IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-07-03

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 : 9/82‐ALC4/2007 MEETING DATE : 03.07.2007 1

Case No.:12/28/83‐ALC1/2006

Party Name:RANBAXY LABORATORIES LTD Meet No/Date:9/82‐ALC4/2007 03.07.2007 Status:Case Approved HQ File :01/83/050/00617/AM07/ RLA File :05/24/040/00400/AM07/ Lic.No/Date:0510189882 31.08.2006 Defer Date: Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product PravastaŚn Sodium under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/171/2006‐PI‐III dated 16.04.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: PravastaŚn Sodium‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. CompacŚn‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.47Kg/Kg. 2. AnŚ Form SAG‐71‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.05Kg/Kg. 3. Acetonitrile‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐7.17Kg/Kg. 4. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.92Kg/Kg 5. AcŚvated Carbon‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.100Kg/Kg. 6. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.05Kg/Kg. RLA concerned may take further necessary acŚon under para 4.7 of HBP as per above decision of the Norms CommiŚee. 2

Case No.:23/26/83‐ALC1/2006

Party Name:NESTOR PHARMACEUTICALS LTD. 03.07.2007 Status:Case Approved HQ File :01/83/050/00638/AM07/ RLA File :05/24/040/00456/AM07/ Lic.No/Date:0510190275 05.09.2006 Defer Date:

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Amoxycillin Oral Suspension BP/USP under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/29/2007‐PI‐III dated 26.06.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export product: Amoxycillin Oral Suspension BP/USP Each 5ml containing Amoxycillin Trihydrate Equivalent to Amocycillin 125mg. 100ml boŚle Import items: Amoxycillin Trihydrate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3012.83mg/boŚle of 100ml. OR Its relevant raw material as per revised SION at Sl.No.A‐58 on pro‐rata basis. 3

Case No.:2/43/83‐ALC1/2006

Party Name:RA CHEM PHARMA LIMITED. 03.07.2007 Status:Case Deferred HQ File :01/83/050/00875/AM07/ RLA File :09/24/040/00206/AM07/ Lic.No/Date:0910028138 07.11.2006 Defer Date:31.07.2007 Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Mebeverine HCL Powder under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 4 weeks. The CommiŚee, accordingly, decided to defer the case for four weeks. 4

Case No.:37/36/83‐ALC1/2006

Party Name:SRINI PHARMACEUTICALS LTD., 03.07.2007 Status:Case Deferred HQ File :01/83/050/00874/AM07/ RLA File :09/24/040/00307/AM07/ Lic.No/Date:0910028137 07.11.2006 Defer Date:31.07.2007

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Lamotrigne under para 4.7 of HBP. The CommiŚee decided to forward complete set of applicaŚon to the Technical Authority for their comments. The case was accordingly deferred for four weeks. 5

Case No.:1/9/82‐ALC4/2007

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 03.07.2007 Status:Case Approved HQ File :01/82/050/01524/AM07/ RLA File :22/21/040/00119/AM06/ Lic.No/Date:2210006342 03.01.2007 Defer Date: Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms of the export product as per revised SION at Sl.No.A‐69 published vide Public NoŚce No.2 dated 19.04.2007. RLA concerned may take further necessary acŚon under para 4.7 of HBP as per above decision of Norms CommiŚee. 6

Case No.:2/9/82‐ALC4/2007

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 03.07.2007 Status:Case Approved HQ File :01/82/050/01549/AM07/ RLA File :22/21/040/00064/AM06/ Lic.No/Date:2210006365 10.01.2007 Defer Date: Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms of the export product as per revised SION at Sl.No.A‐69 published vide Public NoŚce No.2 dated 19.04.2007. 7

Case No.:3/9/82‐ALC4/2007

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 03.07.2007 Status:Case Approved HQ File :01/82/050/01576/AM07/ RLA File :22/21/040/00086/AM06/ Lic.No/Date:2210006395 16.01.2007 Defer Date:

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product Cloxacillin Sodium under para 4.7 of HBP. The CommiŚee in light of the report of the DepŚ. 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 8

Case No.:44/9/82‐ALC4/2007

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 03.07.2007 Status:Case Approved HQ File :01/82/050/01577/AM07/ RLA File :22/21/040/00088/AM06/ Lic.No/Date:2210006396 16.01.2007 Defer Date:

Case No.:21/9/82‐ALC4/2007

Party Name:DSM ANTI‐INFECTIVES INDIA LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/01875/AM07/ RLA File :22/21/042/00079/AM05/ Lic.No/Date:2210006458 02.02.2007 Defer Date:

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product Cloxacillin Sodium (6APA Route) under para 4.7 of HBP. The CommiŚee in light of the report of the DepŚ. 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 10

Case No.:5/9/82‐ALC4/2007

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 03.07.2007 Status:Case Deferred HQ File :01/82/050/01646/AM07/ RLA File :05/24/040/00937/AM07/ Lic.No/Date:0510199268 09.02.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product 3,4 Dihydroxy‐4‐Oxo‐6Acetoxy‐ 7Methoxyquinazole under para 4.7 of HBP. The CommiŚee decided to forward the complete set of applicaŚon to the Technical Authority for their comments. The case was accordingly deferred for four weeks. 11

Case No.:4/9/82‐ALC4/2007

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 03.07.2007 Status:Case Deferred HQ File :01/82/050/01644/AM07/ RLA File :03/94/040/01206/AM07/ Lic.No/Date:0310419586 14.02.2007 Defer Date:31.07.2007

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Losartan Potassium USP under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 12

Case No.:6/9/82‐ALC4/2007

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01728/AM07/ RLA File :09/24/040/00488/AM07/ Lic.No/Date:0910029504 01.03.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Cefdinir under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 13

Case No.:7/9/82‐ALC4/2007

Party Name:CIPLA LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01730/AM07/ RLA File :03/94/040/01369/AM07/ Lic.No/Date:0310421609 01.03.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Rangtetra Bolus 66MG under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 14

Case No.:8/9/82‐ALC4/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 03.07.2007 Status:Case Rejected HQ File :01/82/050/01745/AM07/ RLA File :04/24/040/00458/AM07/ Lic.No/Date:0410088065 05.03.2007 Defer Date:

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Phenylephrine HCL under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the manufacturing of Phenylephrine Base is done by uŚlizing the input Phenylephrine HCL, but in this case the firm has opted reverse chemistry i.e. they have proposed to manufacture Phenylephrine HCL by uŚlizing I‐ Phenylephrine Base. The CommiŚee, therefore, decided to reject the case. RLA concerned may take further necessary acŚon including cancellaŚon of Advance licence under para 4.7 of HBP as per above decision of Norms CommiŚee. 15

Case No.:9/9/82‐ALC4/2007

Party Name:DR. WILLMAR SCHWABE INDIA PVT LTD Meet No/Date:9/82‐ALC4/2007 03.07.2007 Status:Transferred to Different SecŚon HQ File :01/82/050/01748/AM07/ RLA File :05/24/040/00999/AM07/ Lic.No/Date:0510200427 05.03.2007 Defer Date: Decision :The CommiŚee decided to transfer this case to DES‐VI as the export product pertains to Food and Food products. 16

Case No.:10/9/82‐ALC4/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 03.07.2007 Status:Case Approved HQ File :01/82/050/01751/AM07/ RLA File :03/94/040/01190/AM07/ Lic.No/Date:0310421957 06.03.2007 Defer Date: Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Amiodarone HCL under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/102/2006‐PI‐III dated 18.04.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export product: Amiodarone Hcl‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. 2‐Butyl‐3‐(3,5‐Diiodo‐4‐Hydroxybenzoyl)‐‐‐1.04Kg/Kg. 2. Iso Propyl Alcolol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.75Kg/Kg. 3. Toluene‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.95Kg/Kg.

Case No.:11/9/82‐ALC4/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 03.07.2007 Status:Case Approved HQ File :01/82/050/01752/AM07/ RLA File :03/94/040/01244/AM07/ Lic.No/Date:0310421958 06.03.2007 Defer Date: Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Perindopril Erbumine under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/102/2006‐PI‐III dated 18.04.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export product: Perindopril Erbumin‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. 2(S)‐Indoline‐2 Carboxylic Acid‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.50Kg/Kg. 2. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.43Kg/Kg. 3. Rhodium Powder‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.001Kg/Kg. 4. Toluene‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.22Kg/Kg. 5. Methylene chloride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐15.19Kg/Kg. 6. L‐Norvaline‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.900Kg/Kg. 7. 5% Palladium on carbon‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.20Kg/Kg. 8. Acetonitrile‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.57Kg/Kg. 9. Dibenzoly‐L‐tartaric acid‐‐‐‐Neither given earlier nor shown now in either chemistry or material balance. 18

Case No.:12/9/82‐ALC4/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 03.07.2007 Status:Case Approved HQ File :01/82/050/01753/AM07/ RLA File :03/94/040/01245/AM07/ Lic.No/Date:0310421959 06.03.2007 Defer Date:

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Lercanidipine under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/253/2006‐PI‐III dated 18.04.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export product: Lercanidipine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. 3,3‐diphenyl propylamine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.19Kg/Kg. 2. Tetrahydrofuran‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.90Kg/Kg. 3. Methylene chloride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐4.88Kg/Kg. 4. 1‐chloro‐2 Methyl‐2 propanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.507Kg/Kg. 5. Isopropyl acetate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6.83Kg/Kg. 19

Case No.:13/9/82‐ALC4/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 03.07.2007 Status:Case Approved HQ File :01/82/050/01755/AM07/ RLA File :03/94/040/01306/AM07/ Lic.No/Date:0310421961 06.03.2007 Defer Date:

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Olmesartan Medoxomill under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/243/2006‐PI‐III dated 05.12.2006 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export product: Olmesartan Medoxomill‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. 4‐(10Hydroxy‐1‐Ethyl)‐2‐Propyl‐1H‐ Imidazole‐5‐Carboxylic Acid Ethyl Ester 97%‐1.184Kg/Kg. 2. 5‐(4‐(Bromomethyl)1,1‐Biphenyl)‐2YL Triphenyl‐1‐H‐Tetraole 95%‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.75Kg/Kg. 3. 4‐chlromethyl‐5‐methyl‐1, 3‐Dioxalen‐2‐one 95%‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.93Kg/Kg. 4. Dimethyl Formamide‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6.72Kg/Kg. 5. THF‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐3.43Kg/Kg. 6. Potassium Carbonate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.87Kg/Kg. 7. Toluene‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.41Kg/Kg. RLA concerned may take further necessary acŚon under para 4.7 of HBP as per above decision of the Norms. 20

Case No.:25/9/82‐ALC4/2007

Party Name:NECTAR LIFESCIENCES LIMITED, 03.07.2007 Status:Case Deferred HQ File :01/82/050/00007/AM08/ RLA File :22/24/040/00298/AM07/ Lic.No/Date:2210006559 07.03.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Cefpodoxime ProxeŚl under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 21

Case No.:14/9/82‐ALC4/2007

Party Name:LUPIN LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/01780/AM07/ RLA File :03/95/040/01393/AM07/ Lic.No/Date:0310422500 09.03.2007 Defer Date:

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product 7‐ADCA under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms of the export product as per revised SION at Sl.No.A‐35 published vide Public NoŚce No.2 dated 19.04.2007. 22

Case No.:45/9/82‐ALC4/2007

Party Name:LUPIN LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01781/AM07/ RLA File :03/95/040/01384/AM07/ Lic.No/Date:0310422503 09.03.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Cefadroxil under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 23

Case No.:15/9/82‐ALC4/2007

Party Name:INDO GERMAN ALKALOIDS 03.07.2007 Status:Case Approved HQ File :01/82/050/01817/AM07/ RLA File :03/94/040/01358/AM07/ Lic.No/Date:0310423442 16.03.2007 Defer Date: Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Noscapine HCL BP/USP/EP under para 4.7 of HBP. The representaŚve of PI Division informed that the CommiŚee may decide as per Norms CommiŚee MeeŚng No.11/2002 dated 20.06.2001, to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is lower. Export product: Noscapine HCL BP 93‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: Noscapine Base‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.9Kg/Kg.

Case No.:43/9/82‐ALC4/2007

Party Name:KOPRAN LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01818/AM07/ RLA File :03/94/040/01416/AM07/ Lic.No/Date:0310423486 16.03.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Cefpodoxime ProxeŚl under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 25

Case No.:16/9/82‐ALC4/2007

Party Name:LUPIN LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/01832/AM07/ RLA File :03/95/040/01543/AM07/ Lic.No/Date:0310423580 20.03.2007 Defer Date: Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product Cephalexin Monohydrate under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms of the export product as per revised SION at Sl.No.A‐116 published vide Public NoŚce No.2 dated 19.04.2007. 26

Case No.:17/9/82‐ALC4/2007

Party Name:CIPLA LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01837/AM07/ RLA File :03/94/040/01468/AM07/ Lic.No/Date:0310423777 21.03.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Exemestane under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 27

Case No.:18/9/82‐ALC4/2007

Party Name:DR REDDYS LABORATORIES LTD 03.07.2007 Status:Case Approved

HQ File :01/82/050/01843/AM07/ RLA File :09/24/040/00499/AM07/ Lic.No/Date:0910029738 22.03.2007 Defer Date: Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Sertraline Hcl under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/16/2007‐PI‐III dated 17.05.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export product: Sertraline Hcl ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. N‐(4‐(3,4‐Dichlorophenyl)‐3,4‐dihydro‐1 (2H)‐Naphthalenylidene) methalamine‐‐‐‐‐‐‐‐‐3.27Kg/Kg. 2. D(‐)Mandalic acid‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.392Kg/Kg. 3. Sodium Borohydride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.331Kg/Kg. RLA concerned may take further necessary acŚon under para 4.7 of HBP as per above decision of the Norms. 28

Case No.:19/9/82‐ALC4/2007

Party Name:DIVIS LABORATORIES LTD., 03.07.2007 Status:Case Deferred HQ File :01/82/050/01846/AM07/ RLA File :09/24/040/00523/AM07/ Lic.No/Date:0910029739 22.03.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Carvedilol under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 29

Case No.:46/9/82‐ALC4/2007

Party Name:LUPIN LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/01852/AM07/ RLA File :03/95/040/01580/AM07/ Lic.No/Date:0310424040 22.03.2007 Defer Date:

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of Norms for the export product Cephalexin Monohydrate under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms of the export product as per revised SION at Sl.No.A‐116 published vide Public NoŚce No.2 dated 19.04.2007. 30

Case No.:20/9/82‐ALC4/2007

Party Name:CONCORD BIOTECH LTD 03.07.2007 Status:Case Deferred HQ File :01/82/050/01863/AM07/ RLA File :08/24/040/00356/AM07/ Lic.No/Date:0810063862 26.03.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Vamcomycin Hcl under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 31

Case No.:22/9/82‐ALC4/2007

Party Name:CIPLA LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01894/AM07/ RLA File :03/94/040/01500/AM07/ Lic.No/Date:0310424681 28.03.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Tylocip Powder 20%/Tylosin Soluble Powder 20% w/w under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 32

Case No.:23/9/82‐ALC4/2007

Party Name:LUPIN LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/01901/AM07/ RLA File :03/95/040/01622/AM07/ Lic.No/Date:0310424915 29.03.2007 Defer Date:14.08.2007

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Cefpodoxime ProxeŚl under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 33

Case No.:24/9/82‐ALC4/2007

Party Name:MERCK LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/01907/AM07/ RLA File :03/95/040/01596/AM07/ Lic.No/Date:0310424986 29.03.2007 Defer Date: Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Thiamine Disulfide under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/274/2006‐PI‐III dated 26.06.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: Thiamine Disulfide‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. Thiamine Hcl Import Items/BP/USP (Vitamin B1 Hcl)‐‐‐1.4199Kg/Kg. 2. Sodium Hydroxide Pellets‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.4634Kg/Kg. 3. Potassium Hexacyanoferate (III) GR‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.0022Kg/Kg. 4. Hydrochloric Acid fuming 37%‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.3356Kg/Kg 5. Hydrogen peroxide soluŚon 35% extra pure‐‐‐‐‐‐‐‐‐‐‐‐‐0.2157Kg/Kg. 6. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.8702Ltrs/Kg. 34

Case No.:26/9/82‐ALC4/2007

Party Name:SMILAX LABORATORIES LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/00010/AM08/ RLA File :09/24/040/00555/AM07/ Lic.No/Date:0910029933 10.04.2007 Defer Date:31.07.2007

Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product 2‐Chloro methyl‐3‐methyl‐4‐(2,2,2‐trifluoro ethoxy) Pyridine HCL under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 35

Case No.:8/6/83‐ALC1/2007

Party Name:R L FINE CHEM 03.07.2007 Status:Case Deferred HQ File :01/83/050/00123/AM08/ RLA File :07/24/040/00021/AM08/ Lic.No/Date:0710051273 17.04.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Methane Sulfonate of 10.11.Dihydro‐N,N Betatrimethyl 5H under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought deferment for 6 weeks. The CommiŚee, accordingly, decided to defer the case for six weeks. 36

Case No.:27/9/82‐ALC4/2007

Party Name:RANBAXY LABORATORIES LTD 03.07.2007 Status:Case Approved HQ File :01/82/050/00027/AM08/ RLA File :05/24/040/00082/AM08/ Lic.No/Date:0510203211 03.05.2007 Defer Date:

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product SimvastaŚn under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/224/2006‐PI‐III dated 05.12.2006 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: SimvastaŚn‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import items: 1. LovastaŚn‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.648Kg/Kg. 2. Acetone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.042Kg/Kg. 3. AcŚvated Carbon‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.035Kg/Kg. 4. Cychlohexane‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.33Kg/Kg 5. Cyclopropylamine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.23Kg/Kg. 6. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐19.82Kg/Kg. 7. N.Butyl Lithium‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐2.382Kg/Kg. 8. Pyrrolidine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.53Kg/Kg. 9. Tetrahydrofuran‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6.58Kg/Kg. 10. CausŚc flakes‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1.484Kg/Kg. 11. Iodine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.63Kg/Kg. 12. Ethyl acetate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐4.49Kg/Kg. 37

Case No.:28/9/82‐ALC4/2007

Party Name:MEDREICH LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/00034/AM08/ RLA File :07/24/040/00092/AM08/ Lic.No/Date:0710051646 14.05.2007 Defer Date:

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of norms for the export product Paracetamol 250mg + Ibuprofen 200mg Capsules under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms as per details below or as applied for whichever is less. Export product: Paracetamol 250mg + Ibuprofen 200mg Capsules Import items: 1. Paracetamol Crystals BP/USP/EP ‐‐‐‐‐‐‐‐‐‐‐255mg/capsule 2. Ibuprofen BP/USP/EP‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐204mg/capsule 3. Sodium Stearyl Fumarate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐Not shown in DML(Not allowed) 38

Case No.:29/9/82‐ALC4/2007

Party Name:S.M. HERBALS PVT.LTD. 03.07.2007 Status:Case Deferred HQ File :01/82/050/00039/AM08/ RLA File :05/24/040/01075/AM07/ Lic.No/Date:0510203751 16.05.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Camptothecin 5H under para 4.7 of HBP. The CommiŚee decided to forward the complete set of applicaŚon to Department of Ayush. The CommiŚee, accordingly, decided to defer the case for four weeks. 39

Case No.:47/9/82‐ALC4/2007

Party Name:KDL BIOTECH LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/00036/AM08/ RLA File :03/94/040/01456/AM07/ Lic.No/Date:0310429589 16.05.2007 Defer Date:

Case No.:30/9/82‐ALC4/2007

Party Name:PROMED EXPORTS PVT.LTD. 03.07.2007 Status:Case Approved HQ File :01/82/050/00040/AM08/ RLA File :05/24/040/00110/AM08/ Lic.No/Date:0510203862 18.05.2007 Defer Date:

Decision :The case was considered by the CommiŚee as per agenda for raŚficaŚon of Norms for the export product Inokain Eye Drops 0.4% SoluŚon (Vials 5ml No.1) under para 4.7 of HBP. The CommiŚee in the light of wriŚen comments forwarded by PI Division vide their U.O.35011/1/2007‐PI‐III dated 28.02.2007 decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: Inokain Eye Drops 0.4% soluŚon (Vial 5ml No.1)‐‐‐1No. Import item: 1. Benoxinate Hcl‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.021gm/5 ml vial 41

Case No.:31/9/82‐ALC4/2007

Party Name:ALEMBIC LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/00042/AM08/ RLA File :34/24/040/00031/AM08/ Lic.No/Date:3410018811 21.05.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Cefepime (For InjecŚon USP) under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 42

Case No.:32/9/82‐ALC4/2007

Party Name:INDO PHYTOCHEM PHARMACEUTICALS Meet No/Date:9/82‐ALC4/2007 03.07.2007 Status:Case Deferred HQ File :01/82/050/00043/AM08/ RLA File :05/24/040/00093/AM08/ Lic.No/Date:0510203946 22.05.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Yohimbine Hydrochloride USP under para 4.7 of HBP. The CommiŚee decided to forward the complete set of applicaŚon to Department of Ayush and DC(SSI) for their comments. Accordingly, it was decided to defer the case for four weeks.

Case No.:33/9/82‐ALC4/2007

Party Name:DR. WILLMAR SCHWABE INDIA PVT LTD Meet No/Date:9/82‐ALC4/2007 03.07.2007 Status:Transferred to Different SecŚon HQ File :01/82/050/00044/AM08/ RLA File :05/24/040/00826/AM07/ Lic.No/Date:0510203948 22.05.2007 Defer Date: Decision :The CommiŚee decided to transfer the case to DES‐VI secŚon as the export product pertains to Food products. 44

Case No.:34/9/82‐ALC4/2007

Party Name:AGIO PHARMACEUTICALS LTD 03.07.2007 Status:Deffered and Re‐indexed HQ File :01/82/050/00045/AM08/ RLA File :03/94/040/00082/AM08/ Lic.No/Date:0310430135 22.05.2007 Defer Date:17.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Prednisolone SoluŚon for InjecŚon 30mg/1ml under para 4.7 of HBP. The CommiŚee noted that various cases of this form for raŚficaŚon of norms under para 4.7 of HBP. for the abovesaid export product has been closed because the specificaŚon of the export product indicated by the firm in their applicaŚon does not tally with the specificaŚon given in DML. Further, the firm was called for personal hearing before the Norms CommiŚee, but no representaŚve of the firm came for personal hearing. Now the CommiŚee noŚced that the firm has requested for personal hearing to explain their case. The CommiŚee, therefore, decided to call for the firm for personal hearing on 17.07.2007 at 2.30PM. Accordingly, all the cases of the firm which were decided to close, may be re‐listed on the same day. 45

Case No.:35/9/82‐ALC4/2007

Party Name:ALEMBIC LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/00051/AM08/ RLA File :34/24/040/00035/AM08/ Lic.No/Date:3410018854 28.05.2007 Defer Date:14.08.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Methane Azithromycin Step‐3 under para 4.7 of HBP. The CommiŚee decided to call for the complete chemical descripŚon of the export product form the firm. It was, accordingly, decided to defer the case for six weeks. 46

Case No.:36/9/82‐ALC4/2007

Party Name:MAKSON INDUSTRIES PVT. LTD. 03.07.2007 Status:Case Deferred

HQ File :01/82/050/00058/AM08/ RLA File :03/95/040/00142/AM08/ Lic.No/Date:0310430925 29.05.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Vicks Veporub (in packs) under para 4.7 of HBP. The CommiŚee decided to forward the complete set of applicaŚon to DC(SSI) for their comments. It was, accordingly, decided to defer the case for four weeks. 47

Case No.:37/9/82‐ALC4/2007

Party Name:MAKSON INDUSTRIES PVT. LTD. 03.07.2007 Status:Case Deferred HQ File :01/82/050/00059/AM08/ RLA File :03/95/040/00075/AM08/ Lic.No/Date:0310430926 29.05.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Vicks Veporub (in packs) under para 4.7 of HBP. The CommiŚee decided to forward the complete set of applicaŚon to DC(SSI) for their comments. It was, accordingly, decided to defer the case for six weeks. 48

Case No.:38/9/82‐ALC4/2007

Party Name:ALEMBIC LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/00061/AM08/ RLA File :34/24/040/00039/AM08/ Lic.No/Date:3410018874 01.06.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Clarithromycin USP under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 49

Case No.:42/9/82‐ALC4/2007

Party Name:KDL BIOTECH LIMITED 03.07.2007 Status:Case Approved HQ File :01/82/050/00078/AM08/ RLA File :03/94/040/01427/AM07/ Lic.No/Date:0310431464 01.06.2007 Defer Date:

Case No.:39/9/82‐ALC4/2007

Party Name:WOCKHARDT LIMITED 03.07.2007 Status:Case Deferred HQ File :01/82/050/00065/AM08/ RLA File :03/95/040/00157/AM08/ Lic.No/Date:0310431490 04.06.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Flu Strength Hot Lemon Powders 5 gm Sachet under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 51

Case No.:40/9/82‐ALC4/2007

Party Name:WOCKHARDT LIMITED 03.07.2007 Status:Case Deferred

HQ File :01/82/050/00066/AM08/ RLA File :03/95/040/00161/AM08/ Lic.No/Date:0310431494 04.06.2007 Defer Date:31.07.2007 Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Hot Lemon Cold Relief Powders 5 gm Sachet under para 4.7 of HBP. The representaŚve of PI Division present in the meeŚng informed the CommiŚee that the case is under examinaŚon in his Department and he sought 52

Case No.:41/9/82‐ALC4/2007

Party Name:INDO GERMAN ALKALOIDS 03.07.2007 Status:Case Approved HQ File :01/82/050/00068/AM08/ RLA File :03/94/040/00222/AM08/ Lic.No/Date:0310431837 06.06.2007 Defer Date: Decision :The CommiŚee considered the case as per agenda for raŚficaŚon of norms for the export product Ipecacuanha Extract under para 4.7 of HBP. The CommiŚee decided to raŚfy the norms under para 4.7 of HBP as per details below or as applied for whichever is less. These norms were suggested in technical report dated 31.03.2005 prepared in DGFT in consultaŚon with Technical AuthoriŚes. Export product: Ipecacuanha Extract BP/USP‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1Kg. Import item: Ipecacuanha Roots‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐4.10Kg/Kg. Date:13.07.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

Minutes of the Norms Committee Meeting No. 09/08 held on 03.07.07 under the Chairmanship of Shri Sanjay Rastogi, Export Commissioner. The Committee first considered the minutes of the NC Meeting No. 08/08 held on 28.06.07 for confirmation and confirmed and adopted the same.

Case No.A134

M/S Lupin Ltd Meeting No.09/08 File No.01/82/50/1819/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1486/AM’07 Advance licence No.0310423511 Dated 16.03.2007 The Committee considered the case as per agenda for ratification of Norms for the export product 7ADCA under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A35 published vide Public Notice No.2 dated 19.04.2007. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A135

M/S KDL Biotech Ltd Meeting No.09/08 File No.01/83/50/358/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1402/AM’07 Advance licence No.0310429785 Dated 17.05.2007 export product Cefadroxil BP/USP/EP under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for four weeks. The Committee, accordingly, decided to defer the case for four weeks.

Case No.A136

M/S Promed Exports Pvt. Ltd. Meeting No.09/08 File No.01/83/50/1074/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/769/AM’07 Advance licence No.0510197053 Dated 29.12.2006 export product Inokain Eye Drops 0.4% Solution (Vials 5ml No.1) under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O.35011/1/2007PIIII dated 28.02.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: Inokain Eye Drops 0.4% solution (Vial 5ml No.1)1No. Import item: 1. Benoxinate Hcl0.021gm/5 ml vial RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of the Norms Committee.

Case No.A137

M/S Lupin Ltd Meeting No.09/08 File No.01/83/50/51/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1594/AM’07 Advance licence No.0310425912 Dated 09.04.2007 export product Cephalexin Monohydrate under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007.

Case No.A138

M/S Lupin Ltd Meeting No.09/08 File No.01/83/50/177/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/54/AM’08 Advance licence No.0310427685 Dated 24.04.2007 export product 7ADCA under para 4.7 of HBP. The Committee decided to ratify the norms of the export product as per revised SION at Sl.No.A116 published vide Public Notice No.2 dated 19.04.2007.

Case No.A139

M/S Lupin Ltd Meeting No.09/08 File No.01/83/50/50/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1595/AM’07 Advance licence No.0310425910 Dated 09.04.2007 The Committee decided to transfer the case to DESIV Section as the export product is Chemical item.

Case No.A140

M/S Nicholas Piramal India Ltd

Meeting No.09/08 File No.01/83/50/369/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1471/AM’07 Advance licence No.0310430058 Dated 21.05.2007 export product Ultrazyme Tablet (7458X) under para 4.7 of HBP. The Committee decided to forward the complete set of application to Department of Bio Technology. Accordingly, it was decided to defer the case for four weeks.

Case No.A141

M/S Kajay Remedies Pvt. Ltd. Meeting No.09/08 File No.01/83/50/91/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1527/AM’07 Advance licence No.0310426188 Dated 10.04.2007 The Committee decided to transfer the case to DESIV as the export product is Chemical item.

Case No.A142

M/S Nicholas Piramal India Ltd Meeting No.09/08 File No.01/83/50/370/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1389/AM’07 Advance licence No.0310430066 Dated 21.05.2007 export product Concept Quick Unit Dose Solution (9247X) under para 4.7 of HBP. The Committee decided to forward the complete set of application to Department of Bio Technology. Accordingly, it was decided to defer the case for four weeks.

Case No.A143

M/S IPCA Laboratories Ltd Meeting No.09/08 File No.01/83/50/27/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1455/AM’07 Advance licence No.0310425418 Dated 02.04.2007 export product 6Methoxy2Naphthaldehyde under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case is under examination in their Department and he sought deferment for six weeks. Accordingly, it was decided to defer the case for six weeks.

Case No.A144

M/S KDL Biotech Ltd Meeting No.09/08 File No.01/83/50/427/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1401/AM’07 Advance licence No.0310430871 Dated 29.05.2007 export product Cefadroxil BP/USP/EP 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 4 weeks. Accordingly, it was decided to defer the case for four weeks.

Case No.A145

M/S KDL Biotech Ltd Meeting No.09/08 File No.01/83/50/348/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1433/AM’07 Advance licence No.0310429686 Dated 17.05.2007 export product Immobilised Pencillin G Amidase (Enzyme) under para 4.7 of HBP. The Committee decided to forward the complete set of application to Department of Biotechnology for their comments. Accordingly, it was decided to defer the case for six weeks.

Case No.A146

M/S KDL Biotech Ltd Meeting No.09/08 File No.01/83/50/355/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1457/AM’07 Advance licence No.0310429750 Dated 17.05.2007 export product Ampicillin Trihydrate Import Items/USP/EPunder para 4.7 of HBP. The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A69 published vide Public Notice No.2 dated 19.04.2007 or as applied for by the firm whichever is lower. per above decision of Norms Committee.

Case No.A147

M/S KDL Biotech Ltd Meeting No.09/08 File No.01/83/50/357/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1400/AM’07 Advance licence No.0310429783 Dated 17.05.2007 export product Cefadroxil BP/USP/EP under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the case was under examination in their Department and he sought deferment of the case for four weeks. Accordingly, it was decided to defer the case for four weeks.

Case No.A148

M/S Midas Care Pharmaceutical Pvt. Ltd. Meeting No.09/08 File No.01/83/50/404/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/78/AM’08 Advance licence No.0310430644 Dated 25.05.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical sector.

Case No.A149

M/S Morepen Laboratories Ltd Meeting No.09/08 File No.01/83/50/239/AM’08/DESIII Date: 03.07.2007 RLA F.No.05/24/40/80/AM’08 Advance licence No.0510203207 Dated 03.05.2007 export product Montelukast Sodium Min Assay 97% under para 4.7 of HBP.

sought deferment of the case for six weeks. Accordingly, it was decided to defer the case for six weeks.

Case No.A150

M/S Gracure Pharmaceuticals Ltd. Meeting No.09/08 File No.01/82/162/786/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/112/AM’07 Advance licence No.0510185320 Dated 22.06.2006 export product Daxy 200 Tabs under para 4.7 of HBP.

Case No.A151

M/S Lupin Ltd. Meeting No.9/08 F.No.01/83/50/533/AM08 Date: 3.7.2007 RLA F.No.03/95/40/234/AM’08 Advance licence No.0310432279 Dated 11.06.2007 The case was considered by the Committee as per agenda for ratification of Norms for the export product Cefixime Trihydrate under para 4.7 of HBP. The Committee in the light of written comments forwarded by PI Division vide their U.O.35011/22/2007PIIII dated 24.04.2007 decided to ratify the norms under

para 4.7 of HBP as per details below or as applied for whichever is less.

Export Product: Cefixime Trihydrate1Kg. Import items: Sl.No. Description of item Quantity allowed 1. GCLE 1.555Kg/Kg. 2. PGTA Disodium 0.020Kg/Kg. 3. DATMA 0.923Kg/Kg. 4. Methanol 3.69Kg/Kg. 5. chloride Methylene chloride 16.57Kg/Kg. 6. Dimethyl formamide 0.49Kg/Kg. 7. Ethyl acetate 5.98Kg/Kg. 8. MIBK 0.42Kg/Kg. 9. Dimethylamine 0.62Kg/Kg. 10. Formaldehyde 1.7419Kg/Kg. 11. Nmethyl morpholine 0.12Kg/Kg. 12. Activated Carbon 0.100Kg/Kg. 13. Ammonia 0.65Kg/Kg. 14. Celite Not a raw material 15. Phosphorus pentachloride 0.88Kg/Kg. 16. Sodium bicarbonate 0.6471Kg/Kg. 17. Sodium Carbonate 0.2686Kg./Kg. 18. Sodium hydrosulphite 0.001Kg/Kg. 19. Triphenyl phosphine 1.22Kg/Kg. above decision of the Norms Committee.

Case No.A152

M/S Lupin Ltd.

Meeting No.09/08 File No.01/83/50/456/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/187/AM’08 Advance licence No.0310431079 Dated 30.05.2007 export product Cefpodoxime Proxetil under para 4.7 of HBP.

Case No.A153

M/S Neuland Laboratories Ltd. Meeting No.09/08 File No.01/83/50/1337/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/513/AM’07 Advance licence No.0910029660 Dated 14.03.2007 export product Moxifloxacin Hydrochloride under para 4.7 of HBP.

Case No.A154

M/S KDL Biotech Ltd. Meeting No.09/08 File No.01/83/50/338/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1095/AM’07 Advance licence No.0310429585 Dated 16.05.2007 export product Cefadroxil under para 4.7 of HBP.

Case No.A155

M/S Lupin Ltd. Meeting No.09/08 File No.01/82/50/37/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1639/AM’07 Advance licence No.0310425483 Dated 03.04.2007 export product Cephalexin Monohydrate 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.A116 published vide Public Notice No.2 dated 19.04.2007. per the above decision of Norms Committee.

Case No.A156

M/S KDL Biotech Ltd. Meeting No.09/08 File No.01/83/50/347/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/1432/AM’07 Advance licence No.0310429683 Dated 17.05.2007 export product Immobilised PenicillinG Amidase (Enzyme) under para 4.7 of HBP.

The committee decided to forward the complete set of application to Department of Biotechnology. Accordingly, it was decided to defer the case for four weeks.

Case No.A157

M/S Cipla Ltd. Meeting No.09/08 File No.01/82/50/863/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/94/40/415/AM’07 Advance licence No.0310390107 Dated 19.07.2006 export product Equine Butazone Granules/Phenylbutzone Granules under para 4.7 of HBP. It was decided to await reply from the firm and defer the case for four weeks.

Case No.A158

M/S Gland Pharma Meeting No.09/08 File No.01/82/50/1461/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/212/AM’07 Advance licence No.0910027489 Dated 08.09.2006 export product Oxylocin Injection under para 4.7 of HBP. sought deferment of the case for two weeks. Accordingly, it was decided to defer the case for two weeks.

Case No.A159

M/S Gulf Oil Corporation Ltd. Meeting No.09/08 File No.01/82/50/47/AM’08/DESIII Date: 03.07.2007 RLA F.No.09/24/40/538/AM’07 Advance licence No.0910028240 Dated 17.11.2006 export product Fexofenadine Hydrochloride under para 4.7 of HBP.

Case No.A160

M/S Honest Bio Vet. Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1761/AM’07/DESIII Date: 03.07.2007 RLA F.No.08/24/40/304/AM’07 Advance licence No.0810062375 Dated 12.01.2007 export product 3Chloroperoxybenzoic Acid under para 4.7 of HBP.

Case No.A161

M/S Cipla Ltd. Meeting No.09/08 File No.01/82/50/1794/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/94/40//2121/AM’07 Advance licence No.0310418218 Dated 02.02.2007 export product Beclate Aquanase Nasal Sprey (50 mcg/150 MD under para 4.7 of HBP. The Committee decided to ratify the norms of the export product under

para 4.7 as per details below or as applied for whichever is lower.

Export Product: Beclate Aquanase Nasal Spray (50mcg/150 MD) Import items: Sl.No. Description of import item Quantity allowed 1. Beclomethasone Dipropionate Net to Net 2. Vials 10ml amber coloured glass (component) Net to Net with accountability clause 3. Pump Vol., 0.05ml 20mm crimp (component) Net to Net with accountability clause 4. Applicator Nasal Spray EGS (component) Net to Net with accountability clause.

Case No.A162

M/S Cipla Ltd. Meeting No.09/08 File No.01/82/50/168/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/17/AM’07

Advance licence No.0310426065 Dated 10.04.2007 export product Triomune 30/ Lamivudine, Stavudine and nevirapine Tablet and Triomune 40/ Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP.

Case No.A163

M/S Cipla Ltd. Meeting No.09/08 File No.01/82/162/169/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/250/AM’08 Advance licence No.0310432136 Dated 08.06.2007 export product Stavir 15mg, 20mg, 30mg and 40mg capsules and Lamivir S30 and S40 Tablets under para 4.7 of HBP.

Case No.A164

M/S Anus Laboratories Ltd. Meeting No.09/08 File No.01/82/50/886/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/411/AM’07 Advance licence No.0910028963 Dated 10.01.2007 The Committee decided to transfer the case to DESIV Section as the export product pertains to chemical sector.

Case No.A165

M/S Anthea Aromatics Pvt. Ltd. Meeting No.09/08 File No.01/82/50/352/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/120/AM’08 Advance licence No.0310429730 Dated 17.05.2007 The Committee decided to transfer the case to DESIV as the item of export pertains to Chemical sector.

Case No.A166

M/S Glenmark Pharmaceuticals Ltd Meeting No.09/08 File No.01/82/50/101/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/94/40/6/AM’08 Advance licence No.0310426499 Dated 12.04.2007 export product Amiodarone Hcl under para 4.7 of HBP. vide their U.O.35011/127/2006PIIII dated 14.08.2006 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: Amiodarone Hcl1Kg. Import item: 1. 2Butyl3(3,5Diiodo4Hydroxybenzoyl)1.04Kg/Kg. 2. Iso Propyl Alcohol0.75Kg/Kg. 3. Toluene1.95Kg/Kg. per above decision of the Norms Committee.

Case No.A167

M/S DSM AntiInfectives India Ltd Meeting No.09/08 File No.01/82/50/55/AM’08/DESIII Date: 03.07.2007 RLA F.No.22/21/41/85/AM’05 Advance licence No.2210006462 Dated 02.02.2007 The Committee considered the case as per agenda for ratification of Norms for the export product Cloxacillin Sodium (6APA Route) under para 4.7 of HBP. The Committee in light of the report of the Deptt. of C&PC forwarded vide their U.O.No.35011/165/2006/PI III(PartIV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower. Export product Cloxacillin Sodlum from 6 APA Stage1kg Import items 6. 6APA0.490kg 7. Acetone0.0034kg 8. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CKIC Chloride)0.62kg OR 3.a) Ochloro Benzaldehyde0.5034kg 3.b) Hydroxyl Amine Sulphate0.3192kg 3.c) Methyl Acetoacetate0.410kg 3.d) Chloroform0.270kg 3.e) Methylene chloride0.0542kg 9. Methylene chloride/Ethyl Acetate0.620kg 10. 2Ethyl Hexanoic Acid0.150kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A168

M/S Ranbaxy Laboratories Ltd Meeting No.09/08 File No.01/82/50/167/AM’08/DESIII Date: 03.07.2007 RLA F.No.05/24/40/49/AM’08 Advance licence No.0510202775 Dated 20.04.2007 The Committee considered the case as per agenda for ratification of Norms for the export product Pravastatin Sodium under para 4.7 of HBP. vide their U.O.35011/171/2006PIIII dated 16.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is less. Export Product: Pravastatin Sodium1Kg. Import items: 1. Compactin1.47Kg/Kg. 2. Anti Form SAG710.05Kg/Kg. 3. Acetonitrile7.17Kg/Kg. 4. Acetone3.92Kg/Kg 5. Activated Carbon0.100Kg/Kg. 6. Methanol1.05Kg/Kg. per above decision of the Norms Committee.

Case No.A169

M/S Unimark Remedies Ltd. Meeting No.09/08 File No.01/82/50/1207/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/934/AM’07 Advance licence No.0310416945

Dated 23.01.2007 export product Ethyl1,4 Dihydro7Methyl4one1,8Napthyridine3Carboxylate under

para 4.7 of HBP.

Case No.A170

M/S Unimark Remedies Ltd. Meeting No.09/08 File No.01/82/50/1206/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/502/AM’07 Advance licence No.0310416918 Dated 23.01.2007 export product Cefprozil under para 4.7 of HBP.

Case No.A171

M/S Riddhi Pharma Meeting No.09/08 File No.01/82/50/1360/AM’07/DESIII Date: 03.07.2007 RLA F.No.34/24/40/282/AM’07 Advance licence No.3410018343 Dated 20.03.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A172

M/S Salicylates & Chemicals P. Ltd. Meeting No.09/08 File No.01/82/50/82/AM’08/DESIII Date: 03.07.2007 RLA F.No.09/24/40/547/AM’07 Advance licence No.0910029932 Dated 10.04.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A173

M/S Unichem Laboratories Ltd. Meeting No.09/08 File No.01/82/50/453/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/143/AM’08 Advance licence No.0310431069 Dated 30.05.2007 export product Amlodipine Maleate under para 4.7 of HBP.

Case No.A174

M/S DSM AntiInfectives India Ltd. Meeting No.09/08 File No.01/82/50/65/AM’08/DESIII

Date: 03.07.2007 RLA F.No.22/24/40/304/AM’07 Advance licence No.2210006541 Dated 27.02.2007 export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product under

para 4.7 of HBP as per revised SION at Sl.No.A69 published vide Public Notice

No.2 dated 19.04.2007 or as applied for whichever is lower. per above decision of Norms Committee.

Case No.A175

M/S Ranbaxy Laboratories Ltd. Meeting No.09/08 File No.01/82/50/1279/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/975/AM’07 Advance licence No.0510200110 Dated 27.02.2007 export product Ramipril under para 4.7 of HBP.

Case No.A176

M/S Ranbaxy Laboratories Ltd. Meeting No.09/08 File No.01/82/50/1280/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/964/AM’07

Advance licence No.0510200111 Dated 27.02.2007 export product Lisinopril Tablets 5Mg. under para 4.7 of HBP.

Case No.A177

M/S Satya Deeptha Pharmaceuticals Ltd. Meeting No.09/08 File No.01/82/50/1234/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/430/AM’07 Advance licence No.0910029303 Dated 12.02.2007 export product 1,1Cyclohexane Diacetic Acid Anhydride under para 4.7 of HBP.

Case No.A178

M/S Satyam Pharma Chem Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1345/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1440/AM’07 Advance licence No.0310423208 Dated 15.03.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A179

M/S Sridhanada Laboratories Meeting No.09/08 File No.01/82/50/1108/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/398/AM’07 Advance licence No.0910028887 Dated 05.01.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A180

M/S V.V.S. Pharmaceuticals & Chemicals (P) Ltd. Meeting No.09/08 File No.01/82/50/1322/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/471/AM’07 Advance licence No.0910029577 Dated 08.03.2007 export product Sodium Pas Granual 80% (W/W) under para 4.7 of HBP. vide their U.O. No.35011/197/2006PIIII dated 18.10.2006 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for whichever is lower. Export Product: Sodium Pas Granuals 80% (W/W)1Kg. Import items: 1. Sodium Para Amino Salicylate Powder0.808Kg/Kg. 2. Hydroxy Propyl Methyl Cellulose3.00Kg/Kg.

3. Isopropyl alcohol0.050Kg/Kg. 4. Eudragit L 1000.050Kg/Kg. per above decision of Norms Committee.

Case No.A181

M/S Rallis India Ltd Meeting No.09/08 File No.01/82/50/333/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/109/AM’08 Advance licence No.0310429515 Dated 15.05.2007 The Committee decided to transfer the case to DESVIII as the export product pertains to Plastic Sector.

Case No.A182

M/S Suven Life Sciences Ltd. Meeting No.09/08 File No.01/82/50/84/AM’08/DESIII Date: 03.07.2007 RLA F.No.09/24/40/541/AM’07 Advance licence No.0910029935 Dated 10.04.2007 export product 5Cyano Phthalide under para 4.7 of HBP.

Case No.A183

M/S Unichem Laboratories Ltd. Meeting No.09/08 File No.01/82/50/1388/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1488/AM’07 Advance licence No.0310424905 Dated 29.03.2007 export product Amlodipine Maleate under para 4.7 of HBP.

Case No.A184

M/S Shiva Pharmachem Pvt. Ltd Meeting No.09/08 File No.01/82/50/1344/AM’07/DESIII Date: 03.07.2007 RLA F.No.34/24/40/285/AM’07 Advance licence No.3410018324 Dated 15.03.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A185

M/S DSM AntiInfectives India Ltd. Meeting No.09/08 File No.01/82/50/254/AM’08/DESIII Date: 03.07.2007 RLA F.No.22/24/40/8/AM’08 Advance licence No.2210006706

Dated 03.05.2007 export product Amoxycillin Trihaydrate Pen G Route under para 4.7 of HBP. The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A58 published vide Public Notice No.58 dated 26.09.2006 or as applied for whichever is lower. per above decision of Norms Committee.

Case No.A186

M/S Dalas Biotech Ltd Meeting No.09/08 File No.01/82/50/223/AM’08/DESIII Date: 03.07.2007 RLA F.No.05/24/40/1078/AM’07 Advance licence No.0510203062 Dated 27.04.2007 export product 7Amino3Vinyl3Cephem4Carboxylic Acid Diphenyl Ester HCL (7AVCA) under para 4.7 of HBP.

Case No.A187

M/S Rantus Pharma Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1235/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/401/AM’07 Advance licence No.0910029304 Dated 12.02.2007

export product Tramadol Crude under para 4.7 of HBP. The Committee decided to call for the complete specification of the export product showing percentage purity and impurity profiles of the export product form the firm. Accordingly, it was decided to defer the case for six weeks.

Case No.A188

M/S Surya Pharmaceutical Ltd Meeting No.09/08 File No.01/82/50/69/AM’08/DESIII Date: 03.07.2007 RLA F.No.22/24/40/312/AM’07 Advance licence No.2210006594 Dated 19.03.2007 export product Cefixime USP under para 4.7 of HBP. The Committee noted that the firm has not given the technical details as well as the copy of Drug Manufacturing licence alongwith their application. The Committee, therefore decided to reject the case and to ask RLA as to how they have issued the licence without the technical details and copy of DML.

Case No.A189

M/S DSM AntiInfectives India Ltd. Meeting No.09/08 File No.01/82/50/56/AM’08/DESIII Date: 03.07.2007 RLA F.No.22/21/42/6/AM’05 Advance licence No.2210006467 Dated 02.02.2007 export product Amoxycillin Trihaydrate 6APA Route under para 4.7 of HBP.

The Committee decided to ratify the norms under para 4.7 of HBP as per revised SION at Sl.No.A57 published vide Public Notice No.58 dated 26.09.2006 or as applied for whichever is lower. per above decision of Norms Committee.

Case No.A190

M/S R.L. Fine Chem Meeting No.09/08 File No.01/82/50/176/AM’08/DESIII Date: 03.07.2007 RLA F.No.07/24/40/18/AM’08 Advance licence No.0710051369 Dated 23.04.2007 export product Oxo6,11Dihydro Dibenzo (BE) Thiepine under para 4.7 of HBP.

Case No.A191

M/S R.L. Fine Chem Meeting No.09/08 File No.01/82/50/319/AM’08/DESIII Date: 03.07.2007 RLA F.No.07/24/40/109/AM’08 Advance licence No.0710051658 Dated 15.05.2007 export product Lorazepam BP under para 4.7 of HBP.

Case No.A192

M/S Shree Ganesh Remedies Pvt. Ltd. Meeting No.09/08 File No.01/82/50/243/AM’08/DESIII Date: 03.07.2007 RLA F.No.34/24/40/166/AM’07 Advance licence No.3410018711 Dated 03.05.2007 export product Di Methyl Amino Isopropyl Chloride Hydrochloride 65% Solution in Water DMIPC65% under para 4.7 of HBP. The Committee noted that the export product appears to be a Scomet item. The Committee, therefore, decided to advise the firm to obtain Export Licence in the first instance.

Case No.A193

M/S DCM Shriram Industries Ltd Meeting No.09/08 File No.01/82/50/524/AM’08/DESIII Date: 03.07.2007 RLA F.No.05/24/40/166/AM’08 Advance licence No.0510204918 Dated 14.06.2007 export product D()Para Hydroxy Phenyl Glycine Dane Salt under para 4.7 of HBP.

Case No.A194

M/S Dr. Willmar Schwabe India Pvt. Ltd. Meeting No.09/08 File No.01/82/50/379/AM’08/DESIII Date: 03.07.2007 RLA F.No.05/24/40/444/AM’07 Advance licence No.0510203950 Dated 22.05.2007 export product White Sugar Unarzneiliche Globuli (Non Medicated) under para 4.7 of HBP and decided to transfer the case to DESVI since the export product is Food item.

Case No.A195

M/S Shiva Pharmachem Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1330/AM’07/DESIII Date: 03.07.2007 RLA F.No.34/24/40/281/AM’07 Advance licence No.3410018286 Dated 12.03.2007 export product Neodecanoyl Chloride under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A196

M/S Shiva Pharmachem Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1341/AM’07/DESIII Date: 03.07.2007 RLA F.No.34/24/40/284/AM’07 Advance licence No.3410018316 Dated 12.03.2007

export product Isononanoyl Chloride under para 4.7 of HBP. The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A197

M/S R.A. Chem Pharma Ltd Meeting No.09/08 File No.01/82/50/1335/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/463/AM’07 Advance licence No.0910029658 Dated 14.03.2007 export product 2,3,Dichloro Benzoyl Cyanide under para 4.7 of HBP.

Case No.A198

M/S Shilpa Medicare Ltd. Meeting No.09/08 File No.01/83/50/1382/AM’07/DESIII Date: 03.07.2007 RLA F.No.07/24/40/879/AM’07 Advance licence No.0710050972 Dated 29.03.2007 export product N[BRibofuranosyl]5Hydroxyimidazole4Carboxamide Technical Grade under para 4.7 of HBP.

Case No.A199

M/S DSM AntiInfectives India Ltd. Meeting No.09/08 File No.01/82/50/63/AM’08/DESIII Date: 03.07.2007 RLA F.No.22/24/40/296/AM’07 Advance licence No.2210006483 Dated 13.02.2007 export product 6APA (Pen G Route) under para 4.7 of HBP. The Committee decided to ratify the norms of the export product under

para 4.7 of HBP as per revised SION at Sl.No.A33 published vide Public Notice

No.58 dated 26.09.2006 or as applied by the firm whichever is lower. per above decision of Norms Committee.

Case No.A200

M/S DSM AntiInfectives India Ltd. Meeting No.09/08 File No.01/82/50/60/AM’08/DESIII Date: 03.07.2007 RLA F.No.22/21/40/61/AM’06 Advance licence No.2210006479 Dated 08.02.2007 export product Cloxacillin Sodium (6APA Route) under para 4.7 of HBP. The Committee in light of the report of the Deptt. of C&PC forwarded vide their U.O.No.35011/165/2006/PIIII(PartIV) dated 9.3.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower.

Export product Cloxacillin Sodlum from 6 APA Stage1kg Import items 6. 6APA0.490kg 7. Acetone0.0034kg 8. 3(2Chlorophenyl)5Methyl Isoxazole Carbonyl Chloride (CKIC Chloride)0.62kg OR 3.a) Ochloro Benzaldehyde0.5034kg 3.b) Hydroxyl Amine Sulphate0.3192kg 3.c) Methyl Acetoacetate0.410kg 3.d) Chloroform0.270kg 3.e) Methylene chloride0.0542kg 9. Methylene chloride/Ethyl Acetate0.620kg 10. 2Ethyl Hexanoic Acid0.150kg RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A201

M/S Rashmi Pharma Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1327/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/506/AM’07 Advance licence No.0910029625 Dated 09.03.2007 export product Orlistat Pellets 50% (Tetrahydro Lipstatin Pellets 50%) under para 4.7 of HBP. The Committee decided to forward the complete set of application to PI Division. Accordingly, it was decided to defer the case for six weeks.

Case No.A202

M/S Shree Shivshankar Drugs & Pharmaceuticals P. Ltd. Meeting No.09/08 File No.01/82/50/1323/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1445/AM’07 Advance licence No.0310422458 Dated 08.03.2007 The Committee decided to transfer the case to DESIV as the export product pertains to Chemical Sector.

Case No.A203

M/S Srini Pharmaceuticals Ltd. Meeting No.09/08 File No.01/82/50/1306/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/501/AM’07 Advance licence No.0910029522 Dated 02.03.2007 export product Trans3(Methanesulfonyloxy Methyl)4Fluorophenyl)1Methyl Piperidine(Px2) under para 4.7 of HBP. vide their U.O. No.35011/8/2007PIIII dated 28.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: Trans3(Methanesulfonyloxy Methyl)4Fluorophenyl)1 Methyl Piperidine(Px2)1Kg. Import item: ()trans4(4fluoro phenyl) 3hydroxy methylNMethyl piperidine1.016Kg/Kg.

Case No.A204

M/S RA Chem Pharma Ltd. Meeting No.09/08 File No.01/82/50/1149/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/432/AM’07 Advance licence No.0910029095 Dated 19.01.2007 export product Mebeverine HCL under para 4.7 of HBP.

Case No.A205

M/S RA Chem Pharma Ltd. Meeting No.09/08 File No.01/82/50/1336/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/486/AM’07 Advance licence No.0910029659 Dated 14.03.2007 export product Fexofenadine HCL under para 4.7 of HBP. vide their U.O. No.35011/274/2006PIIII dated 17.05.2007 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: Fexofenadine Hcl1Kg. Import items Sl.No. Description of item Quantity allowed 1. Sodium boro hydride 0.332Kg/Kg. 2. 4chloro butryl chloride 1.216Kg/Kg.

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.

Case No.A206

M/S Shri Gayathri Drugs Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1204/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/447/AM’07 Advance licence No.0910029230 Dated 07.02.2007 export product 4(3,4Dichloro Phenyl)3,4dihydro1(2H)Naphthalenone (Tetralone) under para 4.7 of HBP. vide their U.O. No.35011/221/2006PIIII dated 03.07.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product: 4(3,4Dichloro Phenyl)3,4dihydro 1(2H)Naphthalenone (Tetralone))1Kg. Import item: Alpha Naphthol0.95Kg./Kg.

Case No.A207

M/S Vital Healthcare Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1350/AM’07/DESIII Date: 03.07.2007 RLA F.No.03/95/40/1544/AM’07 Advance licence No.0310423385 Dated 15.03.2007 export product Artemether under para 4.7 of HBP. vide their U.O. No.35011/227/2005PIIII dated 22.01.2007 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: Artemether1Kg. Import item: Artemisinin1.50Kg./Kg.

Case No.A208

M/S Om Shree Pharmachem Ltd Meeting No.09/08 File No.01/82/50/82/AM’08/DESIII Date: 03.07.2007 RLA F.No.03/95/40/230/AM’08 Advance licence No.0310432141 Dated 08.06.2007 export product Iso Sorbide 5Mononitrate under para 4.7 of HBP. The Committee noted that no technical details has been given by the firm alongwith the application. The Committee, therefore, decided to call for the technical details from the firm and defer the case for four weeks.

Case No.A209

M/S R.L. Fine Chem Meeting No.09/08 File No.01/83/50/365/AM’08/DESIII Date: 03.07.2007 RLA F.No.07/24/40/16/AM’08 Advance licence No.0710051274 Dated 17.04.2007 export product Nortriptyline Hcl/BP/USP under para 4.7 of HBP.

Case No.A210

M/S XL Laboratories Pvt. Ltd. Meeting No.09/08 File No.01/82/50/934/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/681/AM’07 Advance licence No.0510194718 Dated 20.11.2006 export product Floxwin200 Tablets under para 4.7 of HBP. The Committee on the basis of oral comments given by representative of PI Division 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: Floxwin200 Tablets1 tablet Import item: Ofloxacin USP204mg/tablet

Case No.A211

M/S XL Laboratories Pvt. Ltd. Meeting No.09/08 File No.01/82/50/933/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/679/AM’07 Advance licence No.0510194717 Dated 20.11.2006 export product Cipfast500 Tablets under para 4.7 of HBP.

Case No.A212

M/S XL Laboratories Pvt. Ltd. Meeting No.09/08 File No.01/82/50/1151/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/785/AM’07

Advance licence No.0510198209 Dated 22.01.2007 export product Evirose1000 capsules, 100 capsules and 400 capsules under para 4.7 of HBP.

Case No.A213

M/S Dabur Pharma Ltd. Meeting No.09/08 File No.01/82/162/831/AM’07/DESIII Date: 03.07.2007 RLA F.No.05/24/40/487/AM’07 The Committee considered the case as per agenda for fixation of Norms for the export product Buflomedil Hydrochloride under para 4.7 of HBP. vide their U.O. No.35011/75/2005PIIII dated 26.06.2007 decided to fix the norms under para 4.4.2 of HBP as per details below or as applied for whichever is lower. Export Product: Buflomedil Hcl1 Kg. Import item: 1. Pyrrolidine0.767Kg/Kg. 2. 4chlro butyryl chloride2.03Kg/Kg. 3. 1,3,5 trimethoxy benzene1.24Kg/Kg. 4. Methylene chloride1.62Kg/Kg. RLA concerned may take further necessary action under para 4.4.2 of HBP as per

Case No.B115

M/S Aurbindo Pharma Ltd Meeting No.09/08 File No.01/82/50/1226/AM’06/DESIII Date: 03.07.2007 RLA F.No.09/24/40/386/AM’06 Advance licence No.0910025184 Dated 16.01.2006 export product Cephalexin Monohydrate under para 4.7 of HBP. The Committee decided to examine this case on file.

Case No.B116

M/S Aurbindo Pharma Ltd Meeting No.09/08 File No.01/82/50/1062/AM’06/DESIII Date: 03.07.2007 RLA F.No.09/24/40/300/AM’06 Advance licence No.0910024806 Dated 02.12.2005 export product Cephalexin Monohydrate under para 4.7 of HBP. The Committee decided to examine this case on file.

Case No.B117

M/S Aarti Industries Ltd Meeting No.09/08 File No.01/82/162/1864/AM’04/DESIII Date: 03.07.2007 RLA F.No.03/24/40/1864/AM’04 Advance licence No.0310243197 Dated 22.12.2003 The Committee considered the case as per agenda for allowing corrections in the decision of Norms Committee Meeting No.39/07 dated 10.01.2007 vide case No.B1133 and decided to allow the following corrections after due verification. a) Hq. File No to be read as 01/82/162/968/AM’04/DESIII.

b) Name & Address of the company to be read as M/S Aarti Industries Ltd, Mumbai. c) Licence No. and date to be read as “0310243197 dated 22.12.03. d) RLA File No. to be read as 03/24/040/1864/AM04 RLA may be informed accordingly.

Case No.B118

M/S Biological E Ltd. Meeting No.09/08 File No.01/82/50/1752/AM’05/DESIII Date: 03.07.2007 RLA F.No.09/24/40/327/AM’05 Advance licence No.0910021608 Dated 24.01.2005 The Committee considered the case as per agenda for deletion of condition regarding obtaining the NOC from Central Bureau of Narcotics, Gwalior before import of Noscapine Base. The Committee noted that Central Bureau of Narcotics, Gwalior vide their letter No.2/3/Tech./20043863 dated 10.05.2007 has clarified that Noscapine and Papaverine through derived from opium but these are non narcotic durgs as per the definition under Section 2(xi) read with (xvi) of the Narcotic Drugs and Psychtropic Substances Act, 1985. They have further mentioned that at present no import certificate/export authorization or NOC is necessary for CBN, Gwalior for the said drugs under the NDPS Act or the Rules framed thereunder. The Committee in the light of the above comments of CBN, Gwalior decided to delete the condition regarding obtaining the NOC from CBN Gwalior. The other condition will remain the same. RLA concerned may take further necessary action as per above decision of Norms committee.

Case No.B119

M/S Centaur Chemicals Pvt. Ltd Meeting No.09/08 File No.01/82/50/875/AM’06/DESIII

Date: 03.07.2007 RLA F.No.03/94/40/855/AM’06 Advance licence No.0310354691 Dated 02.11.2005 export product Clonazepam USP27under para 4.7 of HBP. The Committee decided to defer the case and list after 4 weeks.

Case No.B120

M/S Ariane Orgachem Pvt. Ltd Meeting No.09/08 File No.01/87/50/448/AM’07/DESIII File No.01/87/50/662/AM’07/DESIII File No.01/87/50/873/AM’07/DESIII File No.01/87/50/1025/AM’05/DESIII Date: 03.07.2007 Advance licence No.0310300140 dated 10.08.2006 0310278686 dated 2.7.2004 0310394009 dated 13.4.2005 0310405378 dated 24.10.2006 0310414730 dated 5.1.2007 export product Lasamide Furfurylamine Iso Propyl Alcohol under para 4.7 of HBP. The Committee decided to defer the case for four weeks.

Case No.B121

M/S Shilpa Medicare Ltd Meeting No.09/08 File No.01/83/162/566/AM’07/DESIII Date: 03.07.2007 RLA F.No.07/24/40/285/AM03 Advance licence No.0710015550 Dated 13.08.2002 export product 3a 7b Dioxy Cholanic Acid under para 4.7 of HBP.

The Committee decided to examine the case on file.

Case No.B122

M/S Unichem Laboratories Ltd. Meeting No.09/08 File No.01/83/50/16/AM’05/DESIII Date: 03.07.2007 RLA F.No.03/24/40/2386/AM’06 Advance licence No.0310253587 Dated 17.02.2004 export product Bisoprolol Fumarte under para 4.7 of HBP. The Committee noted that the firm has requested for personal hearing to explain the case. Accordingly, it was decided to call the firm for personal hearing on 24.07.2007 to explain their case.

Case No.B123

M/S Dr. Reddy’s Laboratories Ltd Meeting No.09/08 File No.01/82/50/201/AM’06/DESIII Date: 03.07.2007 RLA F.No.09/24/40/65/AM’06 The Committee considered the case as per agenda for fixation of Norms for the export product Chlopromazine Tablets from Kg to Nos. under para 4.7 of HBP. The Committee decided to amend the quantity of the export product from 1Kg. to 1 lakh tablets in the decision of Norms Committee Meeting No.44/82 dated 8.2.2006 vide case No.44/14/82. The other terms and conditions shall remain unchanged. RLA concerned may take further necessary action under para 4.4.2 of HBP as per

Case No.B124

Dr. Reddy’s Laboratories Ltd. Meeting No.09/08 File No.01/82/162/156/AM’07/DESIII Date: 03.07.2007 RLA F.No.09/24/40/43/AM’07 Adv.Lic. No.0910026141 dated 01.05.2006 The Committee considered the case as per agenda for fixation of Norms for the export product Moxifloxacin under para 4.7 of HBP. vide their U.O. No.35011/16/2007PIIII dated 17.05.2007 decided to fix the norms under para 4.7 of HBP as per details below or as applied for whichever is lower. Export Product: Moxifloxacin1 Kg. Import item: 1 Ethyl (1Cyclopropyl6,7 difluoro 8methoxy 4Oxo1,4 dihydro3quinoline) carboxylate1.51Kg/Kg. 2. NMethyl Pyrilidone1.075Kg/Kg. 3. 1,8 Diazabicyclo (5.4.0) undec7ene0.100Kg/Kg. 4. Isopropyl alcohol1.24Kg/Kg. 5. Pyridine2,3dicarboxylic Acid4.86Kg/Kg. 6. 5% Palladium Carbon (50%wet)0.200Kg/Kg. 7. D()Tartaric Acid1.53Kg/Kg. 8. Vitride4.99Kg/Kg. 9. Methyl Isobutyl Ketone1.08Kg/Kg. 10. Methanol9.69Kg/Kg. 11. Dimethyl Formamide1.30Kg/Kg.

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.