

Party Name:SKM PHARMA(P)LTD., 10.07.2007 Status:Case Deferred HQ File :01/83/050/00964/AM07/ RLA File :07/24/040/00534/AM07/ Lic.No/Date:0710048801 01.12.2006 Defer Date:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product For䈆fied Procaine Pencillin 4 Mega Injec䈆on 20ml under para 4.7 of HBP. The Commi찄ee decided to call for the following informa䈆on as advised by PI Division vide their U.O. No.35011/9/2007‐PI‐III dated 07.07.2007 from the firm. Detailed working in line with the DML since the potency of the injec䈆on is not tallying with imported Bulk Drugs. Accordingly, the case was deferred for two weeks. 66

Case No.:12/41/80‐ALC2/2006

Party Name:BRAWN LABORATORIES LTD 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cefadroxil Capsule 500mg under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 67

Case No.:5/43/83‐ALC1/2006

Party Name:SUVEN LIFE SCIENCES LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/00977/AM07/ RLA File :09/24/040/00344/AM07/ Lic.No/Date:0910028525 06.12.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 2,4‐Dichloro Pyrimidine under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/14/2007‐PI‐III dated 16.04.2007 decided to ra䈆fy the Export Product: 2,4‐Dichloro Pyrimidine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1Kg. Import item: 1. Uracil(2,4‐Dihydroxy Pyrimidine) ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.12kg/kg 2. Dichloro methane (Methylene chloride)‐‐‐‐‐‐‐‐‐‐‐ 1.00kg/kg 3. Diethyl aniline ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.24kg/kg. 4. Triethylamine ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.09kg/kg 5. IPA ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.50 kg/kg 68

Case No.:4/45/83‐ALC1/2006

Party Name:SHREE GANESH CHEMICALS 10.07.2007 Status:Case Rejected HQ File :01/83/050/01051/AM07/ RLA File :34/24/040/00216/AM07/ Lic.No/Date:3410017694 22.12.2006

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Di‐Ethyl Amino Ethyl Chloride Hydrochloride The Commi찄ee noted that the export product is a SCOMET item. It was, therefore, decided to advise the firm to obtain the Export licence first. The case may be treated as closed. 69

Case No.:10/43/83‐ALC1/2006

Party Name:SUVEN LIFE SCIENCES LIMITED 10.07.2007 Status:Case Approved HQ File :01/83/050/01067/AM07/ RLA File :09/24/040/00400/AM07/ Lic.No/Date:0910028790 28.12.2006 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Iminoguanidyl‐2,3‐Dichlorobenzoyl Cyamide Phosphate under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/14/2007‐PI‐III dated 16.04.2007 decided to ra䈆fy the Export Product: Iminoguanidyl‐2,3‐Dichlorobenzoyl Cyamide Phosphate‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. 2,3,dichloro benzoyal chloride ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.20kg/kg 2. 1, Amino Guanidine bicarbonate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 0.80kg/kg 3. Poly Phosphoric acid ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐4.00kg/kg. 4. Acetonitrile‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1.00kg/kg 5. Cuprous cyanide ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.56kg/kg 70

Case No.:4/47/83‐ALC1/2006

10.07.2007 Status:Case Deferred HQ File :01/83/050/01080/AM07/ RLA File :05/24/040/00760/AM07/ Lic.No/Date:0510197129 02.01.2007 Defer Date:24.07.2007

Case No.:5/47/83‐ALC1/2006

10.07.2007 Status:Case Approved HQ File :01/83/050/01081/AM07/ RLA File :05/24/040/00743/AM07/ Lic.No/Date:0510197130 02.01.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. The Commi찄ee in light of the report of the Dep찄. of C&PC forwarded vide their U.O.No.35011/165/2006/PI‐III(Part‐IV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm whichever is lower. Export product Cloxacillin Sodium from Pen G route‐‐‐‐1kg Import items 1. Penicillin G Potassium first crystal‐‐‐‐‐1.43 BOU 2. Penicillin G Amidase (Enzyme)‐‐‐‐‐‐0.732gm 3. Methylene chloride‐‐‐‐0.407kg 4. Acetone‐‐‐‐‐0.1254kg 5. 3‐(2‐Chlorophenyl)‐5‐Methyl Isoxazole Carbonyl Chloride (CMIC Chloride)‐‐‐‐‐‐‐‐0.62kg OR 5.a) O‐chloro Benzaldehyde‐‐‐‐‐0.5034kg b) Hydroxy Amine Sulphate‐‐‐‐‐0.3192kg c) Methyl Acetoacetate‐‐‐‐‐0.410kg d) Chloroform‐‐‐‐‐0.270kg e) Methylene chloride‐‐‐‐‐‐‐0.0542kg 6. Methylene Chloride/Ethyl Acetate‐‐‐‐‐0.620kg 7. 2‐Ethyl Hexanoic acid‐‐‐‐‐0.150kg The Commi찄ee also decided to fix SION of the export product as per above comments of PI Division. 72

Case No.:11/46/82‐ALC1/2006

Party Name:BIOLOGICAL E LTD 10.07.2007 Status:Case Deferred

HQ File :01/82/050/01533/AM07/ RLA File :09/24/040/00409/AM07/ Lic.No/Date:0910028883 04.01.2007 Defer Date:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Noscapine Bulk under para 4.7 of HBP. The Commi찄ee decided to forward the copy of applica䈆on as well as the copy of reply received from the firm to the Technical Authority. It was, therefore, decided to defer the case for two weeks. 73

Case No.:3/49/82‐ALC1/2006

Party Name:MAITHRI LABORATORIES (P) LTD., 10.07.2007 Status:Case Approved HQ File :01/82/050/01543/AM07/ RLA File :09/24/040/00353/AM07/ Lic.No/Date:0910028954 10.01.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Atorvasta䈆n Calcium under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/275/2006‐PI‐III dated 26.06.2007 decided to ra䈆fy the Export Product: Atorvasta䈆n Calcium‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1Kg. Import item: 1. (4R‐Cis)‐1,1‐dimethyl ethyl‐6‐cyanomethyl‐2,2 dimethyl 1,3‐dioxane‐4‐acetate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1.08kg/kg 2. Raney Nickle ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.200kg/kg 3. Methanol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.49kg/kg 4. Aquious Ammonia ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.900kg/kg 5. Pivalic acid ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.200kg/kg 6. Cyclohexane ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.82kg/kg 7. Isopropyl alcohol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.24kg/kg 8. Acetonitrile ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.01kg/kg 9. Sodium Carbonate ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.500kg/kg 10. Hydrochloric Acid ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐Not an importable item 11. Sodium hydroxide flakes ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.130kg/kg 12. Toluene ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.37kg/kg 13. Calcium Acetate ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.350kg/kg 14. Carbon ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.100kg/kg 74

Case No.:6/47/83‐ALC1/2006

Party Name:NEO MEDICHEM PVT LTD. 10.07.2007 Status:Case Approved HQ File :01/83/050/01118/AM07/ RLA File :09/21/040/00467/AM07/ Lic.No/Date:0910028960 10.01.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 4(3,4‐Dichloro Phenyl)3,4‐Dihydro‐1‐(2H) Napthalinone under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 17.05.2007 decided to ra䈆fy the Export Product: 4(3,4‐Dichloro Phenyl)3,4‐Dihydro‐1‐(2H) Napthalinone ‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Alpha Naphthol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.95kg/kg 2. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 1.305kg/kg 3. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.87kg/kg 75

Case No.:15/48/82‐ALC1/2006

Party Name:LUPIN LIMITED 10.07.2007 Status:Case Deferred HQ File :01/82/050/01626/AM07/ RLA File :03/95/040/01257/AM07/ Lic.No/Date:0310415601 12.01.2007 Defer Date:24.07.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cefadroxil under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought deferment for two weeks. The Commi찄ee, therefore, decided to defer the case for two weeks. 76

Case No.:20/48/87‐ALC1/2006

Party Name:ALCHEM INTERNATIONAL LTD. 10.07.2007 Status:Case Approved HQ File :01/87/050/00927/AM07/ RLA File :05/24/040/00765/AM07/ Lic.No/Date:0510198359 24.01.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Hyoscine‐N Butyl Bromide or Hyoscine Hydro Bromide under para 4.7 of HBP. The Commi찄ee decided to ra䈆fy the norms of the export product under para 4.7 of HBP as per SION at Sl.No.A‐263. The Commi찄ee also decided to seek clarifica䈆on from RLA as to why the licence has been issued under para 4.7 of HBP while the SION for the export product has already been fixed.

Case No.:21/48/82‐ALC1/2006

Party Name:IPCA LABORATORIES LIMITED 10.07.2007 Status:Case Approved HQ File :01/82/050/01659/AM07/ RLA File :03/94/040/01126/AM07/ Lic.No/Date:0310417068 24.01.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Hydroxy Chloroquine Sulphate under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/64/2006‐PI‐III dated 10.07.2007 decided to ra䈆fy the Export Product: Hydroxy Chloroquine Sulphate ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Ethoxy Methylene Malonic Acid Ester ‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.22kg/kg 2. Metachloro aniline ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.718kg/kg 3. Toluene ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.702kg/kg 4. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 5.045kg/kg 5. Hydroxy Novaldiamine ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.06kg/kg 6. Iso Propyl alcohol ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.49kg/kg 7. Methylene chloride ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.29kg/kg 8. Ac䈆vated carbon ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.100kg/kg 78

Case No.:7/47/83‐ALC1/2006

Party Name:SURYA PHARMACEUTICAL LTD 10.07.2007 Status:Case Deferred HQ File :01/83/050/01170/AM07/ RLA File :05/24/040/00848/AM07/ Lic.No/Date:0510198449 25.01.2007 Defer Date:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Cefpodoxime Proxe䈆l under para 4.7 of HBP. The Commi찄ee noted that the firm has not furnished the technical details alongwith their applica䈆on. It was, therefore, decided to call for the technical details from the firm and also to seek the clarifica䈆on from the office of Jt. DGFT, CLA, New Delhi as to why the advance licence has been issued to the firm without the technical details. Accordingly, the case was deferred for four weeks.

Case No.:6/50/87‐ALC1/2006

Party Name:ALKEM LABORATORIES LTD., 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Amoxycillin and Clavulanate Potassium Tablets The Commi찄ee decided to forward the complete set of applica䈆on to the Technical Authority. The case was, therefore, deferred for four weeks. 80

Case No.:4/1/83‐ALC1/2007

Party Name:VIJAY PERFUMES PVT.LTD. 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product N‐Methyl Benzothiazene Methyl Ester under

para 4.7 of HBP.

The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 81

Case No.:1/10/82‐ALC4/2007

Party Name:HAFFKINE BIO PHARMACEUTICAL CORPN LTD 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Oral Polio Vaccine (OPV) under para 4.7 of HBP. The Commi찄ee decided to forward the applica䈆on of the firm to Department of Bio‐Technology and to defer the case for four weeks. 82

Case No.:2/10/82‐ALC4/2007

Party Name:LEPRO HERBALS PVT. LTD. 10.07.2007 Status:Case Approved

HQ File :01/82/050/01652/AM07/ RLA File :05/24/040/00927/AM07/ Lic.No/Date:0510199597 15.02.2007 : Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Enoxolone EP/BP under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/163/2006‐PI‐III dated 10.07.2007 decided to ra䈆fy the Export Product: Enoxolone EP/BP ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Glycyrrhizinic Acid‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 2.97kg/kg 83

Case No.:3/2/82‐ALC4/2007

Party Name:DR REDDYS LABORATORIES LTD 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 2‐(6‐Methoxy‐2‐naphthyl)propionic acid (DL‐ Acid) under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 84

Case No.:3/10/82‐ALC4/2007

Party Name:LUPIN LIMITED 10.07.2007 Status:Case Approved HQ File :01/82/050/01785/AM07/ RLA File :03/95/040/01509/AM07/ Lic.No/Date:0310422638 09.03.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product 7ADCA from Pen G Route under para 4.7 of HBP. The Commi찄ee decided to ra䈆fy the norms of the export product as per revised SION at Sl.No.A‐35 published vide Public No䈆ce No.2 dated 19.04.2007. 85

Case No.:7/2/82‐ALC4/2007

Party Name:CIPLA LIMITED 10.07.2007 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:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Triomune 30 under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 86

Case No.:4/10/82‐ALC4/2007

Party Name:MSN PHARMACHEM PRIVATE LIMITED 10.07.2007 Status:Case Deferred HQ File :01/82/050/01807/AM07/ RLA File :09/24/040/00422/AM07/ Lic.No/Date:0910029669 14.03.2007 Defer Date:07.08.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Moxifloxacin Hydrochloride under para 4.7 of HBP. The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 87

Case No.:5/10/82‐ALC4/2007

Party Name:GLAXOSMITHKLINE PHARMACEUTICALS LIMITED, 10.07.2007 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:07.08.2007

Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Betamethasone Di‐Sodium Phosphate BP/USP The representa䈆ve of PI Division present in the mee䈆ng informed the Commi찄ee that the case is under examina䈆on in their Department and he sought 88

Case No.:4/4/82‐ALC4/2007

Party Name:SANJAY SALES CORPORATION 10.07.2007 Status:Case Approved HQ File :01/82/050/00021/AM08/ RLA File :03/95/040/01619/AM07/ Lic.No/Date:0310427817 25.04.2007 Decision :The Commi찄ee considered the case as per agenda for ra䈆fica䈆on of norms for the export product Acetyl Salicylic Acid (Aspirin) under para 4.7 of HBP. The Commi찄ee in the light of wri찄en comments forwarded by PI Division vide their U.O. No.35011/1136/2006‐PI‐III dated 18.10.2006 decided to ra䈆fy the Export Product: Acetyl Salicylic Acid (Aspirin) ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: 1. Salicylic Acid ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.820kg/kg 2. Ace䈆c Anhydride ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.697kg/kg. 89

Case No.:6/4/82‐ALC4/2007

Party Name:SHALINA LABORATORIES PVT. LTD. 10.07.2007 Status:Case Withdrawn 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 :Withdrawn as the case has already been considered by the Commi찄ee in its 8/08 mee䈆ng held on 28.06.2007 and was deferred for four weeks.

Minutes of the Norms Committee Meeting No. 10/08 held on 10.07.07 under the Chairmanship of Shri Sanjay Rastogi, Export Commissioner. The Committee first considered the minutes of the NC Meeting No. 09/08 held on 03.07.07 for confirmation and confirmed and adopted the same.

CASE NO. A214

M/S RANBAXY LAB LTD M. No. 10/08 F.NO. 01/82/50/1134/AM07 DATED 10.7.2007 RLA NO.05/24/40/819/AM07 ADV. LIC.NO. 0510197930 DT. 16.01.07 The Committee considered the case as per agenda for ratification of Norms for the Export Product Ciprofloxacin Tablets USP 250 mg/500mg/750mg 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.

CASE NO. A215

M/S WOCKHARDT LTD M. No. 10/08 F.NO. 01/82/50/155/AM08 RLA NO.03/95/40/44/AM08 ADV. LIC.NO.0310427335 DT. 19.04.07 The Committee considered the case as per agenda for ratification of Norms

for the Export Product Hydroxocobalamin Acetate/HCL under para 4.7 of HBP. for four weeks.

CASE NO. A216

M/S SHIVA PHARMACHEM PVT.LTD M. No. 10/08 F.NO. 01/82/50/1302/AM07 RLA NO.34/24/40/257/AM07 ADV. LIC.NO. 3410018220 DT. 1.03.07 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

CASE NO. A217

M/S RANBAXY LAB LTD M. No. 10/08 F.NO. 01/82/50/107/AM08 RLA NO.05/24/40/17/AM08 ADV. LIC.NO. 0510202504 DT. 13.04.07 The Committee considered the case as per agenda for ratification of Norms for the Export Product Isotretinion under para 4.7 of HBP.

for four weeks.

CASE NO. A218

M/S R.A.CHEM PHARMA LTD M. No. 10/08 F.NO. 01/82/50/1238/AM07 RLA NO.09/24/40/404/AM07 ADV. LIC.NO. 0910029307 DT. 12.02.07 The Committee considered the case as per agenda for ratification of Norms for the Export Product 2,3 – Di Chloro Benzoyl Cyanide under para 4.7 of HBP. for four weeks.

CASE NO. A219

M/S AROFINE CHEMICAL INDUSTRIES M. No. 10/08 F.NO. 01/82/50/361/AM08 RLA NO.03/94/40/1188/AM07 ADV. LIC.NO. 0310429793DT. 17.05.07 The Committee decided to transfer the case to DESIV as the export

CASE NO. A220

M/S ALKEM LABORATORIES LTD M. No. 10/08 F.NO. 01/82/50/409/AM08 RLA NO.03/94/40/187/AM08 ADV. LIC.NO. 0310430680 DT. 25.05.07 The Committee considered the case as per agenda for ratification of Norms for the Export Product SUCRALOSE USP under para 4.7 of HBP. The Committee noted that the firm has given an undertaking that the export product is outside Pharma. It was, therefore, decided to transfer the case to DESVI as the export product pertains to Food Products.

CASE NO. A221

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/386/AM08 RLA NO.03/94/40/74/AM08 ADV. LIC.NO. 0310430456 DT. 24.05.07 The Committee considered this case as per agenda for ratification of Norms for the Export Product ZOLPIDEM TARTRATE under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O.No.35011/41/2007PIIII dated 16.04.2007 decided to ratify the norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Export product: Zolpidem Tartrate1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 2Amino 5Methyl Pyridine 1.21Kg/Kg. 2. 4Methoxy Phenacyl Bromide 2.39Kg/Kg. 3. Tri ethyl amine 1.43Kg/Kg. 4. Methanol 3.88Kg/Kg. 5. Acetone 2.60Kg/Kg. 6. Formic Acid 99% 4.33Kg/Kg. 7. Ethylene di chloride 1.88Kg/Kg. 8. Tartaric acid 0.18Kg/Kg. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A222

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/406/AM08 RLA NO.03/94/40/72/AM08 ADV. LIC.NO. 0310430653 DT. 25.05.07 The Committee considered this case as per agenda for ratification of Norms for the Export Product HYDROCORTISONE SODIUM SUCCINATE (BP/USP) under para 4.7 of HBP.

The Committee in the light of written comments forwarded by PI Division vide their U.O.No.35011/41/2007PIIII dated 16.04.2007 decided to ratify the norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: HYDROCORTISONE SODIUM SUCCINATE (BP/USP) 1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. Hydrocortisone 1.10Kg/Kg. 2. Dimethyl Formamide 1.00Kg/Kg. 3. Acetone 1.00Kg/Kg. 4. Isopropyl Alcohol 0.35Kg/Kg.

CASE NO. A223

M/S GLENMAARK PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/50/102/AM08 RLA NO.03/94/40/12/AM08 ADV. LIC.NO. 0310426504 DT. 12.04.07 The Committee considered the case as per agenda for ratification of Norms for the Export Product IMIQUIMOD under para 4.7 of HBP.

The representative of PI Division present in the meeting informed the for four weeks.

CASE NO. A224

M/S GLENMAARK PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/50/108/AM08 RLA NO.03/94/40/16/AM08 ADV. LIC.NO. 0310426673 DT. 13.04.07 The Committee considered the case as per agenda for ratification of Norms for the Export Product NATEGLINIDE under para 4.7 of HBP. 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.

CASE NO. A225

M/S GLENMAARK PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/50/534/AM08 RLA NO.03/94/40/80/AM08 ADV. LIC.NO. 0310432288 DT. 11.06.07

The Committee considered this case as per agenda for ratification of Norms for the Export Product CILOSTAZOL under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O.No.35011/243/2006PIIII dated 05.12.2006 decided to ratify the norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Cilostazol1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 5(4chlorobutyl)1cycloh exyl1H Tetrazole 0.88Kg/Kg. 2. 6Hydroxy3,4Dihydro1HdQuimolin2 one 0.59Kg/Kg. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A226

M/S GLENMAARK PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/50/156/AM08 RLA NO.03/94/40/33/AM08 ADV. LIC.NO. 0310427353 DT. 19.04.07 The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product LERCANIDIPINE under para 4.7 of HBP.

The Committee in the light of written comments forwarded by PI Division vide their U.O. No.35011/253/2006PIIII dated 18.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: Lercanidipine1Kg. Import Items: Sl.No. Description of import items Quantity allowed 1. 3,3diphenyl propolamine 1.19Kg/Kg. 2. Tetrahydrofuran 2.90Kg/Kg. 3. Methylene chloride 4.88Kg/Kg. 4. 1chloro2 Methyl2 propanol 0.507Kg/Kg. 5. Isopropyl acetate 6.83Kg/Kg. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A227

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/405/AM08 RLA NO.03/94/40/169/AM08

ADV. LIC.NO. 0310430651 DT. 25.05.07 The Committee considered this case as per agenda for fixation of I/O Norms for the Export Product CELECOXIB under para 4.7 of HBP. deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A228

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/154/AM08 RLA NO.03/94/40/1475/AM07 ADV. LIC.NO. 0310427333 DT. 19.04.07 Norms for the Export Product Acrylate (Methyl3Cyclopropyl Amino 20(2,4 Dichloro5Fluro Benzyl Acrylate under para 4.7 of HBP. 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.

CASE NO. A229

M/S AARTI DRUGS LTD

M. No. 10/08 F.NO. 01/82/50/137/AM08 RLA NO.03/94/40/1340/AM08 ADV. LIC.NO. 0310427124 DT. 18.04.07 Norms for the Export Product ZOLPIDEM TARTRATE under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O.No.35011/41/2007PIIII dated 16.04.2007 decided to ratify the norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Zolpidem Tartrate1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 2Amino 5Methyl Pyridine 1.21Kg/Kg. 2. 4Methoxy Phenacyl Bromide 2.39Kg/Kg. 3. Tri ethyl amine 1.43Kg/Kg. 4. Methanol 3.88Kg/Kg. 5. Acetone 2.60Kg/Kg. 6. Formic Acid 99% 4.33Kg/Kg. 7. Ethylene di chloride 1.88Kg/Kg. 8. Tartaric acid 0.18Kg/Kg. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A230

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/186/AM08 RLA NO.03/94/40/45/AM08 ADV. LIC.NO. 0310427814 DT. 25.04.07 Norms for the Export Product TICLOPIDINE HYDROCHLORIDE under para 4.7 of HBP sought deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks. .

CASE NO. A231

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/138/AM08 RLA NO.03/94/40/1354/AM07 ADV. LIC.NO. 0310427123 DT. 18.04.07 Norms for the Export Product NIMESULIDE under para 4.7 of HBP.

sought deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks

CASE NO. A232

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/109/AM08 RLA NO.03/94/40/1201/AM07 ADV. LIC.NO. 0310426688 DT. 13.04.07 Norms for the Export Product (S,S)2Azabicyclo(3.3.0(Octane3Carboxylic Acid Benzylester Hydrochloride under para 4.7 of HBP. sought deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A233

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/151/AM08 RLA NO.03/94/40/1304/AM07 ADV. LIC.NO. 0310427319 DT. 19.04.07 Norms for the Export Product CELECOXIB under para 4.7 of HBP.

sought deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A234

M/S AUROBINDO PHARMA LTD M. No. 10/08 F.NO. 01/82/50/1002/AM07 RLA NO.09/24/40/467/AM07 ADV. LIC.NO. 0910029325 DT. 13.02.07 Norms for the Export Product CEPHALEXIN MONOHYDRATE (FROM PEN G ROUTE) The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower.

CASE NO. A235

M. No. 10/08 F.NO. 01/82/50/987/AM07 RLA NO.09/24/40/451/AM07

ADV. LIC.NO. 0910029300 DT. 12.02.07 Norms for the Export Product AMPICILLIN SODIUM STERILE under para 4.7 of HBP. sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.

CASE NO. A236

M. No. 10/08 F.NO. 01/82/50/875/AM07 RLA NO.09/24/40/102/AM07 ADV. LIC.NO. 0910028895 DT. 05.01.07 Norms for the Export Product AMOXYCILLIN TRIHYDRATE (FROM 6APA ROUTE) and Ampicillin Trihydrate (From 6APA Route) under para 4.7 of HBP. The Committee decided to ratify the norms under para 4.7 of the HBP as per revised SION at Sl.No.A57 and A68 published vide Public Notice No.58 dated 26.09.2006 and Public Notice No.2 dated 19.04.2007 respectively. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A237

M. No. 10/08 F.NO. 01/82/50/885/AM07 RLA NO.09/24/40/384/AM07 ADV. LIC.NO. 0910028958 DT. 10.01.07 Norms for the Export Product CEPHALEXIN MONOHYDRATE (FROM PEN G ROUTE) revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower.

CASE NO. A238

M. No. 10/08 F.NO. 01/82/50/1017/AM07 RLA NO.09/24/40/438/AM07 ADV. LIC.NO. 0910029340 DT. 14.02.07 Norms for the Export Product AMPICILLIN TRIHYDRATE (FROM 6APA ROUTE)

The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower.

CASE NO. A239

M. No. 10/08 F.NO. 01/82/50/998/AM07 RLA NO.09/24/40/461/AM07 ADV. LIC.NO. 0910029320 DT. 13.02.07 Norms for the Export Product CEPHALEXIN MONOHYDRATE (FROM PEN G ROUTE) revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A240

M. No. 10/08 F.NO. 01/82/50/1001/AM07 RLA NO.09/24/40/455/AM07 ADV. LIC.NO. 0910029324 DT. 13.02.07 Norms for the Export Product AMPICILLIN TRIHYDRATE (FROM 6APA ROUTE) The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower.

CASE NO. A241

M. No. 10/08 F.NO. 01/82/50/1000/AM07 RLA NO.09/24/40/355/AM07 ADV. LIC.NO. 0910029322 DT. 13.02.07 Norms for the Export Product QUETIAPINE FUMERATE under para 4.7 of HBP.

sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.

CASE NO. A242

M. No. 10/08 F.NO. 01/82/50/986/AM07 RLA NO.09/24/40/302/AM07 ADV. LIC.NO. 0910029299 DT. 12.02.07 Norms for the Export Product STAVUDINE under para 4.7 of HBP. sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.

CASE NO. A243

M. No. 10/08 F.NO. 01/82/50/1067/AM07 RLA NO.09/24/40/367/AM07 ADV. LIC.NO. 0910029461 DT. 27.02.07 Norms for the Export Product CLOXACILLIN SODIUM (FROM 6 APA 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 RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A244

M. No. 10/08 F.NO. 01/82/50/997/AM07

RLA NO.09/24/40/454/AM07 ADV. LIC.NO. 0910029319 DT. 13.02.07 Norms for the Export Product AMPICILLIN TRIHYDRATE (FROM 6APA ROUTE) The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A68 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower.

CASE NO. A245

M. No. 10/08 F.NO. 01/82/50/999/AM07 RLA NO.09/24/40/232/AM07 ADV. LIC.NO. 0910029321 DT. 13.02.07 Norms for the Export Product CEPHALEXIN MONOHYDRATE (FROM PEN G ROUTE) revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007 or as applied by the firm whichever is lower.

CASE NO. A246

M. No. 10/08 F.NO. 01/82/50/1082/AM07 RLA NO.09/24/40/510/AM07 ADV. LIC.NO. 091002951 DT. 06.03.07 Norms for the Export Product NEVIRAPINE (FROM DMF ROUTE) under para 4.7 of HBP. sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.

CASE NO. A247

M/S ANUH PHARMA LTD M. No. 10/08 F.NO. 01/82/50/1122/AM07 RLA NO.03/94/40/1299/AM07 ADV. LIC.NO. 0310423834 DT. 21.03.07

Norms for the Export Product CLOBETASOL PROPIONATE BP under para 4.7 of HBP. for four weeks.

CASE NO. A248

M/S ALEMBIC LTD M. No. 10/08 F.NO. 01/82/50/48/AM08 RLA NO.34/24/40/01/AM08 ADV. LIC.NO. 3410018493 DT. 05.04.07 Norms for the Export Product LEFLUNOMIDE under para 4.7 of HBP. for four weeks.

CASE NO. A249

M/S ALEMBIC LTD M. No. 10/08 F.NO. 01/82/50/244/AM08

RLA NO.34/24/40/22/AM08 ADV. LIC.NO. 3410018712 DT. 03.05.07 Norms for the Export Product VENLAFAXINE HYDROCHLORIDE under para 4.7 of HBP. for four weeks.

CASE NO. A250

M. No. 10/08 F.NO. 01/82/50/141/AM08 RLA NO.09/24/40/01/AM08 ADV. LIC.NO. 0910030047 DT. 18.04.07 Norms for the Export Product ABACAVIR SULFATE (FROM DMF ROUTE) under

para 4.7 of HBP.

sought deferment for four weeks. The Committee, therefore, decided to defer the case for four weeks.

CASE NO. A251

M/S EMMESSAR BIOTECH & NUTRITION LTD M. No. 10/08 F.NO. 01/82/50/98/AM08 RLA NO.03/94/40/1301/AM07 ADV. LIC.NO. 0310426345 DT. 11.04.07 Norms for the Export Product METHYL SULFONY METHANE under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A252

M/S ARIANE ORGACHEM PVT. LTD M. No. 10/08 F.NO. 01/82/50/336/AM08 RLA NO.03/94/40/1422/AM07 ADV. LIC.NO. 0310429564 DT. 16.05.07 Norms for the Export Product FRUSEMIDE BP (FUROSEMIDE BP) under para 4.7 of HBP. deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A253

M/S AMBERNATH ORGANICS PVT. LTD M. No. 10/08 F.NO. 01/82/50/360/AM08 RLA NO.03/94/40/68/AM08 ADV. LIC.NO. 0310429791 DT. 17.05.07 Norms for the Export Product ISATOIC ANHYDRIDE under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A254

M/S ALLIANCE LABORATORIES PVT. LTD M. No. 10/08 F.NO. 01/82/50/424/AM08 RLA NO.03/94/40/160/AM08 ADV. LIC.NO. 0310430399 DT. 23.05.07 Norms for the Export Product ISO SORBIDE5MONONITRATE under para 4.7 of HBP. for four weeks.

CASE NO. A255

M/S ACACIA LIFE SCIENCE PVT. LTD M. No. 10/08 F.NO. 01/82/50/1086/AM07 RLA NO.09/24/40/492/AM07 ADV. LIC.NO. 0910029581 DT. 08.03.07 Norms for the Export Product METHYLOXIME HYDROCHLORIDE under para 4.7 of HBP. for four weeks.

CASE NO. A256

M/S ARVEE CHEM PHARMA PVT. LTD M. No. 10/08 F.NO. 01/82/50/297/AM08 RLA NO.07/24/40/84/AM08 ADV. LIC.NO. 0710051589 DT. 10.05.07 Norms for the Export Product DIBENZOSUBERONE CHEMICAL PRODUCT under

para 4.7 of HBP.

for four weeks.

CASE NO. A257

M/S ASTRIX LABORATORIES LTD M. No. 10/08 F.NO. 01/82/50/440/AM07 RLA NO.09/24/40/440/AM07 ADV. LIC.NO. 0910029251 DT. 8.2.07 Norms for the Export Product LAMIVUDINE (CYCLOHEXYL ESTER ROUTE) under

para 4.7 of HBP.

for four weeks.

CASE NO. A258

M/S ARCH PHARMA LABS LTD M. No. 10/08 F.NO. 01/82/50/1131/AM07 RLA NO.03/94/40/1347/AM07 ADV. LIC.NO. 0310423982 DT. 22.03.07 Norms for the Export Product DICMIC CHLORIDE under para 4.7 of HBP.

The Committee in light of the written comments forwarded by PI Division vide their U.O.No.35011/192/2006PIIII dated 24.4.2007 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 DICMIC Chloride1kg Import items 1. DICMIC acid0.98kg/Kg 2. Phosphorus Pentachloride0.77kg/Kg 3. Methylene chloride/toluene0.70kg/Kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A259

M/S ALEMBIC LTD M. No. 10/08 F.NO. 01/82/50/37/AM08 RLA NO.34/24/40/290/AM07 ADV. LIC.NO. 3410018404 DT. 23.03.07 Norms for the Export Product AZHHROMYCIN CRUDE under para 4.7 of HBP. for four weeks.

CASE NO. A260

M/S AUROBINDO PHARMA LTD M. No. 10/08 F.NO. 01/87/50/988/AM07 RLA NO.09/24/40/347/AM07 ADV. LIC.NO. 0910029301 DT. 12.02.07 Norms for the Export Product CEFTRIAXONE DISODIUM HEMIHEPTAHYDRATE NON STERILE under para 4.7 of HBP. vide their U.O. No.35011/22/2007PIIII dated 28.06.2007 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: Ceftriaxone Sisodium hemiheptahydrate non Sterile (Ceftriaxone Disodium non sterile)1Kg. Import items: Sl.No. Description of import items Quantity allowed 1. 7 ACA 0.662Kg/Kg. 2. 2 Ethyl hexanoic acid 0.816Kg/Kg. 3. Acetone 13.00Kg/Kg. 4. MAEM 0.81Kg/Kg. 5. Tetrahydrofuran 1.22Kg/Kg. 6. Triethylamine 0.419Kg/Kg.

CASE NO. A261

M/S AUCTUS PHARMA PVT. LTD M. No. 10/08 F.NO. 01/87/50/1106/AM07 RLA NO.09/24/40/480/AM07 ADV. LIC.NO. 09100296666 DT. 14.03.07 Norms for the Export Product PANTOPRAZOLE SULFIDE under para 4.7 of HBP vide their U.O. No.35011/274/2006PIIII dated 25.05.2007 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: 5(dichloromethoxy)2[(3,4dimethoxy2pyridinyl)methyl} thio]1 H Benzimidazole (Pentaprazole sulphide)1Kg. Import items: Sl.No. Description of import items Quantity allowed 1. 2chloromethyl3,4dimethoxypyridine Hcl 0.75Kg/Kg. 2. 2,5difluoromethoxy2mercapto1H benzimidazole 0.75Kg/Kg.

Acetone 1.69Kg/Kg. 4. Methanol 3.81Kg/Kg. 5. Methylene chloride 2.91Kg/Kg. 6. Caustic Soda Flakes 0.40Kg/Kg.

CASE NO. A262

M/S CADILA HEALTHCARE LTD M. No. 10/08 F.NO. 01/82/162/1479/AM07 RLA NO.08/24/40/355/AM07 ADV. LIC.NO. 0810063496 DT. 09.03.07 Norms for the Export Product ATORVASTAIN CONDENSATION PRODUCT PHARMA GRADE under para 4.7 of HBP. deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A263

M/S ANUH PHARMA LTD

M. No. 10/08 F.NO. 01/82/50/1430/AM08 RLA NO.03/81/39/03/AM07 ADV. LIC.NO. 0310404537 DT. 17.10.06 Norms for the Export Product ERYTHROMYCIN THIOCYANATE under para 4.7 of HBP. The Committee in the light of the earlier decision of Norms Committee in its42/06 meeting held on 08.02.2006 vide Case No.A199 for the same export product decided to ratify the norms of the export product as per details below or as applied by the firm whichever is lower. Export Product: Erythromycin Thiocyanate1Kg. Import item: Erythromycin Thiocyanate0.900Kg/Kg.

CASE NO. A264

M/S G AMPHRAY LABORATORIES LTD M. No. 10/08 F.NO. 01/82/50/1691/AM07 RLA NO.03/94/40/1193/AM07 ADV. LIC.NO. 0310420496 DT. 22.02.07

Norms for the Export Product PIPERAZINE ADIPATE BP/USP under para 4.7 of HBP. vide their U.O. No.35011/54/2006PIIII dated 27.02.2006 decided to ratify the norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Piperazine Adipate BP/USP1Kg. Import item: 1. Diethyl Diamine Piperazine0.380Kg/Kg. 2. Adipic acid0.675Kg/Kg.

CASE NO. A265

M/S GLENMARK PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/50/1896/AM07 RLA NO.03/94/40/1465/AM07 ADV. LIC.NO. 0310424767 DT. 28.03.07 Norms for the Export Product BUPROPION HYDROCHLORIDE USP under para 4.7 of HBP.

The Committee in light of the written comments forwarded by PI Division vide their U.O.No.35011/191/2006PIIII dated 8.1.2007 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: Bupropion Hcl. USP1kg. Import items 1. Mchloro propiophenone0.85kg/Kg. 2. MethanolNot shown in the processor material balance 3. Methelene chloride/Methelene Dichloride/MDC2.00kg/Kg. 4. Acetonitrile1.00kg/Kg.

CASE NO. A266

M/S GLENMARK PHARMACEUTICAL LTD M. No. 10/08 F.NO. 01/82/50/1754/AM07 RLA NO.03/94/40/1307/AM07 ADV. LIC.NO. 0310421960 DT. 06.03.07 Norms for the Export Product NITAZOXANIDE under para 4.7 of HBP. The Committee in light of the written comments of the Deptt. of C&PC forwarded vide their U.O.No. 35011/253/2006/PIIII dated 16.4.2007 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

Nitazoxanide1kg Import items 1. 2Amino 5 Nitro Thiazole0.472kg 2. OAcetyl Salcyloyl Chloride0.640kg 3. Methylene dlchloride/MDC/Methylene chloride0.750kg 4. Methanol2.00Ltrs./kg 5. Triethylamine0.716kg 6. Tetrahydrofuran1.40kg

CASE NO. A267

M/S HETERO DRUGS LTD M. No. 10/08 F.NO. 01/82/50/1650/AM07 RLA NO.09/24/40/483/AM07 ADV. LIC.NO. 0910029354 DT. 15.02.07 Norms for the Export Product FOSINOPRIL SODIUM under para 4.7 of HBP. for four weeks.

CASE NO. A268

M. No. 10/08 F.NO. 01/82/50/1135/AM07 RLA NO.09/24/40/522/AM07 ADV. LIC.NO. 0910029746 DT. 23.03.07 Norms for the Export Product CITALOPRAM HYDROBROMIDE (FROM DMF ROUTE) for four weeks.

CASE NO. A269

M/S GLENMARK PHARMACEUTICAL LTD M. No. 10/08 F.NO. 01/82/50/157/AM08 RLA NO.03/94/40/47/AM08 ADV. LIC.NO. 0310427357 DT. 19.04.07 Norms for the Export Product LERCANIDIPINE under para 4.7 of HBP. vide their U.O. No.35011/253/2006PIIII dated 18.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: Lercanidipine1Kg.

Import Items: Sl.No. Description of import items Quantity allowed 1. 3,3diphenyl propolamine 1.19Kg/Kg. 2. Tetrahydrofuran 2.90Kg/Kg. 3. Methylene chloride 4.88Kg/Kg. 4. 1chloro2 Methyl2 propanol 0.507Kg/Kg. 5. Isopropyl acetate 6.83Kg/Kg.

CASE NO. A270

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/169/AM08 RLA NO.03/94/40/46/AM07 ADV. LIC.NO. 0310427426 DT. 20.04.07 Norms for the Export Product DICLOFENAC SODIUM under para 4.7 of HBP. for four weeks.

CASE NO. A271

M/S ASSOCIATED CAPSULES PVT. LTD M. No. 10/08 F.NO. 01/82/50/324/AM08 RLA NO.03/94/40/118/AM08 ADV. LIC.NO. 0310429392 DT. 15.05.07 Norms for the Export Product CELLULOSE CAPSULES under para 4.7 of HBP. vide their U.O. No.35011/35/2007PIIII dated 10.07.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: Hydroxy Propyl methyl Cellulose Capsules (Unprinted cellulose capsules)1Kg. Import item: Hydroxy Propyl Methyl Cellulose (Cellulose Ether)1.16Kg.

CASE NO. A272

M/S ENVEE DRUGS PVT. LTD M. No. 10/08 F.NO. 01/82/50/143/AM08 RLA NO.34/24/40/296/AM07 ADV. LIC.NO. 3410018601 DT. 18.04.07 Norms for the Export Product BETAMETHASONE VALERATE BP/USP under para 4.7 of HBP. for four weeks.

CASE NO. A273

M/S HINDUSTAN POLYAMIDES & FIBRES LTD M. No. 10/08 F.NO. 01/82/50/219/AM08 RLA NO.03/94/40/59/AM07 ADV. LIC.NO. 0310428204 DT. 27.04.07 Norms for the Export Product under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A274

M/S HINDUSTAN POLYAMIDES & FIBRES LTD M. No. 10/08 F.NO. 01/82/50/301/AM08 RLA NO.03/94/40/73/AM08 ADV. LIC.NO. 0310429106 DT. 11.05.07 Norms for the Export Product HEXYL SALICYLATE under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A275

M/S AARTI DRUGS LTD M. No. 10/08 F.NO. 01/82/50/153/AM08 RLA NO.03/94/40/1222/AM07 ADV. LIC.NO. 0310427326 DT. 19.04.07 Norms for the Export Product Acrylate (Methyl3Cyclopropyl Amino 2(2,4 Dichloro5Fluro Benzyl Acrylate) under para 4.7 of HBP. deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A276

M/S INDSWIFT LABORATORIES LTD M. No. 10/08 F.NO. 01/82/50/02/AM08 RLA NO.22/24/40/297/AM07 ADV. LIC.NO. 2210006382 DT. 13.02.07 Norms for the Export Product EZETHIMIBE under para 4.7 of HBP. for four weeks.

CASE NO. A277

M/S KDL BIOTECH LTD M. No. 10/08 F.NO. 01/82/162/241/AM07 RLA NO.03/94/40/1280/AM06 Norms for the Export Product IMMOBILISED PENCILLIN ‘G’ AMIDASE (ENZYME)

The Committee in the light of written comments forwarded by Department of Biotechnology vide their O.M. No.BT/IL/05/176/2004/PID dated 20.06.2007 decided to ratify the norms under para 4.7 of HBP by allowing items as applied for at 0% wastage level.

CASE NO. A278

M/S NEO MEDICHEM PVT. LTD M. No. 10/08 F.NO. 01/82/50/1289/AM07 RLA NO.09/24/40/465/AM07 ADV. LIC.NO. 0910029462DT. 27.2.07 Norms for the Export Product 4(3,4Dichloro Phenyl) 3,4Dihydro –1(2H) Napthalinone under para 4.7 of HBP. vide their U.O. No.35011/253/2006PIIII dated 18.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: 4(3,4Dichloro Phenyl) 3,4Dihydro –1(2H) Napthalinone1Kg. Import items:

Sl.No. Description of import item Quantity allowed 1. Alpha Naphthol 0.95Kg/Kg. 2. Methanol 1.305Kg/Kg. 3. Acetone 1.87Kg/Kg.

CASE NO. A279

M/S NAVIN FLUORINE INTERNATIONAL LTD M. No. 10/08 F.NO. 01/82/50/454/AM08 RLA NO.03/95/40/67/AM08 ADV. LIC.NO. 0310431070 DT. 30.05.07 Norms for the Export Product PARA FLUORO BROMO BENZENE/(4 FLUORO BROMO BENZENE) under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A280

M/S NEXUZ PHARMA LTD M. No. 10/08 F.NO. 01/82/50/76/AM08

RLA NO.08/24/40/317/AM07 ADV. LIC.NO. 0810062842 DT. 9.2.07 Norms for the Export Product DEXAMETHASONE IP/BP/USP under para 4.7 of HBP. for four weeks.

CASE NO. A281

M/S KDL BIOTECH LTD M. No. 10/08 F.NO. 01/82/50/77/AM08 RLA NO.03/94/40/1430/AM07 ADV. LIC.NO. 0310429938 DT. 21.05.07 Norms for the Export Product CEFADROXIL BP/UP/EP/MICRONISED/COMPACT POWDER under para 4.7 of HBP. deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A282

M/S LYKA BDR INTL. LTD M. No. 10/08 F.NO. 01/82/50/89/AM08 RLA NO.03/95/40/1309/AM07 ADV. LIC.NO. 0310419266 DT. 12.2.07 Norms for the Export Product under para 4.7 of HBP. for four weeks.

CASE NO. A283

M/S ISHITA DRUGS & INDS. LTD M. No. 10/08 F.NO. 01/82/50/90/AM08 RLA NO.08/24/40/49/AM08 ADV. LIC.NO. 0810065340 DT. 12.06.07 Norms for the Export Product SULFANILAMIDE under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A284

M/S KDL BIOTECH LTD

M. No. 10/08 F.NO. 01/82/50/91/AM08 RLA NO.03/94/40/1458/AM07 ADV. LIC.NO. 0310429941 DT. 12.05.07 Norms for the Export Product AMPICILLIN TRIHYDRATE Pen G Route under para 4.7 of HBP. revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or

CASE NO. A285

M/S KDL BIOTECH LTD M. No. 10/08 F.NO. 01/82/50/92/AM08 RLA NO.03/94/40/1409/AM07 ADV. LIC.NO. 0310429936 DT. 21.05.07 Norms for the Export Product AMPICILLIN TRIHYDRATE Pen G Route under para 4.7 of HBP. revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or

RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

CASE NO. A286

M/S REDOX PHARMA LTD M. No. 10/08 F.NO. 01/82/50/99/AM08 RLA NO.05/24/40/92/AM08 ADV. LIC.NO. 0510203860 DT. 18.05.07 Norms for the Export Product THYMOL ,PARA CYMENE under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A287

M/S RICHY GOLD INTERNATIONAL M. No. 10/08 F.NO. 01/82/50/100/AM08 RLA NO.03/95/40/69/AM08 ADV. LIC.NO. 0310429618 DT. 16.05.07 Norms for the Export Product METHYL DOPA TABLET under para 4.7 of HBP. vide their U.O. No.35011/11/2007PIIII dated 28.02.2007 decided to ratify the

norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: Methyl Dopa tablets 250 mg. Import item: Methyl Dopa288.15 kgm/1 million tablets.

CASE NO. A288

M/S RANBAXY LAB LTD M. No. 10/08 F.NO. 01/82/50/97/AM08 RLA NO.05/24/40/36/AM08 ADV. LIC.NO. 0510202774 DT. 20.04.07 Norms for the Export Product CIPROFLOXACIN TABLETS under para 4.7 of HBP. deferment for two weeks. The Committee, therefore, decided to defer the case for two weeks.

CASE NO. A289

M/S RANBAXY LAB LTD M. No. 10/08 F.NO. 01/82/50/98/AM08 RLA NO.05/24/40/37/AM07 ADV. LIC.NO. 0510202764 DT. 20.04.07 Norms for the Export Product LISINOPRIL under para 4.7 of HBP. vide their U.O. No.35011/228/2006PIIII dated 16.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export product: Lisinopril1Kg. Import items: Sl.No. Description of import items Quantity allowed 1. NTFALLyslLProline 1.39Kg/Kg. 2. Ethyl2oxo4phenyl Butanoate 0.85Kg/Kg. 3. Molecular sieves 0.375Kg/Kg. 4. Methylene chloride 5.59Kg/Kg. 5. Toluene 3.20Kg/Kg. 6. Activated Carbon 0.100Kg/Kg. 7. Isopropyl alcohol 2.21Kg/Kg. 8. Methanol 2.90Kg/Kg.

CASE NO. A290

M/S SHANTA BIOTECHNIC LTD M. No. 10/08 F.NO. 01/82/50/30/AM08 RLA NO.09/24/40/366/AM07 ADV. LIC.NO. 0910028896 DT. 05.01.07 Norms for the Export Product HEPATITIS B VACCINE HUMAN BODIES under para 4.7 of HBP. The Committee was informed that the DBT has requested for deferment of the case. It was decided to defer the case for two weeks.

CASE NO. A291

M/S MAKSON INDS. LTD M. No. 10/08 F.NO. 01/82/50/897/AM07 RLA NO.03/95/40/409/AM07 ADV. LIC.NO. 0310390363 DT. 20.07.06 Norms for the Export Product VIKS VAPORUB IN PACKS under para 4.7 of HBP. The Committee noted that the office of DC(SSI) had called for approved formulation of the export product from the firm vide their letter No.5(9)/2005 Chem. Dated 2.2.2007 and subsequent reminder dated 29.03.2007, but the firm

has not furnished the required information. The Committee, therefore, decided to reject the case. RLA concerned may take further necessary action including cancellation of advance licence etc. under para 4.7 of HBP.

CASE NO. A292

M/S IPCA LABS LTD M. No. 10/08 F.NO. 01/82/50/175/AM08 RLA NO.03/94/40/1338/AM07 Norms for the Export Product TRIAMCINOLONE under para 4.4.2 of HBP. vide their U.O. No.35011/274/2006PIIII dated 25.06.2007 decided to fix the norms under para 4. 4.2 of HBP as per details below or as applied for by the firm whichever is lower. Export product: Triamcinolone Base1Kg. Import item: 9 Beta, 11 BetaEpoxy16 Alpha,17 Alpha, 21Trihydroxypregna1,4Diene320 Dione(5 TR)1.05Kg/Kg.

CASE NO. A293

M/S PARABOLIC DRUGS LTD M. No. 10/08 F.NO. 01/83/50/1133/AM07 RLA NO.22/24/40/290/AM07 ADV. LIC.NO. 2210006385 DT. 16.01.07 Norms for the Export Product AMPICILLIN TRIHYDRATE under para 4.7 of HBP. revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or

CASE NO. A294

M/S PARABOLIC DRUGS LTD M. No. 10/08 F.NO. 01/83/50/1130/AM07 RLA NO.22/24/40/285/AM07 ADV. LIC.NO. 2210006378 DT. 11.01.07

Norms for the Export Product AMPICILLIN TRIHYDRATE under para 4.7 of HBP. revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or

CASE NO. A295

M/S LUPIN LTD M. No. 10/08 F.NO. 01/83/50/112/AM08 RLA NO.03/95/40/19/AM08 ADV. LIC.NO. 0310426714 DT. 13.04.07 Norms for the Export Product D()MANDELIC ACID under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export

CASE NO. A296

M/S KDL BIOTECH LTD M. No. 10/08 F.NO. 01/83/50/340/AM08 RLA NO.03/94/40/1459/AM07 ADV. LIC.NO. 0310429600 DT. 16.05.07

Norms for the Export Product AMPICILLIN TRIHYDRATE under para 4.7 of HBP. revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or

CASE NO. A297

M/S IPCA LABORATORIES LTD M. No. 10/08 F.NO. 01/83/50/414/AM08 RLA NO.03/94/40/158/AM08 ADV. LIC.NO. 0310430731 DT. 28.05.07 Norms for the Export Product MORANTEL CITRATE under para 4.7 of HBP. vide their U.O. No.35011/259/2006PIIII dated 15.05.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export product: Morantel Citrate1Kg. Import items;

Sl.No. Description of import item Quantity allowed 1. 3Methyl Thiophene 0.330Kg/Kg. 2. Acetonitrile 0.180Kg/Kg. 3. Dimethyl Formamide 0.270Kg/Kg. 4. Citric Acid 0.640Kg/Kg. 5. Ethylene dichloride 0.165Kg/Kg. 6. Isopropyl alcohol 0.725Kg/Kg.

CASE NO. A298

M/S PARABOLIC DRUGS LTD M. No. 10/08 F.NO. 01/83/50/1121/AM07 RLA NO.22/24/40/283/AM07 ADV. LIC.NO. 2210006369 DT. 10.01.07 Norms for the Export Product AMPICILLIN TRIHYDRATE under para 4.7 of HBP. revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or

CASE NO. A299

M/S JUBILANT ORGANOSYS LTD M. No. 10/08 F.NO. 01/83/50/127/AM08 RLA NO.05/24/40/41/AM08 ADV. LIC.NO. 0510202622 DT. 17.04.07 Norms for the Export Product 3,4DIHYDRO –4OXO6ACETYLOXY7 METHOXYQUINAZOLINE under para 4.7 of HBP for four weeks.

CASE NO. A300

M/S KAPL M. No. 10/08 F.NO. 01/82/50/49/AM08 RLA NO.07/24/40/775/AM08 ADV. LIC.NO. 0710050408 DT. 2.3.07 Norms for the Export Product CEFUROXIME 750 MG INJECTION USP under para 4.7 of HBP. vide their U.O. No.35011/266/2006PIIII dated 24.04.2007 decided to ratify the

/ / y norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: Cefuroxime 750mg Injection USP, each Vial containing Cefuroxime Sodium USP Equivalent to Cefuraxime 750mg 10ml vial1No. Import item: Cefuroxime Sodium Sterile817.50mg/vial

CASE NO. A301

M/S SHEETAL PHARMA M. No. 10/08 F.NO. 01/82/50/2525/AM08 RLA NO.03/95/40/408/AM07 ADV. LIC.NO. 0310390246 DT. 19.07.06 Norms for the Export Product PARACETAMOL TABLETS –500 MG under para 4.7 of HBP.

for four weeks.

CASE NO. B125

M. No. 10/08 F.NO. 01/82/162/180/AM08 The Committee considered the case as per agenda for amendment in para 4.22.1 of the Hand Book of Procedures regarding extension in export obligation period will not be application to 6APA authorization. The Committee decided that this case may be examined on file first and if required, the same may be placed before Norms Committee.

CASE NO. B126

M/S SANDOZ PVT. LTD M. No. 10/08 F.NO. 01/83/50/820/AM07 RLA NO.03/95/40/735/AM07 ADV. LIC.NO. 0310405563 DT. 26.10.06 The Committee considered this case as per agenda for modification of I/O Norms for the Export Product RIFAMPICIN under para 4.7 of HBP. The Committee decided to defer the case for four weeks.

CASE NO. B127

M/S SHILPA MEDICARE LTD M. No. 10/08 F.NO. 01/83/162/570/AM07 RLA NO.07/24/40/146/AM03 ADV. LIC.NO. 0710014440 DT. 20.06.2002 The Committee considered this case as per agenda for modification of I/O Norms for the Export Product 3 METHYL MERCAPTO ACETANALIDE under para 4.7 of HBP. The Committee decided to defer the case for four weeks.

CASE NO. B128

M/S DIVIS LAB LTD M. No. 10/08 F.NO. 01/82/162/537/AM07 RLA NO.09/24/40/253/AM06 ADV. LIC.NO. 0910024157 DT. 30.09.05 The Committee considered this case as per agenda for modification of I/O Norms for the Export Product under para 4.7 of HBP. The Committee in the light of revised written comments forwarded by PI Division vide their U.O. No.35022/17/2007PIIII dated 17.05.2007 decided to modify the norms already ratified as per details below or as applied by the firm whichever is lower. Export product: () Trans4(4 fluorophenyl)3Hydroxy methylNMethylPiperidine1Kg.

Import items: Sl.No. Description of import items Quantity allowed 1. MethylNMethylamidomalonate 50% solution in ethylacetate 7.70Kg/Kg. 2. DiPToluoylLTartaric Acid 4.00Kg/Kg. 3. Lithium Aluminium Hydride (on 100% basis 0.90Kg/Kg. 4. Pfluorobenzaldehyde 3.06Kg/Kg. 5. Isopropyl alcohol 2.25Kg/Kg. 6. Tetrahydrofuran/NHeptane/Heptane 6.00Kg/Kg. .

CASE NO. B129

M/S UNIMARK REMEDIES LTD M. No. 10/08 F.NO. 01/83/50/429/AM06 RLA NO.03/95/40/832/AM06 ADV. LIC.NO. 0310355180 DT. 11.11.05 Norms for the Export Product CLOXACILLIN SODIUM (PEN G 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

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

CASE NO. B130

M/S UNICHEM LAB LTD M. No. 10/08 F.NO. 01/83/50/16/AM05 RLA NO.03/24/40/2386/AM04 ADV. LIC.NO. 0310253587 DT. 17.02.04 The Committee considered the case as per agenda for amendment in the SION. The Committee observed that this is the case for modification of norms under para 4.7 of HBP and not for amendment in the SION as mentioned by the firm. It was also noted that the same case was considered by the Norms Committee in its 9/08 meeting held on 03.07.2007 and it was decided to call the firm for personal hearing. The Committee, therefore, decided to merge this case with the earlier case.

CASE NO. B131

M/S ALKALOIDS CORPORATION M. No. 10/08 F.NO. 01/87/50/299/AM07 RLA NO.02/24/40/84/AM07 ADV. LIC.NO. 0210090627DT. 26.06.06 The Committee considered this case as per agenda for amendment in the norms already fixed by the Norms Committee for the Export Product ARTESUNATE INT. under para 4.7 of HBP. The Committee after consideration of the case decided to maintain status quo.

CASE NO. B132

M/S HETERO LABS LTD M. No. 10/08 F.NO. 01/82/50/266/AM06 RLA NO.09/24/40/85/AM06 ADV. LIC.NO. 0910023217 DT. 21.06.05 Norms for the Export Product EFAVIENZ under para 4.7 of HBP. vide their U.O.35011/225/2004PIIII dated 23.05.2006 decided to modify the norms already ratified as per details below or as applied for whichever is lower. Export product: Efavirenz1Kg.

Import items: Sl.No. Description of import items Quantity allowed 1. Tert. Butyl Methyl Ether 1.16Kg/Kg. 2. NButyl Lithium (15% in Hexane) (on 100% active basis) 2.13Kg/Kg. 3. Tetrahydrofuran 8.36Ltr/Kg. 4. Acetonitrile 1.79Kg/Kg. 5. PAnisyl Alcohol 1.756Kg/Kg. 6. Cyclopropyl Acetylene 0.870kg/kg 7. 1,4Dibromo Butane 2.75Kg/Kg. 8. 2,3Dichloro5,6Dicyano1,4 Benzoquinone(DDQ) 0.328Kg/Kg. 9. 4Nitrophenyl Chloro Formate 0.96Kg/Kg. 10. Sodium Borohydride 0.06Kg/Kg. 11. 2,2,2 Trifluoro Acetic Acid 1.70Kg/Kg.

CASE NO. B133

M/S GLENMARK PHARMA LTD M. No. 10/08 F.NO. 01/82/50/782/AM07 RLA NO.03/94/40/520/AM07 ADV. LIC.NO. 0310395377 DT. 21.08.06

Withdrawn as the case has already been approved in the NC Meeting No.6/08 dated 06.06.2007.

CASE NO. B134

M/S CADILA PHARMA LTD M. No. 10/08 F.NO. 01/82/50/1433/AM05 RLA NO.08/24/40/95/AM05 ADV. LIC.NO. 0810041718 DT. 6.09.2004 ADV.LIC NO. 0810036678 DT. 05.03.2004 The Committee decided to defer the case for one week.

CASE NO. B135

M/S LAKE CHEMICALS PVT. LTD M. No. 10/08 F.NO. 01/82/162/908/AM07 RLA NO.07/81/160/668/AM05 ADV. LIC.NO. 0710038438 DT. 10.06.2005

CASE NO. B136

M/S MACLEODS PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/50/1700/AM05 RLA NO.03/24/40/2226/AM05 ADV. LIC.NO. 0310311836 DT. 12.01.05

CASE NO. B137

M/S HEMMO PHARMA LTD M. No. 10/08 F.NO. 01/82/50/478/AM05 RLA NO.03/24/40/582/AM05 ADV. LIC.NO. 031019241 DT. 18.8.2003

CASE NO. B138

M/S HEMMO PHARAM LTD M. No. 10/08 F.NO. 01/82/50/1763/AM05 RLA NO.0A3/24/40/2256/AM05 ADV. LIC.NO. 0310313830 DT. 27.01.05

CASE NO. B139

M/S HEMMO PHARMA LTD M. No. 10/08 F.NO. 01/82/50/464/AM02 RLA NO.03/24/40/1025/AM02 ADV. LIC.NO. 03310110660 DT. 19.11.2001

CASE NO. B140

M/S HEMMO PHARMA LTD

M. No. 10/08 F.NO. 01/82/50/338/AM05 RLA NO.03/24/40/65/AM05 ADV. LIC.NO. 0310265856DT. 28.04.2004

CASE NO. B141

M/S HEMMO PHARMA LTD M. No. 10/08 F.NO. 01/82/50/1439/AM05 RLA NO.03/24/41/156/AM05 ADV. LIC.NO. 0310302358 DT. 17.11.2004

CASE NO. B142

M/S INDO GERMAN ALKALOIDS M. No. 10/08 F.NO. 01/82/50/299/AM04 RLA NO.03/24/40/274/AM04 ADV. LIC.NO. 0310212182 DT. 7.04.2003

CASE NO. B143

M/S NESTOR PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/162/173/AM08 ADV. LIC.NO. 0510193028 DT. 19.10.06

CASE NO. B144

M/S NESTOR PHARMACEUTICALS LTD M. No. 10/08 F.NO. 01/82/162/174/AM08 ADV. LIC.NO. 0510200106 DT. 27.02.07

CASE NO. C05

M/S VISHNU CHEMICAL LTD. M. No. 10/08 F.NO. 01/83/162/468/AM07

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